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DRAFT REPORT (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

JURI-PR-753706

Committee on Legal Affairs · Rapporteur: Adrián Vázquez Lázara

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This draft report proposes amendments to the Commission's proposal for a regulation on compulsory licensing for crisis management. It aims to balance crisis response with legal clarity and rights-holder protection. The amendments require voluntary negotiations before a compulsory licence, make the advisory body's opinion binding, and ensure rights-holders are heard and can access files. They also allow the Commission to order disclosure of trade secrets when strictly necessary, and set remuneration based on total gross revenue.

Committee position. The rapporteur proposes amendments to the Commission's proposal to strengthen rights-holder protection, require voluntary negotiations, make advisory opinions binding, and clarify trade secret disclosure and remuneration.

Key points

  1. A Union compulsory licence shall not be issued until the rights-holder has had a fair chance to negotiate a voluntary agreement with the licensee.
  2. The advisory body's opinion shall be binding on the Commission, and the body must consider rights-holders' interests and existing national compulsory licences.
  3. Rights-holders must be notified individually and given the opportunity to comment before a licence is granted; their comments must be forwarded to the advisory body.
  4. The Commission must identify all relevant intellectual property rights and rights-holders before granting a compulsory licence.
  5. The Commission may order the disclosure of trade secrets strictly necessary to achieve the licence's objective, with measures to preserve confidentiality.
  6. Remuneration shall be determined based on total gross revenue from activities under the licence, and paid within a pre-established timeframe.
  7. The licence must clearly state that the licensee is responsible for product liability, absolving the rights-holder.
  8. Licensees must keep acquired information confidential and provide a detailed account of products produced.
  9. Before fines or penalties, the Commission must hear and fully involve the licensee or rights-holder, and justify any rejection of observations within 7 days.
  10. The definition of 'crisis-relevant products' is determined by the Commission with the advisory body's guidance.

Who is affected

  • Rights-holders of patents and other intellectual property: they gain rights to be heard, negotiate, and receive remuneration, but may have to disclose trade secrets.
  • Licensees: they must negotiate in good faith, keep information confidential, and bear product liability.
  • National authorities issuing compulsory licences: they are represented in ad hoc advisory bodies.

Figures and deadlines

  • Remuneration shall be based on total gross revenue, not exceeding 4%.
  • The Commission must reply to observations within 7 days.

Legal basis: Article 294(2) and Article 50(1) and (2)(g) and Article 114 of the Treaty on the Functioning of the European Union