Hungary: Regulatory authority decision weighs in on the Medical Science Liaison position

In brief

Pharma companies often employ Medical Science Liaisons (MSLs) in order to provide healthcare professionals (HCPs) with high-quality professional and scientific information that lacks promotional content thereby distinguishing it from the information provided by medical sales representatives.

In a recently published decision, the National Institute of Pharmacy and Nutrition (NIPN) stated that it does not support distinction between professional and promotional communication. This position leaves pharma companies with two options: either to register MSLs with the NIPN as a medical sales representative, or to try to severely restrict the information an MSL may share with HCPs.


The NIPN investigated the promotional practices of a pharmaceutical company employing an MSL. From an organizational perspective, the MSL was part of the medical department, engaged in reactive communication, which means that the MSL primarily communicated with physicians if they had questions, typically in relation to a particular product. Further, the MSL provided answers to HCPs in the context of product use, and kept contact with them relative to clinical trials.

The NIPN found that although the MSL had a high quality of scientific knowledge compared to the "average" medical sales representative and his primary task was not to sell the company's product portfolio or to incentivize sales, distinction between commercial and professional aspects of medicinal product promotion is not appropriate. Professionalism is an equally essential part of medicinal product promotion since the HCPs may only decide on patient medication on the basis of adequate and scientifically substantiated professional knowledge.

Consequently, the NIPN is of the view that the activities of MSLs do not constitute medicinal product promotion only in the event that the professional knowledge they wish to convey and the manner in which they are disseminated can be completely distinguished from the intention to promote the sale of a specific product. In the NIPN's view, this condition is fulfilled if the information shared by the MSL is severely restricted. Where the activity of the MSL toward HCPs relates to a specific product, that activity qualifies — at least partially or indirectly — as commercial practice, thus, the promotion of medicinal products.

With regard to the practical difficulties in separating the above activities, the NIPN considers it lawful, appropriate and controllable if pharmaceutical companies communicate with HCPs through medicinal sales representatives in relation to both promotional and professional matters, and not through other functions.

The NIPN case-law shows that employing an MSL is risky even if his/her job description and actual activities are carefully designed to focus on scientific and professional communication with HCPs.

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Helga Biro
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