UK: Pharmaceutical Marketing - the Pitfalls to be Aware of When Marketing Drugs for Use in Children

The advertising of pharmaceuticals is governed by the Medicines (Advertising) Regulations 1994. These provide that no person shall issue an advertisement which is likely to lead to the use of a Prescription Only Medicine ("POM"), or any other medicinal products used for treating specified classes of diseases, for example, malignant diseases or sexually transmitted diseases. Advertising of Pharmacy ("P") or General Sale List ("GSL") medicines is permitted provided that they are not used to treat those specified diseases.

Regulation 9 provides that no person may issue an advertisement relating to a medicinal product which contains any material which is directed exclusively or principally at children. For the purpose of these regulations, children are taken to be under 16's.

The Proprietary Association of Great Britain ("PAGB") represents manufacturers of over the counter ("OTC") medicines and operates a prepublication approval system for member companies' consumer advertising. Their code also states that advertising shall not be aimed principally or exclusively at children, and further provides that advertisements shall not show children using, or within reach of, medicines without adult supervision. Therefore, if a company wishes to target children, it will need to do so via the parents.

It is also important that the indications for use which are mentioned in any promotions are those approved in the marketing authorisation. They should not be extended or extrapolated to include unauthorised uses. Guidance issued by the Medicines and Healthcare Products Regulatory Agency ("MHRA") states that an advertisement should not give the impression that the product is particularly suitable for young children unless the marketing authorisation clearly allows such use. This is often a problem due to the difficulties of obtaining marketing authorisation for use in children due, in turn, to the difficulty of using children in clinical trials.

GlaxoSmithKline ("GSK") recently ran into trouble with the MHRA when it published a children's story book, "Mr Sneeze and his allergies", that contained two pages promoting its products at the back. These pages had dotted lines with little scissors along side them suggesting that the parents should remove the pages, but sometimes there were no instructions to do so. GSK stated that they had not had a single complaint from a parent. However, the MHRA took the view that the book could not include as integral parts both literature aimed at children and material promoting medicinal products, and at the request of the MHRA, GSK withdrew the book from circulation and agreed not to reissue it in that form. The PAGB had approved the book, stating that it was a very good way of providing this type of information to children, and that the book had been sent out to parents with a letter advising the parents to remove the pages referring to the products before giving it to children. The MHRA said that the book would continue to be available, but the material for parents would be attached as a separate item.

In summary, there is little scope for advertising products directly to children. It seems that disease awareness campaigns should be targeted primarily at the parents of the children, so that any content that may be directed at children cannot be said to be done so exclusively or principally, but ideally the content for children and the content for adults should be made available separately.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.