On 28 June 2021, the Omnibus Act was published in the Official Gazette of Hungary, which amended the promotional provisions of the Medicines Thrift Act, on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products.
The provisions of the Omnibus Act concerning promotional activities entered into force on 29 June 2021 and immediately became the subject of an extensive discussion among market participants, legal representatives, and industry associations in Hungary.
The textual changes were not extensive and were only to clarify and solidify the known interpretation and market practice at the legislative level. However, the changes also led to broad uncertainty, therefore the Hungarian pharmaceutical authority, the National Institute of Pharmacy and Nutrition (the OGYÉI), decided to publish an (updated) interpretation of the new and newly modified provisions.
The amended definition of promotion and related market interpretations
The definition of promotion was also subject to a minor change which, despite its extent, resulted in several questions concerning the activities of Medical Science Liaisons (the MSLs).
The definition of promotion changed as follows (the relevant modifications are indicated in bold):
The definition of promotion
[Article 12 (1) of the Medicines Thrift Act]
|Before 29 June 2021||After 29 June 2021|
|The promotion of medicinal products, mother’s milk substitutes, mother’s milk supplements, and dietary supplements for special medicinal purposes (in the application of this chapter, hereinafter referred to as “dietary supplements”), as well as medical aids (hereinafter referred to as “promotion”), means commercial practices concerning medicinal products, dietary supplements and medical aids, the composition, and efficacy of medicinal products and dietary supplements and the application of medicinal products, medical aids and dietary supplements applied for or against healthcare professionals authorized to prescribe, provide training on the use thereof, and distribute medicinal products, dietary supplements and medical aids.||The promotion of medicinal products, publicly funded mother’s milk substitutes, publicly funded mother’s milk supplements, and publicly-funded dietary supplements for special medicinal purposes (in the application of this chapter hereinafter referred to as “dietary supplement”), as well as medical aids (hereinafter referred to as “promotion”), means any commercial practices concerning medicinal products, dietary supplements, and medical aids, in particular the composition and efficacy of the medicinal products and dietary supplements and the application of medicinal products, medical aids and dietary supplements applied for or against healthcare professionals entitled to prescribe, provide training on the use thereof, and distribute medicinal products, dietary supplements and medical aids.|
Under the new provision, any ‘commercial practice’ concerning a medicinal product, medical aid, milk substitute, and milk or dietary supplement (or their composition, efficacy, or application) that is aimed at healthcare professionals would be considered a promotion.
Intense interpretational discussions began immediately because those who took a conservative approach argued that the new wording could be interpreted in a way that the strict, highly regulated regime of promotion applied not only to external communications by promoter pharmaceutical companies, addressing healthcare professionals with a commercial intention, but to all, including non-sales related but purely professional internal communications and functions. Accordingly, they believed that the activities of professional employees not engaged in promotion or sales activities, such as MSLs, might also fall under the promotion regime. This interpretation could also entail that MSLs should, like a company’s medical sales representatives, be registered with the OGYÉI in accordance with the provisions of the Medicines Thrift Act.
The OGYÉI’s interpretation
The OGYÉI expressed its view on MSLs in its first promotional resolution published in 2020 where, based on the then-effective definition of promotion, it described the circumstances under which MSLs were not qualified as medical sales representatives.
According to point 4.1.9 of the first resolution:
“The so-called Medical Science Liaison (hereinafter the MSL) does not qualify as a sales representative provided that the materials to be handed over by it as well as the method of handover is completely separable from the intent of fostering the sales of the product, i.e. it does not engage in commercial practices, not even indirectly. According to the OGYÉI, this can only be carried out lawfully if the claims contained in the materials to be shared in connection with the product are either in line with the accompanying documentation or are limited to the exchange of the most recent scientific information concerning products yet to be registered, pursuant to the criteria detailed in the previous point.”
As mentioned above, after the Act was adopted, questions were raised whether, in light of the changes, this interpretation was still applicable. Therefore, in September 2021 the OGYÉI provided a second interpretation on the new and newly modified provisions of the Medicines Thrift Act, in which it reasoned that the previous wording of promotion held the same meaning as the amended one. However, the earlier text was grammatically imprecise, and this has now been corrected.
As for MSLs, the OGYÉI explicitly cited point 4.1.9 of the first resolution under which it confirmed that the earlier interpretation continues to be applicable to MSLs. Furthermore, it added that independent professional congresses and journals should be the primary venues for the dissemination of the latest scientific knowledge.
The OGYÉI’s updated interpretation has dispelled doubts about the position of MSLs as it has been confirmed that an MSL should not be considered a medical sales representative, provided that they do not engage in any activities that would qualify in any way as a commercial practice.
Dóra is a partner and CEE Managing Director at CMS. She co-heads the Commercial practice and heads the Technology, Media, Telecommunications (TMT), heads the Life Sciences & Healthcare Practice, and the Data Protection practices in the Budapest office.
She advises major pharmaceutical, biotechnological and medical device manufacturers at national and European levels on the full range of issues from general pharma law to representing clients before the relevant authorities. Dóra is a leading eHealth expert; she has worked on a number of eHealth projects and currently advises telecommunications and healthcare companies on their projects.
Miriam is a senior associate in the life sciences & healthcare, and commercial teams at CMS Budapest. She is a life sciences specialist who is regularly involved in commercial matters as well.
Miriam has been involved in various pharmaceutical matters mainly involving simple to complex regulatory issues. These issues concern over-the-counter medicines, prescription-only medicines, medical aids, cosmetics, medical devices, and food supplements. Miriam has extensive experience in providing legal advice on clinical trials, categorization of medical devices, and reimbursement of medical aids and medicinal products.
Mercédesz is an associate in the life sciences & healthcare and commercial teams in the Budapest office.
Mercédesz specializes in advising life sciences companies on day-to-day regulatory and general commercial matters. Before focusing on the life sciences sector, she gained experience in a wide range of legal areas, having been involved in corporate matters, as well as financial transactions.