HL Deb 08 July 1993 vol 547 cc1504-6

3.17 p.m.

The Countess of Mar asked Her Majesty's Government:

Whether they conduct any independent scientific tests upon veterinary medicines prior to the issue of product licences in order to ensure that the products meet the manufacturers' claims for safety to the environment, animals and humans.

The Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food (Earl Howe)

My Lords, in common with applications made for licences for human medicines, the Government rely upon the integrity of the data submitted by the pharmaceutical companies in support of veterinary product licence applications. Some of that data can be produced on behalf of applicants by independent organisations.

The Countess of Mar

My Lords, I thank the noble Earl for that reply. Is he aware that organophosphates have never been tested on humans because they are so dangerous? That is therefore treating the users of sheep dips as guinea-pigs. Can he say how many suspected adverse reactions have to be reported before the product licence is withdrawn?

Earl Howe

My Lords, it is important that the noble Countess should understand that the procedures involved in the assessment of data submitted by pharmaceutical companies are extremely stringent. Toxicologists, pharmacists and veterinarians in the Veterinary Medicines Directorate, together with scientists from other government departments, carry out a thorough examination of all data submitted in support of product licence applications. Members of the independent Veterinary Products Committee also apply their own specialist scientific knowledge to complete the assessment process. Manufacturers' claims for safety, quality and efficacy are evaluated on the strength of thorough and critical analyses of the data presented.

Lord Gallacher

My Lords, can the noble Earl say how effectively the Veterinary Products Committee monitors suspected adverse reactions to veterinary medicines? Does the committee rely on the Veterinary Medicines Directorate for monitoring? If so, who pays for the cost of that? Can the Minister also say how secret is the safety monitoring information?

Earl Howe

My Lords, as at 6th July the number of suspected adverse reactions to sheep dips involving humans since 1st January 1985 reported to the Veterinary Medicines Directorate was 397, involving 483 individuals. Those cases are reported in a variety of ways to the directorate; sometimes through GPs, sometimes through the Ministry. That work continues. Every case is followed up and we hope to have a digest from the Veterinary Medicines Directorate when Ministers review the status of organophosphate sheep dips later in the year.

Lord Sanderson of Bowden

My Lords, can my noble friend confirm that his department has issued instructions to those who use organophosphorous sheep dips that care has to be taken in the application by farmers and other people who may use them?

Earl Howe

My Lords, my noble friend is perfectly correct. Information on the potential hazards from individual products is contained on the product label and health and safety data sheets provided by the manufacturer. For sheep dips, following recent recommendations from the Veterinary Products Committee, a new leaflet, a stick-on label and wall poster have been sent to all registered sheep farmers in the UK re-emphasising the requirements for safe use of these products. In addition, the HSE has published a guide to producing a farm COSHH assessment which is available free of charge from local HSE offices.

Lord Jenkin of Roding

My Lords, is my noble friend aware that he will have total support from all those who believe that questions of this kind must be determined by science and not by scares and pressure groups?

Earl Howe

My Lords, my noble friend makes a very good point. The noble Countess's strength of feeling on this issue is well understood. But I hope that she appreciates that the Government must decide these matters on the basis of independent scientific advice. That advice will be coming forward later in the year and Ministers will attend to the issue with the seriousness which it undoubtedly deserves.

Lord Callaghan of Cardiff

My Lords, is the Minister aware that the noble Countess's feelings are not only well understood but are well justified?

Earl Howe

My Lords, the Government will take a view on that later in the year.

Baroness Masham of Ilton

My Lords, with so many antibiotics being used in the farming industry, is there a danger to the food chain and to the resistance of humans to infection?

Earl Howe

My Lords, the tests carried out on all veterinary medicines include safety tests which incorporate tests on medicine residues. I do not believe that there are any licensed veterinary medicines which pose the kind of danger to which the noble Baroness alludes; but if she has any examples, I would be pleased to hear of them.

The Countess of Mar

My Lords, is the noble Earl aware of the two very real concerns that I have? The first is about the integrity of the chemical companies. We all know that if a product is banned in this country it is immediately sent to third world countries still with English labels on so that the users do not understand what they are doing. The second is about the independence of the Veterinary Products Committee, According to last year's annual report only one member of the committee did not have links with the chemical companies.

Earl Howe

My Lords, under the Medicines Act it is a legal requirement that data submitted in support of a product licence application must not be false or incomplete. If it is found that data have been withheld, the licensing authority has the power to suspend, revoke or vary the provisions of the licence. It is in no company's interests to attempt to short-circuit the, proper procedures. I shaft refrain from commenting on the second part of the noble Countess's question for reasons which I hope are obvious.