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European Council Position on Commission Proposal for SPC Manufacturing Waiver

11 February 2019

On 28 May 2018 the European Commission published a proposal for a change in the law (see discussion here), which would permit third parties to manufacture a medicinal product protected by a Supplementary Protection Certificate for the exclusive purpose of export to countries outside the EU.

The European Council has now responded to the proposal. The Council’s position is set out in the Council’s Mandate for negotiations with the European Parliament. The Council largely endorses the Commission’s proposal but argues for changes in some areas, most notably in the transition arrangements which will set the SPCs to which the waiver will apply.

The European Parliament will now consider the Council’s proposals, probably before the European Parliament elections in May 2019.

Manufacturing Permitted by the Proposed Amendment Legislation

The proposed amendment to the SPC Regulation would permit a third party to manufacture a medicinal product protected by an SPC for the exclusive purpose of export to countries outside the EU and for ancillary provisions strictly necessary to enable the manufacture and export of the product. The Council has resisted requests by generic manufacturers to reconsider extending the manufacturing waiver to allow stockpiling for release onto the EU market on SPC expiry.

The proposed legislation will impose some formal requirements on any party seeking to take advantage of this exemption. These formal requirements include an obligation to notify the national Patent Office in the EU state where manufacturing is to take place, including the provision of details of the product to be manufactured and the countries to which the product will be exported. That information will be published. The Council proposes some changes to the information required, requires notification to be made at least three months before manufacture (in contrast the Commission proposed 28 days) and requires notification to both patent offices and SPC holders.

The maker must ensure a specified logo is affixed (indicating it is a product for EU export). The Commission proposal required application of the logo to the outer packaging or, if there is no outer packaging, to its immediate packaging. The Council argues the logo should be affixed to the outer packaging of the product or medicinal product and, where feasible, to its immediate packaging.

Transitional Provisions

The Commission proposed that the new legislation would only apply to SPCs which had not been granted on the first day of the third month following the date of publishing the Regulation in the Official Journal. The Council points out that the Commission proposal based on SPC grant would lead to distortion between EU member states because the date of grant can vary significantly from one member state to another.  

The Council proposes the following transitional provisions:

  • An SPC in force at the date of entry into force of the Regulation: no waiver.
  • An SPC granted on an SPC application filed after the date of entry into force of the Regulation: the waiver applies.
  • An SPC granted on an SPC application filed before the date of entry into force of the Regulation, but where the SPC is not in force on that date: the waiver applies from date of the entry into force of the Regulation plus three years.

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