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 the long-term sustainability of healthcare. Generic cost-containment policies have had no significant impact on overall healthcare budgets as the expenditure for generic medicines is only 2-3%. On the other hand, as underlined by the German Pharma Dialogue, cost-containment measures such as tendering significantly increase the risk of medicines shortages that ultimately undermine patient health. The most extreme examples of medicines shortages in Europe are found in countries with unsustainable pharmaceutical pricing policies such as Romania, where the combination of external reference pricing, price linkage and clawback have led to the withdrawal of 2000 medicines and chronic shortages of inexpensive medicines.
Regrettably, the OECD report does not underline the importance of timely availability of generics and biosimilar medicines in order to facilitate patient access to pharmaceutical therapies and to improve the sustainability of national health systems , which would be in line with the Council conclusions and the ‘Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability’. Aside from financially incentivising prescribers, pharmacists and patients, policies should be put in place to reduce time to market and to educate the population on the quality, safety and efficacy of generic medicines and their equivalence to originator medicines. Furthermore, it is important to emphasise the relevance of putting in place key policy measures to increase the use of biosimilar medicines which play a key role in increasing patient access and in the long-term sustainability of healthcare systems.
Adrian van den Hoven, Medicines for Europe Director General commented: “The State of Health in the EU cycle is an important platform to support health policies in EU countries. We encourage the Commission to focus on generic, biosimilar and value-added medicine policies that increase access to medicines for patients rather than short term and counterproductive cost containment measures. Our medicines are developed and manufactured to serve patient needs not austerity policies”.
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 on December 12, 2016 at the Ramada Hotel Alexanderplatz in Berlin. Titled Preparing Pharmaceutical CMOs & CPOs for Cost-Effective Serialization Compliance, the event will bring together manufacturers, CMOs, CPOs, 3PLs and solution providers for a full day of education and networking around the theme of making real progress toward serialization compliance.
The event is co-hosted with Medicines for Europe (formerly European Generics Association), an organization serving as the voice of Europe’s generic, biosimilar and value-added medicines industries. The December 12 gathering is the latest iteration in a series of such summits initiated by Supply Chain Wizard. Pharmaceutical industry professionals can register for the conference by visiting www.pharmacmosummit.com.
The goal of the event is to address the serious challenges presented by upcoming global serialization mandates, especially those in Europe and the United States. The day-long event will feature keynote addresses on major topics in serialization, along with panel discussions, breakout networking and roundtable sessions. Speakers and workshops will provide manufacturers and CMOs with strategies, processes and tools to prepare for serialization compliance and integration.
The event’s esteemed roster of sponsors speaks to the summit’s overall heft: The list includes Abbott, Teva and other leading pharmaceutical manufacturers. Solution providers will share best IT and packaging technologies, processes and tools for streamlining and enhancing serialization implementation. In addition, the conference will present opportunities for hands-on serialization learning activities, and will stress the sharing of content and experience among participants – a concept often seen as challenging in a largely close-to-the-vest pharmaceutical culture.
Another highlight of the event – one in which Supply Chain Wizard is particularly well-versed – is the opportunities for enhanced business practices through data analytics offered by optimized serialization systems. It is, according to the company, an instance where regulations once deemed onerous are opening doors to smarter manufacturing and supply chain operations.
“The exchange of knowledge this event will facilitate is the cornerstone of its success,” said Evren Ozkaya, founder and CEO of Supply Chain Wizard. “By bringing together multiple perspectives, and sharing both successes and struggles, we are confident attendees will leave this conference with a better understanding of what is needed to assure compliance with looming serialization mandates, and to effectively utilize the resulting data these new processes and systems will provide.”
About Supply Chain Wizard
Supply Chain Wizard, LLC, is a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs. Dedicated to optimizing operations for growth, service and efficiency, Supply Chain Wizard offers strategic innovations in products and services targeting serialization and supply chain transformation initiatives, along with a team of expert consultants providing comprehensive support toward cost-effective compliance with serialization mandates and post-go-live operational support.
