The Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”), dated July 3, 2015, regulates the promotional activities of medicinal products for human use.
Under the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, is prohibited. Pharmaceutical products may be promoted only to physicians, dentists, and pharmacists. Therefore, the interaction between the companies and the patients should be minimized.
The companies may enter into written agreements with physicians to obtain consultation services. The Agency does not regulate the conditions of such service agreements. The industry sets the rules for such contracts via Ethical Codes.
The pharmaceutical companies must notify the Agency of any value transfers that exceed 10% of the current monthly gross minimum wage, made to health institutions, organizations, universities, health professionals, and members of professional associations, trade unions, associations, and foundations, operating in the field of health, and non-governmental organizations established for the protection and development of health. This applies to sponsoring scientific meetings, donating, or obtaining consultancy services. The companies must obtain the consent of healthcare professionals or healthcare organizations before any value transfer occurs to fulfill this obligation.
Similarly, promotional activities for medical devices are regulated by the Regulation on Sales, Advertising, and Promotion of Medical Devices dated May 15, 2014 ("Regulation on Promotion of Medical Devices"). Although the Regulation on Promotion of Medical Devices regulates consumer-targeted advertising activities specifically for different product categories, it does not make a similar distinction for promotional activities targeting healthcare professionals. Promotion is possible by publications distributed and sold to healthcare professionals and technical staff working with medical devices within healthcare institutions and organizations or publications in medical-professional journals with scientific content; supporting or organizing scientific meetings, visiting by sales and promotion staff; providing information about the device, the application of the device and the user manual.
Both in the field of pharmaceuticals and medical devices, another critical aspect of relations with physicians and health institutions is the principle of full-time employment for physicians working in a public health institution or university hospital. In accordance with the legislation, these physicians are prohibited from engaging in trade and other profitable activities. Therefore, all payments made for the services provided by these physicians must be made to the institution they are affiliated with.
In recent years, individual lawsuits have been brought by physicians, who are employed at the university hospitals, against provincial health directorates that refused their applications to establish private clinics. These cases are not considered collectively, as each case binds the physician concerned. The companies must decide whether the payments shall be made to those clinics, considering the possibility that the higher courts may overturn the decision of the first instance court.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.