§ Mr. Michael MorrisTo ask the Secretary of State for Health how many manufacturing sites for generic medicines supplied to the National Health Service are outside the European Community; and how many of these sites have been inspected within the last five years, last two years and last year, respectively.
§ Mrs. Virginia Bottomley[holding answer 23 October 1989]: Manufacturing sites are not differentiated as generic or proprietary. Products currently licensed in the United Kingdom include those produced at 685 manufacturing sites outside the European Community (EC): some of these sites are within signatory countries of the pharmaceutical inspection convention (PIC).
In the last five years the United Kingdom medicines inspectorate has inspected all manufacturing sites which are actively exporting medicinal products to the United Kingdom for use in the NHS and which are located outside the EC but are not within PIC signatory countries.
§ Mr. Michael MorrisTo ask the Secretary of State for Health how many product licences for generic medicines were granted in the years(a) 1985, (b) 1986, (c) 1987 and (d) 1988; and how many of the licence applications that received approval were referred to the Committee on Safety of Medicines.
§ Mrs. Virginia Bottomley[holding answer 23 October 1989]: The information is not available in the form requested. Licences granted for medicinal products are recorded statistically by the Medicines Control Agency according to whether they are new active substances or established drug substances. Product licences granted for established drug substances, including those for products which may subsequently be prescribed generically, are given in the table according to whether or not they were approved by the Committee on Safety of Medicines (CSM).
Licences granted for established drub substances Year Approved by the CSM Others Total 1985 78 565 643 1986 85 570 655 1987 60 564 624 1988 52 487 539
§ Mr. Michael MorrisTo ask the Secretary of State for Health (1) what discussions his Department has had with434W the Food and Drug Administration in the United States of America with specific reference to the licensing of generic medicines;
(2) whether his Department has any intention of categorising generic medicines, licenced by the Medicines Control Agency, into grade A and grade B products similar to the classifications in the orange guide to generics compiled by the Food and Drug Administration of the United States of America;
(3) whether, in view of the corrupt and fraudulent practices related to the submission of falsified data on some generic medicines to the Food and Drug Administration in the United States of America, he has any plans for tightening the procedures for the licensing of generic products by his Department.
§ Mrs. Virginia Bottomley[holding answer 23 October 1989]: We are aware of the allegations made in the United States of America that fraudulent data had been submitted as part of generic licence applications and officials have been in touch with the Food and Drug Administration. There is no evidence to suggest that the alleged malpractice in the United States of America has affected any of the generic products currently licensed in the United Kingdom but the matter will be kept under close review.
All licence applications, including generic products, must satisfy the strict requirements of the licensing authority as to safety, quality and efficacy of the product concerned before a licence is granted. We therefore have no plans for tightening the licensing procedures or for categorising generic drugs as in the United States of America.
§ Mr. Michael MorrisTo ask the Secretary of State for Health (1) what steps he is taking to ensure that National Health Service patients receiving generic medicines are informed of the name of the manufacturer;
(2) whether he intends to ensure that National Health Service patients will receive generic medicines in the manufacturers' original packs and with patient information leaflets in accordance with the proposed European Community Directive.
§ Mrs. Virginia Bottomley[holding answer 23 October 1989]: The question of original pack dispensing is under study. A recent European Community Commission consultative paper discussed the question of information for patients about medicines and made specific suggestions about labels and leaflets. However, this document was described as in no way engaging the Commission whom we understood currently to be considering the responses by Governments and outside organisations. It would be premature to make piecemeal commitments on detailed labelling or leaflet requirements before the Commission submits firm proposals for directives on these matters to the Council of Ministers.
§ Mr. Michael MorrisTo ask the Secretary of State for Health whether he has any plans to ask the public health laboratories to provide laboratory disintegration, dissolution and analytical data in respect of generic medicines that are the subject of product licence applications based purely on data submitted by the manufacturing company.
§ Mrs. Virginia Bottomley[holding answer 23 October 1989]: The licensing authority has access to the results of tests carried out by the National Health Service quality control laboratories on products purchased by the NHS.
435WIn addition, the licensing authority operates a sampling and testing scheme for licensed products, usually at the medicines testing laboratory. Where relevant, such tests would include disintegration, dissolution and analysis. We have no plans to extend these arrangements.