A dilemma in the way of science

THES writers report on changes to legislation on stem-cell research as nations struggle with their consciences.

The UK was the first country in the world to pass laws to permit researchers to use human embryonic stem cells subject to controls generally accepted within the medical research community.

Since then, its competitive edge in research and any commercial potential has been eroded as other countries, notably in the Far East and Israel, have become leaders in the technology. China, South Korea and Singapore have prioritised research in the field, while Australia and Canada are moving rapidly ahead. But critics of the technology have voiced ethical concerns centring on the potential for human cloning - opposition that has hampered its adoption in the US and divided the European Union, where countries with large Roman Catholic populations have proved reluctant to relax controls on experimentation.

The UK last month issued a licence to use embryonic stem cells to the Roslin Institute under regulations devolved to the Human Fertilisation and Embryology Authority. The cells could lead to breakthroughs in the treatment of conditions such as Parkinson's disease and diabetes.

The Medical Research Council is prioritising the training of scientists in the field and has awarded 11 studentships in stem-cell research. It has set up an international forum of research bodies and institutions from countries such as Israel, Canada, the US, Singapore, Australia, Finland and Sweden, to look at global standards.

Euro view

Scientists have welcomed progress towards the release of European Union money for research projects involving stem cells as the European Commission proposed guidelines last week.

The move follows a vote at the EU Council of Ministers in June approving the idea in principle in a directive on the use of human tissues in medicine. Ministers opposed tighter restrictions written into the law by the European Parliament in April.

EU officials said there was a risk of the two pieces of legislation conflicting with each other.

The EC proposal makes rules on the kind of stem-cell studies that can be funded by the Sixth Framework Programme on research. Guidelines include:

• The EU will not fund human embryonic stem-cell research in laboratories of a member state that bans the practice
• Stem cells used for research must be from embryos donated by parents and created before June 2002, as they were already destined for destruction.
• The donors' privacy must be guaranteed
• Potential research project partners applying for EU funding must seek ethical advice in states where the research will take place
• Studies will be funded only where there is no adequate alternative available
• Stem cells must be traceable
• Research consortia will be required to hand over available human embryonic stem cells to other researchers. A European registry of such material will be created.

The move has been welcomed by Sir George Radda, chief executive of the Medical Research Council, who recently met EU commissioner Philippe Busquin to discuss stem-cell research.

"I chair an international stem- cell forum that includes 12 different agencies in ten countries and we are working closely on making sure that stem-cell research is done in an organised and well-controlled and ethically overseen way," Sir George said. "I think that a proposal by the commissioner to allow EU money is going to add to the international effort very significantly."

Sir George acknowledged concern about the research. He said: "What will have to happen is that while the EC will fund this research, it will be up to individual countries to decide whether they would allow it."

EU officials say that so far only nine specific proposals have been received for FP6 spending on projects. The spokesman said that it was thought these studies would entail total spending of E10 million to E40 million (£6.6 million to £.7 million).

Robert Terry, senior policy adviser at the Wellcome Trust, said it would be interesting to see how the financial proposal fared at the European Parliament, given its more negative position on stem-cell research. He worried that MEPs could "make embryonic stem-cell research illegal before any of these proposed funds are released".

The final spending guidelines on EU stem-cell research are sure to be tightly controlled. In the ongoing debate over older legislation on human tissue, where parliament made amendments on stem-cell research, the more liberal Council of Ministers has preserved rules banning stem-cell research involving in vitro and animal-based trials. It also voted to allow member states significant powers to tighten restrictions over stem-cell experiments carried out within their borders.

Member states can insist on the unpaid donation of tissues and cells, and even impose bans on the donation, procurement, testing, processing, preservation, storage, distribution and use of tissues and cells from specific sources, including embryos.

Ministers stressed the proposed directive's insistence on national accreditation and monitoring of establishments handling stem-cell research.

They highlighted its rules on guaranteeing "the traceability of tissues and cells of human origin from donor to patient and vice versa, as well as a system for the regulation of imports of human tissues and cells from third (non-EU) countries."

There was general approval for allowing research on these ethically controversial studies in principle, though Germany reserved its right to oppose the measure.

Ministers also removed bans earlier approved by MEPs on fertility research involving human cloning, and the creation of human embryos purely for research, including stem-cell generation.

