Brussels, 02 October 2023, available online here

The off-patent medicines industry provides 70% of medicines dispensed to patients in Europe covering over 80% of therapy areas. Generic, biosimilar and value added medicines make treatment options affordable, accessible, and available, so that patients can best manage their disease. These medicines also played a pivotal role during the covid outbreak, where between 70% and 90% of ICU medicines were off patent.

As highlighted in the “Resilient EU2030” report, recently published by the Spanish Presidency of the Council of the EU, the objective of the  European Council meeting on 06 October is to strengthen supply chains, manufacturing capacity and ultimately, open strategic autonomy in the field of off patent medicines and API. Medicines for Europe and its members are natural partners who share these objectives and support the creation of a Medicines Security Act – which echoes the Critical Medicines Act called for by Member States - to deliver on this vision.

For it to be successful, Europe needs:

• Market and procurement reform that values security of medicines supply to prevent consolidation and avoid dependencies from other territories. 
• Investment from EU funds and State Aid in new manufacturing processes that are more green and secure for essential medicines and API.
• Digitalisation of the regulatory system by using new and existing databases, such as the EU serialisation system. This will improve our ability to predict shortages and enable solidarity across Member States in managing those that do occur.
• A clear IP system that encourages day-1 launch of off-patent medicines which will prevent the forced delocalisation of off-patent medicines development and manufacturing. This is key for biosimilar medicines, where Europe is a pioneer and where there is potential to increase equitable patient access to medicines.
• More cooperation with major international manufacturing partners such as the US, India, and others.

Commenting ahead of the European Council meeting and ahead of the upcoming European Commission communication on the availability of medicines, Medicines for Europe President Elisabeth Stampa said “The discussion at the European Council could not be more timely.  Increasing investment in API and medicines manufacturing is a completely aligned priority between EU heads of State and Medicines for Europe. My hope is to see actions on a concrete medicines security act, which, along with the revision of the EU pharmaceutical legislation, will support equitable access to and a more secure supply of off patent medicines, for the millions of patients who rely on them.”

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