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Focus on Regulation

Update – The European Commission opens a public consultation concerning EU legislation on Blood and, Tissues and Cells

The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and, tissues and cells. The online consultation has the form of a questionnaire, and it was initially open until the end of August 2017. Upon  the request of various stakeholders, the European Commission has recently decided to keep the online consultation open for two more weeks. The online consultation will, therefore, remain open until the 14th of September 2017.

EU Legislation

In the EU, two pieces of legislation govern blood and, tissues and cells respectively. In 2002, Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (“Blood Directive”) was adopted.

Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (“Tissue and Cells Directive”) was adopted in 2004.

Scope and Target Groups

Since their adoption, neither the Blood Directive nor the Tissue and Cells Directives have been evaluated. Consequently, and reflecting the European Commission’s better regulation package, the European Commission has opened the online consultation.

The online consultation is intended to gather the views of stakeholders to help determine whether the legislation has achieved its intended purpose. The European Commission also intends to evaluate through this initiative the suitability of the EU legislation on Blood and Tissues and Cells. The results of the evaluation will be used as a ground to consider whether changes in the current EU legislative framework are necessary.

Manufacturers of medicinal products using blood, tissues and cells as starting materials, patients or national competent authorities are invited to provide their views and to evaluate the Blood and Tissue and Cells Directives.

Submissions may be provided through the online open questionnaires available at the European Commission’s website.

When the online consultation is closed, the results of the evaluation will be published. The European Commission will host a related stakeholder event on September 20th, 2017 in Brussels. In the event the relevant findings of the consultation will be discussed with the interested parties. The pre-registration form for the event is now available online here.