SPIEF: Drug Safety
Dmitry Zaytsev, CEO of JSC “Pharmstandard”, believes that the past year was tough for the industry, but thanks to a package of anti-crisis measures adopted by the Government, the situation was stabilized.
The session of the Association of Pharmaceutical Manufacturers of the EAEU "Pharmaceutical Industry in Russia: Reset Results" was held at the Drug Safety Forum of the St. Petersburg International Economic Forum. The experts discussed the past year, what aspects are covered by the new industry development strategy "Pharma-2030" and what to be done in its development in the mid-term and long term perspectives.
The moderator of the session, Alexey Kedrin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU, noted that Pharma-2030 is focused on achieving a number of targets by 2030, such as:
• Russian market volume should reach 3.7 tln. rubles
• domestic medicine share should be 42.6%
• share of medicines manufactured on a full cycle and included in the list of strategically important ones should be increased to 80%
• exports should amount to $3.4 bln.
The strategy already today reflects such urgent requests as:
• implementation of a system for controlling the origin of pharmaceutical ingredients
• price preferences for full-cycle medicinal products
• further improvement of pricing for medicinal products included in the Vital and Essential Drugs List
• fight against patent "greening"
• support measures
• accelerated registration of medicines.
Nevertheless, a number of issues remain related to how ambitious and achievable the goals set by the federal executive authorities are, as well as how ready they are to meet new challenges, including in the time horizon until 2040.
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Dmitry Zaytsev, CEO of JSC “Pharmstandard”, believes that last year was certainly tough for the industry, but thanks to the package of anti-crisis measures adopted by the Government (Government Decrees No. 1771, No. 593), the situation was stabilized.
During his speech, the expert noted that the Pharma-2030 strategy gives the special focus on patents and intellectual property. Patents are the cornerstone of the development of everything new. The company has already registered about 40 patents for its in-house developments. In this regard, it is vitally important, if not to review, then at least update the "rules of the game" in the market. Examplarily, CEO of JSC “Pharmstandard” considers it absolutely correct to move away from patent linkage, which is embedded in the industry development strategy. “This is not the mechanism that is needed today, it leads away. Even if we assume that the regulators of all the EAEU countries would take over the function of checking patenting, which is not characteristic of them, the problem would still not be solved, since the rule of delayed (until the end of the patent protection period) entry into force of registration certificates would apply to new registrations. Then it is not clear how it could help to solve the situation with already issued registration certificates. The law in this case does not have retroactive effect, so the issuance of registration certificates through such patent linking is, obviously, a dead end” the expert explained. However, in his opinion, it is necessary to create equal conditions for all market participants, and the Federal Antimonopoly Service could maintain such an order, since patent infringement is an example of unfair competition.
Besides that, the expert drew attention to the problem of "evergreen" patents identified in the Strategy. According to Dmitry Zaytsev, this is not quite the correct name for the phenomenon that the market deals with: there are not “eternal” patents, but renewable protection of a product by patenting its individual aspects, characteristics and properties, i.e. we can rather talk about the "evergreen" protection of the product. An illustrative example of such a situation is patents with imaginary novelty, when in fact there is no new product, and those properties that were already a priori inherent in the product are patented. In fact, this is a deception of the office for intellectual property, which is the greatest danger for conscientious market participants. “Today, Rospatent is pursuing a consistent policy of putting things in order in patent cases, and we expect that, with our help, the agency will pay attention to this category of patents. Earlier, twice - in 2018 and 2021 - changes were made to the 316th Order. We, as pharmaceutical manufacturers, are ready to continue to work together to improve the patent system, to discuss this issue as part of the relevant working teams,” Dmitry Zaytsev summed up.
At the end of his speech, the expert also proposed extending the experience of registering covid products under Decree of the Government of the Russian Federation No. 441 to certain categories of pharmaceutical products, as well as changing the pricing system for blood products and immunobiological products by analogy with the registration of prices for vaccines.
More details are available on the website of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union
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