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MEMO/07/122

Brussels, 29 March 2007

The Framework Programme for Research and Development and human embryonic stem cell research

Today the European Commission has announced the creation of a European registry providing comprehensive information about all human embryonic stem cell lines in Europe (see IP/07/437). This background note gives some more information about the project, as well as describing the context for European support of research using human embryonic stem cells.

Why has the European Commission proposed the creation of a registry of human embryonic stem cell lines and how will it work?

This registry is expected to boost the coordination and the rationalisation of human embryonic stem cell research in Europe. It will provide a platform to maximise reproducibility, comparability and transparency in the field.

It is funded through a Specific Support Action within the ‘Life Sciences, Genomics, and Biotechnology for Human Health’ Priority of the outgoing Sixth Framework Research Programme of the European Union. It is expected to last for 3 years with EU funding of just over €1m.

This European Registry will be jointly operated by Anna Veiga from the Stem Cell Bank of the Centre of Regenerative Medicine in Barcelona (CRMB) and Joeri Borstlap from the CellNet initiative at Berlin-Brandenburg Centre for Regenerative Therapies in Berlin (BCRT).

The CRMB is one of the Spanish research centres approved to carry out research with donated frozen human embryos and human embryonic stem cells, financed - by the Spanish Ministry of Health, and the Catalan Government. The BCRT is a collaboration between Europe’s largest university hospital, the Charité, and Germany’s largest research organization, the Helmholtz association. The centre has recently received substantial financial support from the German Federal Government to develop an internationally visible centre of excellence in regenerative medicine.

Lead partners are Andreas Kurtz, also from the BCRT, who is an expert in regulatory and scientific aspects of embryonic stem cell research in the global context, and Dr. Glyn Stacey, director of the UK Stem Cell Bank, at the UK National Institute of Biological Standards and Control. The other partners are from leading European Public Institutions involved in human embryonic stem cell research.

All these Members constitute the Steering Committee that will be assisted by an Advisory Board including 17 top scientists from Europe and outside Europe in the field of human embryonic stem cell research.

The independent Ethics Advisory Board that will ensure the compliance with ethical requirements and ethical guidance is constituted of 3 experts in Bioethics of International reputation: Anne McLaren (UK), Maria Casado (Spain) and Klaus Tanner (Germany).

Contact details of the coordinators: Dr. Anna Veiga:+34/93.316.03.00 – blc@cmrb.eu

Mr. Joeri Borstlap: +49/30.450.539.501 - coordinator@cellnet.org

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

Three fields of research are explicitly excluded from Community funding:

- Research activities aiming at human cloning for reproductive purposes;

- Research activities intended to modify the genetic heritage of human beings which could make such changes heritable (research relating to cancer treatment of the gonads can be financed);

- 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 (so-called therapeutic cloning).

In addition, the Commission will not fund research in any country where that research is not permitted nor will it fund in any third country research that is forbidden in all the Member States.

What are stem cells and why is research done with them?

Stem cells are those cells in the human body that have the potential to develop into many different cell types in the body. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

Because of this ability to develop into different types of cells, scientists believe that they hold the key to treating major degenerative diseases, such as Parkinson's or Alzheimers, or diseases linked to cells and organs, such as cancer or diabetes. Scientists are also investigating the possibility that damaged parts of the body, for example nerves in the case of paralysis, could be treated with therapies developed using stem cells.

Most of the stem cells used by scientists come from adults (bone marrow or umbilical cord blood are good examples for sources of stem cells). There is also some research going on in certain countries of the EU using human embryonic stem cells. This research is not permitted in all EU countries, as the early-stage embryo from which the stem cells are extracted cannot then develop.

What is the situation in the Seventh Framework Programme for Research (FP7) as regards human embryonic stem cell research?

For the 7th Framework Programme (2007-2013), the European Commission will continue with the same ethical framework for deciding on the EU funding of human embryonic stem cell research as existed in the 6th Framework Programme.

The European Commission proposes the continuation of this ethical framework because it has developed, based on experience, a responsible approach for an area of science which holds much promise and that has proven to work satisfactorily in the context of a research programme in which researchers participate from many countries with very diverse regulatory situations.

Research activities which destroy human embryos, including for the procurement of stem cells, will not receive Community funds. The exclusion of funding of this step of research will not prevent Community funding of subsequent steps involving human embryonic stem cells. This research will continue to be supported on a case by case basis, where strict and transparent criteria are applied.

What is the procedure for the case-by-case examination of human embryonic stem cell proposals?

Each project proposing to use human embryonic stem cells (hESC) must successfully pass a scientific evaluation during which the necessity of using such stem cells to achieve the scientific objectives is assessed by independent scientific 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. This ethical review is based on ethical rules embodied in the European Charter of Fundamental Rights, and relevant international conventions such as the Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 and its additional protocols and the Universal Declaration on the Human Genome and the Human Rights adopted by UNESCO. It also takes account of the Opinions of the European Group on Ethics in Science and New Technologies (EGE). In particular, during the ethical review the panel assesses:

a) whether the proposers have taken into account the legislation, regulations, ethical rules and/or codes of conduct in place in the country(ies) where the research using hESC is to take place, including the procedures for obtaining informed consent;

b) the source of the hESC;

c) the measures taken to protect personal data, including genetic data, and privacy;

d) the nature of financial inducements, if any.

Then a positive opinion from a Regulatory Committee constituted by Member States’ representatives is required.

Finally, participants in research projects must seek the approval of the relevant national or local ethics committees prior to the start of the research activities.

All these conditions are cumulative. In conclusion, each research proposal, involving hESC, which is supported within EU's Research Framework Programme, is assessed by at least two independent ethical reviews: one at the national level (in the country where the research will be carried out) and one at the EU level. No system in the world offers a higher guarantee regarding the respect of fundamental ethical principles.

What EU funding is provided for stem cell research?

A total of around 104 projects are currently supported within the Sixth Framework Programme that involve at least one component of stem cell research. These 104 projects represent in total an EC contribution of around €500 million. Out of these 104 projects, 18 involve human embryonic stem cells (hESC). This means that currently around 83% of the projects only involve somatic stem cells (adult & foetal stem cells) and essentially adult stem cells (at least 95% of these projects) and around 17% also involve hESC. It may be estimated that when all FP6 projects have come to an end, around €21 million will have been dedicated to hESC research. This means around 0,85% of the budget of the health research programme in FP6 (which is around €2,45 billion) and around 0,10% of the total FP6 budget (more than €17,5 billion).

What are the areas of research that use human embryonic stem cells research supported through the Sixth Framework Programme?

The EU's Framework Programme is currently supporting 18 projects that involve at least one component of human embryonic stem cell (hESC) research. This represents around 17% of all the stem cell research projects supported. Most of these 18 projects also involve research with adult stem cells and/or foetal stem cells because the comparison between the stem cells from different origins is often one of the greatest assets of these EU projects. Among these 18 projects:

  • 1 project targets the aspect of storage of stem cells in banks (cryobanking)
  • 2 projects aim at evaluating/comparing properties of hESC and foetal stem cells from umbilical cord blood
  • 3 projects deal with fundamental research aspects (study of lymphatic vasculature/characterisation of existing hESC lines/study of regulatory Ribonucleic acids)
  • 5 projects target in vitro research in view to replace animal experimentation on toxicology related to drug testing or drug development
  • 7 projects mix aspects of fundamental research and aspects of translational research (from basic research to clinical applications) towards specific diseases (skin, musculoskeletal, neurodegenerative including Huntington's disease, heart, hearing impairments, stroke, diabetes).

Which Member States allow research using human embryonic stem cells?

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

Czech Republic, Denmark, Finland, France, Greece, Netherlands, Portugal (the law has not yet entered into force) and Spain have regulations allowing the derivation of new hESC from embryos created as a result of medically-assisted in vitro fertilisation to induce pregnancy, and no longer to be used for that purpose (supernumerary embryos).

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

The other EU countries have no specific regulation on this issue but Austria, Lithuania, Malta, Slovakia and Poland have clearly indicated that they are against 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.

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

Brazil, Canada, Norway, Switzerland and Taiwan have regulations allowing the derivation of hESC from supernumerary embryos.

For more information:

http://ec.europa.eu/research/fp6/index_en.cfm?p=1_stem_projects


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