Important decision on the distinction between marketing and non-commercial information in relation to medicinal products

Setterwalls has previously written about the significance of the distinction between marketing and freedom of speech, for example here. This distinction is of material importance as it determines which rules apply to communications in relation to medicinal products. A recent decision gives us reason to revisit this topic. The decision highlights the importance of pharmaceutical companies reviewing and, if necessary, correcting statements made to journalists, as the company may be held responsible for what is stated in the article.

Background
The Ethical Rules for the Pharmaceutical Industry in Sweden (LER) include rules regarding information from and marketing by companies, directed at healthcare professionals or the public. Non-commercial information, however, is protected by constitutional rules on freedom of speech and thus falls outside the scope of LER’s rules on marketing of medicinal products.

The Information Examiner Committee (IGN), which monitors compliance with LER by pharmaceutical companies that are members of the Swedish Association of the Pharmaceutical Industry (LIF), can refer cases of a principled nature to the Information Practices Committee (NBL). IGN recently referred a case to NBL concerning the distinction between marketing and non-commercial information in relation to medicinal products. In this article we review NBL’s decision (NBL 1136/2024).

In the case in question, a Swedish listed pharmaceutical company was contacted by a financial journalist writing an article about how the company would be affected in the U.S. market by an FDA approval of a competitor’s product. The company’s own product had received FDA approval but had not yet been approved in the EU. The article was a follow-up to a previous article on the subject, which also included comparisons between the two products. The questions were answered by the company’s CEO, but according to the company, the article was independently written by the journalist and published in Dagens Industri without the company’s knowledge or involvement.

NBL’s Assessment
NBL began by noting the importance of company representatives being able to answer questions from journalists and provide information about the company and its research. However, this must be done with discretion so that the information or statements provided are not unintentionally perceived as marketing of medicinal products, thus falling within the scope of LER.

NBL focused on the fact that the company’s CEO made specific statements about percentages, compared different studies and presented information, including value judgments, in such a way that, in NBL’s opinion, the statements conveyed a commercial purpose and were considered to refer to purely commercial conditions. The committee believed that the company could have satisfied its shareholders’ and investors’ interests by expressing itself differently. As a result, NBL found that the statements, based on a comprehensive assessment, constituted medicinal product information, making LER applicable.

Although the article had not been written by the company itself, it contained statements from the company’s CEO. NBL emphasized that it is important for representatives of a pharmaceutical company to always take LER into account in their statements and own communication efforts. Companies should always ensure that they read and, if necessary, correct their statements, as the company may be held responsible for what has been conveyed. NBL assumed that the statements in the article were accurately reproduced and considered that the company should be responsible for the content of the article.

NBL concluded that the statements were in breach of LER. In the article, the company made a comparison between its own product and the competitor’s product in a way that was considered misleading and in breach of LER. Furthermore, several of the statements were considered to be pre-launch information, since the article made information available to the public without the medicinal product having been given marketing authorization in Sweden.

NBL wanted to emphasize that there are no obstacles in LER against pharmaceutical companies responding to, or making, statements to journalists. However, the statements have to be made in such a way that they do not constitute medicinal product information or, if the statements are medicinal product information, that they comply with the rules in LER.

Dissenting Opinions
It is interesting to note that the decision contains dissenting opinions.

Six of the committee members pointed out that an interview situation cannot be equated with a press release written and reviewed by the company. An interview is a special situation where the person answers direct questions of various kinds (i.e. according to the so-called pull and not push principle), often unprepared and without time for preparation. The journalist is responsible for the article as a whole, and the questions asked.

These committee members also looked at the interview in its context and highlighted that it was a follow-up to another article where comparisons and figures regarding side effects etc. were presented, which were repeated in the current article. The members noted that it was not the pharmaceutical company that presented the data in the current article but that the data were already present in several previously published articles. The company was thus interviewed as a result of the already published articles and commented on direct requests. Additionally, these dissenting members believed that the interview and article dealt with an area of importance to the listed company. A company’s CEO must, in this context, be able to answer questions from a financial journalist and give their view of the company’s future, including about confidence in its products.

One committee member largely agreed with the six members’ dissenting opinion but added that it is not possible to freely answer questions from journalists and make any claims about the company’s products. Instead, companies should strive to communicate information that is accurate and maintains a high scientific standard. In her opinion, the statements were unacceptable as they did not meet the scientific standard expected of LIF’s member companies. However, in view of the above-described circumstances the current statements could not be considered to be commercial information.

Comment
The decision shows above all that representatives of pharmaceutical companies should always take LER into account in media statements, even in situations where they are not proactive vis-à-vis the media but are responding to journalists’ questions. Companies should ensure that they read and, if necessary, correct statements and assess whether the upcoming article falls within the scope of LER and, if so, ensure that the statements comply with this regulatory framework.

Setterwalls continues to monitor and report on the latest developments in the field. Our life sciences team has extensive experience in marketing of medicinal products – do not hesitate to contact us for guidance through the regulations!