On 23 July, the BTA submitted a response to the targeted stakeholder consultation on the revision of the EU legislation on blood, tissues and cells (BTC). The consultation, carried out by an external consultancy on behalf of the European Commission, concluded a series of public and targeted stakeholder consultations contributing to the Impact Assessment of the BTC legislation.
The consultation was open for 4 weeks from 28 June to 24 July and took the form of an online questionnaire. The stakeholders were asked to examine 3 policy scenarios against the shortfalls of the current BTC legislation identified in the Commission’s evaluation of the Union’s legislation on blood, tissues and cells. In their response, the BTA Members provided opinion on how the revised BTC legislation could address the challenges related to the protection from avoidable risks, facilitating innovation, unequal oversight and vulnerability to interruptions in BTC supplies.
Earlier this year, the BTA participated to the public consultation issued by the Commission between January and April 2021. In its response, the BTA noted that the future EU blood legislation needs to be flexible enough to allow for new technical developments and blood components to be introduced in a timely manner with a formalised fast-track route for use in times of need. Furthermore, according to the BTA Members, terms including "quality", "safety" and "sufficiency" should be outlined.
The public and targeted stakeholder consultations were part of the Impact Assessment for the revision of the BTC legislation. The Impact Assessment report and the legislative proposal are expected to be presented by the Commission by the end of 2021.