Trade group calls for EU pharma and IP legislation reforms

13 June 2023

Generic and biosimilar medicines significantly lower healthcare treatment costs and are essential for enabling competition and vastly improved access to medicines.

The stated aim of the European Union (EU) pharmaceutical and intellectual property (IP) legislative reform is to encourage the immediate launch of generic and biosimilar medicines once IP protections expire. The 2023 Medicines for Europe Legal Affairs Conference debated these much-needed reforms for access to medicines.

The Bolar exemption should be harmonized and expanded in an unequivocal way to stop well documented, abusive litigation and achieve its stated objective of immediate competition, removing all legal uncertainties for European developers. This includes a clear ban of unlawful patent linkage in Europe, in line with the recommendations of the Pharmaceutical Sector Inquiry Report of 2009.

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