The European Commission published an evaluation of the EU’s blood, tissues and cells legislation in October 2019. In its report, the Commission states that although the legislation helped increase the level of safety and quality of blood, tissues and cells in the EU, it is not adapted to the most recent technological, epidemiological and societal changes. The European Commission thus began developing an Inception Impact Assessment (IIA) for the revision of the EU Blood, Tissues and Cells legislation. Unfortunately, due to COVID-19, the launch of this IIA has been delayed.
An IIA is the Commission's initial analysis of a specific problem, and typically includes the definition of the context and problem, objectives and policy options, a preliminary assessment of expected impacts, such as economic, social, and administrative burden, and a description of the methodology and consultation strategy. This IIA could, therefore, ultimately lead to a revision of the legislation in question. An IIA is usually followed by an Impact Assessment, which leads to the development of the final legislative proposal. Typically, an IIA is open for feedback from stakeholders for a period of 4 weeks, in open-ended question format, usually allowing for a maximum of 4000 characters. However, the BTA has been informed that due to the current context, the feedback period might be extended to 10 weeks. The feedback provided by stakeholders on the IIA will directly feed into the Impact Assessment and consequently into the final legislative proposal which is expected to be published in Q3/Q4 2021. As such, the publication of the IIA will provide the first opportunity for stakeholders to position some of their messages regarding the content and scope of the future legislation.
You can find the evaluation of the EU's Blood, Tissues and Cells legislation of OCtober 2019 here on the European Commission's website.
Delay in the Inception Impact Assessment on the EU’s blood, tissues and cells legislation
