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 most-frequently-asked questions on biosimilar medicines.
What are biosimilar medicines? How are they produced? How are they approved? Are they safe? – These questions and many more are addressed in this paper. Empowering patients to engage, discuss and participate in decisions on their treatment options is key to improving patient outcomes and contributing to the effective treatment of their individual condition(s).
In Europe, the introduction of biosimilar medicines brings competition, with the potential to improve patient access to biological medicines and contribute to healthcare system sustainability. Biosimilar medicines help treat many complex diseases, including cancer, diabetes, and autoimmune diseases (such as rheumatoid arthritis and inflammatory bowel disease). Biosimilar medicines have been used safely in the EU since 2006 as an alternative to reference medicines.
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. This consensus information on biosimilar medicinal products was drafted by and for patients together with representatives of the European Medicines Agency, the European Commission and concerned stakeholders [the European Patients Forum (EPF), the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA), the Standing Committee of European Doctors, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for BioIndustries (EuropaBio) and Medicines for Europe]. The Q&A was first launched in English in January 2017.
The above stakeholders would like to congratulate the European Commissions’ DG GROW and the European Medicines Agency on the developments during this programme. The Patient Q&A amongst other documents, such as “Biosimilars in the EU – Information guide for healthcare professionals” and “What you Need to Know about Biosimilar Medicinal Products – A Consensus Information Document”, have contributed significantly to the increased understanding and acceptance of biosimilar medicines.
The Standing Committee of European Doctors (CPME) represents national medical associations across Europe. We are committed to contributing the medical profession’s point of view to EU institutions and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.
For more information please contact:
Miriam Beatrice Vita D’Ambrosio, Communication and Project Officer
Email: miriam.dambrosio@cpme.eu / Telephone: +32 2 738 03 12
EPF currently represents 74 members, which are national coalitions of patient’ organisations and disease-specific patient organisations working at European level. EPF reflects the voice of an estimated 150 million patients affected by various chronic diseases throughout Europe.
EPF’s vision is that all patients with chronic and/or lifelong conditions in the EU have access to high quality, patient-centred equitable health and social care.
The EPF strategic goals focus on areas such as health literacy, healthcare design and delivery, patient involvement, patient empowerment, sustainable patients’ organisations and non-discrimination.
For more information please contact:
Sara Gayarre, Communications Assistant
Email: sara.gayarre@eu-patient.eu / Telephone: +32 2 274 08 64
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. 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. To learn more about EFPIA, visit: www.efpia.eu
For more information please contact:
Faraz Kermani, Communications Manager – External Affairs
Email: communications@efpia.eu / Telephone: +32 2 626 25 55
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 79 corporate and associate members and bio-regions, and 17 national biotechnology associations in turn representing over 1800 biotech SMEs. Read more about our work at www.europabio.org.
For more information please contact:
Cosmin Popa, Communications and National Associations Manager
Email: c.popa@europabio.org / Telephone: +32 2 739 11 73
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.
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 for patients in Europe and around the world, and supporting the sustainability of the European healthcare systems.
For more information please contact:
Andrea Bedorin, Communications Manager
Email: abedorin@medicinesforeurope.com / Telephone: +32 2 239 20 14
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 soon as possible.
We urge Brexit negotiators on both sides to agree on a transition period that adequately reflects the time needed by companies, as well as all relevant authorities at EU and national level to adapt to changes in view of the UK exiting the EU. The transition period should provide for continued EU-UK partnership on the regulation and supply of medicines, to avoid supply disruption while moving forward towards a future cooperation agreement between the EU and the UK.
Our industry is highly integrated across Europe, and regulated under EU law through a sophisticated system of legal and regulatory arrangements involving EU Institutions, Member States and national competent authorities.
For our sector Brexit represents a challenge in several areas, notably regulatory procedures, quality testing of medicines, supply chain, trade, and intellectual property. For example, medicines companies may need to submit applications for the transfer of marketing authorisation for many products, move batch release sites and duplicate quality testing for products or move personnel into either jurisdiction. This will take a significant amount of time and will result in capacity issues which cannot be resolved before March 2019.
Clarity and certainty are needed as early as possible to enable our industry to make the necessary changes and to transition smoothly into the new framework. This is key to ensure that there is no disruption in the supply of medicines tor patients after March 20191.
Even in the context of the Brexit negotiations where all sectors are looking for clarity on the future, it’s important to recognise that medicines are different. Our goal is ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines through Brexit and beyond, and to ensure that there is no adverse impact on public health. This goal should be front of mind for both the EU and UK negotiating teams.
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 access to these medicines.
Health delivery models in Europe are being challenged by an ageing, rising patient population and current healthcare economic constraints, threatening the sustainability of Europe’s healthcare systems. There is a need for a new value proposition for patients, healthcare professionals and healthcare systems, especially to address clinical (adherence, quality of life) and economic inefficiencies. According to IQVIA, patient non-adherence is undoubtedly the biggest source of these, representing 57% of all inefficiency costs[1], and limiting the ability for patients to best manage their condition. Value added medicines can address these challenges by improving patient adherence and quality-of-life issues, while addressing medicine-related healthcare inefficiencies and improving healthcare provision and organisation thereby contributing to the sustainability of healthcare systems.
Marc-Alexander Mahl, Medicines for Europe President, highlighted that ‘We have a responsibility to look at European healthcare systems and see how we can contribute value to patients, healthcare professionals and society. Value added medicines deliver patient-centric gains. To continue the development of this sustainable innovation, there is a need for a favourable environment, where the development efforts can be reasonably recognised, and the access to value added medicines is well integrated in healthcare systems.’
