The purpose of this Market Review is to provide a general overview of the policies that are currently in place for biosimilar medicines in the different European countries allowing the reader to get a clear understanding. The 2023 Market Review covers the following policy areas: Availability of biosimilar medicines, Pricing & Reimbursement systems, Procurement of biosimilar medicines, prescribing & dispensing policies, and information & education policies
The Generic Market Access Committee (Generic medicines Group, a Medicines for Europe sector group) undertook a 2023 Generic medicines market review consisting of updates on generic medicines policy across Europe (28 European countries).
The highlights of this overview have been consolidated below and illustrate both key challenges and recommendations on how to improve specific policy interventions (e.g., pricing and reimbursement, procurement of medicines) to ensure access to medicines across Europe.
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.
Medicines for Europe welcomes the introduction of harmonised labelling, notably regarding recycling symbols which are sometimes already present in national legislations or the blue box – for example, in Bulgaria, France, and Austria.
The proposal, however, also introduces a requirement to provide information on the material composition, as well as information regarding the manufacturer and its contact details. We are concerned by the introduction of that information as there is limited space available on the packaging of pharmaceutical products.
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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