Quo vadis: the national course of the pharmaceutical industry was discussed at the PROjections of the Future Conference

Accessibility and affordability of medicines for the population, lists and catalogues of drugs, patent protection and innovation in the pharmaceutical industry, the situation in clinical trials, and the specifics of medical device circulation—these and other pressing issues were the subject of a discussion moderated by Victor Dmitriev, Chairman of the Public Council under the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and General Director of the Association of Pharmaceutical Producers (ARPM), «National Course. The State Framework for the Pharmaceutical Industry,» at the PROjections of the Future conference, which opened today in Sochi.

One of the topics was innovation in the pharmaceutical industry. What kind of government support do domestic developers of new drugs need? Some opinions were expressed about the need for some kind of government procurement from the Ministry of Health so that companies understand the field they should pursue. However, there are risks that there will be too many developers in some places and too few in others. The issue of patent protection also remains unresolved. Russian legislation in this area retains loopholes for both patent greenwashing and unscrupulous generic manufacturers, and domestic law enforcement practice in this area is highly ambiguous.

Igor Khasin, Director of Strategic Development Programs at Tonus JSC, discussed aspects of medical device registration, as well as the chaos prevailing on marketplaces regarding the sale of unregistered products. He approached Victor Dmitriev, as head of the Public Council under Roszdravnadzor, with a request to initiate the creation of a working group on the circulation of medical devices. He received a response that such a group is already operating within the Public Council, and that many of the issues raised today are being actively addressed by the Council in conjunction with representatives of industry agencies and medical device manufacturers.

The discussion was concluded by State Duma Deputy and Deputy Chairman of the Health Protection Committee, Yevgeny Nifantyev. He reported that the parliament had passed a bill on the platform economy, which, among other things, requires online platforms to verify that sellers have registration certificates for dietary supplements and medical devices. A bill was also approved for the pre-trial blocking of websites selling dietary supplements that lack state registration and that contain false information about their composition and use. Ensuring the physical availability of medicines and medical devices for residents of remote and hard-to-reach areas is also in the final stages of approval. A pilot project is being proposed for the delivery of medicines and medical devices by mobile pharmacies linked to a specific stationary pharmacy, equipped with a GLONASS system, with stable access to the Drug Movement Monitoring system, and following a specific route agreed upon with municipal authorities. It is expected that these mobile pharmacies will be able to serve up to 50 communities per week, thereby providing their residents with essential pharmaceutical products.

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