Generated by All in One SEO Pro v4.9.10, this is an llms.txt file, used by LLMs to index the site. # Medicines for Europe Better access. Better health. ## Sitemaps - [XML Sitemap](https://www.medicinesforeurope.com/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [MEMO on a competitiveness strategy for the European healthcare sector](https://www.medicinesforeurope.com/2026/06/10/memo-on-a-competitiveness-strategy-for-the-european-healthcare-sector/) - [Review of the SPC Manufacturing Waiver: a 2026 Industry Report](https://www.medicinesforeurope.com/2026/06/09/review-of-the-spc-manufacturing-waiver-a-2026-industry-report/) - [Key BIOS facts and Figures – 2026](https://www.medicinesforeurope.com/2026/01/09/key-bios-facts-and-figures-2025/) - [Recommendations to National Authorities on the Use of External Reference Pricing (ERP)](https://www.medicinesforeurope.com/2026/05/27/recommendations-to-national-authorities-on-the-use-of-external-reference-pricing-erp/) - [Biosimilars in the EU: Approval Overview and Therapeutic Areas](https://www.medicinesforeurope.com/2026/04/12/biosimilars-in-the-eu-approval-overview-and-therapeutic-areas-2/) - [Policy recommendations on uptake of biosimilar medicines in the retail market](https://www.medicinesforeurope.com/2021/11/05/policy-recommendations-on-uptake-of-biosimilar-medicines-in-the-retail-market/) - Revision of EU rules on public procurement (Report - February 2026) Revision of EU rules on public procurement (Factsheet - February 2026) Policy recommendations on uptake of biosimilar medicines in the retail market (November 2021) Unlocking the potential of the biosimilar retail market (November 2021) Retail policy algorithm: Policy recommendations to unlock the potential of - [Assessing the Cost Burden of UWWTD Extended Producer Responsibility on Pharmaceuticals: Implications for the accessibility, availability and affordability of medicines](https://www.medicinesforeurope.com/2026/04/27/assessing-the-cost-burden-of-uwwtd-extended-producer-responsibility-on-pharmaceuticals-implications-for-the-accessibility-availability-and-affordability-of-medicines/) - [Factsheet series on the Biotech Act](https://www.medicinesforeurope.com/2026/04/24/factsheet-series-on-the-biotech-act/) - [Factsheet on the Public procurement Directive](https://www.medicinesforeurope.com/2026/04/16/factsheet-on-the-public-procurement-directive/) - [Biotech Act - Factsheet on European Biosimilar Medicines Sector: Delivering Impact Beyond Health - Economic, Scientific & Strategic Contribution](https://www.medicinesforeurope.com/2026/03/24/biotech-act-factsheet-on-developing-confidence-in-biotech-attractiveness-talent-and-skills/) - [Biotech Act - Factsheet on Developing Confidence in Biotech, Attractiveness, Talent and Skills](https://www.medicinesforeurope.com/2026/03/24/biotech-act-factsheet-on-developing-confidence-in-biotech-attractiveness-talent-and-skills-2/) - [Biotech Act - Factsheet on Optimising Intellectual Property (IP) Framework and Trade Partnerships](https://www.medicinesforeurope.com/2026/03/24/biotech-act-factsheet-on-optimising-intellectual-property-ip-framework-and-trade-partnerships/) - [Biotech Act - Factsheet on Reforming Regulations, Market Entry and Competition for Biosimilar medicines](https://www.medicinesforeurope.com/2026/03/24/biotech-act-factsheet-on-reforming-regulations-market-entry-and-competition-for-biosimilar-medicines/) - [Biotech Act - Factsheet on Investing in Biotech R&D and Manufacturing Platforms](https://www.medicinesforeurope.com/2026/03/24/biotech-act-factsheet-on-investing-in-biotech-rd-and-manufacturing-platforms/) - [Biotech Act - Factsheet on the Proposed 12-month Extension of the Supplementary Patent Protection (SPC)](https://www.medicinesforeurope.com/2026/03/24/biotech-act-factsheet-on-the-proposed-12-month-extension-of-the-supplementary-patent-protection-spc/) - [Position paper on the Issue of Abuses of Divisional Patent Applications](https://www.medicinesforeurope.com/2026/03/20/position-paper-on-the-issue-of-abuses-of-divisional-patent-applications/) - [Open letter on the Critical Medicines Act trilogues negotiations - The CMA must deliver on EU health security](https://www.medicinesforeurope.com/2026/03/10/open-letter-on-the-critical-medicines-act-trilogues-negotiations-the-cma-must-deliver-on-eu-health-security/) - [Product-level Life Cycle Assessments in the Off-Patent Sector](https://www.medicinesforeurope.com/2025/11/24/product-level-life-cycle-assessments-in-the-off-patent-sector/) - [Technical note on the Joint Research Centre report “Updated estimation of the costs of quaternary wastewater treatment in the EU”](https://www.medicinesforeurope.com/2026/02/13/technical-note-on-the-joint-research-centre-report-updated-estimation-of-the-costs-of-quaternary-wastewater-treatment-in-the-eu/) - [Open letter on the urgent need to pause the UWWTD serious risk of causing tsunami of medicine shortages](https://www.medicinesforeurope.com/2026/02/10/open-letter-on-the-urgent-need-to-pause-the-uwwtd-serious-risk-of-causing-tsunami-of-medicine-shortages/) - [Position paper on the Revision of EU Rules on Public Procurement](https://www.medicinesforeurope.com/2026/02/10/position-paper-on-the-revision-of-eu-rules-on-public-procurement/) - [Generic Medicines Market Review 2025 - Key findings](https://www.medicinesforeurope.com/2025/11/06/generic-medicines-market-review-2025-key-findings/) - [Biosimilar Medicines Market Review 2025 - Key findings](https://www.medicinesforeurope.com/2025/11/06/biosimilar-medicines-market-review-2025-key-findings/) - [Vacancies](https://www.medicinesforeurope.com/2024/11/28/vacancies/) - Medicines for Europe represents pharmaceutical companies supplying the largest share of prescription medicines across Europe and is the voice of the generic, biosimilar and value added medicines industries. - [New Angle's study on Securing access, improving lives. Strengthening patients' access to medicines in Europe](https://www.medicinesforeurope.com/2025/09/30/new-angles-study-on-securing-access-improving-lives-strengthening-patients-access-to-medicines-in-europe/) - [Mandatory Stockpiling in the EU](https://www.medicinesforeurope.com/2025/09/26/mandatory-stockpiling-in-the-eu/) - [Mandatory Stockpiling in the EU: Policy recommendations, solutions and alternatives](https://www.medicinesforeurope.com/2025/09/26/mandatory-stockpiling-in-the-eu-policy-recommendations-solutions-and-alternatives/) - [Mandatory security of supply criteria in procurement and pricing & reimbursement under the Critical Medicines Act](https://www.medicinesforeurope.com/2025/09/15/mandatory-security-of-supply-criteria-in-procurement-and-pricing-reimbursement-under-the-critical-medicines-act/) - [Factsheet on funding - Critical Medicines Act](https://www.medicinesforeurope.com/2025/09/15/factsheet-on-funding-critical-medicines-act/) - [Factsheet on stockpiling - Critical Medicines Act](https://www.medicinesforeurope.com/2025/09/15/factsheet-on-stockpiling-critical-medicines-act/) - [Factsheet on demand side measures - Critical Medicines Act](https://www.medicinesforeurope.com/2025/09/15/factsheet-on-demand-side-measures-critical-medicines-act/) - [Switzerland’s approach to quaternary treatment – a more balanced and effective alternative to the EU UWWTD EPR system](https://www.medicinesforeurope.com/2025/09/12/switzerlands-approach-to-quaternary-treatment-a-more-balanced-and-effective-alternative-to-the-eu-uwwtd-epr-system/) - [Use of existing IT data systems to monitor and provide transparency of the supply chain](https://www.medicinesforeurope.com/2025/09/09/use-of-existing-it-data-systems-to-monitor-and-provide-transparency-of-the-supply-chain/) - [Urban Waste Water Treatment Directive (UWWTD) Updated State of Play](https://www.medicinesforeurope.com/2025/07/25/urban-waste-water-treatment-directive-uwwtd-updated-state-of-play/) - [Position Paper on the Critical Medicines Act (CMA)](https://www.medicinesforeurope.com/2025/07/14/position-paper-on-the-critical-medicines-act-cma/) - [Position Paper on the Critical Medicines Act (CMA) - Short version](https://www.medicinesforeurope.com/2025/07/28/position-paper-on-the-critical-medicines-act-cma-short-version/) - [Mandatory stockpiling in the EU: Rethinking today's approach to protect tomorrow's Generic Medicine supply](https://www.medicinesforeurope.com/2025/07/09/mandatory-stockpiling-in-the-eu-rethinking-todays-approach-to-protect-tomorrows-generic-medicine-supply/) - [Medicines for Europe note on Bio Innovation list of substances found in urban wastewater](https://www.medicinesforeurope.com/2025/07/09/medicines-for-europe-note-on-bio-innovation-list-of-substances-found-in-urban-wastewater/) - [Biosimilars Market Review 2025](https://www.medicinesforeurope.com/2025/06/24/biosimilars-market-review-2025/) - [Review of the SPC Manufacturing Waiver: a 2025 Industry Report](https://www.medicinesforeurope.com/2025/06/23/review-of-the-spc-manufacturing-waiver-a-2025-industry-report/) - [Generics Market Review 2025](https://www.medicinesforeurope.com/2025/06/20/generics-market-review-2025/) - [Medicines for Europe Trade Recommendations - Strengthening Global Access to Medicines](https://www.medicinesforeurope.com/2025/06/16/medicines-for-europe-trade-recommendations-strengthening-global-access-to-medicines/) - [The Value of Biosimilar Medicines](https://www.medicinesforeurope.com/2025/04/04/the-value-of-biosimilar-medicines/) - [Short summary: Ramboll Report on Micropollutants in Urban Wastewater](https://www.medicinesforeurope.com/2025/06/03/short-summary-ramboll-report-on-micropollutants-in-urban-wastewater/) - [Medicines for Europe Critical Medicines Act Initial Assessment](https://www.medicinesforeurope.com/2025/05/28/medicines-for-europe-critical-medicines-act-initial-assessment/) - [The Urban Waste Water Treatment Directive (UWWTD) must be simplified via the EU omnibus or essential medicines will no longer be available for patients in Europe](https://www.medicinesforeurope.com/2025/04/28/the-urban-waste-water-treatment-directive-uwwtd-must-be-simplified-via-the-eu-omnibus-or-essential-medicines-will-no-longer-be-available-for-patients-in-europe/) - [Ramboll Report on Micropollutants in Urban Wastewater](https://www.medicinesforeurope.com/2025/05/08/ramboll-report-on-micropollutants-in-urban-wastewater/) - [New Attempt to Introduce Unlawful-Patent Linkage in Bolar](https://www.medicinesforeurope.com/2025/05/07/new-attempt-to-introduce-unlawful-patent-linkage-in-bolar/) - [Medicines for Europe response to the Strategy for European Life Sciences](https://www.medicinesforeurope.com/2025/04/30/medicines-for-europe-response-to-the-strategy-for-european-life-sciences/) - [Note on Proposals to Extend Pharmaceutical Intellectual Property Incentives in reaction to U.S. Tariffs](https://www.medicinesforeurope.com/2025/04/10/note-on-proposals-to-extend-pharmaceutical-intellectual-property-incentives-in-reaction-to-u-s-tariffs/) - [5-Point Pharmaceutical Action Plan to Sustain Investment in Europe, for Europe](https://www.medicinesforeurope.com/2025/04/10/5-point-pharmaceutical-action-plan-to-sustain-investment-in-europe-for-europe/) - [The Severe Impacts of Potential U.S. Tariffs on Pharmaceuticals](https://www.medicinesforeurope.com/2025/04/08/the-severe-impacts-of-potential-u-s-tariffs-on-pharmaceuticals/) - [European Parliament Hearing on the Overreliance on Imports of Active Pharmaceutical Ingredients (APIs)](https://www.medicinesforeurope.com/2025/03/05/european-parliament-hearing-on-the-overreliance-on-imports-of-active-pharmaceutical-ingredients-apis/) - [Streamlining Biosimilar Development: Key Aspects](https://www.medicinesforeurope.com/2024/11/28/streamlining-biosimilar-development-key-aspects/) - [(Short version) Critical Medicines Act: delivering a secure supply of critical medicines and active pharmaceutical ingredients in Europe](https://www.medicinesforeurope.com/2025/01/27/short-version-critical-medicines-act-delivering-a-secure-supply-of-critical-medicines-and-active-pharmaceutical-ingredients-in-europe/) - [Proposals to Accelerate the EU Integration of the Ukrainian Pharmaceutical Industry](https://www.medicinesforeurope.com/2025/02/04/proposals-to-accelerate-the-eu-integration-of-the-ukrainian-pharmaceutical-industry/) - [Position Paper on the Overreliance on imports of Active Pharmaceutical Ingredients (APIs)](https://www.medicinesforeurope.com/2024/09/27/position-paper-on-the-overreliance-on-imports-of-active-pharmaceutical-ingredients-apis/) - [Position Papers on Electronic Product Information (ePI)](https://www.medicinesforeurope.com/2025/01/08/position-papers-on-electronic-product-information-epi/) - [Infographic: Key Figures on Generic Medicines](https://www.medicinesforeurope.com/2016/02/22/infographic-key-figures-on-generic-medicines/) - [Market Access Barriers: An overview of key barriers to generic and biosimilar market entry in select EU trading partners](https://www.medicinesforeurope.com/2024/10/31/market-access-barriers-an-overview-of-key-barriers-to-generic-and-biosimilar-market-entry-in-select-eu-trading-partners/) - [Critical Medicines Act: delivering a secure supply of critical medicines and active pharmaceutical ingredients in Europe](https://www.medicinesforeurope.com/2024/09/25/critical-medicines-act-delivering-a-secure-supply-of-critical-medicines-and-active-pharmaceutical-ingredients-in-europe/) - [European Critical Medicines Act](https://www.medicinesforeurope.com/2024/09/26/https-www-medicinesforeurope-com-wp-content-uploads-2024-04-european-critical-medicines-act-pdf/) - Open - [A new transatlantic partnership for the secure supply of medicines](https://www.medicinesforeurope.com/2024/07/15/a-new-transatlantic-partnership-for-the-secure-supply-of-medicines/) - The European Union and the United States are each other’s main trading partners for medicinal and pharmaceutical products, which are the EU’s most significant exports to the US and the second most significant US exports to the EU. READ MORE - [Review of the SPC Manufacturing Waiver: a 2024 Industry Report](https://www.medicinesforeurope.com/2024/06/10/review-of-the-spc-manufacturing-waiver-a-2024-industry-report/) - The Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation is applicable since 2 July 2022. The SPC Waiver has been introduced with the objective to remove the competitive disadvantage that European manufacturers of generic and biosimilar medicines are facing vis-à-vis third countries’ manufacturers, which can start manufacturing generics and biosimilars earlier due to shorter IP protection - [Infographic: Key Figures on Biosimilar Medicines](https://www.medicinesforeurope.com/2016/02/22/test-article-t/) - To view the full infographic, please click here. - [Key BIOS facts and Figures - 2022](https://www.medicinesforeurope.com/2022/05/07/key-bios-facts-and-figures-2022/) - Open - [Key BIOS facts and Figures - 2024](https://www.medicinesforeurope.com/2024/05/07/key-bios-facts-and-figures-2024/) - Open - [Beneath the Surface: Unravelling the True Value of Generic Medicines - IQVIA](https://www.medicinesforeurope.com/2024/04/10/beneath-the-surface-unravelling-the-true-value-of-generic-medicines/) - Today, generic medicines are an integral part of the healthcare system and demand for these products continues to rise. However, while increased usage of generic medicines has led to unprecedented savings for healthcare systems, perspectives often remain focused solely on their cost-saving potential. This can underplay the societal value of generic medicines in Europe and - [Medicines shortages and national stockpiling requirements in the EU - Position Paper](https://www.medicinesforeurope.com/2024/04/15/medicines-shortages-and-national-stockpiling-requirements-in-the-eu-position-paper/) - Today, generic medicines are an integral part of the healthcare system and demand for these products continues to rise. However, while increased usage of generic medicines has led to unprecedented savings for healthcare systems, perspectives often remain focused solely on their cost-saving potential. This can underplay the societal value of generic medicines in Europe and - [Impact of extending the duration of regulatory data protection in the new EU pharmaceutical legislation](https://www.medicinesforeurope.com/2024/02/14/impact-of-extending-the-duration-of-regulatory-data-protection-in-the-new-eu-pharmaceutical-legislation/) - In the context of the new EU pharmaceutical legislation, this document provides an economic analysis of the extension of regulatory data protection periods proposed in the European Parliament, which have strong political support. These extension proposals derive from a misunderstanding about their concrete impact on the cost and access to medicines (see explanation below) due - [It's time to protect our medicines!](https://www.medicinesforeurope.com/2023/02/27/its-time-to-protect-our-medicines/) - Open - [Medicines Procurement Reform: Strenghtening Supply Security through EU Guidance](https://www.medicinesforeurope.com/2024/02/13/make-medicines-available-via-a-robust-and-digital-supply-chain/) - This paper explores how the design of off-patent multisource, generic medicines procurement can be restructured to ensure greater security of supply of medicines while supporting broader policy objectives for more economically, environmentally, and socially sustainable development. Open - [Bolar - Time for an EU action on equal access: No more delays for patients](https://www.medicinesforeurope.com/2024/01/15/bolar-time-for-an-eu-action-on-equal-access-no-more-delays-for-patients/) - Myths to be dispelled on article 85 of the Pharma Directive, so called “Bolar” Open - [Position Paper - Revision of the Pharmaceutical legislation](https://www.medicinesforeurope.com/2024/01/08/position-paper-revision-of-the-pharmaceutical-legislation/) - Medicines for Europe is committed to improving public health through improved access, availability and affordability of medicines, in line with the pharmaceutical strategy for Europe. Open - [Note for the rapporteurs/shadow rapporteurs of the EU Pharmaceutical legislation: Impact of extending the duration of regulatory data protection in the new EU pharmaceutical legislation](https://www.medicinesforeurope.com/2023/12/07/note-for-the-rapporteurs-shadow-rapporteurs-of-the-eu-pharmaceutical-legislation-impact-of-extending-the-duration-of-regulatory-data-protection-in-the-new-eu-pharmaceutical-legislation/) - In the context of the new EU pharmaceutical legislation, this document provides an economic analysis of the extension of regulatory data protection periods proposed in the European Parliament, which have strong political support. These extension proposals derive from a misunderstanding about their concrete impact on the cost and access to medicines (see explanation below) due - [Medicines for Europe Code of Conduct](https://www.medicinesforeurope.com/2020/01/01/medicines-for-europe-code-of-conducy/) - OPEN - [A Fair and Balanced System for Unitary Supplementary Protection Certificates (SPCs) and Centralised Procedure for Granting National SPCs in the European Union](https://www.medicinesforeurope.com/2023/11/13/a-fair-and-balanced-system-for-unitary-supplementary-protection-certificates-spcs-and-centralised-procedure-for-granting-national-spcs-in-the-european-union/) - Open - [Position Paper - Unitary SPC & Unified Mechanism for the Granting of SPCs](https://www.medicinesforeurope.com/2022/11/13/position-paper-unitary-spc-unified-mechanism-for-the-granting-of-spcs/) - Open - [Time for an EU action on equal access: No more delays for patients!](https://www.medicinesforeurope.com/2023/11/10/time-for-an-eu-action-on-equal-access-no-more-delays-for-patients/) - Open - [Why Clarification & Harmonisation of the Bolar Exemption and an Explicit Prohibition of Patent Linkage Is Needed in the European Union](https://www.medicinesforeurope.com/2023/10/31/why-clarification-harmonisation-of-the-bolar-exemption-and-an-explicit-prohibition-of-patent-linkage-is-needed-in-the-european-union/) - The revised Pharmaceutical Legislation must deliver more access to medicines, fair competition and prevent artificial extensions of monopolies beyond what the EU system foresees. In order to effectively allow timely access to generic and biosimilar medicines for patients and achieve the stated objectives of the ‘Bolar exemption’ (ie. early generic/biosimilar development and approvals for immediate - [IQVIA - Assessing the Biosimilar Void](https://www.medicinesforeurope.com/2023/10/30/iqvia-assessing-the-biosimilar-void/) - While biosimilar competition in Europe has played a vital role in achieving significant healthcare savings and expanding patient access to key medicines, the changing nature of future loss of exclusivity (LoE) events means that competition, and by extension savings, is not always guaranteed. This report provides a timely view of the factors underlying the changing - [Review of Nitrosamine Drug Substance Related Impurities (NDSRI) in Pharmaceutical Drugs](https://www.medicinesforeurope.com/2023/10/30/1-why-clarification-harmonisation-of-the-bolar-exemption-and-an-explicit-prohibition-of-patent-linkage-is-needed-in-the-european-union/) - Nitrosamines are organic compounds with a chemical structure R2N-N=O (Figure 1), where R is usually an alkyl group. These substances are commonly found in food and the environment. Low levels of nitrosamines have been found in a wide array of pharmaceuticals. The acceptable intake (AI) values for many nitrosamines have been published by the regulatory - [Biosimilars Market Review 2023](https://www.medicinesforeurope.com/2023/09/18/biosimilars-market-review-2023/) - The purpose of this Market Review is to provide a general overview of the policies that are currently in place for biosimilar medicines in the different European countries allowing the reader to get a clear understanding. The 2023 Market Review covers the following policy areas: Availability of biosimilar medicines, Pricing & Reimbursement systems, Procurement of - [Market review Biosimilar medicines policy 2023 - Policy Statement](https://www.medicinesforeurope.com/2023/09/27/market-review-biosimilar-medicines-policy-2023-policy-statement/) - The Biosimilar Market Access Committee (Biosimilar medicines Group, a Medicines for Europe sector group) undertook a 2023 Biosimilar market review consisting of updates on biosimilar medicines policy across Europe (28 European countries). The highlights of this overview have been consolidated below and illustrate both key challenges and recommendations on how to improve specific policy interventions - [European strategic stockpile](https://www.medicinesforeurope.com/2023/10/11/https-www-medicinesforeurope-com-wp-content-uploads-2023-10-factsheet-annual-revenue-guarantee-pdf/) - To combat the crisis of antibiotic resistance, solutions must incentivise innovation and ensure access to such treatments. An annual revenue guarantee scheme appears as an effective tool that can encourage antibiotic developers to invest in research and development by providing guaranteed revenue. Open - [Market review Generic medicines policy 2023 - Policy Statement](https://www.medicinesforeurope.com/2023/06/29/policy-market-review-2023/) - The Generic Market Access Committee (Generic medicines Group, a Medicines for Europe sector group) undertook a 2023 Generic medicines market review consisting of updates on generic medicines policy across Europe (28 European countries). The highlights of this overview have been consolidated below and illustrate both key challenges and recommendations on how to improve specific policy - [Generic Market Review 2023](https://www.medicinesforeurope.com/2023/06/29/generic-market-review-2023/) - The Generic Medicines Group Market Access Committee is pleased to present the 2023 Market Review – European Generic Medicine Markets – Policy overview. The purpose of this Market Review is to provide a general overview of the policies that are currently in place for Generic Medicines in the different European countries allowing the reader to - [Position on the Proposal for a Regulation of the European Parliament and of the Council on Packaging and Packaging Waste](https://www.medicinesforeurope.com/2023/06/19/position-on-the-proposal-for-a-regulation-of-the-european-parliament-and-of-the-council-on-packaging-and-packaging-waste/) - Medicines for Europe welcomes the introduction of harmonised labelling, notably regarding recycling symbols which are sometimes already present in national legislations or the blue box – for example, in Bulgaria, France, and Austria. The proposal, however, also introduces a requirement to provide information on the material composition, as well as information regarding the manufacturer and - [Review of the SPC Manufacturing Waiver: a First Industry Report](https://www.medicinesforeurope.com/2023/06/13/review-of-the-spc-manufacturing-waiver-a-first-industry-report/) - The Supplementary Protection Certificate (SPC) is a sui generis protection that extends the market protection of patented medicines by up to five and half years (including a paediatric extension) to compensate the time lost in obtaining regulatory approval of medicines. As such, the European Union protection is the longest in the world. Open - [Infographic - Medicines Manufacturing](https://www.medicinesforeurope.com/2022/11/30/infographic-medicines-manufacturing/) - Open - [Towards a European Medicines Security Act](https://www.medicinesforeurope.com/2023/05/03/towards-a-european-medicines-security-act/) - Open - [Infographic - Medicines Shortages: root causes and policies recommendations](https://www.medicinesforeurope.com/2023/04/05/infographic-medicines-shortages-root-causes-and-policies-recommendations/) - Open - [A dedicated evaluation framework for value added medicines](https://www.medicinesforeurope.com/2023/04/12/fwork/) - Open - [Factsheet - Medicines Shortages: root causes and policies recommendations](https://www.medicinesforeurope.com/2023/03/22/factsheet-medicines-shortages-root-causes-and-policies-recommendations/) - Open - [Note on Transferable Vouchers - April 2022](https://www.medicinesforeurope.com/2022/04/22/note-on-transferable-vouchers-november-2022/) - Open - [](https://www.medicinesforeurope.com/2023/02/22/12286/) - [Podcast - Conversations on EU Pharma](https://www.medicinesforeurope.com/2022/04/10/podcast-conversations-on-eu-pharma/) - Medicines for Europe's podcast exploring the off-patent medicines world Episode 3: The Nurses’ voice on Biosimilar Medicines. An opportunity for integrated care Conversations on EU Pharma is back with a third episode we will explore the role played by specialised nurses in delivering positive patient outcomes with biologic therapies and the development of integrated care - [Eco-Pharmaco-Stewardship (EPS) initiative - Care for People and Our Environment](https://www.medicinesforeurope.com/2021/09/30/eco-pharmaco-stewardship-eps-initiative-care-for-people-and-our-environment/) - Multiple initiatives under the Eco-Pharmaco-Stewardship have contributed over the last couple of years to improving scientific understanding, finding new ways to detect the trace amounts of Pharmaceuticals in the environment (PiE) - [Final recommendations from "Ensuring equitable and sustainable access to medicines through a secure and resilient supply"](https://www.medicinesforeurope.com/2022/11/17/11819/) - Medicines for Europe, the European off-patent medicines association, and CAFF, the Czech generic and biosimilar medicines association, have organised under the auspices of the Czech Presidency of the Council of the European Union a seminar on 10 November 2022 entitled “Ensuring equitable and sustainable access to medicines through a secure and resilient supply”. The event - [A Strong European API Industry Can Achieve Strategic Autonomy of the EU Health System](https://www.medicinesforeurope.com/2022/11/09/a-strong-european-api-industry-can-achieve-strategic-autonomy-of-the-eu-health-system/) - Open - [Generic Medicines](https://www.medicinesforeurope.com/2022/09/28/generic-medicines/) - [Value Added Medicine](https://www.medicinesforeurope.com/2022/10/13/value-added-medicine/) - [Biosimilar Medicines](https://www.medicinesforeurope.com/2022/10/13/biosimilar-medicines/) - [Lessons learned from Covid](https://www.medicinesforeurope.com/2022/10/27/lessons-learned-from-covid/) - [Do you think you know your medicines?](https://www.medicinesforeurope.com/2022/10/27/do-you-think-you-know-your-medicines/) - [New pricing models for generic medicines to ensure long-term healthy competitiveness in Europe](https://www.medicinesforeurope.com/2022/06/30/new-pricing-models-for-generic-medicines-to-ensure-long-term-healthy-competitiveness-in-europe/) - New pricing models for generic medicines to ensure long-term healthy competitiveness in Europe New pricing models for generic medicines to ensure long-term healthy competitiveness in Europe - Strategic recommendations One-Pager: New pricing models for generic medicines - [One- Pager: New pricing models for generic medicines](https://www.medicinesforeurope.com/2022/10/10/one-pager-new-pricing-models-for-generic-medicines/) - How can we ensure a sustainable healthcare system while safeguarding continuous patient access to medicines? Open - [From disruption to care for cancer patients](https://www.medicinesforeurope.com/2022/09/05/from-disruption-to-care-for-cancer-patients/) - Biosimilar medicines are biologic medicines that can be used safely and effectively in oncology and other therapy areas. Some of these medicines are so important that they are included in the WHO essential medicines list. Open - [Translating experience into regulation](https://www.medicinesforeurope.com/2022/08/01/11379/) - More than 15 years of experience with biosimilar medicines show us that these medicines can be used to expand access to treatment, as they are just as safe and effective as their originator counterparts and can therefore be considered interchangeable with them. Open - [EU barometer for resilient access to biologics](https://www.medicinesforeurope.com/2022/07/06/eu-barometer-for-resilient-access-to-biologics/) - Open - [Integrated approaches - Investing in efficient IBD treatment, enabling innovation in patient care delivery](https://www.medicinesforeurope.com/2022/06/22/11286/) - Investing in efficient IBD treatment, enabling innovation in patient care delivery #HealthierTogether - [Neurological diseases - Repurposing as an effective strategy to address unmet medical need](https://www.medicinesforeurope.com/2022/06/22/neurological-diseases-repurposing-as-an-effective-strategy-to-address-unmet-medical-need/) - Repurposing as an effective strategy to address unmet medical need #HealthierTogether - [Diabetes - Off-patent medicines can start a virtuous circle of high-quality treatments and better prevention](https://www.medicinesforeurope.com/2022/06/22/diabetes-off-patent-medicines-can-start-a-virtuous-circle-of-high-quality-treatments-and-better-prevention/) - Off-patent medicines can start a virtuous circle of high-quality treatments and better prevention #HealthierTogether - [Delivering best access to care for people with chronic diseases](https://www.medicinesforeurope.com/2022/06/22/delivering-best-access-to-care-for-people-with-chronic-diseases/) - Delivering best access to care for people with chronic diseases #HealthierTogether - [Respiratory diseases - Value Added Medicines help improve therapy adherence to deliver better health outcomes for patients](https://www.medicinesforeurope.com/2022/06/22/respiratory-diseases-value-added-medicines-help-improve-therapy-adherence-to-deliver-better-health-outcomes-for-patients/) - Value Added Medicines help improve therapy adherence to deliver better health outcomes for patients #HealthierTogether - [Cardiovascular diseases - More patients are being treated while the sustainability of the healthcare system remains ensured](https://www.medicinesforeurope.com/2022/06/22/cardiovascular-diseases-more-patients-are-being-treated-while-the-sustainability-of-the-healthcare-system-remains-ensured/) - More patients are being treated while the sustainability of the healthcare system remains ensured #HealthierTogether - [Covid policy paper 2022 - Lessons learned](https://www.medicinesforeurope.com/2022/05/17/covid-policy-paper-2022-lessons-learned/) - [Digital VAM - challenges](https://www.medicinesforeurope.com/2021/02/28/digital-vam-challenges-1/) - Open - [Digital VAM - Benefit to Patients](https://www.medicinesforeurope.com/2021/02/28/digital-vam-benefit-to-patients/) - Open - [Adherence to therapy infographic](https://www.medicinesforeurope.com/2021/02/28/adherence-to-therapy-infographic/) - Open - [Creating a European ecosystem](https://www.medicinesforeurope.com/2022/02/27/creating-a-european-ecosystem/) - Open - [VAM Advantages](https://www.medicinesforeurope.com/2021/04/01/vam-advantages/) - Open - [VAM Hurdles](https://www.medicinesforeurope.com/2021/04/30/vam-hurdles/) - Open - [Scientific advice for continuous innovation in known molecules](https://www.medicinesforeurope.com/2022/05/05/scientific-advice-for-continuous-innovation-in-known-molecules/) - Continuous innovation, i.e. the development of so-called Value Added Medicines, consists in improving and optimising existing off-patent medicines to address unmet medical need and provide patients, healthcare professionals and payers with additional therapeutic options that may be better suited to their needs. - [Medicines for Europe letter to EC on Divisionals & Patent Linkage re Fingolimod - 13.04.2022](https://www.medicinesforeurope.com/2022/05/03/medicines-for-europe-letter-to-ec-on-divisionals-patent-linkage-re-fingolimod-13-04-2022/) - In regard to the previously discussed issues concerning abuses and misuses of divisional patent procedures as well as patent linkage in several Member States, as urged by several of our members we wish to bring to your attention a number of matters relating to potentially anticompetitive conduct in the European Union... - [Biosimilar Medicines Reading List](https://www.medicinesforeurope.com/2022/04/18/biosimilar-reading-list/) - General information about biosimilar medicines - [Removing access barriers in Central and Eastern Europe - April 2022](https://www.medicinesforeurope.com/2022/04/25/removing-access-barriers-in-central-and-eastern-europe-april-2022/) - Open - [Factsheet: The EU Bolar Exemption](https://www.medicinesforeurope.com/2022/04/22/factsheet-the-eu-bolar-exemption/) - [Advancing Medicines repurposing in the EU](https://www.medicinesforeurope.com/2022/03/14/advancing-medicines-repurposing-in-the-eu/) - Repurposing has emerged as an important strategy to address unmet medical need. Yet, there is still significant untapped potential for its application in the EU. Different approaches can be applied for the generation of data supporting the repurposing of existing medicines, depending on whether the research effort is led by industry or not-for-profit organisations. - [Positioning Statements on Physician-led Switching for Biosimilar Medicines](https://www.medicinesforeurope.com/2021/10/01/positioning-statements-on-physician-led-switching-for-biosimilar-medicines/) - Positioning statements on physician-led switching for biosimilar medicines (October 2021) Biosimilar medicines group position on physician-led switching (July 2015) Biosimilar medicines group position on biologic pharmacy substitution (September 2020) - [The issue of divisional patent applications](https://www.medicinesforeurope.com/2021/04/01/10627/) - Read more - [Open Public Consultation on the revision of EU rules on medicines for children and rare diseases](https://www.medicinesforeurope.com/2021/07/26/open-public-consultation-on-the-revision-of-eu-rules-on-medicines-for-children-and-rare-diseases/) - Open Public Consultation on the revision of EU rules on medicines for children and rare diseases - [Factsheet: Evaluating the impact of international trade on access to medicines](https://www.medicinesforeurope.com/2021/05/21/evaluating-the-impact-of-international-trade-on-access-to-medicines/) - Medicines for Europe is committed to improving access to medicines for all Europeans. Yet, many patients across Europe face restricted access to medicines which undermines public health. The 2019-2024 EU legislature should reshape pharmaceutical policy by prioritising equitable access to essential medicines for all Europeans. - [Factsheet: Market and regulatory reforms to ensure availability and resilience of the supply chain](https://www.medicinesforeurope.com/2021/05/21/factsheet-market-and-regulatory-reforms-to-ensure-availability-and-resilience-of-the-supply-chain/) - Medicines for Europe is committed to improving access to medicines for all Europeans. Yet, many patients across Europe face restricted access to medicines which undermines public health. The 2019-2024 EU legislature should reshape pharmaceutical policy by prioritising equitable access to essential medicines for all Europeans. - [Factsheet: Boosting affordable innovations](https://www.medicinesforeurope.com/2021/05/21/boosting-affordable-innovations/) - Medicines for Europe is committed to improving access to medicines for all Europeans. Yet, many patients across Europe face restricted access to medicines which undermines public health. The 2019-2024 EU legislature should reshape pharmaceutical policy by prioritising equitable access to essential medicines for all Europeans - [Factsheet: Removing barriers to equitable access for timely competition](https://www.medicinesforeurope.com/2021/05/21/removing-barriers-to-equitable-access-for-timely-competition/) - Medicines for Europe is committed to improving access to medicines for all Europeans. Yet, many patients across Europe face restricted access to medicines which undermines public health. The 2019-2024 EU legislature should reshape pharmaceutical policy by prioritising equitable access to essential medicines for all Europeans - [The Issue of Abuses of Divisional Patent Application](https://www.medicinesforeurope.com/2021/04/30/the-issue-of-abuses-of-divisional-patent-application/) - Divisional patent applications are those deriving from an earlier patent application referred to as the "parent". Divisional applications can be used in case the parent application lacks unity of invention, i.e. includes more than one invention and, therefore, the applicant splits the parent into one or more divisional applications each claiming only a single invention. - [VALUE ADDED MEDICINES ONLINE SUMMIT Empowering the healthcare community by improving existing treatments](https://www.medicinesforeurope.com/2021/04/23/value-added-medicines-online-summit-empowering-the-healthcare-community-by-improving-existing-treatments/) - Open - [Biosimilar Medicine Market Review 2020](https://www.medicinesforeurope.com/2021/03/29/biosimilar-medicine-market-review-2020/) - The 2020 Market Review covers 8 main topics: Availability, Pricing system, Retail tendering, Hospital tendering, Reimbursement systems, Physician-related topics, Pharmacist-related policies and Information and education. - [Medicines for Europe Position Paper On Patent Linkage](https://www.medicinesforeurope.com/2021/03/03/medicines-for-europe-position-paper-on-patent-linkage-may-2019/) - Open - [EU industrial policy can dramatically improve medicines manufacturing resilience and security of supply](https://www.medicinesforeurope.com/2021/03/17/eu-industrial-policy-can-dramatically-improve-medicines-manufacturing-resilience-and-security-of-supply/) - Medicines for Europe calls on Heads of State and Governments to build on the lessons learned from the COVID-19 pandemic, with a thoughtful Industrial Policy that should strengthen European manufacturing and critical medicines supply chain resilience, while ensuring equitable access for patients. - [Medicines for Europe Position Paper on Bolar Exemption - Feb 2021](https://www.medicinesforeurope.com/2021/02/15/medicines-for-europe-position-paper-on-bolar-exemption-july-2020/) - Open - [Medicines for Europe Position on IP Action Plan - March 2021](https://www.medicinesforeurope.com/2021/03/13/medicines-for-europe-position-on-ip-action-plan-march-2021/) - Open - [Position Paper. Incentives Review The Orphan and Paediatric Incentives](https://www.medicinesforeurope.com/2021/03/01/position-paper-incentives-review-the-orphan-and-paediatric-incentives/) - [Заповнення прогалини: Filling the gap - Ukrainian translation now available.](https://www.medicinesforeurope.com/2021/03/17/filling-the-gap-заповнення-прогалини/) - Як лікарські засоби після закінчення строку патентного захисту можуть покращити доступ та якість лікування раку - [Maintaining the exchange of critical health data - An adequacy decision on the UK data protection regime](https://www.medicinesforeurope.com/2021/03/05/maintaining-the-exchange-of-critical-health-data-an-adequacy-decision-on-the-uk-data-protection-regime/) - We welcome the draft adequacy decision on the UK data protection regime issued by the European Commission on 19th February 2021. Protecting the benefits of the free flow of personal data must be a top priority. - [Market Review – European Generic Medicine Markets 2020](https://www.medicinesforeurope.com/2021/03/01/market-review-european-generic-medicine-markets/) - The 2020 Market Review covers 8 main topics: Pricing systems, Control of Excessive Spending, Retail tendering, Hospital tendering, Reimbursement systems, Physician incentives, Pharmacist incentives and Patient incentives. - [Market Review – European Generic Medicines Markets 2016](https://www.medicinesforeurope.com/2016/11/10/market-review-european-generic-medicines-markets/) - Open - [Electronic product information: from principles to actions. AESGP, EFPIA and Medicines for Europe reflections on EMAHMA – EC Key principles for electronic product information](https://www.medicinesforeurope.com/2021/02/10/electronic-product-information-from-principles-to-actions-aesgp-efpia-and-medicines-for-europe-reflections-on-emahma-ec-key-principles-for-electronic-product-information/) - Open - [Biosimilars in the EU - Information guide for healthcare professionals - now available in 23 languages](https://www.medicinesforeurope.com/2019/10/29/biosimilars-in-the-eu-information-guide-for-healthcare-professionals/) - Unofficial Ukrainian translation (PDF/600 KB) (PDF/600 KB) English (PDF/1.85 MB) (PDF/1.82 MB) Bulgarian (PDF/1.82 MB) (PDF/1.82 MB) Croatian (PDF/1.81 MB) (PDF/1.81 MB) Czech (PDF/1.86 MB) (PDF/1.86 MB) Danish (PDF/1.84 MB) (PDF/1.84 MB) Dutch (PDF/1.83 MB) (PDF/1.83 MB) Estonian (PDF/656.54 KB) (PDF/656.54 KB) Finnish (PDF/1.79 MB) (PDF/1.79 MB) French (PDF/1.86 MB) (PDF/1.86 MB) German (PDF/1.9 MB) - [Biosimilars in the EU – Information guide for healthcare professionals – unofficial Ukrainian translation now available](https://www.medicinesforeurope.com/2021/02/08/biosimilars-in-the-eu-information-guide-for-healthcare-professionals-unofficial-ukrainian-translation-now-available/) - Open unofficial Ukrainian translation - [Filling the gap: