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Patients generally welcome forthcoming new legislation on human tissues and cells

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Published 21 February 2003, updated 29 January 2010
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human tissue

The Parliament hosted a public hearing on 20 February to consider patients' views on the proposed Directive on quality and safety standards for human tissues and cells.

Three patient group were represented at the hearing: the European Organisation for Rare Disorders (EURORDIS), the Belgian Patients' Association for Metabolic Diseases (BOKS), as well as Life with Mukoviszidose e.V. Bonn.

The main issues raised by the speakers were the following:

  • A European approach to human tissues and cells is very welcome and really needed;
  • EU-wide regulation must match international rules;
  • The scope of the new legislation should be broadened to "in vitro" (outside the living body) and animal research;
  • European legislation should not stop with human tissues and cells, regulation is also needed in the area of organ transplantation;
  • Ethical considerations: one of the speakers criticised the new legislation for harmonising the technical aspects of human cell and tissue but not the ethical problems associated with it (such as the differing definition of a "donor" and an "individual" in each Member State, which is an important issue when the source is an embryo or a fetus);
  • Informed consent: should always be given in writing; minimum requirements for both content and form must be clearly regulated;
  • Remuneration of donation: the current proposal states that Member States shouldencourageprocurement of cells and tissues being carried out on a non-profit basis, which is not a strong enough language to avoid "donor tourism";
  • Genetic information: for the case of germ cell donation, provisions should regulate how the result of cell or tissue testing is disclosed to the donor;
  • Imports: tissue and cell imports from third countries should also comply with the minimum ethical standards established by the directive;
  • Tissue banks: considering that progress is normally driven by economic incentives, commercial tissue banks should be allowed as long as they meet the requirements set by pertinent regulations.

 

Positions: 
Dr. Andreas Reimannspeaking on behalf ofEURORDISexplained that since the roughly 20 million patients with rare diseases are by definition scattered around Europe, an EU-wide approach towards tissue engineering has much potential benefit to them. Setting harmonised technical requirements should help facilitate speedier and equal access to new treatments.

Mr. Rik Serpentier, the representative ofBOKS, explained that metabolic diseases were rare diseases (having a prevalence of less than 5 in 10.000 individuals). Since metabolic diseases have a biochemical cause, a deficient enzyme, cure to such diseases will also have to emerge from the biotechnology industry, involving gene-therapy, enzyme-replacement therapy, and transplantation of tissues and cells. The speaker noted that since international borders do not constrain diseases from spreading, therapies must be made available not only throughout the EU but all over the world.

Mr. Stefan Kruip, president of the working group"Life with Mukoviszidose e.V. Bonn", shared his personal experience of fighting against cystic fibrosis, a genetic disease for which no cure is currently available. Mr. Kruip felt that the Commission's proposal stopped halfway by failing to cover human t issues and cells used for research. The speaker said that general reference to the Charter of Fundamental Rights of the European Union as well as to the Council of Europe's Convention on Human Rights and Biomedicine was not enough and that the directive should explicitly mention that it only establishes minimum standards.

 

Next steps: 
  • The Environment Committee is to vote on Mr. Liese's report on 25 March.
  • Plenary vote is scheduled for April 2003.
  • Political agreement is expected from the Council during its 2-3 June 2003 session.

 

Background: 
The public hearing on 20 February 2003 gave the opportunity to patients' organisations to share their views with RapporteurPeter Liese (EPP-ED, D)on the proposed directive on quality and safety of human tissues and cells. Representatives from the European institutions, industry associations, NGOs and the scientific community had already had a chance to express their opinions on the proposal on 29 January (see alsoEurActiv 31 January 2003).

 

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