Interactions with Health Care Professionals, Transfer of Values and Conditions of Payment

Promotion activities for pharmaceutical products for human use are regulated under the Regulation on the Promotion of Medicinal Products for Human Use dated 3 July 2015 (“Promotion Regulation”).

The Promotion Regulation stipulates that the promotion of pharmaceutical products can only be conducted with healthcare professionals such as doctors, dentists, and pharmacists. As a result, the interaction of pharmaceutical companies with patients are limited, and direct advertisements to the public are prohibited.

Pharmaceutical companies may seek consulting services from healthcare professionals. However, such services agreements must be made through written contracts, must adhere to specific ethical guidelines, and must comply with the Full-Time Work Principle. Additionally, pharmaceutical companies are required to notify the Agency about any value transfers to healthcare institutions or professionals. These notifications are required if the amount of value transfer exceeds the legal limit.

In 2024, a new draft regulation regarding the promotion activities of medicinal products for human use was opened for public consultation twice. These drafts aim to impose stricter oversight and regulations on promotion of pharmaceuticals. The draft aims to establish a clear framework for promotional and advertising practices. It is seen as a positive development in that the draft creates a foundation for content related to patient support programs and product education. However, there is insufficient guidance on other common issues in the sector, such as the training requirements for healthcare professionals and market dynamics. While the new sanctions imposed on healthcare professionals and institutions aim to increase the effectiveness of the regulations, the applicability of these sanctions and the lack of a comprehensive strategy to address sectoral problems are notable concerns. Although the Agency’s steps to raise ethical standards in the sector are important, it should not be overlooked that other challenges also need addressing.

Promotion Activities in the Medical Devices Sector

Promotion activities in the medical devices sector are regulated under the Regulation on the Sale, Advertising, and Promotion of Medical Devices dated 15 May 2014 (“Medical Device Promotion Regulation”).

In the Medical Device Promotion Regulation, rules concerning advertisements directed to consumers are specifically tailored to product categories. However, no such distinction is made regarding promotional activities targeted at healthcare professionals. A variety of methods can be used to promote medical devices to healthcare professionals and technical staff working in healthcare institutions. These methods include scientific publications in medical journals about devices and instructional manuals, scientific conferences, and visits by sales and promotion representatives.