EU Pharma Strategy: Success depends on access to Generic, Biosimilar and Value Added Medicines

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Statement from the President: Now or never: pragmatism & ambition needed in EU pharma strategy to deliver on Europe’s medicines manufacturing

Medicines for Europe is ready with realistic policy proposals to secure manufacturing resilience and supply for patients across Europe, says President Christoph Stoller

Berlin, 07 October 2020, speaking at ‘For a Healthy Europe’, a ProGenerika-German EU Presidency event

The upcoming EU pharmaceutical strategy provides a one of a kind opportunity to strengthen Europe’s role as a global player for medicines manufacturing. The COVID-19 crisis has shone a light on a long-standing issue: the pharmaceutical supply chain is increasingly consolidated, and Europe is gradually losing its pharmaceutical productions, opening up areas of vulnerability which leads in severe cases to shortages. This cannot continue, and solutions must be found.

The first step must be to assess the reality of medicines manufacturing in Europe. Across Europe, our industry has manufacturing sites, working day and night, to produce the essential ingredients and finished products needed to make the medicines in our cabinets, pharmacies and in our hospitals.

In fact, the off-patent medicines sector can count on 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, developing and manufacturing the medicines that patients across Europe needs. Additionally, Europe still accounts for around 35% of API worldwide production (25% India, 33% China, 12%US)[1]. Nevertheless, the sector has been consolidated over time and various aspects of the supply chain have become globalised as a result of sustainability challenges faced by our industry.

But medicines are not like any other commodity. Disruptions in global supply have a much more profound impact on people’s lives than other goods. In that sense, we broadly support the EU’s vision for securing supply and strengthening medicines manufacturing in Europe through its upcoming pharmaceutical strategy. What concerns Medicines for Europe members is that we take this unique moment to put in place the right solutions that will make a tangible and systemic difference for the long term.

As the association representing the medicines manufacturers who provide for almost 70% of dispensed medicines in Europe, Medicines for Europe has defined where action is needed to help achieve this goal:

  • First – Healthcare systems’ unsustainable preference for the lowest cost generic option without regard for companies’ investments to secure supply or pursue Europe’s key transformative priorities like the Green agenda, is playing against the ambition to secure manufacturing in Europe and therefore a more resilient supply chain. This must change by reforming tender policies and designing new pricing models which encourage investments in security of supply and manufacturing resilience, covering the whole value chain from APIs to finished products.
  • Second – Use the power of digitalisation and telematics to create regulatory environment which is flexible enough to ensure fast transfers of information between the industry and regulators and to approve fast shipment of medicines between member states to address shortages;
  • Third – Upgrading the single market IP framework by implementing measures such as a broad Bolar exemption which extends to third party API suppliers;
  • Finally, and leveraging the COVID19 lessons learned, we need at European Level a platform where policy makers, payers, regulators, industry and other actors of the pharmaceutical supply chain can meet regularly to develop and implement sustainable policy reforms, and not a talking shop, so that patients get the medicines they need.

If one positive has come from the COVID-19 crisis, it has been the power of collaboration. When faced with an urgent crisis, industry and Governments worked together to manage the risk and reduce the impact. This should not be confined to crises only. Building manufacturing capacity in Europe is a long term goal, and one which cannot be accomplished by any one actor alone. At Medicines for Europe, we are ready to contribute to an EU pharma strategy that works, that makes sense, and that delivers for patients and health systems in Europe. It’s now or never!

– Christoph Stoller

President, Medicines for Europe (Teva)

[1] Data sources: Charles River Associates and GDUFA

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Am fost foarte mândru de eforturile industriei noastre de a uni și a pune interesul pacienților absolut pe primul loc în timpul acestei crize

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The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, Director General of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets.

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Christoph Stoller and Adrian van den Hoven interviewed by PharmaBoardroom

In the wake of the publication of Medicines for Europe’s Lessons Learned from COVID-19 policy paper, Christoph Stoller & Adrian van den Hoven outline the European generics, biosimilar and value-added-medicines industry’s rapid and comprehensive response to the COVID-19 crisis as well as the potential long-term shifts in European pharmaceutical policy that may come from this tumultuous period.

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COVID-19 a lightning rod for major overhaul of EU pharmaceutical policy

Urgent call for a structured industry-EU dialogue on reform

The upcoming EU pharmaceutical strategy[1] must include the critical lessons learned from COVID-19, experts agreed during a dedicated webinar on the topic today. The webinar follows the launch of the Medicines for Europe policy paper, focused on the lessons learned from the COVID-19 outbreak.

