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EU pharma strategy success depends on access to generic, biosimilar and value added medicines


25 Nov 2020


Health & Consumers
Proposals must enable the sector that delivers majority of medicines to patients

The new EU pharmaceutical strategy must prioritise workable policies for generic, biosimilar and value added medicines to deliver on patient access to medicines to rebuild strained health systems beyond the COVID-19 pandemic.

Generic, biosimilar and value added medicines account for 70% of essential medicines prescribed in Europe, those that are needed every day to help patients manage diseases including cancer, auto-immune and respiratory conditions. Off-patent and repurposed medicines are a cornerstone of the COVID-19 response, facilitating patient treatment in hospital emergency units across the world.

The EU pharmaceutical strategy provides a unique opportunity to strengthen this strategic sector. The  Commission Communication is a first important step to:

  • Ensure that off patent medicines remain available at all times, addressing the root causes of medicines shortages, making them a thing of the past
  • Ensure access to generic, biosimilar and value added medicines for all patients. Often in Europe, patients can only fully access the medicines they need when the off-patent version becomes available. Barriers to off-patent medicines use must be removed, in harmonisation with the Intellectual Property Action Plan
  • Modernise our environment by digitalising medicine regulatory systems to speed up processes and interactions. Patients will benefit from a regulatory system that is fit for a digital age with faster and better safety information, and improved European cooperation on the supply and availability of medicines.
  • Support a resilient manufacturing and industrial policy in Europe, injecting some much-needed competitiveness policies create manufacturing jobs in Europe and improve the resilience of supply chains to deal with health emergencies.

Commenting on the launch of the EU Pharmaceutical strategy, Medicines for Europe President Christoph Stoller (Teva) said “The Pharmaceutical Strategy presented today by the European Commission embodies a key milestone for many patients across Europe and echoes Medicines for Europe’s ambition to secure medicines supply and access for the next decade. Moving forward, there are too many public health, social and economic interests at stake here to get this wrong. More than ever and as proven by the COVID19 lessons learned, we strongly believe that all concerned stakeholders need to work together – EU and national policy makers, regulators, payers, industry and all actors of the supply chain  - if we are to effectively deliver on the Strategy’s ambition and ensure that patients receive the medicines they need when they need them, while keeping a strong, resilient and sustainable manufacturing base in Europe.”