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 unsustainably low levels. This causes manufacturers of generic medicines to withdraw from the market, resulting in the increased risk of medicine shortages[1],[2],[3](see our position paper and reading list).
To address this public health risk, Medicines for Europe has commissioned The Economist Intelligence Unit (EIU) to investigate the impact and causes of medicine shortages. In the recent report, ‘Address medicine shortages in Europe’, the EIU underlines the importance of tackling the economic root causes of medicine shortages with healthy, predictable and pro-competitive market policies as well as regulatory efficiency and transparency in the supply chain from manufacturer to patient.
Adrian van den Hoven, Director General Medicines for Europe, commented: ‘Our industry supplies well over 60% of Europe’s medicines for hundreds of millions of patients each and every day. To avoid medicine shortages, the Economist study shows that we need predictable market policies for companies to continue investing in manufacturing. Preventing and mitigating shortages is a shared responsibility between manufacturers, regulators and payers who need to cooperate better in this field.’
[1] SFK (Foundation for Pharmaceutical Statistics), Pharmaceutisch Weekblad. 2014.
[2] APM Health 2015. Available at: http://www.apmhealtheurope.com/home.php.
[3] QuintilesIMS Health. An International Comparison of Best Practice Approaches to Drug Shortages. 2015.
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 medicines policies in 31 European countries detailing the status of biosimilar medicines availability, pricing system, tendering, reimbursement, and benefit sharing for physicians, pharmacists and patients.
The review illustrates that governments have realized that biosimilar medicines need a tailor-made policy framework and have disentangled their pricing policies from those of generic medicines. Physician-led switching, information and education for patients remain the key drivers for increased use of biosimilar medicines. EU education efforts , led by the European Commission, will facilitate these national activities thanks to the availability of translations into all EU languages later this year.
Adrian van den Hoven, Director General Medicines for Europe, commented: “Biosimilar medicines bring competition to the market and greatly improve access to biological therapies that are out of reach for too many patients in Europe. This overview shows that policy-makers need dedicated policies to provide more sustainable access to biosimilar medicines. Benefit sharing with stakeholders has proven to be the most successful approach to improve access and we encourage governments to learn from the best practices around Europe”.
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 urgently[ii]. The approval of oncology biosimilar medicines now offers patients a major access opportunity in cancer therapies contributing to both greater equality in access to healthcare products and services in the patients’ care pathway while supporting the sustainability of national healthcare systems in the long run.
To add further value to the educational journey of the ESMO 2017 Congress delegates, taking place from 8-12 September in Madrid, the Biosimilar Medicines Group, sector group of Medicines for Europe, has therefore organised an Industry Satellite Symposium, entitled “Biosimilars for Oncologists: what you need to know” [iii]. The aim is to provide an opportunity for oncologists to familiarise themselves with these safe and cost-effective treatment options. A thorough understanding of the science of biosimilar medicines and their development, the vast EU experience with this type of medicines, as well as of the pharmaco-economic impact of oncology products, will support oncologists and their patients in making informed treatment choices whilst maximizing their potential to increase patient access to oncology biologics.
Adrian van den Hoven, Medicines for Europe Director General, commented “Biosimilar medicines are a real game changer for better health. They can transform oncology care, by prioritising greater and equal patient access to biologic medicines treatment, supportive care and other needed health services.”
[i] Biosimilar medicines clinical use: an experience based-EU perspective
[ii] IMS Institute for Healthcare Informatics Global Oncology Trend Report 2016
[iii]ESMO 2017 Industry Satellite Symposium: Biosimilars for Oncologists: what you need to know
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 frameworks to ensure that European patients can benefit from value added medicines. Professor Mondher Toumi emphasised that “value added medicines represent an opportunity for increasing the cost-effectiveness of treatments or services that may bring substantial value to individual patients and society. However, the current European HTA decision frameworks represent various challenges for the full value recognition of these products, which need to be addressed.”
According to the study, which counted on the important feedback of key HTA experts across Europe, value added medicines make a major contribution to patients’ quality of life, health outcomes or adherence, and address a number of medicine-related healthcare inefficiencies, improving healthcare provision and organisation while contributing to the sustainability of healthcare systems. The study underlines the importance of the eligibility of value added medicines for HTA, whenever requested, in order to demonstrate these relevant improvements. There is a need to adjust HTA decision frameworks to ensure that all benefits of value added medicines are appropriately captured and to ensure a patient-centric assessment. The manufacturers of value added medicines should also have the opportunity to get early HTA advice in order to better shape their clinical development plan. Professor Toumi commented that “taking into consideration the specific benefits of value added medicines will need efforts both on the research and policy fronts, but also the involvement of a broad range of stakeholders in the decision-making process”. Ten key recommendations are put forward in the report to ensure that value added medicines can be rightfully assessed by HTA decision frameworks in the future.
