Drugs

HC Deb 19 March 1979 vol 964 cc478-88W

Mr. Ashley

asked the Secretary of State for Social Services what proportion of the drugs exported from Great Britain in 1978 to Third world countries was included in the World Health Organisation's list of 200 essential drugs.

Mr. Moyle

This information is not available.

Mr. Ashley

asked the Secretary of State for Social Services (1) what steps he is taking to standardise information to all recipients of British drugs at home and abroad;

(2) if he will seek to amend the Medicines Act 1968 so as to make it obligatory to provide full information to foreign customers;

(3) if information about the correct dosage of British drugs exported to Third world countries is always provided to the recipients;

(4) pursuant to his reply of 21 July 1978, if he will ask the leading drug exporting companies whether they provide overseas doctors with the same or a similar data sheet, giving particulars of contra-indications, warnings, precautions and action to be taken in the event of an overdose, which is legally required for doctors in the United Kingdom under the Medicines Act; and, if they do not. if he will request them to do so;

(5) pursuant to his reply of 21 July 1978, if he will ask the leading British drug companies whether the warnings given in adverse warning leaflets about six drug substances are heeded in the marketing and recommendations for use of drugs in overseas as well as in the home market;

(6) whether his Department has any control over the overseas marketing practices of British drug companies, their recommendations for the use of drugs, maximum dosage, and their warnings of contra-indications; and, if so, how this is exercised.

Mr. Moyle

Copies of the Committee on Safety of Medicines' Annual Report and Adverse Reactions Warnings Leaflets are routinely supplied to the World Health Organisation for transmission to other drug regulatory authorities.

Apart from dissemination of information by the World Health Organisation, it is open to, and possible for, a foreign government to satisfy itself on the manner in which a product is promoted in the United Kingdom. No further legal powers are required to achieve this. Either it can seek, through the exporting company, an appropriate certificate issued under Section 50 of the Medicines Act or it can approach my Department direct which will provide as much information as is freely available to prescribing doctors in this country. This could include such information as the indications for use, dosage, contra-indications, warnings and precautions. Where a data sheet has been issued this could also be supplied. In addition, copies of the publications supplied to the World Health Organisation and of the medicines review letters are available on request. I cannot comment on Monthly Index of Medical Specialities which is a commercial publication.

The data sheet system is, I believe, at present unique to this country and one which my Department is currently studying with a view to further standardisation, in particular, the layout and content of data sheets. However, it is for importing countries to decide the manner in which information about drugs should be disseminated to their own doctors. This is an issue domestic to the foreign state concerned which the United Kingdom cannot control. It is likely that many governments supply information to their doctors reflecting the licensed status of products in the United Kingdom and in turn, the promotional information used in the United Kingdom which must confirm to that approved status.

Of fundamental importance is the fact that conditions including the availability of medical services, endemic disease, climate and diet may be quite different in other countries. Such differences may reflect on the way in which particular drugs are used in those countries. For this reason, I remain of the opinion that this country cannot deny other countries the opportunity of deciding for themselves which medicines they require and how any information about these is provided to their own doctors.

Mr. Ashley

asked the Secretary of State for Social Services (1) if he will seek legislation to amend the Medicines Act 1968 so as to include exported drugs in licensing controls;

(2) if, when a new drug is refused a licence, he has any powers to prevent that drug being exported from the United Kingdom.

Mr. Moyle

Certain biological products such as antigens, toxins, anti-toxins, sera, anti-sera and vaccines cannot be exported unless licensed under the Medicines Act 1968. Other products for export-only are not subject to licensing controls. In practice, however, many foreign governments will not permit importation unless there is proof of the right of sale in the United Kingdom. By an order made under section 48 of the Act, licensing controls could be extended to all products only where such an arrangement is for the purpose of giving effect to an international agreement to which the United Kingdom is a party. For the reasons advanced by my right hon. Friend the Under-Secretary of State in response to the Adjournment debate on 30 January, I do not at present consider it is reasonable or practicable for me to seek additional powers to extend licensing to medicinal products which are for export.—[Vol. 949; c. 730–44].

