Who: European Medicines Agency
When: 7 June 2013
Law stated as at: 4 July 2013
When, in early 2013, the advertising agency for a major skincare brand came up with the idea of breaking away from the classic ‘woman in white bathrobe’ formula and instead portraying the central character in an advertisement as though she were an addict with a genuine physiological dependency on the cream, they must have thought they were going to be in line for some awards. The advert was clever, eye-catching, memorable and mischievous, a great new way to raise the profile of an established brand. Unfortunately, the public, and a number of drug addiction charities, did not agree.
Within a short space of time the Advertising Standards Authority (ASA) received 60 complaints that the advert trivialised the problem of drug addiction, and the campaign was pulled by the manufacturer.
Public opinion, and the reputational issues arising from a possible adverse finding by the ASA, placed the campaign beyond the pale.
Advertising medicinal products
The skin cream in question was a cosmetic, not a medicine, so there is some irony in having run into trouble by trying to promote it by such a quasi-medical message. No pharmaceutical company could ever contemplate running such a campaign for a medicinal product.
Advertising medicinal products for human use is regulated in the European Union not only under European Directive 2001/83 but also under a comprehensive system of self-regulation. Prescription medicines may not be advertised to the general public at all, but only to those qualified to prescribe or supply them – principally doctors and pharmacists. A proposal to change this has been under discussion at the European Parliament since 2008, but there does not seem to be any prospect of it being enacted in the short term.
Over-the-counter (“OTC”) medicines can be advertised, but subject to strict limits and the over-riding requirement that the advertising should encourage the rational use of medicine by presenting it objectively, without misleading or exaggerating the medicine’s properties. Any claim that the health of the patient can be enhanced by taking the product is precluded, as is the suggestion that failing to take it may affect health. Also prohibited would be the suggestion that the product is a cosmetic, foodstuff or other consumer product – precisely the converse of the implication that the skincream advert tried, too cleverly by half, to raise. Information necessary for the correct use of the product would also have had to be included.
Failure to comply with these requirements is, in the UK, a criminal offence for which a fine and up to two years’ imprisonment may be imposed.
It is unlikely however that a manufacturer of an OTC product would ever find themselves facing such a charge in the UK, since the Pharmaceutical Association of Great Britain operates a pre-approval system for its members so that adverts are vetted for compliance with its Consumer Code before reaching the public domain. This is for example similar to the situation in France and Switzerland, where a pre-approval system of OTC products also exists. Contrary to that, such a pre-approval system does for example not exist in Germany; where all promotional activities by pharmaceutical companies are regulated by law (by the so called Heilmittelwerbegesetz – HWG) and some more specific code of conducts created by two pharma-industry associations (AKG and FSA).
European Medicines Agency draft guidelines on medicine trade names
For prescription medicines authorised centrally through the European Medicines Agency (“EMA”), prior approval is also required at the earlier stage of choosing a trade name under which the product is to be marketed. The naming of medicinal products carries a number of risks to patient safety, whether because patients misunderstand what medicines they are taking, or confuse the products’ names with others already stored in the family medicine cabinet – and which may have been there for several years. The magnitude of risk varies according to what the product is, and what patient groups it is or is not approved for. The EMA has for many years provided guidelines as to what criteria trade names need to meet in order to be acceptable, and has recently issued a draft for a revised guideline drawing upon its experience with the system to date, for comments by 30 August 2013.
To be approved under the guidelines, like advertisements for all kinds of medicinal products, the trade name for a prescription product should not convey misleading therapeutic or pharmaceutical connotations. Further, it must not convey any promotional message about the therapeutic or pharmaceutical characteristics of the product – such as calling it “Cancer-cure” – nor have any offensive or negative connotations in any official EU language (the possible difficulties of pronunciation in any official EU language also need to be considered). Nor, for obvious reasons, should trade names be liable to confusion with the international non-proprietary name (“INN”) for the active ingredient of either the same or any other product; under the proposed new guidelines detailed justification must be provided if the stem of the INN is to be included in the proposed name since even this degree of similarity is disapproved by the World Health Organisation.
Why this matters:
The changes made in the current draft introduce one or two product-type specific criteria, such as for radiopharmaceuticals, and spell out more detail around the use of qualifiers and abbreviations by letter as part of an invented name. Although acceptable in principle, the draft guidelines now explicitly state that the potential to increase confusion as a result of using more complex names needs to be taken into account. The labelling and packaging, especially of non-prescription medicines, are also factors. Further, submission of names very similar to each other is now discouraged; although some one-letter changes such as ZYPREX to ZYPREXA have in the past been sufficient to overcome objections, the guidelines now state that any safety or public health concern associated with one version may apply to the other, increasing the chance of rejection. The approval process itself has also been modified slightly, not least such that only two proposed names may be submitted at one time.
Complete separation of the name review for regulatory purposes from any trade mark law issues remains in place. Approval of a name by EMA is therefore not a guarantee of suitability for registration as a trade mark, and conversely registering a trade mark for the proposed name will not help to persuade the EMA to approve it.
Consequently, pharmaceutical companies need to consider the interplay of advertising, regulatory and trade mark law in order to select and secure the most appropriate brand for their valuable products.