News

Xenotransplantation moves ahead in UK

John Warden, parliamentary correspondent, BMJ

Strict, though not yet statutory, controls over xenotransplantation have been laid down by the British government. They entail applying to a regulatory authority and passing through several other hoops leading to ministerial clearance by the secretary of state for health.

The move coincides with confirmation that a Cambridge based company, Imutran, is within months of applying for a licence to use a pig's liver to provide dialysis until a human organ becomes available. The liver would not be implanted in the body and would be viable for only 48-72 hours.

The new government controls on xenotransplantation are open rather than obstructive. In January 1977 an ethical advisory group concluded that it was not then appropriate to allow xenotransplantation in humans, though it could be acceptable if certain criteria were met. That led to the creation of the UK Xenotransplantation Interim Regulatory Authority (UKXIRA), which last week set out its criteria for handling applications to proceed with xenotransplantation.

A simultaneous health service circular directs the NHS not to facilitate any such treatments for patients without the prior written approval of the secretary of state. It describes the arrangements under which clinical trials or procedures may be undertaken and the system for seeking approval. Any proposal must first be submitted to the UKXIRA for consideration, About six referees will scrutinise each proposal, which may also require the approval of other state bodies dealing with medicines control or gene therapy.

Guidance from the regulatory authority focuses on applications to proceed with xenotransplantation in humans and considerations of animal welfare. Given the novelty of the therapies under development, the authority wants to hear directly from those involved about the work they are undertaking, without prejudice to any future application.

Work is now going on to develop standards of tissue quality and a surveillance system for any xenotransplant recipients. Compliance will be a precondition for making applications. The authority is to hold an international scientific workshop this month to look at the key issue of pig retroviruses. A working group will study infection risks of the various therapies.

The health secretary, Frank Dobson, said that trials in xenotransplantation involving humans will be allowed only if and when he is fully satisfied that the risks are acceptable. Although regulation remains on a non-statutory basis, he is ready to take action at short notice to prevent undesirable activities.

More information can be found on the government's website (http://www.open.gov.uk/doh/new.htm).