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Medicines for Europe represents manufacturers of off-patent medicines supplying close to 70% of dispensed prescription medicines in Europe. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines.

Médecins Sans Frontières (MSF) welcomes the European Commission’s ambition to ensure access to affordable medical tools. Beyond evaluating and revising the pharmaceuticals legislation, the Commission should take a comprehensive approach to revising the EU’s intellectual property (IP) and research and development (R&D) legislation and policies to meet this ambition.

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe…

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and…

Medicines for Europe welcomes the chance to provide feedback on the proposal to review the compulsory licensing system in Europe. Medicines for Europe is strongly convinced that voluntary licensing agreements are the right way forward to tackle health crises.

Médecins Sans Frontières/Doctors Without Borders (MSF) welcomes the European Commission (EC)’s ambition to improve compulsory licensing (CL) in the EU. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the Doha Declaration recognise that WTO members are free to determine the grounds on which to issue a CL.

Medicines for Europe welcomes the opportunity to provide valuable feedback on the EC proposal to review the compulsory licensing system in Europe. At Medicines for Europe, we firmly maintain that voluntary licensing agreements present the most effective approach to tackle health crises.

Medicines for Europe welcomes the chance to provide feedback on the proposal to reduce fragmentation in the SPC system. The Call for Evidence (CfE) makes almost no reference to a need to tackle fragmentation in enforcement/litigation phase of SPC lifecycles, arguably the highest priority for ensuring timely patient access to generic/biosimilar medicines, legal certainty & address national budget issues, ignoring the…

Médecins Sans Frontières (MSF) recently published research in a peer-reviewed journal (attached) on supplementary protection certificates and their impact on access to medicines in Europe.1 The study examines sales revenue of and R&D investments in a number of lifesaving medicines (sofosbuvir, trastuzumab, and imatinib).

Medicines for Europe is glad to be able to provide its feedback and emphasizes the need for safeguards to ensure high quality SPCs, prevent litigation strategies and ensure access to affordable medicines. First, SPC holders should be able to obtain a SPC protection so to enjoy an overall maximum of 14 years of exclusivity from the marketing authorisation.