The revised Pharmaceutical Legislation must deliver more access to medicines, fair competition and prevent artificial extensions of monopolies beyond what the EU system foresees.
In order to effectively allow timely access to generic and biosimilar medicines for patients and achieve the stated objectives of the ‘Bolar exemption’ (ie. early generic/biosimilar development and approvals for immediate competition after Intellectual Property expiry), it is pivotal to ensure
that the final revised Bolar leave no room for diverging interpretations in different Member States and provide clear, unequivocable provisions removing any grey area or legal uncertainty that may allow the use of ‘patent linkage’ to delay competition
While biosimilar competition in Europe has played a vital role in achieving significant healthcare savings and expanding patient access to key medicines, the changing nature of future loss of exclusivity (LoE) events means that competition, and by extension savings, is not always guaranteed.
This report provides a timely view of the factors underlying the changing level of biologic pipeline activity in Europe, highlighting classes of biologics that are at risk of failing to attract biosimilar competition, a concept called “the biosimilar void.” This report also aims to quantify the potential impact of the biosimilar void on healthcare system budgets. Drawing on a wide range of IQVIA proprietary data and engagement with individual stakeholders, the report examines the cohort of biologic medicines that will lose protection over the next 10 years. The period for assessment (2023–2032) has been chosen to reflect the average development timeline for new biosimilar candidates (~7-10 years) and intrinsic limitations with forecasting data beyond 2032. Due to the evolving nature of the IP landscape in Europe, legal and IP barriers are not discussed in the present study.
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).
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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