4,704 everyday items with a “well-known” purpose, 199 medicine donations placed in the wrong hands, informal conversations over a few bites about product development, a missing “excipient register”, a few superficial brochures, a late notification and incomplete administration were enough for a HUF 33,000,000 fine. The extract of the pharmaceutical authority’s latest decision has been published, revealing why OGYÉI imposed a HUF 33,000,000 fine on Egis Gyógyszergyár Zrt. Case number: OGYÉI/214/2022. The details are explained in the summary prepared by PV Partners Law Association.
Down with umbrellas and canvas bags...?
In relation to gifts given to doctors, OGYÉI referred to an earlier decision of the Budapest Court of Appeal, which stated with regard to certain everyday items, such as automatic umbrellas and canvas bags, that their function is commonly known and that they cannot be linked either directly or indirectly to healthcare activities. Therefore, they may not be given as gifts to healthcare professionals. We do not know whether the 4,704 gifts handed over by Egis were umbrellas, canvas bags or perhaps other gift items, but in any event OGYÉI — the National Institute of Pharmacy and Nutrition — did not appreciate this promotional activity.
It is also possible to discuss a non-existent product under the aegis of “commercial practice”
The Authority became aware of events during which Egis discussed product development topics with healthcare professionals, accompanied by hospitality. According to OGYÉI, product development meetings cannot be separated from the sale of medicinal products or from promoting the consumption of the product, and therefore it classified them as commercial events. As a result, hospitality no longer fits within the statutory category of gifts of “negligible value and related to healthcare activities”. It probably did not help Egis’s defence against the Authority that it itself described these events as business hospitality, that medical sales representatives also attended them, and, not least, that Egis itself has a product on the market in the relevant therapeutic area.
The Authority also indicated that, in its view, the appropriate forum for product development discussions is an advisory board, meaning scientific advisory board meetings. This type of event is already subject to a prior notification obligation, which the Authority takes very seriously. This is further supported by the fact that, in Egis’s case, the inspection found unlawfulness in only 1% of all notified professional events: out of 1,167 events examined, there were a total of 17 cases of late notification and 2 cases where notification was missing.
The privilege of institutional chief pharmacists
The 3/2009 EüM Decree, the so-called Promotional Decree, is the regulation to search for if we want to find the rules on medicine donations made for charitable purposes. Similarly to medicinal samples provided to healthcare professionals, administration cannot be spared here either: minutes must be signed on the handover and receipt, then retained, and, moreover, in the case of subsidised products, a courtesy copy of these minutes must also be sent to OGYÉI on a quarterly basis.
At the same time, care must be taken that if the supported healthcare institution provides inpatient care, such donations may be provided exclusively through the institutional chief pharmacist, meaning that they are the person obliged to receive these products. A doctor, hospital department or other organisational unit working within the same inpatient care institution is not entitled to receive them. In addition, institutions providing both inpatient and outpatient care must be treated as a single unit for donation purposes. OGYÉI’s professional reasoning reveals the background to the decision: in its view, if medicine donations could also be given directly to doctors, the professional conditions of use and the ability to monitor such use would be impaired.
“Excipient” list
OGYÉI also addressed the contracts concluded with healthcare professionals, objecting to the fact that the same slides repeatedly appeared in the presentations of healthcare professionals, resulting in presentations that were identical to one another. While the Authority emphasises doctors’ professional independence, the creation of their own intellectual work and freedom of opinion, from the perspective of the promoting company it is also an entirely obvious consideration to ensure the legal and ethical compliance of the knowledge conveyed in the presentation and to maintain coherent professional messages. OGYÉI’s issue was not primarily with the content of the materials, but rather with the fact that Egis did not keep records of what auxiliary materials, such as lists of literature provided, it made available to doctors for the purposes of giving the presentation. As a result, the Authority could not verify which part of the presentation was the doctor’s own work and which part was based on auxiliary materials provided by Egis, raising doubts regarding the speaker’s professional independence and the proportionality between the remuneration and the work performed.
Promotional materials, conflicts of interest and failure to fulfil payment obligations
The following infringements typically appear in the Authority’s previously published decisions, so we list them only briefly for the sake of completeness.
There is nothing new under the sun: OGYÉI continues to pay close attention to commercial brochures handed over to doctors and examines their content based on the levels of statutory infringements already well known from its earlier decisions. In slightly more than half a dozen promotional materials, it objected to deviations from literature sources, lack of consistency with the summary of product characteristics, and, in two cases, incomplete price information. The fine also included the absence of notification of the medical representative and the fact that a person in a legal relationship entitling them to carry out healthcare activities carried out promotional activities on behalf of Egis.
In relation to professional events organised by Egis itself, the daily costs of the invited healthcare professionals exceeded the statutory limit for the events concerned by the inspection. OGYÉI also examined proof of payments made after medical representatives, and found that Egis had failed to fulfil this administrative obligation. The case is presumably set to continue in administrative court proceedings.
The published decisions also contain further findings by the Authority. The full content of the decision is available through the relevant official publication. You may contact us at any time at the following email address; please feel free to reach out to us, we will be pleased to assist you: iroda@pvpartners.hu
The above article is for informational purposes only and shall not be considered legal advice, a legal position or a legal opinion provided by PV Partners Law Association or any of its attorneys or trainee lawyers in relation to any specific matter. PV Partners Law Association excludes its legal liability for the use of this article in any individual case.