HC Deb 18 July 1991 vol 195 cc285-6W
Mr. Amos

To ask the Secretary of State for Health how much of the data on the clinical trials on the drug RU 486 has been published.

Mrs. Virginia Bottomley

I refer my hon. Friend to the well-documented studies in theBritish Journal of Obstetrics and Gynaecology, June 1990, vol. 97, pages 480–86 and in the New England Journal of Medicine, 8 March 1990, vol. 322, No. 10, pages 645–48, copies of which are in the Library.

Mr. Amos

To ask the Secretary of State for Health how the announcement that RU 486 was to receive a product licence in Britain was made.

Mrs. Virginia Bottomley

The company wrote to all doctors (gynaecologists), a duty they have to perform before marketing a product, informing them that a licence for RU 486 had been granted for use in the United Kingdom. This communique included an invitation to attend educational seminars on the drug and to explain the strict conditions of its supply.

Mr. Amos

To ask the Secretary of State for Health what research submissions he took into account in reaching his decision to license the drug RU 486.

Mrs. Virginia Bottomley

The licensing authority took account of all the data from clinical trials and usage in other countries submitted by the company for the product licence application. The licensing authority was satisfied that a product licence should be granted having consulted the independent Committee on Safety of Medicines as to the safety, quality and efficacy of Mifepristone (RU 486).

Mr. Amos

To ask the Secretary of State for Health if he will arrange for the full data on the clinical trials for the drug RU 486 to be published and placed in the Library.

Mrs. Virginia Bottomley

Section 118 of the Medicines Act precludes both Ministers and the Medicines Control Agency from disclosing any information on data submitted by manufacturers in support of clinical trial or product applications.

Mr. Amos

To ask the Secretary of State for Health how many representations he has received in connection with the introduction of RU 486 into Britain; and if he will list the total number(a) in favour of and (b) against its introduction.

Mrs. Virginia Bottomley

Over the past year we have received 815 representations about Mifepristone (RU 486). Twenty-one were in favour of its introduction, 772 were against and 22 sought information.

Mr. Amos

To ask the Secretary of State for Health which organisations were informed before his Department's official announcement that RU 486 was to receive a product licence in the United Kingdom.

Mrs. Virginia Bottomley

None.

Mr. Hind

To ask the Secretary of State for Health what is his Department's estimate of the average cost of(a) an abortion taking RU 486 and prostaglandin including three hospital visits and (b) a surgical abortion; and if he will make a statement.

Mrs. Virginia Bottomley

[holding answer 15 July 1991]: The estimated national health service revenue cost of an abortion using RU 486 and prostaglandin with two out-patient visits and one day visit is £182. The estimated NHS revenue cost of a straightforward surgical abortion as an in-patient is £270. These estimates are based on 1990–91 prices.

The decision on the choice of treatment is a matter for clinical judgment.