Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answers by Lord O’Shaughnessy on 15 November (HL11187 and HL11188), what data are recorded by the Medicines and Healthcare products Regulatory Agency’s pharmacovigilance work and the Yellow Card Scheme regarding drugs and dosages administered to women during IVF treatment and early pregnancy; to what extent this includes off-label drugs in order to monitor their long-term effects on women undergoing IVF treatment; how this compares to the collection of such data in other countries; and why the Human Fertilisation and Embryology Authority has no plans to establish a central database to monitor the long-term health implications of the medicines administered to women during IVF.

The Medicines and Healthcare products Regulatory Agency (MHRA) continuously monitors all reports of suspected adverse drug reactions (ADRs) via the Yellow Card Scheme, including those reported in association with use for assisted reproduction such as in vitro fertilisation (IVF). These include reports of licensed and off-label use of medicines to suppress the natural menstrual cycle, medicines to prepare and stimulate the ovaries for ovulation, medicines at the time of egg collection and embryo transfer and medicines used to support the placenta during early pregnancy. The doses of each medicine used are set out in the product information of licensed medicines and are considered as part of the evaluation process when a potential safety concern is reviewed. A suspected ADR may be reported at any time after the medicine has been taken.

European Union legislation requires Member States to provide spontaneous reporting systems for ADRs to medicines. Such systems are widely used internationally for collection of suspected adverse reactions.

Data from the register of patients and treatments, maintained by the Human Fertilisation and Embryology Authority (HFEA), is already used for research on the long-term health implications of medicines administered during IVF. Among the research projects that have been conducted using HFEA register data are studies that looked at the cancer risk for women undergoing fertility treatment and children born as a result of assisted reproduction.