§ Baroness Masham of Ilton
asked Her Majesty's Government:
Whether they agree with the report of the Scottish Council on Human Bioethics in January which 58WA found that "there is no conclusive clinical evidence that the morning-after pill is safe". [HL6130]
§ Lord Hunt of Kings Heath:
We do not agree with the conclusions reached in the report by the Scottish Council on Bioethics. Levonelle-2, containing levonorgestrel 0.75mg (the morning-after pill), is authorised in the United Kingdom as a prescription only medicine for emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. This followed advice from the independent expert scientific advisory body, the Committee on Safety of Medicines (CSM), which was satisfied as to the quality, safety and efficacy of the product in this indication. Substantial independent evidence reviewed by CSM included two World Health Organisation sponsored pivotal studies. One study involving approximately 2,000 women in 14 countries, including the UK, has been published in The Lancet (1998). The other, published in Human Reproduction (1993), involved 880 women. CSM has also considered evidence from a study of the effects of self-administering emergency contraception (New England Journal of Medicine, 1998). Copies are available in the Library.
There is considerable experience of worldwide use with levonorgestrel. It has been available in the UK in other contraceptives and hormone replacement therapy products for 30 years, although only more recently for emergency hormonal contraception. It has been used for emergency contraception in other parts of the world since the 1980s and between 9 and 23 million women have taken it. No major safety issues have been identified.
The safety of all newly licensed medicines in the UK is monitored closely by the Medicines Control Agency (MCA) and the CSM through the yellow card scheme. This was extended to community pharmacists in November 1999 in order to improve safety monitoring of over-the-counter medicines. The MCA continues to moinitor the safety of levonorgestrel 0.75mg and will review any potential safety issues in the light of any new evidence which may emerge.