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.
EU Pharma strategy provides unique moment to establish a regulatory pathway for Value Added Medicines and level the playing field with US
The absence of a cohesive and unique regulatory framework for value added medicines in Europe acts to the detriment of patients and health care professionals across the continent. Gaps in the pharmaceutical legislation must be addressed to support off-patent innovation.
The outbreak of COVID-19 in Europe highlighted the urgency to support value added medicines. Off-patent, repurposed medicines are among the few treatment options for critically ill COVID patients. Successful repurposing provided access to affordable medicines such as dexamethasone to reduce fatalities in hospitalised COVID-19 patients. Value added innovation also optimised healthcare resources by offering formulations of medicines that enabled patients to receive appropriate care at home, while not being exposed to the risk of contracting COVID-19, thereby relieving much needed hospital resources.
Value added innovation brings meaningful improvements to off-patent medicines for patients by applying modern science and technology to well-established molecules. It is affordable and sustainable. Yet the absence of a designated pathway for these medicines in Europe discourages their development. This is in stark contrast to the US system, which has a clear framework to support patient centred innovation. Our policy framework must catch up and support continuous innovation on off-patent medicines.
Medicines for Europe has launched a series of concrete recommendations to support value added medicines. The report (available here) sets three requirements for value added innovation in Europe. These are:
The Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan (Viatris) commented “Europe drastically lags behind the United States in terms of supporting value added medicines. The US has recognised the importance of off-patent innovation for the most challenging chronic diseases like cancer, respiratory conditions and antimicrobial resistance. Rather than stifling this innovation, the US has facilitated it with a dedicated regulatory pathway. Today, we are launching our recommendations to put Europe at the centre of continuous innovation on off-patent medicines by creating a fit for purpose legal framework under the EU Pharma Strategy.”
Medicines for Europe President Christoph Stoller (Teva) added “Never has the importance of value added medicines been more evident than during COVID-19. Off-patent medicines were investigated and scientifically validated for new indications so that they could be used on critically ill COVID-19 patients and continue to be one of the very few lifelines for hospitals. Additionally, the significant impact of the pandemic on non-COVID-19 patients cannot be underestimated and has demonstrated the need for a shift toward home care delivery, which can be supported by the combination of known molecules with digital technologies. Europe must develop a framework that supports this kind of innovation in the off-patent sector for all patients and disease areas.”
In response to the European Commission Trade Communication published on 18 February 2021. During Covid-19, Medicines for Europe was strongly engaged to ensure continued access to medicines for patients while protectionism, hoarding measures and panic policies undermined these efforts. The emergency has highlighted the need for closer international health collaboration and for governments to work together with industry to balance emergency health measures with free flow of medicine supply chains. Since the pharmaceutical sector is highly regulated, stronger international regulatory cooperation, especially related to generic and biosimilar medicines which represent the overwhelming volume of medicine supplies, would reduce unnecessary duplications for industry and regulatory agencies, and improve equitable access to medicines.
The EU should focus its trade agenda on pharmaceuticals on the following measures: