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Brussels, 17 May 2005

How does the European Commission deal with ethical issues within its Framework Programme for Research and Development?

Janez Potočnik, European Commissioner for Science and Research, has indicated that the European Commission proposes to continue the current strict ethical framework within the future research programme. This note sets out this framework in detail, and provides some information about research carried out under the current programme.

What does the proposal for a Seventh Framework Programme for Research (FP7) say about ethical issues?

In the proposal for a decision on future FP7, the following recital and article are included with regard to the respect of fundamental ethical principles.

Recital 25: Research activities supported by this Framework Programme should respect fundamental ethical principles, including those reflected in the Charter of Fundamental Rights of the European Union. The opinions of the European Group on Ethics in Science and New Technologies are and will be taken into account.

Article 6: All the research activities carried out under FP7 shall be carried out in compliance with fundamental ethical principles.

The Commission’s proposal will now pass to the Council and European Parliament for decision.

How does the Commission deal with research involving sensitive ethical issues?

Sensitive ethical issues are dealt with through a process of ethical review at EU level by an independent, multidisciplinary panel of experts. The role of the ethical review is to ensure that in the design and execution of their projects, applicants identify and address all ethical issues which the proposed research may raise and that they fulfil all ethical and/or legal requirements at national level and conform to the ethical rules of the current 6th Framework Programme (FP6).

This EU level ethical review is additional to ethical review in individual Member States or in other countries where the research may be carried out.

What is the procedure for the case-by-case examination of projects?

All proposals submitted for ethical review, in whatever area, first undergo a very thorough scientific evaluation by independent experts.

Those proposals that pass the scientific evaluation are submitted to a stringent ethical review by a multidisciplinary team of ethical experts from different Member States. Furthermore, each project must, where required, get a favourable opinion from a local or national ethics committee from each country where the research will be carried out.

The ethical review panel will provide a written report to the Commission services on requirements and recommendations necessary to ensure that the reviewed projects will be conducted according to fundamental ethical principles

EU research programmes never fund in a Member State under any circumstances, anything that is forbidden in that particular Member State.

What are “sensitive ethical issues”

Examples of sensitive ethical issues include research on children and others unable to consent; use of genetic and other personal data such as sensitive data about health (e.g. HIV status), sexual lifestyle, ethnicity, political opinion, religious or philosophical conviction; the use of human embryos, human embryonic stem cells (hESC), human fetal tissue, non-human primates, the generation of novel transgenic animals which might be detrimental to the animal’s welfare; cloning of farm animals; research involving developing countries (e.g. clinical trials, use of human and animal genetic resources); potential for dual use (possible military or illegal applications).

When considering the issue of ethics in the Framework Programme, it is clear that the issue of research involving hESC is of significant concern. However, it is also worth noting that of the 330 proposals for projects submitted to the FP6 ethical review process, only 8 have involved the use of hESC. Across the whole of the FP6 research agenda, many other significant and important ethical issues have been successfully identified and addressed through the Commission’s ethical review process[1].

What is the situation regarding human embryos and human embryonic stem cells (hESC) research within the current Sixth Framework Programme?

The relevant specific programme which implements FP6 and is decided by Council, explicitly excludes EU funding for research that involves human reproductive cloning, the creation of human embryos for research (including by means of therapeutic cloning) and research that intends to change the genetic heritage of human beings.

FP6 does allow EU funding of projects involving the derivation and use of hESC derived from supernumerary embryos (i.e. embryos left over from in-vitro fertilisation (IVF) that are destined to be disposed off and for which parents give an explicit agreement that they can be used for research purposes). Such projects are examined on a case by case basis and there are strong ethical safeguards in place.

Priority is given to research on adult stem cells (i.e. derived from adults or umbilical cord blood);

All proposals first undergo a very thorough scientific evaluation by independent experts, where an assessment is made as to the necessity of using hESC has to achieve the scientific objectives of the proposal. Those proposals that pass the scientific evaluation are submitted to a stringent ethical review by a team of ethical experts.

Furthermore, in compliance with the principle of subsidiarity and the diversity of approaches in Europe, participants in research projects must conform to current legislation, regulations and ethical rules in the countries where the research will be carried out. Each project should have a favourable opinion from a local or national ethics committee from each country where hESC research will be carried out. In other terms, each project with a component of hESC research funded at the EU level will be scrutinised by at least two ethical reviews (one at national level and one at EU level), but it can be more if hESC research is expected to be performed in more than one country. In all cases, national provisions apply and no research forbidden in any given Member State will be supported by Community funding in that Member State.

