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 hospital medicines and to maintain the supply of essential medicines across Europe, at a time of unprecedented demand in the early phase of the pandemic.
As our companies scaled up production output by up to 900%, the association worked with the EU to reopen borders for the EU manufacturing supply chain, drive regulatory flexibility across borders while maintaining EU standards, and ensure full functioning of our factories for medicines supply during the pandemic. Christoph also helped the industry to prepare for the major upcoming review of EU pharmaceutical legislation, notably by leading discussions about manufacturing resilience and tackling the economic root causes of shortages. Christoph strongly encouraged the setup of the EU Structured Dialogue on Supply Security and Manufacturing.
Rebecca Guntern takes over following her two-year tenure as Vice-President of the association, during which time she has led on a range of initiatives, particularly improving patient access to biosimilar medicines and guiding the EU Structured Dialogue on resilient supply chains. She will lead the association until the Board can formally elect a new President in the New Year.
Commenting on the end of his term, Christoph Stoller said: “When I began my mandate as President of Medicines for Europe, I could never have known what awaited us with the outbreak of COVID-19. The industry mobilised like never before to deliver medicines despite huge spikes in demand. It was my privilege to lead the association during that time and I am very proud of what we achieved together, to avoid major shortages of essential ICU medicines in Europe and to secure continuous access to medicines for millions of European patients. I leave Medicines for Europe in the best of hands with Rebecca at the helm.”
Beginning her term, Rebecca Guntern said: “The pandemic has shaken our industry and our society to the core and revealed some clear gaps from the policy perspective. Beginning my term, I am looking forward to leading Medicines for Europe with a clear focus on flexible, pragmatic and patient-centric policies that will enable our industry to continue as the principal provider of life-saving medicines to patients in 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 directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. 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 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 lines of the COVID-19 pandemic, supplying critical medicines in a crisis, we acknowledge the efforts of the European Commission and the need for more efficient policies to manage future crises.
HERA will need to be an efficient agency with strong links to healthcare industries, including Medicines for Europe.
A successful HERA must:
Dysfunctional joint procurement policy must change
The European Commission must correct the joint procurement system before using it for HERA. Most importantly:
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 directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. 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.
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 of supply in Europe.
for security of supply, legislative reform should cover:
Speaking at the EU Structured Dialogue, Medicines for Europe President, Christoph Stoller (TEVA) outlined ““Pharmaceutical and industrial policy, must be an enabler for robust supply chains and support our industry efforts to mitigate and address the root causes of supply chain vulnerabilities, while ultimately supporting more investments in European manufacturing. The urgency is to agree and implement smart regulatory and economic policies! In the off patent sector, the race to the lowest price has reached its limit. And rather than punishing companies via penalties or by implementing distortive national requirements such as stockpiling, we should think win win”.
Medicines for Europe Vice President Rebecca Guntern (Sandoz) said: “We need to jointly design a coherent policy to ensure security of supply for essential medicines, which is better aligned with the prevailing market conditions for off-patent medicines. Medicine manufacturing costs cannot be compressed indefinitely. We need policies that enable a meaningful digital framework, promote flexible regulatory systems and phase out unhelpful and short-sighted cost-containment measures”.
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 directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. 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 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% of ICU medicines), anti-infective medicines and chronic care medicines, widely used to treat cancer, cardiac conditions, infectious and respiratory diseases including COVID-19. Essential medicines are produced in over 400 manufacturing sites across Europe. Yet the sector operates under cost-containment policies by member states and has consolidated over time.
While Europe remains a major global manufacturer of active pharmaceutical ingredients (API) and on complex medicine production processes[1], the reality is that India and China are growing their production at a much faster rate. India and China are also pursuing robust industrial strategies to encourage an expansion of medicines production in their territories. The COVID-19 pandemic underlined the critical importance of robust medicines manufacturing capabilities and should encourage the EU to pursue a smart industrial strategy for pharmaceutical production including:
Medicines for Europe President, Christoph Stoller (TEVA) said: “It is painful to see Europe gradually losing its essential pharmaceutical production. This cannot continue. The EU industrial strategy published last week is an important first step to slow this process but tailored actions for the healthcare industry are needed. The EU has set up important initiatives to move in this direction, such as the EU structured dialogue on medicines manufacturing. We need a robust manufacturing policy focusing on critical manufacturing technologies to strengthen EU resilience and deliver equitable access to medicines. but we would like to see this reflected across European Commission directorates. Medicines for Europe will engage constructively to achieve this goal together, supporting the security of supply of medicines.”
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 directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. 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.
[1] European Commission staff working document, page 136
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 set out to identify key recommendations to protect access to affordable medicines, while supporting a vibrant and strategic medicines manufacturing base in Europe.
As COVID-19 changed our perspectives on EU health policy, these issues are gaining traction and are heavily featured in the in the pharmaceutical strategy.
Off-patent medicines deliver equitable access to medicines. Generic medicines have doubled access for patients with diabetes and cardiac conditions and represent 70-90% of ICU medicines. Biosimilar medicines are drastically increasing access to biological therapies for cancer and auto-immune conditions such as rheumatoid arthritis or psoriasis and value added medicines are increasing patients’ quality of life for chronic diseases and we have seen this in action, as medicine repurposing has been a cornerstone in the response to COVID-19.
COVID19 has been a wakeup call and in my view has demonstrated three key priorities which still require action:
– Christoph Stoller
President, Medicines for Europe (Teva)
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 directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. 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.
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 Commission Pharmaceutical Strategy.
Biosimilar medicines have always been a strong asset to offer equitable access to treatment for chronic disease patients including those with cancer. Smart policies that expand biosimilar medicines use have led to efficient outcomes for patients, healthcare professionals and healthcare systems. To deliver their full potential, biosimilar medicines need:
Isabell Remus, Chair of the Biosimilar Medicines sector group, commented “COVID-19 will have a lasting impact on national health systems in Europe and their recovery will be absolutely crucial for all patients. For 15 years, biosimilar medicines provide an effective solution to balance patient access and healthcare sustainability. There are many more opportunities ahead for biosimilar medicines. Their smart use must be facilitated in practice but also in policies, like recognised in the EU Pharmaceutical Strategy and the EU Beating Cancer Plan.”
Note
These issues will be discussed in greater detail with experts from the healthcare community during the 2021 Virtual Summit on Biosimilar medicines. A series of live webinars can be attended free of charge, upon registration here. As part of the summit, the online web platform can be accessed here, with key stakeholder interviews and background documents.
The Biosimilar Medicines Group is a sector group of Medicines for Europe representing the leading companies developing, manufacturing and/or marketing biosimilar medicines across Europe. With more than 10 years of positive patient treatment experience and 20 products successfully launched, biosimilar medicines provide today a huge opportunity to deliver significantly improved access to modern therapies for millions of European patients in both chronic and acute care. Our members bring competition to the biological medicines market, thereby increasing access to highly innovative treatments to patients, in Europe and around the world, and supporting the sustainability of the European healthcare systems.
Biosimilar medicines are increasingly relevant to public health as emphasised by the new Pharmaceutical Strategy for Europe. The latest Biosimilar Market Review provides a comprehensive overview of policies in 26 European countries focusing on availability, pricing systems, retail markets, hospital tendering, reimbursement systems, healthcare practitioner-related policies, information and education.
Since the first approval of a biosimilar medicine in 2006, we have accumulated over 2 billion patient treatment days in Europe alone, transforming treatment by enabling smart reinvestment of healthcare resources in better access to biological treatments while contributing to the sustainability of European healthcare budgets.
While there are still gaps in access across Europe, biosimilar medicine competition has massively increased the number of patients that can be treated. A recent IQVIA report on The Impact of Biosimilar Competition in Europe, highlighted the critical role that biosimilar medicines will play in the future as many more biological medicines are set to lose market (IP) exclusivity. This should compel the EU and member states to implement efficient, goal-oriented biosimilar medicine policies to improve patient access and healthcare sustainability. This should be based on highly successful benefit-sharing models that have proven the ability to stimulate competition and uptake.
Commenting on the launch of the Biosimilar Market Review Kelly Burke, chair of the biosimilar market access committee of Medicines for Europe said: “The Biosimilar Market Review is an important resource for stakeholders and policy-makers interested in improving access to biological therapies. While progress has been made, it is clear much more can be done to leverage benefit-sharing for better access for patients and for a more sustainable healthcare.”
The 2020 Biosimilar market review can be accessed here.