§ Mr. HindTo ask the Secretary of State for Health (1) in considering granting a licence for RU486 how many studies financed by the manufacturers Roussel Uclaf were66W considered by the Medicines Control Agency; by whom they were carried out; how large the samples were; what the results showed; and if he will make a statement;
(2) if he will publish the number of independent research projects commissioned by the Medicines Control Agency into RU486, the names of the research units involved and the results;
(3) how many of the studies commissioned by the Medicines Control Agency into RU486 included post-abortion syndrome studies and follow up studies on the mothers; and if he will make a statement.
§ Mrs. Virginia BottomleyThe Medicines Control Agency does not commission research projects into drugs. The MCA's role is to evaluate the data submitted in support of an application for a licence for a drug in respect of its safety, quality and efficacy for the indication proposed. For all new drugs, the MCA seeks the advice of the Committee on Safety of Medicines and its expert sub-committees. Section 118 of the Medicines Act 1968 precludes both Ministers and the MCA on grounds of commercial confidentiality from disclosing any information on data submitted by manufacturers in support of clinical trials or product licence applications.
I would, however, draw my hon. Friend's attention to the well-documented studies in the British Journal of Obstetrics and Gynaecology, June 1990, Vol. 97, pages 480 to 486, and in the New England Journal of Medicine, 8 March 1990, Vol. 322, No. 10, pages 645 to 648, copies of which are in the Library.
§ Mr. HindTo ask the Secretary of State for Health if he is setting up a special fund along the French lines to provide damages for children born deformed because their mothers have taken RU486 but then refused to take prostaglandin; and if he will make a statement.
§ Mrs. Virginia BottomleyNo. Both the licence holder's data sheet for Mifegyne, for use by the doctor, and the patient information leaflet stress the importance of completing the course of treatment.
§ Mr. HindTo ask the Secretary of State for Health what financial provision he is making in the budgets of regional and district health authorities for legal costs and damages against the possibility of deformed victims of RU486 suing the national health service; and if he will make a statement.
§ Mrs. Virginia BottomleyNo such action is necessary.