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.
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.
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.