The National Institute of Pharmacy and Nutrition (OGYÉI or authority) has recently published several decisions in connection with promotional activities of pharmaceutical companies and their interactions with healthcare professionals (HCPs). The authority stated in its decisions that the investigated companies infringed the laws on pharmaceutical promotion (i.e. Act XCVIII of 2006; hereinafter the Medicines Economy Act), consequently, the OGYÉI imposed a fine on each of the investigated companies. The amount of the fine depended on the gravity of the infringement and other relevant circumstances of the case. We below summarize the most relevant conclusions of the OGYÉI in the cases of the investigated companies.
1. Evaluation of mixed product portfolio
In one case the OGYÉI stated that if a company has mixed product portfolio, i.e. its product portfolio consists of medicinal products, medical devices and food supplements and the medical sales representative that engaged in communication with HCPs about the above products was not registered at the OGYÉI for the promotion of medicinal products and/or medical devices, the medicinal products and medical devices shall not be promoted during the promotion of food supplements.
2. Lack of scientific organizational unit
The marketing authorization holder or its authorized representative must organise the management of commercial communication activities relating to the medicinal products marketed by it within its own organization. Therefore, a scientific organizational unit shall be established to fulfil this obligation. According to the OGYÉI, the purpose of this provision is that (i) the promotional activities shall be reviewed by internal medical professionals; and (ii) the sharing of professional information in association with patient care must be controlled to avoid, for instance, the use of unprofessional claims about the products. The OGYÉI explained that the lack of a scientific organizational unit can lead to loss of control, which can result in the deterioration of the quality of communication which indirectly affects the safety of patient care. If a pharmaceutical company fails to establish a scientific organizational unit, it may infringe the applicable laws according to the authority.
3. Rules on sponsorship of participation in professional events In another case the OGYÉI investigated in-kind supports provided to persons engaged in healthcare or scientific activities. These supports were not in direct connection with professional events, training courses.
According to the authority, there must be a direct connection between the support and the participation in the above-specified events. In the OGYÉI's view, this connection means not only a constraint in place but also a kind of reasonable amount, which is, however, not quantifiable. Expenses directly related to participation in events do include travel expenses, accommodation and attendance fees, meals and hospitality costs. The condition "direct connection" is only fulfilled if the support applies to the accommodation, travel, and meals which align with the starting and ending date of the given event. In addition, the support must be reasonable, i.e. internationally acceptable and it shall comply with the reasonable price of registration, accommodation and hospitality. The term "hospitality" is considered by the authority to be a phrase that may include not only the cost of accommodation but also the cost of meals. However, the participation fee and the accommodation fee may also include the costs of meal. Having regard to these, the authority takes into account the meaning of the words in the ordinary sense and it will assess on a case-by-case basis whether the in-kind support is directly associated with the event.
4. Professional services agreements concluded with HCPs
In addition, the OGYÉI also investigated the contractual relationships of another company with HCPs, in particular the agreements for the sponsorship of participation in professional events abroad and the related professional services to be performed by the HCPs (such as the drafting of a summary on the conclusions of the event to the company or the holding of presentation to colleagues of the HCP). The company investigated by OGYÉI paid extra remuneration to the HCPs for the above services. During the investigation, the OGYÉI came to the conclusion that the services to be rendered by the HCPs were not properly specified in these agreements, and the activity performed by the HCPs was, in certain cases, also required by the rules applicable at the workplace of the HCP. Therefore, the extra remuneration paid to HCPs in connection with their participation in professional events may be capable of improperly influencing the sponsored HCPs and jeopardising the professionalism of patient care.
In another case, based on the subject matter of a consultancy contract, the HCP was involved in the development of the investigated company's commercial and promotional materials (the HCP had to develop a marketing brochure). The OGYÉI concluded that this activity shall be qualified as promotional activity. The purpose of the relevant legislation is to prevent the persons entitled to prescribe medicinal products from entering into a legal relationship with the promoter which may change their professional views. In the present case, the HCP conducted promotional activity for the company which qualifies as a conflict of interest in respect of the same HCP's healthcare activities. Consequently, the investigated company should not have entered into the above professional services agreement with the HCP, thus the payment under the agreement was unlawful.
5. Gifts provided to HCPs In the case of several pharmaceutical companies, the authority also examined the sales promotional tools provided to HCPs, their value and the business practices related to the handing over of gifts. The OGYÉI took into account the primary, everyday function of the gifts. Therefore, in the OGYÉI's view, flowers, coffee or wine should not be regarded, in any case, as a gift related to healthcare activity and the daily work of HCPs. In addition, business lunch / hospitality as an in-kind support is not related to the healthcare activity of HCPs either, therefore, such activity is infringing the applicable laws.
Furthermore, a company provided HCPs with flower and wine. OGYÉI stated that flower and wine were not related to the professional activity of the HCPs and exceeded the statutory value limit for gifts. According to the authority, whenever a gift is given to an HCP at the expense of a company doing promotional activities, the law shall be applied, regardless of (i) the personal relationship between the HCP and the company and (ii) whether promotional activity is simultaneously conducted by the company.
6. Issues related to therapy management program
The OGYÉI reviewed a therapy management program conducted by a pharmaceutical company. The authority also reviewed the professional services agreements concluded with HCPs in connection with the therapy management program. The OGYÉI stated that it is unjustified to enter into a contract with an HCP for the performance of activities which (i) are already part of the statutory duties of the HCP; and (ii) could be conducted by nurses. The contracts did not specify activities regarding the therapy management program that would have been beyond the normal healthcare activities of the HCPs. According to the authority, the payment of a fee under such contracts may encourage the HCP to consider financial aspects when prescribing the product of that company.
7. Events related issues
OGYÉI also investigated the so-called "meet the expert" events and their full documentation in the case of a pharmaceutical company. According to the OGYÉI, the fact that the room lease fee was indicated on the invoice as a separate item in addition to catering (serving food and beverages) does not mean that the lease fee does not have to be taken into account when calculating the cost of hospitality and when assessing the compliance with the statutory hospitality threshold. In the OGYÉI's view, the room lease fee must be included in the cost of hospitality.
In addition, another company organized a theatre performance for HCPs during a company promotional event. The authority found that the theatre piece in question was clearly an artistic activity intended for entertainment purposes and could not be considered as a scientific performance. Therefore, the company infringed the law that requires promotional events to be organized solely for professional, scientific or educational purposes. According to the OGYÉI's opinion, events containing entertainment elements may be capable of significantly influencing HCPs.
8. Registration of medical sales representatives Furthermore, some of the investigated companies did not register their medical sales representatives to the OGYÉI in case of promotional activities. Besides, they did not send the documentation evidencing the payment for the activities of medical sales representatives to the OGYÉI which constituted an infringement of the applicable laws.
The OGYÉI's findings in the above-mentioned decisions are useful as pharmaceutical companies may incorporate them into their daily practice, thereby reducing the chance of legal consequences and sanctions such as a fine to be imposed in a potential investigation of the OGYÉI.