Future of stem cell research in the EU under threat, April 2003

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Series Details 11.4.03
Publication Date 11/04/2003
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Research on stem cells taken from embryos could be banned in the EU in the future after Members of the European Parliament voted to outlaw this type of research at the first reading of a European Commission proposal concerning standards of quality and safety of human tissues and cells on 10 April 2003.

The proposal, adopted by the European Commission on 19 June 2002, sets out quality requirements related to the donation, procurement and testing of tissues and cells as well standards for tissue establishments in order to ensure a comparable level of safety throughout the EU. It also suggests that traceability standards be introduced to ensure that tissues and cells can be followed from donor to patient and back. In recent years, the increased use of human tissues and cells for therapeutic purposes has highlighted the need to provide legislation in this area and the Amsterdam Treaty calls on the EU to ensure a high level of public health protection for substances of human origin.

The European Parliament's vote on 10 April 2003 is the first stage in the lengthy co-decision procedure. Peter Liese, a member of the EP's Committee on the Environment, Public Health and Consumer Policy and rapporteur for the issue, presented a report on the proposal, which suggested more than 80 amendments to the original Commission proposal. These amendments mainly concerned the scope of the directive, compensation for tissue and cell donation, donor consent, donor anonymity and ethical issues. However, one amendment that is likely to provoke the most controversy as the decision-making process continues relates to the introduction of a clause prohibiting embryonic stem cell research that reads:

'For ethical reasons, and for reasons connected with the high risks of a medical nature connected with human cloning, Member States must also explicitly ban the use of tissues and cells from cloned human embryos and of hybrids derived from germ cells or totipotent cells of human and animal origin'.

According to the report, such a ban may be justified because 'the use of cells and tissues derived from cloned human embryos cannot be permitted for ethical reasons, and for reasons connected with the extremely high medical risks involved'. This justification on ethical and medical reasons goes right to the heart of the debate: if medical reasons are cited as sufficient justification for an end to stem cell research then a ban may be introduced; however, binding ethical rules are strictly the responsibility of the Member States and the EU does not have the right to regulate ethical issues under a European Directive. David Byrne, European Commissioner responsible for public health, emphasised this point at the beginning of the Parliament's plenary debate, saying:

'The ethical issues relating to the use of tissues and cells are indeed sensitive. But it is because of their very sensitivity that we must rigorously respect the limits of the Treaty. However well intentioned our motives, we must act within the Community's proper competences. Here, I would like to underline a key point. Article 152 aims to regulate public health issues. It does not foresee an in-depth regulation of ethical issues'.

However, the rapporteur rejects this view citing previous discussions at European level such as that concerning the Biopatent Directive where it has been shown that 'it is not possible to take a decision on regulating genetic and biotechnology without duly taking account of the ethical aspects'. Clearly, a number of Mr. Liese's colleagues share his opinion as the amended proposal was adopted by a majority of 321 votes to 89 with 57 abstentions. Opponents of stem cell research say it is immoral to use embryos because they represent the first stages of human life. However, MEPs who support the use of stem cell research argue that it has the potential to help a number of sick people. MEP David Bowe, a British member of the European socialists cited the example of his young constituent Zain Hashmi, who was able with his parents to get permission to utilise these new technologies to protect his life and safeguard his future.

Embryonic stem cell research is currently legal in the United Kingdom, but it is banned in other Member States and some EU countries have no regulations on it at all. In the UK, where scientists are using pioneering stem cell research to help find cures for a wide range of serious diseases, such as Alzheimer's and Parkinson's, a public opinion survey published on 8 April 2003 revealed that seven out of ten of those surveyed said the use of human embryos was acceptable in research to find treatments for serious diseases and in fertility research. The UK Medical Research Council, reacting to the Parliament's vote, called it 'a blow to medical research', adding:

'We are very disappointed with this initial vote. If it were to lead to legislation it would severely limit embryonic stem cell research and its potential to combat serious human diseases. We believe that it is unnecessary to widen the scope of the Directive to cover the use of human stem cells. The ethical issues associated with stem cell research should be up to each Member State to deal with within their own legal and ethical framework'.

UK stakeholders, such as the MRC, diabetics associations and the Parkinson's Disease Society, are now expected to lobby their local MEPs and government officials to prevent the amended proposal being adopted. The proposal will be discussed by EU health ministers at a council meeting on 2 June 2003. Under the co-decision procedure MEPs will have to vote on the law again at a second reading before it comes into effect.

Links:
 
European Parliament:
10.04.03: Daily Notebook: No to cloning and restrictions on stem cell research
09.04.03: Verbatim Report of Debate Proceedings [in original language]
Report on the proposal for a European Parliament and Council directive on setting standards of quality and safety for the donation, procurement, testing,processing, storage, and distribution of human tissues and cells
Legislative Observatory: Medicine - standards of quality and safety of human tissues and cells
 
European Commission:
19.06.02: Press Release: Quality and safety standards for human tissues and cells [IP/02/894]
07.04.03: Press Release: Commission report on human embryonic stem cell research provides basis for discussion on ethics [IP/03/506]
07.04.03: Memo: Report on human embryonic stem cell research [MEMO/03/81]
Proposal for a Directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells [COM(2002) 319
Commission Staff Working Paper: Report on human embryonic stem cell research [SEC(2003) 441]
European Group on Ethics in Sciences and New Technologies
 
BBC News Online:
10.04.03: MEPs vote to ban stem cell research
08.04.03: Public backs human embryo research
08.04.03: 'Designer baby' ban quashed
 
UK Medical Research Council
Homepage
10.04.03: EU vote on stem cells could restrict vital medical research
 
European Sources Online: In Focus
 
European Sources Online: Topic Guides
The European Union and Public Health

Helen Bower

Compiled: Friday, 11 April 2003

Embryonic stem cell research stem cells taken could be banned in the EU in the future after the European Parliament voted against a European Commission proposal concerning standards of quality and safety of human tissues and cells at its first reading on 10 April 2003.

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