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In brief

In the last month, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) published five new decisions on its website relative to the promotional practices of companies under investigation. The NIPN imposed fines for infringements within the range of HUF 3 million (approx. EUR 7,700) to HUF 31 million (approx. EUR 79,500).

The decisions include several infringement types that have already been assessed in previous cases, including, for example, failure to notify the NIPN regarding certain professional events (referrals, advisory board meetings); failure to send to the NIPN the document certifying the payment of tax on medical sales representatives; as well as improper donation and sampling practices (i.e., in case of an in-patient healthcare institution, both samples and medicinal product donations may only be provided through the institutional chief pharmacist and they must be recorded in the institutional pharmacy).

The following is a summary of the new developments in the recent NIPN decisions.
 


Contents

  1. Risk of employing an MSL
  2. Criteria for compliant speaker presentations by HCPs
  3. Assessment of other service contracts concluded with HCPs
  4. Extension of the applicability of the rules on medicinal product promotion to products not classified as medicinal products or medical aid
  5. Conclusion

Risk of employing an MSL

In connection with the promotional activities of one of the companies, the NIPN investigated the status of the Medical Science Liaison (MSL) employed by the company. 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 healthcare professionals (HCPs) in the context of product use, and kept contact with them relative to clinical trials. The NIPN found that although the MSL has a high level of scientific knowledge compared to the “average” medical sales representative and their primary task was not to sell the company’s product portfolio or to incentivize sales, the NIPN does not support a sharp distinction between commercial and professional aspects of medicinal product promotion. 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. 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.

Criteria for compliant speaker presentations by HCPs

In several decisions, the NIPN concluded that the speaker presentations held by HCPs engaged by pharmaceutical companies fulfilled the criteria of medicinal product promotion; therefore, the HCP engagements were considered as unlawful. According to the Medicines Economy Act, there is a conflict of interest if an HCP that is engaged in healthcare activities at a healthcare service provider participates in or supports the commercial practice (medicinal product promotion) of a pharmaceutical company, thus, HCPs may not be engaged to carry out such an activity. Medicinal product promotion may only be conducted by medical sales representatives registered with the NIPN.

In these recent decisions, the NIPN established that the speaker presentations held by the engaged HCPs contained information specifically and exclusively about the use, application, therapeutic experience and challenges related to a particular product of the company. Competing products and/or therapies were not included in the speaker presentations, not even as a mention. In another decision, the NIPN goes even further and states that a speaker presentation can be considered promotional beyond reasonable doubt if the name, logo and packaging of a particular product are not just marginally mentioned within such presentation, but majority of it discusses exclusively the use of this product or brand and its advantages over the competitor product; encourages the use of the given product; and recommends it. In addition, a presentation can be considered promotional if the slides bear the external appearance of the given product and the product’s name/appearance is indicated on each slide.

Assessment of other service contracts concluded with HCPs

The NIPN considered service contracts concluded with HCPs unlawful where the subject matter was internal trainings for medical sales representatives, reviewing and correcting web articles, and proofreading communication materials. The authority found that such contracts could be regarded as indirect medicinal product promotion supporting the pharmaceutical company’s commercial practices, given that the activities carried out by the HCPs under these contracts constitute elements of commercial practice. Further, the NIPN considered that the company and its medical sales representatives used the knowledge and information acquired in connection with the performance of these contracts in communication materials and during medicinal product promotion. In our view, this interpretation is contrary to the previous authority guidance available on the NIPN’s website, which explicitly indicates — among others — professional proofreading or internal professional training to be held for the employees of the pharmaceutical company as professional service types for which HCPs may be lawfully engaged. 

Extension of the applicability of the rules on medicinal product promotion to products not classified as medicinal products or medical aid

In one of the decisions, the NIPN concludes that if a company carries out promotional activities with medicinal products or medical devices categorized as medical aid, then the company is obliged to notify the NIPN regarding all of its professional events for HCPs, regardless of the subject matter of the event or the topic of the speaker presentations held during the event. In this case, the NIPN established the infringement of failure to notify an event held in connection with biocidal products distributed by the company because, in the NIPN’s view, the professional nature of the event in itself establishes the obligation to notify.

Conclusion

Considering that the NIPN’s case-law might differ not only from the established practices and legal interpretation of pharmaceutical companies, but also from the previous guidance of the NIPN in some cases, it is recommended to continuously monitor the NIPN’s evolving case-law and adapt company practices accordingly for legal compliance.

Author

Dr. Helga Bíró has significant experience in competition, consumer protection and commercial law matters. She co-heads the Firm’s Pharmaceutical and Healthcare practice in Budapest, and is a former counsel of the Ministry of Health. Dr. Bíró mainly handles regulatory matters relating to the pharmaceutical, food, cosmetics and medical device industries — both at the national and regional levels.

Author

Mate Laczko is an Associate in Baker McKenzie, Budapest office.

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