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DRAFT OPINION (COM(2023)0224 – C90151/2023 – 2023/0129(COD))

On the Proposal for a Regulation of the European Parliament and of the Council on Compulsory licensing for crisis management and amending Regulation (EC) 816/2006

INTA-PA-753730

Committee on International Trade · Rapporteur: Helmut Scholz

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The Committee on International Trade's draft opinion amends the proposed regulation on compulsory licensing for crisis management, focusing on export flexibilities and alignment with Regulation (EC) No 816/2006. It allows exports of products made under a Union compulsory licence under conditions of Regulation (EC) No 816/2006, and adjusts customs procedures and information sharing. It also proposes amendments to Regulation (EC) No 816/2006 to align with TRIPS, including on prior negotiation, quantities, and rights-holder involvement.

Committee position. The Committee on International Trade proposes amendments to the Commission proposal, allowing exports under certain conditions and aligning with Regulation (EC) No 816/2006 and TRIPS.

Key points

  1. Calls for allowing exports of products made under a Union compulsory licence, subject to conditions in Regulation (EC) No 816/2006, rather than prohibiting them.
  2. Requires customs authorities to suspend exports of suspected non-compliant products, notify the Commission, and the Commission to conclude within 10 working days.
  3. Requests that information on compulsory licences be entered in the Customs Risk Management System (CRMS).
  4. Amends recitals to note that only one export compulsory licence has been issued in the past two decades.
  5. Changes 'crisis-relevant' to 'relevant' in provisions on information analysis and sharing.
  6. Amends Regulation (EC) No 816/2006 to allow Member States to prescribe formal or administrative requirements for applications.
  7. Amends Article 18 of Regulation (EC) No 816/2006 to remove specification of Member States to be covered by the licence.
  8. Adds 'expected' to amounts of product in applications and production limits, aligning with TRIPS.
  9. Changes requirement for evidence of prior negotiation to evidence of efforts of prior negotiation.
  10. Allows competent authority to give rights-holder opportunity to provide information, not necessarily comment.
  11. Allows licence to be assigned to a non-profit organisation that makes use of the licence.
  12. Adds factors for determining remuneration, including public support and amortization of development costs.

Who is affected

  • Manufacturers and exporters of products under Union compulsory licences: exports allowed under Regulation (EC) No 816/2006 conditions.
  • Customs authorities: must suspend exports of suspected non-compliant products and notify the Commission.
  • Rights-holders: may be consulted by the Commission and have rights to information and remuneration.
  • Applicants for compulsory licences under Regulation (EC) No 816/2006: must show efforts of prior negotiation.

Figures and deadlines

  • 10 working days for the Commission to conclude on compliance with export prohibition.
  • Thirty days period for efforts to obtain authorisation before submitting application.