Umberto Comberiati, Chair of the Value Added Medicines Group ad interim, commented: ‘Research on known molecules is a valuable untapped opportunity for European patients and healthcare professionals alike. There is an urge to support research and adjust the HTA policy frameworks to encourage industry to invest in medicines with high potential value to patients and society and capitalise on healthcare professionals’ expertise. We are ready to work together with patients, healthcare professionals, policy makers and payers on how to ensure patients can benefit from value added medicines in Europe.”
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 the science and benefits of biosimilar medicines.
A new study on value added medicines highlights the necessary reforms in health technology assessment (HTA) decision frameworks in Europe to ensure market entrance of value added medicines to improve the treatment of chronic diseases in areas such as respiratory or mental health treatment. This innovative methodology will also enable new business models for value added antibiotics to address the growing threat of antimicrobial resistance.
Jacek Glinka, Medicines for Europe President commented: “Biosimilar and value added medicines can significantly improve healthcare for patients – if better access is pro-actively supported by all stakeholders. It took 25 years to create access for generic medicines, European patients cannot afford to wait that long for biosimilar medicines to come”.
Adrian van den Hoven, IGBA Chair highlighted that “The IGBA is committed to improving the information about the opportunities that biosimilar medicines can bring for patients around the world. We look forward to close cooperation with the WHO, governments and stakeholders to deliver better access to biological medicines”.
During the two-day conference, pharmaceutical industry leaders and key stakeholders from the generic, biosimilar and value added medicines sectors met in Lisbon to foster international partnership, cooperation and dialogue to address public health challenges for the future. Several key studies presented at the conference highlight the need for a major overhaul of medicines policies to stimulate more access to generic, biosimilar and value added medicines.
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines. Its membership includes Medicines for Europe (Europe), the CGPA (Canada), the AAM (USA), the JAPM (Jordan), the Generic & Biosimilar Southern Africa (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos), Malaysia (MOPI) and Mexico (AMEGI) are Associate Members. The IGBA is at the forefront of stimulating competitiveness and innovation in the pharmaceutical sector by providing high quality pro-competitive medicines to millions of patients around the world. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities (including the European Commission for Europe) as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org
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, several key studies were presented at the conference that highlight the need for a major overhaul of medicines policies to stimulate more access to generic, biosimilar and value added medicines.
Generic medicines now account for the lion’s share (62%) of Europe’s medicines according to the latest data from Quintiles IMS. As the primary industry responsible for providing medicines to patients, we take our public health responsibilities seriously. To sustain this access, it is essential that unsustainable medicine pricing policies are reformed, as they are massively increasing the risk of serious medicines shortages – as outlined in a report by the Economist Intelligence Unit.
Jacek Glinka, Medicines for Europe President commented: “With Generic medicines accounting for 62% of all medicines dispensed in the EU, we call on EU payers to refrain from imposing unsustainable pricing policies that lead to medicines shortages and EU regulators to increase regulatory cooperation to reduce administrative redundancies”.
“We need to implement the recommendations of the WHO Fair Pricing Forum: dialogue between regulators, payers and industry should tackle unsustainable procurement policies”, added Adrian van den Hoven, Chair of the IGBA.
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines. Its membership includes Medicines for Europe (Europe), the CGPA (Canada), the AAM (USA), the JAPM (Jordan), the Generic & Biosimilar Southern Africa (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos), Malaysia (MOPI) and Mexico (AMEGI) are Associate Members. The IGBA is at the forefront of stimulating competitiveness and innovation in the pharmaceutical sector by providing high quality pro-competitive medicines to millions of patients around the world. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities (including the European Commission for Europe) as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org
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 safe and effective medicines through efficient medicines policies.
Governments should adopt medicines policies that support the use of generic and biosimilar medicines to generate the sustained benefits of competition over the long-term. Short-sighted and radical cost-containment measures (such as External Reference Pricing (ERP), single winner tendering, payback/clawback policies and mandated price cuts), endanger medicines supply reliability and ultimately patient health, as is underlined in the Commission’s assessment of the situation in Romania.
