§ Mr. AmessTo ask the Secretary of State for Health (1) if he will publish the medical research and evidence on which the Committee for the Safety of Medicines based their recommendation that levonorgestrel 0.75 mg could be supplied as a pharmacy medication; [129410]
(2) what trials have been conducted in the United Kingdom to test the safety and long-term health effects of levonorgestrel 0.75 mg. [129409]
§ Yvette CooperA product containing levonorgestrel 0.75 mg has been authorised in the United Kingdom as a prescription only medicine. This followed advice from the Committee on Safety of Medicines (CSM) who were satisfied as to the product's quality, safety and efficacy. The evidence considered included two World Health Organisation sponsored pivotal studies. One study involving approximately 3,000 women in 14 countries, including the UK, has been published inthe Lancet (1998). The other, published in Human Reproduction (1993), involved 880 women. Copies are available in the Library. Other supporting data not in the public domain are confidential to the application.
Evidence of safety as stated was taken into account when the CSM considered the proposal for levonorgestrel 0.75 mg to be available without prescription. There is also evidence from a study of the effects of self-administering emergency contraception (New England Journal of Medicine, 1998). Levonorgestrel 0.75 mg has been available from pharmacies in France without a doctor's prescription since June 1999. The criteria for prescription control are defined in the legislation. The CSM considered each of these criteria and advised that they did not apply to levonorgestrel 0.75 mg for emergency contraception in women of 16 and over. They considered that all the steps required to supply emergency contraception safely could be successfully completed in a pharmacy.