Bermuda's new stem cell regulations are unlikely to be in place when the Brown-Darrell Clinic's stem cell facility opens.

Health Minister Nelson Bascome yesterday said his Ministry would establish policy guidelines by May 2009, following talks with Brown-Darrell: Premier Ewart Brown and his wife Wanda who have teamed up with California-based Stemedica.

However, Mr. Bascome conceded that these guidelines would not have the teeth of regulations.

He said they would act as an interim measure to "assure the public" while the Ministry develops regulations, but the Ministry was unable to say when those regulations would be ready.

The stem cell facility was initially scheduled to open in 2007, but has been delayed following a storm of protests from international doctors about Bermuda's lack of stem cell regulations. Brown-Darrell has repeatedly refused to say when it will open, although the Premier announced last summer it would be "in the not too distant future".

Brown-Darrell has repeatedly failed to respond when asked if it will delay treating stem cell patients until regulations are established on the Island.

In a statement yesterday, Mr. Bascome said: "The Ministry of Health is presently developing policy guidelines for the operation of facilities in Bermuda. These will also be the foundation upon which regulations would eventually exist.

"You will be aware that the development of regulations is an involved and sometimes long process. The Ministry has taken the decision to establish policy guidelines in the first instance to ensure that facilities operating in Bermuda do so according to accepted international best practice as it relates to patient care and safety.

"The Ministry is working very closely with the Brown-Darrell Clinic and they have committed to abide by guidelines established by the Ministry. We envision the policy guidelines being in place before May 2009.

"The policy guidelines will consider established frameworks from other jurisdictions but will also take into consideration the local context.

"The Minister recognises that guidelines don't necessarily have the teeth of regulation but in communicating what Bermuda's standards are, policy guidelines will allow the Ministry the ability to assure the public whether or not a particular entity meets an acceptable standard of care and safety of patients. Guidelines will serve to bridge the gap between policy and regulation."

On hearing about the proposal in 2007, International Society for Stem Cell Research president George Daley said he was sceptical of any group running experimental treatment in jurisdictions without regulatory oversight. Dr. Daley warned desperately ill patients not to be misled into thinking stem cells are a miracle cure.

Responding last night, Shadow Health Minister Louise Jackson asked why the Ministry of Health was rushing to introduce guidelines before the regulations are ready.

She said in a statement: "The United Bermuda Party is already on record calling for proper oversight of stem cell research and treatment in Bermuda.

"Every First World jurisdiction involved in stem cell work has adopted very clear ethical and regulatory guidelines and rigorous institutional oversight.

"The Minister's statement that Bermuda will proceed with the establishment of policy guidelines 'in the first instance', even though they do not 'necessarily have the teeth of regulation', is very concerning.

"Our concerns are deepened by the fact that the Minister has made no mention of the need for a qualified, independent oversight committee including stem cell clinicians to review patient treatment plans before they are carried out.

"This is crucial for patient protection, reflecting best practices in First World jurisdictions.

"The fact that we are not taking the time to put in place a proper regulatory and oversight system before undertaking stem cell therapies prompts us to ask: Why the rush? Why not first put in place legislation to enable internationally recognised stem cell research and treatment to take place within a transparent and well-regulated framework?

"To proceed in any other way puts Bermuda's reputation at risk and opens us to the accusation of medical tourism."