The legal framework for disease awareness campaigns

Disease awareness campaigns become more and more common. Below you can find out more about the legal framework for such campaigns as well as the implication of the rules in the use of such campaigns.

Background
A disease awareness campaign is aimed at raising awareness and providing knowledge regarding a specific disease rather than a pharmaceutical product. It can be beneficial for patients who want to learn more about their disease, as well as individuals who believe they may have the disease in question and wish to find out more about it.

The legal framework for marketing pharmaceutical products in general
The marketing of pharmaceutical products is governed by the Medicinal Products Act (Sw: Läkemedelslagen) and the medicinal products agency’s regulation LVFS 2009:6 on marketing of pharmaceuticals for human use (the “Regulation”). These implement the marketing provisions of EU Directive 2001/83/EC on the Community code relating to medicinal products for human use. Members of LIF, the research-based pharmaceutical industry in Sweden, must also comply with the Ethical rules for the Pharmaceutical Industry (the “LER rules”). In addition, the general rules on marketing apply, e.g. the Marketing Act (Sw. Marknadsföringslagen), which states inter alia that marketing should be in line with good marketing practice. What is considered good practice in the field of marketing of pharmaceutical products can be derived from inter alia the LER rules.

The marketing of pharmaceutical products is subject to review by the committees IGN (Sw. Informationsgranskningsnämnden) and NBL (Sw. Nämnden för Bedömning av Läkemedelsinformation). It is also under the supervision of the Medical Products Agency (Sw. Läkemedelsverket).

The legal framework
Marketing of prescription pharmaceuticals (Rx products) to the general public is prohibited. However, the Regulation states that information on health or diseases is exempted from the regulations on marketing of pharmaceutical products, provided that no reference, even indirectly, is made to pharmaceutical products. It is apparent from both IGN case law, as stated in inter alia W1379/12 and IGN137, as well as LIF’s guidance on the use of digital channels, that a website that is predominantly problem-based and product-neutral is not considered marketing within the meaning of the LER rules. Such websites may be referred to as educational websites and are exempted from the provisions regarding marketing.

A disease awareness website is therefore not considered marketing of pharmaceutical products provided that it meets the criteria regarding educational websites described above. The distinction between educational websites and marketing is, however, not always clear. Educational websites may therefore be reviewed by IGN and NBL for compliance with the LER rules on marketing of pharmaceutical products.

For reference, in a recent IGN case (IGN137, mentioned above), the committee was to consider the marketing of a disease awareness website via a television commercial. IGN stated that since no product names were mentioned on the website and the website was problem-based and product-neutral, the website was considered an educational website. As a consequence, the television commercial marketing the website was found to not be in breach of the LER rules.

No Rx products may be named by their brand names on an educational website, and the website may not provide links to FASS regarding specific products. This applies not only to the main text but also to infographics and content adjacent to the text. However, a company name may be used in a disease awareness campaign, as the company name does not designate any specific product. Nevertheless, the campaign should focus on the disease rather than specific treatments so that it does not risk being considered indirect marketing of a pharmaceutical product.

Further, testimonials from individual patients regarding the use of a pharmaceutical product are prohibited. However, testimonials from individual patients regarding a disease are not prohibited. As such, “disease testimonials” may be used by a pharmaceutical company in a disease awareness campaign. Nevertheless, it is important that such information does not mention any specific pharmaceutical products nor provide positive accounts of a specific type of treatment.

Moreover, all pages or websites under the control of the pharmaceutical company are the responsibility of the company in regard to inter alia adverse event reporting. Hence, if someone were to leave a comment in connection with a disease awareness campaign specifying an adverse effect of one of the company’s pharmaceutical products, the company must comply with the requirements on adverse event reporting. It must also ensure that there are no comments made that could be considered testimonials regarding the use of a pharmaceutical product. Hence, it is important to have procedures in place regarding comments made on disease awareness websites.

Disease awareness campaigns and influencers
One way to promote a disease awareness campaign is through influencers, i.e. influential social media personalities. Influencers may be used by companies who wish to market their products to the influencer’s followers or, in the case of disease awareness, raise awareness regarding the disease among the influencer’s followers.

It is important to know that the rules on marketing of pharmaceutical products in general also apply to marketing of pharmaceutical products through influencers. Hence, the principles governing marketing in general, along with the LER rules, apply to the content published by the influencer. Therefore, if an influencer is to be used in a disease awareness campaign, it is important to ensure that the influencer’s content cannot be considered marketing of a pharmaceutical product or a testimonial regarding the use of a pharmaceutical product.

Further, it is important to note that the pharmaceutical company is normally responsible for comments made on an influencer’s contributions to a disease awareness campaign that are considered testimonials regarding the use of a pharmaceutical product or adverse event reporting.

In conclusion
In summary, there are a multitude of aspects to be considered when creating a disease awareness campaign, not only in terms of content but also of presentation and implementation. Above we have outlined certain aspects a pharmaceutical company should consider, but the legal framework is complex and includes many discretionary assessments. Setterwalls’ life science team has extensive experience in the field of marketing of pharmaceutical products, both Rx and OTC, and are happy to assist in any related matters.