Supply Chain Wizard organizes serialization roundtables, summits and training programs throughout Europe, Asia Pacific and the United States, and runs frequent webinars to support clients with their regulatory and compliance challenges. Committed to helping clients maintain significant and sustainable performance improvements, Supply Chain Wizard guides customers to a more secure supply chain via the implementation of high return-on-investment initiatives.
Supply Chain Wizard is headquartered in Princeton, NJ, with additional offices in Germany, Turkey and India. For more information, please visit www.supplychainwizard.com.
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 treatments for all patients across Europe.
Further to the EC Consensus paper on Biosimilar Medicines (adopted in 2013), and responding to a need for patient-friendly and reliable information on biosimilar medicines, this new document comes as an extension of the joint stakeholder work achieved so far. The Q&A is written by and for patients and aims to provide answers to the most frequently asked questions regarding alternative therapeutic options. The Q&A consists of a joint stakeholder document developed with the support of Medicines for Europe, EFPIA, EuropaBio, EPF, CPME, the European Commission and the European Medicines Agency (EMA) to educate patients on biological medicines, including biosimilar medicines.
Adrian van den Hoven, Medicines for Europe Director General highlighted that: “The European Commission has once again shown its leadership in improving information for stakeholders with this Q&A for patients. Building trust is important to promote more access to biosimilar medicines. The expanding use of biosimilar medicines ensures an increased access to treatment for patients and encourages competition”. He added: “We strongly encourage the European Commission to continue fostering competition in the biologic market and the use of biosimilar medicines in the medical practice as a way to contribute to the sustainability of healthcare systems”.
Note: This Q&A is an initiative 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. It was developed by a joint stakeholder group: Medicines for Europe, EFPIA, EuropaBio, EPF, CPME, the European Commission and the European Medicines Agency (EMA).
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 with their reference product, under the supervision of a clinical decision-maker, so that individual patient factors can be duly taken into account (Position Paper). The NOR-SWITCH study is the largest such study to date and its results reinforce the available positive clinical evidence gathered with the use of biosimilar medicines in the last decade in Europe.
While there is a large number of ongoing physician-led switching and observational studies involving biologic medicines (originator and biosimilar), it is essential to highlight the uniqueness of the Norwegian framework in which this study was performed: the NOR-SWITCH study forms an integral part of a wider policy framework from the Norwegian government which involved all concerned stakeholders, including patients’ representatives, in the introduction of biosimilar medicines in clinical practice.
Adrian van den Hoven, Medicines for Europe Director General commented: “This study is part of the growing body of real world evidence available on EU approved biosimilar medicines which provide alternative treatment options for both physicians and patients in 5 key therapeutic areas. It reinforces the Biosimilar Medicines Group efforts to ensure acceptance of biosimilar medicines through education and real world evidence gathering”.
What is a medical or physician-led switch?
A switch is a decision by a physician to exchange one medicine for another medicine with the same therapeutic intent. There are several scenarios however, which all involve a clinical decision maker:
A physician-led switch can be between versions of the same active substances (i.e. originator and biosimilar, biosimilar and biosimilar) but also between medicines in the same therapeutic class (e.g. anti-TNFs). The administered medicine is to be recorded in the patient file and the patients should always be involved in decisions regarding their treatment and informed about the medicine they are prescribed or given. This systematic approach strengthens also traceability in case of any adverse drug reaction (ADRs).
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 to ensure fiscally sustainable access to good quality services for all. Increased use of generic and biosimilar medicines in medical practice is a central policy option put forward to increase the health status of the European population without necessarily increasing expenditure. The report highlights the need for policy action to safeguard and sustain the contribution of healthcare and long-term care systems to improve population health. Several recommendations are presented in order to get more value for money, ensure access to medicines and increase the cost-effectiveness of healthcare and long-term care services. Generic and biosimilar medicines in particular have a pivotal role to play in this process.
Adrian van den Hoven, Medicines for Europe Director General commented: “This report once again underlines the important role of generic and biosimilar medicines for sustainable healthcare. Medicines for Europe and its national association members are ready to partner with the EU and Member States to develop the most effective policies to increase access to generic and biosimilar medicines”.
