|Author (Corporate)||European Commission: DG Health and Food Safety|
|Series Details||COM (2022) 338|
|Content Type||News, Policy-making|
Legislative initiative tabled by the European Commission on 14 July 2022, concerning standards of quality and safety for substances of human origin intended for human application.
Directive 2002/98/EC - also known as Blood Directive - and Directive 2004/83/EC - also known as Tissues & Cells Directive - set out quality and safety requirements as regards blood transfusion, transplantation and medically assisted reproduction. This legislative framework helped ensures the safety of millions of patients in activities spanning from donation to human application.
However, an evaluation carried out on the legislation showed that it no longer addressed the scientific and technical state of the art and required updating. The COVID-19 (coronavirus) pandemic further highlighted some of those shortcomings. The European Commission thus tabled this draft law on 14 July 2022 aimed at revising the legislative framework. Its overall objective is to ensure a high level of health protection for citizens donating or receiving vital substances of human origin (SoHO). The proposal repeals the existing legislation and is seen as the concluding building block in the revision of the framework for blood, tissues and cells.
|Subject Tags||Public Health|
|International Organisations||European Union [EU]|