Advertising of medical products to the public and healthcare professionals (HCPs): how to minimize risks?

• LifeSciences
• SME

Advertising of medicinal products is in the focus of increased attention of competent state authorities and industrial self-regulatory bodies. Moreover, it is not uncommon for companies to closely monitor and analyse the advertising materials and practices of their competitors in order to detect improper advertising claims or other potential violations of legal requirements and to take appropriate action against such competitors (e.g. before Swissmedic, courts or the Code Secretariat under the local Pharma Code).

Legal requirements for the advertising of medicinal products

The promotion of medicinal products in Switzerland is strictly regulated. There are specific legal requirements for each type of promotion. The requirements for advertising medicines to the general public (so-called “public advertising”) are different from those for advertising to healthcare professionals (so-called “professional advertising”). Further, unlike over-the-counter(OTC) drugs, prescription only drugs (Rx medicines) cannot be advertised to the general public. There are also a number of other restrictions, for example, advertising of medicines must not:

• be misleading;
• give rise to the expectation that the effect of the medicinal product is equivalent or superior to that of another treatment or another medicinal product;
• create the expectation that the condition of a healthy human being will be improved by the use of the medicinal product;
• raise the fear that the condition of a healthy person will deteriorate without the use of the medicinal product;
• etc.

There are also a number of specific regulatory requirements for promoting medicinal products online, including in various digital communication channels such as social media, e-mail correspondence, websites, webinars, podcasts, blogs and application software (apps). In our next blogs, we will provide more details on the specifics of different types of promotion of medicinal products, including public advertising versus professional promotion to HCPs, online advertising, comparative advertising, promotion of OTC and Rx medicinal products, sampling of medicines, providing information about unapproved medicines and unapproved indications, as well as regarding different types of interactions of companies with healthcare professionals (HCPs), healthcare organizations (HCOs), patients and patient organizations.

Law-enforcement practice

There is a significant amount of law enforcement practice regarding the promotion of medicines. For example, the competent state authorities of some countries have already conducted investigations into the advertising of medicinal products that contained information about:

• quick effect of the medicinal product (e.g., such advertising statements as “quick action”, “quick relief”, “immediate elimination of symptoms”, “…from the first use…”, “…in a few seconds…”, etc.);
• quality of medicinal products (e.g., “high quality”, “highest quality”);
• prices for medicinal products (e.g., “reasonable price”, “affordable price”);
• leadership of medicinal products (e.g., “No. 1 in the world”, “leader”, etc.);
• novelty of medicinal products (e.g., “new”, “the newest”, etc.).

The abovementioned advertising claims are “red flags” and may be considered to be misleading in certain circumstances. When formulating advertising claims (e.g., “No. 1 in the world”, “leader”, “newest”, etc.) that indicate the leadership qualities of the relevant medicinal product and/or the business entity engaged in its production and/or sale, it is necessary to:

• adhere to the most correct wording,
• ensure that advertising claims are based on scientific evidence,
• refrain from exaggerations, pay special attention to the period of time when the relevant studies confirming the leadership or novelty of the medicinal products were conducted and when the relevant advertising is distributed.

In particular, in accordance with the position of competent state authorities of some countries:

• Information that is disseminated, for example, in 2023, but is based on data created in 2021 (or earlier), is not considered to be consistent with actual data (i.e. such information is deemed to be out-of-dated).
• Confirmed “leadership” in 50 countries cannot be presented in advertising claims as evidence of the leadership of a particular medicinal product worldwide.

According to the Code of Conduct of the Pharmaceutical Industry in Switzerland (the so-called “Pharma Code”), the use of the word “safe” is prohibited in advertising of medicinal products as it can be misleading (unless accompanied by an appropriate objective qualification).

Moreover, under the Pharma Code, it is prohibited to use the word “new” in medicines advertising, unless the following conditions are met: 1) medicinal products, indications, possible applications, dosages, pharmaceutical forms and packaging may only be described as “new” for the first 12 months after they have become available or have been advertised in Switzerland; 2) as such, they may only be called “new” for 18 months after they were first authorised in Switzerland. The information in the advertising must make clear on what this attribute “new” is based.

Each advertising claim should be analysed in its entirety in each specific case, taking account a number of circumstances, including the potential perception of the addressee of such advertising.

As practice shows, even if the relevant statement/slogan is registered as a trademark, this does not eliminate the risk of misleading.

How to minimise risks

In order to minimise the risk of fines and other sanctions being imposed on pharmaceutical companies for violation of the rules of medicinal products advertising, it is strongly recommended to use a number of risk mitigation tools, including, inter alia:

• conducting legal review of all advertising materials and ensuring their compliance with the requirements of applicable law (including specific requirements for advertising of medicinal products to the public and HCPs, as well as unfair competition law), guidelines issued by a competent state authority, relevant self-regulatory codes of conduct and current law enforcement practice;
• checking whether the advertisement contains all necessary warnings and disclaimers (including those explanations that are necessary and important to minimise the risks of misleading), checking their essence (i.e. how they can be perceived by the recipients of this particular advertisement, e.g. by patients and/or healthcare professionals) and the way such explanations are placed in the advertisement (i.e., how convenient and easy it is for the addressee of the advertisement to notice and read the text), in particular: placement, size, type, colour of the font, as well as the background of both the main information and additional explanations to it, etc.;
• developing and implementing an internal advertising approval process;
• developing an internal policy which should be taken into account by the company’s employees while preparing advertising and other promotional materials, identifying “red flags” and mitigating risks;
• conducting trainings for company’s employees engaged in advertising and other promotion activities to familiarise them with the legal requirements and the best practices in this area;
• avoiding ambiguous, unclear, manipulative and unconfirmed statements, as well as exaggeration of the properties of medicinal products in advertising;
• using an exact, substantiated, balanced, fair, objective and sufficiently complete information in advertising;
• collecting and retaining all available materials and research results that support the statements to be used in advertising;
• checking such materials for the correctness of the applied research methodology and sample representativeness.