In its 2021 work programme, the Commission announced a revision of the blood, tissues and cells legal framework, namely Directive 2002/98/EC on safety and quality of human blood and blood components and Directive 2004/23/EC on safety and quality of human tissues and cells and their implementing acts.

According to the Commission, this initiative aims to update the current legislation to allow for a more flexible alignment to scientific and technological developments. It aims to address the (re-)emergence of communicable diseases, including lessons learned from the coronavirus pandemic, as well as the increasing commercialisation and globalisation of the sector, so contributing to the European health union. With the revision, many technical provisions would be removed, which would allow a faster updating of standards. Moreover, the revision would allow for the possibility to merge the basic acts into a single instrument.

The inception impact assessment was published on 12 November 2020. A public consultation closed on 15 April 2021.

The legislative proposal was put forward by the Commission on 14 July 2022 and is a new step towards building a strong European Health Union by establishing new rules aimed at increasing the safety and quality of substances of human origin.

The proposed regulation establishes measures setting high standards of quality and safety for all substances of human origin ('SoHOs') intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction. The proposed regulation is without prejudice to national legislation which establishes rules relating to aspects of SoHOs other than their quality and safety and the safety of SoHO donors.

As underlined in the proposal, every year, EU patients are treated with 25 million blood transfusions (during surgery emergency, cancer or other care), a million cycles of medically assisted reproduction, over 35 000 transplants of stem cells (mainly for blood cancers) and hundred thousands of replacement tissues (e.g., for orthopaedic, skin, cardiac or eye problems). These therapies are only available thanks to the willingness of fellow citizens to make altruistic donations. In the European Union, the collection, processing and supply of each individual unit is typically organised on a local small-scale by public services, (academic) hospitals and non-profit actors.

On 8 September 2022, European Parliament's ENVI Committee debated with the European Commission on the proposal. The rapporteur on the file is Nathalie Colin-Oesterlé (France, EPP).

On 27 October 2022, the European Economic and Social Committee adopted its positive opinion on the proposal.

During the Czech Presidency, three meetings of the Working Party on Public Health (16 September, 7 October, 14 October 2022) and an informal virtual meeting of members of the Working Party on Public Health (8 November 2022) were dedicated to the proposal. On 9 December 2022, the Czech presidency presented at the EPSCO (Health) Council the state of play of the proposal currently being examined by the EU Member States.

On 2 March 2023, European Parliament's ENVI Committee debated on the draft report. The report is expected to be adopted by ENVI in June 2023.

References:

• EP Legislative Observatory, Procedure file on standards of quality and safety for substances of human origin intended for human application, 2022/0216(COD)
• European Commission, 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, COM/2022/338 final, 14 July 2022
• European Commission, 2021 Commission work programme, 20 October 2020
• European Commission, Commission staff working document ‑ Evaluation of the Union legislation on blood, tissues and cells, SWD(2019) 375, with its Executive summary, SWD(2019) 376
• European Commission, Blood, tissues and cells for medical treatments & therapies – revised EU rules, website
• European Commission, press release European Health Union: Stronger rules for greater safety and quality of blood, tissues, and cells, 14 July 2022
• EESC opinion, 27 October 2022
• Council, progress report, 1 December 2022

Author: Laurence Amand-Eeckhout, Members' Research Service, legislative-train@europarl.europa.eu

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