• The European Parliament adopted the SPC manufacturing waiver with a huge majority.
  • The waiver will improve access to medicine and create manufacturing job opportunities for Europe as of July 2022.
  • Medicines for Europe will work with its members to facilitate the practical use of the waiver and will monitor and act against any potential misuse of the notification system for frivolous litigation.

The European Parliament today voted overwhelmingly with 572 Members of Parliament in favour to adopt the Supplementary Protection Certificate (SPC) manufacturing waiver.  The SPC manufacturing waiver is now expected to be formally adopted by the European Council in the coming weeks.

Medicines for Europe commends the EU institutions for successfully concluding this important step in the adoption of the waiver. We congratulate the European Commission for proposing the waiver and the rapporteurs and shadow rapporteurs of the Legal, Trade and Health committees of the European Parliament as well as the European Council for substantially improving the manufacturing waiver to deliver access to medicines for European patients.

The SPC manufacturing waiver will enable the European pharmaceutical industry to compete on a level playing field globally for manufacturing opportunities in generic and biosimilar medicines which is growing year on year.

The waiver will come into force in July 2019 and companies will be able to start manufacturing under the waiver from July 2022. The Commission has evaluated the tremendous investments in new, high-skill jobs that this manufacturing for export and for day 1 launch can deliver for Europe[1]. The waiver’s notification measures should therefore not be misused to block generic and biosimilar medicines competition.

Adrian van den Hoven, Director General of Medicines for Europe commented “Today’s vote on the SPC manufacturing waiver reflects the EU’s commitment to access to medicines, manufacturing jobs in Europe and putting EU industry on a level playing field globally. Europe has everything to gain from fully implementing the waiver to enable more competition on the pharmaceutical market and to improve its own security of medicines supply.

[1] https://ec.europa.eu/docsroom/documents/29463