Brussels, 12 June 2002
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) - Approval of the amendments adopted by the European Parliament at second reading. Information note. Brussels, 7 June 2002 (document 2001/0053 (COD) 9668/02 RECH 101 CODEC 716; No. prev. doc.: 8992/02 RECH 85 CODEC 612 + ADD 1; No. Cion prop: 14565/01 RECH 162 ATO 102 CODEC 1263). Full text
Statements to the Council Minutes
It should be noted that, in addition to the statements to the Council minutes contained in doc. 8992/02 ADD 1 RECH 85 CODEC 612 relating to the 6th Framework Programme (EC), the amendments of the European Parliament to which were approved by the Council on 3 June 2002 as an "A" item, the following statements will also figure in the Council Minutes:
Ethical Issues
(a) Statement by Austria, Germany, Ireland, Italy and Portugal
Germany, Ireland, Italy, Austria and Portugal welcome the 6th Framework Programme as an important decision to enhance the scientific and technological basis of the Community and to further the development of its competitiveness in important areas. However they consider it extremely important that an acceptable solution be found for the inclusion of bioethical guidelines for European research under the 6th Framework Programme in areas of reproductive and therapeutic cloning, human germ line intervention and embryonic stem cell research.
The five Member States recall the declaration by the Council of 10th December 2001 stating 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".
In this context they agree to work together to elaborate and include, as part of the decision on the Specific Programmes, more detailed guidelines regarding bioethical principles.
In any event, any research activities arising from the Programme, will have to respect the legislation, regulations and ethical guidelines in countries where the research will be carried out.
(b) Statement by the UK and Sweden
The United Kingdom and Sweden reiterate that the ethical acceptability of various field of research is covered by the cultural and religious diversity of the Member States, and is rightly governed by national law in accordance with the principle of subsidiarity. Participants in research projects funded under the Sixth Framework Programme must conform to current legislation and regulations in the countries where the research is carried out.
In implementing the Sixth Framework Programme, the Commission must exclude financing for a project if the research fields are prohibited in all of the Member States. However, the view of the UK and Sweden is that financing should not be excluded for a project in a research field that is allowed in one or several Member States.
Some fields of research are very fast moving, opinion on the ethics of research in frontier technologies may develop and change as more becomes known, and regulations and practices in the Member States may change. The United Kingdom and Sweden therefore insist that the Commission must keep any exclusions under constant review, where appropriate taking advice from relevant ethics committees.
(c) Statement by Germany
The individual Member States have different opinions on the new possibilities for biomedical research, particularly in the field of research into embryos and stem cells. Germany refers in this connection to the statement for the Council minutes of 10 December 2001, according to which the fundamental ethical principles referred to in Article 3 need to be made more specific through more detailed guidelines. In addition, the Federal Republic refers to the statement for the minutes which it made together with Italy and Austria on 10 December 2001 regarding bans on the funding of certain research activities.
Germany shares the view of the Commission, which it has stated for the minutes, that no research work on cloning for reproductive purposes, germ line intervention and creation of embryos for research purposes or to procure stem cells, including cloning for therapeutic purposes, may be financed from the Framework Programme.
Furthermore, the German delegation takes the view that research work at European level on so-called "surplus" embryos and on embryo stem cells, where it involves use of stem cells other than those already existing, should not be financed from the Framework Programme.
The German delegation refers in this connection to the statement which it made with regard to the 1956th Coreper meeting on 22 March 2002. It therefore regrets the fact that no corresponding bans have been prescribed in the Framework Programme. Germany therefore expects corresponding arrangements to be made in the Specific Programmes.
(d) Statement by Ireland
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 Italy
Italy, in expressing complete satisfaction with the approval of the Sixth EC Framework Programme of Research - a decision of major importance for the completion of the European Research Area and for the development of a more competitive European productive system -, nevertheless considers it essential that appropriate bioethical principles be included in the Specific Programmes for some areas of research.
We would refer in this context to the statement unanimously approved by the Council of Research Ministers of 10 December 2001 to the effect that "the requirements 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".
Italy asks that in the Specific Programmes shortly to be approved provision be made for the total exclusion from Sixth Framework Programme funding of all research activities covering:
- human cloning for whatever purpose;
- modification of the human genetic heritage leading to hereditary change;
- the creation and use, for whatever purpose, of human embryos and their derivatives.
(f) Statement by Luxembourg
Luxembourg welcomes the 6th research Framework Programme as an important decision designed to develop the European Community's scientific and technological base and help it to become more competitive in major areas; however, Luxembourg feels that an acceptable solution must be found for the inclusion of bioethical guidelines for the funding of research activities under the 6th Framework Programme in certain sensitive areas. Luxembourg wishes to draw attention to the Council statement of 10 December 2001 in which 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.
(g) Statement by Austria:
In earlier statements, the Austrian Ministers for Research and Technology pointed to ethical issues and emphasised that without clarification of the latter Austria would be unable to agree to the 6th Framework Programme. In its opinion of 8 May 2002 on stem cell research issues in the context of the 6th EU Framework Programme in the field of research, the Bioethical Committee at the Federal Chancellor's Office concludes that certain areas of research should not be funded:
­ cloning of humans for reproductive purposes;
­ modifications to the genetic heritage as a result of which such modifications could become hereditary;
­ breeding of human embryos exclusively for research purposes or to procure stem cells, including through the nuclear transfer of somatic cells.
These restrictions are also asserted by the Commission in its statement of 10 December 2001.
However, the Austrian Bioethical Committee is calling for even more restrictions, such as ethically unjustifiable further research into "surplus" early-stage human embryos. The Bioethical Committee is in favour of further intense research into adult cells.
Moreover, Austria refers to the joint statement by Austria, Germany, Ireland, Italy and Portugal.