http://www.reutershealth.com/archive/2001/11/27/eline/links/20011127elin029.html

By Peter O'Donnell

BRUSSELS, Nov 27 (Reuters Health) - The European Parliament's second major discussion this month on healthcare research, to be held this week, looks set to generate yet more controversy over the use of stem cells.

This Thursday, the Parliament will hold a wide-ranging debate on the ethical, legal, economic and social implications of human genetics. The outcome is likely to influence the political climate for some critical imminent decisions in the European Union on biotechnology in general and stem cell research in particular.

The report before the Parliament has been drafted over the course of this year by a special committee set up for the purpose. Its 300 pages cover gene therapy, genetic testing, patenting and a wide range of other controversial issues.

But the hottest discussions will be on how much research on stem cells the EU should allow, particularly stem cells from embryos.

In its current form, the report takes a conservative stance, arguing against using EU research funding, and urging strict controls on the use of embryos.

But hundreds of draft amendments have been tabled by members of the European Parliament over recent days. Many seek a less rigid regulatory framework, in the interests of promoting EU research.

Italian Euro-MP Francesco Fiori, who drafted the report, said in a statement on Tuesday that his report "reconciles freedom of research with respect for the dignity of human life, protection of public health, non-discrimination on the basis of genetics, protection of privacy, prohibition of financial profit, and clearer discipline on patentability."

He is calling for an explicit EU prohibition of reproductive cloning through binding legislation.

But Robert Goebbels, chairman of the Parliament's special genetics committee, told Reuters Health that the draft report adopted by his own committee earlier this month is "sub-optimal" and needs further change when the Parliament discusses it on Thursday. He pointed out that the committee adopted the draft only by a slender majority (18-13, with three abstentions), because the committee's members were deeply divided over the limits it sought to impose on research.

"The Fiori report might have been 'mainstream' had it not been for some 600 amendments made to it in its final stages in committee, often also by only a slim majority," Goebbels stated.

"As a result the report is too long, is full of contradictions and is unnecessarily repetitive: it currently contains eight calls for a ban on human cloning--but one would be enough," he said.

In particular, by seeking such tough limitations on embryonic stem cell research, it risks "putting EU developments in this promising field at an international disadvantage," Goebbels added.

The report says that priority should be given to research on adult stem cells as an alternative to stem cells from human embryos.

"Reproductive cloning of human beings should be banned regardless of the technique used," it says. New legislation should be enacted, the report states, to prevent use of embryonic stem cells or human embryos created in vitro for any other purpose than bringing about a pregnancy.

The report calls for a "harmonised regulatory framework" so as to give "precedence to the interests of the public, health, and the research community, and to lay down strict and clear-cut rules to govern not only the development, but also testing and approval of new biotechnological drugs and reagents for genetic testing."

Goebbels has himself tabled amendments to the report, on behalf of his Socialist group in the Parliament, in a bid to make it more balanced.

One says: "Research on embryo or foetal stem cells deriving from spontaneous or therapeutic abortion may be funded."

But other amendments from other parties and groups seek to tighten rather than relax the controls proposed in the report. German members of the European Peoples Party, for instance, are urging stricter European rules on the grounds that "the development and testing of these new biotechnological medicines on an EU-wide scale is a difficult activity that is up till now not properly regulated."

German and Austrian Christian Democrats, the Green Group, some Communists and some German Social Democrats in the Parliament are in favour of tighter rules. Most Socialists, and most members of all parties from the UK and the Nordic countries, say they will be voting for a more pro-research approach.

Peter Liese, a German Christian Democrat who has tabled numerous amendments tending towards tighter controls, told Reuters Health Tuesday that the report is "not radical." He said that just because Belgium and the UK currently take a more liberal stance on embryo research does not mean that the EU should follow them; instead, he noted, the EU should set the lead. He said he was in favour of going beyond merely cutting off research funding for stem cells from embryos: it should be banned altogether, he added.

The recent announcement of cloning experiments by Advanced Cell Technology is likely to colour the debate, too. The European Commissioner responsible for research, Philippe Busquin, said in a statement Monday that US developments "show the need for the EU to reach a position on research involving embryonic stem cells."

Goebbels said the outcome of the Parliament debate is still too close to call, but he hopes that what he calls good sense will prevail. He pointed out that Parliament did back stem cell research on some embryos in its mid-November vote on the EU's upcoming 6-year research programme. He is confident that growing understanding of biotechnology among members of the Parliament is defusing some of the current widespread European hostility to research in this area.

Over the coming weeks, the EU is to hold a major public debate on the ethics of stem cell research. It is due to discuss next year a strategic approach to biotechnology based on a document the European Commission is now working on for publication early in the new year.
 

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