(2) what regulations govern the use of combined human and pig (a) organs and (b) cells for research purposes; and if she will make a statement.
To date there have been no human transplant procedures in the United Kingdom using pig organs.
European Union (EU) legislation on medicinal products (Commission Directive 2003/63/EU) and the Clinical Trials Regulations (2004) make specific provision for such transplantation proposals. In December 2006, the Department issued guidance which covers all aspects of animal to human transplant procedures, which reflect international recommendations. The guidance is available in the Library and from the Departments website:
www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063075
In addition, the use of animals in such research, or as sources for clinical animal to human transplantation requires appropriate authorisation under the terms of the Animal (Scientific Procedures) Act 1986, which is the responsibility of the Home Office.
The Human Fertilisation and Embryology Act 1990 prohibits mixing live human gametes with the live gametes of any animal, except in certain circumstances for testing the fertility or normality of human sperm. The Government have undertaken a wide-ranging review of the law on assisted reproduction and embryology and expects shortly to publish draft legislation for pre-legislative scrutiny.