Adrian van den Hoven, Director General at Medicines for Europe commented that “The OECD[1], the European Commission[2],[3] and the European Council[4] have highlighted the importance of the timely availability of generic and biosimilar medicines for healthcare systems. In this light, Medicines for Europe has developed a set of Country Recommendations for France, Italy, The Netherlands, Spain, Portugal, Bulgaria and Ireland to help the EU and member states develop effective policies that support access to medicines for patients”.
To fully realise the potential of generic and biosimilar medicines, European governments should encourage competition from generic and biosimilar medicines based on four overarching recommendations as well as specific measures for each country:
More details on the Medicines for Europe recommendations can be found here.
[1] OECD, Fiscal Sustainability of Health Systems: Bridging Health and Finance Perspectives, 2015
[2] Investing in Health, 2013, DG SANCO, European Commission, http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
[3] DG ECFIN and Economic Policy Committee (Ageing Working Group), Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability, 2016, http://ec.europa.eu/economy_finance/publications/eeip/ip037_en.htm
[4] Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States – http://www.consilium.europa.eu/en/press/press-releases/2016/06/17-epsco-conclusions-balance-pharmaceutical-system/
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 taken, the burden of deaths from antimicrobial resistance could be as high as 10 million lives each year by 2050 – more than cancer. Without effective treatments like antibiotics, or prevention measures like vaccines, the most common health conditions or interventions would become more dangerous, and infections resistant to antibiotics would affect people from all ages.
The scale of the challenge of tackling antimicrobial resistance may seem daunting, but has certainly galvanised action. The life-sciences industry has been a longstanding partner in finding sustainable solutions to the problem. In an unprecedented effort, over 100 companies and trade associations signed the Industry Declaration on AMR at the World Economic Forum in Davos in 2016, followed by the adoption of a Roadmap by a number of pharmaceutical companies at the UN High-Level Meeting on later that year. They set out a common set of principles for global action that focus on reducing the development of antimicrobial resistance, invest in R&D to meet public health needs and improve access to antibiotics, vaccines and diagnostics.
The AMR Industry Alliance ties these two initiatives and brings together a wide-range of stakeholders from research-based pharmaceutical companies, generics, diagnostics, and biotech companies, and associations representing these industries. The AMR Industry Alliance will ensure that signatories collectively deliver on the specific commitments made in the Declaration and the Roadmap and will measure progress made in the fight against antimicrobial resistance.
One of the initial key objectives of the Alliance will be to develop a reporting mechanism to track progress, identify gaps and set targets for the future. This will increase accountability from industry and inform decision-making at global level. The first progress report will be launched in 2018 at the World Economic Forum in Davos for the 2 year anniversary of the Declaration. The Alliance will show how – from Davos 2016 to Davos 2018 – industry has been delivering on its commitments and demonstrating this through concrete actions, by adopting a more practical approach and leading by example to curb antimicrobial resistance.
Hosted at IFPMA, the Alliance will establish and implement an advisory group to inform industry on actions it should take to reach the Declaration and Roadmap’s commitments. While the emphasis will be on the life-sciences industry’s activities, the Alliance will also assess and facilitate partnerships to support continued progress by all the stakeholders, including governments, needed to combat AMR.
“I am pleased to announce the launch of this Alliance at the B20 Health Conference, where the focus is on the role global business can play in finding sustainable solutions to curb antimicrobial resistance. The AMR Industry Alliance will create a broad industry momentum and facilitate the collaboration between the public and private sectors. Only by working together can we strive for real change”, said Thomas Cueni, IFPMA Director-General.
Additional partners quotes
Steve Bates, the Vice-Chair of the International Council of Biotech Associations (ICBA) “Small and medium-sized enterprises (SMEs) stand ready to be powerful innovators to develop new and pioneering medicines adding to our arsenal of antimicrobial drugs”. Jim Greenwood, President and CEO, Biotechnology Innovation Organization (BIO) added: “The formation of the AMR Industry Alliance further underscores the deep dedication of the biopharmaceutical industry to address the growing global crisis of antimicrobial resistance. BIO and our member companies are eager to engage with the Alliance to ensure that the commitments and vision laid forth in the Davos Declaration are most effectively realized”.
Adrian van den Hoven, Director General, Medicines for Europe: “To ensure that antibiotic medicines remain effective for patients, we need rational prescribing and better information on use for patients. But we can do more. Value added medicines can help patients comply with the treatment course and can provide more options for doctors to deal with resistant patients. We also need to maintain sufficient manufacturing capacity with equal market conditions to secure and stay ahead of technological developments. The AMR Industry Alliance offers an opportunity to engage constructively on these solutions with policy makers and stakeholders”.
