BRACE lawyer Anna Ivanova’s commentary was published in Ekaterina Pogontseva’s article “Samples Caught in the Crossfire”, published in the Pharmaceutical Bulletin magazine, on the issue of distributing medicinal product samples at specialized events for pharmaceutical and medical workers.
As Anna noted, when providing medicinal product samples at scientific events, industry exhibitions and other specialized events, a number of points must be taken into account.
Firstly, pharmaceutical companies are legally prohibited from providing drug samples for the purpose of handing them over to patients (except in cases related to clinical trials of drugs for medical use).
Despite the fact that the ban is not absolute, but relative: for the purpose of handing them over to patients, in practice the risk of violating it is very high. “As a rule, if a medicinal product is handed out at events, the purpose of the handing over is not specified,” Ivanova explained. — Considering that pharmaceutical companies are focused on promoting their drugs, it can be assumed that samples are given to doctors both for familiarization with the products and for subsequent prescription to patients. If drug samples have inscriptions prohibiting further distribution to patients, then the risk of qualifying a violation of the ban may be lower”. With regard to medicinal product containing narcotic drugs and psychotropic substances, the Advertising Law establishes an absolute ban on the transfer of such samples, the lawyer emphasized. According to her, the legislator's logic in this matter is completely clear and does not allow for ambiguous interpretations.
Secondly, medical workers are legally prohibited from accepting gifts from organizations engaged in the development, production and (or) sale of drugs. A gift is understood as a gratuitous transfer of ownership of things or property rights. Therefore, the handed over drug samples can formally be considered gifts, and then the ban is violated, the expert summarizes. It cannot be ruled out that after receiving the drug samples, the doctor will independently decide to recommend them to his patients or even transfer the presented samples to them. The current legislation does not provide for special liability for a healthcare worker for violating this ban, the lawyer clarified. In this case, the doctor can only be brought to disciplinary responsibility at the initiative of the employer, if he deems it necessary, which in practice almost never happens.
In one of the industry chats, a representative of a pharmaceutical company convinced other participants in the discussion that it is possible to distribute samples during the first years after the launch of the drug. As Anna noted, there is no such legal norm in Russian legislation. However, a similar rule can be found in the Code of Good Practice of the Association of International Pharmaceutical Manufacturers (AIPM), according to which pharmaceutical companies can provide samples of pharmaceutical products exclusively to non-profit medical organizations for the purpose of familiarization. Samples can be provided only within two years from the date of the pharmaceutical product's launch on the Russian market. At the same time, it is permissible to provide a sample only in the smallest packaging within the framework of the dosage regimen and indications specified in the instructions for medical use available on the market.
According to the Code of Good Practice, it is prohibited to provide healthcare workers with samples of medicines either for subsequent transfer to patients or for personal use.
At the same time, it is permitted to demonstrate training items without transferring them at the venues of medical or pharmaceutical exhibitions, seminars, conferences and other events for healthcare workers.
“Although this document is not mandatory and applies only to members of the association, it can be used by pharmaceutical companies as part of their independent regulation of their activities when assessing risks,” the lawyer noted.
The restrictions on the transfer of samples do not apply to dietary supplements, the expert noted. To qualify the legality/illegality of the actions of the event organizer, it is important to establish whether the samples being transferred were medicinal products. At the same time, with respect to all samples, the risks of violating advertising legislation remain if the Advertising Law is applicable to the samples and materials being distributed.
More detailed information about the article and commentary can be found in the appendix and on the website of the publication: https://pharmvestnik.ru/articles/Obrazcy-popali-pod-razdachu-Chem-chrevato-vruchenie-preparatov-medicinskim-i-farmacevticheskim-rabotnikam.html
