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Compagnie nationale des agents en propriété industrielle (CNCPI) is the French official body comprising all industrial property agents, namely the liberal professionals specialising in industrial property operating in France. In the context of the public consultation on the European Biotech Act, the CNCPI wishes to bring the attached position paper to the attention of the European Commission.

Filed in French · English published by the European Commission

On behalf of the Biosimilar medicines group, a Medicines for Europe sector group, please find attached our contribution on the future Biotech Act. The Biosimilar Medicines Group represents the leading companies developing, manufacturing and/or marketing biosimilar medicines across Europe. Our members contribute actively to the European biotech ecosystem, including through innovation on processes.

Dear Sir/Madam, Enclosed you will find the contribution of the Biosimilar medicines group, a Medicines for Europe sector group to the European Commissions call for feedback on the proposed European Biotech Act I (Health). We remain at disposal should you need any clarification. Kind regards

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.

The CNCPI, a body set up by the French Intellectual Property Code and representing the regulated liberal profession of all French patent agents, thanked the European Commission for the opportunity to participate in this call for contributions and welcomed its willingness to consult with a view to possible legislative work on compulsory patent licences.

Filed in French · English published by the European Commission

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…

The CNCPI, a body representing the regulated liberal profession comprising all French patent agents, thanks the European Commission for the opportunity to participate in this call for contributions and welcomes its desire to review the system for granting supplementary protection certificates (SPCs).

Filed in French · English published by the European Commission

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.