“Off patent medicines essential for a fairer, healthier, and sustainable Europe” says President Christoph Stoller

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:

  • Off-patent medicines must be clearly recognised in EU pharma strategy’s implementation à Off-patent medicines deliver equitable access to medicines. Barriers to access on day-1 of generic and biosimilar medicines competition should be removed. Generic and biosimilar medicines uptake should be promoted.
  • Resilient and robust supply chain should be fostered à Smart and sustainable market reforms (also via procurement reforms to introduce multi winner, multi criteria models) should be implemented. These drive value for healthcare systems and patients rather than a race to the bottom by focusing on cost only, a factor in driving manufacturing outside Europe. Regulatory optimisation is needed including embracing digital solutions and processes (such as variations, telematics and eLeaflet).
  • Embrace digital and at-home solutions for patients à Value added medicines have come to the fore during COVID-19. We must find a way to accelerate this and benefit from the lessons we’ve learned to date, including to reflect on the impact that COVID-19 has on non-COVID-19 patients.

– Christoph Stoller

President, Medicines for Europe (Teva)

 

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 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.

European patients need improved access to biosimilar medicines

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:

  • The right market conditions and incentives
  • A fit-for-purpose regulatory environment, tailored to their specificities
  • To be part of standard patient care.

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

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.

New report assesses progress on biosimilar medicine policies across Europe

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 systemsretail markets, hospital tendering, reimbursement systems,  healthcare practitioner-related policies, information and education. 

Since the first approval of 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 Europehighlighted 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 efficientgoal-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 more sustainable healthcare. 

The 2020 Biosimilar market review can be accessed here.     

A new medicines trade and health security agenda for the European Commission

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:

  • Stronger cooperation on supply chain security. While emergency health measures are needed in a crisis, they can unintentionally undermine access to medicines by blocking trade in medicines or their components.  In a joint effort with the WHO and the WTO (to cover health emergency and trade matters), governments should align on specific mechanisms to limit the potential disruption caused by emergency health measures to the medicines manufacturing supply chain. This could be complemented at the bilateral level by extending Good Manufacturing Practice (GMP) mutual recognition agreements with other highly regulated markets starting with the UK.
  • Stronger regulatory cooperation. The Commission should promote global generic and biosimilar development programmes to accelerate access to essential medicines and eliminate the unnecessary duplication of regulatory steps.
  • Defend open trade. The EU should vigorously support the opening of medicines procurement markets and oppose with equal vigour the reneging of existing commitments by the US in the WTO Government Procurement Agreement;
  • Stronger cooperation on Intellectual Property. Europe has one of the strongest IP system at global level. It is fundamental that any negotiation on IP with third countries is balanced and take into account the market, legal and regulatory environment of both regions. Therefore, in trade negotiations, the European Commission should evaluate the concrete impact of IP on generic and biosimilar medicines access for both parties. In addition, it should be assessed whether the imposition of European IP standards in third countries has a positive effect on export of European manufactured medicines.

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