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Revision of the blood, tissues and cells legislation

In “Promoting our European Way of Life”

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In its 2021 work programme, the European 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.

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.

On 8 September 2022, European Parliament's ENVI Committee debated with the 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. 

On 13 June 2023 the EPSCO  Council assessed the state of play of the proposal, based on a progress report prepared by the Swedish presidency.

On 18 July 2023, ENVI Committee adopted its report, with 59 votes in favour, 4 against and 4 abstentions. ENVI committee MEPs want to reinforce measures to ensure improved protection for citizens who donate blood, tissues or cells, or are treated with these substances.

The European Parliament voted on its negotiating mandate during the September 2023 plenary session (483 votes in favour, to 82 votes against, with 59 abstentions). On 25 October 2023, the Council agreed its negotiating mandate. Negotiations began on 6 November 2023.

On 14 December 2023, the European Parliament and Council reached a provisional agreement on the proposal. They agreed that EU Member States can compensate donors, in line with the principle of voluntary and unpaid donation and based on transparent criteria. The conditions for this compensation would be established in national legislation, including by setting an upper limit for compensation that aims to guarantee that no financial gain or loss is incurred by the donor as a result of the donation ('financial neutrality'). Member States would have to ensure that promotion activities in support of donations do not include references to compensation. Concerning safeguarding supply, Member States would establish national emergency plans, setting out measures to be applied when the 'demand or the supply situation for critical SoHO present or are likely to present a serious risk to human health'. They also agreed on the establishment of the SoHO Coordination Board (SCB), an advisory body designed to coordinate the application of the regulation and support Member States in its implementation.

The agreement has to be formally approved by both institutions.

Coreper approved it on 30 January 2024.

ENVI Committee vote took place on 14 February 2024 (65 votes in favour, 3 against and 5 abstentions).

A plenary vote took place on 24 April 2024. The European Parliament approved the agreement with 461 votes in favour, 56 against and 66 abstentions. This vote was welcomed by the European Commission the same day.

The Council approved the agreement on 27 May 2024.

The signature took place on 13 June 2024.

The SoHO Regulation will come into force three years after its publication in the Official Journal of the European Union. The new rules will facilitate the cross-border exchange of SoHO in the EU, improve patients' access to necessary treatments in all Member States, and promote greater cooperation between national public health authorities.  

Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/ECA was published on 17 July 2024 in the Official Journal of the EU.

References:

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

As of 15/12/2024.