The European Union and the United States are each other’s main trading partners for medicinal and pharmaceutical products, which are the EU’s most significant exports to the US and the second most significant US exports to the EU.
Today, generic medicines are an integral part of the healthcare system and demand for these products continues to rise. However, while increased usage of generic medicines has led to unprecedented savings for healthcare systems, perspectives often remain focused solely on their cost-saving potential. This can underplay the societal value of generic medicines in Europe and underestimate their contributions, compounding the challenges that healthcare systems are facing today.
Nitrosamines are organic compounds with a chemical structure R2N-N=O (Figure 1), where R is usually an alkyl group. These substances are commonly found in food and the environment. Low levels of nitrosamines have been found in a wide array of pharmaceuticals. The acceptable intake (AI) values for many nitrosamines have been published by the regulatory agencies. Many of these are unworkable and have led to recalls of some products (Health-Canada 2023b).
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 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.