Significant technological and scientific development over the last few years has shown that the EU’s framework on blood, tissues and cells (BTC legislation), adopted in 2002 and 2004, has not been a proper match to the rate of innovation in human tissue technologies.

The industry has been facing several hurdles as BTC legislation requirements are not adequate to the challenges brought by rapid technological and scientific development. Additionally, throughout the BTC legislation’s life span, the existence of different transposition rules enacted by Member States has recurringly been identified as a significant barrier, impacting on the development of much needed advanced therapies.

Following the evaluation of the BTC legislation, the European Commission has introduced an initiative to review and revise both Directive 2002/98/EC on the safety and quality of human blood and blood components and Directive 2004/23/EC on the safety and quality of human tissues and cells, with the aim of:

• updating the legislation in the direction of a more flexible alignment with scientific and technological developments;
• tackling the (re-)emergence of communicable diseases;
• focusing on the increasing commercialisation and globalisation of the sector;
• removing from legislation many technical provisions, which will allow a faster update of standards; and
• possibly merging the basic acts into a single instrument.

The revision is planned to be adopted in the last quarter of 2021, and is currently open for two consultations: an online public consultation, and an online targeted consultation aimed at organisations that are directly involved in, or impacted by, the BTC legislation.

Both public consultations will end on April 15, 2021.

The Commission’s evaluation on the BTC legislation can be accessed at https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/swd_2019_376_en.pdf, and a summary of the initiative can be accessed at https://ec.europa.eu/health/blood_tissues_organs/policy/revision_en.