The European Commission opens online public consultations on the Review of the Blood, Tissues and Cells Directives – Lexology

On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive. Both Directives are more than fifteen years old, and their implementation diverges widely across the member states. The rules on human blood and tissue gain increasing importance for companies active in advanced therapies, and are arguably no longer fully fit for purpose. Both public consultations will end on April 15, 2021.

These consultations represent a good opportunity for the industry to explain its experience and the issues it faces with existing legislation. This blog outlines the options for revision of the rules being considered by the European Commission. Providing input to the Commission will ensure that the future legislation will be appropriate and adapted to the need of companies involved in the sector.

Objective of the consultations

The Commission seeks to update the blood, tissues and cells (BTC) legislation to resolve gaps identified in the 222-page Evaluation Report of October 2019 (the report is available here). The main issues were the following:

Policy Options Considered by the European Commission

The European Commission is considering various policy options to remedy gaps of the existing legislation.

The Commission is contemplating the following policy options:

Finally, the Commission is not ruling out an option based on a combination of these three alternatives.

Public Consultations

The European Commission opened:

Companies interested in submitting their comments, share their experience with the existing legislation and provide input may do so by clicking here (for the general consultation) and/or by clicking here (for the targeted consultation).

Both public consultations will end on April 15, 2021.

Read more here:
The European Commission opens online public consultations on the Review of the Blood, Tissues and Cells Directives - Lexology

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