article / 15 May 2019

SPC Waiver adopted by the EU’s Council of Ministers

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Yesterday, the Council adopted with a margin, but against protests, the proposal for amendments to the EU Regulation on the supplementary protection certificate (SPC) for medicinal products (no. 469/2009), thus the manufacturing exemptions for export and stockpiling purposes (SPC Waiver). In all likelihood, the SPC Waiver will enter into force this summer. Setterwalls follows this closely. Claes Almberg and Oskar Svenburg report.

As Setterwalls flagged for in articles on 9 April and 18 April, the Council was, depending on political priorities, in a position to adopt, before the end of summer, the legislation recently approved by the European Parliament. This was done yesterday by a majority of 22 countries in a vote in which four countries voted against (Denmark, Malta, Sweden, the United Kingdom) and two countries abstained (Austria, Czech Republic): see link. The adopted legislation can be scrutinized here.

Next, the legislation should be signed by the President of the European Parliament and the Council respectively. Subsequently, it will be published in the EU Official Journal. 20 days after publication, the SPC waiver will enter into force. This is expected to happen 1 July. The Waiver will mainly apply to SPCs that are applied for on or after the date of entry into force.

This change poses new challenges and opportunities for players and stakeholders on the European pharmaceutical market. Setterwalls has extensive experience with SPCs. We follow developments closely, standing ready to advise and to assist. Welcome to contact us.

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