The National Institute of Pharmacy and Nutrition (“OGYÉI“) published new decisions on its webpage concerning pharmaceutical promotional activities and interactions with HCPs. The OGYÉI investigated the commercial practices of Aramis Pharma Kft., Lilly Hungária Kft. and Sager Pharma Kft. and imposed fines due to alleged infringements.
The key findings of the decisions are the following:
1) Several types of contracts concluded with HCPs for professional services were considered as unlawful commercial practices
Contracts for services not related to the healthcare activities of HCPs
The OGYÉI objected contracts based on which the HCPs were mandated to hold professional trainings for medical sales representatives of a pharmaceutical company. The role of the HCPs was to “host” the medical sales representatives within a professional role play and later to comment on the performance of the same medical sales representatives.
According to the OGYÉI, the professional role play is not directly related to the healthcare activities of the HCPs participating in the simulation. Contracts concluded with HCPs for providing professional services shall only be concluded for the provision of services closely related to the professional activity of the HCPs and shall not serve promotional purposes. The OGYÉI concluded that the objected contracts had a promotional character, therefore, payments made under such agreements were unlawful.
Contracts for holding professional presentations with promotional content
The OGYÉI objected contracts based on which HCPs held presentations at roundtable events organized by a pharmaceutical company because the presentations had promotional nature as medicinal products of the company were easily identifiable. The OGYÉI found that the aim of these contracts was to facilitate the commercial practice and promotion of medicinal products of the pharmaceutical company under investigation.
As it was already laid down in former case-law, the OGYÉI highlighted that while performing contracts concluded with HCPs for professional speaker services, the use of company-branded presentation materials and backgrounds shall be avoided and the presentation shall not contain either the name of the company, its products, or the company logo or image. Therefore, payment for such professional presentations were also considered as unlawful financial benefit.
Contracts for drafting professional articles published in company branded publications
The OGYÉI objected processional services agreements based on which HCPs were mandated to draft professional articles or case reviews to be published in the pharmaceutical company’s own professional publication. The OGYÉI found that the publications were of promotional nature for the following reasons: (i) they were branded; i.e. it was clear from the outset that it is the publication of the pharmaceutical company under investigation; (ii) the articles focused on a product of the company and trials related to that product; and (iii) the publication was distributed by medical sales representatives and at stands or booths of the pharmaceutical company at professional events.
In the OGYÉI’s view, these contractual relationships went beyond the healthcare activity and the sharing of professional experience of the HCPs as the performance of these contracts was meant to facilitate the promotional activity of the company.
Speaker services to subordinates of the speaker and presentations overlapping with professional work duties of HCPs
The OGYÉI considered the speakers’ fees paid for presentations held by HCPs in front of an audience which predominantly comprised of their own subordinates who work at the same department/institution and whom they have daily contact with as prohibited financial benefit. The remuneration provided for holding these presentations at hospitals was capable of motivating HCPs to discuss products of the pharmaceutical company at forums where their subordinates are dutifully present whereby inducing them to follow the recommendations of seniors and apply the presented products in their healthcare practice.
In addition to that, the OGYÉI objected speaker agreements in cases where HCPs had a duty, based on their job description with the hospital, to hold similar presentations at the internal meetings of the hospital (typically so-called referral meetings).
2) Group detailing versus events
In one of the OGYÉI decisions, the OGYÉI noted that in case hospitality is being provided at the events typically called “referral meetings, business meetings or business referrals”, the events shall not be qualified as group detailing activities. This is because on the one hand, HCPs were participating in the events, on the other hand they were organized or their organization was actively facilitated by the pharmaceutical company or its medical sales representatives. The OGYÉI shall be notified of such events 15 days in advance.
3) Establishment and operation of a scientific organizational unit within the company for the management of commercial communication activities
The OGYÉI highlighted that the task the scientific organizational units is to ensure the delivery of professionally verifiable, substantively accurate information during communication with HCPs. The OGYÉI expects that such an organizational unit should operate at each pharmaceutical company under the direct supervision of the management. In the OGYÉI’s view, if such department does not exist at a pharmaceutical company, the efficient control of commercial communication will be undermined that may result in poor quality of communication.
4) Sponsorship provided for attending conferences abroad
The OGYÉI highlighted in one of its decisions that pharma companies may only sponsor the participation of HCPs at conferences abroad if the participation at the conference is justifiable. Pharma companies are therefore expected to assess if the resources required for the subject-matter of the event or the necessary expertise are available only abroad, at the location of the event, and the costs of organizing such event at a location closer to the workplace of the participants would be disproportionately higher.
The pharmaceutical company under investigation sponsored the participation of an HCP in the Singapore conference of the European Society for Medical Oncology (ESMO).
The OGYÉI found the sponsorship was unreasonable and unlawful given that there was another ESMO conference organized in Europe presenting essentially the same topics at the same time as the Singapore conference.
5) Compliance recommendations
In one of the decisions, the OGYÉI made recommendations on commercial practices of the pharmaceutical company under investigation.
One of the recommendation refers to sponsoring accommodation at domestic professional events and states that it would be practical to ask for justification from the participants in the application form concerning the sponsorship of accommodation in domestic professional events.
In the other recommendation the OGYÉI repeatedly draws attention to the fact that business meals offered to HCPs by company employees are not related to the healthcare activity of HCPs, therefore they shall qualify as prohibited benefit.
The extracts of the OGYÉI decisions are available in Hungarian language at the following links: