Yesterday, 29^th November, members of the Competitiveness Council expressed strong support for an SPC manufacturing waiver. While we regret that a couple of countries are clearly supporting vested interests in their complete opposition to the waiver, at least it is now clear that they simply working to block the constructive efforts of the rest of the Council to reposition Europe as a global hub for the production of medicines. This constructive dialogue in the Council will pave the way for future trialogue negotiations with the European Parliament where we see similar efforts toward a comprehensive manufacturing waiver.

In this technical discussion, it is important to remember the objectives of the SPC manufacturing waiver for Europe:

• Stop forced delocalisation of medicines production: The current SPC regime forces the generic and biosimilar medicines industry to transfer production outside of Europe to manufacture for export to countries without SPCs and to prepare for day 1 launch in Europe. This leads to job and R&D losses, increases our dependency on foreign manufacturers and increases the costs of medicines for patients. As the generic and biosimilar medicines industry supplies over 62% of Europe’s medicine, this needs to change.
• Maintain the SPC monopoly rights of the originator industry: The originator industry benefits from up to 5 years of additional monopoly thanks to the SPC regulation. The SPC manufacturing waiver will maintain this up to 5 year monopoly period. There will be no loss for the originator industry and investments in R&D will continue to stimulate discovery of new drugs.
• Strengthen generic and biosimilar medicine manufacturing in Europe: Generic and biosimilar medicines increase access to medicines in Europe – by 100% on average. They are also the backbone of essential pharmacy care for healthcare professionals and for patients. A robust and high tech manufacturing sector – from API to finished form – is essential to public health and security of supply.

Medicines for Europe reiterates its request to make the SPC manufacturing waiver a success for Europe by:

• Enabling the waiver to be applicable as soon as possible to stop further delocalisation of production which can be documented product by product.
• Allowing day-1 launch under the waiver so that we can produce medicines for European patients after SPC expiry.
• Remove the anti-competitive clauses of the notification system by empowering judges and courts to ensure compliance with EU law (as it should be). No company should be forced to disclose confidential business information to its competitor simply because it chooses to manufacture in Europe.

Medicine’s for Europe Director General Adrian van den Hoven said "The Council and Parliament can choose to support the manufacturing of generic and biosimilar medicines in Europe over delocalisation. We trust that the European interest will prevail."