Mr. Ashley

asked the Secretary of State for Social Services how many World Health Organisation certificates have been issued, since the beginning of the scheme, for the export of drugs from the United Kingdom which are not registered for use in the United Kingdom; and to what proportion of the total number of exported drugs they apply.

Mr. Moyle

None. The United Kingdom has agreed to participate in the scheme subject to the reactivation of section 48 of the Medicines Act, thereby allowing the United Kingdom licensing authority to grant licences relating to products that are only for export. Until such time as an order is made under section 48, the United Kingdom cannot comply fully with the terms of the scheme, although export certificates issued under section 50 of the Medicines Act continue to provide certain assurances in relation to the manufacture of products.

Mr. Ashley

asked the Secretary of State for Social Services (1) if exporting manufacturers are required to issue certificates of quality, relating to individual batches of drugs, before permission to export can be given;

(2) if he is empowered to make checks to determine whether the quality claimed for drugs exported to Third world countries is accurate; what checks have been made in each of the last five years; and with what results;

(3) what checks are made on the quality of drugs imported into the United Kingdom; and how these checks and procedures differ from checks made on samples of drugs exported to Third world countries;

(4) if his inspectors have powers to inspect or approve manufacturing facilities or operations relating to the manufacture of drugs for export,

(5) if he is satisfied with the quality of drugs exported to Third world countries, and what checks he makes to prevent the export of substandard batches;

(6) what protection is offered to those countries importing United Kingdom drugs known to have negligible testing facilities, whereby they can satisfy themselves of the quality of the products they import.

Mr. Moyle

The Medicines Act 1968 requires that all medicinal products, whether for the United Kingdom or elsewhere, are manufactured in accordance with a manufacturer's licence. The granting of such a licence indicates that the licensing authority is satisfied as to the premises, equipment and other facilities concerned and as to the qualifications of the staff under whose supervision manufacturing operations are carried out. Manufacturers are required to conduct manufacturing and assembly operations in such a way as to ensure that all medicines processed by them, whether for the home or export markets, shall conform with the standards of strength, quality and purity applicable to them. Inspections are carried out to ensure that manufacturers comply with the provisions of their licences. Furthermore, samples of medicines are taken from manufacturers and off the market. These are tested by the Medicines Testing Laboratory operated on behalf of the Department by the Pharmaceutical Society of Great Britain. Thus very considerable steps are taken to safeguard the quality of medicines for the home and export markets.

Checks carried out on the quality of medicines imported into the United Kingdom are essentially the same as for those manufactured here, although it is not possible for scrutiny of overseas manufacture to be as close as it is in the United Kingdom. Information on the checks carried out over the last five years in connection with products exported to Third world countries is not available since records do not differentiate between products for the home and export markets.

It is for importing countries themselves to determine whether or not manufacturers should be required to provide certificates of quality relating to individual batches.

I am satisfied that the general arrangements for securing the quality of manufactured medicinal products are reasonable and responsible in respect of both home and exported medicinal products.

Mr. Ashley

asked the Secretary of State for Social Services what information he has about the frequency, seriousness and effectiveness of drug recalls undertaken for safety reasons; what procedures are followed when a recall campaign is initiated only after suspect batches have been exported from the United Kingdom; if foreign Governments have been notified; under what agreements; and what notifications have been given to foreign Governments in the past three years.

Mr. Moyle

A 24-hour service for handling reports of suspected defects in medicines is provided by the Defect Report Centre within my Department's Medicines Division. On average, about 25 full recalls a year are effectively carried out for safety and other reasons. Any reports from abroad of suspected defective batches would be handled by the centre under the same procedure as for medicines on the home market. Recall would be initiated through the commercial channels with assistance, where necessary, from officials of the division. It has not been necessary to notify any foreign governments, although such action would be considered in case of need whether or not there were agreements to this effect.

