§ Mr. CohenTo ask the Secretary of State for Health what was the local research ethics committee, including its composition, which approved the trial of the copper intra-uterine contraceptive device on patients in the United Kingdom for experimental purposes; what consideration it gave to the fact that the device had not been approved by the relevant authorities in the United States at that time and to notifying the patients that they were being used for experimental test purposes; and what steps he has taken to avoid United Kingdom patients being unknowingly tested by foreign drug companies occurring again.
§ Mr. MellorInformation about particular local research ethics committees is not held centrally.
With regard to the testing of medical products and the conditions under which they are administered to patients, I refer the hon. Member to my answer to the hon. Member for Lewisham, Deptford (Ms. Ruddock) at column 542 on 29 June.
§ Sir Michael McNair-WilsonTo ask the Secretary of State for Health how many complaints of infertility in women who have used the Copper 7 intra-uterine contraceptive device have been reported to his Department; and when the device was approved by the Department for use.
§ Mr. FreemanIn 20 letters received by the Department, women have expressed the belief that they have been adversely affected by the device, known in this country as the Gravigard. However infertility is not specified either in these individual cases, or in reports received under the scheme whereby doctors are asked to notify suspected adverse reactions.
The Gravigard's product licence was granted on 17 December 1973 and took effect retrospectively from 7 November 1973.