How off-patent medicines can improve the equity and quality of cancer care](https://www.medicinesforeurope.com/2021/02/04/filling-the-gap-how-off-patent-medicines-can-improve-the-equity-and-quality-of-cancer-care-2/) - Open - [Filling the gap: How off-patent medicines can improve the equity and quality of cancer care](https://www.medicinesforeurope.com/2021/02/04/filling-the-gap-how-off-patent-medicines-can-improve-the-equity-and-quality-of-cancer-care/) - Open - [Medicine Shortages Webinar: Damian Holly Supply Chain Resilience Overview.](https://www.medicinesforeurope.com/2020/12/11/medicine-shortages-webinar-damian-holly-supply-chain-resilience-overview/) - [The total clinical experience with biosimilar medicines exceeds 2 billion patient treatment days](https://www.medicinesforeurope.com/2020/12/16/the-total-clinical-experience-with-biosimilar-medicines-exceeds-2-billion-patient-treatment-days/) - [Biosimilar medicines are available in therapy areas which represent 65% of the biologics market by value](https://www.medicinesforeurope.com/2020/12/16/biosimilar-medicines-are-available-in-therapy-areas-which-represent-65-of-the-biologics-market-by-value/) - [In Europe, biosimilar medicines have captured 7% more of the biologics market over a 5-year period](https://www.medicinesforeurope.com/2020/12/16/in-europe-biosimilar-medicines-have-captured-7-more-of-the-biologics-market1-over-a-5-year-period/) - [Growing number of biologic therapies offers future opportunities for biosimilar development](https://www.medicinesforeurope.com/2020/12/16/growing-number-of-biologic-therapies-offers-future-opportunities-for-biosimilar-development/) - [Educational material on biosimilar medicines, developed by IGBA (International Generic and Biosimilar Medicines Association)](https://www.medicinesforeurope.com/2020/11/02/educational-material-on-biosimilar-medicines-developed-by-igba-international-generic-and-biosimilar-medicines-association/) - The era of biological medicinesSince their first use in the 1980s, biological medicines (including biosimilar medicines) have grown to become an indispensable tool in modern medicine. Worldwide, millions of patients have already benefited from approved biological medicines, but what exactly are they, and how are they produced? Open Biological medicines ― the major social and - [White Paper: Anatomy of a failure to launch: A review of barriers to generic and biosimilar market entry and the use of competition law as a remedy](https://www.medicinesforeurope.com/2020/11/05/white-paper-anatomy-of-a-failure-to-launch-a-review-of-barriers-to-generic-and-biosimilar-market-entry-and-the-use-of-competition-law-as-a-remedy/) - Open - [Second wave pandemic preparedness: procurement principles](https://www.medicinesforeurope.com/2020/08/24/second-wave-pandemic-preparedness-procurement-principles/) - [Policy Roadmap for Medicines Manufacturing Leadership](https://www.medicinesforeurope.com/2020/07/06/a-policy-roadmap-for-medicines-manufacturing-leadership/) - [COVID-19 “Round 2” – Findings & way forward (Kearney)](https://www.medicinesforeurope.com/2020/06/22/covid-19-round-2-findings-way-forward-kearney/) - [Call for tenders SANTE/2020/C3/29 for the supply of medicinal products used for intensive care patients subject to the novel coronavirus (COVID-19) disease – policy and technical concerns](https://www.medicinesforeurope.com/2020/06/25/call-for-tenders-sante-2020-c3-29-for-the-supply-of-medicinal-products-used-for-intensive-care-patients-subject-to-the-novel-coronavirus-covid-19-disease-policy-and-technical-concerns/) - [Preparing for a potential second COVID-19 wave. Joint statement by Medicines for Europe and EFPIA with Kearney](https://www.medicinesforeurope.com/2020/06/22/preparing-for-a-potential-second-covid-19-wave-joint-statement-by-medicines-for-europe-and-efpia-with-a-t-kearney-22-june-2020/) - [LESSONS LEARNED FROM COVID-19 - POLICY PAPER](https://www.medicinesforeurope.com/2020/06/22/lessons-learned-from-covid-19-policy-paper/) - [Position Paper. Reference safety information: challenges to the generic industry due to labelling harmonisation issues among different Member States](https://www.medicinesforeurope.com/2020/05/08/position-paper-reference-safety-information-challenges-to-the-generic-industry-due-to-labelling-harmonisation-issues-among-different-member-states/) - [Overarching recommendations for improved access to generic and biosimilar medicines in the hospital setting](https://www.medicinesforeurope.com/2019/10/07/overarching-recommendations-for-improved-access-to-generic-and-biosimilar-medicines-in-the-hospital-setting/) - [AMR Industry Alliance 2020 Progress Report](https://www.medicinesforeurope.com/2020/01/16/amr-industry-alliance-2020-progress-report/) - [Why is Now the Right Time to Modernise the Eu Variations System?](https://www.medicinesforeurope.com/2020/01/30/why-is-now-the-right-time-to-modernise-the-eu-variations-system/) - [Medicines for Europe Commentary on the Draft EMA regulatory science strategy 2025](https://www.medicinesforeurope.com/2019/06/28/medicines-for-europe-commentary-on-the-draft-ema-regulatory-science-strategy-2025/) - [Open letter to the Members of the European Parliament on the importance to sustain EU progress in fighting against antimicrobial resistance (AMR)](https://www.medicinesforeurope.com/2019/09/11/open-letter-to-the-members-of-the-european-parliament-on-the-importance-to-sustain-eu-progress-in-fighting-against-antimicrobial-resistance-amr/) - OPEN - [SPC manufacturing waiver](https://www.medicinesforeurope.com/2017/10/24/spc-manufacturing-waiver/) - SME Intergroup Conclusions - Boosting SMEs through the SPC Waiver Memo on EC study - Assessing the economic impacts of changing exemption provision during patent and SPC protection in Europe Note on SPC manufacturing waiver Oct 2017 SPC manufacturing waiver - Benefits and Myths - [Position Paper: for an ambitious EU industrial strategy](https://www.medicinesforeurope.com/2017/10/24/position-paper-for-an-ambitious-eu-industrial-strategy/) - [Life Science Industry Coalition Position paper](https://www.medicinesforeurope.com/2017/12/14/life-science-industry-coalition-position-paper/) - [Physicians recognised potential of Value Added Medicines](https://www.medicinesforeurope.com/2020/06/03/physicians-recognised-potential-of-value-added-medicines/) - [Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic](https://www.medicinesforeurope.com/2020/04/10/questions-and-answers-on-regulatory-expectations-for-medicinal-products-for-human-use-during-the-covid-19-pandemic/) - [Medicines Shortages: Causes and Recommendations](https://www.medicinesforeurope.com/2020/01/17/medicines-shortages-causes-and-recommendations/) - [Perceptions and recommendations of physicians/KOLs on value added medicines](https://www.medicinesforeurope.com/2019/11/21/perceptions-and-recommendations-of-physicians-kols-on-value-added-medicines/) - Open - [The secret to improve access to value added medicines](https://www.medicinesforeurope.com/2019/11/14/the-secret-to-improve-access-to-value-added-medicines/) - OPEN - [Improving healthcare delivery in hospitals by optimized utilization of medicines](https://www.medicinesforeurope.com/2019/10/07/improving-healthcare-delivery-in-hospitals-by-optimized-utilization-of-medicines/) - [Value Added Medicines: Rethink, Reinvent & Optimize Medicines, Improving Patient Health & Access](https://www.medicinesforeurope.com/2016/05/31/value-added-medicines-rethink-reinvent-optimize-medicines-improving-patient-health-access/) - [ISPOR 2016 EU - Value Added Medicines](https://www.medicinesforeurope.com/2016/11/18/ispor-2016-eu-value-added-medicines/) - Healthcare System Inefficiencies Related To Medicines: Any Potential Room For Improvement? OPEN Value Added Medicines: The Need to Establish One Common Terminology for Repurposed Medicines OPEN Value Added Medicines: What Value Repurposed Medicines Might Bring to Society? OPEN Obstacles for Adoption of Value Added Medicines: Call for Policy Changes for Value Recognition of Repurposed Medicines - [Case Studies for Value Added Medicines. Unlocking the potential of patient-centric continuous innovation](https://www.medicinesforeurope.com/2019/02/26/case-studies-for-value-added-medicines-unlocking-the-potential-of-patient-centric-continuous-innovation/) - [A digital future for value added medicines](https://www.medicinesforeurope.com/2019/09/24/a-digital-future-for-value-added-medicines/) - [Calls to action to improve access to value added medicines](https://www.medicinesforeurope.com/2019/02/26/calls-to-action-to-improve-access-to-value-added-medicines/) - [How can your healthcare system support a wider access to Value Added Medicines?](https://www.medicinesforeurope.com/2019/05/27/how-can-your-healthcare-system-support-a-wider-access-to-value-added-medicines/) - [Position paper on Best Procurement Practices](https://www.medicinesforeurope.com/2018/04/28/position-paper-on-best-procurement-practices/) - Open - [Annual Medicines for Europe and IGBA Conference 2019](https://www.medicinesforeurope.com/2019/04/04/annual-medicines-for-europe-and-igba-conference-2019/) - REGISTER NOW! - [Infographic: Value Added Medicines Provide a Wide Range of Different and Important Benefits to Patients, Healthcare Professionals and Healthcare Systems](https://www.medicinesforeurope.com/2019/04/03/infographic-value-added-medicines-provide-a-wide-range-of-different-and-important-benefits-to-patients-healthcare-professionals-and-healthcare-systems/) - [17th Biosimilar Medicines Conference](https://www.medicinesforeurope.com/2018/11/16/17th-biosimilar-medicines-conference/) - REGISTER NOW! - [15th Legal Affairs Conference](https://www.medicinesforeurope.com/2018/12/14/15th-legal-affairs-conference/) - REGISTER NOW! - [18th Regulatory and Scientific Affairs Conference](https://www.medicinesforeurope.com/2018/10/10/18th-regulatory-and-scientific-affairs-conference/) - REGISTER NOW! - [Do you care about patient access? The SPC manufacturing waiver can help!](https://www.medicinesforeurope.com/2018/10/09/do-you-care-about-patient-access-the-spc-manufacturing-waiver-can-help/) - [12th Pharmacovigilance Conference](https://www.medicinesforeurope.com/2018/10/10/12th-pharmacovigilance-conference/) - [Gif: How Can Value Added Medicines Make A Difference?](https://www.medicinesforeurope.com/2017/10/03/gif-how-can-value-added-medicines-make-a-difference/) - [Gif - What are the Therapy Areas Covered by Value Added Medicines?](https://www.medicinesforeurope.com/2017/10/03/gif-what-are-the-therapy-areas-covered-by-value-added-medicines/) - [Gif - 6 Reasons why Value Added Medicines are Important](https://www.medicinesforeurope.com/2017/10/03/gif-6-reasons-why-value-added-medicines-are-important/) - [Gif - 4 Ways to Produce Value Added Medicines](https://www.medicinesforeurope.com/2017/10/03/gif-4-ways-to-produce-value-added-medicines/) - [Gif - Value Added Medicines Encompass a Wider Variety of Healthcare Solutions](https://www.medicinesforeurope.com/2017/10/03/gif-value-added-medicines-encompass-a-wider-variety-of-healthcare-solutions/) - [Infographic 2: Integrating Patient’s Preferences in the Healthcare Agenda](https://www.medicinesforeurope.com/2017/11/24/infographic-2-integrating-patients-preferences-in-the-healthcare-agenda/) - [Infographic 1: Integrating Patient’s Preferences in the Healthcare Agenda](https://www.medicinesforeurope.com/2017/11/24/infographic1-integrating-patients-preferences-in-the-healthcare-agenda/) - [Infographic: Value Added Medicines: Enable Patient-Centric-Innovation](https://www.medicinesforeurope.com/2017/10/03/infographic-enable-oatient-centric-innovation/) - [IGBA 2017 achievements - Adrian van den Hoven](https://www.medicinesforeurope.com/2017/12/21/igba-2017-achievements-adrian-van-den-hoven/) - [My Voice Matters! Integrating Patient’s Preferences in the Healthcare Agenda](https://www.medicinesforeurope.com/2017/11/24/my-voice-matters-integrating-patients-preferences-in-the-healthcare-agenda/) - [10th Medicines for Europe Pharmacovigilance Conference. Save the date!](https://www.medicinesforeurope.com/2016/11/25/10th-medicines-for-europe-pharmacovigilance-conference-save-the-date/) - [11th Medicines for Europe Pharmacovigilance Conference](https://www.medicinesforeurope.com/2017/12/22/11th-medicines-for-europe-pharmacovigilance-conference/) - [14th Legal Affairs Conference](https://www.medicinesforeurope.com/2018/01/05/14th-legal-affairs-conference/) - [17th Regulatory and Scientific Affairs Conference](https://www.medicinesforeurope.com/2017/12/23/17th-regulatory-and-scientific-affairs-conferenc/) - [16th Biosimilar Medicines Conference](https://www.medicinesforeurope.com/2018/01/06/16th-biosimilar-medicines-conference/) - [Switch Management between Similar Biological Medicines. A Communication and Information Guide for Nurses.](https://www.medicinesforeurope.com/2018/06/27/switch-management-between-similar-biological-medicines-a-communication-and-information-guide-for-nurses/) - [Joint pharmaceutical industry statement on the Commission’s proposal for a Regulation on health technology assessment (HTA)](https://www.medicinesforeurope.com/2018/06/21/joint-pharmaceutical-industry-statement-on-the-commissions-proposal-for-a-regulation-on-health-technology-assessment-hta/) - [Medicines For Europe Country Specific Market Access Policies](https://www.medicinesforeurope.com/2018/05/24/medicines-for-europe-country-specific-market-access-policies-2/) - [IGBA position on identification of biological, including biosimilar medicines (2018 update of facts & figures)](https://www.medicinesforeurope.com/2018/04/20/igba-position-on-identification-of-biological-including-biosimilar-medicines/) - [Hospital Tendering](https://www.medicinesforeurope.com/2018/05/15/hospital-tendering/) - [Global Healthcare Trends and Outlook](https://www.medicinesforeurope.com/2017/06/15/global-healthcare-trends-and-outlook/) - [The impact of SPC Manufacturing Waiver on jobs, competitiveness & patient access to medicines](https://www.medicinesforeurope.com/2018/02/21/the-impact-of-spc-manufacturing-waiver-on-jobs-competitiveness-patient-access-to-medicines/) - [What are the key messages of the ESMO 2017 symposium?](https://www.medicinesforeurope.com/2017/12/11/what-are-the-key-messages-of-the-esmo-2017-symposium/) - [How come that biosimilar medicines are still heavily debated today?](https://www.medicinesforeurope.com/2017/12/11/how-come-that-biosimilar-medicines-are-still-heavily-debated-today/) - [What is needed to familiarize oncologists with biosimilar medicines?](https://www.medicinesforeurope.com/2017/12/11/what-is-needed-to-familiarize-oncologists-with-biosimilar-medicines/) - [What is the role of clinical trials in biosimilar development?](https://www.medicinesforeurope.com/2017/12/11/what-is-the-role-of-clinical-trials-in-biosimilar-development/) - [Joint statement - European health community calls on the EU and UK to prioritise patients as crunch Article 50 decision approaches](https://www.medicinesforeurope.com/2017/12/07/joint-statement-european-health-community-calls-on-the-eu-and-uk-to-prioritise-patients-as-crunch-article-50-decision-approaches/) - Today a group of organisations representing patients, healthcare professionals and the health care industry have called on the EU and UK to prioritise patients in the Brexit negotiations. To coincide with the EPSCO Council of EU Health Ministers in Brussels, this policy statement comes just one week ahead of the crunch European Council meeting where - [Biosimilars — Can the dream of affordable cancer care come true?](https://www.medicinesforeurope.com/2017/09/08/biosimilars-can-the-dream-of-affordable-cancer-care-come-true-2/) - [A Clinician´s Guide to Biosimilars in Oncology: Understanding the Science of Extrapolation and Interchangeability](https://www.medicinesforeurope.com/2017/09/08/a-clinicians-guide-to-biosimilars-in-oncology-understanding-the-science-of-extrapolation-and-interchangeability/) - [Addressing medicine shortages in Europe](https://www.medicinesforeurope.com/2017/09/29/addressing-medicine-shortages-in-europe/) - Position paper Reading list Commentary + EIU document - [Reading List | Medicine Shortages](https://www.medicinesforeurope.com/2017/09/29/reading-list-medicine-shortages/) - Reading list Position paper Report Address medicine shortages in Europe - [Position Paper Medicines Shortages](https://www.medicinesforeurope.com/2017/09/29/position-paper-medicines-shortages/) - Position paper Reading list Report Address medicine shortages in Europe - [Fighting counterfeit medicines in Europe: the effect on access to medicines](https://www.medicinesforeurope.com/2017/09/14/fighting-counterfeit-medicines-in-europe-the-effect-on-access-to-medicines/) - The implementation of the Falsified Medicines Directive, and its Delegated Regulation with detailed specifications of safety features, will provide an additional obstacle for counterfeiters. The implementation of the Directive aims to prevent falsified medicines from reaching patients, and is in the interest of public health. However, the financial burden for manufacturers to implement these additional - [2017 Market Review – Biosimilar Medicines Markets - Policy Overview](https://www.medicinesforeurope.com/2017/09/12/market-review-biosimilar-medicines-markets-policy-overview/) - [Value Added Medicines: Time to Adjust the HTA Decision Frameworks](https://www.medicinesforeurope.com/2017/09/05/value-added-medicines-time-to-adjust-the-hta-decision-frameworks/) - [US FDA Advisory committee hears first-hand about the decade of EU experience with biosimilar medicines use](https://www.medicinesforeurope.com/2017/07/13/us-fda-advisory-committee-hears-first-hand-about-the-decade-of-eu-experience-with-biosimilar-medicines-use/) - Medicines for Europe Director General Adrian van de Hoven participated in the Open Public Hearing (OPH) of the July 13, 2017 Oncologic Drugs Advisory Committee US FDA Advisory Committee involving biosimilar medicines on 13 July 2017. Biosimilar medicines clinical use: an experience based-EU perspective The Biosimilar Medicines Group contribution to the US FDA Docket For - [Letter from European and UK Life Sciences Organizations Underlining the Importance of Securing Ongoing Cooperation Between the UK and EU on Medicines](https://www.medicinesforeurope.com/2017/07/13/letter-from-european-and-uk-life-sciences-organizations-underlining-the-importance-of-securing-ongoing-cooperation-between-the-uk-and-eu-on-medicines/) - [Position Paper External Reference Pricing for Generic and Biosimilar Medicines](https://www.medicinesforeurope.com/2017/07/01/position-paper-external-reference-pricing-for-generic-and-biosimilar-medicines/) - [The Benefits of Biosimilar Medicines](https://www.medicinesforeurope.com/2017/06/20/the-benefits-of-biosimilar-medicines/) - [Medicines for Europe - Better Access. Better Health](https://www.medicinesforeurope.com/2016/12/19/medicines-for-europe-better-access-better-health/) - [Join Medicines for Europe - 2017](https://www.medicinesforeurope.com/2017/06/15/join-medicines-for-europe-2017/) - [Biosimilars: can the dream of affordable cancer care come true?](https://www.medicinesforeurope.com/2017/02/28/biosimilars-can-the-dream-of-affordable-cancer-care-come-true/) - by Paul Cornes Cancer is the world’s biggest killer, and the complex biological medicines used to treat it are expensive. Even the world’s richest countries will struggle with the cost of these drugs and so tackling the issue of affordable cancer care is something we need to address now. One of the solutions could be biosimilars. - [Medicines for Europe Country Specific Market Access Policies](https://www.medicinesforeurope.com/2017/05/23/medicines-for-europe-country-specific-market-access-policies/) - [Patent-Related Barriers to Market Entry for Generic Medicines in the European Union](https://www.medicinesforeurope.com/2009/06/30/patent-related-barriers-to-market-entry-for-generic-medicines-in-the-european-union/) - [The Impact of Biosimilar Competition in Europe](https://www.medicinesforeurope.com/2017/05/08/the-impact-of-biosimilar-competition-in-europe/) - [RSAC conference 2016](https://www.medicinesforeurope.com/2016/01/28/rsac-conference-2016/) - [Q&A for patients - Biosimilar medicines explained](https://www.medicinesforeurope.com/2016/11/22/qa-for-patients-biosimilar-medicines-explained/) - The European Commission has published improved information for patients on biosimilar medicines. The Q&A are available in 7 languages (English, French, German, Italian, Polish, Portuguese and Spanish) offering patients access to unbiased and reliable information. Biological medicines (including biosimilars) come from living organisms (cells) that have been modified using biotechnology. A biosimilar medicine is developed - [Tweetup with Jacek Glinka | Friday 24 March 2017 | 10.00 – 10.45 (CET)](https://www.medicinesforeurope.com/2017/03/10/tweetup-with-jacek-glinka-friday-24-march-2017-10-00-10-45-cet/) - 15th Biosimilar Medicines Conference BIOSIMILAR MEDICINES: A GAME CHANGER FOR HEALTHCARE SUSTAINABILITY Friday 24 March 2017 | 10.00 – 10.45 (CET) CONNECT BY USING THE HASHTAG #ASKJACEKGLINKA - [Biosimilars - the question of trials and approval](https://www.medicinesforeurope.com/2017/02/28/biosimilars-the-question-of-trials-and-approval/) - by Robin Foà Robin Foà, MD from the Sapienza University, Rome, Italy discusses the question of how the trials on biosimilars should be run and what needs to be done for biosimilars to get approved. According to Prof. Foà, this is a difficult question and he points out that the European Medicines Agency (EMA) has stated - [Biologics and biosimilars explained](https://www.medicinesforeurope.com/2017/02/28/biologics-and-biosimilars-explained/) - [15th Biosimilar Medicines Conference: a game changer for healthcare sustainability](https://www.medicinesforeurope.com/2016/11/25/15th-biosimilar-medicines-conference-a-game-changer-for-healthcare-sustainability/) - [Biosimilar Medicines, an Opportunity for Healthcare – Video with subtitles in 15 languages](https://www.medicinesforeurope.com/2015/11/06/biosimilar-medicines-an-opportunity-for-healthcare-video-playlist/) - [GfK – Factors Supporting a Sustainable European Biosimilar Medicines Market](https://www.medicinesforeurope.com/2014/09/09/factors-supporting-a-sustainable-european-biosimilar-medicines-market/) - A study about the future sustainability of the biosimilar medicines market undertaken by GfK Market Access on behalf of the European Biosimilars Group, now the Biosimilar Medicines Group. - [IMS Institute – Biosimilar Report](https://www.medicinesforeurope.com/2016/03/31/ims-institute-biosimilar-report-march-2016/) - IMS Institute Biosimilar Report March 2016 - [IMS – The Impact of Biosimilar Competition (2015)](https://www.medicinesforeurope.com/2015/11/01/the-impact-of-biosimilar-competition/) - This document sets out to describe the effects on price, volume and market share following the arrival and presence of biosimilar competition in the European Economic Area (EEA). The document consists of a set of indicators and guidance on how to interpret these indicators. It has been prepared as a set of indicators to monitor the impact of - [IMS – The Impact of Biosimilar Competition (2016)](https://www.medicinesforeurope.com/2016/06/01/the-impact-of-biosimilar-competition-2/) - [Infographic: Delivering on the Potential of Biosimilar Medicines](https://www.medicinesforeurope.com/2016/11/16/delivering-on-the-potential-of-biosimilar-medicines/) - [Infographic: Clinical Experience with Biosimilar Medicines](https://www.medicinesforeurope.com/2016/11/16/clinical-experience-with-biosimilar-medicines/) - Open Open Open - [Simon-Kucher. Policy Requirements for a Sustainable Biosimilar Market (September 2016)](https://www.medicinesforeurope.com/2016/09/19/policy-requirements-for-a-sustainable-biosimilar-market-simon-kucher-2016/) - [What you Need to Know About Biosimilar Medicinal Products](https://www.medicinesforeurope.com/2015/02/22/test-article-p/) - European Commission Consensus Information Document: What you Need to Know About Biosimilar Medicinal Products. To view the full report, please click here. - [EAHP satellite on Biosimilar medicines](https://www.medicinesforeurope.com/2016/03/24/2095/) - Maarten Van Baelen - Intro + Niklas Ekman - Biosimilars from the perspective of an EU regulator Maarten Van Baelen Niklas Ekman Arnold Vulto - Biosimilars concerns of prescribers and how to address them as a hospital pharmacist Arnold Vulto Paul Cornes - Biosimilars – can we do without them Paul Cornes Please find the - [PACT poster](https://www.medicinesforeurope.com/2016/11/18/pact-poster/) - [What can you do to fight Antimicrobial resistance? Adrian van den Hoven](https://www.medicinesforeurope.com/2016/11/17/what-can-you-do-to-fight-antimicrobial-resistance-adrian-van-den-hoven/) - [Essential Medicines for Universal Health Coverage](https://www.medicinesforeurope.com/2016/11/07/essential-medicines-for-universal-health-coverage/) - [Universal Access to Health 2014 Event - 8 April 2014 – Video Playlist](https://www.medicinesforeurope.com/2014/04/08/universal-access-to-health-2014-event-8-april-2014/) - Universal Access to Health: Your Voice in the EP 2014 Elections Rebecca Taylor MEP take home message: Leonardo Palumbo (European Public Health Alliance) take home message: Cynthia Bonsignore (European Patients Forum) take home message: Andrey Kovatchev MEP take home message: EGA Director General take home message: - [Joint 22nd EGA and 19th IGBA Annual Conference (8-10 June 2016)](https://www.medicinesforeurope.com/2016/03/23/joint-22nd-ega-and-19th-igba-annual-conference-8-10-june-2016/) - JOINT 22nd EGA and 19th IGBA ANNUAL CONFERENCE (8-10 June 2016) - [Rebranding Medicines for Europe](https://www.medicinesforeurope.com/2016/06/16/rebranding-medicines-for-europe/) - [Infographic: Rethink, Reinvent & Optimise Medicines, Improving Patient Health & Access](https://www.medicinesforeurope.com/2016/05/31/infographic-rethink-reinvent-optimise-medicines-improving-patient-health-access/) - [Infographic: The Role of Generic Medicines in Sustaining Healthcare Systems](https://www.medicinesforeurope.com/2016/02/22/the-role-of-generic-medicines-in-sustaining-healthcare-systems/) - [Infographic: Value of Generic Medicines](https://www.medicinesforeurope.com/2016/03/01/value-of-generic-medicines/) - [#EGA20 - 26 June 2014 - Video Playlist](https://www.medicinesforeurope.com/2014/06/26/ega20-26-june-2014/) - The role of video in the patient recovery journey - Pablo Galiana: At the Avant-Garde of Wearable Health - Sara Navarro Medina: We All Are The New Media - Jaume Duch: Moving forward the Participatory Medicine: A Conversation with Dr. Sergio Vañó: Social is Healing: Accessing the Patients - Óscar Brihuega: Let's Patients Help! - - [How to Increase Patient Access to Generic Medicines](https://www.medicinesforeurope.com/2009/06/30/how-to-increase-patient-access-to-generic-medicines/) - [Generic Medicines: Essential Contributor to the Long-Term Health of Society](https://www.medicinesforeurope.com/2010/03/21/generic-medicines-essential-contributor-to-the-long-term-health-of-society/) - [EGA Q&A on the Revised EMA Bioequivalence Requirement](https://www.medicinesforeurope.com/2010/06/22/test-environment-1/) - To view the full report, please click here. - [IMS Health 2015: The Role of Generic Medicines in Sustaining Healthcare Systems: A European Perspective, June 2015](https://www.medicinesforeurope.com/2015/06/01/ims-health-2015-the-role-of-generic-medicines-in-sustaining-healthcare-systems-a-european-perspective-june-2015/) - To view the full report, click here To view the infographic, click here - [IGES Report: Value of Generic Medicines - Health Economics Study, Berlin, 5 October 2015](https://www.medicinesforeurope.com/2015/10/05/iges-report-value-of-generic-medicines-health-economics-study-berlin-5-october-2015/) - To consult the infographics, please click here. - [Infographic: Factors Supporting a Sustainable European Biosimilar Medicines Market (GfK report)](https://www.medicinesforeurope.com/2015/11/22/factors-supporting-a-sustainable-european-biosimilar-medicines-market-2/) - [13th EGA European Biosimilars Group Conference - 23 April 2015 - Video Playlist](https://www.medicinesforeurope.com/2015/04/23/13th-ega-european-biosimilars-group-conference-23-april-2015/) - For information on the 14th gathering of the world's Biosimilars experts on 28-29 April 2016, go to: http://www.egaevents.org/bios/ Sabine Juelicher - Welcome and Keynote Address (1/2): Sabine Juelicher - Welcome and Keynote Address (2/2): Nick Haggar - Opening Keynote Speech (1/2): Nick Haggar - Opening Keynote Speech (2/2): Martina Weise - The science of extrapolation - [Understanding the Science of Extrapolation and Defining Interchangeability - Dr. Elena Wolff-Holz, EULAR Symposium London](https://www.medicinesforeurope.com/2016/06/10/understanding-the-science-of-extrapolation-and-defining-interchangeability-dr-elena-wolff-holz-eular-symposium-london-june-10-2016/) - [Factsheet: Medicines for Europe Vision](https://www.medicinesforeurope.com/2016/03/09/providing-sustainable-access-to-high-quality-medicines-for-all-european-patients/) - [Factsheet: About Medicines for Europe](https://www.medicinesforeurope.com/2016/03/09/about-medicines-for-europe/) - [Factsheet: About The Generic Medicines Group](https://www.medicinesforeurope.com/2016/03/09/the-generic-medicines-group/) - [Factsheet: What is a Generic Medicine](https://www.medicinesforeurope.com/2016/03/09/what-is-a-generic-medicine/) - [Factsheet: About the Biosimilar Medicines Group](https://www.medicinesforeurope.com/2016/03/09/1491/) - [Factsheet: What is a Biosimilar Medicine](https://www.medicinesforeurope.com/2016/03/09/1501/) - [Factsheet: What is a Value Added Medicine](https://www.medicinesforeurope.com/2016/05/31/factsheet-what-is-a-value-added-medicine/) - [Factsheet: About The Value Added Medicines Group](https://www.medicinesforeurope.com/2016/05/31/factsheet-about-the-value-added-medicines-group/) - [EMA Questions and Answers on Biosimilar Medicines (Similar Biological Medicinal Products)](https://www.medicinesforeurope.com/2012/09/27/ema-questions-and-answers-on-biosimilar-medicines-similar-biological-medicinal-products/) - [Emergence of Biosimilar Medicines - The Biosimilar Company Point of View, Paul Greenland, Belgium Federal Parliament, Brussels, 22 November 2012 (PPT)](https://www.medicinesforeurope.com/2012/11/22/emergence-of-biosimilar-medicines-the-biosimilar-company-point-of-view-paul-greenland-belgium-federal-parliament-brussels-22-november-2012-ppt/) - [Production and Control of Biosimilars versus Innovators, Biosimilars Present and Future - Da Silva, Infarmed, Lisbon, 3 April 2013 (PPT)](https://www.medicinesforeurope.com/2013/04/03/production-and-control-of-biosimilars-versus-innovators-biosimilars-present-and-future-da-silva-infarmed-lisbon-3-april-2013-ppt/) - [Biosimilar Monoclonal Antibodies - 11th EGA International Symposium on Biosimilar Medicines, Gudbjorg Edda Eggertsdottir, London, 25 April 2013](https://www.medicinesforeurope.com/2013/04/25/biosimilar-monoclonal-antibodies-11th-ega-international-symposium-on-biosimilar-medicines-gudbjorg-edda-eggertsdottir-london-25-april-2013/) - [Safe Prescription,Safe Dispensing, Identification and Track&Trace of All Biologicals in the Context of the Re-opened Biosimilars INN Debate - 11th EGA Symposium on Biosimilar Medicines, Suzette Kox, London 2013](https://www.medicinesforeurope.com/2013/04/25/safe-prescriptionsafe-dispensing-identification-and-tracktrace-of-all-biologicals-in-the-context-of-the-re-opened-biosimilars-inn-debate-11th-ega-symposium-on-biosimilar-medicines-suzette-kox-l/) - [International Generic Pharmaceutical Alliance (IGPA) Letter Regarding TGA Guidance Titled “Evaluation of Biosimilars”, 2013](https://www.medicinesforeurope.com/2013/09/18/international-generic-pharmaceutical-alliance-igpa-letter-regarding-tga-guidance-titled-evaluation-of-biosimilars-2013/) - [WHO BQ Proposal - EGA’s perspective, 59th INN Consultation, WHO, Geneva, 14 October 2014](https://www.medicinesforeurope.com/2014/10/14/1928/) - [Labelling & Naming - EBG Perspective, DIA Berlin 2014](https://www.medicinesforeurope.com/2014/12/03/labelling-naming-ebg-perspective-dia-berlin-2014/) - [French Parliament Public Hearing on Biosimilar Medicines, Paris, 29 January 2015 - Intervention from EMA Spokesperson Camille Vleminckx](https://www.medicinesforeurope.com/2015/01/29/french-parliament-public-hearing-on-biosimilar-medicines-paris-29-january-2015-intervention-from-ema-spokesperson-camille-vleminckx/) - [Considerations on WHO’s BQ Proposal - Joerg Windisch, 60th INN Consultation WHO, Geneva, 13 April 2015 (PPT)](https://www.medicinesforeurope.com/2015/04/13/considerations-on-whos-bq-proposal-joerg-windisch-60th-inn-consultation-who-geneva-13-april-2015-ppt/) - [The Science of Extrapolation - Martina Weise, EBG Biosimilars 2015, London (PPT)](https://www.medicinesforeurope.com/2015/04/23/test-article-h/) - To view the full presentation, please click here. Part I of II Part II of II - [EMA & Biosimilar Update: Trends from marketing authorisation applications, scientific advice procedures and policies - Peter Richardson, EBG Biosimilars 2015, London (PPT)](https://www.medicinesforeurope.com/2015/04/24/ema-biosimilar-update-trends-from-marketing-authorisation-applications-scientific-advice-procedures-and-policies-peter-richardson-ebg-biosimilars-2015-london-ppt/) - [Investing in People Centred Health Service Delivery - Paul Cornes, Riga Health Conference - How to Improve Health Systems Through Technology? 29-30 June 2015, Riga, Latvia (PPT)](https://www.medicinesforeurope.com/2015/06/29/investing-in-people-centred-health-service-delivery-paul-cornes-riga-health-conference-how-to-improve-health-systems-through-technology-29-30-june-2015-riga-latvia-ppt/) - [EGA-EBG Considerations on WHO’s BQ Proposal - Suzette Kox, WHO INN Open Session with Stakeholders, Geneva, 13 October 2015 (PPT)](https://www.medicinesforeurope.com/2015/10/13/ega-ebg-considerations-on-whos-bq-proposal-suzette-kox-who-inn-open-session-with-stakeholders-geneva-13-october-2015-ppt/) - [The value of generic medicines](https://www.medicinesforeurope.com/2015/11/26/the-value-of-generic-medicines/) - Read more about the value of generic medicines PDF version or download the presentation PPT version - [Biosimilar Product Labelling](https://www.medicinesforeurope.com/2016/02/02/test-article-k/) - To view the full paper, please click here. - [EGA-EBG Summary Position Regarding the WHO Biologic Qualifier Proposal (INN Working Doc. 14.342)](https://www.medicinesforeurope.com/2016/03/21/ega-ebg-summary-position-regarding-the-who-biologic-qualifier-proposal-inn-working-doc-14-342/) - [Medicines for Europe’s Contribution to WHO’s Biological Qualifier (BQ) Developments (PRESENTATION and SPEECH)](https://www.medicinesforeurope.com/2016/10/18/medicines-for-europes-contribution-to-whos-biological-qualifier-bq-developments/) - 18 October 2016 Suzette Kox Senior Director International Biosimilar Medicines Group - [Biosimilars Handbook (translations)](https://www.medicinesforeurope.com/2016/02/19/biosimilars-handbook/) - This handbook describes the science and technology behind biosimilar medicines, how they are produced and regulated, and many specific questions surrounding them, namely: the terminology used D the meaning of ‘quality, efficacy and safety’ and ‘comparability’ the purposes and methodologies of non-clinical and clinical tests and trials the role of pharmacovigilance and risk management the - [Biosimilar Medicines Handbook (new edition)](https://www.medicinesforeurope.com/2016/04/25/biosimilar-medicines-handbook-new-edition/) - Biosimilar Medicines Handbook (new edition) - [Value Added Medicines: Rethink, reinvent & optimise medicines - 31 May 2016 at European Parliament](https://www.medicinesforeurope.com/2016/05/18/2291/) - [Christian Siebert (European Commission) speech at the Biosimilar Medicines conference 2016](https://www.medicinesforeurope.com/2016/04/28/christian-siebert-european-commission-speech-at-the-ebg-conference-2016/) - [Universal Access to Health 2015 Event - 5 May 2015 - Video Playlist](https://www.medicinesforeurope.com/2015/05/05/universal-access-to-health-event/) - One year after the EU elections: Take home message of Adrian van den Hoven: Interview with Alojz Peterle MEP Interview with Karin Kadenbach MEP Interview with Nicola Bedlington, Secretary General - EPF Interview with Frank Vanbiervliet, European Project Coordinator - Doctors of the World Interview with Menno Aarnout, Executive Director - AIM - [Jacek Glinka - EGA Becomes Medicines for Europe](https://www.medicinesforeurope.com/2016/03/10/jacek-glinka-ega-becomes-medicines-for-europe/) - [EGA Vision - Nick Haggar (EGA's President)](https://www.medicinesforeurope.com/2015/04/14/ega-vision-nick-haggar-egas-president/) - [EGA Supports the Fight Against Antimicrobial Resistance](https://www.medicinesforeurope.com/2015/11/17/ega-supports-the-fight-against-antimicrobial-resistance/) - [KPMG Report: Advice on the implementation of EU-Directive 2011/62/EU](https://www.medicinesforeurope.com/2013/02/22/test-article-v/) - According to the European Commission (hereinafter ‘EC’) of the European Union (hereinafter ‘EU’), the threat to public health and safety from falsified medicinal products is on the rise: ‘Falsified medicines […] are a major threat to public health and safety. As falsifications become more sophisticated, the risk of falsified medicines reaching patients in the EU - [EGA Vision 2015](https://www.medicinesforeurope.com/2015/07/19/test-factsheet-1/) - To view the full report, please click here. - [EMA Information Session on Biosimilars for Patients and Healthcare Professionals](https://www.medicinesforeurope.com/2015/03/05/ema-information-session-on-biosimilars-for-patients/) - [Regulatory Efficiency Report](https://www.medicinesforeurope.com/2015/03/10/regulatory-efficiency-report/) - To view the full report, please click here. - [EMA mAb Workshop - Stepwise Approach to Non-Clinical Program](https://www.medicinesforeurope.com/2013/10/31/ema-mab-workshop-stepwise-approach-to-non-clinical-program/) - [EMA mAb Workshop - Quality Target Product Profile in the Development of a Biosimilar](https://www.medicinesforeurope.com/2013/10/31/ema-mab-workshop-quality-target-product-profile-in-the-development-of-a-biosimilar/) - [EMA mAb Workshop - Guideline on Similar Biological Medicinal Products](https://www.medicinesforeurope.com/2013/10/31/ema-mab-workshop-guideline-on-similar-biological-medicinal-products/) - [Launch of European Value Added medicines (EVA), a new EGA sector group, will deliver efficiency](https://www.medicinesforeurope.com/2015/06/12/launch-of-european-value-added-medicines-eva-a-new-ega-sector-group-will-deliver-efficiency/) - Brussels - The European Generic and Biosimilar medicines Association (EGA) announced today the launch of the European Value Added medicines (EVA) group, a new sector group of the EGA. “EVA will be the leading voice of a broad-multi-stakeholder coalition supporting value-added medicines in Europe, engaging with patients and healthcare professionals in response to their needs and ## Pages - [Medicines for Europe](https://www.medicinesforeurope.com/) - Medicines For Europe (formerly EGA) represents the European generic, biosimilar and valued added pharmaceutical industries. - [Key topics - REGULATORY AND LEGAL FRAMEWORK](https://www.medicinesforeurope.com/key-topics-regulatory-and-legal-framework/) - [WHO WE ARE - BECOME A MEMBER](https://www.medicinesforeurope.com/who-we-are-become-a-member/) - [WHO WE ARE - STRUCTURE](https://www.medicinesforeurope.com/who-we-are-structure/) - [Sustainability Academy webinars](https://www.medicinesforeurope.com/sustainability-academy-webinars/) - 14 January 2026 Omnibus I – Understanding the EU’s Simplification Package and What It Means for the Off-Patent Sector REGISTER HERE Past Sustainability Academy webinars: 23 October 2025 Life Cycle Assessment (LCA): Understanding its role – and why it’s not a good fit for off-patent medicines This session explored the theory and practical implications - [Key topics - SUSTAINABILITY](https://www.medicinesforeurope.com/key-topics-environment/) - [PRIORITIES](https://www.medicinesforeurope.com/manifesto-2024/) - [Key topics - MEDICINE SHORTAGES](https://www.medicinesforeurope.com/key-topics-medicine-shortages/) - [Key topics - INDUSTRIAL POLICY](https://www.medicinesforeurope.com/key-topics-industrial-policy/) - [Key topics - FALSIFIED MEDICINES](https://www.medicinesforeurope.com/key-topics-falsified-medicines/) - [Key topics - ANTIMICROBIAL RESISTANCE](https://www.medicinesforeurope.com/key-topics-antimicrobial-resistance/) - [Key topics - ACCESS](https://www.medicinesforeurope.com/key-topics-access/) - [WHO WE ARE - ABOUT MEDICINES FOR EUROPE](https://www.medicinesforeurope.com/medicines-for-europe/) - [Medicines for Europe](https://www.medicinesforeurope.com/biosimilar-medicines/who-we-are/) - [Who we are](https://www.medicinesforeurope.com/value-added-medicines/who-we-are/) - [Medicines for Europe](https://www.medicinesforeurope.com/generic-medicines/who-we-are/) - [Become a member](https://www.medicinesforeurope.com/become-a-member/) - Medicines for Europe is the official trade association for the European generic, biosimilar and value-added pharmaceutical industries, representing, supporting and developing our common scientific and technical interests within the European Union, Europe as a whole as well as between the European Union and third countries Why become a member Medicines for Europe provides many benefits - [WHO WE ARE - DISCLOSURE](https://www.medicinesforeurope.com/who-we-are-disclosure/) - [Podcast - Conversations on EU Pharma](https://www.medicinesforeurope.com/podcast/) - Welcome to Conversations on EU Pharma! The podcast created by Medicines for Europe that explores the off-patent medicines world. - [Biosimilar medicines - homepage](https://www.medicinesforeurope.com/biosimilar-medicines/) - Biosimilar Medicines Today Biosimilar medicines were invented in Europe 20 years ago to address the pressing need for better access to biopharmaceuticals in Europe. For example, a recent study demonstrated the inequity in access to biologic medicines for treatment of rheumatoid arthritis because lower income countries in Europe cannot afford such therapies. However even within high-income - [Generic medicines - homepage](https://www.medicinesforeurope.com/generic-medicines/) - Generic medicines today The generic medicines industry is at the heart of public health delivery. This industry provides essential medicines that European patients, healthcare professionals and healthcare systems rely on to treat most acute and chronic ailments ranging from cardiovascular, to diabetes and even to cancer. Generic medicines have transformed healthcare in Europe by significantly - [WHO WE ARE - MEMBERS](https://www.medicinesforeurope.com/who-we-are-members/) - [Value added medicines - homepage](https://www.medicinesforeurope.com/value-added-medicines/) - Value Added Medicines Today Value Added Medicines contribute to addressing unmet patient needs. Moving from a one-size-fits-all to a much more tailored and patient specific approach, value added medicines are one of the key components of the customisation of healthcare. By answering patients' unmet needs, they represent a new horizon for those who are currently - [WHO WE ARE - CODE OF CONDUCT](https://www.medicinesforeurope.com/who-we-are-code-of-conduct/) - [WHO WE ARE - OUR VALUES – OUR 5 PILLARS](https://www.medicinesforeurope.com/who-we-are-our-values-our-5-pillars/) - [WHO WE ARE - PURPOSE AND OBJECTIVES](https://www.medicinesforeurope.com/who-we-are-purpose-and-objectives/) - [OUR VALUES – OUR 5 PILLARS](https://www.medicinesforeurope.com/our-values-our-5-pillars/) - [Events](https://www.medicinesforeurope.com/events/) - Medicines for Europe - upcoming events - [Privacy Policy](https://www.medicinesforeurope.com/privacy-policy/) - Medicines for Europe Events In accordance with our privacy policy and the EU GDPR regulation, your data will be processed and sent to the event organisers for registration at the selected event. 