Mr. Ashley

asked the Secretary of State for Social Services if existing regulations or administrative procedures require the destruction of sub-standard batches of drugs, or other appropriate procedure, such as relabelling; and, if so, what supervision or enforcement over this exists.

Mr. Moyle

The possibility of substandard batches of medicinal products being released for sale or supply are minimised through the general licensing arrangements made under the Medicines Act and in particular by the inspection of manufacturers and the sampling and testing of medicines by the Department and by individual manufacturers. As a batch may be sub-standard for various reasons, total destruction may not be called for. For example, it may be appropriate to re-work a product which has not been manufactured in accordance with its specification so that valuable active ingredients may be recovered; on the other hand, all that may be necessary for a labelling error is correction and re-presentation of the batch.

Mr. Ashley

asked the Secretary of State for Social Services how many applications for drug licences have been made in each of the last five years; and how many have been refused.

Mr. Moyle

The most recent available figures on applications for product licences are:

	Applications received	Refused
1977	660	16
1976	762	9
1975	623	14
1974	704	23
1973	514	16

Approximately a quarter of the applications are withdrawn by the applicant or returned by the licensing authority as being inadequate for assessment.

Mr. Ashley

asked the Secretary of State for Social Services if, on any occasion in the past three years, he has received representations from any foreign Government about the quality of drugs exported from the United Kingdom; and what was contained in such representations.

Mr. Moyle

As explained in my reply to my hon. Friend on 16 March 1979—[Vol. 964, c.348]—there has been only one such representation. Not all the drugs required by the purchasing authority would necessarily be manufactured in, or indeed exported from, the United Kingdom; and the overseas government has expressed its satisfaction with the information we gave which made it possible for an adequate control system to be arranged.

Mr. Ashley

asked the Secretary of State for Social Services, pursuant to his reply of 27 July 1978, if he will ask the leading British drug companies whether the definitive recommendations made in the 42 medicine review letters, referring to 128 products, are being observed by the companies in all export markets.

Mr. Moyle

No. A definitive recommendation of the Committee on the Review of Medicines is a scientific statement on an ingredient or drug substance related to conditions in the United Kingdom. The acceptability of drugs in other countries is a matter for these countries.

Mr. Ashley

asked the Secretary of State for Social Services, pursuant to his reply of 27 July 1978, if he will list the British companies which manufacture the 128 products about which definitive recommendations have been made.

Mr. Moyle

The product licence holders notified of the definitive recommendations of the Committee on the Review of Medicines mentioned in my reply to my hon. Friend on 27 July 1978 [Vol. 954, c.928–30], are as follows:

• Approved Prescription Services Ltd.
• Bayer Pharmaceuticals Ltd.
• Berk Pharmaceuticals Ltd.
• Biorex Laboratories Ltd.
• Boehringer Ingelheim Ltd.
• The Boots Co., Ltd.
• E. H. Butler & Son Ltd.
• Cambrian Chemicals Ltd.
• Carlton Industrial Ltd.
• Chelsea Drug & Chemical Co., Ltd.
• Ciba-Geigy (UK) Ltd.
• Arthur H. Cox & Co., Ltd.
• Cox Continental Ltd.
• Richard Daniels & Son.
• DDSA Pharmaceuticals Ltd.
• Evans Medical Ltd.
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• Halewood Chemicals Ltd.
• Harris Pharmaceuticals Ltd.
• Thomas Kerfoot & Co., Ltd.
• Lilly Industries Ltd.
• Macarthys Ltd.
• Macfarlan Smith Ltd.
• May & Baker Ltd.
• Merck, Sharp & Dohme Ltd.
• Parke, Davies & Co.
• Regent Laboratories Ltd.
• R. P. Drugs Ltd.
• M. A. Steinhard Ltd.
• Syntex Pharmaceuticals Ltd.
• Thornton & Ross Ltd.
• Ticen Ltd.
• VAC International Ltd.
• Wallace Laboratory Sales Ltd.
• Wm. R. Warner & Co., Ltd.
• Wellcome Research Ltd.
• G. O. Woodward & Co., Ltd.

