- 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 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 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 is one of the key activities supporting the Impact Assessment for the revision of the BTC legislation. The aim is 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. 214 stakeholders responded to the general consultation on the Have your Say Portal and a factual summary of the responses is published there. One hundred and sixty organisations, directly impacted by the legislation, responded to a more technical targeted survey on this page. The results of that targeted consultation will be summarised as part of the BTC Impact Assessment to be published later this year.
In addition to the online consulations, 14 stakeholder workshops were organised to gather focused/specific input through direct interaction. Three were organised by DG SANTE in the form of Hearings and minutes are published:
- Regulating for Suffiency – 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 were organised by ICF International in the context of a study they are conducting for DG SANTE to support the BTC Impact Assessment (see below). These were interactive workshops with stakeholders from across the affected fields. They focused on 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 International has provided these short summaries of those workshops.
A study supporting the IA has been contracted to ICF. A steering committee composed of 3 senior BTC experts, subcontracted by ICF, will lead the process.
A parallel study focuses on the future implementation. The SOHO-X feasibility study is 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 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.