Today, the European Council, Parliament and Commission agreed a compromise deal on the SPC manufacturing waiver which will allow the co-legislators to adopt the amendment to the SPC Regulation under the current legislature.
The SPC manufacturing waiver will contribute to better patient access, to create manufacturing opportunity and jobs and to increase Europe’s capacity to manufacture and supply its own medicines. Medicines for Europe thanks the EU for addressing many of its proposals for a comprehensive waiver including the possibility to manufacture for export and day 1 launch and a balanced date of applicability. The compromise foresees a review in five years, specifically of the day 1 launch duration, which provides us with an opportunity to assess its benefits.
Recognising the complex legal nature of the SPC manufacturing waiver, we thank the many European Parliamentary, Council, Commission and national representatives who engaged thoughtfully with our industry and with stakeholders to move this legislation to a conclusion based on the benefits for Europe.
We deeply regret that the manufacturing waiver includes unnecessary and redundant notification requirements. This will require generic and biosimilar medicines manufacturers to publish commercially confidential information to allegedly prevent our industry from circumventing the rules of the waiver – notably the re-import of medicines manufactured under the export waiver for day 1 launch. This is obviously redundant now that the manufacturing waiver also authorises its use for day 1 launch manufacturing.
Medicines for Europe therefore calls on authorities to closely monitor any potential misuse of the notification system for frivolous litigation which could delay competition from generic and biosimilar manufacturers in markets where SPCs have expired.
We now call on the Parliament and the Council to rapidly adopt the SPC manufacturing waiver and look forward to strengthening Europe’s pharmaceutical manufacturing for access, jobs and growth.