§ Mr. BakerTo ask the Secretary of State for Health (1) what plans he has in place to contain a potential outbreak of a lethal infectious disease as a result of pig-to-human transplants; [99324]
(2) what recent assessment he has made of the scale of the risks and hazards posed by pig-to-human transplants. [99325]
§ Mr. DenhamThe Government are advised on all issues relating to animal-to-human transplants by the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA). Evidence about the safety of xenotransplantation is kept under constant review by the UKXIRA. Safety remains of paramount importance. Any clinical trial in xenotransplantation involving humans will be allowed to take place only when we are fully satisfied that the risk associated with the particular procedure involved is acceptable.
The precautions to be adopted by applicants for minimising the risk of infectious disease transmission will be a key factor in deciding whether or not to approve clinical trials. In this respect, the UKXIRA has issued two draft documents for widespread consultation. "Guidance notes on Biosecurity considerations in relation to xenotransplantation" sets out best practice for the processes and procedures to be employed in facilities where source animals are raised and kept. The "Report of the Infection Surveillance Steering Group" describes a framework for monitoring the health of xenotransplant recipients and in particular surveilling them for any signs of zoonotic infection that might be the direct result of the xenotransplant. This includes a possible mechanism for responding to suspected infection incidents. The UKXIRA would expect any applicant seeking permission to undertake a clinical trial involving a xenotransplantation procedure to have due regard to the recommendations of these documents.
Both documents are available on the UKXIRA website, www.doh.gov.uk/ukxira.htm.