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DRAFT REPORT (COM(2022)0338 – C90226/2022 – 2022/0216(COD))

On the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

ENVI-PR-738661

Committee on the Environment, Public Health and Food Safety · Rapporteur: Nathalie ColinOesterlé

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This is the rapporteur's draft report on the Commission proposal for a regulation on quality and safety standards for substances of human origin (SoHOs), repealing Directives 2002/98/EC and 2004/23/EC. It proposes amendments to the Commission's text, including new definitions, rules on voluntary and unpaid donation and compensation, and a new derogation for preparations where no therapeutic alternative exists. It asks for a strategy on European self-sufficiency in SoHO supply, national donor recruitment programmes, and annual review of national emergency plans. It strengthens the role of the SoHO Coordination Board and the EU SoHO Platform, and gives observer roles to HERA, the EMA and the European Parliament.

Committee position. The rapporteur proposes to amend the Commission proposal to strengthen donor protection, harmonise oversight, promote European self-sufficiency and add flexibility for exceptional clinical use, while supporting the overall objectives.

Key points

  1. The regulation would set high quality and safety standards for all SoHOs intended for human application and strengthen continuity of supply.
  2. New definitions are added, including 'issuing', 'financial neutrality of donation', 'patient blood management', 'donor base resilience', 'free and informed consent' and 'European self-sufficiency'.
  3. Member States may introduce additional measures to build a European supply chain and achieve self-sufficiency, and may restrict imports from third countries.
  4. Donation programmes should be founded on voluntary and unpaid donation; compensation must be financially neutral, set by national authorities, and never an incentive to donate.
  5. Member States must report to the Commission on compensation conditions two years after entry into force and every three years thereafter; the Commission may establish a single register of European donors.
  6. A new derogation allows competent authorities to authorise SoHO preparations exceptionally where a patient has no therapeutic alternative and the preparation is deemed safe and effective.
  7. Competent authorities must consult the EMA and the Medical Device Coordination Group on regulatory status questions and must submit requests to the SoHO Coordination Board for its opinion.
  8. Inspectors must be independent and impartial and receive specific induction training; the Commission must ensure the independence of experts and observers on the Coordination Board.
  9. The Commission must publish a strategy for European SoHO supply self-sufficiency within two years, with targets and actions such as a European day for essential SoHO donations.
  10. Member States must adopt national priority action programmes for donor recruitment within two years of the strategy and review their national SoHO emergency plans annually.
  11. The EU SoHO Platform must be interoperable with other Union platforms, including the EMA's European Shortages Monitoring Platform, and give the EMA, ECDC and HERA access to information within their remits.
  12. Article 62 on national SoHO emergency plans would apply twelve months after entry into force, while the rest of the regulation would apply two years after entry into force.

Who is affected

  • SoHO donors: compensation must be financially neutral and never an incentive; frequent donors must be registered in cross-entity registries.
  • SoHO entities: must obtain authorisation for preparations and establishments, and must not make substantial changes without prior approval.
  • Member States: may adopt additional measures for self-sufficiency, must report on compensation, and must draw up national emergency plans.
  • Competent authorities: must ensure inspector independence, consult other authorities on regulatory status, and inform HERA, ECDC or EMA of serious incidents.
  • SoHO recipients and offspring: must be protected from risks, and patient blood management practices should be applied to avoid unnecessary use.

Figures and deadlines

  • At least 2 years of experience required for the responsible person for release of SoHOs.
  • Member States must report on compensation conditions two years after entry into force and every three years thereafter.
  • The Commission must publish the self-sufficiency strategy within two years after adoption of the regulation.
  • Member States must adopt national donor recruitment programmes within two years after publication of the strategy.
  • Article 62 applies twelve months after entry into force; the rest applies two years after entry into force.

Legal basis: Article 294(2) and Article 168(4), point (a), of the Treaty on the Functioning of the European Union.