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A step forward for the secure supply of medicines and manufacturing and for public health


25 Oct 2023


Health & Consumers
The off-patent medicines industry provides 70% of medicines dispensed to patients in Europe, covering over 80% of therapy areas. Medicines for Europe is committed to working with the EU to secure the supply of essential and critical medicines for public health. 
The Commission communication addressing medicine shortages in the EU is an important step to tackle the root causes of shortages and work towards a Critical Medicines Act. Building on this communication, it must include:
  • Legal guidance on medicines public procurement and security of supply.
  • A strategic EU reserve of essential medicines.
  • EU funds and State aid projects to incentivise investments in greener and more secure manufacturing processes for essential medicines and active pharmaceutical ingredients (APIs).
  • Digitalisation of the regulatory system and more use of data to increase the visibility and solidarity of medicines allocation in a shortage.  This should include the use of European Medicines Verification System (EMVS) data.
  • Regulatory flexibility to harmonise pack sizes and presentations which will reduce unnecessary complexities in the supply chain.
Commenting on the release of the Communication, Medicines for Europe President, Elisabeth Stampa, said “In response to Member States and Parliament calls for a Critical Medicines Act, this communication is a positive first step for the security of supply of medicines. Medicines for Europe will partner with the EU to implement these important reforms. With the right market, regulatory and state aid policies, we can leverage private sector investment and manufacturing know-how to restore strategic autonomy in this vital sector for public health.”
Resource hub
Medicines for Europe proposal for a Medicines Security Act, below and at
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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 please follow us at and on Twitter @medicinesforEU.