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Quod quidem quale sit, etiam in bestiis quibusdam animadverti potest, quae ex se natos ita amant ad quoddam tempus et ab eis ita amantur ut facile earum sensus appareat. - [Register](https://www.medicinesforeurope.com/register/) - [wpmem_form register] - [No Access](https://www.medicinesforeurope.com/no-access/) - [dlm_no_access] ## Team Members - [James Burt](https://www.medicinesforeurope.com/team_member/james-burt/) - [Nivedita Valentine](https://www.medicinesforeurope.com/team_member/nivedita-valentine/) - [Benjamin May](https://www.medicinesforeurope.com/team_member/benjamin-may/) - [Adrian van den Hoven](https://www.medicinesforeurope.com/team_member/adrian-van-den-hoven-3/) - [Kristof Roox](https://www.medicinesforeurope.com/team_member/kristof-roox-2/) - [Marcel van Raaij](https://www.medicinesforeurope.com/team_member/marcel-van-raaij/) - [Sven Bostyn](https://www.medicinesforeurope.com/team_member/sven-bostyn-2/) - [George Moore](https://www.medicinesforeurope.com/team_member/george-moore/) - [Sergio Napolitano](https://www.medicinesforeurope.com/team_member/sergio-napolitano-5/) - [Agnieszka Deeg-Tyburska](https://www.medicinesforeurope.com/team_member/agnieszka-deeg-tyburska-2/) - [Tomos Shillingford](https://www.medicinesforeurope.com/team_member/tomos-shillingford-2/) - [Ingrid Sollerer](https://www.medicinesforeurope.com/team_member/ingrid-sollerer/) - [Bibianne Bon](https://www.medicinesforeurope.com/team_member/bibianne-bon/) - [Falk Nuernberger](https://www.medicinesforeurope.com/team_member/falk-nuernberger/) - [Matthew Royle](https://www.medicinesforeurope.com/team_member/matthew-royle/) - [Christoph de Coster](https://www.medicinesforeurope.com/team_member/christoph-de-coster/) - [Harald Mische](https://www.medicinesforeurope.com/team_member/harald-mische-2/) - [Brian Malkin](https://www.medicinesforeurope.com/team_member/brian-malkin/) - [Stevens & Bolton LLP](https://www.medicinesforeurope.com/team_member/stevens-bolton-llp/) - [Alica Daly](https://www.medicinesforeurope.com/team_member/alica-daly/) - [Jennifer Sunderland](https://www.medicinesforeurope.com/team_member/jennifer-sunderland/) - [Jurgen Figys](https://www.medicinesforeurope.com/team_member/jurgen-figys/) - [Floris ten Have](https://www.medicinesforeurope.com/team_member/floris-ten-have-2/) - [Rainer Becker](https://www.medicinesforeurope.com/team_member/rainer-becker/) - [Raphaël De Coninck](https://www.medicinesforeurope.com/team_member/raphael-de-coninck/) - [Kristin Cooklin](https://www.medicinesforeurope.com/team_member/kristin-cooklin-2/) - [Pinsent Masons](https://www.medicinesforeurope.com/team_member/pinsent-masons/) - [European Patent Office](https://www.medicinesforeurope.com/team_member/european-patent-office/) - [Amaryllis Verhoeven](https://www.medicinesforeurope.com/team_member/amaryllis-verhoeven/) - [Toni Santamaria](https://www.medicinesforeurope.com/team_member/toni-santamaria/) - [Corinna Sundermann](https://www.medicinesforeurope.com/team_member/corinna-sundermann-2/) - [Imre Gonda](https://www.medicinesforeurope.com/team_member/imre-gonda-2/) - [Michael Herschdorfer](https://www.medicinesforeurope.com/team_member/michael-herschdorfer/) - [David Rose](https://www.medicinesforeurope.com/team_member/david-rose/) - [Roberto Romandini](https://www.medicinesforeurope.com/team_member/roberto-romandini-2/) - [Karin Pramberger](https://www.medicinesforeurope.com/team_member/karin-pramberger-2/) - [Christoph Stoller](https://www.medicinesforeurope.com/team_member/christoph-stoller-5/) - [Dr. Stacey Ricci](https://www.medicinesforeurope.com/team_member/dr-stacey-ricci/) - [Dr. rer. nat. Petra Nies, LL.M.](https://www.medicinesforeurope.com/team_member/dr-petra-nies/) - [Murray Aitken](https://www.medicinesforeurope.com/team_member/murray-aitken/) - [Eva Temkin](https://www.medicinesforeurope.com/team_member/eva-temkin/) - [Emer Cooke](https://www.medicinesforeurope.com/team_member/emer-cooke/) - [Usman Khan](https://www.medicinesforeurope.com/team_member/usman-khan/) - [Christoph Stoller](https://www.medicinesforeurope.com/team_member/christoph-stoller-4/) - [Dirk Van Den Steen](https://www.medicinesforeurope.com/team_member/dirk-van-den-steen-2/) - [Isabell Remus](https://www.medicinesforeurope.com/team_member/isabell-remus/) - [European Social Insurance Platform (ESIP) representative](https://www.medicinesforeurope.com/team_member/european-social-insurance-platform-esip-representative/) - [Philippe Van Wilder](https://www.medicinesforeurope.com/team_member/philippe-van-wilder/) - [Floriane Pelon](https://www.medicinesforeurope.com/team_member/floriane-pelon/) - [Maciej Miłkowski](https://www.medicinesforeurope.com/team_member/maciej-milkowski-2/) - [Dr. Thierry Schaeverbeke](https://www.medicinesforeurope.com/team_member/dr-thierry-schaeverbeke/) - [Dr. Holger Neye](https://www.medicinesforeurope.com/team_member/dr-holger-neye/) - [Vera Pataki](https://www.medicinesforeurope.com/team_member/vera-pataki/) - [Ana Hidalgo](https://www.medicinesforeurope.com/team_member/ana-hidalgo/) - [Elena Wolff–Holz](https://www.medicinesforeurope.com/team_member/elena-wolff-holz-3/) - [Kelly Robinson](https://www.medicinesforeurope.com/team_member/kelly-robinson/) - [Niklas Ekman](https://www.medicinesforeurope.com/team_member/niklas-ekman-2/) - [EURORDIS representative (inv)](https://www.medicinesforeurope.com/team_member/eurordis-representative-inv/) - [Government/Payer representative](https://www.medicinesforeurope.com/team_member/government-payer-representative/) - [Anna Rose Welch](https://www.medicinesforeurope.com/team_member/anna-rose-welch-2/) - [Sandra L. Kweder, M.D.](https://www.medicinesforeurope.com/team_member/sandra-l-kweder-m-d/) - [Giorgio Riccò](https://www.medicinesforeurope.com/team_member/giorgio-ricco/) - [TBN](https://www.medicinesforeurope.com/team_member/tbn/) - [Kaisa Immonen](https://www.medicinesforeurope.com/team_member/kaisa-immonen/) - [Shanti Pal](https://www.medicinesforeurope.com/team_member/shanti-pal/) - [Ellen Swanborn](https://www.medicinesforeurope.com/team_member/ellen-swanborn/) - [Dr. Luther Gwaza](https://www.medicinesforeurope.com/team_member/luther-gwaza/) - [Rúna Hauksdóttir Hvannberg](https://www.medicinesforeurope.com/team_member/runa-hauksdottir-hvannberg/) - [Uwe Gudat](https://www.medicinesforeurope.com/team_member/uwe-gudat/) - [Sonia Ribeiro](https://www.medicinesforeurope.com/team_member/sonia-ribeiro/) - [Jan Welink](https://www.medicinesforeurope.com/team_member/jan-welink/) - [Sabine Straus](https://www.medicinesforeurope.com/team_member/sabine-straus/) - [Anjana Pindoria](https://www.medicinesforeurope.com/team_member/anjana-pindoria/) - [Sarah Faircliffe](https://www.medicinesforeurope.com/team_member/sarah-faircliffe/) - [Peter Bachmann](https://www.medicinesforeurope.com/team_member/peter-bachmann/) - [Laure Geslin](https://www.medicinesforeurope.com/team_member/laure-geslin/) - [Andrew Donaldson](https://www.medicinesforeurope.com/team_member/andrew-donaldson/) - [Benedicte Lunddahl](https://www.medicinesforeurope.com/team_member/benedicte-lunddahl/) - [Remco Munnik](https://www.medicinesforeurope.com/team_member/remco-munnik/) - [Koosje van Lessen Kloeke](https://www.medicinesforeurope.com/team_member/koosje-van-lessen-kloeke/) - [Isabel Chicharo](https://www.medicinesforeurope.com/team_member/isabel-chicharo/) - [Stephanie Kohl](https://www.medicinesforeurope.com/team_member/stephanie-kohl/) - [Juan García-Burgos](https://www.medicinesforeurope.com/team_member/juan-garcia-burgos/) - [Geraldine Moore](https://www.medicinesforeurope.com/team_member/geraldine-moore/) - [Koen Laenen](https://www.medicinesforeurope.com/team_member/koen-laenen/) - [Adrian van den Hoven](https://www.medicinesforeurope.com/team_member/adrian-van-den-hoven-2/) - [Laura Oliveira Santamaria](https://www.medicinesforeurope.com/team_member/laura-oliveira-santamaria/) - [Georg Neuwirther](https://www.medicinesforeurope.com/team_member/georg-neuwirther/) - [Astrid Krupp](https://www.medicinesforeurope.com/team_member/astrid-krupp/) - [Andrzej Rys, Dr](https://www.medicinesforeurope.com/team_member/andrzej-rys/) - [Lei Zhang, Ph.D.](https://www.medicinesforeurope.com/team_member/lei-zhang-ph-d/) - [Esther Martinez](https://www.medicinesforeurope.com/team_member/esther-martinez/) - [Stuart Izod](https://www.medicinesforeurope.com/team_member/stuart-izod/) - [Peter Arlett](https://www.medicinesforeurope.com/team_member/peter-arlett/) - [Pavel Farkas](https://www.medicinesforeurope.com/team_member/pavel-farkas/) - [Kora Doorduyn-van der Stoep](https://www.medicinesforeurope.com/team_member/kora-doorduyn-van-der-stoep-2/) - [Lorraine Nolan](https://www.medicinesforeurope.com/team_member/lorraine-nolan/) - 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Desai](https://www.medicinesforeurope.com/team_member/jeremy-b-desai/) - [Enrique Ordieres](https://www.medicinesforeurope.com/team_member/enrique-ordieres/) - [Elisabeth Stampa](https://www.medicinesforeurope.com/team_member/elisabeth-stampa/) - [Pierluigi Antonelli](https://www.medicinesforeurope.com/team_member/pierluigi-antonelli/) - [Rabia Khan](https://www.medicinesforeurope.com/team_member/rabia-khan/) - [Heikki Pälve](https://www.medicinesforeurope.com/team_member/heikki-palve/) - [Jaime Espín](https://www.medicinesforeurope.com/team_member/jaime-espin/) - [Michele Uda](https://www.medicinesforeurope.com/team_member/michele-uda-2/) - [Matthias Diessel](https://www.medicinesforeurope.com/team_member/matthias-diessel/) - [Constance Vercambre](https://www.medicinesforeurope.com/team_member/constance-vercambre-2/) - [Jody Cox](https://www.medicinesforeurope.com/team_member/jody-cox/) - [Manuel Campolini](https://www.medicinesforeurope.com/team_member/manuel-campolini/) - [Ravinder Chahil](https://www.medicinesforeurope.com/team_member/ravinder-chahil/) - [Ravinder Chahil](https://www.medicinesforeurope.com/team_member/ravinder-chahil-2/) - [Ber Oomen](https://www.medicinesforeurope.com/team_member/ber-oomer/) - [Michele Uda](https://www.medicinesforeurope.com/team_member/michele-uda/) - [Abhijit Barve](https://www.medicinesforeurope.com/team_member/abhijit-barve/) - [Ferdinand Breedveld](https://www.medicinesforeurope.com/team_member/ferdinand-breedveld-professor/) - [Matthias Liefner](https://www.medicinesforeurope.com/team_member/matthias-liefner/) - [Gérard Dossmann](https://www.medicinesforeurope.com/team_member/gerard-dossmann/) - [Michael Koenig](https://www.medicinesforeurope.com/team_member/lowri-evans/) - [Ivana Knezevic, MD, PhD](https://www.medicinesforeurope.com/team_member/ivana-knezevic-phd/) - [Cornelia Ulm](https://www.medicinesforeurope.com/team_member/cornelia-ulm/) - [Matthew Hall](https://www.medicinesforeurope.com/team_member/matthew-hall/) - [Ana Hidalgo-Simon, MD, PhD](https://www.medicinesforeurope.com/team_member/ana-hidalgo-simon/) - [Sergio Napolitano](https://www.medicinesforeurope.com/team_member/sergio-napolitano/) - [Leon van Aerts](https://www.medicinesforeurope.com/team_member/leon-van-aerts/) - [Mark Levick, MD PhD](https://www.medicinesforeurope.com/team_member/mark-levick-phd/) - [Francesco Florindi](https://www.medicinesforeurope.com/team_member/francesco-florindi/) - [Elena Wolff-Holz, MD](https://www.medicinesforeurope.com/team_member/elena-wolff-holz-md-phd/) - [Patrice Monain](https://www.medicinesforeurope.com/team_member/patrice-monain/) - [Daniela Marreco Cerqueira](https://www.medicinesforeurope.com/team_member/daniela-marreco-cerqueira/) - [Sascha Stolzenberger](https://www.medicinesforeurope.com/team_member/sascha-stolzenberger/) - [Gyorgy Thaler, Dr.](https://www.medicinesforeurope.com/team_member/gyorgy-thaler-dr/) - [Tim Clark, Dip. Stat., PhD](https://www.medicinesforeurope.com/team_member/tim-clark-dip-stat-phd/) - [Mathias Flume](https://www.medicinesforeurope.com/team_member/mathias-flume-dr/) - [Klaus Martin](https://www.medicinesforeurope.com/team_member/klaus-martin/) - [Stephen Vinter](https://www.medicinesforeurope.com/team_member/stephen-vinter/) - [Barbara Claus](https://www.medicinesforeurope.com/team_member/barbara-claus/) - [Sophie Colyn](https://www.medicinesforeurope.com/team_member/sophie-colyn/) - [Ronny Gal](https://www.medicinesforeurope.com/team_member/ronny-gal/) - [Julie Maréchal-Jamil](https://www.medicinesforeurope.com/team_member/julie-marechal-jamil/) - [Karl Heinz Emmert, PhD](https://www.medicinesforeurope.com/team_member/karl-heinz-emmert-phd/) - [Younjoo Park, PhD](https://www.medicinesforeurope.com/team_member/younjoo-park-phd/) - [Leah Christl, PhD](https://www.medicinesforeurope.com/team_member/leah-christl-phd/) - [Valerie Field](https://www.medicinesforeurope.com/team_member/valerie-field/) - [Susana Almeida, Dr.](https://www.medicinesforeurope.com/team_member/susana-almeida-dr-inv/) - [Iris Grossman, PhD](https://www.medicinesforeurope.com/team_member/iris-grossman/) - [Jean-Louis Robert](https://www.medicinesforeurope.com/team_member/jean-louis-robert/) - [Phil Tregunno](https://www.medicinesforeurope.com/team_member/phil-tregunno/) - [Lynne Byers](https://www.medicinesforeurope.com/team_member/lynne-byers/) - [Kevin Airey B.Sc (Chem), M.Sc (Pharm)](https://www.medicinesforeurope.com/team_member/kevin-airey/) - [Ignacio Moreno](https://www.medicinesforeurope.com/team_member/ignacio-moreno/) - [Marieke Van Dalen](https://www.medicinesforeurope.com/team_member/marieke-van-daelen/) - [Julia Appelskog](https://www.medicinesforeurope.com/team_member/julia-appelskog/) - [Christa Wirthumer-Hoche, Dr. techn., Dipl. Ing.](https://www.medicinesforeurope.com/team_member/christa-wirthumer-hoche-dr-techn-dipl-ing/) - [Michael Forstner](https://www.medicinesforeurope.com/team_member/michael-forstner/) - [Pierre Meulien](https://www.medicinesforeurope.com/team_member/pierre-meulien/) - [Joan Boye](https://www.medicinesforeurope.com/team_member/joan-boye/) - [Christin Olofsson](https://www.medicinesforeurope.com/team_member/christin-olofsson/) - [Mark Birse](https://www.medicinesforeurope.com/team_member/mark-birse/) - [Constant van Belkum](https://www.medicinesforeurope.com/team_member/constant-van-belkum/) - [Hugo Hurts](https://www.medicinesforeurope.com/team_member/hugo-hurts/) - [Tomas Salmonson](https://www.medicinesforeurope.com/team_member/tomas-salmonson/) - [Nicole Lang](https://www.medicinesforeurope.com/team_member/nicole-lang/) - [June Raine, Dr.](https://www.medicinesforeurope.com/team_member/june-raine-dr/) - [John Barber](https://www.medicinesforeurope.com/team_member/john-barber/) - [Jamie Wilkinson, MSc, PGCert, MPharm (Hons), Dip HE, FRSPH](https://www.medicinesforeurope.com/team_member/jamie-wilkinson-msc-pgcert-mpharm-hons-dip-he-frsph/) ## Team - [teamLAC20](https://www.medicinesforeurope.com/team/teamlac20/) - [teamBIOS20](https://www.medicinesforeurope.com/team/teambios20/) - [teamPHV20](https://www.medicinesforeurope.com/team/teamphv20/) - [teamRAC20](https://www.medicinesforeurope.com/team/teamrac20/) - [teamVAM19](https://www.medicinesforeurope.com/team/teamvam19/) - [teamANNUAL19](https://www.medicinesforeurope.com/team/teamannual19/) - [teamLAC19](https://www.medicinesforeurope.com/team/teamlac19/) - [teamBIOS19](https://www.medicinesforeurope.com/team/teambios19/) - [teamPHV19](https://www.medicinesforeurope.com/team/teamphv19/) - [teamRAC19](https://www.medicinesforeurope.com/team/teamrac19/) - [teamVAM18](https://www.medicinesforeurope.com/team/teamvam18/) - [teamANNUAL18](https://www.medicinesforeurope.com/team/teamannual18/) - [teamBIOS18](https://www.medicinesforeurope.com/team/teambios18/) - [teamLAC18](https://www.medicinesforeurope.com/team/teamlac18/) - [teamRAC18](https://www.medicinesforeurope.com/team/teamrac18/) - [teamPHV18](https://www.medicinesforeurope.com/team/teamphv18/) - [teamvam17](https://www.medicinesforeurope.com/team/teamvam17/) - [Annual17](https://www.medicinesforeurope.com/team/annual17/) - [Bios17](https://www.medicinesforeurope.com/team/bios17/) - [LAC17](https://www.medicinesforeurope.com/team/lac17/) - [rac17](https://www.medicinesforeurope.com/team/rac17/) - [teamphv17](https://www.medicinesforeurope.com/team/teamphv17/) ## Slides - [Generic Medicines Market Review 2025](https://www.medicinesforeurope.com/slide/generic-medicines-market-review-2025/) - Generic Medicines Market Review 2025 Report that provides an overview on the different policies that are currently in place for generic medicines in Europe OPEN REPORT - [Biosimilar Medicines Market Review 2025](https://www.medicinesforeurope.com/slide/biosimilar-medicines-market-review-2025/) - Biosimilar Medicines Market Review 2025 Report that provides an overview on the different policies that are currently in place for biosimilar medicines in Europe OPEN REPORT - [#USEYOURVOTE](https://www.medicinesforeurope.com/slide/useyourvote/) - #USEYOURVOTE READ MORE - [Beneath the Surface: Unravelling the True Value of Generic Medicines](https://www.medicinesforeurope.com/slide/beneath-the-surface-unravelling-the-true-value-of-generic-medicines/) - Beneath the Surface: Unravelling the True Value of Generic Medicines READ MORE - [#Levelling up the European Health Union](https://www.medicinesforeurope.com/slide/levelling-up-the-european-health-union/) - #Levelling up the European Health Union READ MORE - [Medicines Procurement Reform](https://www.medicinesforeurope.com/slide/medicines-procurement-reform/) - Medicines Procurement Reform Strengthening Supply Security through EU Guidance OPEN POSITION PAPER - [IQVIA – ASSESSING THE BIOSIMILAR VOID](https://www.medicinesforeurope.com/slide/iqvia-assessing-the-biosimilar-void/) - Assessing the Biosimilar Void Achieving Sustainable Levels of Biosimilar Competition in Europe More details - [5th
VALUE ADDED MEDICINES CONFERENCE](https://www.medicinesforeurope.com/slide/5thvalue-added-medicines-conference/) - 5th VALUE ADDED MEDICINES CONFERENCE THE HOTEL, BRUSSELS 7 NOVEMBER 2023 More details - [Conversations on EU PHARMA](https://www.medicinesforeurope.com/slide/conversations-on-eu-pharma/) - Conversations on EU PHARMA OPEN PODCAST - [LESSONS LEARNED FROM COVID-19](https://www.medicinesforeurope.com/slide/lessons-learned-from-covid-19/) - LESSONS LEARNED FROM COVID-19 After several months of crisis, we can discern some of the key lessons learned from COVID-19 for the future of pharmaceutical policy in Europe. More details Watch Webinar - [creativeceutical](https://www.medicinesforeurope.com/slide/creativeceutical/) - New pricing models for generic medicines to ensure long-term healthy competitiveness in Europe OPEN REPORT INFOGRAPHIC STRATEGIC RECOMMENDATIONS - [Filling the gap](https://www.medicinesforeurope.com/slide/filling-the-gap/) - Filling the gap How off-patent medicines can improve the equity and quality of cancer care REPORT FACTSHEET PRESS RELEASE - [Creating a European ecosystem](https://www.medicinesforeurope.com/slide/creating-a-european-ecosystem/) - Creating a European ecosystem for safe, timely and affordable patient-centric innovation WHITE PAPER FACTSHEET PRESS RELEASE - [Advancing Medicines Repurposing in the EU](https://www.medicinesforeurope.com/slide/advancing-medicines-repurposing-in-the-eu/) - Advancing Medicines Repurposing in the EU OPEN DOCUMENT - [21st Regulatory Affairs and Pharmacovigilance Virtual Conference](https://www.medicinesforeurope.com/slide/21st-regulatory-affairs-and-pharmacovigilance-virtual-conference/) - 21st REGULATORY AFFAIRS AND PHARMACOVIGILANCE VIRTUAL CONFERENCE 6 WEBINARS 24-26-31 JANUARY AND 2-3-9 FEBRUARY 2022 More details - [VAM webinars report](https://www.medicinesforeurope.com/slide/vam-webinars-report/) - Webinars Report Empowering the healthcare community by improving existing treatments23-24-25 February 2021 Open report - [missing link](https://www.medicinesforeurope.com/slide/missing-link/) - WEBINAR The missing link in the Digital Health Strategy: connecting European and Member States medicines agencies 15 January 2021 - 14:00 (CET) Webinar Registration - [Webinar: Anatomy of a failure to launch](https://www.medicinesforeurope.com/slide/webinar-anatomy-of-a-failure-to-launch/) - White Paper: Anatomy of a failure to launch: A review of barriers to generic and biosimilar market entry and the use of competition law as a remedy OPEN WHITE PAPER OPEN PRESS RELEASE - [Global Biosimilar week](https://www.medicinesforeurope.com/slide/global-biosimilar-week/) - Participate in the first ever Global Biosimilars Week between the 16 – 20 Nov. Visit official website - [Generic medicines - subgroup header](https://www.medicinesforeurope.com/slide/generic-medicines-static/) - The Generic Medicines Group is a sector group of Medicines for Europe, representing the generic medicines developers and manufacturers, which provide high-quality cost-competitive medicines to millions of patients in Europe and around the world. About us - [Country Scorecards for Biosimilar Sustainability](https://www.medicinesforeurope.com/slide/country-scorecards-for-biosimilar-sustainability/) - Country Scorecards for Biosimilar Sustainability More details - [Perceptions and recommendations of physicians/KOLs on value added medicines](https://www.medicinesforeurope.com/slide/perceptions-and-recommendations-of-physicians-kols-on-value-added-medicines/) - Perceptions and recommendations of physicians/KOLs on value added medicines European Medical Advisory Board on Value Added Medicines Open report Open infographic - [Medicines for Europe Executive members message on COVID-19](https://www.medicinesforeurope.com/slide/medicines-for-europe-executive-members-message-on-covid-19/) - Medicines for Europe Executive members message on COVID-19 Watch video - [Stronger together in the fight against COVID19](https://www.medicinesforeurope.com/slide/stronger-together-in-the-fight-against-covid19/) - A statement from the President on COVID-19 Read more - [COVID-19](https://www.medicinesforeurope.com/slide/covid-19/) - Key Topics: COVID-19 Medicines for Europe urge immediate action EU wide to ensure supply of essential medicines to health systems, hospitals and patients in Europe. The global supply chain must continue to operate. More details - [ANNUAL MEDICINES FOR EUROPE AND IGBA CONFERENCE](https://www.medicinesforeurope.com/slide/annual-medicines-for-europe-and-igba-conference/) - ANNUAL MEDICINES FOR EUROPE AND IGBA CONFERENCE DIVANI APOLLON HOTEL, ATHENS 17-19 JUNE 2020 More details - [18th BIOSIMILAR MEDICINES CONFERENCE](https://www.medicinesforeurope.com/slide/18th-biosimilar-medicines-conference/) - 18th BIOSIMILAR MEDICINES CONFERENCE HILTON HOTEL, AMSTERDAM 17-18 SEPTEMBER 2020 More details - [Key topics: medicines shortages](https://www.medicinesforeurope.com/slide/key-topics-medicines-shortages/) - Key Topics: Medicines Shortages Generic medicines have proven to be pivotal in increasing patient access and preventing medicine shortages through increased choice and availability of treatments. More details - [Uocoming events](https://www.medicinesforeurope.com/slide/uocoming-events/) - Upcoming Events > LATEST DEVELOPMENTS > MARKET TRENDS > LEADING EXPERTS > OPEN EXCHANGE View all our Events - [Unlocking the potential of patient-centric continuous innovation: case studies for value added medicines](https://www.medicinesforeurope.com/slide/unlocking-the-potential-of-patient-centric-continuous-innovation-case-studies-for-value-added-medicines/) - Unlocking the potential of patient-centric continuous innovation: case studies for value added medicines WEBINAR 11th September 5 - 6pm CET More details - [TOGETHER FOR HEALTH](https://www.medicinesforeurope.com/slide/together-for-health/) - TOGETHER FOR HEALTH SHAPING A PHARMACEUTICAL POLICY THAT DELIVERS ON PATIENT ACCESS view our policy priorities - [Unlock the potential of patient - centric continuous innovation](https://www.medicinesforeurope.com/slide/unlock-the-potential-of-patient-centric-continuous-innovation/) - Unlock the potential of patient - centric continuous innovation Case Studies for Value Added Medicines Open report Press release - [15th LEGAL AFFAIRS CONFERENCE](https://www.medicinesforeurope.com/slide/15th-legal-affairs-conference/) - 15th LEGAL AFFAIRS CONFERENCE HOTEL OKURA, AMSTERDAM 26-27 MARCH 2019 More details - [SPC MANUFACTURING WAIVER](https://www.medicinesforeurope.com/slide/spc-manufacturing-waiver/) - SPC MANUFACTURING WAIVER For quicker access to medicines for patients www.spcwaiver.com - [14th Legal Affairs Conference](https://www.medicinesforeurope.com/slide/14th-legal-affairs-conference/) - 14th LEGAL AFFAIRS CONFERENCE WITH 24 APRIL NETWORKING DINNER WITH LEGAL EXPERTS LONDON, GRANGE TOWER BRIDGE HOTEL 25 APRIL 2018 More details - [bios2018](https://www.medicinesforeurope.com/slide/bios2018/) - 16th BIOSIMILAR MEDICINES CONFERENCE BIOSIMILAR MEDICINES: UNLOCKING THE FULL POTENTIAL OF BIOLOGICS LONDON, GRANGE TOWER BRIDGE HOTEL 26-27 APRIL 2018 More details - [ACCESS TO MEDICINES: BETTER CARE FOR MORE PATIENTS](https://www.medicinesforeurope.com/slide/access-to-medicines-better-care-for-more-patients/) - ACCESS TO MEDICINES: BETTER CARE FOR MORE PATIENTS www.accesstomedicines.eu - [Medicines for Europe announces new President, launches Access to Medicines campaign](https://www.medicinesforeurope.com/slide/medicines-for-europe-announces-new-president-launches-access-to-medicines-campaign/) - Medicines for Europe announces new President, launches Access to Medicines campaign Read more - [Biosimilars for Oncologists. What you need to know](https://www.medicinesforeurope.com/slide/biosimilars-for-oncologists-what-you-need-to-know/) - Biosimilars for Oncologists. What you need to know ESMO 2017 Industry Satellite Symposium FRIDAY 8 SEPTEMBER 2017 18:00-20:00 PAMPLONA AUDITORIUM, HALL 4 IFEMA FERIA DE MADRID, SPAIN More details - [tweetup with Jacek Glinka](https://www.medicinesforeurope.com/slide/tweetup-with-jacek-glinka/) - Joint 23rd Medicines for Europe and 20th IGBA Annual Conferencece EVERYTHING YOU ALWAYS WANTED TO KNOW ABOUT MEDICINES BUT WERE AFRAID TO ASK Friday 16 June 2017 | 12.00 - 12:45 (CET) Connect by using the hashtag #AskJacekGlinka - [Medicines for Europe Country Specific Market Access Policies](https://www.medicinesforeurope.com/slide/medicines-for-europe-country-specific-market-access-policies/) - Medicines for Europe Country Specific Market Access Policies 2017 Open - [The Impact of Biosimilar Competition in Europe](https://www.medicinesforeurope.com/slide/the-impact-of-biosimilar-competition-in-europe/) - The Impact of Biosimilar Competition in Europe QuintilesIMS report Open - [Biosimilars in the EU](https://www.medicinesforeurope.com/slide/biosimilars-in-the-eu/) - Biosimilars in the EU Information guide for healthcare professionals Prepared jointly by the European Medicines Agency and the European Commission Open - [UAH2017](https://www.medicinesforeurope.com/slide/uah2017/) - Universal Access to Health, How can WE contribute? 27 April 2017 Renaissance Brussels Hotel REGISTER HERE - [European Commission Question & Answer](https://www.medicinesforeurope.com/slide/european-commission-question-answer/) - European Commission Question & Answer What I need to know about Biosimilar Medicines INFORMATION FOR PATIENTS Open - [Season’s Greetings](https://www.medicinesforeurope.com/slide/seasons-greetings/) - [Pharma CMO Summit](https://www.medicinesforeurope.com/slide/pharma-cmo-summit/) - PHARMA CMO SUMMIT 12th DECEMBER 2016 Ramada Hotel Alexanderplatz / Berlin Preparing Pharmaceutical CMOs & CPOs for Cost-Effective Serialisation Compliance for EU FMD and US DSCSA Read More - [Top 10 reasons to Become a Member of Medicines for Europe](https://www.medicinesforeurope.com/slide/top-10-reasons-to-become-a-member-of-medicines-for-europe/) - Top 10 reasons to Become a Member of Medicines for Europe Read More - [Biosimilar Medicines for Rheumatologists: Understanding the Science of Extrapolation](https://www.medicinesforeurope.com/slide/httpwww-medicinesforeurope-comwp-contentuploads20160520160518-eular-biosimilar-medicines-group-satellite-programme-booklet-pdf/) - Biosimilar Medicines for Rheumatologists: Understanding the Science of Extrapolation London, 10 June 2016 MORE INFO - [Value Added Medicines: Rethink, Reinvent & Optimise Medicines, Improving Patient Health & Access](https://www.medicinesforeurope.com/slide/value-added-medicines-rethink-reinvent-optimise-medicines-improving-patient-health-access/) - Value Added Medicines: Rethink, Reinvent & Optimise Medicines, Improving Patient Health & Access European Parliament, 31 May 2016 MORE INFO - [Value added medicines - subgroup header](https://www.medicinesforeurope.com/slide/value-added-medicines-static/) - The Value Added Medicines Group is a sector group of Medicines for Europe which aims to optimise, rethink and reinvent medicines based on known molecules and by bringing untapped innovation to improve care delivery. About us - [Jacek Glinka](https://www.medicinesforeurope.com/slide/jacek-glinka/) - Jacek Glinka Medicines for Europe President Jacek Glinka on why EGA has become Medicines for Europe - [Value added medicines](https://www.medicinesforeurope.com/slide/value-added-medicines/) - OUR VISION The Value Added Medicines Group is a sector group of Medicines for Europe which aims to optimise, rethink and reinvent medicines based on known molecules and by bringing untapped innovation to improve care delivery. About us - [Medicines for Europe](https://www.medicinesforeurope.com/slide/medicines-for-europe/) - OUR VISION Medicines for Europe's vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. About us - [Generic medicines](https://www.medicinesforeurope.com/slide/generics-medicines/) - OUR VISION The Generic Medicines Group is a sector group of Medicines for Europe, representing the generic medicines developers and manufacturers. Through partnership with key EU stakeholders, the generic medicines industry aims to increase access to medicines without increasing the overall treatment cost. About us - [Biosimilar medicines - subgroup header](https://www.medicinesforeurope.com/slide/biosimilar-medicines-static/) - The Biosimilar Medicines Group represents the leading companies developing, manufacturing and marketing biosimilar medicines across Europe. Our members bring competition to the biologic medicines market, thereby increasing access to highly innovative medical treatments to patients in Europe and around the world, and supporting the sustainability of the European healthcare systems. About us - [Biosimilar medicines](https://www.medicinesforeurope.com/slide/biosimilar-medicines/) - OUR VISION The Biosimilar Medicines Group is a sector group of Medicines for Europe, representing the leading companies developing, manufacturing and marketing biosimilar medicines across Europe. Our vision is to provide access to high quality biologic medicines to patients in Europe and worldwide. About us ## Member logos - [Pharos](https://www.medicinesforeurope.com/member-logo/pharos/) - [Pharos](https://www.medicinesforeurope.com/member-logo/pharos-3/) - [VGA (LT)](https://www.medicinesforeurope.com/member-logo/vga-lt/) - [ALMA (Alliance des Médicaments Abordables)](https://www.medicinesforeurope.com/member-logo/gemme/) - [Gedeon Richter Plc.](https://www.medicinesforeurope.com/member-logo/gedeon-richter-ltd/) - [DEMO Pharmaceuticals S.A.](https://www.medicinesforeurope.com/member-logo/demo-pharmaceuticals-s-a/) - [medac pharma production a.s](https://www.medicinesforeurope.com/member-logo/oncomed/) - [ProGenerika (DE)](https://www.medicinesforeurope.com/member-logo/progenerika/) - [Aurobindo Pharma](https://www.medicinesforeurope.com/member-logo/aurobindo-pharma/) - [Samsung Bioepis](https://www.medicinesforeurope.com/member-logo/samsung-bioepis/) - [Medicines for Ireland](https://www.medicinesforeurope.com/member-logo/medicines-for-ireland/) - [TEVA](https://www.medicinesforeurope.com/member-logo/teva/) - [Iperion](https://www.medicinesforeurope.com/member-logo/adamed-2/) - [Pharmanovia](https://www.medicinesforeurope.com/member-logo/pharmanovia/) - [Dr. Reddy’s](https://www.medicinesforeurope.com/member-logo/dr-reddys/) - [Consilient Health](https://www.medicinesforeurope.com/member-logo/consilient-health/) - [Medicines UK (UK)](https://www.medicinesforeurope.com/member-logo/bgma/) - [Olpha](https://www.medicinesforeurope.com/member-logo/olpha/) - [Kent Pharma UK Ltd](https://www.medicinesforeurope.com/member-logo/kent-pharma-uk-ltd/) - [Billev Pharma East](https://www.medicinesforeurope.com/member-logo/billev-pharma-east/) - [FRESENIUS KABI](https://www.medicinesforeurope.com/member-logo/fresenius-kabi/) - [Colonis](https://www.medicinesforeurope.com/member-logo/colonis/) - [Adamed](https://www.medicinesforeurope.com/member-logo/adamed/) - [Alfred E. Tiefenbacher](https://www.medicinesforeurope.com/member-logo/alfred-e-tiefenbacher/) - [FARMOZ](https://www.medicinesforeurope.com/member-logo/farmoz/) - [Adalvo](https://www.medicinesforeurope.com/member-logo/adalvo/) - [BIOCON Biologics](https://www.medicinesforeurope.com/member-logo/biocon/) - [EQUALMED (PT)](https://www.medicinesforeurope.com/member-logo/apogen/) - [Baxter](https://www.medicinesforeurope.com/member-logo/baxter/) - [Extedo](https://www.medicinesforeurope.com/member-logo/extedo/) - [PZPPF (PL)](https://www.medicinesforeurope.com/member-logo/pzppf/) - [BOGIN (NL)](https://www.medicinesforeurope.com/member-logo/bogin/) - [MAGYOSZ (HU)](https://www.medicinesforeurope.com/member-logo/magyosz-hu/) - [Synthon](https://www.medicinesforeurope.com/member-logo/synthon/) - [EGIS](https://www.medicinesforeurope.com/member-logo/egis/) - [Remedica](https://www.medicinesforeurope.com/member-logo/remedica/) - [ESPERANTE Development](https://www.medicinesforeurope.com/member-logo/disphar-international/) - [TOWA](https://www.medicinesforeurope.com/member-logo/towa/) - [Luye Pharma](https://www.medicinesforeurope.com/member-logo/luye-pharma/) - [Farmak](https://www.medicinesforeurope.com/member-logo/farmak/) - [Advanz Pharma](https://www.medicinesforeurope.com/member-logo/advanz-pharma/) - [LUPIN](https://www.medicinesforeurope.com/member-logo/lupin-2/) - [Pharma Patent](https://www.medicinesforeurope.com/member-logo/pharma-patent/) - [medichem](https://www.medicinesforeurope.com/member-logo/medichem/) - [Insud Pharma](https://www.medicinesforeurope.com/member-logo/insud-pharma/) - [Glenmark](https://www.medicinesforeurope.com/member-logo/glenmark/) - [ELPEN Pharmaceuticals](https://www.medicinesforeurope.com/member-logo/elpen-pharmaceuticals/) - [Bluefish Pharmaceuticals](https://www.medicinesforeurope.com/member-logo/bluefish-pharmaceuticals/) - [Cipla](https://www.medicinesforeurope.com/member-logo/cipla/) - [ALKALOID](https://www.medicinesforeurope.com/member-logo/alkaloid/) - [Viatris](https://www.medicinesforeurope.com/member-logo/mylan/) - [JSC Farmak](https://www.medicinesforeurope.com/member-logo/jsc-farmak/) - [West Pharmaceutical Services](https://www.medicinesforeurope.com/member-logo/west-pharmaceutical-services/) - [mAbxience](https://www.medicinesforeurope.com/member-logo/mabxience/) - [Egualia (IT)](https://www.medicinesforeurope.com/member-logo/assogenerici/) - [Polpharma Biologics](https://www.medicinesforeurope.com/member-logo/polpharma-biologics/) - [Polpharma](https://www.medicinesforeurope.com/member-logo/polpharma/) - [Celltrion](https://www.medicinesforeurope.com/member-logo/celltrion/) - [Asphalion](https://www.medicinesforeurope.com/member-logo/asphalion/) - [Farmoz/Tecnimede](https://www.medicinesforeurope.com/member-logo/farmoz-tecnimede/) - [CAFF (CZ)](https://www.medicinesforeurope.com/member-logo/caff/) - [Afaquim (ES)](https://www.medicinesforeurope.com/member-logo/afaquim-es/) - [Farma Norge](https://www.medicinesforeurope.com/member-logo/farma-norge/) - [Italian Biosimilars Group (a group of Egualia) (IT)](https://www.medicinesforeurope.com/member-logo/assogenerici-italian-biosimilars-group/) - [Alvotech](https://www.medicinesforeurope.com/member-logo/alvotech/) - [Alvotech](https://www.medicinesforeurope.com/member-logo/alvotech-2/) - [GENAS (SK)](https://www.medicinesforeurope.com/member-logo/genas-sk/) - [Panhellenic Union of Pharmaceutical Industries (GR)](https://www.medicinesforeurope.com/member-logo/panhellenic-union-of-pharmaceutical-industries/) - [Codema Pharma](https://www.medicinesforeurope.com/member-logo/codema-pharma/) - [ZENTIVA](https://www.medicinesforeurope.com/member-logo/sanofi/) - [SANDOZ](https://www.medicinesforeurope.com/member-logo/sandoz/) - [Medaxes (BE)](https://www.medicinesforeurope.com/member-logo/febelgen/) - [Accord Healthcare](https://www.medicinesforeurope.com/member-logo/accord-healthcare/) - [Sanaclis](https://www.medicinesforeurope.com/member-logo/sanaclis/) - [Pharma Medica Research Inc.](https://www.medicinesforeurope.com/member-logo/pharma-medica-research-inc/) - [Formycon](https://www.medicinesforeurope.com/member-logo/formycon/) - [FGA (FI)](https://www.medicinesforeurope.com/member-logo/fga-2/) - [CEA - PIA (HR)](https://www.medicinesforeurope.com/member-logo/cea-pia-hr/) - [InterGenerika (CH)](https://www.medicinesforeurope.com/member-logo/intergenerika/) - [Probiosimilars (a group of ProGenerika) (DE)](https://www.medicinesforeurope.com/member-logo/probiosimilars-a-group-of-progenerika/) - [British Biosimilars Association ( a group of BGMA) (UK)](https://www.medicinesforeurope.com/member-logo/british-biosimilars-association-a-group-of-bgma/) - [STADA](https://www.medicinesforeurope.com/member-logo/stada/) - [OEGV (AT)](https://www.medicinesforeurope.com/member-logo/oegv/) - [MEDOCHEMIE](https://www.medicinesforeurope.com/member-logo/medochemie/) - [KRKA](https://www.medicinesforeurope.com/member-logo/krka/) - [JGL](https://www.medicinesforeurope.com/member-logo/jgl/) - [IGL (DK)](https://www.medicinesforeurope.com/member-logo/igl/) - [GE (HU)](https://www.medicinesforeurope.com/member-logo/ge/) - [FGL (SE)](https://www.medicinesforeurope.com/member-logo/fgl/) - [BGPharmA (BG)](https://www.medicinesforeurope.com/member-logo/bgpharma/) - [APMGR (RO)](https://www.medicinesforeurope.com/member-logo/apmgr-2/) - [AESEG (ES)](https://www.medicinesforeurope.com/member-logo/aeseg-2/) - [JGL](https://www.medicinesforeurope.com/member-logo/jgl-2/) ## News - [EU policies must not push essential medicines off market: new Medicines for Europe president](https://www.medicinesforeurope.com/news/eu-policies-must-not-push-essential-medicines-off-market-new-medicines-for-europe-president/) - President Steffen Saltofte argues that EU policy must protect timely and equitable access to essential medicines, safeguarding affordability while supporting competitiveness. Read the words of our President and full Article below. Open - [UWWTD: European Parliament stands with patients and security of medicine supplies](https://www.medicinesforeurope.com/news/uwwtd-european-parliament-stands-with-patients-and-security-of-medicine-supplies/) - [The off patent medicines industry is a strategic partner for Europe](https://www.medicinesforeurope.com/news/the-off-patent-medicines-industry-is-a-strategic-partner-for-europe/) - [Twenty years of the Legal Affairs Conference: Driving Europe’s competitiveness and timely access to medicines](https://www.medicinesforeurope.com/news/medicines-for-ireland-and-medicines-for-europe-welcome-irish-court-referral-of-eu-water-directive-to-cjeu-2/) - [Medicines for Ireland and Medicines for Europe welcome Irish Court referral of EU Water Directive to CJEU](https://www.medicinesforeurope.com/news/medicines-for-ireland-and-medicines-for-europe-welcome-irish-court-referral-of-eu-water-directive-to-cjeu/) - [Critical Medicines Act: a step forward for secure medicines supply](https://www.medicinesforeurope.com/news/critical-medicines-act-a-step-forward-for-secure-medicines-supply/) - [The Biosimilar Advantage: Powering patient access and industrial resilience](https://www.medicinesforeurope.com/news/the-biosimilar-advantage-powering-patient-access-and-industrial-resilience/) - [Leading manufacturers appeal in proceedings against discriminatory wastewater fees on medicine before European Court of Justice](https://www.medicinesforeurope.com/news/leading-manufacturers-appeal-in-proceedings-against-discriminatory-wastewater-fees-on-medicine-before-european-court-of-justice/) - [Gemme is transforming and becoming ALMA - Alliance des Médicaments Abordables](https://www.medicinesforeurope.com/news/gemme-is-transforming-and-becoming-alma-alliance-des-medicaments-abordables/) - [Open Letter on Critical Medicines Act trilogues negotations - The CMA must deliver on EU health security](https://www.medicinesforeurope.com/news/medicines-for-europe-open-letter-on-critical-medicines-act-trilogues-negotations-the-cma-must-deliver-on-eu-health-security/) - [New EU Pharma Legislation to safeguard patient access and boost off-patent medicines efficiency](https://www.medicinesforeurope.com/news/new-eu-pharma-legislation-to-safeguard-patient-access-and-boost-off-patent-medicines-efficiency/) - [Call to ‘Stop the Clock’ on UWWTD – Urgent reassessment needed to protect competitiveness and supply](https://www.medicinesforeurope.com/news/call-to-stop-the-clock-on-uwwtd-urgent-reassessment-needed-to-protect-competitiveness-and-supply/) - [Press statement on UWWTD Court Decision](https://www.medicinesforeurope.com/news/press-statement-on-uwwtd-court-decision/) - [‘Access Is A Right, Not A Privilege’ – Medicines For Europe’s Saltofte Sets Out Priorities](https://www.medicinesforeurope.com/news/access-is-a-right-not-a-privilege-medicines-for-europes-saltofte-sets-out-priorities/) - The president of Medicines for Europe, Steffen Saltofte, says Medicines for Europe will focus on ensuring equitable access to medicines as a right, not a privilege, while also strengthening industry resilience, competitiveness, a harmonised regulatory framework