Biosimilar medicines were invented in Europe over 15 years ago. Since then, they have increased patient access to essential biologic medicines needed to treat the most serious of diseases like cancer, autoimmune conditions and diabetes by well over 50%.
Today, the Members of the Parliament’s health committee (ENVI) adopted a compromise position on the EU Pharmaceutical legislation review (comprising of a new Pharmaceutical Directive and Regulation). The Parliament has prioritised advancing this important legislation to improve the access, availability, and affordability of medicines ahead of the EU elections in June 2024 and prevent further delays of this much needed reform.
The position adopted today by the European Parliament on the proposals for the Unitary Supplementary Protection Certificate (SPC) and SPC Regulation recast, led by MEP Tiemo Wolken, is a significant milestone for innovation and access to medicines across Europe in this important legislative process.
Medicines for Europe’s newly published position paper explores how the current design of procurement rules in EU Member States, often aimed exclusively at reducing costs, has led to the consolidation of supply and increased risks for supply security.
Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany in October 2023.
Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany in October 2023.
Medicines for Europe and the European Business Association (EBA) have jointly proposed strategic steps for the integration of Ukraine’s pharmaceutical industry into the European Union, which we believe can be implemented before Ukraine’s full accession to the EU. This initiative aligns with Ukraine’s candidacy for EU membership and aims to harmonize the country’s healthcare system and pharmaceutical market with EU standards.
Medicines for Europe is deeply concerned about the Extended Producer Responsibility (EPR) system in the Urban Wastewater Treatment Directive under discussion in trilogue negotiations.
By 2032, the biosimilar medicines contribution to health systems access and sustainability will soon match the impact of generic medicines. The number of biological medicines set to lose market exclusivity represents an opportunity for competition to free up invaluable resources for healthcare systems, to improve patient access and budget sustainability.
the continuous increase in the prices of input raw materials as well as the increase in the cost of production and transport of medicines are in direct contrast to the ongoing price reduction of generic and biosimilar drugs in the Slovak Republic. The consequence is a rising shortage of medicines for patients. Even a short interruption in the availability of medicines can have a major impact on a patient’s health and life. Every patient has a right to certain access to the medicines they need. This access is a fundamental aspect of providing quality healthcare.