Andrew Fish, Executive Director, AdvaMedDx: “We are pleased to join the AMR Industry Alliance representing manufacturers of diagnostic tests, as a coordinated global response to combat antibiotic resistance is key in turning around this public health crisis. Diagnostic tests are an underutilized resource in the fight against antimicrobial resistance, and the formation of this Alliance is an important step in helping to educate patients, providers and others on the value of diagnostic tests and improve appropriate use of these tests around the world”.
About IFPMA
IFPMA represents research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 2 million employees research, develop and deliver medicines and vaccines that improve the life of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health. IFPMA advocates policies and practices that encourage the discovery of and access to life-saving and life-enhancing medicines and vaccines, for people everywhere.
For further information, please contact
Morgane De Pol
IFPMA
Manager, Communications & Public Affairs
Email: m.depol@ifpma.org
Tel: +41 22 338 32 20
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Daniel Seaton
Biotechnology Innovation Organization (BIO)
Director, Health Communications
Email: dseaton@bio.org
Tel: +1.202.470.5207
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Doris Casares
Medicines for Europe
Communications Director
Email: doris@medicinesforeurope.com
Tel: +32 (0)2 736 84 11
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Elyse Petroni
AdvaMed
Director, Digital Advocacy and Social Media
Email: EPetroni@AdvaMed.org
Tel: +1 202-434-7271
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, the overall trend in Europe is that biosimilar medicines are increasingly being used in medical practice and are increasing access to medicines for patients. Biosimilar competition in this high value market contributes to sustainable healthcare budgets. For many countries, especially in Eastern Europe, biosimilar medicines provide access to patients where it had previously been denied.
The QuintilesIMS report also highlights the need for multiple biosimilar players in the market to take advantage of the full benefits of competition in the long-run, which is in line with earlier findings[1]. Governments should refrain from pursuing drastic short-term policies that limit the number of competitors in the market. Aligning payers’ and manufacturers’ understanding of the short, medium and long term benefits of biosimilar medicines is a cornerstone of sustainable biosimilar policy-making and healthcare sustainability. In addition and as highlighted during the event organised by the European Commission last week in Brussels[2], the availability of information and education around the use of biosimilar medicines is important to build stakeholder confidence in biosimilar medicines. Evidence-based discussions in a multi-stakeholder setting have largely contributed to the success of gainsharing schemes thanks to which biosimilar medicines have been introduced in medical practice across Europe for better access.
Adrian van den Hoven, Director General Medicines for Europe, commented: “Biosimilar medicines form an essential part of healthcare provision in Europe today. They have brought and will continue bringing competition to the market, providing access to biological therapies that are out of reach for too many patients in Europe. Medicines for Europe acknowledges the role of the European Commission and its partnership with QuintilesIMS in pursuing the dialogue and close monitoring of the unfolding of the competition in the biologics market”.
[1] Simon Kucher & Partners, Payer’s price and market access policies supporting a sustainable biosimilars market
[2] 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 across Europe.
The event has provided a great platform for information sharing on topics such as the importance of collaboration in encouraging the use of biosimilar medicines and building stakeholder confidence in biosimilar medicines through evidence-based information sharing.
In addition, following the successful launch of a Q&A for patients on biosimilar medicines at the end of 2016, the European Commission and EMA have jointly introduced an information guide for healthcare professionals. This document provides reliable information for EU healthcare professionals with reference information on the science and regulation underpinning the use of biological medicines, including biosimilars.
The European pharmaceutical industry fully supports the increased competition in the biologics markets and its contribution to the sustainability of healthcare systems and commends the European Commission which has contributed to the acceptance of and trust in biosimilar medicines in Europe. The broad range of stakeholders that attended the event from across Europe reflects the increasing interest and relevance of biosimilar medicines.
About the issuers of this press release
The industry is represented by the European Federation of Pharmaceutical Industries, and Associations (EFPIA), the European Association for Bioindustries (EuropaBio) and Medicines for Europe-Biosimilar Medicines Group.
For further information, please contact:
EFPIA: Communications Team, +32 2626 2555, communications@efpia.eu
EuropaBio: Cosmin Popa, +32 2 739 11 73, c.popa@europabio.org
Medicines for Europe: Doris Casares, +32 2 533 98 18, doris@medicinesforeurope.com
About EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 39 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
About EuropaBio
EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 77 corporate and associate members and bio regions, and 16 national biotechnology associations in turn representing over 1800 biotech SMEs.
Read more about our work at www.europabio.org.
About Medicines for Europe – Biosimilar Medicines Group
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.
The Biosimilar Medicines Group is a sector group of Medicines for Europe and 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.