Umberto Comberiati, Chair of the Value Added Medicines Group at Medicines for Europe, commented: “The wide range of stakeholders present at today’s conference has confirmed the wide interest surrounding value added medicines. We actively engage all the stakeholders from policymakers to patients, industry and payers to see how together we can address patients’ needs through the relevant outcomes that value added medicines can deliver. These benefits need to be more widely recognised and incentivised to promote the development of value added medicines in Europe. Pricing, HTA and market access pathways should be adapted to fully appreciate the benefits of this patient centric innovation”.
[1] IQVIA European Thought Leadership; IQVIA Institute 2012 “Responsible use of Medicine”
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 it carries out for public health.
Of course, the real work starts now. Looking to the next steps in the process, we hope for a well elaborated relocation plan, which will provide certainty for both EMA staff and for the continuity of the work of the agency. In particular, we hope to see key EMA projects and coordination run smoothly, to avoid disruptions in pharmaceutical regulatory activities – ranging from the approval for marketing to the post-marketing surveillance of medicines. In this regard, we particularly look forward to the EMA continuing to implement important information technology projects like ISO-IDMP, and to lead the way on biosimilar medicines, both in the EU and globally. The pioneering work of the EMA on biosimilars in Europe has ensured that patient access to treatment has increased, and to let this, as well as other projects of the EMA, slip during relocation would have serious negative consequences.
Our primary concern is that now this decision has been taken, we as healthcare stakeholders now focus on continuing this work, which of course is paramount to ensuring supply and access to medicines for patients. We look forward to continuing this important work in Amsterdam, the new home of the EMA.
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 measures would create a more competitive industry as demonstrated in the CRA study sponsored by the European Commission “Assessing the economic impacts of changing exemption provisions during patent and SPC protection in Europe”. According to the report, the SPC manufacturing waiver would:
The SPC compensates originator drug manufacturers for regulatory approval delays by extending their monopoly for up to 5 years after patent expiry. Whilst our industry does not challenge the principle of compensation for delays, the application of the SPC forces generic and biosimilar manufacturers to manufacture outside of Europe for export to countries without SPCs or whose SPC expires earlier than in Europe. With the SPC manufacturing waiver European medicine manufacturers will be able to re-invest in high skill jobs in Europe. To improve access to life saving medicines for patients, the SPC manufacturing waiver complements the Bolar provision and enable European manufacturers to bring competition at the date of SPC expiry and without unnecessary delays.
As proposed by the European Commission and confirmed in several studies, the SPC manufacturing waiver will not affect originator drug manufacturers as they will continue to benefit from the longest period of monopoly protection globally for most drugs.
Adrian van den Hoven, Director General at Medicines for Europe commented that “the CRA study shows the huge benefits that the SPC Manufacturing Waiver and Bolar harmonisation offer Europe in terms of jobs, manufacturing and a lower overall medicines bill. The Commission must now legislate to make this a reality.”
Medicines for Europe Communications:
Andrea Bedorin abedorin@medicinesforeurope.com
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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 Executive Vice President Business Unit Generic Drugs at Fresenius Kabi, Marc-Alexander Mahl chaired the Hospital Sector at Medicines for Europe. A physician by training, he completed his specialization in transfusion medicine and blood banking in 2001, the year he also joined Fresenius Kabi. He also holds an Executive MBA from INSEAD.
Today, in Warsaw, Marc-Alexander Mahl explained: “European healthcare is under financial constraint with many patients struggling to get access to treatments. The increasing overall cost of healthcare will force policy-makers to make difficult and unpopular choices about how best to allocate resources. Yet there is a very simple and obvious way to ensure access while managing healthcare budgets: to promote generic, biosimilar and value added medicines use by patients, medical professionals and pharmacists.” The new campaign will provide compelling data and proposals to help policy-makers and stakeholders improve access to medicines. In particular, the campaign will help policy-makers encourage competition in complex, specialty medicine markets where there are tremendous opportunities to increase access, spend resources more efficiently and improve overall care for patients.
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 group of Medicines for Europe, will participate in the ISPOR 20th Annual European Congress on an Issue Panel entitled “Value Added Medicines: Time To Adjust The Health Technology Assessment Decision Frameworks?”.
Moderated by Professor Michael Drummond (Professor of Health Economics at the Univerity of York), the panellists (Professor Mondher Toumi from the Public Health Department of Aix-Marseille University, Professor Ulf Persson from the Swedish Institute of Health Economics and Luigi Burgio – Head of Market Access Teva Italy and Chairman of the HTA Working Group at Medicines for Europe) will debate current challenges for capturing the benefits of value added medicines as well as key recommendations to integrate and recognise patient-centric innovation in HTA decision frameworks.
Umberto Comberiati, the Chairman of the Value Added Medicines Group,: “The time has come to explore new areas to deliver better health and access for patients, tapping into a sustainable source of patient-centric innovation. Value added medicines are an opportunity to deliver benefits to patients, payers and healthcare systems. However, there is a challenge to ensure that benefits can be appropriately assessed via HTA decision frameworks. The ISPOR Issue Panel will allow an informed debate among experts, industry and stakeholders.”
Medicines for Europe invites you to join the ISPOR European Congress in Glasgow and please follow us on Twitter and LinkedIn to know more about how European patients can better benefit from value added medicines. More information on the Issue Panel and the challenges and recommendations on adjusted HTA decision frameworks for value added medicines can be found here.
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