Since July 1978, the Committee has made further definitive recommendations on ingredients contained in some 600 drugs for which product licences are held by the following companies or individuals:

• C. Abernatty MPS.
• Abbott Laboratories Ltd.
• Abdine Ltd.
• Allen & Hanbury Ltd.
• Antigen Exports Ltd.
• Antigen International Ltd.
• Ashe Laboratories Ltd.
• Askit Ltd.
• Ayrton Saunders & Co., Ltd.
• G. Baldwin & Co.
• Becken & Son Ltd.
• Beechams Products
• Beecham Research Laboratories Ltd.
• Bengue & Co., Ltd.
• Booker Export Services Ltd.
• W. H. Box.
• British Chemotheutic Products Ltd.
• British Felsol Ltd.
• Bristol Laboratories.
• British Schering Ltd.
• British Weleda (UK) Ltd.
• Brome & Schimmer Ltd.
• W. J. Bush & Co., Ltd.
• Carnrick Laboratories.
• Carr's Mendip Herbal Products.
• Carter-Wallace Ltd.
• Cartwrights (Rawdon) Ltd.
• Cathay of Bournemouth Ltd.
• Charnwood Pharmaceuticals Ltd.
• Chemipharm Ltd.
• Chilva Laboratories Ltd.
• Clarkes Proprietry Medicines UK Ltd.
• Consolidated Chemicals Ltd.
• Co-operative Wholesale Society Ltd.
• Crookes-Anestan Ltd.
• Cullen & Davison Ltd.
• Cupal Ltd.
• Cuxson Gerrard & Co., Ltd.
• Dales Pharmaceuticals Ltd.
• Dalmuir Trading Co., Ltd.
• F. C. Davidson & Son (Chemist) Ltd.
• E. C. De Witt & Co., Ltd.
• Diopharm (Pharmaceuticals) Ltd.
• Duncan Flockhart & Co., Ltd.
• English Grains Ltd.
• Ethipharm.

• Eucryl Ltd.
• Ex-Lax Ltd.
• Farrilon Ltd.
• Fennings Pharmaceuticals Ltd.
• Fisons Ltd.
• R. F. Fleming Smith.
• Ford Jackson & Co., Ltd.
• D. R. H. Forman.
• Charles E. Frosst & Co.
• G. T. Fulford & Co., Ltd.
• Galen Laboratories Ltd.
• Glynwed Wholesale Chemists.
• Dr. G. Godfrey.
• Graesser Salicylates Ltd.
• W. N. Grayson.
• Greens Pharmaceutical (Holdings) Ltd.
• Thorn. Guest & Co., Ltd.
• Halas Laboratories Ltd.
• Halls Hygeine Ltd.
• Charles Hammerton.
• Harker Stagg Ltd.
• Phillip Harris Medical Ltd.
• Hill's Pharmaceuticals Ltd.
• Hough Hoseason & Co., Ltd.
• Industrial Pharmaceutical Services Ltd.
• International Chemical Co., Ltd.
• International Laboratories Ltd.
• International Medications Services Ltd.
• Interox Chemicals.
• Isola Manufacturing Co., Ltd.
• Ernest Jackson & Co., Ltd.
• Janniel Ltd.
• Janssen Pharmaceutical Ltd.
• Kennedy's Medical Hall Ltd.
• Kerbina Ltd.
• H. & T. Kirby & Co., Ltd.
• Knox Laboratories Ltd.
• Laboratories for Applied Biology Ltd.
• G. R. Lane Health Products Ltd.
• Laporte Industries Ltd.
• Lewis Laboratories Ltd.
• Lincoln & Midlands Counties Drug Co., Ltd
• London Co-operative Chemists.
• J. M. Loveridge Ltd.
• L. R. Industries Ltd.
• J. K. Lunt.
• Mawson & Proctor Pharmaceuticals Ltd.
• Mayfair Chemical Ltd.
• McClure Young & Co. (Export), Ltd.
• M. C. P. Pharmaceuticals Ltd.
• Medo-Chemicals Ltd.
• Menley & James Laboratories.
• Miles Laboratories Ltd.
• Miller of Golden Square.
• Montedison Pharmaceuticals Ltd.
• J. R. Napier.
• Neo Laboratories Ltd.
• Newton Chemical Ltd.
• Nicholas Laboratories Ltd.
• Norma Chemicals Ltd.
• Northern Pharmaceuticals Ltd.
• H. N. Norton & Co., Ltd.
• Nu-Organic Remedies Ltd.
• Optrex Ltd.
• Organon Laboratories Ltd.
• Parker Robinson Ltd.
• Parkinsons Ltd.
• Pfizer Group.
• Pharmitalia.
• Pharmax Ltd.
• Potters Ltd.
• Pritchards Ltd.
• W. M. Ransom & Son Ltd.
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• Reckitt & Colman Ltd.
• Reynolds & Branson.
• Rice Steele & Co., Ltd.
• Richardson-Merrell (Vick International) Ltd.
• Richardson-Merrell Ltd.
• Rickard Lane Herbal Remedies.
• Riker Laboratories.
• F. Roberts (Herbal Dispensary).
• Roberts Laboratories Ltd.
• A. H. Robins & Co., Ltd.
• J. Robinson & Sons Ltd.
• Roche Products Ltd.
• Rosmarine Manufacturing Co. (1954) Ltd.
• Roussel Laboratories Ltd.
• Ruscoe Ltd.
• Sandoz Products Ltd.
• Sarindus.
• Savory & Moore Ltd.
• Scotia Pharmaceutical Products.
• Selles Dispensing Chemist.
• Sinclair Pharmaceuticals Ltd.
• Smith Kendon Ltd.
• Smith Kline & French Laboratories Ltd.
• Southon Laboratories Ltd.
• J. G. Squires Ltd.
• F. A Stackhouse (Chemists) Ltd.
• Stafford-Miller.
• Sterling-Winthrop Group Ltd.
• Sundrops Ltd.
• Surf Ski International.
• TCL (Park Royal) Ltd.
• Chas K. Thackeray Ltd.
• Hubert A. C. Thomas & Co., Ltd.
• Thompson & Capper Ltd.
• Thompson & Joseph Ltd.
• Miss P. H. Topping.
• Trinders Forty (Chemists) Ltd.
• Typharm Ltd.
• Unigreg Ltd.
• Unimed Pharmaceuticals Ltd.
• Upiohn Ltd.
• Vestric Ltd.
• Veterinary Drug Co., (York) Ltd.
• Wade Pharmaceuticals Ltd.
• Walker Davis & Co., Ltd.
• Wallace Cameron & Co., Ltd.
• Wallace Manufacturing.
• Wallis Laboratories Ltd.
• A. Wander Ltd.
• J. Water House & Co., Ltd.
• W. B. Pharmaceuticals Ltd.
• Westone Products Ltd.
• J. F. White & Co., Ltd.
• White Laboratories Ltd.
• Wigglesworth Ltd.
• Willcox/Jozeau Ltd.
• W. Woodward Ltd.
• Walter Worthington.
• Wright Layman & Umney Ltd.
• John Wyeth & Brothers Ltd.
• Zamit Ltd.

Notes

1. 1. A product licence authorises the holder to sell, supply, or import the product. Many product licence holders also manufacture but it is not possible without disproportionate effort to identify cases where manufacture is by a company other than the product licence holder.
2. 2. These lists may contain companies or individuals whose licences are in process of cancellation. It has not been possible to verify within the time available that all licences are currently valid.