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8 Jul 2003 : Column 785W—continued
Sunblocks
Mrs. Anne Campbell: To ask the Secretary of State for Health if he will reclassify high factor sunblock as a medicine. [123353]
Miss Melanie Johnson: The decision as to whether a particular product is a medicinal product is made by the Medicines and Healthcare products Regulatory Agency, using the definition of that term in Article 1 of Directive 2001/83, relevant legal precedent and its own published guidance. Products, which are presented to the consumer for treating or preventing disease, would be classified as medicinal products. Sunburn is an adverse medical condition and direct or implied product claims to treat or prevent sunburn would bring the product within the definition of a medicinal product, regardless of the product's level of sun protection factor. Products that modify physiological function could also be classified as medicinal products.
Certain creams or lotions with a sun protection factor of 15 or above, which are not licensed or marketed as medicines, may be assessed by the Advisory Committee on Borderline Substances (ACBS) as being regarded as drugs for the management of specific conditions. Products so recommended by the ACBS may be prescribed under the National Health Service.
World Health Organisation
Mr. Key: To ask the Secretary of State for Health pursuant to his answer of 30 June 2003, Official Report, column 118W, ref 121295, if he will list the scientific evidence on which the answer is based; and if he will make a statement on the procedures developed by the World Health Organisation. [123494]
Miss Melanie Johnson: Scientific evidence that should be taken into account in the safety assessment include: composition, effects of processing and cooking,
8 Jul 2003 : Column 786W
transformation procedure, the genetic modification event, protein expression of the novel DNA (including function, potential toxicity and potential allergenicity), potential secondary effects from gene expression, and potential intake regulatory impact.
The safety assessment of genetically modified (GM) food is undertaken by independent scientists on a case by case basis in accordance with the European Commission guidelines that accompany the EC Novel Foods Regulation (EC/258/97). Regulation 1852/2001 requires the European Commission to publish the data, which supports each GM food application made under EC 258/97.
Several organisations (Organisation for Economic Co-operation and Development and the Food and Agriculture Organisations of the United Nations), including the World Health Organisation have agreed that the assessment procedure for GM foods requires an integrated and stepwise, case-by-case approach.
Xenotransplantation
Mr. Godsiff: To ask the Secretary of State for Health for what reasons his Department does not intend to publish the findings of the report which it commissioned on the legality of xenotransplantation from Professor McLean and Dr. Williamson at the University of Glasgow. [123334]
Ms Rosie Winterton: The United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) advises my right hon. Friend, the Secretary of State, on issues about xenotransplantation (transplantation of live animal organs and cells into humans). The Department of Health commissioned a series of three reviews on different aspects of xenotransplantation on behalf of the UKXIRA between 1999 and 2001. The first two—on infection and on physiology—were published 2001 and 2002. A third review, on the legal and ethical aspects of xenotransplantation, was commissioned from Professor Sheila McLean, of the University of Glasgow, who was also a member of the UKXIRA from 1997 to 2002.
The UKXIRA has considered the review and concluded that it made some useful discussion points and that the summary of the research papers should be placed on the UKXIRA website. While there are no plans to publish Professor McLean's whole review as a Department of Health/UKXIRA document, Professor McLean is free to publish it if she wishes.
Private Sector Operations
Dr. Evan Harris: To ask the Secretary of State for Health how many people classed as self pay undertook operations in the private sector in each year since 1997, broken down by type of operation. [122791]
Mr. Hutton: The Department of Health does not collect information on the number of patients having operations carried out in the private sector, nor on the source of funding for those operations.