News Digest 28.11.2025 — 05.12.2025
Regulators
The launch of the scoring system for assessing drug localization will be postponed
The Russian Ministry of Industry and Trade has proposed extending the transition periods related to confirming the country of origin of drugs. This period should be synchronized with the launch date of the "second-odds-to-be-used" mechanism for drugs on the list of strategically important drugs. The corresponding amendments will be made to Russian Government Resolution No. 1875 of December 23, 2024, and Russian Government Resolution No. 1392 of September 10, 2025. Public comment on the drafts will last until December 19.
If the amendments are adopted, confirming the country of origin of drugs and certain medical devices using the ST-1 certificate of origin will be possible until June 30, 2026, according to the press service of the Russian Ministry of Industry and Trade. Until November 30, 2026, this will still be possible using a point-free entry in the industrial product registry, obtained before July 1, 2026. The entry into force of the point-based system for assessing the country of origin of medicines has been postponed to July 1, 2026.
The amendments were prepared in connection with the ongoing transition to a point-based system for assessing the country of origin of certain medical devices, as well as the need to align the aforementioned regulatory legal acts with the entry into force of the "second wheel" mechanism for medicines on the list of strategically important medicines produced in the EAEU using a full cycle. Previously, the Russian Ministry of Finance initiated a postponement of the "second wheel" mechanism to July 1, 2026, as reported by FV.
Industry representatives reacted differently to the news that the launch of the "second wheel" mechanism was once again postponed.
"The 'second wheel' rule represents an important step in supporting the domestic pharmaceutical industry and strengthening its position in the domestic market," AlPharma Sales Director Marina Ostrovskaya commented to FV. "At the same time, it requires careful preparation and support both to mitigate negative consequences and to ensure maximum benefits for the economy and public health."
The Lekmedobrashchenie Association notes that pharmaceutical companies have been waiting for the "second wheel" rule to begin for over five years. According to analytical data, the share of localized drugs in government procurement in ruble terms decreased from 43.8% to 39.1% between 2020 and 2025. This clearly indicates both stagnation in the expansion of local production capacity and the inadequacy of local production support measures during this period, the association states, calling for the mechanism to be launched as planned, on January 1, 2026.
Market news
The volume of major public medical procurement for the first nine months amounted to almost 1.1 trillion rubles
The volume of medical procurement in the first three quarters of 2025 exceeded 1 trillion rubles, according to RTS-Tender data. The value of contracts concluded for the purchase of medicines and materials exceeded 764 billion rubles. This is less than for the same period in 2024, but more than data for January-September 2023.
The total volume of major medical procurement for January-September 2025 under Federal Laws Nos. 44 and 223 amounted to 1 trillion 87 billion rubles. This data includes the purchase of medicines and materials, medical instruments and equipment, vaccinations, and employee medical examinations. These statistics were compiled by experts at RTS-Tender (part of the Russian digital procurement and sales platform B2B-RTS) after reviewing open data from the Unified Information System.
In the first nine months of 2025, approximately 320,000 tenders for the procurement of medicines and materials (OKPD2 21) were held, with the value of contracts exceeding 764 billion rubles. This is less than for the same period in 2024 (867.2 billion rubles), but higher than the data for January-September 2023 (632.6 billion rubles).
Moscow accounts for almost 28% of the total procurement value. Over the first three quarters of 2025, Moscow-based customers held 29,400 tenders for the supply of medicines and materials, with procurement volume amounting to 212.5 billion rubles. The top five regions by procurement volume also included St. Petersburg (42.9 billion), the Moscow Region (31.7 billion), Krasnoyarsk Krai (20.7 billion), and Rostov Region (17.8 billion).
Another key procurement area in the industry is the acquisition of medical equipment and instruments (OKPD2 32.5). In the first nine months of 2025, nearly 199,000 tenders for their supply were held in Russia, with contracts worth 312.5 billion rubles already signed. For comparison, the same period in 2024 saw procurement volumes of 307.8 billion rubles, and in 2023, 270.9 billion rubles.
Moscow also leads the way, accounting for over 25% in monetary terms. Over the first three quarters of 2025, 23,000 tenders were published in the capital, with contracts worth 83 billion rubles signed. St. Petersburg (26.3 billion), Bashkortostan (15.7 billion), the Moscow Region (9.7 billion), and Krasnodar Krai (8.3 billion) follow.
RTS-tender experts note that vaccinations for employees of government organizations and state-owned companies are becoming increasingly popular. They are primarily ordered under OKPD2 86.90.15 – medical laboratory services. From January to September 2025, 4,500 tenders for vaccination services were placed in Russia, with contracts worth 6.4 billion rubles. For the first nine months of 2024 and 2023, procurement volumes amounted to 5.8 billion and 6 billion rubles, respectively.
Routine medical examinations (OKPD2 86.21.10.120 – diagnostic procedures) for employees of state-owned companies and government institutions are currently less active. In the first three quarters of 2025, customers published 6,900 tenders for medical examinations, with contracts signed for 3.7 billion rubles (4.6 billion for the first nine months of 2024 and 3.95 billion for 2023).
The acquisition of medical devices, medications, and preventive measures are key areas of the state's social policy. Stable demand in government procurement confirms this. In the off-the-shelf segment, demand for medications is more than doubling. For January–September 2025, contracts for the supply of medications totaled 4.2 billion rubles, compared to 2.1 billion rubles for all of 2024. According to the Unified Information System (UIS), the peak period for medical procurement is November–December. Taking this into account, RTS-tender estimates that the procurement of medicines, materials, and medical examination services (along with the purchase of equipment and vaccinations) by the end of 2025 will also exceed last year's figures.
Other
The UK was the first country to receive a full exemption from US tariffs on pharmaceuticals
The UK became the only country to avoid Donald Trump's tariffs on pharmaceuticals and medical devices. To achieve this, London had to agree to higher-priced purchases and make concessions to pharmaceutical corporations.
The US has exempted the UK from tariffs on drugs, pharmaceutical active ingredients, and medical devices.
The Trump administration signed the corresponding agreement with the British government, according to a press release from the US Trade Representative.
The UK became the only country in the world to achieve duty-free import of its pharmaceuticals into the US. The White House had previously set tariffs at 15% for Switzerland, Japan, South Korea, and the European Union (EU). In October, Donald Trump announced a 100% tariff on branded and patented drugs from all countries that do not transfer production to the US or do not reach a deal.
According to the agreements reached, the tariff exemptions will be in effect for at least three years. Washington also agreed not to challenge the UK's internal drug pricing mechanism until the end of Donald Trump's presidential term.
In exchange, London pledged to revise the methodology for assessing the cost-effectiveness of purchasing new drugs through the National Health Service (NHS), the country's public system that fully or partially covers the cost of medications for citizens through taxes. This methodology is based on the QALY metric—the calculation of the value of each additional year of life gained by a drug. Previously, the threshold ranged from £20,000 to £30,000. If these values were exceeded, the British government refused to purchase the drugs. Now, the upper limit will be raised by 25%, to £35,000.
Furthermore, the UK previously approved the sale of expensive new drugs from abroad, but forced pharmaceutical companies to return 23.5% of sales revenue to the treasury or offer discounts on older products. