Inception Impact Assessment (IIA) on the EU’s blood, tissues and cells legislation

The BTA welcomes the European Commission’s Inception Impact Assessment (IIA) on the revision of the blood, tissues and cells (BTC) legislation published on 17 November.

The initiative aims to review EU legislation on the safety and quality standards of BTC for medical treatments and therapies, their continuous access, and the establishment of frameworks to facilitate innovation in BTC therapies. The IIA aims to evaluate three policy options:

  1.  Improved quality and safety requirements as defined by BTC establishments.
  2.  EU requirements on safety and quality outlined by European Expert Bodies.
  3.  EU requirements on safety and quality enshrined in the BTC legislation.

An IIA is the Commission's initial analysis of a specific problem, and is usually followed by an Impact Assessment, which leads to the development of the final legislative proposal. The feedback provided by stakeholders on the IIA will directly feed into the Impact Assessment and consequently into the final legislative proposal. As such, the publication of the IIA will provide a first opportunity for stakeholders to position some of their messages regarding the content and scope of the future legislation. 

The IIA was open for feedback until 14 December, and the BTA shared a contribution with the European Commission.  Although the BTA members are committed to identifying viable alternatives for developing new materials, they are concerned that the envisaged timeframe for sunsetting the use of DEHP together with the revision of the EU BTC legislation would hamper the availability of blood bag sets across the EU.

The drafting of the Impact Assessment is expected to take place between Q1 and Q3 2021. In view of this, the Impact Assessment Report and legislative proposal are foreseen to be adopted by the Commission in Q4 2021. Nevertheless, it is important to consider that the publication of the inception impact assessment has been delayed since the end of 2019 on a regular basis. Considering that the Commission Work Programme is only foreseen to be adopted in July 2021, there is a risk that the currently foreseen legislative timeline may change in 2021 if the Commission priorities shift.

You can find the Inception Impact Assessment through this link, and the BTA's comment here

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