Α.The advertising of medicinal products.
The Directive 2001/83/EC on the Community Code relating to medicinal products for human use provides a harmonized framework for the advertising and promotion of medicines. The directive has been implemented to Greek law via Ministerial Decision ΔΥΓ3α/οικ.82161.
According to the Directive’s Article 86, “advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”. Such advertising particularly includes the advertising of medicinal products both to the general public and to Healthcare Practitioners (HCP), visits by medical sales representatives to HCP, while it also includes the supply of samples and sponsorship of promotional meetings attended by HCP etc.
However, the above definition, originally given by Directive 2001/83/EC article 86, does not include any indication as to the author of advertising. For example, it doesn’t clarify whether HCP, medical and healthcare agencies or journalists are also, apart from pharmaceutical companies, entitled to advertise medicinal products and if so, under which conditions. It is worth noting at this point, that the Greek Doctors’ Code of Ethics strictly forbids the advertising in any possible way of medicinal products or medical devices by doctors (article 6 par.4).
Furthermore, the Directive’s Articles 87 and 88 introduce two significant prohibitions relating to the advertising of medicinal products. In particular, article 87 prohibits any advertising of a medicinal product that has no marketing authorization according to EU law, while article 88 prohibits the advertising to the general public of medicinal products which are only available on medical prescription, or contain substances defined as psychotropic or narcotic by international convention. The ban shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
European law therefore prescribes that the advertising of medicinal products must encourage rational use of the medicine, by presenting it objectively and without exaggerating its properties; it must not be in any way misleading. In addition, all parts of the advertising must comply with the content of the summary of product characteristics (SmPC). “Off-label promotion” of medicinal products is, therefore, strictly prohibited.
The Directive also foresees several other prohibitions relating to the advertisment of medicinal products to the public such as their direct distribution to the public by the industry for promotional purposes. As exclusion, the Directive nevertheless permits the advertising of medicinal products to the general public, products that by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment (over-the-counter advertising).
Furthermore, all advertising to the general public must be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as medicinal. Naturally, it must also include basic information such as the name of the medicine and all the necessary information regarding its correct usage. It should not include, however, any misleading material regarding its characteristics and efficiency.
In Greece, EOF’s role (National Organization of Medicines) is to ensure that there is sufficient control regarding the advertising of medicinal products. In this context, EOF has also introduced certain guidelines, in full accordance to the Directive’s intent. In particular, according to EOF’s circular number 49393/2011, advertising of a POM to the general public must include the name of the medicine, as well as its common name, all the necessary information for its correct use as well as an express, legible invitation to read carefully the instructions on the package leaflet or the outer packaging.
On the other hand, advertising to HCP is regulated by slightly different rules, given the fact that HCP possess extensive and specialized knowledge which allows them, to a certain point of course, to identify whether an advertisement is misleading or not. According thus to the Directive any advertising of a medicinal product to HCP must include the essential information which is compatible with the summary of product characteristics and the supply classification of the product. The same rule also applies to any documentation relating to a medicinal product which is transmitted as part of the medicine’s promotion.
Moreover, medical sales representatives must have adequate training by the firm which employs them and must also have sufficient scientific knowledge in order to provide information which is precise and complete about the medicinal products which they promote. We would also like to point out that during the promotion period, any gifts, pecuniary advantages or benefits in kind to HCP are strictly prohibited, unless they are inexpensive and relevant to the practice of medicine or the pharmacy.
In conclusion, SFEE as a member of EFPIA has also implemented respective dispositions, regarding the advertising of medicinal products, in its Code of Ethics.
Our law firm’s comment
The existing European legislation regarding the advertising of medicinal products undoubtedly rises in prominence in the European regulatory framework and for good reasons. It foresees common rules for all Member States, ensuring therefore the safety of all consumers and all HCP. In particular issues, problems on misleading advertising can be dealt with securely meeting in a common-sense ground, both ensuring consumer and HCP protection and allowing the industry to function competitively.