According to the timeline presented by the Commission, the Impact Assessment and Legislative proposal on the revised blood, tissues and cells (BTC) legislation (Directive 2002/98/EC and Directive 2004/23/EC) are expected to be published in Q4 2021. In October 2019, the Commission published the results of the evaluation of the BTC legislation. The Commission concluded that although the legislation had effectively improved the safety and quality of these substances in the EU, several shortcomings and gaps had been identified. Following the Inception Impact Assessment on the revision of the BTC legislation published in Q4 2020, a series of public and targeted consultations were launched to consult stakeholders on key issues raised in the Commission’s evaluation.
On 23 July, the ICF – an external consultancy mandated by the Commission to collect additional feedback from selected stakeholders – concluded the final targeted stakeholder consultation. The inputs are now being considered by the Commission in the process of writing the upcoming Impact Assessment report and the Legislative Proposal. The adoption by the Commission will be followed by another 8-week consultation, which will provide the BTA Members and other stakeholders with another opportunity to provide feedback. The file will then follow the ordinary legislative procedure in the Parliament and the European Council.
Blood, tissues and cells Legislative Proposal officially expected by the end of this year
