Community Research and Development Information Service - CORDIS

Fifth Framework Programme will restrict funding for research involving cloning humans

Research which involves cloning human beings or which results in a change in an individual's genetic inheritance will not be supported under the Fifth Framework Programme.

The decision is contained in the text of the specific programme in Quality of Life and Management of Li...
Research which involves cloning human beings or which results in a change in an individual's genetic inheritance will not be supported under the Fifth Framework Programme.

The decision is contained in the text of the specific programme in Quality of Life and Management of Living Resources agreed at the meeting of the Council of Ministers on 22 December. This text will be enacted into law after it has been translated into all the EU's official languages, probably later in January.

According to the text, "No research activity which modifies or is intended to modify the genetic heritage of human beings by alteration of germ cells or by acting at any other stage in embryonic development and which can make such alteration hereditary will be supported under the present framework programme."

"In the same way, no research activity understood in the sense of the term "cloning", with the aim of replacing a germ or embryo cell nucleus with that of the cell of any individual, a cell from an embryo or a cell coming from a later stage of development to the human embryo, will be supported."

This is likely to mean in practice that researchers working on cloning tissues taken from embryos will be eligible for support in certain circumstances. For example, projects aimed towards finding a cure for infertility or trying to diagnose serious genetic or chromosomal defects may be eligible to receive funding.

Any research funded under the Fifth Framework Programme will require approval from relevant ethics committees and will have to comply with international declarations and codes of conduct and national legislation.

Policy on experiments on animal embryos was also agreed at the Council meeting in December, and future legislation will allow funding of research into cloning whole organisms, so long as ethical conditions are met. The proposal agreed was as follows:

"Modification of the genetic heritage of animals and animal cloning will be envisaged within this programme only for objectives which are justified on ethical grounds and when carried out under conditions respecting animal welfare and genetic diversity".

The full passage of the relevant text is as follows:

"Research activities under this programme must comply with the international conventions and codes of conduct, and in particular the Helsinki declaration of the World Medical Association adopted by the World Medical Assembly.

Account will also be taken of the declaration of the European Council of Amsterdam and the European Parliament's resolution on the banning of human cloning (OJ C 115 of 14 April 1997), the European Convention on Human Rights and Biomedicine of the Council of Europe; the opinions of the Group of Advisors on the Ethical Implications of Biotechnology (1991-1996) and the opinions of the European group on ethics in science and new technologies (as from 1998); the Universal Declaration on the Human Genome and Human Rights of UNESCO of 11 November 1997 and the resolutions of the WHO, as well as relevant EC legislation for example, Council Directives of 26 January 1965 and 20 May 1975 on the approximation of the laws, regulations and administrative provisions relating to proprietary medicinal products (65/65/EEC and 75/319/EEC) - Council Directive of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the protection of animals used for experimental and other scientific purposes (86/609/EEC).

No research activity which modifies or is intended to modify the genetic heritage of human beings by alteration of germ cells or by acting at any other stage in embryonic development and which can make such alteration hereditary will be supported under the present framework programme. In the same way, no research activity understood in the sense of the term "cloning", with the aim of replacing a germ or embryo cell nucleus with that of the cell of any individual, a cell from an embryo or a cell coming from a later stage of development to the human embryo, will be supported.

Concerning animal experimentation, the principle of replacement by alternative methods, reduction of the number of animals and refinement of experiments must be applied to the extent possible. Animal suffering must be avoided or kept to a minimum and special attention must be paid to animal experimentation involving species that are the closest to human beings. Modification of the genetic heritage of animals and animal cloning will be envisaged within this programme only for objectives which are justified on ethical grounds and when carried out under conditions respecting animal welfare and genetic diversity.

Participants in EC research projects must conform to national legislation and applicable codes of conduct and seek the approval of the relevant ethics committee prior to the start of the RTD activities."
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