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Therapeutic culture: the list of strategically important drugs will be enshrined in law
The concept of a list of strategically important drugs and the mechanisms for its formation will be introduced into the law on the provision of medicines to the population. Thedraft law developed by the Ministry of Health has been supported by the Cabinet of Ministers. The list will include drugs that meet the basic needs of Russian healthcare. And getting on the list will guarantee priority in public procurement. Now Russia already has a similar list, but not in the legislation of the federal level. The level of the federal law will make its use mandatory and transparent, experts noted.
How the amendments will work
The concept of the list of strategically important medicines (SMLS) in the law on circulation of medicines was proposed by the Ministry of Health. On Monday, December 23, the amendments were approved by the Government Commission on Legislative Activity (the document is at Izvestia's disposal). This was reported by the editorial board's sources in the Cabinet of Ministers.
Now there is such a list, since 2010 it exists as a normative act of the government, but now it will be enshrined in the law.
The list of strategically important drugs, the production of which should be provided on the territory of the country, first appeared in 2010. At that time it contained only 57 drugs. The list was enlarged only ten years later - in 2020 it was expanded to 215 items - these are, in particular, drugs intended for emergency medical care, treatment of insulin-dependent diabetes mellitus, oncological and orphan diseases, HIV infection, hepatitis. The list was created within the framework of the federal target program and the state program "Pharma-2020", which was implemented by the Ministry of Industry and Trade.
In April 2024, the government approved a plan to implement the strategy for the development of the pharmaceutical industry until 2030, Vladimir Gruzdev, Chairman of the Board of the Russian Bar Association, reminded Izvestia.
- The purpose of the strategy is to improve the development of healthcare in terms of providing the population with necessary medicines," he explained. - The document will legislate the concept of the list of strategically important medicines, as well as authorize the government to approve the list of SZLS, the procedure and criteria for its formation.
Thus, the list will include drugs that provide priority health care needs. The list will be formed of vital and essential drugs (VED), but not all of them. The condition for getting on the list will be, in particular, production in Russia at all stages of the technological process.
Manufacturers of drugs included in the list will be provided with support measures - they will be purchased on a priority basis in the course of government procurement.
Thechanges will favorably affect the subjects of entrepreneurial and economic activity, explained Vladimir Gruzdev.
- They are aimed at ensuring stable demanded production of medicines included in the list, which should guarantee the availability of jobs at these productions and social guarantees, - he emphasized.
If approved, the document will come into force on May 1, 2025. The amendments have been agreed with the Ministry of Finance, Ministry of Economic Development, Ministry of Industry and Trade, FMBA, FAS, Roszdravnadzor.
"Izvestia also sent inquiries to the Ministry of Health and the Ministry of Industry and Trade with a request to comment on why it was necessary to fix the list of strategically important drugs in the law, when this list has been formed since 2010, as well as what measures of state support guarantee for pharmaceutical companies to be included in the list.
In April 2024, the government drew up a detailed action plan for the implementation of the strategy and appointed responsible agencies, including the Ministry of Health, Ministry of Industry and Trade, FMBA, FAS and a number of others. The Cabinet of Ministers said at the time that it expects systemic measures to support domestic pharmaceutical production, training of specialists for the industry should be streamlined, and domestic pharmaceutical products should receive priority market access.
Why change is important
The list of strategically important drugs is formed on the basis of drugs within the VED list and represents a squeeze of products that are important for the provision of medical care to the population. This was told to "Izvestia" by Nikolay Bespalov, Development Director of the analytical company RNC. According to him, there are now many drugs on this list that are not considered an absolute baseline for the patient.
- For example, the list includes xylometazoline-based runny nose sprays, but you can do without them, while it is technically impossible without vaccines or insulin," he emphasized. - Accordingly, the level of state support for important products should be different. In fact, the NWLS list includes the most important products for the healthcare system, and it is these drugs that are given priority in deepening production and state support measures.
Experts noted that the level of federal law and the existence of departmental bylaws, which many years ago determined the creation of this list, makes the process mandatory and transparent.
- The current list of strategically important drugs was formed long ago and needs to be updated," added Alexey Kedrin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU. - For the procedure and criteria to be adopted, the government should be authorized to do so, and the norm with the definition should be fixed at the level of the law on circulation of medicines.
Nikolay Bespalov is sure that the updated list of strategically important drugs will be shorter than the list of VEDs. At the same time, he noted that the list should cover a significant number of items, then it will stimulate companies to deepen the production cycle, create raw materials or turn to Russian pharmaceutical companies.
According to the expert, the list will stimulate Russian pharma to build long production chains, increasing the stability of drug supply and maintaining the price level of products. In the future, it is possible to enter export markets, he added.
However, market participants were wary of the introduction of the "second superfluous" rule - when drugs from the list will be prioritized for government procurement.
"Inclusion in the list of a drug already produced in Russia on a full cycle, taking into account the application of the "second extra" rule, may create risks of monopolization on the part of such a manufacturer," the Infarma association said in an appeal to the Ministry of Health (Izvestia has it). - Under such conditions, there is a high risk of defects and unforeseen reduction in supply in case the manufacturer has problems with the production of the drug, since other pharmaceutical companies, actually excluded from the auction, will not be able to replenish supplies.
Vadim Kukava, Executive Director of Infarma, also believes that when forming the list, it is necessary to take into account not only the active ingredient, but also the dosage form by analogy with the VED list.
"Izvestia sent requests to Russian pharmaceutical companies Biocad, R-Pharm, Binnopharm, Binnopharm, Pharmasintez and Pharmstandard, as well as foreign companies Roche, Johnson & Johnson, MSD, Novartis and AstraZeneca to comment on how the approval of the list of strategically important drugs will affect them and the pharmaceutical market. At the time of publication only one company responded.
Adoption of the list of strategically important drugs within the Pharmaceutical Industry Development Strategy until 2030 is only the first stage, which should be followed by specific measures and actions aimed at developing domestic pharmaceutical production, reducing dependence on imports, regulating prices and increasing the availability of drugs, Rustem Muratov, General Director of Binnopharm Group, told Izvestia.
These measures, he said, will help stabilize the market, but will also require a careful balance between supporting business and respecting consumers' interests: the government should ensure transparency and efficiency in implementing these measures to avoid negative consequences, such as monopolization, or reduced innovation activity, or price increases, both for the government and end consumers.
