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Revision of the EU legislation on blood, tissues and cells
In October 2020, the Commission adopted its Work Programme for 2021. The REFIT Annex (#37 p.15) to the Work Programme includes the revision of
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.
This revision comes after an evaluation of the legislation, published in October 2019, confirming that the legislation had improved safety and quality of blood, tissues and cells used for transfusion, transplantation or medically assisted reproduction. The evaluation also highlighted a number of gaps and short-comings which will be addressed to ensure the framework is up-to-date, fit for purpose and future-proof.
The initiative aims at
updating the legislation in the direction of a more flexible alignment with scientific and technological developments
tackling the (re-)emergence of communicable diseases, including lessons learnt from the COVID-19 pandemic
focusing on the increasing commercialisation and globalisation of the sector
removing from legislation many technical provisions, which will allow a faster update of standards
possibly merging the basic acts into a single instrument.
The revision is planned to be adopted in the last quarter of 2021. The legal basis is provided by Article 168(4)(a) of the Treaty on the Functioning of the European Union.
In line with the Commission's Better Regulation Guidelines, the legislative proposal will be preceded by an Impact Assessment, including the following steps:
Inception Impact Assessment
The Commission published a roadmap describing the scope of the initiative, defining the problems and outlining possible policy options to be considered in the Impact Assessment.
Stakeholders, authorities and citizens were invited to submit comment on the roadmap up to 14 December 2020. The feedback period is now closed and, at the same link, the 82 submissions received are published. The feedback received will be taken into account as the Impact Assessment proceeds.
Stakeholder consultation will be one of the key sources of evidence used to support the Impact Assessment. The aim will be to collect views and opinions on the proposed options. The following will be carried out
an online public consultation on a number of questions related to the defined policy options with publication of a Summary, together with the individual submissions (consent permitting)
meetings with key stakeholder organisations to gather focused/specific input through direct interaction. Summary minutes will be published on the DG Health and Food Safety website
External Study(ies)
One or more external studies will be commissioned to gather evidence to support the Impact Assessment and will be published.
Drafting of legislative proposal
The Commission will draft a legislative proposal, based on the results of the Impact Assessment. Once adopted by the Commission, the proposal will proceed through the Co-decision process in the Parliament and the European Council.
The process can be followed on this web-page, where all details will be published as they become available.
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