


To combat the crisis of antibiotic resistance, solutions must incentivise innovation and ensure access to such treatments. An annual revenue guarantee scheme appears as an effective tool that can encourage antibiotic developers to invest in research and development by providing guaranteed revenue.
The Generic Medicines Group Market Access Committee is pleased to present the 2023 Market Review – European Generic Medicine Markets – Policy overview.
The purpose of this Market Review is to provide a general overview of the policies that are currently in place for Generic Medicines in the different European countries allowing the reader to get a clear overview on how generic medicines policies are set in the reviewed countries. The 2023 Market Review covers the following policies: Pricing & Reimbursement systems, Control of excess spending, Generic medicines substitution and Procurement of medicines.
The Supplementary Protection Certificate (SPC) is a sui generis protection that extends the market protection of patented medicines by up to five and half years (including a paediatric extension) to compensate the time lost in obtaining regulatory approval of medicines. As such, the European Union protection is the longest in the world.
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Medicines for Europe, the European off-patent medicines association, and CAFF, the Czech generic and biosimilar medicines association, have organised under the auspices of the Czech Presidency of the Council of the European Union a seminar on 10 November 2022 entitled “Ensuring equitable and sustainable access to medicines through a secure and resilient supply”.
The event has been organised in line with the main objectives stated in the European Commission pharmaceutical and updated industrial strategies for Europe, which have been published setting up clear goals for the European Union that delivers on access, availability and affordability while achieving a great open strategic autonomy, also taking into account the Covid-19 pandemic lesson learned.