EFPIA slams Commission proposals for SPC manufacturing waiver, which is welcomed by generic drugmakers

Today the European Commission launched a legislative proposal for a Supplementary Protection Certificate (SPC) Manufacturing Waiver, which received opposite reactions from pharma and generics trade groups, though the latter also has some reservations.

SPCs extend patent protection for medicinal products which must undergo lengthy testing and clinical trials prior to obtaining regulatory marketing approval. Due to the waiver, in the future European Union-based companies will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed. The waiver will support Europe's pioneering role in pharmaceutical research and development, according to the Commission.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents 40 of the biggest investors in life science research and development is deeply concerned with the European Commission’s proposal.