The publication of the Impact Assessment and Legislative Proposal on the revised blood, tissues and cells (BTC) legislation (Directive 2002/98/EC and Directive 2004/23/EC), originally foreseen for Q4 2021, is now confirmed to be published in Q1 2022. The European Commission confirmed the new timeline in its presentation during the Employment, Social Policy, Health and Consumer Affairs Council meeting and on the website.
The revision process began in October 2019 when the Commission published the results of the evaluation of the BTC legislation which identified several shortcomings and gaps stemming from the two directives. To collect inputs from key stakeholders, the Commission carried out a number of public and targeted consultations which were then considered in the process of drafting the Impact Assessment report as well as the Legislative Proposal.
Once the proposal for the BTC legislation is adopted by the Commission, stakeholders will be given 8 weeks to provide feedback. The file will then follow the ordinary legislative procedure in the European Parliament and the Council of the EU. Assuming that the ordinary legislative procedure takes approximately 18 months on average, the revised BTC legislation is unlikely to be adopted earlier than in the second half of 2023.