The European Commission (EC) is proposing a targeted adjustment to IP rules to help Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.

The EC proposes a targeted amendment: the so-called ‘export manufacturing waiver’ to Supplementary Protection Certificates (SPCs). The waiver will support Europe’s pioneering role in pharmaceutical research and development.

Thanks to the waiver:

  • in the future EU-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.
  • IP protection for medicine production in Europe will remain the strongest in the world. SPC-protected medicines will retain their full market exclusivity in the EU.

Read the full proposal and find further information here.


Source: IPR Helpdesk News
Pharmaceuticals: Commission refines intellectual property rules