ALAN HUNTER, director of law, regulatory and intellectual property and secretary to the Association of the British Pharmaceutical Industry, replies:

We write to respond to Mr Shaw's letter and offer our comments upon the labelling issues raised, although we should point out that it is the Medicines and Healthcare products Regulatory Agency that has responsibility for the regulation of medicines labels and for enforcement under the Medicines Act 1968 according to its interpretation of the law.

The rules relating to the supply of unlicensed medicines by pharmaceutical companies are complex but, in principle, if a doctor makes an unsolicited request for the supply of a product with a particular specification that is not licensed in the UK, a company can obtain it and supply it to that doctor for administration to particular patients of his and on his direct personal responsibility. This is the case whether or not the product is specially manufactured (the products to which Guidance Note 14 mentioned by Mr Shaw applied) or is a finished product licensed elsewhere that is specially imported (products in part covered by old Medicines Act Leaflet 30).

Although in the UK such supply has sometimes been described as "named-patient supply", there has never, in fact, been a requirement that the patient actually be named to the company. This would be difficult when supplies are made to a practitioner to compose stock which may then be used for particular patients — whose names may not be known when the initial stock is supplied.

However, the company is required to keep records of the names of the health professionals to whom the unlicensed product is supplied. In MAL 30 the licensing authority also stated that, although not a requirement, it welcomed being informed (presumably by the relevant doctor) of the prescribing of unlicensed products, including the name and address of the patient, the condition to be treated and the drug to be administered.

Although the UK's implementation of EU pharmaceutical law has created some uncertainties as to how such products should be labelled by the company, there appears to be no statutory requirement for the company to put the name of the patient on the label. However, there is no obligation upon companies to supply unlicensed medicines and, therefore, it is open to them to make it a condition of supply that the name of the patient be supplied to them, whether for product liability or other reasons.

Supply of the patient's name without the patient's consent would be a breach of confidentiality by the patient's doctor. Nevertheless, it is generally considered good practice for doctors to counsel patients on the fact that treatment with an unlicensed product is proposed and if, as part of this process, consent is given by the patient for supply of his or her name to the company in question, no problem ought to arise. Of course, the receiving company would be required to maintain confidentiality consistent with prevailing data privacy rules.

As regards off-label use, manufacturers cannot promote products in a way inconsistent with the approved prescribing information. However, the use of products off-label by doctors is not addressed in the pharmaceutical legislation because it is essentially a matter for the clinical judgement of health professionals. Certainly, unless a requirement arises from a special monitoring scheme in force pursuant to obligations contained in the marketing authorisation (of the type, for example, imposed in relation to use of Clozaril [clozapine]), there is no general obligation imposed upon a company to require information from doctors as to the names of patients for whom a company's licensed product has been prescribed off-label.