Promotional activities of human medicinal products is regulated by the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated July 3, 2015.
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 companies and patients should be minimised.
Companies may enter into written agreements with physicians to obtain consultation services. The TMMDA does not regulate the conditions of such service agreements. The industry sets the rules for such agreements via Ethical Codes.
In addition, pharmaceutical companies must notify the TMMDA of any value transfers that exceed 10% of the current monthly gross minimum wage 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, making donations, or obtaining consultancy services. Companies must obtain the healthcare professionals’ or healthcare organizations’ consent before any value transfer occurs to fulfil this obligation.
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.
Recent times have seen individual lawsuits brought by physicians employed at university hospitals against provincial health directorates that refused their applications to open private clinics. These cases are not considered collectively, and as each case binds the physician concerned, it is necessary for pharma companies to decide on whether the payments shall be made to those clinics, considering the possibility that the higher courts may overturn the decision of court of first instance given in the case.