Medicines Control Agency (Hansard, 18 January 1999)

§ Mr. Mitchell
To ask the Secretary of State for Health what representations he has recently received from(a) right hon. and hon. Members and (b) others in relation to the Medicines Control Agency Consultation 380W Document MLX 249; and how many of these representations (a) broadly supported and (b) broadly opposed the detail of the proposals. [65723]

§ Ms Jowell
[holding answer 14 January 1999]: We have received 69 letters from hon. and right hon. Members and 278 representations from other interested bodies and individuals. Three representations broadly support the proposals. The remainder are critical of the proposals to some degree.

§ Mr. Swayne
To ask the Secretary of State for Health what plans he has to extend the powers of the Medicines Control Agency; and if he will make a statement. [66362]

§ Ms Jowell
The powers of the licensing authority, of which the Medicines Control Agency is an executive arm, are set out in the Medicines Act 1968 and secondary legislation including the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994. There are no plans to extend those powers.
However, the MCA's Consultation Letter MLX 249 proposes amendments to these Regulations. The proposed amendments relate to a new statutory procedure for determinations by the licensing authority of whether a product is a medicinal product requiring licensing. The procedure would allow for representations to be made against a provisional determination that a product requires licensing. If a final determination is made, it will be sufficient evidence for the purposes of legal proceedings that the product requires licensing under the Regulations, unless it can be shown that the determination was made unreasonably or has been annulled. There is a further proposal that, when a final determination has been made that a product requires licensing, the licensing authority be able to serve a notice in writing on a person requiring that he refrain from placing the product on the market or otherwise marketing the product, and that it be an offence to breach such a notice. Decisions of the licensing authority would be subject to judicial review or other challenge in the civil courts.
When consideration of responses to the consultation is complete, we will consider whether and what legislative proposals should be put before Parliament.