Patient safety and cutting-edge medical research will be put at risk by government plans to merge its watchdogs for fertility treatment and human tissue to save money, leading doctors and scientists said yesterday.

The proposal to replace the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) with a combined super-regulator has prompted criticism from every significant professional and patient group that is affected.

Clinicians and researchers say that the remit of the new Regulatory Authority for Tissues and Embryos (Rate) will be so broad that it will lack the expertise it needs, while creating extra tiers of bureaucracy and expense. Its shortage of specialist knowledge will jeopardise public and professional confidence, and could even compromise its ability to oversee complex areas of medicine with implications for patient safety, the critics say.

A committee of MPs and peers scrutinising the draft legislation that will establish the authority has been inundated with complaints, and it is expected to urge ministers to abandon the merger when it reports this month.

Written evidence that is highly critical of the plan, seen by The Times, has been submitted by the British Medical Association, the Medical Research Council (MRC), the Wellcome Trust, the Royal College of Obstetricians and Gynaecologists (RCOG), the Royal College of Pathologists, the Royal Society, the Academy of Medical Sciences and the Royal College of Nursing. Representatives of patient groups such as Infertility Network UK have also questioned the merger.

Despite this opposition, Gordon Brown confirmed this week that the Human Tissues and Embryos Bill will form part of his Government’s first Queen’s Speech. The merger was proposed in 2004 after the Department of Health’s review of arm’s-length bodies recommended cutting its 38 quangos to 20 to save £500 million. The new body, however, will cost between £2 million and £7 million to set up, for the sake of savings of £700,000 a year.

The HFEA regulates fertility treatment and embryo research, including embryonic stem cells, while the HTA covers anatomy, pathology, organ transplants, research using human tissue and the display of human remains in museums and galleries.

Rate will oversee all these areas, together with blood transfusions and banks, which are currently under the Medicines and Healthcare products Regulatory Agency. It is anticipated that its ruling authority will have between 15 and 20 members with a lay majority and a lay chair, like each of the bodies it replaces. The critics argue that this means a maximum of seven or eight doctors or scientists will have to provide expertise across a wide range of medical and ethical fields.

Both existing authorities struggle to amass sufficient specialist knowledge to master narrower briefs, and the new one will have to cover topics as diverse as IVF, postmortem examinations, the safety of new products such as artificial blood, and the bodies in Gönther von Hagens’ Bodyworlds exhibition. Rate will rely heavily on expert advisory panels that are not directly accountable to Parliament, but which it will lack the knowledge to overrule.

“The problem is that the body that is responsible for making decisions will not have expertise in the areas it is regulating,” the BMA said. “As a result, there is a very real risk that Rate will lack credibility and the confidence of those regulated, the public and Parliament . . . It will be difficult for Rate to reject the advice of expert groups and so it is likely to be seen as simply ‘rubber-stamping’ their decisions.”

Vivienne Nathanson, the BMA’s head of science and ethics, added: “A lack of expertise could affect patient safety.”

Peter Braude, of the RCOG, said: “The differences between dealing with lives created through assisted reproduction and managing autopsies or body shows are gigantic. If you lump all these together you are not going to have the right expertise.”

The MRC and the Wellcome Trust, Britain’s biggest funders of medical research, said that the new body would be poorly placed to assess new experiments, and expressed concern at the likely high cost of its licences.

The Department of Health said that Rate was smaller in scope than comparable merged bodies such as the Food Standards Agency and Ofcom.

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