Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-03-08-Speech-2-361"
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"en.20050308.29.2-361"2
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".
Mr President, human tissues and cells have become an important part of healthcare. Their therapeutic use continues to increase, not only in terms of the frequency of use of tissues and cells, but also in the range of ways in which they can be used.
The Commission is conscious of the importance of encouraging the voluntary and unpaid donation of tissues and cells of high quality and safety. That, in my opinion, is the best way to avoid illicit trade. In this respect, the Commission also considers it very important to encourage Member States to incorporate the principle of voluntary and unpaid donation into their national legislation. Tissue and cell donation programmes should be founded on that basis.
Tissues and cells are often acquired through cross-border exchanges. Over the past decade, the interchange of these human substances, both within Europe and between Europe and third countries, has increased. The fact that the exchange of tissues and cells can result in the transmission of disease has focused attention on the need for increased safety measures. The European institutions responded to this concern by adopting a directive in March 2004 establishing quality and safety requirements for human tissues and cells. The directive ensures that an increasing number of patients in Europe treated with human tissues and cells can trust that these substances are safe and of good quality. That constitutes yet another step forward in fulfilling the mandate in Article 152 of the Treaty, which is to set high standards of quality and safety for substances of human origin.
The directive has to be transposed by 7 April 2006 in all Member States. On that date, it must, therefore, be applied in all Member States, including the United Kingdom, and will also be part of the Community
to be implemented by Romania under the enlargement process.
I would like to underline a key point. Article 152, upon which the directive is based, aims to regulate public health issues. As was made clear during the debate in Parliament leading up to the adoption of the directive, although fundamental ethical principles can be raised and endorsed, it is not possible to have binding Community regulations.
On the question of voluntary unpaid donations of tissues and cells, this was debated at length during the codecision procedure on the tissues and cells directive. I know it was an important issue for the European Parliament and I believe that a good compromise solution was reached. Article 12 of the directive states that Member States shall endeavour to ensure voluntary and unpaid donations of tissues and cells. Donors may receive compensation but this is strictly limited to making good expenses and inconveniences related to the donation. In that case, Member States define the conditions under which compensation should be granted. Both the Council and Parliament accepted this solution. It goes to the limit of what the Commission believes to be legally acceptable, given the provisions of Article 152 of the Treaty.
This does not mean, however, that the directive is unclear on the conditions of exchange of tissues and cells. On the contrary, Article 12 conveys a very clear message as to the voluntary and unpaid character that such exchanges should have. This, of course, refers back to values that go beyond safety issues.
Accordingly, the Commission considers that paying substantial fees to obtain human egg cells would go against the philosophy of the tissues and cells directive. It could open the door to a trade where people in need could be drawn into acts that should instead be motivated by altruistic principles. Both the Charter of Fundamental Rights of the European Union and the Convention on Human Rights and Biomedicine of the Council of Europe prohibit turning the human body and its parts into a source of financial gain.
The Commission will monitor carefully the implementation of the tissues and cells directive in the current and future Member States. We will do so with regard to its banning provisions and also with regard to the overall spirit of the directive, such as the principle of voluntary unpaid donation, clearly expressed in Article 12.
To ensure proper interpretation in the candidate countries, the Commission organised a peer review in Romania and Bulgaria in 2004. This review analysed the situation in the two countries and identified future actions to be taken to ensure compliance with EU requirements in this field. This process led to a number of recommendations. The competent authorities of the two countries are willing to incorporate the principles of the directive into national legislation. This will be followed up this year."@en1
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