and sustainability for the European off-patent, generics, biosimilars and value added medicines sector. Read the words of our President - [Overview of the pilots in Europe testing the use of the electronic product information (ePI) for medicines](https://www.medicinesforeurope.com/news/overview-of-the-pilots-in-europe-testing-the-use-of-the-electronic-product-information-epi-for-medicines/) - [Parliament makes the Critical Medicines Act meaningful but significant risks to future access persist](https://www.medicinesforeurope.com/news/parliament-makes-the-critical-medicines-act-meaningful-but-significant-risks-to-future-access-persist/) - [Steffen Saltofte (Zentiva) named President of Medicines for Europe](https://www.medicinesforeurope.com/news/steffen-saltofte-zentiva-named-president-of-medicines-for-europe/) - [The EU Biosimilar industry, which is central to competitiveness, needs Ambitious, Coherent, & Competition-Driven Biotech Policies](https://www.medicinesforeurope.com/news/the-eu-biosimilar-industry-which-is-central-to-competitiveness-needs-ambitious-coherent-competition-driven-biotech-policies/) - [Parliament SANT Committee vote takes the high road on medicines security in Critical Medicines Act Report](https://www.medicinesforeurope.com/news/parliament-sant-committee-vote-takes-the-high-road-on-medicines-security-in-critical-medicines-act-report/) - [The Safe Hearts Plan should improve access to affordable innovation and better treatment for all patients](https://www.medicinesforeurope.com/news/the-safe-hearts-plan-should-improve-access-to-affordable-innovation-and-better-treatment-for-all-patients/) - [Pharma legislation deal important for the future EU pharmaceutical industry but most importantly for access to medicine](https://www.medicinesforeurope.com/news/pharma-legislation-deal-important-for-the-future-eu-pharmaceutical-industry-but-most-importantly-for-access-to-medicine/) - [Environment omnibus and impact study fail to address huge flaws in Urban waste water treatment directive](https://www.medicinesforeurope.com/news/environment-omnibus-and-impact-study-fail-to-address-huge-flaws-in-urban-waste-water-treatment-directive/) - [Europe’s antibiotic shortages are a policy failure requiring urgent reform](https://www.medicinesforeurope.com/news/europes-antibiotic-shortages-are-a-policy-failure-requiring-urgent-reform/) - Europe faces chronic antibiotic shortages driven by rising production costs and rigid low-price policies that make supplying off-patent antibiotics economically unviable. The Director General of Medicines for Europe talks about these market dynamics and the need to reform pricing and procurement policies, including through the EU’s Critical Medicines Act. Read the comment of our Director - [Biosimilars 2025: A Turning Point for equitable access and EU competitiveness](https://www.medicinesforeurope.com/news/biosimilars-2025-a-turning-point-for-equitable-access-and-eu-competitiveness/) - [European study shows falling prices, rising costs and shortages - findings released during World AMR Awareness Week](https://www.medicinesforeurope.com/news/european-study-shows-falling-prices-rising-costs-and-shortages-findings-released-during-world-amr-awareness-week/) - [Healthcare Associations warn of risks from PFAS restriction approach - Failure to assess the impact on the availability of human and animal medicines](https://www.medicinesforeurope.com/news/healthcare-associations-warn-of-risks-from-pfas-restriction-approach-failure-to-assess-the-impact-on-the-availability-of-human-and-animal-medicines/) - [European Commission risks repeating past mistakes in Urban Wastewater Treatment Directive cost study](https://www.medicinesforeurope.com/news/european-commission-risks-repeating-past-mistakes-in-urban-wastewater-treatment-directive-cost-study/) - [Industry unites for a bold Critical Medicines Act that prioritises secure supply of medicines for patients](https://www.medicinesforeurope.com/news/industry-unites-for-a-bold-critical-medicines-act-that-prioritises-secure-supply-of-medicines-for-patients/) - [Open Letter to COREPER: Council’s homeopathic approach to Critical Medicines Act will succeed - in watering down EU health security](https://www.medicinesforeurope.com/news/open-letter-to-coreper-councils-homeopathic-approach-to-critical-medicines-act-will-succeed-in-watering-down-eu-health-security/) - The president of Medicines for Europe talks about the need for an urgent pause in the adoption of the Extended Producer Responsibility (EPR) scheme under the Urban Waste Water Treatment Directive (UWWTD) to safeguard patient access and medicine supply while a fairer, more practical solution is reviewed. Read the comment of our President and full - [Generic medicine Industry join calls for an urgent pause to the extended producer responsibility scheme for urban wastewater to avert a healthcare crisis.](https://www.medicinesforeurope.com/news/generic-medicine-industry-join-calls-for-an-urgent-pause-to-the-extended-producer-responsibility-scheme-for-urban-wastewater-to-avert-a-healthcare-crisis/) - The president of Medicines for Europe talks about the need for an urgent pause in the adoption of the Extended Producer Responsibility (EPR) scheme under the Urban Waste Water Treatment Directive (UWWTD) to safeguard patient access and medicine supply while a fairer, more practical solution is reviewed. Read the comment of our President and full - [SANT Committee prioritises manufacturing competitiveness in draft report on the Critical Medicines Act](https://www.medicinesforeurope.com/news/sant-committee-prioritises-manufacturing-competitiveness-in-draft-report-on-the-critical-medicines-act/) - [European Industry Calls For Support As It Juggles Multiple Challenges](https://www.medicinesforeurope.com/news/european-industry-calls-for-support-as-it-juggles-multiple-challenges/) - At Medicines for Europe’s Legal and Annual Conferences in Brussels last week, multiple key issues were discussed to support the role of generics and biosimilars at a critical time for EU pharma reform. Read the comment of our President and full Article below. Open - [‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead](https://www.medicinesforeurope.com/news/europe-has-to-make-up-its-mind-medicines-for-europes-sieger-on-the-path-ahead/) - The president of Medicines for Europe talks about what the European healthcare sector needs and what the off-patent sector can deliver. Read the comment of our President and full Article below. Open - [Medicines for Europe intervenes in legal challenge against Urban Wastewater Treatment Directive's EPR scheme](https://www.medicinesforeurope.com/news/medicines-for-europe-intervenes-in-legal-challenge-against-urban-wastewater-treatment-directives-epr-scheme/) - [Pro-competitive policies matter for public health, for security and for strategic autonomy](https://www.medicinesforeurope.com/news/pro-competitive-policies-matter-for-public-health-for-security-and-for-strategic-autonomy/) - [Pharma reform should provide for more timely patient access in Europe](https://www.medicinesforeurope.com/news/pharma-reform-should-provide-for-more-timely-patient-access-in-europe/) - [Medicines for Europe outlines trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing](https://www.medicinesforeurope.com/news/medicines-for-europe-outlines-trade-policy-recommendations-to-strengthen-access-to-medicines-and-the-competitiveness-of-eu-manufacturing/) - [Markus Sieger takes the helm as President ad interim at Medicines for Europe](https://www.medicinesforeurope.com/news/markus-sieger-takes-the-helm-as-president-ad-interim-at-medicines-for-europe/) - [Council agreement on review of EU pharmaceutical legislation](https://www.medicinesforeurope.com/news/council-agreement-on-review-of-eu-pharmaceutical-legislation/) - [Medicines for Europe calls for balanced safeguards on access to medicines in EU Water Resilience Strategy](https://www.medicinesforeurope.com/news/medicines-for-europe-calls-for-balanced-safeguards-on-access-to-medicines-in-eu-water-resilience-strategy/) - [Medicines for Europe Executive Letter to EU 27 Prime Ministers](https://www.medicinesforeurope.com/news/europe-must-act-now-to-protect-patients-access-and-medicines-supply/) - [European Parliament report urges for reassessment of Urban Wastewater Treatment Directive’s impact on medicines](https://www.medicinesforeurope.com/news/european-parliament-report-urges-for-reassessment-urban-wastewater-treatment-directives-impact-on-medicines/) - [Europe must act now to protect patients and medicines supply](https://www.medicinesforeurope.com/news/europe-must-act-now-to-protect-patients-and-medicines-supply/) - [Medicines for Europe Letter on the Implementation of the Bolar Provision in Ukraine](https://www.medicinesforeurope.com/news/medicines-for-europe-letter-on-the-implementation-of-the-bolar-provision-in-ukraine/) - [Press statement following meeting with Commission President Ursula von der Leyen on tariffs](https://www.medicinesforeurope.com/news/press-statement-following-meeting-with-commission-president-ursula-von-der-leyen-on-tariffs/) - [New Horizons for Biosimilar Medicines Policy: Delivering better access, outcomes, and biotech manufacturing in the future](https://www.medicinesforeurope.com/news/new-horizons-for-biosimilar-medicines-policy-delivering-better-access-outcomes-and-biotech-manufacturing-in-the-future/) - [EU multiannual financial framework funding for critical medicines manufacturing vital for strategic autonomy](https://www.medicinesforeurope.com/news/eu-multiannual-financial-framework-funding-for-critical-medicines-manufacturing-vital-for-strategic-autonomy/) - [IGBA Statement on trade barriers and their impact on healthcare systems and patients’ health](https://www.medicinesforeurope.com/news/igba-statement-on-trade-barriers-and-their-impact-on-healthcare-systems-and-patients-health/) - [Building A Sustainable Market: new Medicines for Europe President sets out priorities](https://www.medicinesforeurope.com/news/building-a-sustainable-market-new-medicines-for-europe-president-sets-out-priorities/) - Newly appointed Medicines for Europe President Stephan Eder discusses the association’s key priorities with Generics Bulletin, focusing on ensuring a sustainable future for the generics, biosimilars, and value-added medicines industry in Europe. Read the full Article below. Open - [Ambitious Critical Medicines Act vital to secure supply](https://www.medicinesforeurope.com/news/ambitious-critical-medicines-act-vital-to-secure-supply/) - [Medicines for Europe supports legal action against provisions in the Urban Wastewater Treatment Directive (UWWTD), which puts access to medicines at risk](https://www.medicinesforeurope.com/news/medicines-for-europe-supports-legal-action-against-provisions-in-the-urban-wastewater-treatment-directive-uwwtd-which-puts-access-to-medicines-at-risk/) - [Pharma reform brings new opportunities for better regulation, access and security of medicines supply](https://www.medicinesforeurope.com/news/pharma-reform-brings-new-opportunities-for-better-regulation-access-and-security-of-medicines-supply/) - [Harmonising Bioequivalence: Advancing Global Access to Generic Medicines](https://www.medicinesforeurope.com/news/harmonising-bioequivalence-advancing-global-access-to-generic-medicines/) - [PharmaBoardroom's interview with President Stephan Eder](https://www.medicinesforeurope.com/news/pharmaboardrooms-interview-with-president-stephan-eder/) - President of Medicines for Europe, Stephan Eder, highlights the association's priorities for driving change in the off-patent medicines sector, addressing how Europe can move beyond price-driven policies to better support innovation, resilience and patient access. Read the full Article below. Open - [Biosimilar medicines: the intersection of access, affordability, and innovation](https://www.medicinesforeurope.com/news/biosimilar-medicines-the-intersection-of-access-affordability-and-innovation/) - Director of Biosimilar Policy & Science at Medicines for Europe, Julie Maréchal-Jamil, discusses the necessary strategies at both European and national levels to ensure the continued advantages of biosimilar medicines. Read the full Article below. Open - [STADA’s Stephan Eder sets Access, Manufacturing and Sustainability at heart of Medicines for Europe Presidency](https://www.medicinesforeurope.com/news/stadas-stephan-eder-sets-access-manufacturing-and-sustainability-at-heart-of-medicines-for-europe-presidency/) - [Industry Proposes Phased Rollout of ePI for Patient Safety and Environmental Sustainability](https://www.medicinesforeurope.com/news/industry-proposes-phased-rollout-of-epi-for-patient-safety-and-environmental-sustainability/) - [Maximising the impact of Biosimilar Medicines requires strategic action in Europe](https://www.medicinesforeurope.com/news/maximising-the-impact-of-biosimilar-medicines-requires-strategic-action-in-europe/) - [Medicines for Europe Statement on Unitary SPC Legislative Process](https://www.medicinesforeurope.com/news/medicines-for-europe-statement-on-unitary-spc-legislative-process/) - [Joint Industry Statement on EU-Mercosur Negotiations](https://www.medicinesforeurope.com/news/joint-industry-statement-on-eu-mercosur-negotiations/) - [Council adoption of Urban Waste Water Treatment Directive will generate a tsunami of essential and critical medicine shortages across Europe](https://www.medicinesforeurope.com/news/council-adoption-of-urban-waste-water-treatment-directive-will-generate-a-tsunami-of-essential-and-critical-medicine-shortages-across-europe-2/) - [New report highlights market access barriers for EU-based generic and biosimilar companies in third countries](https://www.medicinesforeurope.com/news/new-report-highlights-market-access-barriers-for-eu-based-generic-and-biosimilar-companies-in-third-countries/) - [Urban Wastewater Treatment Directive risks undoing Europe’s efforts to improve the availability, affordability and accessibility of medicines](https://www.medicinesforeurope.com/news/urban-wastewater-treatment-directive-risks-undoing-europes-efforts-to-improve-the-availability-affordability-and-accessibility-of-medicines/) - [Medicines for Europe delegation leads on manufacturing, sustainability and access at CPHI congress](https://www.medicinesforeurope.com/news/medicines-for-europe-delegation-leads-on-manufacturing-sustainability-and-access-at-cphi-congress/) - [EU Critical Medicines Act must protect secure supply of essential medicines](https://www.medicinesforeurope.com/news/eu-critical-medicines-act-must-protect-secure-supply-of-essential-medicines/) - [Elisabeth Stampa: ‘Many drugs that used to be produced in Europe are now manufactured in Asia. This makes us vulnerable to shortages’](https://www.medicinesforeurope.com/news/elisabeth-stampa-many-drugs-that-used-to-be-produced-in-europe-are-now-manufactured-in-asia-this-makes-us-vulnerable-to-shortages/) - The president of Medicines for Europe considers that the supply of essential drugs is at risk if governments do not allow the price of cheap drugs to be revised in line with inflation. Read the comment of our President and full Article below. Open - [Availability of Treatment in Slovakia within the framework of European Legislation - Expert Forum Brings Solutions](https://www.medicinesforeurope.com/news/availability-of-treatment-in-slovakia-within-the-framework-of-european-legislation-expert-forum-brings-solutions/) - The international conference Expert Forum, organized by the GENAS association, attracted key healthcare players to Bratislava on Monday, including representatives from the European Commission (DG SANTE), the Permanent Representation of the Slovak Republic to the EU, Medicines for Europe, Slovak and European experts and analysts. The participation of significant stakeholders underscores the importance of the - [Prioritising access and EU solidarity should drive Health Ministers’ agenda in next EU talks](https://www.medicinesforeurope.com/news/prioritising-access-and-eu-solidarity-should-drive-health-ministers-agenda-in-next-eu-talks/) - Ministers of Health will meet in Brussels on Friday 21st June to discuss EU coordination on health. Ahead of this meeting, Medicines for Europe calls on Member States, including small Member States and Central Eastern Europe Countries, to prioritise equitable access for all patients. Open - [Off-patent medicines industry marks 30 years of delivering public health impact](https://www.medicinesforeurope.com/news/eu-health-union-has-promise-to-deliver-on-equitable-access-to-medicines-2/) - Medicines for Europe marks 30 years of delivering more equitable access to off-patent medicines as it opens its annual European conference in Dublin, in partnership with Medicines for Ireland. Open - [Reformed incentives system promises better patient access in Europe](https://www.medicinesforeurope.com/news/reformed-incentives-system-promises-better-patient-access-in-europe/) - A well-balanced incentives system for pharmaceuticals is essential to support the development, production, and supply of off patent medicines. These medicines account for 70% of medicines dispensed in Europe, for the most serious conditions like cancer, auto immune diseases and cardiovascular disease. Open - [EU Health Union has promise to deliver on equitable access to medicines](https://www.medicinesforeurope.com/news/eu-health-union-has-promise-to-deliver-on-equitable-access-to-medicines/) - One of the key milestones of the current European Commission mandate on health has been achieved with the formal establishment of the European Health Union. Initiated by the importance of coordinated action during the pandemic, the Health Union promises to improve access to medicines with available, accessible and affordable medicines. Open - [EU medicines procurement policy must 'prescribe' security of supply for patients](https://www.medicinesforeurope.com/news/eu-medicines-procurement-policy-must-prescribe-security-of-supply-for-patients/) - Today, the European Commission presented EU guidance on public procurement of medicines which is critical to improve the security of supply for patients and health systems. There is a need for concrete improvements to the procurement process, including better demand predictability and ensuring multiple suppliers on the market. Open - [Biosimilar Strategy pivotal to a stronger European Health Union](https://www.medicinesforeurope.com/news/biosimilar-strategy-pivotal-to-a-stronger-european-health-union/) - 2024 marks the occasion of the 20th annual biosimilar medicines conference. Since its first edition, the conference has been the stage of vivid multi-stakeholders debates and discussions. Year-on-year, it has provided the opportunity to hear for EU and international experts and witness the unfolding of a regulatory-science success story and more importantly, a story where - [EU critical medicines act must partner with essential industry](https://www.medicinesforeurope.com/news/eu-critical-medicines-act-must-partner-with-essential-industry/) - Over 90% of the EU critical medicines list are essential, generic medicines. Medicines for Europe members manufacture these medicines so patients can live better and healthier lives, and health systems can be sustainable and strong to serve them. These medicines include treatments for cardiovascular disease, intensive care units, infections and cancers. Open - [Relaunching European Competitiveness - A Joint European Industry Manifesto](https://www.medicinesforeurope.com/news/patient-information-leaflets-putting-patients-first-aesgp-efpia-mfe-joint-pr-2/) - European industry is making a united call to prevent the risk of de-industrialisation on our continent by relaunching Europe’s competitiveness. The EU enters a new policy cycle at a challenging time, with technology and geopolitics acting as global disruptors, adding pressure to an already difficult economic situation. Now is the time to start building a - [Letta Report underlines need to improve equitable access to medicines and support for critical medicines production in Europe](https://www.medicinesforeurope.com/news/biosimilar-strategy-pivotal-to-a-stronger-european-health-union-2/) - Enrico Letta’s Report on the Future of the Single Market highlights the need to encourage equity of medicine access, sustainable pricing and procurement models for supply and EU-wide funds for investments in medicine manufacturing in Europe. Open - [Patient Information Leaflets Putting Patients First - AESGP EFPIA MfE Joint PR](https://www.medicinesforeurope.com/news/patient-information-leaflets-putting-patients-first-aesgp-efpia-mfe-joint-pr/) - The European pharmaceutical industry, represented by AESGP, EFPIA, and Medicines for Europe, has joined forces to enhance the content of medicinal product information leaflets, prioritising patients’ needs. These associations have put together key recommendations to improve leaflet content and accessibility, thus advancing health literacy. Open - [Medicines are manufactured for patients not for stockpiles: the EU must act!](https://www.medicinesforeurope.com/news/medicines-are-manufactured-for-patients-not-for-stockpiles-the-eu-must-act/) - To tackle shortages, some EU Member States (France, Germany, Czech Republic, Austria, Greece, Denmark and Poland) are increasingly instructing medicine manufacturers to stockpile, undermining EU solidarity and counter-intuitively exacerbating the risk of shortages. Stockpiling mandates prevent manufacturers from reallocating medicines to another EU country to solve a shortage. Open - [EU-Canada Free Trade Agreement: an Opportunity to Create Manufacturing Jobs in the Generic and Biosimilar Medicines Industries](https://www.medicinesforeurope.com/news/eu-canada-free-trade-agreement-an-opportunity-to-create-manufacturing-jobs-in-the-generic-and-biosimilar-medicines-industries/) - Medicines for Europe welcomes the approval by the European Parliament of the EU and Canada Comprehensive Economic and Trade Agreement (CETA) that can be an opportunity for medicine manufacturers in the two regions. The Medicines for Europe trade agenda works to promote access for patients to high quality medicines around the world. The CETA has - [As Parliament chapter closes, Council chapter opens on EU pharma legislation to deliver equitable access to medicines](https://www.medicinesforeurope.com/news/as-parliament-chapter-closes-council-chapter-opens-on-eu-pharma-legislation-to-deliver-equitable-access-to-medicines/) - Today, the European Parliament formally endorsed the deal on the revision of the European Pharmaceutical legislation. This compromise is the result of intense and lengthy debate, which aimed to improve the access, availability, and affordability of medicines and to prevent further delays of this much needed reform. Open - [Generic medicines: 70% of dispensed medicines and critical to healthcare](https://www.medicinesforeurope.com/news/generic-medicines-70-of-dispensed-medicines-and-critical-to-healthcare/) - For the last three decades, the availability of cost-effective generic medicines has driven increased access to life-saving treatments for millions of patients in Europe. Today, these medicines are an integral part of the healthcare system. Open - [The Future EU health agenda should bring EU solidarity to life](https://www.medicinesforeurope.com/news/the-future-eu-health-agenda-should-bring-eu-solidarity-to-life/) - Medicines for Europe members supply most of the essential prescription medicines in Europe, accounting for 67% of dispensed medicines. These medicines cover 80% of therapy areas, including for major and debilitating diseases such as cardiovascular disease, auto-immune conditions, cancer, and diabetes, among many others. Open - [Vote to level up the European Health Union in upcoming elections](https://www.medicinesforeurope.com/news/vote-to-level-up-the-european-health-union-in-upcoming-elections/) - The upcoming European elections will have a significant impact on the future of health policy in Europe. EU policies and decisions can shape national health systems and influence the health and well-being of millions of citizens across Europe. Open - [European Commission Biotech initiative must spearhead next wave of EU biosimilar advances for patients and stimulate manufacturing](https://www.medicinesforeurope.com/news/european-commission-biotech-initiative-must-spearhead-next-wave-of-eu-biosimilar-advances-for-patients-and-stimulate-manufacturing/) - Biosimilar medicines were invented in Europe over 15 years ago. Since then, they have increased patient access to essential biologic medicines needed to treat the most serious of diseases like cancer, autoimmune conditions and diabetes by well over 50%. Open - [Parliament compromise on pharmaceutical legislation accelerates much needed reform](https://www.medicinesforeurope.com/news/parliament-compromise-on-pharmaceutical-legislation-accelerates-much-needed-reform/) - Today, the Members of the Parliament’s health committee (ENVI) adopted a compromise position on the EU Pharmaceutical legislation review (comprising of a new Pharmaceutical Directive and Regulation). The Parliament has prioritised advancing this important legislation to improve the access, availability, and affordability of medicines ahead of the EU elections in June 2024 and prevent further - [The enormous and unknown healing power of old medicines (ES)](https://www.medicinesforeurope.com/news/the-enormous-and-unknown-healing-power-of-old-medicines-es/) - The legislative reform being prepared by the EU plans to promote the use of already approved drugs for new ailments. This route allows to accelerate the approval of treatments and save costs in research. Read the comment of our Director general and full Article below Open - [Parliament’s balanced stand on Unitary SPC regulation rewards innovation via an efficient Unitary SPC system that protects against access to medicines delays](https://www.medicinesforeurope.com/news/changes-in-medicines-procurement-policies-urgently-needed-to-ensure-secure-supply-of-essential-medicines/) - The position adopted today by the European Parliament on the proposals for the Unitary Supplementary Protection Certificate (SPC) and SPC Regulation recast, led by MEP Tiemo Wolken, is a significant milestone for innovation and access to medicines across Europe in this important legislative process. Open - [Changes in medicines procurement policies urgently needed to ensure secure supply of essential medicines](https://www.medicinesforeurope.com/news/health-policy-watch-forum-discusses-high-drug-prices-in-wealthy-countries-and-access-to-medicines-in-conflicts-2/) - Medicines for Europe’s newly published position paper explores how the current design of procurement rules in EU Member States, often aimed exclusively at reducing costs, has led to the consolidation of supply and increased risks for supply security. Open - [Health Policy Watch: Forum Discusses High Drug Prices in Wealthy Countries and Access to Medicines in Conflicts](https://www.medicinesforeurope.com/news/health-policy-watch-forum-discusses-high-drug-prices-in-wealthy-countries-and-access-to-medicines-in-conflicts/) - Adrian van den Hoven, chair of the International Generic and Biosimilar Medicines Association (IGBA), which aims to foster market access for generic medicines, said that the evergreening of patent agreements artificially stretches monopolies and harms access to medicines. Read the full Article below Open - [Joint statement Association for Accessible Medicines - Medicines for Europe ahead of 5th EU-U.S. Trade and Technology Council Ministerial meeting](https://www.medicinesforeurope.com/news/joint-statement-association-for-accessible-medicines-medicines-for-europe-ahead-of-5th-eu-u-s-trade-and-technology-council-ministerial-meeting/) - Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany in October 2023. Open - [Court decision on Supplementary Protection Certificate (SPC) manufacturing waiver risks undermining its use](https://www.medicinesforeurope.com/news/court-decision-on-supplementary-protection-certificate-spc-manufacturing-waiver-risks-undermining-its-use/) - Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany in October 2023. Open - [Medicines for Europe and European Business Association propose priority steps to continue the EU integration of the Ukrainе’s pharmaceutical industry](https://www.medicinesforeurope.com/news/medicines-for-europe-and-european-business-association-propose-priority-steps-to-continue-the-eu-integration-of-the-ukrainеs-pharmaceutical-industry/) - Medicines for Europe and the European Business Association (EBA) have jointly proposed strategic steps for the integration of Ukraine's pharmaceutical industry into the European Union, which we believe can be implemented before Ukraine's full accession to the EU. This initiative aligns with Ukraine's candidacy for EU membership and aims to harmonize the country's healthcare system - [The European Union cannot jeopardise patient access to generic medicines through the Urban Wastewater Treatment Directive](https://www.medicinesforeurope.com/news/the-european-union-cannot-jeopardise-patient-access-to-generic-medicines-through-the-urban-wastewater-treatment-directive/) - Medicines for Europe is deeply concerned about the Extended Producer Responsibility (EPR) system in the Urban Wastewater Treatment Directive under discussion in trilogue negotiations. Open - [Biosimilar medicines critical for future medicines access and sustainability but more biologic competition is needed in the EU](https://www.medicinesforeurope.com/news/biosimilar-medicines-critical-for-future-medicines-access-and-sustainability-but-more-biologic-competition-is-needed-in-the-eu/) - By 2032, the biosimilar medicines contribution to health systems access and sustainability will soon match the impact of generic medicines. The number of biological medicines set to lose market exclusivity represents an opportunity for competition to free up invaluable resources for healthcare systems, to improve patient access and budget sustainability. Open - [(Original in SK) How low pricing of generic and biosimilar drugs relates to their shortage](https://www.medicinesforeurope.com/news/original-in-sk-how-low-pricing-of-generic-and-biosimilar-drugs-relates-to-their-shortage/) - the continuous increase in the prices of input raw materials as well as the increase in the cost of production and transport of medicines are in direct contrast to the ongoing price reduction of generic and biosimilar drugs in the Slovak Republic. The consequence is a rising shortage of medicines for patients. Even a short - [OPEN LETTER: Members of the European Parliament and EU 27 Ministers of Health on the revision of the pharmaceutical legislation](https://www.medicinesforeurope.com/news/open-letter-members-of-the-european-parliament-and-eu-27-ministers-of-health-on-the-revision-of-the-pharmaceutical-legislation/) - Medicines for Europe, the European association representing generic, biosimilar and valued added medicines manufacturing, is writing to underline the key principles that we support in relation to the reform of EU pharmaceutical legislation which is currently under review in the European Parliament and the Council. Open - [Now or never: Europe must seize the Pharma Legislation opportunity to ensure patient access to continuous innovation for existing medicines](https://www.medicinesforeurope.com/news/now-or-never-europe-must-seize-the-pharma-legislation-opportunity-to-ensure-patient-access-to-continuous-innovation-for-existing-medicines/) - Medicines for Europe, representing the European value-added medicines industry, is calling for legislative reforms that will pave the way for patient access to safe, timely and affordable innovation for known medicines. Medicines repurposing has emerged as an important strategy to address patients’ needs. Open - [New IQVIA report points to window of opportunity for the EU to foster future-proof biosimilar competition](https://www.medicinesforeurope.com/news/new-iqvia-report-points-to-window-of-opportunity-for-the-eu-to-foster-future-proof-biosimilar-competition/) - The EU is currently reviewing its Pharmaceutical Legislation, and the latest IQVIA white paper “Assessing the biosimilar void” sheds light on the growing biological medicines market and the opportunity to improve equitable access with biosimilar medicines competition. Open - [Reformed SPC regulation would enhance timely access to essential medicines](https://www.medicinesforeurope.com/news/reformed-spc-regulation-would-enhance-timely-access-to-essential-medicines/) - The first drafts of the European Parliament position on the proposals for Unitary SPC and SPC Regulation recast proposed by the Rapporteur Tiemo Wölken and published last week by the European Parliament are a step in the right direction for access to medicines across Europe. Open - [A step forward for the secure supply of medicines and manufacturing and for public health](https://www.medicinesforeurope.com/news/a-step-forward-for-the-secure-supply-of-medicines-and-manufacturing-and-for-public-health/) - The off-patent medicines industry provides 70% of medicines dispensed to patients in Europe, covering over 80% of therapy areas. Medicines for Europe is committed to working with the EU to secure the supply of essential and critical medicines for public health. Open - [New pricing models for generic medicines to ensure long-term sustainable competition in Europe](https://www.medicinesforeurope.com/news/new-pricing-models-for-generic-medicines-to-ensure-long-term-sustainable-competition-in-europe/) - Background: Price erosion of generic medicines over time as a result of existing pricing policies in combination with increasing operational costs of these products due to high inflation, undermine long-term sustainable competition in European off-patent medicines markets. Therefore, the aim of this study is to identify new potential pricing models for retail generic medicines in - [Time for the EU to take steps: a medicines security act is needed for health security](https://www.medicinesforeurope.com/news/time-for-the-eu-to-take-steps-a-medicines-security-act-is-needed-for-health-security/) - The off-patent medicines industry provides 70% of medicines dispensed to patients in Europe covering over 80% of therapy areas. Generic, biosimilar and value added medicines make treatment options affordable, accessible, and available, so that patients can best manage their disease. These medicines also played a pivotal role during the covid outbreak, where between 70% and - [A streamlined, digital regulatory framework is the foundation for equitable access to medicines](https://www.medicinesforeurope.com/news/a-streamlined-digital-regulatory-framework-is-the-foundation-for-equitable-access-to-medicines/) - The off-patent medicines sector accounts for almost 70% of medicines dispensed in Europe, helping to manage the most prevalent chronic diseases including cancer, auto-immune conditions, cardiac disease, and diabetes. Value added medicines promise affordable, patient-centred innovation which can address serious health needs. Open - [European Parliament report on the Urban Wastewater Treatment directive acknowledges the critical importance of patient access to medicine](https://www.medicinesforeurope.com/news/european-parliament-report-on-the-urban-wastewater-treatment-directive-acknowledges-the-critical-importance-of-patient-access-to-medicine/) - The European Parliament ENVI Committee voted today to ensure that the Extended Producer Responsibility (EPR) system, envisaged in the Urban Wastewater Treatment Directive, does not jeopardise the affordability, accessibility and availability of generic medicines, which account for around 70% of prescriptions. Open - [Medicines for Europe gears up for Ukraine’s future accession to the EU](https://www.medicinesforeurope.com/news/medicines-for-europe-gears-up-for-ukraines-future-accession-to-the-eu/) - Medicines for Europe met today in Brussels with a high level Ukrainian government delegation led by Maryna Slobodnichenko, Deputy Minister of Health European Integration. Medicines for Europe put forward ideas on how to plan for the future integration process which requires a lot of regulatory and market policy alignment. Open - [(LT) Lithuanian Government - Vyriausybės kanclerė aptarė vaistų tiekimo ir prieinamumo klausimus su „Medicine for Europe“ generaliniu direktoriumi](https://www.medicinesforeurope.com/news/the-chancellor-discussed-the-supply-and-availability-of-medicines-with-the-ceo-of-medicine-for-europetimes-malta-improved-access-to-medicine-in-small-markets-discussed-2/) - Antradienį Vyriausybės kanclerė Giedrė Balčytytė susitiko su organizacijos „Medicine for Europe“ generaliniu direktoriumi Adrianu van den Hovenu, su kuriuo aptarė Europoje ir pasaulyje pastaruoju metu stebimus vaistų tiekimo sutrikimus ir būtinybę užtikrinti vaistų prieinamumą pacientams. Kaip pabrėžė kanclerė, Lietuvos Vyriausybė laiko prioritetu vaistų įperkamumą gyventojams, todėl ir toliau aktyviai dalyvaus vaistų politikoje ir stebės situaciją - [OPEN LETTER: Medicines for Europe concern on security of supply of medicines in Lithuania](https://www.medicinesforeurope.com/news/medicines-for-europe-concern-on-security-of-supply-of-medicines-in-lithuania/) - We understand the importance of stimulating competition in the pharmaceutical market for budget sustainability. However, EURIPID and other authorities have clearly indicated that ERP should not be applied in combination with generic reference pricing policies because this distorts the market and undermines the commercial viability of supplying the market. Open - [Spanish Presidency set to advance medicines supply resilience for European strategic autonomy](https://www.medicinesforeurope.com/news/spanish-presidency-set-to-advance-medicines-supply-resilience-for-european-strategic-autonomy-2/) - The EU pharmaceutical strategy aims to improve accessibility, affordability and sustainability of medicines for European patients and healthcare systems with a focus on the Central and Eastern European (CEE) region. Generic, Biosimilar and Value-Added Medicines play an essential role in the sustainability of healthcare systems by bringing competition to the market, providing healthcare systems budget - [European Parliament lends its support to a fair cost-based approach on EMA fees](https://www.medicinesforeurope.com/news/european-parliament-lends-its-support-to-a-fair-cost-based-approach-on-ema-fees/) - The EU pharmaceutical strategy aims to improve accessibility, affordability and sustainability of medicines for European patients and healthcare systems with a focus on the Central and Eastern European (CEE) region. Generic, Biosimilar and Value-Added Medicines play an essential role in the sustainability of healthcare systems by bringing competition to the market, providing healthcare systems budget - [(IT) Healthcare Policy - Autonomia strategica nel Pharma. Serve un’azione politica](https://www.medicinesforeurope.com/news/autonomia-strategica-nel-pharma-serve-unazione-politica/) - Open - [Generic medicine pricing reforms needed in Slovakia to ensure supply for patients](https://www.medicinesforeurope.com/news/generic-medicine-pricing-reforms-needed-in-slovakia-to-ensure-supply-for-patients/) - The EU pharmaceutical strategy aims to improve accessibility, affordability and sustainability of medicines for European patients and healthcare systems with a focus on the Central and Eastern European (CEE) region. Generic, Biosimilar and Value-Added Medicines play an essential role in the sustainability of healthcare systems by bringing competition to the market, providing healthcare systems budget - [EBA and Medicines for Europe signed a memorandum of agreement to accelerate Ukraine's integration into the EU pharmaceutical market](https://www.medicinesforeurope.com/news/eba-and-medicines-for-europe-signed-a-memorandum-of-agreement-to-accelerate-ukraines-integration-into-the-eu-pharmaceutical-market/) - At the Ukraine Recovery Conference in London, the European Business Association and Medicines for Europe signed a Memorandum of Agreement to accelerate Ukraine's integration into the EU pharmaceutical market. Open - [Malta Independent - Improved access to medicines in small markets emphasized during Commissioner Kyriakides’ visit](https://www.medicinesforeurope.com/news/malta-independent-improved-access-to-medicines-in-small-markets-emphasized-during-commissioner-kyriakides-visit/) - Shortages of medicines within the EU and the improved access to innovative medication across the Union, particularly in small markets such as Malta, were the main focus of discussions between Deputy Prime Minister and Minister for Health Chris Fearne and European Commissioner for Health and Food Safety, Stella Kyriakides, during her official visit to Malta. - [Times Malta - Improved access to medicine in small markets discussed](https://www.medicinesforeurope.com/news/times-malta-improved-access-to-medicine-in-small-markets-discussed/) - Medicine shortages within the EU and improved access to innovative medication across the union, particularly in small markets such as Malta, were the main focus of discussions between Health Minister Chris Fearne and European Health Commissioner Stella Kyriakides. Open - [TVM News - Malta agrees on a common medicines market in the EU](https://www.medicinesforeurope.com/news/tvm-news-malta-agrees-on-a-common-medicines-market-in-the-eu/) - Malta agrees with the European Commission’s legislative proposals to improve access to medicines and to establish a pharmaceutical common market in the European Union. Talks between Malta’s deputy Prime Minister and Health Minister, Chris Fearne and the EU Commissioner for Health and Food Safety, Stella Kyriakides, focused on the challenges of small markets, such as - [MEDICHEM - Medichem hosts Wuropean commissioner for health and food safety and Malta’s deputy prime minister and minister for health at manufacturing sites](https://www.medicinesforeurope.com/news/medichem-medichem-hosts-european-commissioner-for-health-and-food-safety-and-maltas-deputy-prime-minister-and-minister-for-health-at-manufacturing-sites/) - European Commissioner for Health and Food Safety, Stella Kyriakides, along with Christopher Fearne, the Deputy Prime Minister and Minister for Health of Malta, visited the Medichem manufacturing sites as part of the Commissioner’s visit to Malta to speak at the Medicines for Europe Annual Conference. The conference has taken place from the 14th to the - [Off-patent medicines ready to drive pharma policy reform for equitable access, availability and security of medicines supply](https://www.medicinesforeurope.com/news/off-patent-medicines-ready-to-drive-pharma-policy-reform-for-equitable-access-availability-and-security-of-medicines-supply/) - The EU has initiated a major overhaul of EU pharma legislation ranging from regulation to intellectual property and supply chains. The off-patent medicines industry is fully engaged to ensure that