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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

A-9-2023-0250

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

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Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

Parliament's amended version of the Commission proposal for a regulation on standards of quality and safety for substances of human origin (SoHOs) intended for human application, replacing Directives 2002/98/EC and 2004/23/EC. It sets rules on donor and recipient protection, authorisation of SoHO preparations and establishments, inspections, vigilance and traceability, and adds new provisions on SoHO clinical studies, issuing of SoHOs and emergency supply measures. It requires Member States to draw up national SoHO emergency and continuity of supply plans and the Commission to publish a strategy for European SoHO supply autonomy. It reinforces the principle of voluntary and unpaid donation, bans advertising linked to financial reward, and requires Member States to report discriminatory donor restrictions.

Committee position. The Committee on the Environment, Public Health and Food Safety proposes to adopt Parliament's position at first reading with amendments to the Commission proposal, reinforcing donor and recipient protection, voluntary and unpaid donation, supply autonomy and coordination between Member States.

Key points

  1. The regulation sets high standards of quality and safety for all SoHOs intended for human application and for related activities, and aims to strengthen continuity of supply.
  2. It applies to SoHOs, SoHO preparations, products manufactured from SoHOs, donors, recipients and offspring, and lists SoHO activities including donor recruitment, issuing and SoHO clinical studies.
  3. Articles 53, 54, 55 and 56 also apply to SoHO donations intended for research, and the regulation does not apply to breast milk expressed solely to feed the mother's own child.
  4. Member States may keep or introduce more stringent measures based on scientific evidence, but must report restrictions that could discriminate between donors, in particular on grounds of sexual orientation.
  5. Competent authorities must act independently and transparently, publish annual declarations of interests, and make public decisions on non-compliance and on revoked, suspended or reinstated authorisations.
  6. SoHO preparation authorisations are valid throughout the Union, must be concluded within 3 months, and may be withdrawn for non-compliance; substantial modifications require a new authorisation.
  7. SoHO clinical studies need authorisation by competent authorities, must prioritise participants' safety and well-being, and must be registered on the EU SoHO Platform with results published.
  8. SoHO entities must protect donors' physical and mental health, obtain informed consent, verify donation frequency through national registries, and must not discriminate against donors or recipients.
  9. Compensation or reimbursement for living donors must be financially neutral, must not serve as an incentive or cause cross-border competition, and advertising linked to financial reward is prohibited.
  10. Member States must draw up national SoHO emergency and continuity of supply plans, promote public participation in donation, and set quantitative collection targets for critical SoHOs.
  11. The Commission must publish a strategy for European SoHO supply autonomy with targets for each critical SoHO, and the EU SoHO Platform must be interoperable with other Union platforms.
  12. The Commission must assess the application of the regulation five years after its date of application and consider a central register for SoHO donations.

Who is affected

  • SoHO donors, recipients and offspring from medically assisted reproduction, who gain protection of their health, safety and rights.
  • SoHO entities and establishments, which must obtain authorisations, maintain vigilance systems and report on supply.
  • Member States and their competent authorities, which must designate a single SoHO National Authority and carry out supervisory activities.
  • The Commission, which must set up the EU SoHO Platform, adopt delegated acts and publish a supply autonomy strategy.
  • The SoHO Coordination Board, which coordinates application of the regulation and issues opinions on regulatory status.

Figures and deadlines

  • SoHO preparation authorisation steps must be concluded within 3 months from receipt of the application.
  • The interval between inspections shall not exceed 4 years.
  • The responsible person for release of SoHOs must have at least 2 years of experience in the relevant field.
  • The digital communication channel for exchange of information on SoHO availability must be available no later than two years after entry into force.
  • The Commission shall assess national conditions for compliance with voluntary and unpaid donation by two years after entry into force and every three years thereafter.
  • Member States shall submit their national plans to the Commission and the SCB by two years after entry into force and review them every two years.
  • The Commission shall publish a strategy for European SoHO supply autonomy by two years after entry into force.
  • The Commission shall assess the application of the regulation five years after its date of application.

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