Ethical issues in research: statements for minutes of Research Council, 10 December 2001

March 18, 2002

Brussels, 15 March 2002

2398th meeting of the Council (RESEARCH), held in Brussels on 10 December 2001. Draft minutes. Brussels, 4 February 2002 (22.02) (document 15133/01 LIMITE PV/CONS 80 RECH 181). Full text

Re Item 3: Statements regarding the 6th Framework Programmes (EC and EURATOM) 2002-2006

A. EC Framework Programme

1. Re Article 3: Ethical issues

(a) Statement by the Council

"The Council agrees that the requirement of Article 3 for all research activities to be carried out in compliance with fundamental ethical principles will be elaborated to give more detailed guidelines in respect of Community research, in particular regarding the protection of human dignity and human life in genomics and biotechnology research."

(b) Statement by the Commission

"In line with the opinion of the European Parliament on the Sixth Framework Programme proposal and with the advice of the European Group on Ethics in Science and New Technologies, the Commission considers that:

- the following fields of research should not be financed under the Framework Programme:

= research activity aiming at human cloning for reproductive purposes;

= research activity intended to modify the genetic heritage of human beings which could make such changes heritable;

= research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer;

- animal experiments should be replaced with alternatives wherever possible, and suffering by animals should be avoided or kept to a minimum."

(c) Statement by the German, Italian and Austrian delegations:

"In line with the European Parliament's Opinion on the 6th EC Framework Research Programme and the recommendations of the European Group on Ethics in Science and New Technologies under the auspices of the European Commission, Germany, Italy and Austria hereby state that the following fields of research should not be financed from the 6th EC Framework Research Programme:
- research work on reproductive cloning;
- research work on germ line therapy;
- creation of embryos for the purpose of research or for the purpose of stem cell procurement, including cell nuclear transfer ("therapeutic cloning").

The Common Position on the 6th EC Framework Research Programme does not otherwise rule out research on surplus embryos in accordance with national rules.

The EU Member States each hold differing views on this matter.

Although the proposed rules provide that such work may be done only in those Member States in which it is allowed, until an agreement on the European level has been established, research work on surplus embryos should not be financed under the 6th EC Framework Programme.

Austria endorses the above and would like the list of research which may not be financed from the 6th EC Framework Research Programme to include: "research work on existing stem cell lines"."

(d) Statement by the Irish delegation:

Ireland wishes to state that its constitutional provisions must be fully respected in any research carried out in Ireland under the Programme.

The Constitution states at Article 40.3.3:

"The State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect and, as far as practicable, to defend and vindicate that right."

Any research carried out in Ireland would have to comply with this provision. It would also have to recognise that the interpretation of this provision would not be open to the researchers..No research on human embryos is undertaken in Ireland. While this area is not regulated by law, the Medical Council's Guide to Ethical Conduct and Behaviour states that the creation of new forms of life for experimental purposes or the deliberate and intentional destruction of human life already formed is professional misconduct. The Guide also states that the creation of embryos for experimental purposes would be professional misconduct."

(e) Statement by the Spanish delegation:

"While endorsing the Council's position, Spain nevertheless points out that Spanish legislation:

- prohibits the creation of human embryos for research purposes (Article 18(2) of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, done at Oviedo on 4 April 1997 and ratified by Spain on 23 July 1999);

- allows authorisation, subject to certain conditions, of research or experimentation on non-viable pre-embryos if it is scientifically established that such research or experimentation cannot be carried out on the animal type, if it is carried out on the basis of a project duly submitted and authorised by the competent health and scientific authorities and if it takes place within the authorised periods (Articles 15, 16 and 17 of Law No 35/1998 of 22 November 1998). When it is intended for purposes of research or experimentation and has been authorised by the public health and scientific authorities, only the obtaining and use of biological structures from dead embryos or foetuses shall be authorised (Articles 1, 6 and 8(2) of Law No 42/1988 of 28 December 1988)."

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