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Holly's Law

Answer

I refer the hon. Member to my repliesgiven on 20 December 2005, Official Report, column 2688W and 2726W.Current evidence supports the safety of medical abortion in the United Kingdom, and this is a method of abortion recommended by the Royal College of Obstetricians and Gynaecologists.The safety of all medicines in the United Kingdom is continuously monitored by the Medicines and Healthcare products Regulatory Agency. Since initial licensing in 1991, the safety of mifepristone (Mifegyne, RU-486)—a medicine used for abortion has been carefully monitored through review of reports of suspected adverse drug reactions and through periodic safety reports submitted by the manufacturer. Such reviews have evaluated both suspected complications and deaths relating to this medicine.In 2005, following new advice from the United States Food and Drug Administration, where this product is used in combination with another medicine that is not licensed for this purpose in the UK, reports of suspected serious adverse reactions associated with mifepristone, including cases of serious bacterial infection, were thoroughly reviewed. The regulatory authorities within Europe, including the UK, did not identify any new safety issues in this review. No additional enquiry is necessary. Regulatory action to withdraw this medicine in the UK, equivalent to that proposed in H.R. 1079 (Holly's Law) in the United States, is not appropriate since European Union advice, including UK expert advice, is that the balance of risks and benefits of mifepristone remains positive.

Secondary information

Type

Written question

Reference

65482; 445 c1701-2W;445 c1701-2W

Session

2005-06

Subjects

Abortion Drugs Mifepristone

Link

View this Written question on www.publications.parliament.uk