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.
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.