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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-AD-753730

Committee on International Trade · Rapporteur: Helmut Scholz

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The Committee on International Trade proposes amendments to the proposed regulation on compulsory licensing for crisis management, focusing on export restrictions, customs enforcement, and alignment with the TRIPS Agreement. It also suggests changes to Regulation (EC) 816/2006 to streamline procedures for exporting pharmaceutical products to countries with public health problems.

Committee position. The Committee on International Trade proposes amendments to the proposed regulation and to Regulation (EC) 816/2006, focusing on export flexibility, customs enforcement, and procedural streamlining.

Key points

  1. Products under a Union compulsory licence should be predominantly for the internal market, with exports only under conditions set by the Commission.
  2. Customs authorities should ensure products are not exported except when allowed, and the Commission should decide on suspected non-compliance within 10 working days.
  3. The Commission may request exporters to take corrective actions or dispose of non-compliant products.
  4. A Union compulsory licence should also be available for export under Regulation (EC) 816/2006, and its conditions should be reviewed to align with TRIPS.
  5. An automatic evaluation should be triggered if no compulsory licence is granted within five years.
  6. The licence should not be limited to the Union territory, and information gathering should include all relevant data.
  7. Amendments to Regulation (EC) 816/2006 require applicants to indicate multiple applications and expected quantities, and allow authorities to give rights-holders an opportunity to comment.
  8. Applicants must show efforts to obtain authorisation within 30 days, and licences are non-assignable except with the part of the enterprise using them.
  9. The amount of products manufactured must not exceed what is needed for the importing countries, and authorities may request proof of exportation and importation.
  10. Applications for export licences must include specific details, and urgent implementing acts can be adopted immediately.

Who is affected

  • Manufacturers and exporters of pharmaceutical products under compulsory licences.
  • Customs authorities in member states.
  • Rights-holders of patents and supplementary protection certificates.
  • Importing countries with public health problems and their authorised representatives.

Figures and deadlines

  • 10 working days for the Commission to conclude on compliance with export restrictions.
  • Five years without a compulsory licence triggers an automatic evaluation.
  • Thirty days before submitting an application for prior negotiation efforts.