The European Parliament has adopted a report calling for increased use of off-patent medicines in Europe to improve patient access, highlighting lessons learned during the Covid-19 pandemic and urging the European institutions to address them directly in future healthcare policy initiatives.

The Parliament, in its own initiative report, stresses the central role of generic, biosimilar and value-added medicines as the European Commission works to revise the legislative framework of the European pharmaceutical industry. Off-patent medicines already account for close to 70% of those used by patients in Europe.

The call for increased use of off-patent medicines also implies a tailored regulatory pathway for value added medicines innovation, an area where the EU has been lagging behind the US for years*.

The report highlights that an efficient and optimised regulatory system for pharmaceuticals is also a priority. This includes digitalising regulatory processes and embracing environmentally friendly solutions like electronic patient information leaflets.

The report calls on the European Commission to actively remove barriers to competition from loss of exclusivity. This includes reviewing the use of intellectual property incentives and assessing the framework for off-patent orphan and paediatric medicines. Adapting these frameworks could enable increased access for the rare disease population but a level playing field is needed to facilitate the development and manufacturing of these medicines.

Commenting on the European Parliament vote, Medicines for Europe President ad-interim, Rebecca Guntern said: “It is highly encouraging to see the European Parliament take such clear directions to increase access to off-patent medicines. I am particularly pleased to see the European Parliament factor in the lessons learned from COVID-19. Generics, biosimilars and value-added medicines are key pillars for the long-term resilience and sustainability of European healthcare systems. The review of the EU pharmaceutical legislation is a one-time opportunity to make sure Europe has a fit-for-purpose, efficient, digital and simplified regulatory framework. We look forward to continuing our work with the European institutions and Member States in the coming months. We cannot afford to miss this opportunity.”

Reference

*For more on this, see https://www.cep.eu/fileadmin/user_upload/cep.eu/Studien/cepInput_Off_Patent_Innovation/cepInput_Incentivising_Pharmaceutical_Off-Patent_Innovation_in_the_EU.pdf