Enhanced requirements for disease awareness campaigns?

While the marketing of prescription pharmaceuticals to the general public is forbidden, disease awareness campaigns are becoming more and more common. Such campaigns are aimed at providing problem-oriented information, such as awareness of specific diseases, without promoting specific medicinal products or specific treatments. There has been some development in recent case law, possibly enhancing the requirements for such disease awareness campaigns. Johan Reimer and Karolina Jivebäck Pap, part of Setterwalls Life Sciences team, elaborate below.

Background and legal framework

The marketing of medicinal products is governed by the Medicinal Products Act and regulation LVFS 2009:6 on the marketing of pharmaceuticals for human use, as well as the general rules on marketing in the Marketing Act. Only members of industry organisation LIF are formally bound by the Ethical rules for the Pharmaceutical Industry (the ‘LER rules’) and the associated review by the committees ‘IGN’ (Sw. Informationsgranskningsnämnden; Information Review Board) and ‘NBL’ (Sw. Nämnden för Bedömning av Läkemedelsinformation; Pharmaceutical Information Evaluation Board). However, the LER rules and the judgments issued by the committees may be considered good practice for the marketing of medicinal products.

In accordance with the rules mentioned above, marketing of prescription pharmaceuticals to the general public is prohibited (see Chapter 12, Section 1 of the Medicinal Products Act, as well as article 102 of the LER rules). However, information about health or diseases is not considered marketing of medicinal products, as long as no reference is made (even indirectly) to specific medicinal products. A disease awareness campaign is thus a campaign aimed at raising awareness and providing knowledge regarding a specific disease, rather than a medicinal product or a specific treatment. Such problem-oriented information is protected by freedom of speech.

Testimonials from individual patients regarding the use of a specific medicinal products are also prohibited (see article 108 of the LER rules). As with the above, testimonials from individual patients regarding a disease, i.e. ‘disease testimonials’, are not considered marketing and are protected by freedom of speech. Such testimonials are often used as part of a disease awareness campaign. To ensure that the testimonial in question remains a “disease testimonial”, it is important to ensure that the patient does not, either directly or indirectly, refer to a specific pharmaceutical product. If such reference is made, it would be considered marketing of said medicinal product through the use of a patient testimonial.

Recent case law

In three recent cases, the NBL concluded that three separate disease awareness campaigns were to be considered marketing and included testimonials from individual patients. In reaching its conclusions, the board applied a very narrow interpretation of the aforementioned exemptions. The cases are set out below:

• The first case concerned a film in which a patient described both her disease and how a treatment had made her feel better. Even though the patient did not mention the name of the pharmaceutical used nor give any details of the treatment, the NBL concluded that her statements where a testimonial made by an individual patient, which included a subjective evaluation of a treatment. The board concluded that since a pharmaceutical company had produced the film, whoever saw the film would get the impression of a connection with pharmaceuticals within the relevant area of treatment. This connection would be made no matter which pharmaceutical the patient in the film was actually treated with. Thus, the film was deemed to constitute the marketing of prescription pharmaceuticals to the general public, which also contained a testimonial from a patient.
• The other two cases concerned an article describing a treatment, which, in one case, had simplified the treatment of the disease, and, in the other, had made the patient feel better. As with the above case, the committee concluded that, even though the pharmaceutical was not named or described, it regarded the statement as confirmation regarding an individual patient, including subjective evaluations of a specific treatment. As the pharmaceutical companies in question had contributed to the article, and were named in the article, this gave the reader the impression of a connection to the pharmaceutical company’s products within the relevant area of treatment. This connection would be made no matter which pharmaceutical was actually used by the patients. The article was consequently deemed to be marketing of prescription pharmaceuticals to the general public, containing a testimonial from a patient.

In summary, the scope for making reference to treatments of the diseases was considered very limited. If a disease awareness campaign includes a testimonial where the patient describes a treatment, and the campaign is made in collaboration with a pharmaceutical company, the board concludes that the recipient of the information would associate the treatment mentioned with the pharmaceutical company in question. Thus, the reference to a treatment within a disease awareness campaign is to be considered indirect marketing of any medicinal product within the specific therapy area, by the pharmaceutical company in question.

Consequences and analysis of these cases

It could be argued that by applying the same reasoning as the board in the cases described above, it would not be possible for a pharmaceutical company to even contribute to a disease awareness campaign, as the recipient of the information would associate any information with the products of the company behind the marketing. At first glance, it could therefore be argued that the requirements have been enhanced for disease awareness campaigns.

However, bearing in mind previous case law, where a similar approach based on the risk of patients perceiving information as relating to a specific treatment was applied, the outcome of the cases described above was largely expected. Furthermore, the complete prohibition of problem-based information would be considered unlawful and an unnecessary restriction of freedom of speech.

Nevertheless, the cases show that it is increasingly important for pharmaceutical companies to ensure that any disease awareness campaigns refrain from marketing the treatment of a disease, i.e. a solution-based approach, rather than addressing the disease itself, i.e. a problem-based approach. However, it remains to be seen whether stricter demands are to be applied when it comes to ‘indirect’ marketing of medicinal products in general, and disease awareness campaigns in particular.