- Directive 2002/98/EC on safety and quality of human blood and blood components
- Directive 2004/23/EC on safety and quality of human tissues and cells
and their implementing acts.
This revision came 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 to be addressed to ensure the framework was up-to-date, fit for purpose and future-proof.
The initiative aimed 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 was planned to be adopted in the second quarter of 2022. 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 was 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. Eighty-two submissions were received, and are now published at the same link. These were also taken into account during the impact assessment.
Stakeholder consultation was one of the key activities supporting the impact assessment for the revision of the blood, tissues and cells (BTC) legislation. The aim was to collect views and opinions on the proposed policy options.
Two online consultations were opened on 21 January 2021 and closed on 15 April 2021. The general consultation received responses from 214 stakeholders and a factual summary is published on the Have your Say Portal. Moreover, 160 organisations directly impacted by the legislation responded to a more technical targeted survey on this page. The responses to both surveys were taken into account in the impact assessment, and further details are available in Annex 18 of the final report.
In addition to the online consultations, 14 stakeholder workshops were organised to gather focused/specific input through direct interaction. Three were organised by the Health and Food Safety department in the form of hearings and minutes were published:
- Regulating for Sufficiency – blood and plasma – 4 May 2021
- Regulating for Sufficiency – tissues and cells – 5 May 2021
- Setting Technical Rules for BTC – 6 May 2021
The remaining 11 workshops were organised by ICF S.A. in the context of a study they conducted to support the BTC impact assessment (see below). These were interactive workshops with stakeholders from across the affected fields.
The workshops were dedicated to the following topics: Authorising Novel BTC, Regulating Point-of-Care BTC Processing, Strengthening Protection of Donors and Children Born from Medically Assisted Reproduction, Strengthening Oversight, Key Definitions, Refining the Scope, Ethical Principles and Borderlines with Other Regulated Frameworks. ICF S.A. has provided these short summaries of those workshops.
A study supporting the impact assessment has been contracted to ICF S.A.. A steering committee composed of 3 senior BTC experts, subcontracted by ICF S.A., led the process. The study, together with an executive summary was published together with the Commission proposal for a Regulation on standards of quality and safety for substances of human origin.
A parallel study focused on the future implementation. The SOHO-X feasibility study was run by Deloitte to design an EU-wide data system in the SOHO sector, to support the use of best available evidence and data for the professionals, health providers, innovators, public authorities and other stakeholders.
Drafting and adoption of legislative proposal
The Commission has drafted a legislative proposal, based on the results of the impact assessment. The Commission adopted its proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directive 2002/98/EC and Directive 2004/23/EC in July 2022. This closes the drafting process in the Commission and sets in motion the co-decision process between the European Parliament and the Council.
Further updates can be found on the Proposal for a Regulation on substances of human origin webpage.