The Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation is applicable since 2 July 2022. The SPC Waiver has been introduced with the objective to remove the competitive disadvantage that European manufacturers of generic and biosimilar medicines are facing vis-à-vis third countries’ manufacturers, which can start manufacturing generics and biosimilars earlier due to shorter IP protection periods.
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.
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.
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.