Finally, before receiving funding, projects involving the use of hESC which have passed the scientific and ethical reviews are submitted to the Member States, meeting in a regulatory committee. No project is funded that does not receive a favourable opinion from that Committee.

The EU has thus the most sophisticated monitoring system on ethics and research ever established in a public institution.

The FP6 framework provided for hESC research is fully in line with the opinion of the European Group on Ethics in Sciences and New Technologies on this issue as well as legislation in the majority of countries in the world that allow this type of research.

What are the potentials of this type of research?

This type of research has already resulted in stem cell therapies, which are currently being used to treat several types of cancer, such as leukaemia and lymphoma, through bone marrow or umbilical cord blood transplantations. Current research on the fundamental properties and behaviour of stem cells using both adult stem cells and hESC, has two major expectations. The first, and more immediate, is to increase our understanding of a wide range of diseases and thereby develop better treatments and especially new families of drugs. The second, more for the long term, is to develop new stem cell therapies through transplantations. The list of diseases which look promising in this regard is sizeable and wide-ranging, and includes various forms of cancer, stroke, spinal cord injury, Alzheimer’s and Parkinson’s diseases, chronic heart diseases and diabetes as well as rare genetic diseases (e.g. Huntington’s disease, cystic fibrosis, muscular dystrophy).

What EU funding is available for stem cell research?

All research on stem cells, whether adult or embryonic, takes place within projects tackling a specific health issue, with a component of research using stem cells. There is no element of the programme devoted primarily to calls for proposals on human embryonic stem cell research (hESC).

Priority is given in all circumstances to research on adult stem cells (i.e. derived from adults or umbilical cord blood).

At this stage, as a result of the 1st call for proposals of FP6, the Commission is currently funding 25 projects involving component of stem cell research representing an EU contribution of about €160 million. These mainly concern adult stem cells. Only 2 projects from the health priority involve a component of hESC research; these projects have both received a favourable opinion from the Member States (through the regulatory committee). Within these 2 projects, it can be estimated that a total of about €500,000 is specifically dedicated to hESC research, which is less than 0.1% of the EU research money available for the health priority in the 1st call for proposals, and about 0.002% of the total FP6 budget. 6 additional proposals with a component of hESC research are being considered for funding within the health priority; 1 from the second call for proposals just received a favourable opinion from the regulatory committee of Member States and 5 from the third call are in the process of being submitted to this regulatory committee.

In the context of the decision-making process of FP6, the Commission has committed itself to supporting the establishment of a European registry of hESC lines, similar to the NIH registry in the USA. Support for such a registry, which would allow an ethical tracking of existing hESC lines in Europe and their optimal use, has been the subject of the second and third calls for proposals under FP6. In both cases, the proposals received were found by the evaluators to be of insufficient quality to be funded. Because the Commission attaches great importance to this subject, it will be reopened for proposals in the fourth call for proposals in the course of 2005.

Which Member States allow research using human embryonic stem cells?

Belgium, UK and Sweden allow therapeutic cloning, which is expressly excluded from FP6.

Denmark, Finland, France, Greece, Spain, Netherlands have regulations allowing the derivation of new hESC from supernumerary IVF embryos.

Estonia, Hungary, Latvia and Slovenia have no specific regulations on hESC, but allow some research on supernumerary IVF embryos.

Germany and Italy have regulations which restrict hESC research. These regulations mean that scientists in these countries cannot derive new hESC, but can import them. In Germany, these cells have to have been derived before 1 January 2002.

Austria, Lithuania and Poland have legislation prohibiting hESC research.

What is the worldwide situation?

In the US, federal funds are restricted to funding research on hESC derived before 9 August 2001. There are no restrictions for industrial, private or state funds, though some states are currently reviewing their funding rules. New rules are currently going through the US legislative process.

China, India, Israel, Singapore and South Korea currently allow therapeutic cloning.

Australia, Brazil, Canada, Japan, Switzerland and Taiwan have regulations allowing the derivation of hESC from supernumerary IVF embryos. The Swiss rules were approved by a public referendum in November 2004.

[1] including for example, clinical trials, research on children, research protocols involving the use of animals, GMOs, nanotechnology and IT research, dual use and research involving the implantation of ICT devices into the human body

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