Vaccines: Animal Materials (Hansard, 9 July 2002)

§ Lord Hunt of Kings Heath

There have been guidelines for the pharmaceutical industry to follow on the use of certain animal materials in the production of vaccines and other medicines since 1989. The latest version of the guidelines was drawn up by the European scientific committee, the Committee for Proprietary Medicinal Products (CPMP), and adopted in May 2001. The latest version of the guidelines became legally binding from 1 July 2000 for new applications for a licence for a medicinal product and from 1 March 2001 for products that were already licensed.

The scope of guidance at any one time, and its implications for pharmaceutical companies, have often been unclear. Following a thorough review of the information supplied to Parliament on bovine spongiform encephalopathy-related issues in vaccines, the Government have established that, regrettably, incorrect and misleading information was given to Ministers by the Medicines Control Agency and thus has been given in response to a number of Parliamentary Questions. My honourable friend the Parliamentary Under-Secretary of State for Health (Ms Blears) made a Statement in the other place on Friday 5 July setting out the reasons for these errors and the current state of compliance with the guidelines. An account of the questions incorrectly answered and the correct information has now been placed in the Library, and letters sent to Members of both Houses who asked those questions.

We have also placed in the Library:

a copy of the Government's Chief Medical Officer's report on the withdrawal of the Medeva-Evans oral polio vaccine in October 2000;

a copy of the Committee on Safety of Medicine's (CSM) consolidated review of transmissible spongiform encephalopathy (TSE) agents and the safety of United Kingdom authorised human medicines;

86WA

a report by the MCA that explains in detail the development of the guidance for the pharmaceutical industry to follow on the use of certain animal-derived materials in the manufacture of medicines, and the approach taken by the agency to its implementation.

For all practical purposes, nothing in the reports that have been published changes the safety profile of any vaccine licensed for use in the UK. In particular, the CSM's review is reassuring in concluding that t here are no TSE-related issues arising from the use of animal materials in the manufacture of UK licensed vaccines.