• The changing IP landscape for pharmaceuticals was heavily debated at the Medicines for Europe Legal Affairs Conference in Amsterdam today
  • The highly anticipated SPC manufacturing waiver is a major advancement for pharmaceutical manufacturing in Europe
  • Major barriers to access to medicines still need to be addressed such as patent linkage and ensuring the quality of patent systems in Europe

The SPC manufacturing waiver, which will put an end to the legal requirement to delocalise pharmaceutical production outside of Europe, was lauded as a positive step for competition and security of supply of medicines at the 15th Legal Affairs conference in Amsterdam.

Stakeholders, government representatives, lawyers and industry experts took stock of the ten 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 Member States despite the clear decision 10 years ago to ban this anti-competitive practice as a conclusion of the Enquiry.

Experts also questioned why the European patent system has failed to address documented problems with patent quality in relation to the pharmaceutical sector. Failing to address this issue undermines the credibility of the system and risks delaying access to medicines.

Experts also exchanged best practice in litigation strategies to promote greater access to biosimilar medicines at expiry.

Sergio Napolitano, Legal and External Affairs Director at Medicines for Europe commented “.  EU Governments rely more and more on generic and biosimilar medicines to ensure equity of access to medicines for patients.  It is essential to ensure that the patent system and regulatory incentives for pharmaceuticals do not unduly delay access to medicines for patients. The SPC manufacturing waiver shows that the EU can easily tailor regulatory incentives to favour access and growth in Europe while maintaining strong incentives for the originator industry.”