§ Mr. Teddy TaylorTo ask the Secretary of State for Health what representations he has received from the pharmaceutical industry about the consequences for pharmaceutical research in the United Kingdom of proposals on the duration of patent protection; and if he will make a statement setting out the nature and origin of the problem.
§ Mrs. Virginia BottomleyRepresentations have been received from individual companies and the Association of the British Pharmaceutical Industry on the relationship between pharmaceutical research and patent life. I refer my hon. Friend to the reply my hon. Friend the Parliamentary Under-Secretary of State for Industry and Consumer Affairs gave to my hon. Friend the Member for York (Mr. Gregory) on 15 April at columns32–33.
§ Mr. Teddy TaylorTo ask the Secretary of State for Health if he will outline the duties of the Medical Control Authority which supervises pharmaceutical and medical items; and if he will indicate whether there is any appeal system against items being classified as medical or drug treatments.
§ Mrs. Virginia BottomleyThe Medicines Control Agency of the Department of Health acts on behalf of Ministers for the protection of public health through the licensing and control of medicines under the Medicines Act 1968 and EC regulations and directives Items for496W which medicinal claims are made are licensable as medicines, though "instruments, apparatus and appliances" are expressly excluded from the Act's scope. In cases of doubt, the Medicines Control Agency expresses an opinion on a product's status, which a company may or may not accept. Ultimately, only the courts can provide an authoritative interpretation of the law if mutual agreement on status cannot be reached.