In July 2022, the European Commission adopted the proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application. By repealing the Blood Directive (2002/98/EC) and the Tissues and cells Directive (2004/23/EC) (both evaluated in 2019), the proposed Regulation concludes the revision of the legal framework for blood, tissues and cells, which was included in the REFIT Annex (#37 p.15) of the Commission’s Work Programme for 2021.
This new proposal
- supports the continued provision of SoHO therapies, now and in the future, based on high safety and quality standards and up-to-date technical rules
- extends protective measures to new groups of patients, to donors and to offspring born from medically assisted reproduction
- improves harmonisation across Member States, facilitating cross-border exchange of SoHO and improving patient access to the therapies they need
- creates conditions for safe, effective and accessible innovation in a unique sector driven by public health services and voluntary and unpaid donations
- improves crisis preparedness and resilience to safeguard access to therapies
- implements digital-ready policies
- contributes to the European Health Union by pooling of technical expertise and achieving economies of scale.
As the Directives it repeals, the proposed Regulation has Article 168(4)(a) of the Treaty on the Functioning of the European Union as its legal basis. Feedback on the proposal was collected from 14 July 2022 to 08 September 2022 on the Have your Say Portal.
Impact assessment
The measures taken in the proposal were examined in a thorough impact assessment consisting of
The dedicated webpage for the revision process as well as the impact assessment report (Commission SWD and its annexes, and executive summary) provide further details.
Next steps
The proposal put forward by the European Commission will now be discussed in parallel by the Council and the European Parliament. Once the final text is agreed and adopted, it will come into force although there will be a 2-year transition period before most provisions apply and a 3-year period for some particular provisions. Other relevant information will be added to this webpage as they become available.
