Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – 2nd Report on Voluntary and Unpaid Donation of Tissues and Cells

Donated tissues and cells, such as skin, bones, tendons, corneas and haematopoietic stem cells, are increasingly used in medical therapies and as starting material for advanced therapy medicinal products (ATMP). In addition, reproductive cells are used in the field of medically assisted reproductive technology (ART), e.g. in vitro fertilization (IVF) and other so-called ART techniques to achieve pregnancy by artificial or partially artificial means.

The principles governing tissue and cell donation are set out in article 12 of Directive 2004/23/EC. It states that Member States shall endeavour to ensure voluntary and unpaid donations of tissues and cells. Donors may receive compensation, which is strictly limited to making good the expenses and inconveniences related to the donation. In that case, Member States define the conditions under which compensation may be granted.

This report aims to provide an overview of the practice of voluntary and unpaid donation of tissues and cells, focusing on (1) legislative provisions, guidelines and policies, (2) compensation and incentives, (3) promotion and advertising, and (4) procurement and supply.

EUR-Lex: COM(2011)352: Follow the progress of this document through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2011:352:FIN

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