With MEPs having the right of veto over the proposal, the parliament is expected during its second reading of the proposals to negotiate changes to the regulations agreed by the council. There is expected to be a tussle in the European Parliament over the commission's proposed rules for European money to be spent on stem-cell research.

United States

Two years after the Bush administration imposed restrictions on the use of human embryonic stem cells in research, bipartisan political opposition is beginning to stir in response to a resulting near-paralysis in the field, writes Jon Marcus.

Despite some breakthroughs, the research has been handicapped dramatically in the US by the president's decision to give government grants for only those studies using embryonic stem cells that existed on the date of his order two years ago. George W. Bush equates the embryos - obtained from unsuccessful in-vitro fertilisation - with living humans. Since then, encouraged by the potential of stem-cell research to help cure maladies ranging from heart failure to Alzheimer's disease, others have stepped in to pay for it. The state of California, for example, has promoted such research. Entrepreneur Andrew Grove, founder of Intel, has pledged up to $5 million (£3 million) for it.

But scientists have testified before Congress that the research is still all but paralysed. They said it took more than a year to receive promised allocations of stem cells from permitted sources, and that US scientists were travelling to Europe and Asia to do their work.

"American science should be conducted on American soil," Gerald Schatten, professor and vice-chairman of the University of Pittsburgh School of Medicine, testified before a congressional hearing. US law, he said, was "hindering invaluable research, undermining the wisest expenditures and delaying the day when we'll know whether stem cells can be used to treat diseases".

The problem was made worse by the fact that many of the 78 separate colonies, or "lines", of stem cells eligible to be used in government-funded research were cultivated using mouse cells to help them grow more quickly. Now there is concern that these stem-cell lines carry mouse viruses.

Republican senator Arlen Specter and Democratic senator Tom Harkin, members of the congressional subcommittee that oversees the National Institutes of Health, are pushing for a loosening of the president's restrictions.

Spain

The government is to legalise stem-cell research after years of debate. Outdated legislation had until now left scientists in a legal vacuum and forced some to travel abroad to continue research, writes Rebecca Warden.

On July 4, health minister Ana Pastor said that the government would allow research with stem cells from embryos that had been stored for more than five years and so could not be used for reproduction. The cells may be used for medical research only and cloning will be banned.

A bill will be put before parliament shortly. Most scientists are keen to see a more liberal position and their stance is backed by much public opinion. By October 2002 more than 1.3 million people had signed the Spanish Federation of Diabetics' petition calling for a change in the law.

Bernat Soria, Spain's leading researcher in the therapeutic use of stem cells, is working on a cure for diabetes. In September 2002, he began setting up a laboratory in Singapore to carry on the work he was not allowed to do in Spain. In January this year, the Andalusian regional government passed a law allowing research with embryonic stem cells and offered Professor Soria the chance to continue his experiments in Seville.

Other regional governments controlled by the socialists were planning to join Andalusia.

East Asia

Some Chinese geneticists are calling for legislation to control human cloning and genome research. Present law allows research on human embryos and cloning for therapeutic purposes. In 2001, two national committees on medical ethics and bioethics proposed ethical guidelines on human embryonic stem-cell research, but the legislative process is expected to take years.

Singapore has encouraged research with a liberal climate and substantial funding. The Bioethics Advisory Committee recommends that research using embryos less than 14 days old should be strictly regulated.

South Korea answered some ethical concerns with the introduction of a life ethics and safety measures bill last September that restricts the cloning of human cells as well as somatic cells and prohibits embryonic stem-cell research.

Hungary

What, legally speaking, are stem cells? This is the key question of a lawsuit in Hungary brought by parents who wanted stem cells from their infant's umbilical cord stored for possible future use in the child's treatment, writes Vera Rich.

At first glance, the idea seems reasonable and prudent - analogous to the storing of a future patient's blood for auto-transfusion. But Hungary's medical watchdog, the Health Care Scientific Council, thought otherwise.

Removing stem cells, it ruled, ranked as "research carried out on human beings" - and was therefore illegal.

The parents, and the firm that would have stored the cells, Sejtbank Egeszseguegyi Szolgaltato (Cellbank Health Service), challenged the decision. Cellbank claimed the country's chief medical officer had ruled that stem cells were legally "blood", and therefore no special permission was required for removing and storing them.

