Our summary shows how the terms ‘promotion’ and ‘commercial practice’ have changed, what new rules govern the interactions between healthcare professionals and pharmaceutical companies, and we cover the new changes concerning promotional events and patient support programs, as well.
On 18 June 2021, the provisions of Act XCVIII of 2006 (”Medicine Economy Act”) entered into force. Without claiming completeness, our office has compiled the most important changes of the legislation:
The term ‘commercial practice’ now covers not only activity, display, marketing or other commercial communication capable of fostering the ordering, procurement, sale or consumption of medicinal products, dietary supplements and medical aids, but professional, scientific or other information, as well.
On the one hand, when amending the term ‘promotion’, it was clarified that only reimbursed infant formulas and dietary supplements (follow-on formula, dietary supplements for special medicinal purposes) are involved in the promotion, thus the provisions of the promotion do not apply to non-reimbursable infant formulas. On the other hand, the legislator has broadened the term ‘promotion’, as one of the basic elements of the promotion, the legislator extended the exhaustive activity essentially as follows: not only the commercial practices relating to the composition, effects and application of the products, but also any other commercial practice or communication may qualify as promotion, relating to a medicinal product, medical aid or other product covered by the legislation.
Nor does the ministerial reasoning of the amendment reveal a significant legislative purpose, but in interpreting the amendment, it may arise that actually commercial practice concerning any medicinal product constitutes promotion.
Based on the recent decisions of the National Institute of Pharmacy and Nutrition (the “OGYÉI”), the authority does not encourage the practice that the pharmaceutical companies seek the help of the healthcare professionals in the development of their commercial practices. The Medicine Economy Act raised the former legal interpretation of the authorities to legislative force by stating that a healthcare professional cannot, in essence, be involved in the development of the commercial practice, except the scientific and/or copyright-protected activities.
The provisions that broaden OGYÉI’s supervisory powers are intended to support the new regulation. In case of an official inspection, the inspected company must prove that no information, activity, communication or display fostering the sale, prescription, distribution of the product of the promoter of medicinal products may be realized as a result of the contractual relationship between the promoter of medicinal products and the healthcare professional. In other words, in a possible procedure of the authority, the pharmaceutical distributor must prove that the subject of the contract does not seek to the creation of information, activity, communication or display fostering the sale, prescription or distribution of the product. The former burden of proof is reversed.
On the one hand, the amendment of the Medicine Economy Act defined the concept of so called “supporting events for promotional activities” (this has not been done so far explicitly). Accordingly, events organized for healthcare professionals who are entitled to the training and the distribution of the ordering and the usage of the medicinal products, infant formulas and medical aids are considered as such events. The events can only be organized for professional, scientific or educational purposes.
The legislator has made a small but significant change regards the costs. Under the former rules, explicitly only the per capita costs of the hospitality of such events could not exceed the 5% of the minimum wage; according to the new rules, the total cost of the event per day and per participant must remain below the limit mentioned above.
The Medicine Economy Act states as a general prohibition that gifts, material benefits or other benefits in-kind can only be given to the healthcare professionals in the context of the commercial practice and if it is related to healthcare activities and has low value. Professional, scientific work and non-exchange benefits cannot be given to healthcare professionals. [Essentially, it means the complete prohibition of the so-called ”courtesy” hospitality/gifts (e.g. birthday candy/flower).] Apparently, according to the amendment, all the professional events organized as promotional events are subject to the notification requirement.
A provision of the Medicine Economy Act supplemented by an amendment prohibits the fostering, remuneration or rewarding in any form of the collection, processing as well as the transfer of personal data relating to diseases or medication habits in an identifiable way under patient support or other programs.
In commercial communication no additional information may be communicated other than what is indicated in the label text of the homeopathic preparations, and the ban on pharmaceutical advertising for children has been extended, as well, from now on it is prohibited in general to publish medicine commercials in programs or publications intended for children.
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The information above possesses exclusively informative nature, therefore, it shall not be considered as legal advice of Germus and Partners Attorneys At Law, any attorneys or trainee lawyers thereof.