EU Pharma Strategy Success Depends On Access To Generic, Biosimilar And Value Added Medicines

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

The new EU pharmaceutical strategymust 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 CommissionCommunication 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. Oftenin 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 medicinesthey need when they need them, while keeping a strong, resilient and sustainable manufacturing base in Europe.”

About Medicines for Europe
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, visit www.medicinesforeurope.com.