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.
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.
This paper explores how the design of off-patent multisource, generic medicines procurement can be restructured to ensure greater security of supply of medicines while supporting broader policy objectives for more economically, environmentally, and socially sustainable development.
Myths to be dispelled on article 85 of the Pharma Directive, so called “Bolar”
Medicines for Europe is committed to improving public health through improved access, availability and affordability of medicines, in line with the pharmaceutical strategy for Europe.
In the context of the new EU pharmaceutical legislation, this document provides an economic analysis of the extension of regulatory data protection periods proposed in the European Parliament, which have strong political support. These extension proposals derive from a misunderstanding about their concrete impact on the cost and access to medicines (see explanation below) due to the complex interplay between the EU pharmaceutical
legislation and other patent and SPC laws.
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 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.