[1] The European Commission’s Directorate-General for Economic and Financial Affairs
Medicines for Europe Communications:
Doris Casares doris@medicinesforeurope.com
Andrea Bedorin abedorin@medicinesforeurope.com
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 impact on the treatment cost, according to the conclusions of the IMS Institute for Healthcare Informatics study on The Role of Generic Medicines in Sustaining Healthcare Systems: A European and Italian Perspective presented today in Rome during the Assogenerici Public Assembly.
The Assembly was attended by high level officials from the Italian authorities, Medicines for Europe Executive members, and more than 200 participants ranging from patient groups, physician organisations, scientific groups and the main bodies of the Italian pharma supply chain. Ahead of the presentation of the study, the President of Assogenerici Enrique Häusermann commented: “Generic medicines bring great benefits for patients and enable European states to increase patient access to treatment while simultaneously decreasing expenditure”. This is especially important for Italy where out of pocket expenses for medicines can be high.
Generic medicines also drive economic development. Pierluigi Antonelli, Medicines for Europe Vice-President highlighted that: “The generics industry is a fundamental part of the future of the Italian and European healthcare systems and we have to be a central stakeholder in the light of the future challenges for our healthcare systems around Europe. Our industry is a significant contributor to economic growth, with major production located in Italy”.
Millions of European patients have benefited from better access to gold standard therapies, treating most acute and chronic ailments ranging from cardiovascular to diabetes and even to cancer. The generic medicines industry employs more than 160,000 people in Europe and generic medicines today represent 56% of the medicines prescribed in Europe.
About ASSOGENERICI
Assogenerici is the official representative body of the Italian generic and biosimilar pharmaceutical industry. Formed in 1993, Assogenerici represents over 50 pharmaceutical companies and their subsidiaries. Companies represented within Assogenerici provide over 10,000 direct and indirect jobs in Italy and are operating with a manufacturing base of 37 plants located in Italy. Cost-effective generic and biosimilar medicines save Italian patients and healthcare systems over €400 million each year, thus helping to ensure patient access to essential medicines and providing urgently needed headroom for new and innovative treatments. Assogenerici plays an important consultative role in Italian healthcare policy-making. Assogenerici and its members work with Italian authorities to develop affordable solutions for pharmaceutical care and to increase Italy’s competitive strength in the global pharmaceutical medicines market.
Assogenerici Communications: Paola Marzoto p.marzotto@assogenerici.it
About MEDICINES FOR EUROPE
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. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
Medicines for Europe Communications: Doris Casares doris@medicinesforeurope.com
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 & Optimise Medicines: Improving Patient Health and Access. The report by Mondher Toumi, Professor of Public Health at Aix-Marseille University, identified several areas of healthcare inefficiencies in Europe. It highlights new opportunities for innovation, health improvements and budget efficiency but also identifies several barriers to the uptake of value added medicines. To ensure that all stakeholders concerned can access and take advantage of this innovation, we need clear market access pathways that recognise the benefits these medicines provide.
Christoph Stoller, Chair of the Value Added Medicines Group called on companies investing in this important innovation to join Medicines for Europe in improving medicine options for patients “We need to move from responding to sickness towards improving well-being, keeping people healthy, looking ahead and thinking in the widest sense about care that is holistic, efficient and effective. “We need more companies to join us in strengthening the dialogue with policy makers, payers, patients, and healthcare professionals to address the barriers to access so that patients can benefit from value added medicines.”
The Value Added Medicines Group is open to existing members of Medicines for Europe and new Medicines for Europe members (i.e. not already member of any Medicines for Europe sector group) interested in developing this industrial sector. For more information please contact: info@medicinesforeurope.com
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. Nowadays, generic medicines account for 35% of all dispensed medicines in France but account for only 18% of the pharmaceutical expenditure. Generic medicines contribute significantly to healthcare in France by ensuring greater access to medicines for patients and offering more options to healthcare professionals to treat their patients.
The French campaign is displayed through a website and will use communications platforms as social media, television, radio, posters in pharmacies and newspapers with a special section open to questions on generic medicines coming from citizens. The campaign is part of a wider generic strategy which should also stimulate generic prescribing by physicians in both general practice and the hospital setting.
