Brussels, 10 Apr 2003
Peter LIESE (EPP-ED, D)
Report on Medicine: standards of quality and safety of human tissues and cells
Doc.: A5-0103/2003 [may not be available yet]
Procedure: Codecision (1st reading)
The Parliament today adopted over 80 amendments to the Commission proposal to set quality and safety standards for the donation, procurement, testing, processing, storage and distribution of human tissues and cells. The amended proposal was approved by 321/89/57.
While generally welcoming the proposal, the Parliament adopted amendments concerning the scope of the directive, compensation for tissue and cell donation, donor consent, donor anonymity and ethical issues.
Ethical issues On ethics, MEPs insist that this directive expressly recognises the right of Member States to maintain or introduce more stringent protective measures that comply with the provisions of the Treaty (am 28). Member States shall at least prohibit research on human cloning for reproductive purposes and research designed to create human embryos solely for research purposes or to supply stem cells, including by means of the transfer of somatic cell nuclei. Cloned human embryos, and human/animal hybrid embryos produced by cloning, aggregation or any other procedure, and cells and tissues derived from them, shall be excluded as sources of material for transplant. Moreover, MEPs adopted an amendment (93=95) saying that the procurement of tissues after an abortion shall require special rules. No abortion shall be performed to obtain foetal tissue. It shall be ensured by appropriate measures that no pregnant woman is put under any kind of pressure to undergo an abortion in order to obtain tissue. The timing of an abortion and the way it is carried out shall not be influenced by the wish to obtain foetal tissue.
Donations to be voluntary and unpaidMEPs welcome the Commission's view that tissue and cell transplantation programmes should be based on voluntary and unpaid donation, anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient. Although MEPs do not want to keep the private sector out completely, an amendment was adopted demanding that Member States encourage strong public and non-profit sector involvement in the provision of tissue and cell transplant services and the related research. Another amendment calls for donations to be made with the donor's free will and without any payment except compensation, for example travel expenses. However, rules on compensation should be left to the Member States.
Traceability and anonymity MEPs also insist that EU-wide rules should be laid down to ensure the traceability of tissues and cells of human origin. Even though anonymity of donors was strongly supported, the Parliament adopted an amendment saying that in the case of gametes (sperm and eggs) in particular, Member States may waive anonymity in order to respect the right of children to know their genetic parents, but only in exceptional circumstances (am 94).
Donor consent Another key issue is the procurement of human tissues or cells, which the Commission says should be carried out only after all mandatory consent requirements in force in a Member State are met. The Parliament wants to go considerably further by demanding that the EU Member States take account of at least the following requirements:
Before any procurement of tissues or cells, living donors must have given their prior, informed and express consent in writing or, in exceptional cases, orally in the presence of witnesses. Until the moment the donated or cells are actually used, donors shall have the right to withdraw their consent without having to face any negative consequences. The donor must be informed about this right and must have had the opportunity, in a prior interview with a doctor, to understand the objectives, risks and inconveniences of retrieval, and the conditions under which it is to be conducted (am 82).
In the case of procurement of tissues and cells from deceased persons, donors must not have expressly refused their consent during their lifetime. In the absence of any declaration by donors during their lifetime, tissues or cells may only be procured if the relatives of the deceased has given prior and express consent.
Cells and tissues may not be retrieved for the purpose of allogeneic donation from individuals who are not in a position to give informed legal consent. Exceptionally regenerative tissue and regenerative cells may be retrieved under strict conditions, e.g. if the recipient is a brother or sister of a donor, the donation is potentially lifesaving for the recipient and the potential donor does not refuse.
Clarification of scope of the directive The Commission proposal excludes blood and blood products, human organs as well as organs tissues or cells of animal origin from the scope of the directive. The Parliament clarifies the directive's scope even further by including the research use of tissues, haematopoietic peripheral blood, placenta and bone marrow stem cells, reproductive cells (eggs, sperm), foetal tissues and cells, adult and embryonic stem cells. On the other hand, the Parliament excluded hair, nails and body waste products form the directive.
Although MEPs rejected amendments calling for organs to be covered by the directive, they urged the Commission to bring forward before July 2003 a separate legislative proposal on human organ transplants, saying that the Commission should take into account the severe shortages that result in many patients going untreated. The Parliament also adopted an amendment saying that reprogrammed differentiated cells, and genetically modified cells or tissues for human therapy are still in the research phase, but nevertheless pose different regulatory problems that will need to be addressed in due course (am 83).
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European Parliament Daily Notebook 0410
European Parliament Daily Notebook 0410