Strasbourg, 8 March 2005
President, Honourable Members,
Human tissues and cells have become an important part of health care. 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.
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, in March of last year, a Directive establishing quality and safety requirements for human tissues and cells.
The Directive ensures that the increasing number of patients in Europe treated with human tissues and cells can trust that these substances are safe, and are also of good quality.
This constitutes yet another step forward in fulfilling the mandate in Article 152 of the Treaty to set high standards of quality and safety of 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 of course the UK, and will also be part of the Community acquis to be implemented by Romania under the enlargement process.
Here, 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 debates in Parliament leading up to adoption of the Directive, fundamental ethical principles can be raised and endorsed, but it is not possible to have binding Community regulations.
Turning to the question of voluntary, unpaid donations of tissues and cells, this was debated at length during the co-decision procedure on the Tissues and Cells Directive. I know this was an important issue for the European Parliament.
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 the expenses and inconveniences related to the donation. In that case, Member States define the conditions under which compensation should be granted.”
This solution was accepted by both the Council and the Parliament. 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. And 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 be against the philosophy of the Tissues and Cells Directive. This could open the door to a trade where people in need could be drawn into acts that should instead be motivated by altruistic principles.
This is fully in line with both the Charter of Fundamental Rights of the European Union and the Convention on Human Rights and Biomedicine of the Council of Europe. Both 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 binding 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 applicant 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.
It 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.
The Commission is very conscious of the importance of encouraging the donation of tissues and cells of high quality and safety. This, 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 in their national legislation the principle of voluntary and unpaid donation. Tissue and cell donation programmes should be founded on this basis.
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