Adrian van den Hoven, Director General at Medicines for Europe commented on the campaign: “France has one of the lowest generic market shares in Europe. We therefore strongly support this first step in the implementation of the French « Plan Générique ». All measures in the «Plan Générique » should now be rapidly implemented – especially the incentives for physicians to prescribe within the substitution list (« Répertoire ») to ensure access to medicines for French patients and to contribute to a more sustainable healthcare budget ”.
[1] IMS Institute for Healthcare Informatics Report The role of generic medicines in sustaining healthcare systems: a European perspective: https://www.medicinesforeurope.com/2015/06/01/ims-health-2015-the-role-of-generic-medicines-in-sustaining-healthcare-systems-a-european-perspective-june-2015/
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 Portugal during the seminar “The Value of Generic Medicines”, organised by APOGEN.
The study concluded that by 2050 the European population aged over 65 will increase from 129 to 191 million, with a consequent increase in the incidence of chronic diseases and the corresponding impact on the health expense of states. Between 2005 and 2014, generic medicines made it possible for European countries to double the number of patients treated, whilst maintaining the same pharmaceutical budget.
The study Value of Generic Medicines – Health Economics Study conducted by IGES Institute for Medicines for Europe also presented, concludes also that with the use of generic medicines, it is possible to treat a considerably a greater number of patients suffering from hypertension maintaining the same levels of expenditure; treat as many patients with breast cancer with lower levels of expenditure and treat more patients suffering from depression, with a slight increase in expense.
The seminar was attended by national and international experts as Adrian van den Hoven, Medicines for Europe Director General, António Vaz Carneiro, Professor, Faculty of Medicine of Lisbon and Director of CEMBE, Carlos Gouveia Pinto, Associate Professor of ISEG, Hélder Mota Filipe, member of the Board of INFARMED, IP or Paul Lilaia, President of APOGEN.
“APOGEN’s mission is to disseminate the concepts of generic and biosimilar medicines, actively contributing to the development of this market segment in Portugal, making medicines more affordable, in a sustainable health system” says Paul Lilaia, President of APOGEN. “The presentation of these two studies concludes that generic medicines bring great benefits for patients and for European states to increase patient access to treatment and simultaneously decrease the expense of the states with medicines.”
Adrian van den Hoven, Medicines for Europe Director General highlighted that “IMS report confirms the efforts by generic manufacturers to invest to bring better access for patients and more sustainability to pharmaceutical markets in Portugal and across Europe. Over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas without increasing the overall treatment cost. Millions of European patients have benefited from better access to gold standard therapies, treating most acute and chronic ailments ranging from cardiovascular, to diabetes and even to cancer”.
Also worth noting that the generic medicines industry employs more than 160,000 people in Europe and generic medicines already represent today 56 percent of the medicines prescribed in Europe.
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 and US would strongly stimulate efficiency and help ensure the quality of medicines while removing unnecessary duplications for both the industry and regulators. A joint Medicines for Europe and GPhA delegation led by their top management and composed of member companies’ senior managers has made a round of meetings in Washington DC during last week on the negotiations for a Transatlantic Trade and Investment Partnership (TTIP). USTR, FDA, and several offices of Congress were amongst the visited US institutions.
Adrian van den Hoven, Medicines for Europe Director General, highlighted during this visit that: “We appreciate the efforts employed by the EMA and the European Commission and the FDA to further align on approval processes of generic and biosimilar medicines. This will speed up access to these medicines for patients in EU and the US, and allow the EU and US to play a leading role in international regulatory cooperation initiatives on pharmaceuticals”.
David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA, said: “Improving regulatory coordination can avoid unnecessary duplication of product development, regulatory review, and approval efforts; as well as help alleviate significant delays in getting safe, effective and more affordable medicines to patients. GPhA continues to support a joint regulatory strategy where generic drug guidances and guidelines are coordinated and adopted by both the EU and the US regulatory authorities. For example, if generic drug manufacturers could follow a single development pathway it would expedite patient access and grow health system savings.”
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. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
Medicines for Europe Communications:
Doris Casares doris@medicinesforeurope.com
Andrea Bedorin abedorin@medicinesforeurope.com
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on Twitter: @gpha.
GPhA Communications:
Steve Arnoff sarnoff@gphaonline.org