We expect that the European Union will open a process in 2021 to revise the Directives for Tissues and Cells. These directives set the regulatory framework for HSC collection and processing, donor care and product coding. EBMT will follow the process closely and provide input on behalf of our members.
EU legislation provides high safety and quality standards for blood, tissues and cells used for medical treatments and therapies. The EU Directives on tissues and cells establish the legal framework for cell collection and processing so have a direct impact on EBMT members' practices and obligations.
The European Commission is preparing to update the EU rules on scientific and technological developments in this field, including innovative therapies. This process will also address the (re)emergence of communicable diseases, including lessons learnt from the COVID-19 pandemic, and the increasing commercialisation and globalisation of this sector, so contributing to the European Health Union.
On 17 November, the Commission opened an inception impact assessment for public feedback. The deadline is 14 December. EBMT will prepare a response to this consultation but all professionals may also consider submitting a response.
According to the timeline published on the Commission website, the Commission expects to adopt a proposal for regulation in the last quarter of 2021.
Read related news “EU’s evaluation of the current Tissues and Cells Directives and how the EBMT community can have an impact on future EU regulation” (17 December 2019).