The outbreak of COVID-19 in Europe placed health systems, healthcare professionals and medicines manufacturers under extreme pressure to cope with surges in demand for patient care. Challenges arose in the form of closed border crossings between EU states, spikes in demand for Intensive Care Unit (ICU) essential medicines, integrating digital and tele medicine as part of the treatment norm, as well as challenges for patient continuity of care for those with chronic conditions. Medicines for Europe was proud to pioneer a forecasting project on ICU medicines supply, to ensure these essential medicines continued to reach hospitals and patients who needed them most. Success in this field was thanks largely to close cooperation between the industry, the European Commission and the European Medicines Agency and the network of national medicines agencies.

The outbreak of COVID-19 in Europe also sparked a renewed debate about strengthening medicines supply chains and manufacturing in Europe. The first step should be to support existing manufacturing capacity and be innovative to support its expansion. This includes a mix of smart policy making in the following key areas: investment, competitiveness, market-based incentives and a modernised regulatory framework.

The EU pharmaceutical strategy should apply the lessons learned from COVID-19 for pandemic situations and improvements to the pharmaceutical market in general. Different initiatives enabled the industry to respond to demand spikes including regulatory flexibilities agreed with authorities, ICU medicines forecasting to supply hospitals around Europe and establishing green lanes to preserve medicines logistics across borders in Europe.

Speaking at the webinar, Medicines for Europe President, Christoph Stoller said “The outbreak of COVID-19 in Europe acted as a lightning rod for change. If one positive has come from the experience, it is the value of EU partnership and coordination. We can be proud that our industry delivered on a timely supply of medicines to where they were needed most at various stages of the outbreak. But we cannot waste the opportunity to learn from this experience and strengthen EU pharma policy to support a resilient and diversified industry, so the system functions well in times of a pandemic and beyond. We will be advocating for an EU pharmaceutical strategy that prioritises equitable and sustainable access to medicines for all patients in Europe, and a structured dialogue and framework that enables industry to deliver on that vision.” 

[1] Medicines for Europe response to open consultation can be accessed here https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12421-Pharmaceutical-Strategy-Timely-patient-access-to-affordable-medicines/F536437

IQVIA Institute Scorecards show biosimilar medicines offer win for patients, policymakers and healthcare systems across Europe

  • Policies that foster sustainable biosimilar competition offer governments and authorities an immediate, clear path to supporting healthcare systems through efficient medicines use.
  • IQVIA Institute Country Scorecards for Biosimilar Sustainability, developed with Medicines for Europe, provide policy models for combining healthy competition and stakeholder engagement in 12 countries.
  • The country scorecards quantify the positive contribution of biosimilar medicines to healthcare sustainability and evaluate the success of national policies.
  • The scorecards can help decision-makers implement better biosimilar medicine policies to maximise benefits for patients, physicians and pharmacists.

Good biosimilar medicine policies balance the benefits of multi-source competition, volume uptake which increases patient access, and price discounts that generate savings. By acting decisively to tailor policies to local needs, governments and authorities can free up healthcare resources to improve access and make healthcare systems more sustainable.

The Country Scorecards for Biosimilar Sustainability launched today by the IQVIA Institute and the Biosimilar Medicines Sector Group of Medicines for Europe analyses the pros and cons of biosimilar policies in 12 countries – Denmark, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Romania, Spain, Sweden and the UK. Specifically, the scorecards assess the level of competition, price evolution and volume development for seven key biologic molecules – adalimumab, etanercept, infliximab, insulin glargine, insulin lispro, rituximab and trastuzumab – in each of the 12 countries.

The project also includes a detailed sustainability check, in areas such as regulatory environment and clinical guidelines, awareness and education, incentives, pricing rules and dynamics, and purchasing mechanisms. Positive policy elements are specified for each country, as well as challenges and solutions. Furthermore, an ideal scorecard describes how effective policy measures can deliver a competitive and sustainable market.

With numerous reports showing that patient treatment regimens for diseases such as cancer and arthritis have been disrupted by the COVID-19 pandemic, biosimilar medicines offer hope to deliver timely, standard of care to a broader group of patients.

Commenting on the launch of the report Adrian van den Hoven, Director General of Medicines for Europe said “This IQVIA Institute report is a helpful guide for policy makers to deliver sustainable access to biologic medicines. While the report shows that policy measures should be tailored to national contexts, the report provides clear recommendations on how measures can be combined and adapted to deliver effective results.  Our ambition is to use this guide to improve sustainable access to biosimilar medicines across Europe.”

Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science said “We are pleased to collaborate with Medicines for Europe in developing these scorecards that convey the progress that has been made in establishing biosimilar medicines as a meaningful contributor to healthcare sustainability across Europe.  The importance of biosimilar medicines’ role is greater than ever, and the systematic tracking of their contribution is a critical means for policymakers and stakeholders to measure progress and achievement of goals for patients and the entire health system.”

ACCESS THE FULL REPORT