§ Mr. DevaTo ask the Secretary of State for Health what was the outcome of the review of the Medicines Control Agency; and if will make a statement. [360]
§ Mr. SackvilleThe first evaluation study of the work of the Medicines Control Agency since its establishment as an agency, and the prior options study for its future operation, have recently been completed.
The evaluation study concludes that the MCA has been successful in safeguarding public health through the effective control of the sale and supply of pharmaceuticals in the United Kingdom. While maintaining the high level of public protection required for pharmaceuticals licensed for use in the UK, the MCA has provided a much improved service to the pharmaceutical industry and is now acknowledged as the fastest licensing authority in the world.
The prior options study concluded that abolition, privatisation and the contracting out of the MCA's core function are neither practical nor feasible. It notes, however, that some support functions might beneficially be placed on a contractual basis. It confirms the practical and legal requirement for a UK regulatory authority and proposes that UK Ministers should remain responsible for its core work. The work and the workload of the agency are expected to change over the coming years because of the implications of the new European systems for the regulation of pharmaceuticals. Until the impact of these new systems can be properly assessed, the report confirms that the executive agency model operating as a trading fund continues to represent the best organisational framework for the MCA.
I support the findings of the evaluation study and the prior options study, the results of which will feed into the revision of the agency's framework document which is now in hand.
I have today placed a summary of the reviews' findings in the Library.