Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-04-09-Speech-3-364"
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"en.20030409.7.3-364"2
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".
Mr President, Commissioner, this proposal for a directive seeks to introduce safety and quality standards to regulate therapeutic activities based on the use of human-derived tissues and cells, which are carried out in Europe every year and now concern hundreds of thousands of patients. The sector is also certain to expand, not only in the traditional field of transplants – for example, corneal and skin grafts and heart valves – but also, as a result of advances in biotechnology, in those of reconstructive surgery, reproductive medicine and the treatment of disorders such as cancer, diabetes and Parkinson’s disease. It is therefore undoubtedly of interest to research centres and European firms and must be allowed to develop.
Nevertheless, respect for ethical imperatives is vital in the use of tissues and cells of human origin. The proposal for a directive in question therefore lays down high safety and quality standards relating to substances of human origin, in order to protect health. However, these ethical imperatives need to be still better defined. The first issue concerns the need to ensure complete safety from the point of view of health, in order to prevent or reduce the risk of disease transmission in the case of human tissues and cells from third countries too. Secondly, respect for the human body must be assured with regard to removal from both living and deceased donors. In this connection, the requirement for informed consent on the part of the donor, supplied in a specific form either by the donor or by next of kin is particularly important, as is the prohibition of the removal of cells or tissues from foetuses originating from the voluntary interruption of pregnancy or from cloned human cells. The third issue concerns respect for privacy and protection of the confidentiality of the information collected when tissues are removed. Donation must be anonymous as regards both the donor and the recipient (except for the requirements regarding traceability). Personal and family data may not be disclosed to third parties (for example, employers or insurance companies); this is also to avoid the risk of unjustified discrimination. The fourth principle concerns the fact that donation is unpaid. This represents a voluntary act of human solidarity which may, however, be appropriately encouraged by specific measures and by proper information on the part of the Member States. This requirement must be retained, not least with regard to imports from third countries.
On the basis of these considerations, I believe that, over all, the directive can be said to represent a step forwards in the harmonisation of Member States’ legislation, allowing Member States to provide greater protection for the health of the European citizens."@en1
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