SPC Manufacturing Waiver approved by European Parliament

The proposed European legislation to amend the SPC Regulation and introduce a manufacturing waiver (for export and stockpiling) has now been approved by the European Parliament on first reading.

Following the proposal to amend the SPC Regulation (EC/469/2009) to introduce a manufacturing waiver was debated by the European Parliament on 16 April 2019, and approved on the next day (572 votes to 36, with 22 abstentions). The vote was one of the final votes cast under the 2014 - 2019 mandate before the European elections begin on 23 May 2019.

UPDATE: Please see here for our more recent article reporting and updating on the legislation, as approved by the European Parliament.

Following approval by the European Parliament, all that’s left now is for the approved text to be formally endorsed by the European Council. This is expected in the coming weeks, especially since the European Council has already indicated it will approve the proposal should it pass through Parliament unchanged from the Compromise Text. Following endorsement, the new SPC Regulation would enter into force 20 days following its publication in the Official Journal of the EU (which is expected to occur in June or July 2019).

The weight of support for the waiver was shown in a press release published on the same day as the vote, in which the European Commission called the waiver a “well-calibrated adjustment to the current regime striking a balance between ensuring the attractiveness of Europe for innovative pharmaceutical companies and allowing EU-based generics and biosimilar to compete on the global market”.

Elżbieta Bieńkowska, the Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, commented that “the new regime will be decisive for Europe to stay attractive for innovative pharmaceutical companies while being able to compete with non-EU companies. The Commissioner also thanked the co-legislators “for all their efforts to make this important reform of Europe's patent rules possible”.

Similarly, the approval was welcomed by the generics/biosimilar industry, who consider that the proposal “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”.

In contrast, the European Federation for Pharmaceutical Industries and Associations (EFPIA) felt that adoption of the waiver “sends a negative signal to the world that Europe is devaluing its intellectual property framework, making Europe a less attractive location for research and development, impacting on jobs and investment”. EFPIA called on the next European Commission to look for opportunities to “redress the balance” by supporting research, development and innovation more broadly. For example, EFPIA urged the Commission to improve the EU’s position in fast-tacking breakthrough therapies by developing the EU’s existing incentives and rewards mechanisms for R&D in new medical areas, and by supporting a flexible framework for public-private partnerships in health to “foster medical R&D activities and modernised manufacturing to tackle the health challenges of the future”.

How these requests will be answered by the next Commission remains to be seen, and it is hard to say in which direction momentum will swing, especially in light of the elections next month. One area that might give such an indication could be the ongoing evaluation of the Orphan and Paediatric Regulations. Feedback on the public consultation, which opened on 18 October 2018 last year, was due by January 2019, so we could see an update on the progress of this evaluation later this year.

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