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Off-patent medicines ready to drive pharma policy reform for equitable access, availability and security of medicines supply


15 Jun 2023


Health & Consumers

Malta, 15 June 2023

The EU has initiated a major overhaul of EU pharma legislation ranging from regulation to intellectual property and supply chains. The off-patent medicines industry is fully engaged to ensure that reforms transform healthcare delivery and access for patients. Generic and biosimilar medicines help the majority of patients with major chronic diseases such as cancer, cardiovascular disease, diabetes, autoimmune conditions and others. Value added medicines promise affordable, patient-centred innovation which can address unmet medical needs and the crisis in hospitals with personnel shortages and greater demand for healthcare.

Medicines for Europe sees the revision of EU pharmaceutical legislation as an opportunity to accelerate patient access to safe, effective, and affordable medicines and to improve Europe’s security of supply.

For this to succeed, Medicines for Europe calls for a particular focus on: 

  • Optimising use: timely competition and uptake measures that encourage greater access to off-patent medicines.
  • Flexibility: A regulatory system that facilitates timely access for patients and embraces digital tools like electronic patient information leaflets.
  • Prevention: An emphasis on preventing shortages, through guidance on procurement policies and EU finding policies that safeguard well established, inexpensive but essential medicines, with a dedicated Medicines Security Act.

Speaking at the Medicines for Europe annual conference, association President Elisabeth Stampa said “Medicines for Europe is strongly engaged in the EU pharma policy reform process to ensure that patients have equitable and timely access to secure supplies of medicines in Europe. This will entail comprehensive support of manufacturing and addressing the trends that persistently drive medicines shortages, through a Medicines Security Act. We believe that a joint effort with the European Parliament, Council and Commission with our industry is essential to tackle the challenges faced by health systems in every country in Europe. By working together, we can develop policies that promote sustainable and efficient manufacturing practices, create a framework for value added, affordable innovation, work to eliminate medicines shortages of essential medicines, and vastly improve access to medicines for better health outcomes for European patients.”


The Deputy Prime Minister and Minister for Health of Malta, Chris Fearne said that he “welcomes the long due reform and the proposed modernisation of the EU Pharmaceutical Regulatory Framework. The current framework is problematic in that it unnecessarily complicates supply chains, is costly to industry, and does not benefit patients. It is essential that we break down current barriers within the internal market to the benefit of all EU patients. The new approach within the Commission proposals in which incentives for innovative products are linked to access to patients within all Member States is the right approach and should be the basis of future negotiations. It is likewise important that we take this opportunity to stimulate development of new antibiotics, since the status quo is not an option”.


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