§ Sir Michael McNair-WilsonTo ask the Secretary of State for Health if he has any proposals to change the procedures followed by the Committee on Safety of Medicines in licensing new drugs; and whether he will bring forward proposals for an interim procedure before full licensing while medical data about side-effects are established.
§ Mrs. Virginia BottomleyThe internal procedures of the Committee on Safety of Medicines (CSM) are a matter for CSM itself under schedule 1, paragraph 4 of the Medicines Act 1968. We respect and value the independent scientific judgments made by the CSM on the information laid before it and have no plans to amend schedule 1, paragraph 4.
Measures are already in place and are already used to assess safety and efficacy before a licensing decision is taken. Applicants for licences are required to report 675W information and data derived from tests laid down in detail by directive 75/318 EEC, including toxicity tests and clinical trials.
After licensing, data sheets communicate to doctors the licensed uses of medicines and precautions, warnings, and necessary information about side-effects. Newly introduced medicines are subject to the black triangle scheme on product literature for at least two years after initial marketing. This is to alert doctors to report all adverse reactions (side-effects) to these medicines to CSM. Also, CSM monitors them intensively and takes appropriate action for example, by special "current problem" communication to all doctors, if new adverse reactions are identified. In addition, there is a legal requirement on companies to report adverse reactions to their own products. Since 1986, the CSM has recommended that companies carry out post-marketing surveillance studies on new medicines for widespread long-term use.
The existing system is therefore comprehensive in its scope to the objects of making the best scientific judgment before licensing and for monitoring after licensing. It is in line with present European Community pharmaceutical directives.