The Brown-Darrell Clinic last night pledged to encourage new stem cell legislation after the British Foreign and Commonwealth Office expressed concern over a potential risk to Bermuda's reputation.

The adult stem cell clinic — being set up by Premier Ewart Brown, his wife Wanda and California-based Stemedica — released a statement saying it shared the FCO's concerns about stem cell use in the absence of robust regulatory frameworks.

It follows comments about Bermuda's lack of stem cell regulations from doctors in the UK and the US, where the practice is heavily monitored.

"We would welcome and encourage legislation consistent with the international protocol practised by countries engaged in stem cell research," said the Brown-Darrell statement.

Hours earlier, the Opposition United Bermuda Party released a letter from the FCO suggesting stem cell legislation be introduced.

The FCO said it understood the UBP's concerns about the potential risk to Bermuda's reputation, and has given Government contact details of the Human Tissue Authority, a group in the UK which offers guidance over codes of practice and licensing information.

The Brown-Darrell Clinic is due to open in Winterhaven, Smith's, from early 2008, when it intends to treat one or two "no option" patients a week. No suggestion was made that the opening of the clinic will be delayed, while no reference was made to how long it would take for new laws to be introduced.

Shadow Health Minister Louise Jackson and Opposition Leader Michael Dunkley wrote to the FCO in September to express concerns over Brown-Darrell.

They included a supporting letter from Arthur Tucker, the Bermudian chairman of East London and the City Research Ethics Committee, who expressed concern of the consequences if adult stem cell work goes wrong.

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A response to the UBP from Helen Nellthorp, head of the FCO's Bermuda, Caribbean and Policy Issues Team, said: "Although, as Dr. Tucker says in his letter, measures such as Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) do exist, they are only guidelines and are solely reliant on their application via the regulatory regimes of sovereign states.

"As my colleagues, Leigh Turner and Hugo Frost, explained to your Shadow Minister for Education, Dr. Grant Gibbons, last week, we understand your concern about the therapeutic application of stem cells in the absence of robust international or local regulatory frameworks and the potential risk that may present to Bermuda's reputation."

The letter describes the Human Tissue Authority as an organisation with a regulatory remit to offer advice and guidance in line with statute, which engages closely with professionals and public stakeholders in developing policies and regulatory arrangements.

"We consulted the HTA, who suggested that you might review their website, particularly looking at the section about licensing for human application; specifically the HTA Directions and the Compliance Report Licence Application," it states.

"Together they set out the standards expected of an establishment in the UK, when it comes to procuring, processing, storing and distributing stem cells for human application.

"Looking to the future, and perhaps beyond this immediate proposal, Bermuda may want to consider the introduction of legislation to enable internationally recognised stem cell research and treatment to take place within a transparent and well-regulated framework."

The Brown-Darrell Clinic responded: "The Brown-Darrell Clinic is very much aware of the international protocols relative to stem cell research and treatment.

"Although we were not privy to the discussion between Dr. Grant Gibbons and UK authorities last week relative to Brown-Darrell, both Stemedica and Brown-Darrell share the FCO's concern regarding the application of stem cells in the absence of robust international or local regulatory frameworks and the potential risk that such applications may present to the reputations of Bermuda as well as Stemedica.

"It has always been our intent to ensure that our operations are conducted under the aegis of a robust international regulatory framework and all of the established and well-known international protocols.

"As such, all research and treatment functions performed at Brown-Darrell will incorporate the best regulatory and ethics practices of the World Health Organisation and, further, will include, as an affixed part of each treatment protocol, the Declaration of Helsinki.

"In short, nothing is more important to Brown-Darrell than patient safety and the moral and medical efficacy associated with advancing the clinical application of adult stem cells.

"As to legislation, we would welcome and encourage legislation consistent with the international protocols practiced by countries engaged in stem cell research."

Last month, The Royal Gazette reported how George Daley, president of the International Society for Stem Cell Research, warned desperately sick patients who could be heading to Bermuda not to be misled into believing the treatment was a miracle cure.

Dr. Daley, an associate professor at Harvard Medical School, fears patients across the world with life-threatening illnesses are already being treated by medics who, he believes, take advantage of hype over stem cell treatment at great expense to the patient with no assurance of success.

Mrs. Jackson said in a statement yesterday afternoon: "Our concern in this matter is for patient protection and the reputation of Bermuda.

"It is clear that the FCO believes Bermuda needs to first set up a regulatory framework before allowing the establishment of stem cell research and treatment facilities.

"There are internationally recognised protocols regulating experimentation on human beings that we can adapt and adopt to see that this is done. Failure to do so may well subject Bermuda to huge reputational damage.

"We have to be very careful that Bermuda is not seen as a jurisdiction that allows unregulated human medical research and treatment. Consequently, we believe that no licence or permit should be issued for the proposed clinic until the many serious and outstanding issues can be satisfactorily addressed and resolved by credible independent authorities."

The Ministry of Health has repeatedly refused to answer questions over Bermuda's legislations. In September, the Bermuda Sun reported the Bermuda Health Council was in the process of preparing recommended regulations for the Minister of Health, meaning the Council does not currently issue licences.

Yesterday, the Ministry again failed to respond to questions asking whether that was still the position.

Health Minister Michael Scott did not respond to a series of questions, including whether he would push for legislation or try to delay the opening of the Brown-Darrell Clinic until new legislation is in place or the issue has been debated.

Cabinet Secretary Marc Telemaque said it was "perhaps unwise" to comment as Cabinet Office did not have a copy of the letter.

Asked if he would be prepared to comment if The Royal Gazette forwarded him the letter, he replied: "Afraid not. It seems to me it's the United Bermuda Party's letter and for them to comment upon and not really for anyone else. The FCO has never corresponded with the Government on the matter."

Regulatory bodies in other countries include: the Medicine and Healthcare Products Regulatory Agency in the UK; the Food and Drug Administration in the US; and the Stem Cell Oversight Committee in Canada.