Major challenges in the IP environment for pharmaceuticals in Europe

The changing intellectual property (IP) landscape for pharmaceuticals was debated at the Legal Affairs Conference in held today in Amsterdam by Medicines for Europe, the lobbying group for biosimilars and generic drugmakers.

The Supplementary Protection Certificate (SPC) manufacturing waiver, which will put an end to the legal requirement to delocalize pharmaceutical production outside of Europe, was lauded as a positive step for competition and security of supply of medicines at the conference.

Stakeholders, government representatives, lawyers and industry experts took stock of the 10-year anniversary of the EU Pharmaceutical Sector Enquiry at the event. Experts expressed major concerns that patent linkage continues to be a barrier to competition and timely access to generic and biosimilar medicines in several EU member states despite the clear decision 10 years ago to ban this anti-competitive practice as a conclusion of the Enquiry