Manufacturing Waiver to Include Stockpiling

19 February 2019

On 28 May 2018 the European Commission published a proposal for a change in the law which would permit third parties to manufacture a medicinal product protected by a Supplementary Protection Certificate (see discussion here and here).

Earlier this month we reported the Council’s position for negotiations with the European Parliament (see discussion here and here). The European Parliament published its own position and the negotiators have since met. The outcome was briefly reported in a press statement from the Parliament on 14 February 2019 here. This press statement does not identify how all areas of disagreement were resolved, but does suggest that Parliament negotiators were successful in pressing for the waiver to be extended to stockpiling for day 1 release in the EU. The proposal now moves to Parliament and Council for formal approval.

Manufacturing Permitted by the Proposed Amendment Legislation

The proposed amendment to the Supplementary Protection Certificate (SPC) Regulation would permit a third party to manufacture a product (active ingredient) or medicinal product containing that product where the product is protected by an SPC for the purpose of export to countries outside the EU and for ancillary provisions strictly necessary to enable the manufacture and export. The Parliament negotiators argued for this to be extended to making the product or medicinal product during the final two years of SPC validity for the purpose of storing to place on the market as from day 1 after SPC expiry.

All proposals include 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, and to provide details of the product to be manufactured and the countries to which the product will be exported. The Council proposed some changes to the original Commission proposal, requiring notification to be made at least three months before manufacture (in contrast the Commission proposed 28 days) and requiring notification to both patent offices and SPC holders. Parliament’s proposal was notification at least two months before the start date of manufacture. There were some differences between the Council and Parliament positions on what information was to be provided to the local patent office, how much of this needed to also be provided to the SPC holder and how much would be published. The 14 February 2019 press statement does not reveal how these differences were resolved.

The maker must ensure a specified “EU export” logo is affixed to products manufactured solely for export. There was a difference between the Council and Parliament negotiating position as to whether this needed to be affixed solely to the outer packaging (Parliament) or to both outer and intermediate packaging (Council). The 14 February 2019 press statement does not reveal how these differences were resolved.

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 pointed 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. Parliament agrees. 

Council and Parliament proposed 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 Council proposed that the waiver applies from date of the entry into force of the Regulation plus three years; Parliament proposed that the waiver will apply to SPCs where the basic patent expires on or after 1 January 2021. The 14 February 2019 press statement does not identify which option was agreed.

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