reforms transform healthcare delivery and access for patients. Generic and biosimilar medicines help the majority of patients with major chronic diseases such as cancer, cardiovascular - [Common Statement: Supporting Statement for the Council Non-paper on Improving the Security of Medicines Supply in Europe](https://www.medicinesforeurope.com/news/common-statement-supporting-statement-for-the-council-non-paper-on-improving-the-security-of-medicines-supply-in-europe/) - As trade associations representing off-patent medicines and Active Pharmaceutical Ingredients (APIs) large, medium and small companies in Europe, directly providing highly skilled jobs, investing heavily in manufacturing R&D and accounting for 24% of API global production and 70% of prescription medicines supplied in Europe, this initiative demonstrates a comprehensive understanding of the complex challenges faced - [Access to medicines and security of supply should be central to EU pharma and IP legislation reforms in Europe](https://www.medicinesforeurope.com/news/access-to-medicines-and-security-of-supply-should-be-central-to-eu-pharma-and-ip-legislation-reforms-in-europe/) - Generic and biosimilar medicines significantly lower healthcare treatment costs and are essential for enabling competition and vastly improved access to medicines. The stated aim of the EU pharmaceutical and IP legislative reform is to encourage the immediate launch of generic and biosimilar medicines once IP protections expire. The 2023 Medicines for Europe Legal Affairs Conference - [EU must bolster Biosimilar medicines policy to increase equity of access and bring much needed savings to healthcare budgets](https://www.medicinesforeurope.com/news/eu-must-bolster-biosimilar-medicines-policy-to-increase-equity-of-access-and-bring-much-needed-savings-to-healthcare-budgets/) - Open - [LETTER: Medicines Security of Supply](https://www.medicinesforeurope.com/news/medicines-for-europe-joins-the-antimicrobial-amr-one-health-network/) - Open - [Future of pharmaceutical policy rests on secure supply of essential medicines](https://www.medicinesforeurope.com/news/future-of-pharmaceutical-policy-rests-on-secure-supply-of-essential-medicines/) - The recently published EU pharmaceutical revision aims to improve medicines affordability, accessibility, and availability in Europe. The secure supply of essential medicines is the foundation to achieve these goals. Open - [Bulgarian National Television - The EU is preparing the most extensive changes in medical legislation in 20 years](https://www.medicinesforeurope.com/news/bulgarian-national-television-the-eu-is-preparing-the-most-extensive-changes-in-medical-legislation-in-20-years/) - Open - [Euronews - New EU medicine rules, articifical intelligence and fast fashion](https://www.medicinesforeurope.com/news/euronews-new-eu-medicine-rules-articifical-intelligence-and-fast-fashion/) - Adrian Van Der Hoven joins panelists elaborating on the EU Pharma Package and the potential showdown with the pharma sector and called Europe out for being late to the Artificial Intelligence party. Open - [Across Europe - on average - 26% of all generic medicines have disappeared](https://www.medicinesforeurope.com/news/across-europe-on-average-26-of-all-generic-medicines-have-disappeared/) - Affordable generic medicines available on the market just 10 years ago are disappearing and supply is too consolidated, according to new data shared today. This rapid decline and consolidation, higher in certain therapy areas such as cancer care and antibiotics, risks creating more shortages and threatens vital access for patients. Open - [Patients should benefit from greater access under new patent package proposals](https://www.medicinesforeurope.com/news/patients-should-benefit-from-greater-access-under-new-patent-package-proposals/) - Open - [Reaction to EU Pharmaceutical legislation: Timely and equitable access for patients and security of supply essential for reform](https://www.medicinesforeurope.com/news/reaction-to-eu-pharmaceutical-legislation-timely-and-equitable-access-for-patients-will-be-delayed-by-the-reform/) - Open - [Harmonised bioequivalence guideline paves the way for global generic medicine development and access to medicines](https://www.medicinesforeurope.com/news/harmonised-bioequivalence-guideline-paves-the-way-for-global-generic-medicine-development-and-access-to-medicines/) - Open - [Pharmaphorum - Why ‘reduce, reuse, and recycle' medicine is the future](https://www.medicinesforeurope.com/news/pharmaphorum-why-reduce-reuse-and-recycle-medicine-is-the-future/) - Open - [Market reforms needed to secure essential antibiotics against AMR, report says](https://www.medicinesforeurope.com/news/market-reforms-needed-to-secure-essential-antibiotics-against-amr-report-says/) - Recent shortages of essential antibiotics in Europe have renewed the urgency to reform the pricing and industrial infrastructure for these essential medicines. The off-patent sector manufactures and supplies most antibiotics in Europe needed to control bacterial infections. Pricing policies for these antibiotics must urgently be reviewed so that they remain viable to produce and supply. - [EURACTIV - Adjust prices to save drugs, generics industry tells EU](https://www.medicinesforeurope.com/news/12118/) - The generics industry is urging EU and national governments to show “leadership” and take immediate action against rising inflation, which has resulted in drug shortages and has put patients in need to the test. Open - [REUTERS - Why Europe's drug shortages may get worse](https://www.medicinesforeurope.com/news/why-europes-drug-shortages-may-get-worse/) - When Ignasi Biosca-Reig heard there were shortages of amoxicillin in Spain, he quickly added shifts at his drug company's factories to boost production of the popular antibiotic. But a few extra shifts was as far as he could go. Open - [CORREO FARMACEUTICO - Elisabeth Stampa Stampa, Presidenta de Medicines for Europe y Consejera Delegata de Medichem](https://www.medicinesforeurope.com/news/correo-farmaceutico-elisabeth-stampa-stampa-presidenta-de-medicines-for-europe-y-consejera-delegata-de-medichem/) - Elisabeth Stampa Stampa, Presidenta de Medicines for Europe y Consejera Delegata de Medichem - [REGULATORY FOCUS - New reports address generics pricing, innovation in the EU](https://www.medicinesforeurope.com/news/new-reports-address-generics-pricing-innovation-in-the-eu/) - Open - [REUTERS - Europe's generic drugmakers say they may cut output due to energy bills](https://www.medicinesforeurope.com/news/europes-generic-drugmakers-say-they-may-cut-output-due-to-energy-bills/) - The generic drug industry lobby group Medicines for Europe on Tuesday sent an open letter to European Union member states' energy and health ministers. Open - [PHARMACEUTICAL TECHNOLOGY - Inflation drives pharma manufacturing to focus on sustainability](https://www.medicinesforeurope.com/news/inflation-drives-pharma-manufacturing-to-focus-on-sustainability/) - Inflation is at an all-time high, opening an opportunity for CDMOs to invest in potentially cheaper sustainable alternatives. Open - [MANUFACTURING CHEMIST - EU supply chain regulation: what will it mean for companies attending CPHI?](https://www.medicinesforeurope.com/news/eu-supply-chain-regulation-what-will-it-mean-for-companies-attending-cphi/) - Ahead of her session on “Manufacturing Excellence” at CPHI Frankfurt (1–3 November), Elisabeth Stampa, President of Medicines for Europe, along with Adrian van den Hoven, Director General of Medicines for Europe, map out the impact of EU supply chain regulation on pharma companies in an exclusive article for Manufacturing Chemist Open - [PHARMA BOARDROOM - Inflation’s Impact on Medicine Supply: Challenges for the Off-Patent Industry](https://www.medicinesforeurope.com/news/inflations-impact-on-medicine-supply-challenges-for-the-off-patent-industry/) - Victor Mendonça, chair of the Generic Market Access Committee at Medicines for Europe, outlines why patient access to medicines is at risk due to intense price pressure and unprecedented inflation and proposes ways to tackle this. Open - [POLITICO - Everything you wanted to know about the EU’s pharma reform (but were too afraid to ask)](https://www.medicinesforeurope.com/news/everything-you-wanted-to-know-about-the-eus-pharma-reform-but-were-too-afraid-to-ask/) - Can the European Union bring eye-wateringly expensive medicines to the poorest parts of Europe, find cures for untreatable diseases, and solve the problem of antimicrobial resistance, all with a stroke of its pen? Read more - [EU pharmaceutical legislation reform critical to sustain biosimilar medicines competition for the future](https://www.medicinesforeurope.com/news/11700/) - The EU plans to update its 20-year-old pharmaceutical legislation early next year to improve access to medicines and to make innovation more affordable. The introduction of biosimilar medicines was one of the pioneering and most successful reforms of the previous legislation in 2004. Now we need to update the legislation to make it fit for - [Generic industry boss: SPC manufacturing waiver won’t harm originators’ innovation](https://www.medicinesforeurope.com/news/generic-industry-boss-spc-manufacturing-waiver-wont-harm-originators-innovation/) - [Increasing access to cancer medicines: what role do biosimilar medicines play?](https://www.medicinesforeurope.com/news/increasing-access-to-cancer-medicines-what-role-do-biosimilar-medicines-play/) - [Joint Declaration on Pharmaceuticals in the Environment](https://www.medicinesforeurope.com/news/joint-declaration-on-pharmaceuticals-in-the-environment/) - We, the signatories of this declaration, recognise and understand the concerns regarding the presence of pharmaceuticals in the environment. We believe that these concerns can only be addressed through a dialogue with policy-makers, taking into account public health and environmental aspects, as well as their policy ramifications, and we pledge our commitment to remain open - [Stakeholders To Gather In London To Plan Biosimilar Market's Future](https://www.medicinesforeurope.com/news/stakeholders-to-gather-in-london-to-plan-biosimilar-markets-future/) - [SPC manufacturing waiver, Competition policy, Brexit, pharma incentives European Patent Office take centre stage at 14th Legal Affairs Conference](https://www.medicinesforeurope.com/news/spc-manufacturing-waiver-competition-policy-brexit-pharma-incentives-european-patet-office-take-centre-stage-at-14th-legal-affairs-conference/) - Key authorities, lawyers and industry leaders discussed today in London the key issues in the spotlight for the pharmaceutical industry legal framework: Brexit, the SPC regulation and changes in the EPO. The high level event assessed how various aspects of law affect access to generic, biosimilar and value added medicines in Europe. The fast changing - [Access to Biosimilars in EU Expected to Continue to Outpace US and Canada](https://www.medicinesforeurope.com/news/access-to-biosimilars-in-eu-expected-to-continue-to-outpace-us-and-canada/) - [Biosimilar Medicines: essential for sustainable access to medicines](https://www.medicinesforeurope.com/news/biosimilar-medicines-essential-for-sustainable-access-to-medicines/) - Opening the 16th Biosimilar Medicines Conference, Keith Ridge, Chief Pharmaceutical Officer of NHS England illustrated how 3 biosimilar medicines (Infliximab, Etanercept and Rituximab) have increased access to treatment for patients while lowering overall cost of treatment in important therapy areas. Carol Lynch, President Sandoz US, Head of North America and Chair of the Biosimilar Medicines - [Up to 25,000 pharma jobs if EU alters patent rules](https://www.medicinesforeurope.com/news/up-to-25000-pharma-jobs-if-eu-alters-patent-rules/) - [Generics driving pharmerging market growth? ‘There is still opportunity for EU’ says Medicines for Europe](https://www.medicinesforeurope.com/news/generics-driving-pharmerging-market-growth-there-is-still-opportunity-for-eu-says-medicines-for-europe/) - [EU Semester Country Specific Recommendations: Improve patient access to medicine and ensure healthcare sustainability](https://www.medicinesforeurope.com/news/eu-semester-country-specific-recommendations-improve-patient-access-to-medicine-and-ensure-healthcare-sustainability/) - The European Semester Country Specific Recommendations show that healthcare systems need to improve their efficiency. Access to healthcare is challenged by growing demand for service and the limited financial capacity of governments to cover that demand. Generic and biosimilar medicines provide the greatest opportunity to improve access to safe and effective medicines but require efficient - [Comprehensive SPC manufacturing waiver key for patient access to medicines, jobs and growth in Europe](https://www.medicinesforeurope.com/news/comprehensive-spc-manufacturing-waiver-key-for-patient-access-to-medicines-jobs-and-growth-in-europe/) - Medicines for Europe commends the European Commission for proposing an SPC manufacturing waiver which will have a positive impact on the export of European generic and biosimilar medicines, particularly for small and medium enterprises (SMEs). Nonetheless, we are concerned that the legislative proposal does not fully address the unintended effects of the SPC Regulation, specifically - [IGBA Joins ICH Management Committee and Welcomes the Positive Vote of the General Assembly](https://www.medicinesforeurope.com/news/igba-joins-ich-management-committee-and-welcomes-the-positive-vote-of-the-general-assembly/) - [Andriukaitis: SPC manufacturing waiver does not damage pharma innovation](https://www.medicinesforeurope.com/news/andriukaitis-spc-manufacturing-waiver-does-not-damage-pharma-innovation/) - [El sistema español podría mejorar su coste-eficiencia con un plan nacional](https://www.medicinesforeurope.com/news/el-sistema-espanol-podria-mejorar-su-coste-eficiencia-con-un-plan-nacional/) - [European report calms common concerns](https://www.medicinesforeurope.com/news/european-report-calms-common-concerns/) - [Europe needs change to drive added value](https://www.medicinesforeurope.com/news/europe-needs-change-to-drive-added-value/) - [Addressing medicine shortages in Europe: Competition is crucial for patient access](https://www.medicinesforeurope.com/news/addressing-medicine-shortages-in-europe-competition-is-crucial-for-patient-access/) - Generic medicines have proven to be pivotal in increasing patient access and preventing medicine shortages. However, generic medicines policies have recently focused exclusively on reducing prices thereby increasing the risk of shortages. Short-term cost-cutting measures, such as ad-hoc price cuts, external reference pricing, payback, tendering etc., have driven the prices of some off-patent medicines to - [Medicines for Europe llama a poner en marcha políticas para evitar desabastecimientos](https://www.medicinesforeurope.com/news/medicines-for-europe-llama-a-poner-en-marcha-politicas-para-evitar-desabastecimientos/) - [Medicines for Europe to join the ISPOR Issue Panel on value added medicines](https://www.medicinesforeurope.com/news/medicines-for-europe-to-join-the-ispor-issue-panel-on-value-added-medicines/) - Value added medicines represent a major opportunity to improve patients’ quality of life, health outcomes or adherence, and to address a number of medicine-related healthcare inefficiencies, improving healthcare provision and organisation while contributing to the sustainability of healthcare systems. To ensure access to value added medicines for patients, the Value Added Medicines Group, a sector - [Medicines for Europe announces new President, launches Access to Medicines campaign](https://www.medicinesforeurope.com/news/medicines-for-europe-announces-new-president-launches-access-to-medicines-campaign/) - The newly elected President of Medicines for Europe – Marc-Alexander Mahl – launched the “Access to Medicines: Better Care for More Patients” campaign which calls on health ministers to fully embrace generic, biosimilar and value-added medicines to improve the sustainability of healthcare systems across Europe. Dr. Mahl takes over the Presidency of Medicines for Europe for 2 years. As - [Commission sponsored study shows Supplementary Protection Certificate (SPC) Manufacturing Waiver will create Jobs, strengthen the pharmaceutical sector and reduce medicine costs](https://www.medicinesforeurope.com/news/commission-sponsored-study-shows-supplementary-protection-certificate-spc-manufacturing-waiver-will-create-jobs-strengthen-the-pharmaceutical-sector-and-reduce-medicine-costs/) - On Thursday 12 October, the Directorate-general for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) launched a public consultation on the Supplementary Protection Certificate (SPC) Manufacturing Waiver and the Bolar exemption. Medicines for Europe calls for a swift introduction of the SPC manufacturing waiver in EU legislation and for a wide definition of Bolar. These - [Manufacturing cost transparency could combat pricing criticism, says expert](https://www.medicinesforeurope.com/news/manufacturing-cost-transparency-could-combat-pricing-criticism-says-expert/) - [Medicines for Europe welcomes decision on EMA relocation to Amsterdam](https://www.medicinesforeurope.com/news/medicines-for-europe-welcomes-decision-on-ema-relocation-to-amsterdam/) - Medicines for Europe is very glad to see the Council of the European Union reach a decision today, to relocate the European Medicines Agency (EMA) to Amsterdam. This is an important milestone in the Brexit process, bringing us from a point of uncertainty to clarity concerning the future of the EMA and the important work - [Medicines for Europe calls for greater cooperation on value added medicines to improve patient-centric innovation](https://www.medicinesforeurope.com/news/medicines-for-europe-calls-for-greater-cooperation-on-value-added-medicines-to-improve-patient-centric-innovation/) - The 1st Value Added Medicines conference organised by the Value Added Medicines Group, a sector group of Medicines for Europe, which took place today, 22nd November, gathered a wide range of experts in the healthcare community to raise awareness and foster debate on a common approach to present solutions for patient-centric innovation and better patient - [Europe’s life science industry urges the UK and EU27 to safeguard patients’ access to medicines with a clear transition period and a future cooperation agreement after Brexit](https://www.medicinesforeurope.com/news/europes-life-science-industry-urges-the-uk-and-eu27-to-safeguard-patients-access-to-medicines-with-a-clear-transition-period-and-a-future-cooperation-agreement-after-brexit/) - The associations representing the European and British life science industry (AESGP, EFPIA, EuropaBio, EUCOPE, Medicines for Europe, ABPI, BGMA, BIA, PAGB) have today underlined the importance of securing cooperation between the UK and EU on medicines regulation. Whilst we respect the phased approach of negotiations, we urge progress to be made in the negotiations as - [European Commission launches: “What I need to know about Biosimilar Medicines - Information for patients”, in 23 EU languages](https://www.medicinesforeurope.com/news/european-commission-launches-what-i-need-to-know-about-biosimilar-medicines-information-for-patients-in-23-eu-languages/) - The European Commission launched today additional translations of the Q&A paper “What I Need to Know about Biosimilar Medicines – Information for patients’’ making it available now in 23 official European languages, in order to provide patients with easy-to-understand information about biosimilar medicines. The Q&A was written to empower patients by providing answers to the - [The associations representing the European and British life science industry (AESGP, ABPI, BGMA, BIA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today launched a joint policy document on the potential impact of the United Kingdom’s exit from the European Union](https://www.medicinesforeurope.com/news/the-associations-representing-the-european-and-british-life-science-industry-aesgp-abpi-bgma-bia-efpia-eucope-europabio-medicines-for-europe-pagb-have-today-launched-a-joint-policy-document/) - Today, organisations representing the life science industry in the EU and the UK have called for medicines to be a priority in phase 2 of the Article 50 negotiations. Setting out their priorities in advance of the European Council taking place on 14-15th December in Brussels, the sector has sent a clear message that the - [Pharmacovigilance, traceability and building trust in biosimilar medicines](https://www.medicinesforeurope.com/news/pharmacovigilance-traceability-and-building-trust-in-biosimilar-medicines/) - [Value-added medicines: how repurposed medicines bring value to patients and pharmacists](https://www.medicinesforeurope.com/news/value-added-medicines-how-repurposed-medicines-bring-value-to-patients-and-pharmacists/) - [Did The 2017 Biosimilar Industry Pave The Way For A Productive 2018?](https://www.medicinesforeurope.com/news/did-the-2017-biosimilar-industry-pave-the-way-for-a-productive-2018/) - [2018 Outlook: Biosimilar Trends To Watch](https://www.medicinesforeurope.com/news/2018-outlook-biosimilar-trends-to-watch/) - [What Challenges Should Biosimilar Companies Expect In 2018?](https://www.medicinesforeurope.com/news/what-challenges-should-biosimilar-companies-expect-in-2018/) - [Access to Medicines at Sustainable Price: Pharma Industry and Governments Transforming Challenges into Opportunities](https://www.medicinesforeurope.com/news/access-to-medicines-at-sustainable-price-pharma-industry-and-governments-transforming-challenges-into-opportunities/) - [Jacek Glinka: "Biossimilares podem poupar ao SNS 120 milhões de euros"](https://www.medicinesforeurope.com/news/jacek-glinka-biossimilares-podem-poupar-ao-sns-120-milhoes-de-euros/) - ["É possível fazer os médicos portugueses prescreverem mais genéricos"](https://www.medicinesforeurope.com/news/e-possivel-fazer-os-medicos-portugueses-prescreverem-mais-genericos/) - [Europäer zahlen zu viel für Pillen](https://www.medicinesforeurope.com/news/europaer-zahlen-zu-viel-fur-pillen/) - [País pode poupar “mais 100 milhões por ano” com genéricos](https://www.medicinesforeurope.com/news/pais-pode-poupar-mais-100-milhoes-por-ano-com-genericos/) - [Pharma expert: EU drug agency should be ‘easily’ accessible to all](https://www.medicinesforeurope.com/news/pharma-expert-eu-drug-agency-should-be-easily-accessible-to-all/) - [Pharma expert: new ‘value added medicines’ offer cheaper, customised treatment](https://www.medicinesforeurope.com/news/pharma-expert-new-value-added-medicines-offer-cheaper-customised-treatment/) - [Commission to Look into 'Skyrocketing' EU Drug Prices, Availability, and Patient Access](https://www.medicinesforeurope.com/news/commission-to-look-into-skyrocketing-eu-drug-prices-availability-and-patient-access/) - [Understanding the financial implications of the upcoming falsified medicines regulations](https://www.medicinesforeurope.com/news/understanding-the-financial-implications-of-the-upcoming-falsified-medicines-regulations/) - European Pharmaceutical Review - VOLUME 21 ISSUE 3 2016 "Understanding the financial implications of the upcoming falsified medicines regulations" - Maarten Van Baelen and Johan Verhaeghe - [European biosimilar manufacturers want less discounts than for generics](https://www.medicinesforeurope.com/news/european-biosimilar-manufacturers-want-less-discounts-than-for-generics/) - by Guillaume Bietry PARIS, July 20 (APM) - Generics and biosimilars body Medicines for Europe is campaigning for a smaller price difference between biosimilars and their originator drugs than that between generics and their branded equivalents, president Jacek Glinka has told APM. About 20 biosimilars have been approved in Europe since 2006, but the optimal - [Generic Medicines Increase Access to Treatments](https://www.medicinesforeurope.com/news/generic-medicines-increase-access-to-treatments/) - [The global scourge of counterfeit medicines](https://www.medicinesforeurope.com/news/the-global-scourge-of-counterfeit-medicines/) - [The global scourge of counterfeit medicines](https://www.medicinesforeurope.com/news/the-global-scourge-of-counterfeit-medicines-2/) - The statistics are truly disturbing, with an annual death toll of around 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017. But industry and regulatory authorities are fighting back with new measures to identify - [Les génériques rament pour accéder au marché](https://www.medicinesforeurope.com/news/les-generiques-rament-pour-acceder-au-marche/) - [Medicines for Europe: Better Access, Better Health](https://www.medicinesforeurope.com/news/medicines-for-europe-better-access-better-health/) - [EGA Prioritises Pursuing Sustainability Agreements](https://www.medicinesforeurope.com/news/ega-prioritises-pursuing-sustainability-agreements/) - [The European Biosimilars Group Appoints New Leadership Team With Sandoz’ Carol Lynch and Polpharma's Klaus Martin](https://www.medicinesforeurope.com/news/the-european-biosimilars-group-appoints-new-leadership-team-with-sandoz-carol-lynch-and-polpharmas-klaus-martin/) - Last week in Brussels, the European Biosimilar medicines Group (EBG – a sector group of the EGA) elected its new leadership team with Sandoz’ Carol Lynch as Chair of the overall sector group and Polpharma’s Klaus Martin, Chair of the market access group of the EBG. Carol Lynch is Global Head of Biopharmaceuticals and Oncology - [EGA Welcomes the Delegated Regulation as a Tool To Fight Counterfait Medicines](https://www.medicinesforeurope.com/news/ega-welcomes-the-delegated-regulation-as-a-tool-to-fight-counterfeit-medicines/) - Brussels - The European Generic and Biosimilar Medicines Association (EGA) welcomes the publication in the official journal today of the Delegated Regulation supplementing Directive 2001/83/EC, which implements the Falsified Medicines Directive (2011/62/EU), on the safety features appearing on the packaging of medicines. This Delegated Regulation will determine the technical specificities of the Unique Identifier and the - [Shaping The 2020 Regulatory Landscape For Patient Needs](https://www.medicinesforeurope.com/news/shaping-the-2020-regulatory-landscape-for-patient-needs/) - London - 61 regulators from 25 countries made progress in improving the generic and biosimilar medicines regulatory landscape for patient needs at the 15th Regulatory and Scientific Affairs Conference organised by the European Generic and Biosimilar medicines Association (EGA). The EMA/HMA Strategy 2020, complemented by the CMDh 2020 Strategy Paper, will pursue operational excellence in the EU - [Industry Coming Together To Improve Safety For Patients](https://www.medicinesforeurope.com/news/industry-coming-together-to-improve-safety-for-patients/) - London - In London this week, the European Generic and Biosimilar medicines Association (EGA) will gather some of the key national authorities, regulators and industry leaders to discuss how to improve safety for patients in the regulatory frame. More than three years after the new pharmacovigilance legislation became operational, a continuous and open dialogue between regulators and - [Piden fabricar genéricos en periodo de extensión](https://www.medicinesforeurope.com/news/piden-fabricar-genericos-en-periodo-de-extension/) - El presidente de la EGA considera que actualmente la industria europea de genéricos está "atada de manos". Read more - [Global Pharmaceutical Industry Calls on Governments to Work with Them to Beat the Rising Threat of Drug Resistance](https://www.medicinesforeurope.com/news/global-pharmaceutical-industry-calls-on-governments-to-work-with-them-to-beat-the-rising-threat-of-drug-resistance/) - More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections – so- called ‘superbugs’ – with a joint declaration launched today at the World Economic Forum in Davos, - [Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance](https://www.medicinesforeurope.com/news/declaration-by-the-pharmaceuticalbiotechnology-and-diagnostics-industries-on-combating-antimicrobial-resistance/) - Antimicrobials, and specifically antibiotics, play a crucial role in modern medicine. These precious medicines are often taken for granted and are not only necessary to treat life-threatening infections, but are also vital to underpin most common surgical procedures and many chronic treatments such as chemotherapy and HIV and transplant medicines. They also play a crucial - [Spain and Europe Join Forces To Bring Access To Generic Medicines To The Market](https://www.medicinesforeurope.com/news/spain-and-europe-join-forces-to-bring-access-to-generic-medicines-to-the-market/) - Barcelona - At their joint Executive meeting in Barcelona today, the Spanish Generic Medicines Association (AESEG) and the European Generic and Biosimilar Medicines Association (EGA) confirmed their commitment to join forces and bring access to generic medicines to the Spanish market, reinforcing the industry’s commitment to increase patient access to high quality medicines. A recent IGES - [Ethics: EGA Adopts Disclosure Requirements For The Generic, Biosimilar And Value Added Medicines Industry](https://www.medicinesforeurope.com/news/ethics-ega-adopts-disclosure-requirements-for-the-generic-biosimilar-and-value-added-medicines-industry/) - Brussels - Today, EGA members unanimously adopted disclosure rules for the generic, biosimilar and value added medicines industry. This will form an integral part of the EGA’s Code of Conduct that was adopted one year ago, available here. The new chapter provides a framework to disclose support for patient organisations, healthcare professionals (HCPs) such as meetings - [Generic and Biosimilar Medicines Essential for Italian Healthcare System](https://www.medicinesforeurope.com/news/generic-and-biosimilar-medicines-essential-for-italian-healthcare-system/) - Brussels - Generic and biosimilar medicines represent an essential opportunity to optimize the efficiency of healthcare systems in Italy, according to an article published this week in the Journal of Generic Medicines, Generic and Biosimilar Medicines Use and Expenditure: A Report from the National Observatory on the Use of Medicines (OsMed) of the Italian Medicines Agency - [Para Permitirse los Fármacos Innovadores Hay que Apoyar los Genéricos](https://www.medicinesforeurope.com/news/para-permitirse-los-farmacos-innovadores-hay-que-apoyar-los-genericos/) - [EFG: la EGA Califica de "Mala Noticia" la Eliminación de la Discriminación Positiva](https://www.medicinesforeurope.com/news/efg-la-ega-califica-de-mala-noticia-la-eliminacion-de-la-discriminacion-positiva/) - [A Comprehensive And Fair Solution To The Price Of Medicines](https://www.medicinesforeurope.com/news/a-comprehensive-and-fair-solution-to-the-price-of-medicines/) - After a long dry spell, the pharmaceutical research industry has brought to market a spate of innovative treatments that can extend life and often have fewer side effects than older treatments. But these medicines are not affordable to most of the people who need them. Recent treatments for hepatitis C and cancer - both widespread - [El Gobierno Español Todavía Tiene Margen para Promover la Competencia del Genérico](https://www.medicinesforeurope.com/news/el-gobierno-espanol-todavia-tiene-margen-para-promover-la-competencia-del-generico/) - [Interview with Adrian van den Hoven in EV Healthcare](https://www.medicinesforeurope.com/news/interview-with-adrian-van-den-hoven-in-ev-healthcare-belgium/) - No longer a niche market, generics are claiming new market space. An exclusive interview with Adrian van den Hoven, director general of the European generic medicines association. The generic industry has developed to the point that it now accounts for much more than half the prescription medicines volume in Europe – but it is facing - ["Hay un enorme potencial para el mercado biosimilar si el marco es el adecuado"](https://www.medicinesforeurope.com/news/hay-un-enorme-potencial-para-el-mercado-biosimilar-si-el-marco-es-el-adecuado/) - La patronal de genéricos anima a trasladar el foco desde la contención a la coste-eficiencia. Estos productos pueden evitar desigualdades dentro de la UE en el acceso a biológicos. Read more - [Analysis of the proposal for a regulation of a manufacturing exception related to the SPC and aimed to make the European industry competitive](https://www.medicinesforeurope.com/news/analysis-of-the-proposal-for-a-regulation-of-a-manufacturing-exception-related-to-the-spc-and-aimed-to-make-the-european-industry-competitive/) - [Future and Challenges of the Pharmaceutical Industry](https://www.medicinesforeurope.com/news/future-and-challenges-of-the-pharmaceutical-industry/) - [Biosimilars ‒ Policy failings that deny savings to countries that need it most](https://www.medicinesforeurope.com/news/biosimilars-‒-policy-failings-that-deny-savings-to-countries-that-need-it-most/) - Read more - [Practical measures are paramount for robust medicines manufacturing](https://www.medicinesforeurope.com/news/practical-measures-are-paramount-for-robust-medicines-manufacturing/) - [Decisive action on medicines shortages should be included in pharmaceutical and industrial strategies](https://www.medicinesforeurope.com/news/press-release-decisive-action-on-medicines-shortages-should-be-included-in-pharmaceutical-and-industrial-strategies/) - [Joint press statement of European Pharmaceutical industry associations](https://www.medicinesforeurope.com/news/joint-press-statement-of-european-pharmaceutical-industry-associations/) - [IGBA: Global Roadmap for Tailored Clinical Biosimilar Development: Instrumental for Sustainable Access to Biologics](https://www.medicinesforeurope.com/news/igba-global-roadmap-for-tailored-clinical-biosimilar-development-instrumental-for-sustainable-access-to-biologics/) - [Joint EU-UK pharmaceutical industry response to Specialised Committee outcome](https://www.medicinesforeurope.com/news/joint-eu-uk-pharmaceutical-industry-response-to-specialised-committee-outcome/) - [EU Industry Welcomes New Schengen Strategy’s Green Lanes](https://www.medicinesforeurope.com/news/eu-industry-welcomes-new-schengen-strategys-green-lanes/) - "EU Industry Welcomes New Schengen Strategy’s Green Lanes” Read more - [EU Industry Welcomes New Schengen Strategy’s Green Lanes](https://www.medicinesforeurope.com/news/eu-industry-welcomes-new-schengen-strategys-green-lanes-2/) - "EU Industry Welcomes New Schengen Strategy’s Green Lanes” Read more - [Arun Narayan, Chairman of the Value Added Medicines Sector Group interviewed by the European Pharmaceutical review](https://www.medicinesforeurope.com/news/10481/) - The interview of Arun Narayan, Chairman ofthe Value Added Medicines Sector Group at Medicines for Europe, for the European Pharmaceutical Review on the importance of Value Added Medicines in achieving sustainable innovation, showing how existing molecules can offer various benefits for both patients & the healthcare sector when repurposed, reformulated, combined or paired with services - [IGBA Calls on all Stakeholders to Join the Biosimilars Movement on Advancing Access](https://www.medicinesforeurope.com/news/igba-calls-on-all-stakeholders-to-join-the-biosimilars-movement-on-advancing-access/) - Read more - [Margaritis Schinas and Adrian Van Den Hoven visited ELPEN](https://www.medicinesforeurope.com/news/margaritis-schinas-and-adrian-van-den-hoven-visited-elpen/) - The Vice President of the European Commission for promoting our European Way of Life, Margaritis Schinas, and the Director General of Medicines for Europe, Adrian Van Den Hoven, visited the manufacturing facility of ELPEN in Pikermi and toured ELPEN’s under construction Research and Innovation Park in Spata. - [Open letter: Urgent call to amend the Temporary State Aid Framework to achieve the Recovery and Resiliency Facility objectives](https://www.medicinesforeurope.com/news/open-letter-urgent-call-to-amend-the-temporary-state-aid-framework-to-achieve-the-recovery-and-resiliency-facility-objectives/) - Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines, and its national associations call on Governments and the European Commission to align European recovery and resilience policies, including the adjustment of the general criteria for the Temporary State Aid Framework, to serve the purpose of the Next Generation EU: short term recovery and long term prosperity. - [OPEN LETTER Time for a new medicine security contract for Europe](https://www.medicinesforeurope.com/news/open-letter-time-for-a-new-medicine-security-contract-for-europe/) - The purpose of Medicines for Europe members is to improve access to medicines and provide a better availability and supply security for European patients. However, the current situation is challenging our ability to fulfil this objective. Open - [EU can do more for equitable access to medicines](https://www.medicinesforeurope.com/news/11948/) - The Hungarian Permanent Representation to the European Union hosted the event “Sustainable ways to finance innovation” organised in collaboration with the Slovak Presidency of the Visegrad 4 Group, the Permanent Representation of the Netherlands and Medicines for Europe Open - [IGBA taking action to tackle shortages of antibiotic medicines](https://www.medicinesforeurope.com/news/igba-taking-action-to-tackle-shortages-of-antibiotic-medicines/) - The global generic medicines industry supplies most of the world’s antibiotic medicine and is aware of the surge in demand of these products that is leading to shortages. The surge is driven by an unusually high rate of respiratory conditions and infections that are occurring as we exit the most acute phase of the Covid-19 - [Commission study highlights need for procurement reform to ensure patient access to medicines](https://www.medicinesforeurope.com/news/11870/) - To improve access to medicines, we need European-wide legal guidance on medicines procurement covering security of supply, MEAT criteria and biosimilar competition. Open - [Billions more euros to re-invest in better healthcare thanks to biosimilar medicines](https://www.medicinesforeurope.com/news/billions-more-euros-to-re-invest-in-better-healthcare-thanks-to-biosimilar-medicines/) - Biosimilar medicines deliver access for patients suffering from serious and debilitating conditions such as cancer, auto immune diseases, and diabetes. The benefits of using biosimilar medicines center on increasing the number of patients treated, leading to better health, and further advantages to health systems and healthcare professionals. Open - [Ready in a crisis: Medicines for Europe commits at one year anniversary of HERA](https://www.medicinesforeurope.com/news/ready-in-a-crisis-medicines-for-europe-commits-at-one-year-anniversary-of-hera/) - Medicines for Europe members are major suppliers of medicines for health crises. During the COVID pandemic, up to 90% of medicines needed in intensive care units were off-patent medicines and our members have donated over 1200 truckloads of medicines to help Ukraine. Open - [2022 Health at a Glance Report highlights the need to rethink investments in health after the COVID-19 pandemic](https://www.medicinesforeurope.com/news/2022-health-at-a-glance-report-highlights-the-need-to-rethink-investments-in-health-after-the-covid-19-pandemic/) - Over the last two years, major crises have had dramatic impacts on patient population health across Europe. The COVID-19 pandemic disrupted the provision of primary care, cancer screening and treatment, care continuity, and elective surgery, impacting health outcomes of patients across Europe. The 2022 Health at a Glance Report, examined the key challenges to develop - [Giving medicines a new life: EU should foster patients’ access to Value Added Medicines](https://www.medicinesforeurope.com/news/giving-medicines-a-new-life-eu-should-foster-patients-access-to-value-added-medicines/) - The added value of innovating on existing medicines may be in finding a new indication, by treating a different disease with the same medicine or treating a specific sub-population, improving efficacy of the treatment, being easier to tolerate, or improving overall adherence. Open - [Pharmaceutical legislation reforms must support equitable access to medicine in Central and Eastern Europe and security of medicines supplies](https://www.medicinesforeurope.com/news/pharmaceutical-legislation-reforms-must-support-equitable-access-to-medicine-in-central-and-eastern-europe-and-security-of-medicines-supplies/) - Open - [Proposals on wastewater treatment will jeopardise patient access to medicines without helping green transition](https://www.medicinesforeurope.com/news/proposals-on-wastewater-treatment-will-jeopardise-patient-access-to-medicines-without-helping-green-transition/) - Medicines have a unique value to public health and society at large. They are vital for our wellbeing, either to manage serious conditions such as cancer, diabetes, bacterial infections, cardiovascular diseases, auto-immune conditions, or to prevent illness and manage symptoms that allow everyone to carry on with their lives. Open - [Rapid policy action needed to protect patient access to essential medicines as inflation bites](https://www.medicinesforeurope.com/news/rapid-policy-action-needed-to-protect-patient-access-to-essential-medicines-as-inflation-bites/) - Inflation across Europe has risen beyond 10%. This increases the manufacturing costs of essential, off patent medicines, which account for 70% of those dispensed in Europe. These medicines treat serious, debilitating conditions such as cancer, diabetes, cardiovascular diseases, and auto-immune conditions. Open - [Updated Guide to empower nurses managing patients on biological therapies](https://www.medicinesforeurope.com/news/updated-guide-to-empower-nurses-managing-patients-on-biological-therapies/) - Nurses in all health domains and specialities play a crucial role in the management of patients with serious noncommunicable diseases such as cancer, auto-immune conditions, and diabetes. The incidence of these diseases is increasing, and more patients require biological therapies to manage their condition. Learn more in the ESNO guide Switch Management between Similar - [Open Medicines for Europe letter ahead of the Energy Council - 27 September 2022](https://www.medicinesforeurope.com/news/open-medicines-for-europe-letter-ahead-of-the-energy-council-27-september-2022/) - For the last decade, off-patent medicines, which represent the 70% of dispensed medicines in the European Union, have been subject to strict price regulation, budget austerity measures, and lowest-price tender rules, causing substantial price erosion and an unsustainable situation for manufacturers. This has been exacerbated by the Covid-19 crisis and the war in Ukraine, which - [EMA/HMA share definitive EU-wide position on biosimilar medicines