Myths and Reality of the Decree on Restricting Imported Medical Devices for State Needs

Resolution No. 102 of February 5, 2015, "On Establishing Restrictions on the Admission of Medical Devices Originating in Foreign Countries to Meet State and Municipal Needs," adopted in February of this year, has been in effect for six months. In August of this year, the Ministry of Industry and Trade proposed expanding this list. Numerous proposals were submitted during two weeks of public consultations, leading to the extension of the review period until September 31. The discussion generated widespread public dissonance, as this resolution is perceived in a controversial manner. Below are the main myths and misconceptions regarding the Resolution on Restricting Imported Medical Devices for State Needs. Myth 1: The specified list of medical devices is completely prohibited from import into Russia. Not prohibited. This resolution does not prohibit the supply of imported medical devices. The restrictions apply only to state and municipal procurement and only when at least two domestic manufacturers participate in the competition. If no domestic manufacturers participate in the tender, or only one, then the purchase of imported medical devices is possible. Myth 2. Domestic healthcare institutions will be prohibited from purchasing foreign medical instruments and equipment. Customers must reject all applications for foreign medical equipment included in the list. This Resolution establishes a restriction, not a ban, on the purchase of medical equipment. Moreover, the restriction is imposed only on state and municipal healthcare institutions, i.e., on those medical institutions that purchase medical devices for state and municipal needs. Myth 3. Russia does not have a sufficient supply base to fully meet all healthcare institutions' needs for the items on the list. Shortages in medical institutions may arise in the near future. Until domestic production can fully meet all healthcare institutions' needs, this is not a priority. The goal of the medical industry development strategy is to create a high-tech and competitive industry for the development and manufacture of medical devices. As a result, it is planned to increase the share of domestic medical devices in domestic consumption to 40%. The resolution does not oblige medical institutions to purchase only domestic products; it prioritizes Russian manufacturers that submit applications for state and municipal procurement tenders. Manufacturers submit applications only to tenders whose terms they can fully meet. If two Russian manufacturers are not among the participating bidders, the healthcare institution may purchase imported medical devices. Myth 4: The quality of domestic medical devices leaves much to be desired. Russian products often utilize outdated technologies from foreign companies. Products from Russian medical manufacturers have long been recognized by the medical community, both in Moscow and in the regions. Currently, there are numerous positive reviews about their high clinical efficacy, quality, and ease of use. A number of domestic medical device manufacturers successfully supply not only Russian healthcare institutions but also export abroad. For example, ElePS LLC, a domestic manufacturer of endoscopic equipment and instruments, actively supplies medical endoscopes, endoscopic video cameras, endoscopic stands, and other endoscopic system components to countries such as India, Mexico, Cameroon, Tajikistan, and elsewhere. Domestic manufacturers continually conduct research and development to improve the performance of medical devices. The developments of Russian manufacturers are supported by patents. As part of the state program for the development of the medical and pharmaceutical industries, the Ministry of Industry and Trade of the Russian Federation actively collaborates with domestic manufacturers on the development and implementation of innovative and advanced medical technologies. Before entering the market, all medical devices undergo a registration process to confirm their safety, quality, and effectiveness. If side effects are detected, they do not meet quality requirements, or there is a risk of a threat to human life and health, Roszdravnadzor (Federal Service for Surveillance in Healthcare) recalls the medical device from circulation. This applies to absolutely all medical devices circulating on the Russian market, regardless of whether they are domestically or foreign-made. Myth 5: The regulation will create a monopoly for domestic manufacturers and lead to higher prices. Some Russian companies will purchase imported products and repackage them, thereby inflating their actual cost. The regulation has been in effect since February 2015. During this period, there was a smooth and painless increase in the share of domestically produced medical devices, which, in turn, was the purpose of the regulation. According to Rosstat, production increased 114% compared to the previous year. Moreover, the regulation operates without detriment to the healthcare system: if domestic manufacturers for any reason do not participate in the tender, imported goods are purchased; there is no monopoly on Russian manufacturers. Healthy competition is also maintained: restrictions only apply if two Russian manufacturers submit bids.