Representatives of pharmaceutical manufacturers: are the rules changing?
Important for pharmaceutical manufacturers and their representative offices!
Changes have been made to the procedure for informing medical and pharmaceutical workers about medicines.
After recent very significant changes dated January 09, 2023 to the Instruction on the procedure and conditions for informing medical and pharmaceutical workers about medicines included in the State Register of Medicines of the Republic of Belarus by representatives of medicine manufacturers (approved by the Decree of the Ministry of Health of April 17, 2015 No. 44) , a new resolution of the Ministry of Health of April 11, 2023 No. 51 was adopted, which introduced another important change. Effective May 1, 2023.
Among the innovations:
Relations on advertising, ensuring organization and functioning of pharmacovigilance system are excluded from the scope of the Instruction. At the same time, the issue of distinguishing between advertising and information activities remains relevant;
Permissible legal forms of relations between a drug manufacturer and a manufacturer's representative are defined. Representatives of drug manufacturers may be:
- employees of drug manufacturers (registration certificate holders) or their representative offices,
- employees of other legal entities that have concluded a civil law contract with drug manufacturers (registration certificate holders) or their representative offices,
- other individuals who have concluded a civil law contract with drug manufacturers (registration certificate holders) or their representative offices;
the implementation of certain acceptable forms of informing medical workers has been clarified, in particular, oral presentation allows the demonstration of printed and other information materials, the provision of information materials to the organization in electronic form or on paper should be carried out without interaction with the employees of the organization. At the same time, the list of forms of informing remains, as before, closed;
the list of illegal actions of representatives of pharmaceutical manufacturers has been supplemented. Representatives are not entitled to inform employees aimed at drawing attention to a particular medicinal product (medicines), creating or maintaining interest in it and (or) promoting it on the market. The subjective-evaluative nature of this criterion for qualifying the actions of representatives as unlawful is alarming. At the same time, the question of the legal consequences of such actions remains open (especially in the context of the fact that advertising relations are directly removed from the scope of the Instruction).