EDITORIAL

The cost of prescribing unlicensed medicines

SINCE the passage of the 1968 Medicines Act, animal medicines have been licensed by law, and the object of that law is to protect the public.

Such protection is not simply that afforded to the consumer eating food from treated animals; animal medicines licensing is designed to protect the user, such as the stockman or pet owner, the animal patient, the worker mixing medicated feeds in the feed mill, the business purchaser such as the farmer, racehorse trainer or dog breeder and of course the veterinary surgeon and his staff. And equally important is the protection of the environment from animal health residues or out of date medicinal products.

Protection’ does not simply mean safety. There is also the need to protect the purchaser’s rights to ensure that animal medicines are of good quality and that they will do the job for which they are intended. Safety, quality and efficacy are common to all medicine licensing systems the world over.

However, before the days of licensing it was up to the veterinary surgeon, the pharmacist or the farmer to prescribe or administer the product that was thought appropriate. It was for this reason that when the Veterinary Surgeons Act of 1947 came into effect, veterinary surgeons were given considerable latitude to choose the products and substances best suited, in their professional judgement, for the treatment of the animals under their care.

That ‘right to prescribe’ has become increasing- ly important for two reasons. First, the product licence review which was instituted as a result of EC legislation has so far effectively removed 674 products from the market and placed a further 400 under threat. This is for the simple reason that the cost of providing data to meet the licens- ing authorities’ requirements has proved uneco- nomic to the companies concerned. Secondly, the diversification of farming and the fashion for ‘exotic’ pets has placed veterinary surgeons in the position of needing to prescribe for species or circumstances in which a licensed medicine or indication simply does not exist.

So we are faced with conflicting social trends. On the one hand there is increasing pressure to codify and restrict the use of animal medicines to protect the public. On the other, the need to treat

animals for which there is no licensed medicine available.

In September, 1989, the leaders of the veteri- nary profession reiterated the rules concerning the use of unlicensed medicines. These state that food producing animals should be treated only with medicinal products licensed for animal use; and that non-food producing animals may be treated with unlicensed veterinary medicinal products or human medicinal products only when no equivalent veterinary licensed product is available.

The importance of heeding these rules is con- siderable, for the cost of not doing so will inevitably impact upon the animal health indus- try, the veterinary surgeon and ultimately the welfare of all farm and companion animals.

Development costs of new products are extremely high, up to $100 million for a major product, all of which has to be financed out of sales. Meanwhile, the company has to forsee a good return on its investment if it is to proceed with development, licensing, production and marketing. Each time a veterinary surgeon choos- es to prescribe an unlicensed product in place of a suitable licensed one, further investment in research and development is undermined.

The loss effects not only companies, but also universities, veterinary schools and research establishments, all of which rely on contract research income, while new products - safer, faster-acting, less prone to resistance or more environmentally friendly, are not developed. The veterinary profession thus has to rely on an increasingly aged range of treatments.

In addition, unlicensed medicines provide no fee income to the Veterinary Medicines Direc- torate which supervises both wholesalers and manufacturing sites, indeed they mean an increase in fees from licence holders to fund the service.

The ‘right to prescribe’ is important to the vet- erinary profession, but it is one which should not be abused. Licensing is there to protect the pub- lic and to assist the veterinary surgeon’by provid- ing him with the medicines he needs. And off-label recommendations only serve to damage the licensing system.

ROGER COOK

485