interchangeability](https://www.medicinesforeurope.com/news/ema-hma-share-definitive-eu-wide-position-on-biosimilar-medicines-interchangeability/) - The Biosimilar medicines group, a Medicines for Europe sector group, is pleased to note the EMA/HMA jointly closing the discussion on biosimilar medicines interchangeability. The statement reflects a harmonised view on today’s common clinical practice in many European Member States whereby prescribers and their patients can safely choose from all available authorised options of a - [Medicines for Europe is part of the REMEDi4ALL consortium! An EU-funded research initiative aiming at driving forward the repurposing of medicines in Europe](https://www.medicinesforeurope.com/news/medicines-for-europe-is-part-of-the-remedi4all-consortium/) - REMEDi4ALL launched yesterday with the aim of making a major leap forward in drug repurposing. This promising approach to drug development consisting in the identification, testing, and validation of new therapeutic indications for existing medications, is a developing field but faces numerous barriers and systemic inefficiencies. Still, its potential to significantly bring down times and - [Medicines for Europe warns strongly against energy rationing for medicines production](https://www.medicinesforeurope.com/news/medicines-for-europe-warns-strongly-against-energy-rationing-for-medicines-production/) - In line with today European Commission’s Guidelines on a European Gas Demand Reduction Plan, Medicines for Europe urges Governments to maintain energy supply to medicines production sites in the event of energy restrictions in Europe. Open - [The Supplementary Protection Certificate (SPC) manufacturing waiver becomes operational!](https://www.medicinesforeurope.com/news/the-supplementary-protection-certificate-spc-manufacturing-waiver-becomes-operational/) - Today the transitional period for the application of the Supplementary Protection Certificate (SPC) manufacturing waiver ends. The SPC manufacturing waiver will become operational and generic and biosimilar medicines companies will be able to start manufacturing in Europe for export, stockpiling, and day 1 launch in Europe. Open - [The off-patent medicines industry is a vital part of the solution for healthcare resilience](https://www.medicinesforeurope.com/news/11353/) - Health systems face tremendous challenges across Europe. The management of COVID-19, war in Ukraine and high inflation rates are challenging supply chains for the most essential medicines. Off patent medicines account for 70% of those dispensed in Europe, treating severe conditions such as cancer, auto-immune conditions, respiratory diseases, and cardiovascular disease. These medicines are clearly - [Smart reform of EU pharma and IP legislation key to boosting access to essential medicines](https://www.medicinesforeurope.com/news/smart-reform-of-eu-pharma-and-ip-legislation-key-to-boosting-access-to-essential-medicines/) - Generic and biosimilar medicines lower healthcare treatment costs dramatically and are essential for enabling access to medicines. The EU has therefore made the prompt launch of generic and biosimilar medicines a high priority objective of the Pharmaceutical Strategy for Europe. The 2022 Medicines for Europe Legal Affairs Conference debated the much-needed reforms to ensure timely - [Statement on the war in Ukraine](https://www.medicinesforeurope.com/news/statement-on-the-war-in-ukraine/) - Collaboration Since the beginning of the war in Ukraine, Medicines for Europe immediately engaged with partners (Ukrainian Government and embassies, European Institutions, European Medicines Agency, civil protection agencies, national Strategic Reserve Agencies, World Health Organizaton and NGOs such as Médicins sans Frontières, Red Cross, International healthcare partners, Direct Relief, European Society for Paediatric Endocrinology, UAid - [EPSCO (Health) Council - Open letter from Medicines for Europe Executive Committee to European Health Ministers and responsible European Commissioners on inflation impacting the supply of essential medicines](https://www.medicinesforeurope.com/news/epsco-health-council-open-letter-from-medicines-for-europe-executive-committee-to-european-health-ministers-and-responsible-european-commissioners-on-inflation-impacting-the-supply-of-essential-me/) - Open We, Medicines for Europe Executive Committee members, are writing to Health Council and the European Commission to express our concern over the impact of rampant inflation on the secure supply of essential medicines for European patients. - [“Better patient access to medicines and restoring Europe’s (manufacturing) security of supply more critical than ever” says new President, as Elisabeth Stampa begins mandate](https://www.medicinesforeurope.com/news/better-patient-access-to-medicines-and-restoring-europes-manufacturing-security-of-supply-more-critical-than-ever-says-new-president-as-elisabeth-stampa-begins-mandate/) - The Covid-19 pandemic has highlighted the critical link between patient access to medicine and a robust medicines manufacturing sector. As health systems begin to recover from the pandemic, a new crisis threatens stability and secure supply of medicines in Europe. This heightens the urgency to coordinate EU action on essential medicines and access to care, - [Repurposing: a golden opportunity for patient centric health investment in Europe](https://www.medicinesforeurope.com/news/repurposing-a-golden-opportunity-for-patient-centric-health-investment-ineurope/) - Report shows the future of meeting unmet medical needs relies on developing tailored EU pathways for value added medicines Widely researched and resourced during the early stages of the COVID-19 pandemic, repurposing has shown its worth in an emergency. Facilitating repurposing beyond the pandemic promises sustainable developments and patient centric health outcomes in a range - [Pharmaboardroom - An EU Pharma Policy Framework for Better Access to Affordable Medicines](https://www.medicinesforeurope.com/news/an-eu-pharma-policy-framework-for-better-access-to-affordable-medicines/) - Open - [EU can do more for patients with smart use of biosimilar medicines](https://www.medicinesforeurope.com/news/eu-can-do-more-for-patients-with-smart-use-of-biosimilar-medicines/) - Open - [Central & Eastern European patients have inequitable access to medicines for life-threatening conditions](https://www.medicinesforeurope.com/news/central-eastern-european-patients-have-inequitable-access-to-medicines-for-life-threatening-conditions/) - Open - [Call on EU leaders to safeguard access to medicines and build resilience in response to Russia-Ukraine war](https://www.medicinesforeurope.com/news/call-on-eu-leaders-to-safeguard-access-to-medicines-and-build-resilience-in-response-to-russia-ukraine-war/) - The supply of medicines is critical yet unstable as war continues in Ukraine. As a key medicines supplier, our sector is doing everything possible to support Ukrainians and welcomes the recent establishment of a more coordinated EU approach to the donation of medicines to Ukraine. We are also mobilising our logistical capabilities in close coordination - [Essential medicines must be included in EU industrial policy plans](https://www.medicinesforeurope.com/news/essential-medicines-must-be-included-in-eu-industrial-policy-plans/) - Political ambitions to strengthen EU supply chain resilience following the Covid crisis will not be successful unless economic and regulatory systemic reforms, such as on procurement, are put in place and provisions are made to access funds for the manufacturing of essential medicines. Off patent medicines account for 70% of those dispensed in Europe for - [Electronic product information: new report shows it is time to move from principles to action](https://www.medicinesforeurope.com/news/electronic-product-information-new-report-shows-it-is-time-to-move-from-principles-to-action/) - Open - [Supply crunch for essential cancer medicines shows the urgent need to revise unsustainable pricing and tendering policies](https://www.medicinesforeurope.com/news/supply-crunch-for-essential-cancer-medicines-shows-the-urgent-need-to-revise-unsustainable-pricing-and-tendering-policies/) - Reports of supply shortages of breast cancer medicine (Tamoxifen) in Germany raise legitimate concerns for patients and highlight the difficulties faced by off-patent medicines manufacturers operating in markets driven by cost-containment policies. For the generics industry, the priority is to avoid bottlenecks in supply as far as possible and make sure patients can continue to - [The European Commission needs to prioritise equitable access to biosimilar medicines in Europe](https://www.medicinesforeurope.com/news/the-european-commission-needs-to-prioritise-equitable-access-to-biosimilar-medicines-in-europe/) - Over 15 years ago, the world’s first biosimilar was launched. This was very much a European success story, with the European Medicines Agency leading the way to bringing more affordable biologics to patients. Biosimilars have had a tremendous impact on: Patient access: Biosimilars paved the way for millions of patients to access life changing therapies, - [Regulatory reforms critical to improve patient access to medicines](https://www.medicinesforeurope.com/news/regulatory-reforms-critical-to-improve-patient-access-to-medicines/) - The ongoing review of the EU pharmaceutical legislation framework is a major opportunity to update the EU regulatory system. Future reforms should focus on a system that delivers meaningful benefits to patients, particularly timely access to medicines supported by efficient regulatory processes, readily accessible information on medicines and better systems to manage medicines shortages. The - [EU pharmaceutical legislation must support a competitive off-patent industry to deliver equitable access to medicines](https://www.medicinesforeurope.com/news/eu-pharmaceutical-legislation-must-support-a-competitive-off-patent-industry-to-deliver-equitable-access-to-medicines/) - Open - [Strong support for new measures to protect patient access to medicines in Northern Ireland](https://www.medicinesforeurope.com/news/strong-support-for-new-measures-to-protect-patient-access-to-medicines-in-northern-ireland/) - Open - [Biosimilar medicines have delivered 18BN€ total savings for Europe but more action needed to translate this potential into patient access and sustainable health](https://www.medicinesforeurope.com/news/biosimilar-medicines-have-delivered-18bne-total-savings-for-europe-but-more-action-needed-to-translate-this-potential-into-patient-access-and-sustainable-health/) - Open - [Commission study highlights market framework conditions are main driver for medicines shortages](https://www.medicinesforeurope.com/news/commission-study-highlights-market-framework-conditions-are-main-driver-for-medicines-shortages/) - Open - [European Parliament report calls for increased use of off-patent medicines to improve patient access](https://www.medicinesforeurope.com/news/european-parliament-report-calls-for-increased-use-of-off-patent-medicines-to-improve-patient-access/) - Open - [Access to essential medicines threatened by combination of increasing inflation and potential further price cuts in EU countries](https://www.medicinesforeurope.com/news/access-to-essential-medicines-threatened-by-combination-of-increasing-inflation-and-potential-further-price-cuts-in-eu-countries/) - Open - [The EU must stop the offshoring of essential medicines manufacturing investments](https://www.medicinesforeurope.com/news/the-eu-must-stop-the-offshoring-of-essential-medicines-manufacturing-investments/) - Open - [Adjustments to IP framework needed to improve access to medicines in Europe](https://www.medicinesforeurope.com/news/adjustments-to-ip-framework-needed-to-improve-access-to-medicines-in-europe/) - Access to generic and biosimilar medicines can be improved with coherent proposals for IP and pharmaceutical reform in Europe that encourage Day 1 launch. This has been echoed in the recent European Parliament report, which supports finetuning the IP system towards higher quality and timely access to generic and biosimilar medicines. This includes the timely evaluation of the SPC manufacturing waiver that entered into - [Access to medicines critical in European Parliament vote on EU IP action plan](https://www.medicinesforeurope.com/news/access-to-medicines-critical-in-european-parliament-vote-on-eu-ip-action-plan/) - The European Parliament Own Initiative Report on an intellectual property action plan is an important step to support the EU’s recovery and resilience following the pandemic and on equitable access to medicine. The report outlines critical policies to address weaknesses in the current system such as Stopping abuses of divisional patent applications that artificially - [European Commission pilot project on repurposing brings value added innovation to life](https://www.medicinesforeurope.com/news/european-commission-pilot-project-on-repurposing-brings-value-added-innovation-to-life/) - Innovation on existing, well-known molecules through repurposing can deliver huge benefits for patients and address unmet medical needs sustainably. Today the European Commission Safe and Timely Access to Medicines for Patients (STAMP) expert group, established in 2015 has launched a project to assist bringing value added repurposing to life. - ["Central Role For Industry Beckons As Europe Rebuilds After COVID” - Interview to Rebecca Guntern](https://www.medicinesforeurope.com/news/10605/) - Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview. - [Digitalisation the key to efficient EU pharmaceutical regulation and easing of localised drug shortages](https://www.medicinesforeurope.com/news/digitalisation-the-key-to-efficient-eu-pharmaceutical-regulation-and-easing-of-localised-drug-shortages/) - "Digitalisation the key to efficient EU pharmaceutical regulation and easing of localised drug shortages” Current EU regulatory systems too overwhelmed by paper, head of European association representing generics, biosimilars and value added medicines industries tells CPhI Worldwide online conference Digitalisation is needed to update inefficient and paper-based European pharmaceutical regulatory systems as well as help ease localised medicines - [Smart use of off-patent medicines will be critical to rebuild healthcare systems successfully post-Covid](https://www.medicinesforeurope.com/news/smart-use-of-off-patent-medicines-will-be-critical-to-rebuild-healthcare-systems-successfully-post-covid/) - Health systems have been severely jolted by COVID-19, causing widespread disruption to the provision of health care worldwide. As countries shift to investment in healthcare system recovery and ongoing management of COVID-19, off-patent medicines will be critical to their success. - [Baton passes from Christoph Stoller to Rebecca Guntern as President of Medicines for Europe](https://www.medicinesforeurope.com/news/baton-passes-from-christoph-stoller-to-rebecca-guntern-as-president-of-medicines-for-europe/) - Rebecca Guntern (Sandoz) today begins an interim term as President of Medicines for Europe for a period of 3 months, as Christoph Stoller (Teva) steps down following his two-year mandate. Christoph Stoller led the industry through the most challenging health care crisis in generations. Our industry coordinated with the EU to prevent shortages of emergency - [HERA must address outstanding weaknesses in EU pharma framework to be successful](https://www.medicinesforeurope.com/news/hera-must-address-outstanding-weaknesses-in-eu-pharma-framework-to-be-successful/) - Medicines For Europe strongly supports the EU’s drive to learn from COVID-19 and to improve its crisis preparedness and response. The proposal to establish a European Health Emergency Preparedness and Response Authority (HERA) is an important contribution to that policy and we support its creation and will contribute to its work for the security of all Europeans. Having been at the front - [EU must take the lead to ensure security of supply for medicines](https://www.medicinesforeurope.com/news/eu-must-take-the-lead-to-ensure-security-of-supply-for-medicines/) - Legislative reforms aligned with current off-patent market conditions are the precondition for a coherent policy to improve the secure supply of essential medicines. The EU structured dialogue on medicines manufacturing is a critical first step to align stakeholders on workable reforms. As the biggest supplier of prescription medicines, our industry is committed to improving security - [Opinion piece by Christoph Stoller for Friends of Europe](https://www.medicinesforeurope.com/news/10370/) - "Too much at stake in the EU pharma strategy to get it wrong: how the EU can deliver equitable access to medicines” Read more - [Open borders that prioritise essential goods key to medicines supply in Europe](https://www.medicinesforeurope.com/news/open-borders-that-prioritise-essential-goods-key-to-medicines-supply-in-europe/) - The open border Schengen system is key to EU mobility and internal market, including of essential medicines. Its coherent implementation between Members States is crucial to ensure medicines can continue to flow between countries, moving from factories to supply of thousands of hospitals and pharmacies in other countries. - [EU Industrial strategy should be key to improving medicines supply chains](https://www.medicinesforeurope.com/news/eu-industrial-strategy-should-be-key-to-improving-medicines-supply-chains/) - The newly launched update of the industrial strategy aims to support Europe’s recovery and boost open strategic manufacturing in Europe. With COVID-19 still a threat, Europe’s economic health and global interdependence requires attention. Few sectors could be considered more strategic than healthcare. Medicines for Europe members supply and manufacture the majority of emergency medicines (70-90% - ["Off patent medicines essential for a fairer, healthier, and sustainable Europe" says President Christoph Stoller](https://www.medicinesforeurope.com/news/off-patent-medicines-essential-for-a-fairer-healthier-and-sustainable-europe-says-president-christoph-stoller/) - Christoph Stoller will speak at 3A CONFERENCE - Availability, Accessibility, Affordability of Medicines and Medical Devices, organised by the Portuguese Presidency of the European Union at 11.30AM CET. When I took over the Presidency of Medicines for Europe in 2019, I made sustainable and equitable access to medicines a priority for our sector. I - [European patients need improved access to biosimilar medicines](https://www.medicinesforeurope.com/news/european-patients-need-improved-access-to-biosimilar-medicines/) - Fifteen years after the first global approval, biosimilar medicines systemically increase access to medicines for patients who need them, while contributing to the sustainability of our healthcare systems. We are at a unique moment for pharmaceutical policy, given the ongoing pressure from COVID-19 and the upcoming opportunities to build healthcare efficiency presented by the European - [New report assesses progress on biosimilar medicine policies across Europe](https://www.medicinesforeurope.com/news/press-release-biosimilar-market-review/) - The 2020 Market Review covers 8 main topics: Availability, Pricing system, Retail tendering, Hospital tendering, Reimbursement systems, Physician-related topics, Pharmacist-related policies and Information and education. - [EU industrial policy can dramatically improve medicines manufacturing resilience and security of supply](https://www.medicinesforeurope.com/news/eu-industrial-policy-can-dramatically-improve-medicines-manufacturing-resilience-and-security-of-supply/) - Medicines for Europe calls on Heads of State and Governments to build on the lessons learned from the COVID19 pandemic, with a thoughtful Industrial Policy that should strengthen European manufacturing and critical medicines supply chain resilience, while ensuring equitable access for patients. - [New report reveals need for pricing and reimbursement and procurement reforms to ensure patient access and healthcare sustainability](https://www.medicinesforeurope.com/news/new-report-reveals-need-for-pricing-and-reimbursement-and-procurement-reforms-to-ensure-patient-access-and-healthcare-sustainability/) - [Smart policies will encourage more critical medicines manufacturing in Europe](https://www.medicinesforeurope.com/news/smart-policies-will-encourage-more-critical-medicines-manufacturing-in-europe/) - Open - [EU must address barriers to continuous off-patent innovation and grasp opportunity for patients and healthcare](https://www.medicinesforeurope.com/news/eu-must-address-barriers-to-continuous-off-patent-innovation-and-grasp-opportunity-for-patients-and-healthcare/) - EU Pharma strategy provides unique moment to establish a regulatory pathway for Value Added Medicines and level the playing field with US The absence of a cohesive and unique regulatory framework for value added medicines in Europe acts to the detriment of patients and health care professionals across the continent. Gaps in the pharmaceutical legislation - [A new medicines trade and health security agenda for the European Commission](https://www.medicinesforeurope.com/news/a-new-medicines-trade-and-health-security-agenda-for-the-european-commission/) - In response to the European Commission Trade Communication published on 18 February 2021. During Covid-19, Medicines for Europe was strongly engaged to ensure continued access to medicines for patients while protectionism, hoarding measures and panic policies undermined these efforts. The emergency has highlighted the need for closer international health collaboration and for governments to work - [No further excuse to delay digital regulatory infrastructure for medicines after Covid-19 pandemic](https://www.medicinesforeurope.com/news/no-further-excuse-to-delay-digital-regulatory-infrastructure-for-medicines-after-covid-19-pandemic/) - Open - [Smarter use of generic, biosimilar and value added medicines will ensure equitable access to cancer care](https://www.medicinesforeurope.com/news/smarter-use-of-generic-biosimilar-and-value-added-medicines-will-ensure-equitable-access-to-cancer-care/) - Europe’s Beating Cancer plan is a welcome milestone to drive focused policy frameworks for cancer care in Europe. To achieve its mission, the cancer plan must support sustainable policies that improve access to generic, biosimilar and value added medicines. - [AESGP, EFPIA and Medicines for Europe reflections on the European Medicines Agency, the Heads of Medicines Agencies and the European Commission “Key principles for the use of electronic product information for EU medicines” press release.](https://www.medicinesforeurope.com/news/aesgp-efpia-and-medicines-for-europe-reflections-on-the-european-medicines-agency-the-heads-of-medicines-agencies-and-the-european-commission-key-principles-for-the-use-of-electronic-produc/) - Open - [Window of opportunity to enhance EU regulatory systems wide open as EU pharma strategy prioritises stronger EU networks](https://www.medicinesforeurope.com/news/window-of-opportunity-to-enhance-eu-regulatory-systems-wide-open-as-eu-pharma-strategy-prioritises-stronger-eu-networks/) - [IGBA Launches First Global Biosimilars Week](https://www.medicinesforeurope.com/news/igba-launches-first-global-biosimilars-week/) - [European Health Union – first step to greater EU solidarity in health crisis situations](https://www.medicinesforeurope.com/news/european-health-union-first-step-to-greater-eu-solidarity-in-health-crisis-situations/) - [EU Pharma Strategy: Success depends on access to Generic, Biosimilar and Value Added Medicines](https://www.medicinesforeurope.com/news/eu-pharma-strategy-success-depends-on-access-to-generic-biosimilar-and-value-added-medicines/) - [All routes to healthcare efficiency include biosimilar medicines](https://www.medicinesforeurope.com/news/all-routes-to-healthcare-efficiency-include-biosimilar-medicines/) - [EU digital strategy requires investments in the digitalisation of Europe’s medicines regulatory agencies to succeed](https://www.medicinesforeurope.com/news/eu-digital-strategy-requires-investments-in-the-digitalisation-of-europes-medicines-regulatory-agencies-to-succeed/) - [Joint Press Statement of European Pharmaceutical Industry Association on the Commission’s Update on the Progress and Implementation of the European Union Strategic Approach to Pharmaceuticals in the Environment](https://www.medicinesforeurope.com/news/joint-press-statement-of-european-pharmaceutical-industry-association-on-the-commissions-update-on-the-progress-and-implementation-of-the-european-union-strategic-approach-to-pharmaceuticals/) - [Failure to launch: white paper explores the role of inappropriate use of IP in blocking access to generic and biosimilar medicines](https://www.medicinesforeurope.com/news/failure-to-launch-white-paper-explores-the-role-of-inappropriate-use-of-ip-in-blocking-access-to-generic-and-biosimilar-medicines/) - [Comunicato Stampa Assogenerici Assemblea Pubblica](https://www.medicinesforeurope.com/news/comunicato-stampa-assogenerici-assemblea-pubblica/) - [Open letter from Medicines for Europe Executive on the upcoming EU pharmaceutical strategy](https://www.medicinesforeurope.com/news/open-letter-from-medicines-for-europe-executive-on-the-upcoming-eu-pharmaceutical-strategy/) - [Statement from the President: Now or never: pragmatism & ambition needed in EU pharma strategy to deliver on Europe’s medicines manufacturing](https://www.medicinesforeurope.com/news/statement-from-the-president-now-or-never-pragmatism-ambition-needed-in-eu-pharma-strategy-to-deliver-on-europes-medicines-manufacturing/) - Medicines for Europe is ready with realistic policy proposals to secure manufacturing resilience and supply for patients across Europe, says President Christoph Stoller - [Am fost foarte mândru de eforturile industriei noastre de a uni și a pune interesul pacienților absolut pe primul loc în timpul acestei crize](https://www.medicinesforeurope.com/news/am-fost-foarte-mandru-de-eforturile-industriei-noastre-de-a-uni-si-a-pune-interesul-pacientilor-absolut-pe-primul-loc-in-timpul-acestei-crize/) - Interviu cu Adrian van den Hoven, director general Medicines for Europe Asociația Medicines for Europe, al cărui director general sunteți, a sesizat în perioada pandemiei o serie de probleme, întâlnite aproape în toate țările UE, anume disfuncționalități în asigurarea stocurilor de medicamente și proceduri greoaie de achiziții de produse și echipamente medicale. Care sunt propunerile dv. pentru rezolvarea - [IQVIA Institute Scorecards show biosimilar medicines offer win for patients, policymakers and healthcare systems across Europe](https://www.medicinesforeurope.com/news/iqvia-institute-scorecards-show-biosimilar-medicines-offer-win-for-patients-policymakers-and-healthcare-systems-across-europe/) - Good biosimilar medicine policies balance the benefits of multi-source competition, volume uptake which increases patient access, and price discounts that generate savings. By acting decisively to tailor policies to local needs, governments and authorities can free up healthcare resources to improve access and make healthcare systems more sustainable. The Country Scorecards for Biosimilar Sustainability launched - [Interview: Medicines for Europe Reports on EU Biosimilar Success](https://www.medicinesforeurope.com/news/interview-medicines-for-europe-reports-on-eu-biosimilar-success/) - The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, Director General of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets. Read more - [Christoph Stoller and Adrian van den Hoven interviewed by PharmaBoardroom](https://www.medicinesforeurope.com/news/christoph-stoller-and-adrian-van-den-hoven-interviewed-by-pharmaboardroom/) - In the wake of the publication of Medicines for Europe’s Lessons Learned from COVID-19 policy paper, Christoph Stoller & Adrian van den Hoven outline the European generics, biosimilar and value-added-medicines industry’s rapid and comprehensive response to the COVID-19 crisis as well as the potential long-term shifts in European pharmaceutical policy that may come from this tumultuous period. - [COVID-19 a lightning rod for major overhaul of EU pharmaceutical policy](https://www.medicinesforeurope.com/news/covid-19-a-lightning-rod-for-major-overhaul-of-eu-pharmaceutical-policy/) - Urgent call for a structured industry-EU dialogue on reform The upcoming EU pharmaceutical strategy[1] must include the critical lessons learned from COVID-19, experts agreed during a dedicated webinar on the topic today. The webinar follows the launch of the Medicines for Europe policy paper, focused on the lessons learned from the COVID-19 outbreak. The outbreak - [EU Pharmaceutical Strategy Roadmap: high time to improve patient access to medicines and to apply the lessons from Covid19](https://www.medicinesforeurope.com/news/eu-pharmaceutical-strategy-roadmap-high-time-to-improve-patient-access-to-medicines-and-to-apply-the-lessons-from-covid19/) - [Letter to EU Trade Ministers. European Industry trade and supply chain needs to respond to Covid-19](https://www.medicinesforeurope.com/news/letter-to-eu-trade-ministers-european-industry-trade-and-supply-chain-needs-to-respond-to-covid-19/) - [A statement from the President on COVID-19](https://www.medicinesforeurope.com/news/a-statement-from-the-president-on-covid-19/) - OPEN STATEMENT - [Medicines for Europe welcomes European Commission decision to enable secure supply of hospital medicines](https://www.medicinesforeurope.com/news/medicines-for-europe-welcomes-european-commission-decision-to-enable-secure-supply-of-hospital-medicines/) - OPEN - [Statement: Supply of essential ICU medicines](https://www.medicinesforeurope.com/news/statement-supply-of-essential-icu-medicines/) - [European Commission guidelines: Free movement of workers during COVID-19 outbreak](https://www.medicinesforeurope.com/news/european-commission-guidelines-free-movement-of-workers-during-covid-19-outbreak/) - 2020-2051-Communication-free-movement_EN (1) - [Prioritise Medicines in COVID19 Actions](https://www.medicinesforeurope.com/news/prioritise-medicines-in-covid19-actions/) - [Digital transformation of healthcare](https://www.medicinesforeurope.com/news/digital-transformation-of-healthcare/) - [Best practice guidance for truck drivers in relation to Covid-19](https://www.medicinesforeurope.com/news/best-practice-guidance-for-truck-drivers-in-relation-to-covid-19/) - [Call for action: heads of state and government should prioritise medicines in covid-19 actions](https://www.medicinesforeurope.com/news/call-for-action-heads-of-state-and-government-should-prioritise-medicines-in-covid-19-actions/) - [OECD and EUIPO publish study on counterfeit medicinal products](https://www.medicinesforeurope.com/news/oecd-and-euipo-publish-study-on-counterfeit-medicinal-products/) - Today the OECD and the European Union Intellectual Property Office published an extensive study on the issues and challenges posed by trade in counterfeit pharmaceutical products for governments, businesses and society. Medicines for Europe member companies are at the forefront of the fight against counterfeit medicines. The European Union and industry have been working hand-in-hand - [Statement on air freight of critical medicines & supplies](https://www.medicinesforeurope.com/news/statement-on-air-freight-of-critical-medicines-supplies/) - [Urgent call to governments Air freight must reopen for critical medicines and supplies for their manufacture](https://www.medicinesforeurope.com/news/urgent-call-to-governments-air-freight-must-reopen-for-critical-medicines-and-supplies-for-their-manufacture/) - [Critical to keep the supply chain of essential medicines manufacturing operating at full capacity](https://www.medicinesforeurope.com/news/critical-to-keep-the-supply-chain-of-essential-medicines-manufacturing-operating-at-full-capacity/) - [EMA clarifies no scientific evidence to deter use of ibuprofen to manage coronavirus symptoms](https://www.medicinesforeurope.com/news/ema-clarifies-no-scientific-evidence-to-deter-use-of-ibuprofen-to-manage-coronavirus-symptoms/) - The European Medicines Agency (EMA) has published today a press release to address concerns about the use of ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) in COVID-19 patients. According to the Agency, when starting treatment for fever or pain in COVID-19, patients and healthcare professionals should consider all available treatment options including paracetamol and NSAIDs. - [Best practice guidance on how to protect workers in relation to Covid-19](https://www.medicinesforeurope.com/news/best-practice-guidance-on-how-to-protect-workers-in-relation-to-covid-19/) - Maintaining a fully operational pharmaceutical industry is considered essential, as it is critical to ensure an adequate supply of medicines. Despite not being exposed to the same risk as healthcare professionals, industry personnel can follow many of the specific recommendations for healthcare professionals outlined in the national guidelines. These are general recommendations only, which should - [Medicines for Europe update regarding medicines production and supply related to Covid-19](https://www.medicinesforeurope.com/news/medicines-for-europe-update-regarding-medicines-production-and-supply-related-to-covid-19/) - [Medicines for Europe urgent requests to Interior & Transport ministries regarding medicines production and supply](https://www.medicinesforeurope.com/news/medicines-for-europe-urgent-requests-to-interior-transport-ministries-regarding-medicines-production-and-supply/) - [Impact of COVID-19 on active ingredient and medicines manufacturing and supplies in Europe](https://www.medicinesforeurope.com/news/impact-of-covid-19-on-active-ingredient-and-medicines-manufacturing-and-supplies-in-europe/) - [Coordination with industry on potential impact of Covid-19 on medicines manufacturing and supplies in Europe](https://www.medicinesforeurope.com/news/coordination-with-industry-on-potential-impact-of-covid-19-on-medicines-manufacturing-and-supplies-in-europe/) - [Medicines for Europe statement on COVID-19 (‘coronavirus’)](https://www.medicinesforeurope.com/news/medicines-for-europe-statement-on-covid-19-coronavirus/) - [European Industries welcome an important industry focus from the European Commission](https://www.medicinesforeurope.com/news/european-industries-welcome-an-important-industry-focus-from-the-european-commission/) - [Protecting health: Active generic and biosimilar policies central to EU pharmaceutical strategy](https://www.medicinesforeurope.com/news/protecting-health-active-generic-and-biosimilar-policies-central-to-eu-pharmaceutical-strategy/) - Equitable and sustainable access to medicines is a concern across the EU. Policy reforms were discussed during the seminar “A European Union that ensures Patient Access & Sustainability”, organised by the Hungarian Permanent Representation to the EU with the support of the Croatian Presidency of the European Council. The seminar assembled high-level experts from the - [Biosimilar Uptake in Europe: Big Challenges; Bigger Rewards](https://www.medicinesforeurope.com/news/biosimilar-uptake-in-europe-big-challenges-bigger-rewards/) - Since the first treatment was approved in 2006, Europe has been at the vanguard of the biosimilar medicines sector, approving more treatments over the last 10 years than anywhere else in the world. However, it is only in the last few years that usage has significantly increased, and biosimilars have begun to challenge the established - [Resolving and mitigating medicine shortages in the EU](https://www.medicinesforeurope.com/news/resolving-and-mitigating-medicine-shortages-in-the-eu/) - Drug shortages can greatly impact patients and the pharmaceutical industry. Adrian van den Hoven, Director General of Medicines for Europe, explains how to prevent and reduce the effects of medicinal scarcities in the EU. Read More - [The European Medicines Verification System (EMVS) celebrates 1 year of successful operation across Europe](https://www.medicinesforeurope.com/news/the-european-medicines-verification-system-emvs-celebrates-1-year-of-successful-operation-across-europe/) - [Arun Narayan – Chairman, Value Added Medicines Group, Medicines for Europe](https://www.medicinesforeurope.com/news/arun-narayan-chairman-value-added-medicines-group-medicines-for-europe/) - Arun Narayan is the Chairman of the Value Added Medicines Sector Group at Medicines for Europe, in addition to serving as Head of Global Portfolio Strategy and Head of European Business Operations at Mylan. Narayan introduces compelling reasons why payers in Europe should consider Value Added Medicines, including cost savings and improved rates of adherence, - [Time to modernise the EU pharmaceutical regulatory framework to deliver on access](https://www.medicinesforeurope.com/news/time-to-modernise-the-eu-pharmaceutical-regulatory-framework-to-deliver-on-access/) - To maintain its leadership in pharmaceutical regulatory science, the EU should integrate digital tools in the regulatory process. Delivering results on digitalisation, updated variations procedures, streamlined development processes and medicines availability are clearly within the pharmaceutical mission of the recently appointed European Commission and are clearly aligned with the access objectives of the EMA-HMA regulatory - [Smart Pharmacovigilance Essential for Patient Safety](https://www.medicinesforeurope.com/news/smart-pharmacovigilance-essential-for-patient-safety/) - Medicines are developed and manufactured to help patients so, it is important to monitor their use for potential adverse events through pharmacovigilance. At the 13th Annual Medicines for Europe Pharmacovigilance Conference, stakeholders agreed that pharmacovigilance is not only mechanical exercise in regulatory compliance. Rather, smart pharmacovigilance should allow us to leverage the experience of the - [AMR life science industry 2020 report: Successes and setbacks in fighting superbugs](https://www.medicinesforeurope.com/news/amr-life-science-industry-2020-report-successes-and-setbacks-in-fighting-superbugs/) - AMR Industry Alliance reports breakthroughs in the responsible manufacturing of antibiotics and positive steps to improve how patients access and use antibiotics. But its report also highlights concerning levels of research and development (R&D) investment. - [Hanan Sboul takes over the position of IGBA Chair](https://www.medicinesforeurope.com/news/hanan-sboul-takes-over-the-position-of-igba-chair/) - [Better access to medicines in Bulgaria prioritised by Medicines for Europe President](https://www.medicinesforeurope.com/news/better-access-to-medicines-in-bulgaria-prioritised-by-medicines-for-europe-president/) - Christoph Stoller, the President of Medicines for Europe, led an important mission to Bulgaria to improve access to medicines in partnership with the Bulgarian Generic Pharmaceutical Association chaired by Nikolay Hadjidontchev. Bulgaria has limited public funding for medicines and patients face the highest drug co-payment costs in all of Europe according to the State of - [Key topics: medicines shortages](https://www.medicinesforeurope.com/news/medicine-shortages/) - [Medicines shortages: root causes and potential solutions](https://www.medicinesforeurope.com/news/medicines-shortages-root-causes-and-potential-solutions/) - [Generic & biosimilar medicines pivotal for safe, effective and affordable access to medicines in Europe](https://www.medicinesforeurope.com/news/generic-biosimilar-medicines-pivotal-for-safe-effective-and-affordable-access-to-medicines-in-europe/) - The European Commission has identified the use of generic and biosimilar medicines as crucial for EU health systems in a report released today. Detailing the potential benefits of generic and biosimilar medicines use, the European Commission identified the urgency to foster the use of biosimilar medicines specifically, an urgency heightened due to the expenditure rate - [Open letter from Medicines for Europe Executive on medicines shortages](https://www.medicinesforeurope.com/news/open-letter-from-medicines-for-europe-executive-on-medicines-shortages/) - Open - [European industries unite to call for an ambitious EU industrial strategy](https://www.medicinesforeurope.com/news/european-industries-unite-to-call-for-an-ambitious-eu-industrial-strategy/) - Read more - [‘Health revolution’: when smart innovation benefits patients](https://www.medicinesforeurope.com/news/health-revolution-when-smart-innovation-benefits-patients/) - Value added medicines conference urges paradigm shift across the healthcare access and regulatory landscape Value added medicines deliver sustainable and continuous innovation with existing molecules and enhance patients’ well-being. The 3rd Value Added Medicines Conference brought together thought leaders to discuss the future of digital delivery and the regulatory and market access framework for value - [Medicines for Europe, APOGEN and Fresenius Kabi hold Open Industry Day in Portugal](https://www.medicinesforeurope.com/news/medicines-for-europe-apogen-and-fresenius-kabi-hold-open-industry-day-in-portugal/) - Almost 70% of medicines dispensed in Europe are generic medicines Medicines for Europe and APOGEN have pleasure in announcing today’s Open Industry Day in Portugal which aims to showcase the quality and safety of generic, biosimilar and value added medicines production in Europe and to discuss current and future market challenges. This initiative is the - [Biosimilar medicines: competition, sustainability and early* access on the agenda of DG GROW stakeholder workshop](https://www.medicinesforeurope.com/news/biosimilar-medicines-competition-sustainability-and-early-access-on-the-agenda-of-dg-grow-stakeholder-workshop/) - Medicines for Europe welcomes 5th European Commission Stakeholder event on biosimilar medicines products organised today by the Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG GROW). The event will discuss the competitive forces driving the European biologics market, how to ensure the sustainability of biosimilar medicines development and manufacturing and how to - [WHO signs MoU with International Generic and Biosimilar Medicines Association to promote access](https://www.medicinesforeurope.com/news/who-signs-mou-with-international-generic-and-biosimilar-medicines-association-to-promote-access/) - [Report identifies 9 key ingredients to improve access to medicines in the hospital setting](https://www.medicinesforeurope.com/news/report-identifies-9-key-ingredients-to-improve-access-to-medicines-in-the-hospital-setting/) - Many European countries are grappling with the efficiency of hospital care, which is facing growing demands from an increasingly elderly population. The optimal use of generic, biosimilar and value added medicines is one major contributor to this efficiency. A new report by KPMG launched today titled ‘Improving healthcare delivery in hospitals by optimized utilization of - [EU manufacturers call for urgent reforms to achieve reciprocity and a level-playing field in public procurement](https://www.medicinesforeurope.com/news/eu-manufacturers-call-for-urgent-reforms-to-achieve-reciprocity-and-a-level-playing-field-in-public-procurement/) - Brussels, 30 September 2019 – Amidst discussions on the International Procurement Instrument (IPI) relaunched in Council and the hearings of Commissioners-designate taking place this week, AEGIS Europe, the industry alliance representing more than 20 key industries, today urged the EU to take a stronger stance on reciprocity and other reforms needed in the field of - [Christoph Stoller (Teva) Appointed as new President of Medicines for Europe
