FP6 for research sent to EP, with statements from Council, Commission and member states

January 31, 2002

Brussels, 30 January 2002

Proposal for a Decision of the European Parliament and of the Council concerning the Sixth Framework Programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation (2002-2006) - Adoption of the common position. "I/A" item note from General Secretariat to COREPER/Council. Brussels, 17 January 2002 (document 5226/02 LIMITE 2001/0053 (COD) RECH 6 CODEC 32). Text of note

1. The above proposal was submitted to the Council on 5 March 2001. The European Parliament delivered its Opinion in first reading on 14 November 2001. The Economic and Social Committee delivered its Opinion on 11 July 2001.

2. The Commission subsequently submitted a modified proposal to the Council on 23 November 2001.

3. At its session on the 10 December 2001, the Council reached a political agreement on the Common Position with a view to proceeding to its formal adoption after finalisation of the text by the legal/linguistic experts. This text is contained in Doc. 15483/01 RECH 191 CODEC 1389.

4. To respect the timetable for adoption by June 2002 endorsed by the Heads of State and government at the Stockholm European Council, the common position is due to be transmitted to the European Parliament for its session of 4 February 2002 for second reading in accordance with Article 251 of the Treaty.

5. It is suggested, therefore, that the Committee recommends the Council to:

- adopt the Common Position contained in doc. 15483/01 RECH 191 CODEC 1389, as well as the statement of the Council's reasons (Doc. 15483/01 ADD 1 RECH 191 CODEC 1389);

- enter the statements set out in Addendum 1 to this note in the Council minutes;

- forward the Common Position, the statement of the Council's reasons and the statements to the Council Minutes made by the Institutions to the European Parliament for its session beginning 4 February 2002.

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Addendum to the "I/A" item note from General Secretariat to COREPER/Council. Brussels, 17 January 2002 (document 5226/02 ADD 1 LIMITE 2001/0053 (COD) RECH 6 CODEC 32). Text of addendum

1. Ad 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).

2. Ad Article 5: the implementation of the Framework Programme

The Council, while noting the Commission's proposals for specific programmes which provide for a single specific programme covering, amongst others, the thematic priorities under Heading I "Focussing and Integrating Community Research", states that the provisions of Article 5 are without prejudice to the decision which it will take regarding the number and scope of specific programmes when examining these proposals. Moreover, in this context, the Council and the Commission agree that the management approach to be adopted should ensure clarity, transparency and efficiency of the management, execution and control of the research activities undertaken in the specific programmes.

3. Ad Annex I, Chapter 1.2.1: procedural aspects relating to research activities supporting Community policies or anticipating scientific and technological needs:

The Council and the Commission state that the choice of research topics, areas and subjects will be made by the Commission, in compliance with the committee procedures decided by the Council under the relevant specific programme, on the basis of an assessment by an internal group of users, taking due account of the opinion of Member States and of an independent consultative body made up of high-level scientific and industrial experts.

Moreover, the Council and the Commission state that for the implementation of research activities responding to new and emerging scientific and technological problems and opportunities, recourse may be had to a two-step mechanism: calls for expressions of interest open to any entity or organisation in the Community to identify needs precisely, followed by open calls for proposals on the themes selected on this basis. The proposals received will be evaluated by independent experts. In accordance with their spirit and objective, the activities carried out under this heading will be implemented promptly taking into account the nature and urgency of the topics concerned, wherever feasible, on the basis of annual decisions.

4. Ad Annex I, Chapter 1.3: Joint Research Centre (JRC) activities

The Council and the Commission, having agreed on the overall JRC budget (EUR 1050 million), recognise that some existing JRC large facilities used for reference measurement and fundamental research, which were initially foreseen in the Commission proposal for the Euratom Framework Programme, cover, in fact, objectives that go beyond the nuclear field and should better be funded under the EC Framework Programme in the development of the research training facilities of the ERA.

5. Ad Annex I, Chapter 2.2: Human resources and mobility (4th indent under "actions envisaged")

The Commission considers that support for the creation and development of European Research teams should in particular favour the start up phase of new research teams involving younger researchers.

6. Ad Annex I, Chapter 2.3: Research infrastructures

The Commission states that, in relation to the funding for new infrastructures in duly justified cases, due attention will be given to the opinion of the high level group on infrastructures.

Moreover, the relevant management committee under the specific programme will be required to discuss the Community funding of all proposals for new infrastructures irrespective of their financial importance.

7. Ad Annex III: Instruments

The Commission states that, in accordance with the procedures for the implementation of each specific programme,

- it will identify for the opinion of the relevant programme committee the instruments to be used on a priority basis. The Commission will also regularly report on their application to the relevant programme committee;

- it will take into account and make available to the programme committee the evaluation referred to in Annex III (instruments); any resulting adjustments to the use of the instruments will similarly be submitted for opinion to the relevant programme committee.

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