Brussels, 8 April 2005
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 this framework out in detail, and provides some information about research carried out under the current research programme.
What does the proposal for a Seventh Framework Programme for Research says about ethical issues?
In the proposal for a decision on 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 the Seventh Framework Programme 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.
What is the situation regarding human embryos and embryonic stem cells within the Sixth Framework Programme?
The current Sixth Framework Programme’s specific programme on “Integrating and Strengthening the European Research Area”, decided by Council in agreement with Parliament, explicitly forbids EU funding for research that involves human reproductive cloning, the creation of human embryos for research (often referred to as therapeutic cloning) and research that would change the genetic heritage.
The European Group on Ethics has delivered an opinion on ethical questions in EU research programmes and another opinion on EU funding for stem cell research.
The Sixth Framework Programme does allow EU funding of projects involving the derivation and use of human embryonic stem cells (HESC) derived from supernumerary embryos (i.e. embryos left over from in-vitro fertilisation that are most often 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.
What is the procedure for the case-by-case examination of projects?
EU research programmes never fund in a Member State under any circumstances anything that is forbidden in that particular Member State.
Priority is given in all circumstances to research on adult stem cells (i.e. derived from adults or umbilical cord blood), which pose no ethical problems.
All proposals received 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 pluralist team of ethical experts. Furthermore, each project should get 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 is expected to be performed in more than one country.
As long as there is no decision on ethical criteria for EU funding of human embryonic stem cell research, the Commission has committed itself not to fund a project that involves the derivation of stem cells from human supernumerary embryos (i.e. implying the destruction of the supernumerary embryo in question), but only to fund projects involving HESC that were derived outside the scope of the EU-funded project in question.
Those proposals that pass the scientific evaluation and the ethical review are submitted for opinion to Member States, meeting as a regulatory committee. No project is funded that does not receive a favourable opinion from that Committee.
What EU funding is available for stem cell research?
There is no element of the programme that directly calls for proposals on 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.
At this stage, as a result of the first call for proposals under the “health” priority of FP6, the Commission is currently funding 25 projects involving component of stem cell research. These mainly concern adult stem cells. Only two projects involve a component of human embryonic stem cell research; these projects have both received a favourable opinion from the Member States (through the regulatory committee). The funding for these two projects amounts to about €500,000, less than 0.1% of the EU research money available for health research in the first call for proposals, and about 0.002% of the Sixth Framework Programme budget
Following the second call for proposals under the health priority, a proposal involving the use of existing HESC lines (addressing diabetes, called BetaCellTherapy) has been positively reviewed, both scientifically and ethically, and has just received a favourable opinion from the regulatory committee of Member States.
In the context of the decision-making process on FP6, the Commission has committed itself to supporting the set up 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 4th call for proposals in the course of 2005.
Which Member States allow research using human embryonic stem cells?
Belgium, UK and Sweden allow research using therapeutic cloning, which is expressly forbidden from receiving EU research programme funding.
Denmark, Finland, France, Greece, Spain, Netherlands have regulations allowing the derivation of new human embryonic stem cells from supernumerary IVF embryos.
Estonia, Hungary, Latvia and Slovenia have no regulations, but allow some research on supernumerary IVF embryos.
Germany and Italy have regulations which restrict human embryonic stem cell research. These regulations mean that scientists in these countries cannot derive new human embryonic stem cells, but can import them. In Germany, these cells have to have been derived before 1 January 2002.
Austria, Ireland, Latvia and Poland have legislation prohibiting human embryonic stem cell research.
What is the worldwide situation?
In the US, federal funds are restricted to funding research on existing human embryonic stem cells derived before 9 August 2001. There are no restrictions for industrial, private or state funds, though some states are currently reviewing their funding rules.
China, India, Israel, Singapore and South Korea currently allow therapeutic cloning.
Australia, Brazil, Canada, Japan, Switzerland and Taiwan have regulations allowing the derivation of human embryonic stem cells from supernumerary IVF embryos. The Swiss rules were approved by a public referendum in November 2004.