The parents further argued that, by banning the storage of the cells, the council had infringed their parental rights. But the Budapest court backed the council's ruling.

The court's decision was qualified. It stated that the only issue it had considered was whether the council could legally make such a ruling; it had not examined whether the council's stance was "well founded". Cellbank plans to appeal to a higher court.

Australia

Australia's first committee to assess submissions from researchers to use excess human embryos for research has begun its work, writes Geoff Maslen.

The nine-member committee was appointed following adoption of controversial federal legislation that allows embryonic stem-cell research.

But the act also imposes a three-year moratorium on therapeutic cloning.

Passage of the legislation followed several years of public debate and demands from across the political spectrum for tighter controls over the use of embryos for research.

Archbishop Philip Wilson of the Australian Catholic Bishops Conference said his church was appalled by the result. He said: "Parliament has created for the first time in Australian political and legal history a class of human life which is statutorily expendable."

Under the act, the committee decides on applications from researchers for a licence to use excess human embryos. Inspectors will monitor compliance with the legislation.

The majority of Australians support the use of foetal tissue for research but only with excess IVF embryos or from abortions carried out for other reasons.

Canada

A Canadian funding framework for stem-cell research is being set up despite a proposed law on reproductive technology, writes Philip Fine.

The Canadian Institutes of Health Research has decided to review research projects involving the use of human pluripotent stem cells.

The federal funding agency is forming a committee that could begin approving funding before the passage of the law.

The stem-cell section of the bill on reproductive technology mirrors CIHR guidelines banning the creation of embryos solely for the purpose of research, human cloning and the mixing of human and animal stem cells.

Surplus embryos would be used only for medical research until 14 days after conception and would need consent from donors; no financial incentives are allowed in the donation or creation of reproductive material.

Canadian researchers say the science is too important to wait on parliament. Canadian projects on ways to trigger muscle repair and on pancreatic cell regeneration have been among some of the most promising stem-cell discoveries.

France

Stem-cell research in France is banned under laws that should have been revised four years ago. And even when a change in legislation takes place, it will still be too restrictive, medical researchers say, writes Jane Marshall.

Strict bioethics laws came into force in 1994, forbidding all research on human embryos. They were due for revision after five years. The Roman Catholic Church opposed any relaxation.

President Jacques Chirac and the National Commission of Human Rights pronounced against therapeutic cloning, while the prestigious Academy of Sciences and the National Ethics Committee were in favour. Some French scientists left for the US, the UK and Switzerland to continue their work.

In January 2002, the National Assembly approved the first reading of a bill that would have opened the way to human stem-cell research. But a general election in May returned a conservative government.

This January the Senate passed a version of the bill that maintains the general ban on human embryo research, including therapeutic and reproductive cloning, while allowing use of surplus embryos from fertility treatment in limited cases. The question now is when the reform will become law.

Germany

Parliament has approved a law to allow the import and use of embryonic stem-cell lines created before January 1 2002, writes Alisa Roth.

Creating or killing embryos for research is forbidden, while research on animal and adult stem-cell lines is permitted.

During the debate on the new law, chancellor Gerhard Schroder said: "I think that a complete import ban on embryonic stem cells - and with that a complete ban on research - would not only be unreasonable but difficult to uphold constitutionally."

Israel

Michel Revel, chairman of the bioethics committee at Israel's National Academy of Sciences and Humanities, has said the Jewish faith allows the use of embryos to save people's lives, writes Helena Flusfeder.

"According to Jewish law, an embryo does not have full human rights until birth... it is ethical to use these embryos to save other peoples' lives, people who could be cured by a transplant with embryonic stem cells," said Professor Revel, a scientist at the Weizmann Institute of Science.

But embryos cannot be created for research purposes. While cloning a human being is illegal, there is no prohibition against cloning embryos.

Italy

The power of the Catholic Church means Italy's conditions on stem-cell research are among the most restrictive in Europe, writes Paul Bompard. No law exists yet, but the conservative government is finalising a legislative package on artificial insemination that also bans "all research on human embryos".

Elena Cattaneo, a biologist at Milan University who works with stem cells and was also a member of the Italian delegation to the EU for the recent discussions, said that if the Italian legislation were passed it would be "devastating for Italy's researchers".