Immediately calls on new President of EU Commission to prioritise Healthcare ](https://www.medicinesforeurope.com/news/christoph-stoller-teva-appointed-as-new-president-of-medicines-for-europeimmediately-calls-on-new-president-of-eu-commission-to-prioritise-healthcare/) - Christoph Stoller was elected as President of Medicines for Europe today for a 2 year period. Christoph is currently General Manager for Teva Germany and Austria, and has taken an active role on the Medicines for Europe Board over the last 5 years. To mark the launch of his Presidency, Christoph outlined four key priorities - [A DIGITAL FUTURE FOR VALUE ADDED MEDICINES – IQVIA publication shares the future of the sector](https://www.medicinesforeurope.com/news/a-digital-future-for-value-added-medicines-iqvia-publication-shares-the-future-of-the-sector/) - The value added medicines sector group of Medicines for Europe welcomes the publication from IQVIA’s Thought Leadership “A Digital Future for Value Added Medicines”. The publication provides valuable insights on the drivers behind the sector, its challenges and what the future holds for value added medicines. The importance of regulatory and payer environments to evolve - [Ready to drive access to medicines](https://www.medicinesforeurope.com/news/ready-to-drive-access-to-medicines/) - Medicines for Europe is ready to engage with the EU to drive the access to medicines agenda in line with the European Council declaration of 20th June on good healthcare access. Our industry supplies close to 70% of prescription medicines and plays a fundamental role in lifting barriers for patient access to therapy. Generic medicines - [European Specialised Nurses Organisation (ESNO) launches translations into multiple European languages of switch management guide between similar biological medicines, for nurses](https://www.medicinesforeurope.com/news/european-specialised-nurses-organisation-esno-launches-translations-into-multiple-european-languages-of-switch-management-guide-between-similar-biological-medicines-for-nurses/) - Open - [Committing to Global Health: Balancing Access and Sustainability key to success](https://www.medicinesforeurope.com/news/committing-to-global-health-balancing-access-and-sustainability-key-to-success/) - Global medicine manufacturers gathered in Warsaw this week to discuss the contribution of the generic, biosimilar and value added medicines to patient access and durable healthcare systems around the world. Delivering access is at the core of the off patent sector. Generic medicines provide for 67% of dispensed medicines in Europe alone and have doubled - [Huge European Parliament majority votes to adopt the SPC manufacturing waiver](https://www.medicinesforeurope.com/news/huge-european-parliament-majority-votes-to-adopt-the-spc-manufacturing-waiver/) - The European Parliament today voted overwhelmingly with 572 Members of Parliament in favour to adopt the Supplementary Protection Certificate (SPC) manufacturing waiver. The SPC manufacturing waiver is now expected to be formally adopted by the European Council in the coming weeks. Medicines for Europe commends the EU institutions for successfully concluding this important step in - [‘Together for Health’: Medicines for Europe launches election manifesto to deliver on equitable patient access](https://www.medicinesforeurope.com/news/together-for-health-medicines-for-europe-launches-election-manifesto-to-deliver-on-equitable-patient-access/) - Medicines for Europe has launched its vision for pharmaceutical policy ahead of the European elections. ‘Together for Health’ outlines the generic, biosimilar and value added medicines industry’s commitment to sustainable access to healthcare for all patients across Europe. The campaign is designed around four key pillars: Equitable access to medicines for all patients in Europe - [Accelerating the biosimilar medicines access journey through benefit-sharing](https://www.medicinesforeurope.com/news/accelerating-the-biosimilar-medicines-access-journey-through-benefit-sharing/) - Biosimilar medicines have significantly increased equity of access to important biological treatments across Europe and can massively improve disease management for patients with chronic conditions and cancer. They offer more prescribing options for physicians, their patients, and alleviate financial pressure on healthcare systems in an era of rapidly growing healthcare expenditure. Biosimilar medicines can only - [Major challenges in the Intellectual Property (IP) environment for pharmaceuticals debated at Medicines for Europe Legal Conference](https://www.medicinesforeurope.com/news/major-challenges-in-the-intellectual-property-ip-environment-for-pharmaceuticals-debated-at-medicines-for-europe-legal-conference/) - The SPC manufacturing waiver, which will put an end to the legal requirement to delocalise pharmaceutical production outside of Europe, was lauded as a positive step for competition and security of supply of medicines at the 15th Legal Affairs conference in Amsterdam. Stakeholders, government representatives, lawyers and industry experts took stock of the ten year - [Joint Press Statement of the Inter Associations Initiative (IAI) Pharmaceuticals in the Environment Task Force (AESGP, EFPIA, Medicines for Europe) – European Union Strategic Approach to Pharmaceuticals in the Environment](https://www.medicinesforeurope.com/news/joint-press-statement-of-the-inter-associations-initiative-iai-pharmaceuticals-in-the-environment-task-force-aesgp-efpia-medicines-for-europe-european-union-strategic-approach-to-pharm/) - [Report calls for better environment to improve patient access to value added medicines](https://www.medicinesforeurope.com/news/report-calls-for-better-environment-to-improve-patient-access-to-value-added-medicines/) - A new report launched today lays out clear recommendations to boost access to value added medicines in Europe. The IQVIA report points out the necessary adjustments to healthcare processes from defining regulatory pathways to pricing and reimbursement policies that consider value added benefits based on tailored and efficient use of evidence. The report also flags - [Interview: Adrian van den Hoven, Director General of Medicines for Europe](https://www.medicinesforeurope.com/news/interview-adrian-van-den-hoven-director-general-of-medicines-for-europe/) - Over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas and have provided massive savings for healthcare systems in Europe. In this exclusive interview with Adrian van den Hoven, director general of Medicines for Europe, we discuss the importance of the generic industry, the disparity - [Medicines for Europe applauds compromise on SPC manufacturing waiver](https://www.medicinesforeurope.com/news/medicines-for-europe-applauds-compromise-on-spc-manufacturing-waiver/) - Today, the European Council, Parliament and Commission agreed a compromise deal on the SPC manufacturing waiver which will allow the co-legislators to adopt the amendment to the SPC Regulation under the current legislature. The SPC manufacturing waiver will contribute to better patient access, to create manufacturing opportunity and jobs and to increase Europe’s capacity to - [New safeguards for patient safety as Falsified Medicines Directive comes into force](https://www.medicinesforeurope.com/news/new-safeguards-for-patient-safety-as-falsified-medicines-directive-comes-into-force/) - The EU Falsified Medicines Directive was adopted in 2011 to prevent falsified medicines from reaching patients in Europe. Following lengthy discussions on the technical requirements to serialise between 10 and 14 billion packs of medicine every year, the system will start functioning across Europe as of the 9th February. Prescription medicines in hospitals and pharmacies - [SUPPORT a comprehensive SPC manufacturing waiver: for patient access, sustainable healthcare and manufacturing jobs](https://www.medicinesforeurope.com/news/support-a-comprehensive-spc-manufacturing-waiver-for-patient-access-sustainable-healthcare-and-manufacturing-jobs/) - [SPC manufacturing waiver cannot be derailed by foreign vested interests](https://www.medicinesforeurope.com/news/spc-manufacturing-waiver-cannot-be-derailed-by-foreign-vested-interests/) - Medicines for Europe calls on the European Council, Parliament and Commission to resist pressure from foreign vested interests to derail the adoption of the Supplementary Protection Certificate (SPC) manufacturing waiver. All parties involved in these discussions are well aware that these foreign vested interests fear the competition from EU biosimilar medicines manufacturers where we have - [A shared vision for better regulatory science: – Moving toward the light at the end of the tunnel](https://www.medicinesforeurope.com/news/a-shared-vision-for-better-regulatory-science-moving-toward-the-light-at-the-end-of-the-tunnel/) - This week in London, Medicines for Europe gathers regulators and industry leaders to discuss the future of regulation of generic, biosimilar and value added medicines industries. Our industries, which supply 67% of Europe’s medicines, face an unprecedented set of regulatory challenges in the year ahead. With less than two months to adapt to the UK - [Efficient use of pharmacovigilance data essential for patient safety](https://www.medicinesforeurope.com/news/efficient-use-of-pharmacovigilance-data-essential-for-patient-safety/) - National authorities, regulators, industry leaders, and stakeholders gathered in London to discuss the role of pharmacovigilance in ensuring patient safety and access to safe medicines at the 12th Medicines for Europe Pharmacovigilance Conference. As we move into an increasingly patient-centred future, simplification and improved communication should be at the heart of our pharmacovigilance strategy. Digital - [Competition policy essential for access to medicines](https://www.medicinesforeurope.com/news/competition-policy-essential-for-access-to-medicines/) - Medicines for Europe welcomes the publication of the European Commission Report on Competition Enforcement in the Pharmaceutical Sector (2009-2017). This compilation of pharmaceutical competition law cases is part of the Health Council Conclusions of June 2016 on strengthening the balance in the pharmaceutical systems in the EU. These conclusions aim to ensure the timely availability - [Crucial European Parliament vote vastly improves SPC manufacturing waiver](https://www.medicinesforeurope.com/news/crucial-european-parliament-vote-vastly-improves-spc-manufacturing-waiver/) - Medicines for Europe welcomes today’s vote of the Legal Committee of the European Parliament (JURI), which combines the opinions of the Health (ENVI) and Trade (INTA) committees in support of a comprehensive SPC manufacturing waiver. The compromise agreement by the JURI Committee includes the possibility to produce generic and biosimilar medicines during the SPC period - [Parliament’s Trade Committee votes for jobs and access to medicines with a comprehensive SPC Manufacturing Waiver](https://www.medicinesforeurope.com/news/parliaments-trade-committee-votes-for-jobs-and-access-to-medicines-with-a-comprehensive-spc-manufacturing-waiver/) - The Medicines for Europe Board unanimously applauds last night’s vote in the European Parliament where, once again, parliamentarians voted for a comprehensive Supplementary Protection Certificate (SPC) manufacturing waiver. This has the potential of unlocking huge industrial job opportunities and healthcare savings as SPCs expire on blockbuster medicines over the next few years. The International Trade - [Value added medicines: Continuous innovation crucial to improve healthcare across Europe](https://www.medicinesforeurope.com/news/value-added-medicines-continuous-innovation-crucial-to-improve-healthcare-across-europe/) - The 2nd Value Added Medicines conference gathered a wide range of experts in the healthcare community to raise awareness, inform and debate with the mutual intention to present solutions for maximising the benefits of and encouraging the development of continuous innovation. Adjustments in the healthcare processes – eg. adjustments on purchasing/procurement processes, acceptance of adequate - [Medicines for Europe welcomes Competitiveness Council discussion to stop delocalisation of medicine manufacturing. It is time to effectively position Europe as a global hub for the production of medicines](https://www.medicinesforeurope.com/news/medicines-for-europe-welcomes-competitiveness-council-discussion-to-stop-delocalisation-of-medicine-manufacturing-it-is-time-to-effectively-position-europe-as-a-global-hub-for-the-production-of-medic/) - Yesterday, 29th November, members of the Competitiveness Council expressed strong support for an SPC manufacturing waiver. While we regret that a couple of countries are clearly supporting vested interests in their complete opposition to the waiver, at least it is now clear that they simply working to block the constructive efforts of the rest of - [Parliament’s Health Committee (ENVI) introduces constructive amendments to SPC Manufacturing waiver vote in its official opinion to the Parliament’s Legal Committee (JURI)](https://www.medicinesforeurope.com/news/parliaments-health-committee-envi-introduces-constructive-amendments-to-spc-manufacturing-waiver-vote-in-its-official-opinion-to-the-parliaments-legal-committee-juri/) - The introduction of comprehensive SPC manufacturing waiver key to unlocking huge industrial opportunities and healthcare savings, with €90 billion of blockbuster medicines coming off patent in 2020. The Parliament’s Health Committee (ENVI) sent a clear signal of support with the adoption of a “day one” launch possibility to supply European patients with European manufactured medicines. - [Health at a Glance Report highlights public value of generic, biosimilar and value added medicines](https://www.medicinesforeurope.com/news/health-at-a-glance-report-highlights-public-value-of-generic-biosimilar-and-value-added-medicines/) - The European Commission and OECD – Health at a Glance: Europe 2018 –recommends further use of generic and biosimilar medicines to further tackle wasteful spending in healthcare systems. The uptake of generic and biosimilar medicines varies widely across countries despite the opportunities to treat more patients and improve the sustainability of healthcare budgets. There is - [Driving local excellence, delivering European results](https://www.medicinesforeurope.com/news/driving-local-excellence-delivering-european-results/) - Medicines for Europe is glad to announce the occasion of the first European Open Industry Day in Romania, which took place in Bucharest on October 31st. The objective of the day was to open up our industry’s doors to interested institutional stakeholders. This initiative has been designed together with APMGR, the Romanian generic association, and - [US interference unacceptable in EU legislative proposal for an SPC manufacturing waiver](https://www.medicinesforeurope.com/news/us-interference-unacceptable-in-eu-legislative-proposal-for-an-spc-manufacturing-waiver/) - The US patent and trademark office (USPTO), together with the US Trade Office (USTR) and the US Department of Commerce, is holding this week a dedicated, Government official only briefing on the EU legislative proposal for a Supplementary Protection Certificate (SPC) manufacturing waiver. The meeting, which will be conducted under Chatham house rules, will take - [Risk that European Council will “neuter” SPC manufacturing waiver and give foreign (non-EU) manufacturers strong advantage over EU-based manufacturers](https://www.medicinesforeurope.com/news/risk-that-european-council-will-neuter-spc-manufacturing-waiver-and-give-foreign-non-eu-manufacturers-strong-advantage-over-eu-based-manufacturers/) - There is a concrete risk that disproportionate influence on the Council of the European Union will hamper the progress of an effective, usable SPC manufacturing waiver and maintain the status quo. Medicines for Europe, which represents the EU’s generic and biosimilar medicines industry, says that it is extremely concerned about discussions taking place at the - [SPC manufacturing waiver is good news for Europe](https://www.medicinesforeurope.com/news/spc-manufacturing-waiver-is-good-news-for-europe/) - An SPC manufacturing waiver should be extremely beneficial for Europe and will increase net sales of the EU pharmaceutical industry… Read More - [CJEU decision on Gilead’s SPC on Truvada® leads to successful clarification in English court](https://www.medicinesforeurope.com/news/cjeu-decision-on-gileads-spc-on-truvada-leads-to-successful-clarification-in-english-court/) - An English Court has determined that the contested supplementary protection certificate (SPC) on Truvada® held by Gilead is invalid by applying the criteria laid down by a recent referral to the Court of Justice of the EU (CJEU). Mr Justice Arnold held that Gilead’s SPC failed the CJEU’s test as Gilead’s basic patent on which - [SPC manufacturing waiver moves a step closer as influential European Parliament ENVI Committee supports reform](https://www.medicinesforeurope.com/news/spc-manufacturing-waiver-moves-a-step-closer-as-influential-european-parliament-envi-committee-supports-reform/) - Medicines for Europe welcomes the European Parliament’s Committee on Environment, Public Health and Food Safety’s (‘ENVI’) support for an SPC manufacturing waiver. ENVI voiced its support in its Draft Opinion on the proposal which was published by the Committee on 13 September last. The ENVI Committee Rapporteur, MEP Tiemo Wölken (S&D, Germany), welcomed the proposal - [Multi-stakeholder workshop on biosimilar medicines a crucial milestone in achieving increased patient access to biological therapies](https://www.medicinesforeurope.com/news/multi-stakeholder-workshop-on-biosimilar-medicines-a-crucial-milestone-in-achieving-increased-patient-access-to-biological-therapies/) - [European Organisation for Specialised Nurses (ESNO) launches switch management guide between similar biological medicines - a guide for nurses](https://www.medicinesforeurope.com/news/european-organisation-for-specialised-nurses-esno-launches-switch-management-guide-between-similar-biological-medicines-a-guide-for-nurses/) - Open - [Medicines for Europe members publish disclosure of Transfers of Value to the healthcare community](https://www.medicinesforeurope.com/news/medicines-for-europe-members-publish-disclosure-of-transfers-of-value-to-the-healthcare-community/) - Medicines for Europe is committed to bringing accessible, high quality medicines to patients across Europe. Already today our industry supplies 63% of dispensed medicines in Europe. As part of our commitment to improve public health, Medicines for Europe and its members regularly engage and collaborate with the stakeholder community, including healthcare professionals and patient representatives. - [Access, sustainability and manufacturing competitiveness highlighted at global generic, biosimilar and value added pharmaceutical conference in Budapest](https://www.medicinesforeurope.com/news/access-sustainability-and-manufacturing-competitiveness-highlighted-at-global-generic-biosimilar-and-value-added-pharmaceutical-conference-in-budapest/) - The joint 24th Medicines for Europe and 21st IGBA Annual Conference began today with key industry leaders coming together in Budapest, Hungary, to discuss the challenges and opportunities for the global generic, biosimilar and value added medicines industries. Challenges related to industry sustainability were debated with key experts, who shared perspectives on topics such as - [Statement in response to the EU Council ratifying the Brexit transition deal](https://www.medicinesforeurope.com/news/statement-in-response-to-the-eu-council-ratifying-the-brexit-transition-deal/) - Today’s agreement on a transition period is welcome news for Europe’s Life Sciences industry. While expecting a deal on the withdrawal agreement as soon as possible, this gives companies more certainty about the time they will have to prepare for the UK’s departure from the EU. At the current status of negotiations, we continue to - [European health community issues key questions Article 50 negotiations must answer for patients and public health](https://www.medicinesforeurope.com/news/european-health-community-issues-key-questions-article-50-negotiations-must-answer-for-patients-and-public-health/) - The European Health Community has warned that time is running out to secure patients’ interests in Brexit negotiations. With Phase 2 of the negotiations looming, health groups across Europe have drawn up a list of crucial unanswered questions that must be answered by the EU and UK negotiators to ‘put patients first’ in the negotiations. - [Supply chain commitment to tackling problem of medicine shortages](https://www.medicinesforeurope.com/news/supply-chain-commitment-to-tackling-problem-of-medicine-shortages/) - [IGBA launches a biosimilar medicines information campaign](https://www.medicinesforeurope.com/news/igba-launches-a-biosimilar-medicines-information-campaign/) - [IGBA congratulates the Australian government for maintaining their biologics naming convention and for strengthening pharmacovigilance](https://www.medicinesforeurope.com/news/igba-congratulates-the-australian-government-for-maintaining-their-biologics-naming-convention-and-for-strengthening-pharmacovigilance/) - [2018 – A year of unprecedented challenges and opportunities for pharmaceutical regulatory systems](https://www.medicinesforeurope.com/news/2018-a-year-of-unprecedented-challenges-and-opportunities-for-pharmaceutical-regulatory-systems/) - This week in London, Medicines for Europe gathers regulators and industry leaders to discuss future opportunities and challenges in the regulatory environment of the generic, biosimilar and value added medicines industry. Future changes in the regulatory landscape as a result of Brexit and the implementation of the Falsified Medicines Directive (FMD) will be discussed over - [Vigilance saves lives! More focus needed on sustainability and patient engagement](https://www.medicinesforeurope.com/news/vigilance-saves-lives-more-focus-needed-on-sustainability-and-patient-engagement/) - National authorities, regulators, industry leaders and key stakeholders gathered in London this week to discuss how to improve patient access to safe medicines with an effective pharmacovigilance framework. This 11th edition of the Medicines for Europe pharmacovigilance conference highlighted the need to engage effectively with patients and making sure the information is communicated in a - [Report shows life sciences industry alliance is taking action to curb antimicrobial resistance, with more to come](https://www.medicinesforeurope.com/news/report-shows-life-sciences-industry-alliance-is-taking-action-to-curb-antimicrobial-resistance-with-more-to-come/) - Geneva, 18 January 2018 – Today, the AMR Industry Alliance launches its first report that shows the commitment of the life sciences industry to tackle the public health threat of antimicrobial resistance (AMR). The Alliance brings together over 100 biotech, diagnostics, generics and research-based biopharmaceutical companies and trade associations from 20 countries. The report was - [2017 Biosimilar Medicines Policy Overview: better access is crucial; tailored solutions essential for EU governments](https://www.medicinesforeurope.com/news/2017-biosimilar-medicines-policy-overview-better-access-is-crucial-tailored-solutions-essential-for-eu-governments/) - Biosimilar medicines are transforming treatment by enabling better access to biological medicines while improving the sustainability of European healthcare budgets. For the first time, Medicines for Europe has reviewed the policies supporting biosimilar medicines in Europe in the ‘2017 Market Review – Biosimilar Medicines Markets’. The 2017 Market Review provides a comprehensive overview of biosimilar - [Oncology, the new era for biosimilar medicines](https://www.medicinesforeurope.com/news/oncology-the-new-era-for-biosimilar-medicines/) - With more than 10 years of positive experience and 700 Million patient days[i] in different therapeutic areas, including in supportive cancer care, biosimilar medicines are now entering the therapeutic armamentarium for primary oncology care. Disparities in access to cancer medicines vary widely among countries, including for the standard of care, and need to be addressed - [Value Added Medicines: Time to adjust the HTA Decision Frameworks for more patient-centric innovation](https://www.medicinesforeurope.com/news/value-added-medicines-time-to-adjust-the-hta-decision-frameworks-for-more-patient-centric-innovation/) - A new study “Value Added Medicines: Time to Adjust the HTA Decision Frameworks” was launched today in Brussels with the support of the Value Added Medicines Group, a sector group of Medicines for Europe. The study, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, highlights the need for adjustments in HTA decision - [Latest Data Shows the Need to Promote Biosimilar and Value Added Medicines for Better Health](https://www.medicinesforeurope.com/news/latest-data-shows-the-need-to-promote-biosimilar-and-value-added-medicines-for-better-health/) - Biosimilar medicines are transforming treatment by enabling better access to biological medicines in Europe and around the world, as stated today during the second day of the joint Medicines for Europe-IGBA conference in Lisbon. The IGBA (International Generic and Biosimilar Association) has commissioned new user-friendly material to acquaint and empower stakeholders with relevant information on - [62% of Medicines Dispensed in Europe are Generic, according to IMS New Data](https://www.medicinesforeurope.com/news/62-of-medicines-dispensed-in-europe-are-generic-according-to-ims-new-data/) - Pharmaceutical industry leaders and key stakeholders from the generic, biosimilar and value added medicines sectors are meeting in Lisbon, Portugal 14-16 June to foster international partnership, cooperation and dialogue to address public health challenges for the future during the joint 23rd Medicines for Europe and 20th IGBA Annual Conference. In addition to international regulatory cooperation, - [EU Semester Country Specific Recommendations: More Efficient Medicine Policies Needed for Patient Access](https://www.medicinesforeurope.com/news/eu-semester-country-specific-recommendations-more-efficient-medicine-policies-needed-for-patient-access/) - The European Semester Country Specific Recommendations show that healthcare systems need to improve in terms of efficiency. The EU commitment to ensuring equity of access to healthcare is challenged by the limited financial capacity of governments to cover growing demand for healthcare services. Generic and biosimilar medicines provide the greatest opportunity to improve access to - [New Alliance to Drive and Measure Industry Progress to Curb Antimicrobial Resistance](https://www.medicinesforeurope.com/news/new-alliance-to-drive-and-measure-industry-progress-to-curb-antimicrobial-resistance/) - Speaking at the B20 Health Conference in Berlin, IFPMA Director-General Thomas Cueni announced the launch of the AMR Industry Alliance, which will help give impetus to the life-sciences industry efforts to curb antimicrobial resistance. The threat of antimicrobial resistance causing drug-resistant infections is now more urgent than ever. It is estimated that, unless action is - [Biosimilar Medicines Opportunity: Dramatic Increase in Patient Access across Europe](https://www.medicinesforeurope.com/news/biosimilar-medicines-opportunity-dramatic-increase-in-patient-access-across-europe/) - The new report on The Impact of Biosimilar Competition in Europe highlights the visible benefits of biosimilar competition to increase patient access to highly innovative biological treatments. The new report was prepared by QuintilesIMS Health at the request of the European Commission with contributions from EFPIA, EuropaBio and Medicines for Europe. Despite differences between countries, - [Industry Welcomes the 3rd European Commission Workshop on Biosimilar Medicines](https://www.medicinesforeurope.com/news/industry-welcomes-the-3rd-european-commission-workshop-on-biosimilar-medicines/) - The European pharmaceutical industry welcomes the 3rd workshop on access to biosimilars, organised today by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) on access to biosimilar medicines in Europe. The event brought together patients, doctors, pharmacists, academics, authorities, press and industry to share experiences with biosimilar medicines - [Over 100 Participants Explore Opportunities to Ensure Universal Access to Health](https://www.medicinesforeurope.com/news/over-100-participants-explore-opportunities-to-ensure-universal-access-to-health/) - Over 100 participants explored different ways and opportunities to ensure universal access to healthcare, together with members of the European Parliament (MEPs) and healthcare stakeholders during the Universal Access to Health event that took place today in Brussels. At this year's event, Medicines for Europe, the European Patients’ Forum (EPF), the European Public Health Alliance - [Biosimilar medicines: Increasing access to modern essential medicines while supporting sustainability of healthcare systems](https://www.medicinesforeurope.com/news/biosimilar-medicines-increasing-access-to-modern-essential-medicines-while-supporting-sustainability-of-healthcare-systems/) - Biologic medicines have revolutionised the management of many serious diseases over the last three decades. However, the potential of biologic medicines has not been fully realised, as many patients who could benefit from these state-of-the-art treatments do not have real access to them. Read More - [Biosimilar medicines. Essential for increasing access to important medicines and the sustainability of healthcare systems](https://www.medicinesforeurope.com/news/biosimilar-medicines-essential-for-increasing-access-to-important-medicines-and-the-sustainability-of-healthcare-systems/) - Biologic medicines have revolutionised the management of many serious diseases over the last three decades. Unfortunately, the potential of biologic medicines has not been fully realised, as many who would benefit from these state-of-the-art treatments cannot effectively access them. A key driver of this limited availability is the increasing struggle to finance new medicines within - [Biosimilar interchangeability: Do you know your switching from your substitution?](https://www.medicinesforeurope.com/news/biosimilar-interchangeability-do-you-know-your-switching-from-your-substitution/) - US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe. In the EU, where biosimilars have been present for over a decade, the definitions of switching, interchangeability and substitution are as follows... Read More - [Biosimilars at work: Access. Experience. Science.](https://www.medicinesforeurope.com/news/biosimilars-at-work-access-experience-science/) - Biosimilar medicines are a part of today’s therapeutic armamentarium – a “must-have weaponry” and a “catalyst for equal access” for physicians [1]. They have a track record of delivered healthcare benefits over the years. Armed with over 10 years of positive clinical experience, physicians and patients are now focusing conversations on the long-term future of - [Some EU countries effectively delay market entry of generics](https://www.medicinesforeurope.com/news/some-eu-countries-effectively-delay-market-entry-of-generics/) - The harmonisation of different regulatory environments in the EU member states will help generic drugs enter the market, resulting in reduced prices for medicine and better patient access, Jacek Glinka told EURACTIV.com in an interview. Jacek Glinka is the president of the Medicines for Europe, which represents the European generic, biosimilar and valued added pharmaceutical - [22nd EAHP Conference in Cannes](https://www.medicinesforeurope.com/news/22nd-eahp-conference-in-cannes/) - A special satellite symposium was organized on “Value added medicines – What value repurposed medicines might bring to hospital pharmacists”. Christoph Stoller, chair of the Value Added Medicines Group, chaired the session and opened with a short introduction to value added medicines. Professor Doctor Stephan Krähenbuhl, from the University Hospital of Basel, explained to the - [Biosimilar Medicines: a Game Changer for Oncology Care](https://www.medicinesforeurope.com/news/biosimilar-medicines-a-game-changer-for-oncology-care/) - With 10 years of positive experience with biosimilar medicines, medical societies and regulators across Europe have now adopted clear guidance in support of biosimilar medicines use and in physician-led switching from reference to biosimilar medicine. Biosimilar medicines are an essential part of healthcare provision in Europe today in the therapeutic areas where they have been - [Stimulating Investment in European Generic, Biosimilar and Value Added Medicines through a Transparent Legal Environment](https://www.medicinesforeurope.com/news/stimulating-investment-in-european-generic-biosimilar-and-value-added-medicines-through-a-transparent-legal-environment/) - Key authorities, eminent lawyers and industry leaders discussed today in London the proposals put forward by the European Commission to stimulate jobs and growth in the pharmaceutical sector in Europe at the Medicines for Europe 13th Legal Affairs Conference. The high level participation at the event was crucial to advance discussions on key legal and - [European Parliament Recognises the Major role of Generic, Biosimilar and Value Added Medicines in Improving Access](https://www.medicinesforeurope.com/news/european-parliament-recognises-the-major-role-of-generic-biosimilar-and-value-added-medicines-in-improving-access/) - Today, the European Parliament voted on the report on ‘Options for improving access to medicines’ that places generic, biosimilar and value added medicines at the heart of the debate on access to medicines. Together with the June 2016 Council Conclusions, this report provides the Commission and the Member States with a clear mandate to encourage - [European Parliament prioritises Generic, Biosimilar and Value Added Medicines Competition to improve Access](https://www.medicinesforeurope.com/news/european-parliament-prioritises-generic-biosimilar-and-value-added-medicines-competition-to-improve-access/) - Today, the Environment, Public Health and Food Safety Committee (ENVI) voted on an initiative report that places generic, biosimilar and value added medicines at the heart of the debate on access to medicines, which is expected to be adopted in Plenary in March. The report underlines that generic medicines are a cornerstone of European healthcare, biosimilar - [European Experience and Evidence of Physician-led Switching of Biological Medicines Give Hope to Patients around the World](https://www.medicinesforeurope.com/news/european-experience-and-evidence-of-physician-led-switching-of-biological-medicines-give-hope-to-patients-around-the-world/) - On 9th March, IFPMA launched jointly with EFPIA and EBE a position paper entitled Considerations for physicians on switching decisions regarding biosimilars. Physician-led switching of biological medicines is a well-known medical practice. Although data on the frequency of switching in clinical practice is scarce, no evidence from clinical trials or post marketing surveillance data has - [Experience and Evidence of Physician-led Switching of Biological Medicines Fully Recognised in Europe](https://www.medicinesforeurope.com/news/experience-and-evidence-of-physician-led-switching-of-biological-medicines-fully-recognised-in-europe/) - Medicines for Europe welcomes the fact that EFPIA (supported by EBE and IFPMA) recognises in its recently released paper the well-established nature of physician-led switching for biological medicines. This medical practice is common place, way beyond the sole field of biosimilar medicines. The three associations also acknowledge that the similarity between a biosimilar medicine and - [Joint Declaration for an ambitious EU industrial strategy](https://www.medicinesforeurope.com/news/joint-declaration-for-an-ambitious-eu-industrial-strategy/) - Europe is the cradle of the manufacturing industry and has been at the forefront of industrial revolutions and technological innovations. The industry directly employs over 34 million people across all Member States, in supply chains comprising hundreds of thousands of SMEs and larger suppliers. It also indirectly accounts for millions of additional jobs in related - [Health Minister Can Take Action to Increase Patient Access to Biosimilar Medicines in Ireland](https://www.medicinesforeurope.com/news/health-minister-can-take-action-to-increase-patient-access-to-biosimilar-medicines-in-ireland/) - Today, Medicines for Europe engaged alongside its Irish national association Health Enterprise Alliance (HEA) in illustrating the benefits of stimulating competition in the biologic medicines market in Ireland. Market barriers have unintentionally led to low levels of competition and as a result Ireland has lost out on the benefits of biosimilar medicines. Ireland currently has - [Joint statement on Shortages](https://www.medicinesforeurope.com/news/joint-statement-on-shortages/) - The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists have announced a series of recommendations on the provision of information, designed to help tackle medicines shortages. Focusing on the transparency and the availability of medicine shortage data, the Associations’ statement is part of their wider commitment to tackling the issue. - [Building a 21st Century Regulatory Environment for Better Patient Access to Medicines](https://www.medicinesforeurope.com/news/building-a-21st-century-regulatory-environment-for-better-patient-access-to-medicines/) - This week in London, Medicines for Europe gathers national authorities, regulators and industry leaders to discuss future challenges and opportunities in the regulatory environment of the generic medicines industry. Important topics such as the future model of patient treatment and care, the evolution of generic medicines, the use of modern technology to support patient needs - [Opportunities that Technology and Social Media Bring to Pharmacovigilance Explored in London this Week](https://www.medicinesforeurope.com/news/opportunities-that-technology-and-social-media-bring-to-pharmacovigilance-explored-in-london-this-week/) - National authorities, regulators, industry leaders and pharmacists gathered in London this week to discuss how to improve patient access to safe medicines with an effective pharmacovigilance policy. This 10th edition of our Medicines for Europe conference highlighted how, if steered appropriately, technology and social media could strengthen the pharmacovigilance system. Participants also reviewed experience gained - [European Commission Initiative Improves Information for Patients on Biosimilar Medicines](https://www.medicinesforeurope.com/news/european-commission-initiative-improves-information-for-patients-on-biosimilar-medicines/) - Today, the European Commission published a unique Q&A for patients with reliable information on biosimilar medicines. Stakeholders value these efforts to provide unbiased, scientifically correct and yet easy to understand information on biosimilar medicines through the Q&A on Biosimilar Medicines, now available in 7 EU languages. This consensus information on biosimilar medicinal products was drafted - [Serialization Expert Supply Chain Wizard Announces Partnership with Medicines for Europe](https://www.medicinesforeurope.com/news/serialization-expert-supply-chain-wizard-announces-partnership-with-medicines-for-europe/) - Strategic Alliance Made Official Following Successful mid-December Pharma CMO Summit Event in Berlin Princeton, NJ – Supply Chain Wizard (SCW) – a leading full-service global consulting firm specializing in serialization and traceability, supply chain strategy and operational transformation programs – has officially partnered with Medicines for Europe, which represents the generic, biosimilar and value-added medicines industries - [Serialization Expert Supply Chain Wizard to Co-Host Gathering for Pharma CMOs, CPOs & 3PLs in Berlin](https://www.medicinesforeurope.com/news/serialization-expert-supply-chain-wizard-to-co-host-gathering-for-pharma-cmos-cpos-3pls-in-berlin/) - Summit to Provide Insight into Cost-Effective Compliance with Track & Trace Mandates for Pharma Contract Organizations in Europe & U.S. Princeton, NJ – Supply Chain Wizard – a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs – is co-hosting the Pharma CMO Summit - [Authorities, Regulators and Pharma Industry from India and Europe Meet to Strengthen Regulatory Cooperation](https://www.medicinesforeurope.com/news/authorities-regulators-and-pharma-industry-from-india-and-europe-meet-to-strengthen-regulatory-cooperation/) - Medicines for Europe and Pharmexcil today organised a Workshop on Global Pharmaceutical Operations in New Delhi, gathering key authorities, regulators and senior pharma executives from India and Europe for the first time. During the workshop, the conference participants debated on mutual reliance with regard to the effects of globalisation and the interplay of trust, regulation - [Medicines for Europe can contribute much more to improve healthcare sustainability than described in the OECD “Health at a Glance 2016” report](https://www.medicinesforeurope.com/news/medicines-for-europe-can-contribute-much-more-to-improve-healthcare-sustainability-than-described-in-the-oecd-health-at-a-glance-2016-report/) - Medicines for Europe assessed the publication of the report ‘Health at a Glance 2016’ launched yesterday prepared by the OECD for the European Commission. The report acknowledges that the development of generic medicines markets increases efficiency in pharmaceutical spending, however it focusses on short term cost-containment rather than taking into account access to medicines and - [European Commission Question & Answer Document for Patients Builds Trust and Understanding on Biosimilar Medicines across Europe](https://www.medicinesforeurope.com/news/european-commission-question-answer-document-for-patients-builds-trust-and-understanding-on-biosimilar-medicines-across-europe/) - Today, the European Commission published a Q&A for patients on biosimilar medicines. This important document provides a unique information resource for patients and healthcare professionals in support of a better understanding of the key scientific aspects related to biosimilar medicines as an alternative therapeutic option, and its role in generating greater access to high quality - [Generic, Biosimilar and Value Added Medicines Industry Leaders Join Forces to Drive Access to Medicines Agenda](https://www.medicinesforeurope.com/news/generic-biosimilar-and-value-added-medicines-industry-leaders-join-forces-to-drive-access-to-medicines-agenda/) - Industry leaders from the generic, biosimilar and value added medicines industries will engage in an intense dialogue in Dubrovnik over the next two days to improve worldwide patient access to pharmaceuticals. - [Biosimilar Medicines for Rheumatologists: Bridging the Gap between Regulatory Science and Medical Societies](https://www.medicinesforeurope.com/news/biosimilar-medicines-for-rheumatologists-bridging-the-gap-between-regulatory-science-and-medical-societies/) - Over the past decade, biosimilar medicines have generated more than 400 million patient days of positive treatment experience mainly in areas such as endocrinology and supportive cancer care. With the European approvals of biosimilar infliximab and etanercept products, these treatment options are now available to treat more patients in rheumatology. A clear understanding of the - [Fulfilling the Biosimilar Promise: Report Highlights Key Principles in Support of a Sustainable Market](https://www.medicinesforeurope.com/news/fulfilling-the-biosimilar-promise-report-highlights-key-principles-in-support-of-a-sustainable-market/) - Biosimilar medicines provide a tremendous opportunity for governments throughout Europe to increase patient access to treatment with modern biologic therapies while at the same time supporting the sustainability of healthcare budgets. These benefits will however only continue provided the biosimilar medicines market is developed in a sustainable way. The cornerstone of a sustainable biosimilar medicines - [EU countries urged to promote generics, biosimilars to meet rising costs of long-term care - report](https://www.medicinesforeurope.com/news/eu-countries-urged-to-promote-generics-biosimilars-to-meet-rising-costs-of-long-term-care-report/) - LONDON, Oct 18 (APM) - European countries should promote greater use of generics and biosimilars, as well as adopting drug price-control policies to meet long-term care costs, a report advises. Unveiled late last week, the European Commission's 'Joint Report on Health Care and Long-Term Care Systems and Fiscal Sustainability', prepared by the Commission Services (Directorate-General - [NOR-SWITCH Study: Another Significant Example of Positive Real World Evidence on Physician-led Switching to Biosimilar Medicines](https://www.medicinesforeurope.com/news/nor-switch-study-another-significant-example-of-positive-real-world-evidence-on-physician-led-switching-to-biosimilar-medicines/) - Today at the United Gastro-Enterology (UEG) week in Vienna, the NOR-SWITCH results were presented highlighting that the physician-led switching between medicines containing the originator and biosimilar (CT-P13) versions of infliximab led to the absence of statistical difference in patient outcomes. This result is consistent with the fact that biosimilar medicines are approved to be medically interchangeable - [European Commission Strongly Recommends the Use of Generic and Biosimilar Medicines to Ensure the Sustainability of Healthcare Systems](https://www.medicinesforeurope.com/news/european-commission-strongly-recommends-the-use-of-generic-and-biosimilar-medicines/) - Medicines for Europe welcomes the publication of the ‘Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability’ prepared by DG ECFIN[1] and the Economic Policy Committee (Ageing Working Group). The report presents policy challenges for healthcare and long-term care, and options on how to contain spending pressures through efficiency gains, in order - [Generic medicines have enabled twice as many patients to get treatment for the same budget](https://www.medicinesforeurope.com/news/generic-medicines-have-enabled-twice-as-many-patients-to-get-treatment-for-the-same-budget/) - Presentation of the report “The Value of Generic Medicines” GENERIC MEDICINES HAVE ENABLED TWICE AS MANY PATIENTS TO GET TREATMENT FOR THE SAME BUDGET Generic medicines save European countries 100 billion euros per year Rome, October 12, 2016 – Through generic medicine competition , twice as many patients were able to get treatment without any - [The Value Added Medicines Group Highlights the Importance of Access to Health during the CPhI Conference](https://www.medicinesforeurope.com/news/the-value-added-medicines-group-highlights-the-importance-of-access-to-health-during-the-cphi-conference/) - The Value Added Medicines Group a sector group of Medicines for Europe, participated in the CPhI Pre-connect Conference today to promote greater access to medicines for patients across Europe. During the conference, Pieter Dylst, Senior Manager Market Access & Value Added Medicines at Medicines for Europe presented the new study Value Added Medicines: Rethink, Reinvent - [Generic Medicines at the Heart of the French Public Health System](https://www.medicinesforeurope.com/news/generic-medicines-at-the-heart-of-the-french-public-health-system/) - Medicines for Europe strongly supports the French government campaign to boost generic medicines. Thanks to generic medicines, in Europe twice as many patients in 7 key therapeutic areas[1] (diabetes, depression, epilepsy, cardiovascular disease, hypertension, asthma/COPD, gastro-intestinal disease) have been able to be treated over the last ten years with no impact on overall treatment costs. - [Generic Medicines save European Countries 100 Billion Euro per Year](https://www.medicinesforeurope.com/news/generic-medicines-save-european-countries-100-billion-euro-per-year/) - Lisbon, September 28, 2016 - Without the use of generic medicines, European countries would spend a hundred billion euros more per year to treat patients. This is one of the conclusions of the IMS Institute for Healthcare Informatics study on The Role of Generic Medicines in Sustaining Healthcare Systems: A European Perspective presented today in - [European Health Ministers Call for More Competition in Pharmaceutical Markets](https://www.medicinesforeurope.com/news/european-health-ministers-call-for-more-competition-in-pharmaceutical-markets/) - Medicines for Europe will engage rapidly with Health Ministers across Europe to implement the Health Council Conclusions on “strengthening the balance in the pharmaceutical system in the EU and its Member States”. The Conclusions underline the importance of the timely availability of generics and biosimilar medicines to improve patient access to therapy and to ensure - [Medicines for Europe and GPhA commit to supporting positive developments of the negotiations for a TTIP](https://www.medicinesforeurope.com/news/medicines-for-europe-and-gpha-commit-to-supporting-positive-developments-of-the-negotiations-for-a-ttip/) - Medicines for Europe and GPhA (Generic Pharmaceutical Association) are committed to supporting positive developments of the negotiations for a TTIP agreement and in particular the single development of biosimilar and complex generic medicines and the regulatory cooperation on pharmaceuticals therein. The conclusion of a Mutual Recognition Agreement on Good Manufacturing Practices (GMP) inspections between the EU - [UN Meeting on Antimicrobial Resistance (AMR): Medicines for Europe engaged in addressing the Global Threat of AMR](https://www.medicinesforeurope.com/news/un-meeting-on-antimicrobial-resistance-amr-medicines-for-europe-engaged-in-addressing-the-global-threat-of-amr/) - As a signatory of the Davos Declaration we welcome the continued high level political focus on Antimicrobial Resistance (AMR). The high-level meeting convened on 21 September 2016 by the President of the UN General Assembly gathered key stakeholders in this unique public health, economic and scientific challenging situation. Medicines for Europe welcomes the UN’s Political - [European generics manufacturers want French government to promote generics more](https://www.medicinesforeurope.com/news/european-generics-manufacturers-want-french-government-to-promote-generics-more/) - by Guillaume Bietry PARIS, July 20 (APM) - European generics manufacturers want the French government to take more measures to encourage the development of a market that lags considerably behind those in other countries, the president of industry body Medicines for Europe Jacek Glinka has told APM. While the generic penetration rate for Europe as - [Industry Welcomes the European Commission Workshop on the Uptake of Biosimilar Medicines](https://www.medicinesforeurope.com/news/industry-welcomes-the-european-commission-workshop-on-the-uptake-of-biosimilar-medicines/) - The European pharmaceutical industry welcomes the workshop organised today by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) on access to biosimilar medicines in Europe, in relation to the Corporate Responsibility Programme. Patients, doctors, pharmacists, academics, authorities, press and industry will gather at this workshop to share experiences - [Value Added Medicines: Rethink, Reinvent & Optimise Medicines, Improving Patient Health & Access](https://www.medicinesforeurope.com/news/value-added-medicines-rethink-reinvent-optimise-medicines-improving-patient-health-access/) - A new study Value Added Medicines: Rethink, Reinvent & Optimise Medicines: Improving Patient Health and Access was launched today in Brussels by the Value Added Medicines Group, a sector group of Medicines for Europe. The report, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, identified several areas of healthcare inefficiencies in Europe - [IGBA Joins ICH and Welcomes the Positive Vote of the General Assembly](https://www.medicinesforeurope.com/news/igba-joins-ich-and-welcomes-the-positive-vote-of-the-general-assembly/) - The International Generic and Biosimilar Medicines Association (IGBA) very much welcomes today’s decision of the ICH General Assembly - [Biosimilar Medicines for Rheumatologists: Understanding the Science of Extrapolation / 10th June 2016, 08:15–09:45 Capital Suite 09, ExCel London](https://www.medicinesforeurope.com/news/httpwww-medicinesforeurope-comwp-contentuploads201605eular-booklet-20160527-pdf/) - [Medicines for Europe Joins Global Campaign to Fight Fake Medicines](https://www.medicinesforeurope.com/news/medicines-for-europe-joins-global-campaign-to-fight-fake-medicines/) - Medicines for Europe, the voice of the generic, biosimilar and value added medicines in Europe, is proud to announce its partnership in the Fight the Fakes campaign. By joining this initiative, Medicines for Europe acknowledges the magnitude of the problem related to the existence of fake medicines. Fake medicines can be branded or generic, prescription - [The European Parliament Votes for Jobs in the EU Generic and Biosimilar Medicines Industries](https://www.medicinesforeurope.com/news/the-european-parliament-votes-for-jobs-in-the-eu-generic-and-biosimilar-medicines-industries/) - Medicines for Europe, the voice of the generic, biosimilar and added value medicine industries, applauds the adoption of the European Parliament’s report on the Single Market Strategy in Plenary. In their report, Members of the Parliament urged the European Commission to introduce and implement before 2019 an SPC (Supplementary Protection Certificate) manufacturing waiver to boost - [Value Added Medicines: Rethink, Reinvent & Optimise Medicines, Improving Patient Health & Access / 31 May 2016 17:30 - 19:30, European Parliament](https://www.medicinesforeurope.com/news/value-added-medicines-rethink-reinvent-optimise-medicines-improving-patient-health-access-31-may-2016-1730-1930/) - [10 Years of Biosimilar Medicines: Transforming Healthcare](https://www.medicinesforeurope.com/news/10-years-of-biosimilar-medicines-transforming-healthcare/) - Biosimilar medicines provide an opportunity to increase patient access to high quality treatments and to improve the efficiency of healthcare systems worldwide, as demonstrated in the white paper Delivering on the Potential of Biosimilar Medicines: the Role of Functioning Competitive Markets[1]. Over 50 new products in clinical development are expected to increase access to medicines - [IGBA calls for full transparency and new timelines for impact assessment with regard to the voluntary WHO biological qualifier (BQ) proposal](https://www.medicinesforeurope.com/news/igba-calls-for-full-transparency-and-new-timelines-for-impact-assessment-with-regard-to-the-voluntary-who-biological-qualifier-bq-proposal/) - IGBA welcomes the WHO’s continuous interest in the development of a global identification system for biological substances - [The European Parliament Calls on the Commission to Boost Manufacturing and Export of EU Generic and Biosimilar Medicines](https://www.medicinesforeurope.com/news/the-european-parliament-calls-on-the-commission-to-boost-manufacturing-and-export-of-eu-generic-and-biosimilar-medicines/) - Launched on 28 October 2015 , the European Commission’s new strategy ‘A Single Market Strategy for Europe - Analysis and Evidence’ proposes a manufacturing waiver during the SPC period to allow the EU generic and biosimilar medicines industries to create up to 64.000 high-tech jobs in the EU and dozens of new companies, with a - [6 out of 10 Doctors Have Already Prescribed Biosimilar Medicines, According to EuropaBio Paper](https://www.medicinesforeurope.com/news/6-out-of-10-doctors-have-already-prescribed-biosimilar-medicines-according-to-europabio-paper/) - 88,6% of doctors know what biosimilar medicines are and 59% have already prescribed biosimilar medicines as a high quality treatment for their patients - [100% increase in Patient Access to Biologic Treatments thanks to Biosimilar Medicines](https://www.medicinesforeurope.com/news/100-increase-in-patient-access-to-biologic-treatments-thanks-to-biosimilar-medicines/) - Biosimilar medicines represent an essential opportunity to optimise patient access to high quality treatments and the efficiency of healthcare systems worldwide, according to the white paper “Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets”, published by the IMS Institute for Healthcare Informatics this week. Some 50 new products in clinical development are - [Medicines for Europe Reinforces its Commitment to Promote Universal Access to Health](https://www.medicinesforeurope.com/news/medicines-for-europe-reinforces-its-commitment-to-promote-universal-access-to-health/) - Medicines for Europe is organising today in Brussels the third edition of “Universal Access to Health, how can we contribute?” in collaboration with the EPF, AIM) and EPHA. - [EGA becomes Medicines for Europe](https://www.medicinesforeurope.com/news/ega-becomes-medicines-for-europe/) - The European Generic and Biosimilar Medicines Association is now Medicines for Europe Better access. Better health. Generic medicines are now the cornerstone of European healthcare, the Biosimilar medicines sector is developing rapidly, and the need and opportunity for Value Added medicines will further transform healthcare. Our industries supply the majority of Europe’s prescription medicines which - [Launch of European Value Added medicines (EVA), a new EGA sector group, will deliver efficiency](https://www.medicinesforeurope.com/news/test-news/) - Brussels - The European Generic and Biosimilar medicines Association (EGA) announced today the launch of the European Value Added medicines (EVA) group, a new sector group of the EGA. “EVA will be the leading voice of a broad-multi-stakeholder coalition supporting value-added medicines in Europe, engaging with patients and healthcare professionals in response to their needs and ## Social widgets - [Generic medicines](https://www.medicinesforeurope.com/social-widget/generic-medicines/) - [Biosimilar medicines](https://www.medicinesforeurope.com/social-widget/biosimilar-medicines/) - [Value added medicines](https://www.medicinesforeurope.com/social-widget/value-added-medicines/) - [Medicines for Europe](https://www.medicinesforeurope.com/social-widget/medicines-for-europe/) ## Social icons - [Flickr - EGA](https://www.medicinesforeurope.com/social-icon/flickr-ega/) - [Twitter - valueaddedeu](https://www.medicinesforeurope.com/social-icon/twitter-valueaddedeu/) - [Twitter - biosimilarseu](https://www.medicinesforeurope.com/social-icon/twitter-biosimilarseu/) - [Twitter - genericseu](https://www.medicinesforeurope.com/social-icon/twitter-genericseu/) - [Twitter - medicinesforEU](https://www.medicinesforeurope.com/social-icon/twitter-ega-generics/) - [LinkedIn - EGA](https://www.medicinesforeurope.com/social-icon/linkedin-ega/) - [Google + - EGA](https://www.medicinesforeurope.com/social-icon/google-ega/) - [Youtube - EGA Medicines](https://www.medicinesforeurope.com/social-icon/youtube-ega-medicines/) ## Extranet posts - [Test extranet post](https://www.medicinesforeurope.com/extranet/test-extranet-post/) - Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque ## Events - [25th Regulatory Affairs Conference](https://www.medicinesforeurope.com/events/rac27/) - [4th Bioequivalence Conference](https://www.medicinesforeurope.com/events/bioeq27/) - [20th Legal Affairs Conference](https://www.medicinesforeurope.com/events/lac26/) - [32nd Annual Conference](https://www.medicinesforeurope.com/events/annual26/) - [Biosimilar Medicines Conference](https://www.medicinesforeurope.com/events/bios26/) - [24th Regulatory Affairs Conference](https://www.medicinesforeurope.com/events/rac26/) - [23rd Regulatory Affairs Conference](https://www.medicinesforeurope.com/events/rac25/) - [19th Legal Affairs Conference](https://www.medicinesforeurope.com/events/lac25/) - [31st Annual Conference
BUILDING A RESILIENT HEALTH UNION: SECURITY, ACCESS, AND COMPETITIVENESS](https://www.medicinesforeurope.com/events/annual25/) - [Biosimilar Medicines Conference
FUELLED BY THE PAST, GEARING UP FOR THE FUTURE](https://www.medicinesforeurope.com/events/bios25/) - [3rd Bioequivalence Conference](https://www.medicinesforeurope.com/events/bioeq25/) - Hilton Amsterdam Airport Schiphol, 26 ferbruary 2025 - [19th Biosimilar Medicines Conference
THE FUTURE IS BIOLOGIC: STRENGTHENING BIOSIMILAR POLICY FOR BETTER HEALTH IN EUROPE](https://www.medicinesforeurope.com/events/bios23/) - [30th Anniversary
Annual Conference](https://www.medicinesforeurope.com/events/annual2024/) - Portmarnock Hotel & Golf Links, Dublin - 12-13 June 2024 - [18th Legal Affairs Conference](https://www.medicinesforeurope.com/events/lac2024/) - [20th Biosimilar Medicines Conference](https://www.medicinesforeurope.com/events/bios24/) - Hilton Amsterdam Airport Schiphol - - [WEBINARS
22nd Regulatory Affairs and
Pharmacovigilance Conference](https://www.medicinesforeurope.com/events/phvrac23virtual/) - [5th Value Added Medicines Conference](https://www.medicinesforeurope.com/events/vam23/) - [22nd Regulatory Affairs and
Pharmacovigilance Conference](https://www.medicinesforeurope.com/events/phvrac23/) - [17th Legal Affairs Conference](https://www.medicinesforeurope.com/events/lac23/) - [28th Annual Conference](https://www.medicinesforeurope.com/events/annual23/) - [2nd Bioequivalence Workshop](https://www.medicinesforeurope.com/events/bioeq23/) - [4th Value Added Medicines Conference
GIVING MEDICINES A NEW LIFE](https://www.medicinesforeurope.com/events/vam2022/) - [UPCOMING EVENTS](https://www.medicinesforeurope.com/events/upcoming-events/) - Test text - [18th Biosimilar Medicines Conference
TRANSLATING THE PHARMACEUTICAL LEGISLATION INTO ACCESS & AFFORDABILITY](https://www.medicinesforeurope.com/events/bios22/) - [27thAnnual Conference](https://www.medicinesforeurope.com/events/annual2022/) - [16th Legal Affairs Conference](https://www.medicinesforeurope.com/events/lac2022/) - [Biosimilar medicines: Changing Patient
Care Pathways, Changing Outcomes](https://www.medicinesforeurope.com/events/bios22live/) - [21st Regulatory Affairs and Pharmacovigilance
Virtual Conference](https://www.medicinesforeurope.com/events/racphv2022/) - [20th Regulatory Affairs and Pharmacovigilance
Virtual Conference](https://www.medicinesforeurope.com/events/racphv2021/) - [Open Legal Affairs Webinar](https://www.medicinesforeurope.com/events/lac21/) - [19th Regulatory and
Scientific Affairs
Conference
](https://www.medicinesforeurope.com/events/rac2020/) - [13th Pharmacovigilance
Conference
](https://www.medicinesforeurope.com/events/phv20/) - [
Annual Medicines for Europe
and IGBA Conference
](https://www.medicinesforeurope.com/events/annual21/) - [
Annual Medicines for Europe
and IGBA Conference
](https://www.medicinesforeurope.com/events/annual19/) - [BIOSIMILAR MEDICINES
Virtual Summit 2021

Biosimilars:
Investment in Health that Matters](https://www.medicinesforeurope.com/events/bios21/) - [VALUE ADDED MEDICINES
Online Summit
Empowering the healthcare community
by improving existing treatments](https://www.medicinesforeurope.com/events/vam2021/) - [17th Biosimilar Medicines
Conference](https://www.medicinesforeurope.com/events/bios19/) - [Anatomy of a failure to launch:
Barriers to generic market entry
and the use of competition law
as a remedy](https://www.medicinesforeurope.com/events/anatomy-of-a-failure-to-launch-barriers-to-generic-market-entry-and-the-use-of-competition-law-as-a-remedy/) - [1st Value Added Medicines Conference - A new value proposition for patients, healthcare practitioners and systems](https://www.medicinesforeurope.com/events/vam2017/) - [3rd Value Added Medicines
Conference
](https://www.medicinesforeurope.com/events/vam19/) - [15th Legal Affairs Conference](https://www.medicinesforeurope.com/events/lac19/) - [18th Regulatory and
Scientific Affairs Conference
](https://www.medicinesforeurope.com/events/rac2019/) - [12th Pharmacovigilance
Conference
](https://www.medicinesforeurope.com/events/phv2019/) - [2nd Value Added Medicines Conference](https://www.medicinesforeurope.com/events/vam2018/) - [16th Biosimilar Medicines Conference - Biosimilar medicines: unlocking the full potential of biologics](https://www.medicinesforeurope.com/events/bios2018/) - [Global Generic, Biosimilar and
Value Added Medicines Conference
Joint 24th Medicines for Europe and 21st IGBA Annual Conference](https://www.medicinesforeurope.com/events/annual2018/) - [14th Legal Affairs Conference - with 24 April networking dinner with legal experts (separate registration)](https://www.medicinesforeurope.com/events/lac2018/) - [11th Pharmacovigilance Conference](https://www.medicinesforeurope.com/events/phv2018/) - [17th Regulatory and Scientific Affairs Conference](https://www.medicinesforeurope.com/events/rac2018/) - [Joint 23rd Medicines for Europe and
20th IGBA Annual Conference](https://www.medicinesforeurope.com/events/joint-23rd-medicines-for-europe-and-20th-igba-annual-conference/) - [13th Legal Affairs Conference](https://www.medicinesforeurope.com/events/lac/) - [15th Biosimilar Medicines Conference](https://www.medicinesforeurope.com/events/bios-2017/) - Biosimilar medicines: a game changer for healthcare sustainability. London, Grange Tower Bridge Hotel. 23-24 MARCH 2017 - [16th Regulatory and Scientific Affairs Conference](https://www.medicinesforeurope.com/events/rac17/) - [10th Pharmacovigilance Conference](https://www.medicinesforeurope.com/events/phv-2017/) - Register now for the 10th edition of the Pharmacovigilance Conference. In the 2016 edition 21 competent authorities were present together with industry representatives - [JOINT 22nd MEDICINES FOR EUROPE AND 19th IGBA ANNUAL CONFERENCE](https://www.medicinesforeurope.com/events/dubrovnik/) - Test text ## Speakers - [Vivian Frittelli](https://www.medicinesforeurope.com/speaker/vivian-frittelli/) - Vivian Frittelli has been involved in the pharmaceutical industry for over a quarter of a century. He headed Hoffmann La Roche’s Marketing and Sales Division in South Africa before doing a stint as Country Manager for Roche in Saudi Arabia. Upon returning to South Africa he was appointed Regional Director of an NGO, The Smile - [Christoph Stoller](https://www.medicinesforeurope.com/speaker/christoph-stoller/) - Christoph Stoller is Teva’s Senior Vice President Generics and Commercial Operations Europe. He is also serving as Vice President of Medicines for Europe and leads Medicines for Europe’s sector group on Value Added Medicines. Christoph has been working for Teva Europe since 2011 after having joined Teva as General Manager in Switzerland in July 2008. - [Heather Bresch](https://www.medicinesforeurope.com/speaker/heather-bresch/) - Heather Bresch is CEO of Mylan, one of the world’s leading pharmaceutical companies. She also serves on the company’s board of directors. Throughout her 25-year career with Mylan, Bresch has held roles of increasing responsibility in more than 15 functional areas, and played a key leadership role in a series of large, transformative acquisitions, which - [Jacek Glinka](https://www.medicinesforeurope.com/speaker/jacek-glinka/) - Jacek Glinka is the President Europe for Mylan, one of the world’s leading global pharmaceutical companies, dedicated to providing the world’s 7 billion people access to high quality medicine, present in 38 countries in the European region and in approximately 145 countries and territories globally. He will assume the role of President of EGA in - [Dipankar Bhattacharjee](https://www.medicinesforeurope.com/speaker/dipankar-bhattacharjee/) - Biography not available yet. - [Martin Albert](https://www.medicinesforeurope.com/speaker/martin-albert/) - Martin is in charge to build Sanofi’s Global Generic portfolio and to manage global drug product development programs until launch. Since he joined Sanofi / Zentiva in 2012, he has worked in various roles in commercial operations and industrial affairs. Martin has started his industrial career at Sandoz in 2002, where he held several positions - [Prof. Mondher Toumi](https://www.medicinesforeurope.com/speaker/prof-mondher-toumi/) - Prof. Mondher Toumi is M.D. by training, M.Sc. in Biological Sciences and Ph.D. in Economic ciences. Mondher Toumi is Professor of Public Health at Aix-Marseille University. After working for 12 years as Research Manager in the laboratory of pharmacology at the University of Marseille, he joined the Public Health Department in 1993. He worked from - [Annie Pannelay](https://www.medicinesforeurope.com/speaker/annie-pannelay/) - Annie Pannelay leads the healthcare consulting practice of the EIU. Her role is global. The healthcare vertical includes the policy analysis services to the industry, as well as more specialised services, including value consulting. She helps her clients navigate the challenges presented by the current environment, including the increasing need for clinical and economic evidence - [Pierluigi Antonelli](https://www.medicinesforeurope.com/speaker/pierluigi-antonelli/) - Pierluigi Antonelli, in Sandoz since August 2015, is Head of Western Europe for Sandoz International and Member of the Sandoz Executive Committee. Pierluigi started his career as entrepreneur in the automotive business before joining McKinsey, where he worked both in the US and Italy. He then spent the last sixteen years in the Pharmaceutical/Healthcare industry, - [Emer Cooke](https://www.medicinesforeurope.com/speaker/emer-cooke/) - Emer has worked in a number of management roles for the European Medicines Agency for over twelve years. Currently, she is Head of International Affairs (formally the International and European Cooperation Sector) responsible for liaison and cooperation with non EU regulators; she has previously worked in the European Commission, a national regulatory authority and spent - [Michael Dilger](https://www.medicinesforeurope.com/speaker/michael-dilger/) - Michael Dilger is a Partner with Simon-Kucher & Partners Strategy & Marketing Consultants GmbH, working out of the company’s head office in Bonn, Germany. He specializes in strategic marketing of pharmaceuticals, value-to-customer, market entry and P&R strategies, and pricing within the pharmaceutical industry. Michael has developed numerous international pricing and market access strategies. To date, - [Simon Goeller, Dr.](https://www.medicinesforeurope.com/speaker/simon-goeller-dr/) - Simon Goeller is a Partner based in Munich and the global leader of McKinsey's Generics Practice. Since joining McKinsey in 2002, Simon has worked for clients around the world on topics related to generics, branded generics, LOE management, pharma distribution and retail. He serves pharmacos, wholesalers, retailers/pharmacy chains, and PE firms. His recent experiences include - [Belinda Wood](https://www.medicinesforeurope.com/speaker/belinda-wood/) - Belinda Wood is the CEO of the Generic and Biosimilar Medicines Association (GBMA). Previously the Generic Medicines Industry Association, GBMA is the Australian association representing companies that manufacture, supply and export generic and biosimilar medicines. Belinda has over 20 years’ experience in the pharmaceutical industry and was appointed CEO in December 2014 having been the - [Vytenis Andriukaitis](https://www.medicinesforeurope.com/speaker/vytenis-andriukaitis/) - Vytenis Povilas Andriukaitis was appointed European commissioner for Health and Food Safety in November 2014. He was born on August 9 in Siberia where his family was deported in 1941. He returned in 1959 together with his mother and two brothers. His father was allowed to return only when year later. Vytenis Andriukaitis graduated in ## External events - [Omnibus I – Understanding the EU’s Simplification Package and What It Means for the Off-Patent Sector](https://www.medicinesforeurope.com/externalevents/sustainability-academy-webinars/) - [Universal Access to Health, How Can We Contribute?](https://www.medicinesforeurope.com/externalevents/universal-access-to-health-how-can-we-contribute-3/) - Radisson Red, Rue d’Idalie 35, 1050 Brussels #AccessHealth AGENDA 15.00 Coffee & Registration 15.15 Welcome remarks – Moderator Tamsin Rose 15.30 Access to health care: what are the gaps? Willy Palm, European Observatory on Health Systems and Policies 15.45 How will the incoming European Commission tackle access to medicines? Agnes Mathieu-Mendes, DG SANTE, European Commission - [25TH IGBA ANNUAL CONFERENCE](https://www.medicinesforeurope.com/externalevents/25th-igba-annual-conference/) - READ MORE - [SUSTAINABLE WAYS TO SUPPORT PHARMACEUTICAL INNOVATION](https://www.medicinesforeurope.com/externalevents/sustainable-ways-to-support-pharmaceutical-innovation/) - workshop at the Hungarian Permanent Representation. Brussels, 12 January 2023 - [Ensuring equitable and sustainable access to medicines through a secure and resilient supply](https://www.medicinesforeurope.com/externalevents/ensuring-equitable-and-sustainable-access-to-medicines-through-a-secure-and-resilient-supply/) - Ensuring equitable and sustainable access to medicines through a secure and resilient supply - [Ensuring equitable and sustainable access to medicines through a secure and resilient supply](https://www.medicinesforeurope.com/externalevents/ensuring-equitable-and-sustainable-access-to-medicines-through-a-secure-and-resilient-supply-2/) - OPEN AGENDA REGISTER NOW - [For a healthy Europe: Strengthening of the supply security and pharmaceutical production in Europe](https://www.medicinesforeurope.com/externalevents/for-a-healthy-europe-strengthening-of-the-supply-security-and-pharmaceutical-production-in-europe/) - MORE DETAILS - [A European Union that ensures patient access and sustainability](https://www.medicinesforeurope.com/externalevents/a-european-union-that-ensures-patient-access-and-sustainability/) - OPEN AGENDA - [Unlocking the potential of patient-centric continuous innovation: case studies for value added medicines](https://www.medicinesforeurope.com/externalevents/unlocking-the-potential-of-patient-centric-continuous-innovation-case-studies-for-value-added-medicines/) - [IQVIA REPORT LAUNCH: Unlock the potential of patient - centric continuous innovation](https://www.medicinesforeurope.com/externalevents/iqvia-report-launch-unlock-the-potential-of-patient-centric-continuous-innovation/) - OPEN REPORT PRESS RELEASE AGENDA 15:30 Introduction of the session Arun Narayan, Chairman of the value added medicines sector group 15:40 Keynote speech Ms Lieve Wierinck, Member of the European Parliament (ALDE) 15:55 Presentation of results of IQVIA report Rebecca Coady, Associate Principal, IQVIA Consulting Services 16:20 Panel discussion Moderator: Adrian van den Hoven, Director - [Universal Access to Health, How Can We Contribute?](https://www.medicinesforeurope.com/externalevents/universal-access-to-health-how-can-we-contribute-2/) - AGENDA 9.30 Coffee & Registration 10.00 Welcome remarks – moderator Jacqueline Bowman-Busato, Third-I As the European Parliament mandate ’14-’19 draws to a close, what have we achieved in advancing Universal Access to Healthcare and where do we go next? Andrey KOVATCHEV (EPP, BG) (TBC) Alojz PETERLE (EPP, SL) (TBC) Jose-Ignacio FARIA (EPP, PT) (TBC) 10.45 - [12th European Patients’ Rights Day](https://www.medicinesforeurope.com/externalevents/12th-european-patients-rights-day/) - The event was an occasion to foster communication among different partners/actors in the healing and caring process to improve adherence to treatments and take commitments to increase the respect of patients’ rights. Read more - [Patient access to medicines: how to prevent medicine shortages?](https://www.medicinesforeurope.com/externalevents/patient-access-to-medicines-how-to-prevent-medicine-shortages/) - AGENDA Welcome address Marc-Alexander MAHL - President, Medicines for Europe Keynote speech Lieve WIERINCK - Member of the European Parliament, ALDE Belgium Introduction Agnes MATHIEU, European Commission Interventions: Andreas SCHWAB, member of the European Parliament, EPP Germany Cristian-Silviu BUŞOI, Member of the European Parliament, EPP Romania Panel Introduction: Marc-Alexander MAHL - President, Medicines for Europe - [My Voice Matters! Integrating Patient’s Preferences in the Healthcare Agenda](https://www.medicinesforeurope.com/externalevents/my-voice-matters-integrating-patients-preferences-in-the-healthcare-agenda/) - [ISPOR 20th Annual European Congress](https://www.medicinesforeurope.com/externalevents/ispor-20th-annual-european-congress/) - It was with great pleasure that the Value Added Medicines Group, sector group of Medicines for Europe, participated in a panel at ISPOR 20th Annual European Congress (Glasgow, Scotland; 6 November), entitled Value Added Medicines: Time To Adjust The Health Technology Assessment Decision Frameworks?. This panel counted on notable speakers – Pr. Michael Drummond, Pr. - [Biosimilar Medicines Group ESMO 2017 Industry Satellite Symposium](https://www.medicinesforeurope.com/externalevents/biosimilar-medicines-group-esmo-satellite-symposium/) - Biosimilars for Oncologists: what you need to know Abstract Book Presentations A Clinician´s Guide to Biosimilars in Oncology: Understanding the Science of Extrapolation and Interchangeability Elena Wolff-Holz, MD Paul-Ehrlich Institute, Germany Chair of the European Medicines Agency’s Biosimilar Medicinal Products Working Party (BMWP) Member of the Oncology Working Party (OWP) Alternate member of the Scientific - [Pharma CMO Summit](https://www.medicinesforeurope.com/externalevents/pharma-cmo-summit-2/) - FMD Regulation Is Less Than 2 Years Away, This Is A Unique Chance For Pharmaceutical Trading Partners To Get Together And Make Real Progress Towards Compliance. Event Objectives Include:. Provide Manufacturers & CMOs with strategies, processes and tools to prepare for serialisation compliance & on-boarding / integration Educating trading partners on the challenges expected in - [Pharma CMO Summit](https://www.medicinesforeurope.com/externalevents/pharma-cmo-summit/) - FMD Regulation Is Less Than 2 Years Away, This Is A Unique Chance For Pharmaceutical Trading Partners To Get Together And Make Real Progress Towards Compliance. Event Objectives Include: Provide Manufacturers & CMOs with strategies, processes and tools to prepare for serialisation compliance & on-boarding / integration Educating trading partners on the challenges expected in - [Universal Access to Health, How Can We Contribute?](https://www.medicinesforeurope.com/externalevents/universal-access-to-health-how-can-we-contribute/) - AGENDA 9.30 Coffee & Registration 10.00 Introduction: the event, rationale of the partnership, 4th edition, goal of the debate, setting Moderator: Sarantis Michalopoulos, Euractiv 10.15 Welcome Address and MEPs’ perspectives MEP José Inácio Faria, EPP group, PT MEP Andrey Kovatchev, EPP group, BU 10.30 European Commission’s overview Sylvain Giraud, Head of Unit, DG Santé 10.45 - [Biosimilar medicines in clinical practice - Important role for hospital pharmacists](https://www.medicinesforeurope.com/externalevents/biosimilar-medicines-in-clinical-practice-important-role-for-hospital-pharmacists/) - During this 90-minutes symposium, hospital pharmacists will be navigated through the following areas: Introducing biosimilar medicines in the hospital: What are the key aspects to be taken in consideration? Understanding the scientific concept of biosimilar medicines and their clinical experience. How best to communicate on the safety and efficacy of biosimilar medicines? The role of - [Tweetup with Jacek Glinka](https://www.medicinesforeurope.com/externalevents/tweetup-with-jacek-glinka-2/) - 15th Biosimilar Medicines Conference BIOSIMILAR MEDICINES: A GAME CHANGER FOR HEALTHCARE SUSTAINABILITY Friday 24 March 2017 | 10.00 – 10.45 (CET) CONNECT BY USING THE HASHTAG #ASKJACEKGLINKA - [Value added medicines - What value repurposed medicines might bring to hospital pharmacists](https://www.medicinesforeurope.com/externalevents/value-added-medicines-what-value-repurposed-medicines-might-bring-to-hospital-pharmacists/) - During this 90-minutes symposium, hospital pharmacists will be navigated through the following areas: What is the concept of value added medicines? What is the importance of continuous innovation on existing medicines? How will value added medicines transform the daily work of hospital pharmacists and healthcare professionals in general? How can hospital procurement decisions acknowledge the - [Tweetup with Jacek Glinka](https://www.medicinesforeurope.com/externalevents/tweetup-with-jacek-glinka/) - Access to Medicines: join us in the debate! The role of generic, biosimilar and value added medicines in increasing access to innovative treatment Date: Monday 5 December – Time: 16.00-16.45 (CET) CONNECT BY USING THE HASHTAG #ASKJACEKGLINKA ## Tags - [video](https://www.medicinesforeurope.com/tag/video/) - [IMS report](https://www.medicinesforeurope.com/tag/ims-report/) - [Biosimilar. Handbook](https://www.medicinesforeurope.com/tag/biosimilar-handbook/) - [AMR](https://www.medicinesforeurope.com/tag/amr/) - [antimicrobial resistance](https://www.medicinesforeurope.com/tag/antimicrobial-resistance/) - [antibiotics](https://www.medicinesforeurope.com/tag/antibiotics/) ## Team Groups - [teamphv17](https://www.medicinesforeurope.com/team_group/teamphv17/) - dddd - [rac17](https://www.medicinesforeurope.com/team_group/rac17/) - [bios17](https://www.medicinesforeurope.com/team_group/bios17/) - [lac17](https://www.medicinesforeurope.com/team_group/lac17/) - [annual17](https://www.medicinesforeurope.com/team_group/annual17/) - [vam17](https://www.medicinesforeurope.com/team_group/vam17/) - [PHV18](https://www.medicinesforeurope.com/team_group/phv18/) - [rac18](https://www.medicinesforeurope.com/team_group/rac18/) - [bios18](https://www.medicinesforeurope.com/team_group/bios18/) - [lac18](https://www.medicinesforeurope.com/team_group/lac18/) - [annual18](https://www.medicinesforeurope.com/team_group/annual18/) - [vam18](https://www.medicinesforeurope.com/team_group/vam18/) - [PHV19](https://www.medicinesforeurope.com/team_group/phv19/) - [rac19](https://www.medicinesforeurope.com/team_group/rac19/) - [bios19](https://www.medicinesforeurope.com/team_group/bios19/) - [lac19](https://www.medicinesforeurope.com/team_group/lac19/) - [annual19](https://www.medicinesforeurope.com/team_group/annual19/) - [vam19](https://www.medicinesforeurope.com/team_group/vam19/) - [PHV20](https://www.medicinesforeurope.com/team_group/phv20/) - [RAC20](https://www.medicinesforeurope.com/team_group/rac20/) - [bios20](https://www.medicinesforeurope.com/team_group/bios20/) - [lac20](https://www.medicinesforeurope.com/team_group/lac20/) ## Categories - [Generic medicines](https://www.medicinesforeurope.com/?member-logo-group=generic-medicines) - [Biosimilar medicines](https://www.medicinesforeurope.com/?member-logo-group=biosimilar-medicines) - [Value added medicines](https://www.medicinesforeurope.com/?member-logo-group=value-added-medicines) - [General](https://www.medicinesforeurope.com/?member-logo-group=general) ## Types - [Factsheets](https://www.medicinesforeurope.com/type/factsheets/) - [Infographics](https://www.medicinesforeurope.com/type/infographics/) - [Reports](https://www.medicinesforeurope.com/type/reports/) - [Policy](https://www.medicinesforeurope.com/type/policy/) - [Videos](https://www.medicinesforeurope.com/type/videos/) - [External Resources](https://www.medicinesforeurope.com/type/external-resources/) - [PODCAST](https://www.medicinesforeurope.com/type/podcast/) ## News types - [Press releases](https://www.medicinesforeurope.com/news-type/press-releases/) - [In the news](https://www.medicinesforeurope.com/news-type/in-the-news/) ## Categories - [Generic medicines](https://www.medicinesforeurope.com/news-category/generic-medicines/) - [Biosimilar medicines](https://www.medicinesforeurope.com/news-category/biosimilar-medicines/) - [Value added medicines](https://www.medicinesforeurope.com/news-category/value-added-medicines/) ## Sections - [Member companies](https://www.medicinesforeurope.com/member-logo-section/member-companies/) - [Affiliate members](https://www.medicinesforeurope.com/member-logo-section/affiliate-members/) - [National associations - full members](https://www.medicinesforeurope.com/member-logo-section/national-full/) - [National associations – affiliate members](https://www.medicinesforeurope.com/member-logo-section/national-affiliate/) - [Partner Members](https://www.medicinesforeurope.com/member-logo-section/partner-members/) - [Partner](https://www.medicinesforeurope.com/member-logo-section/partner/)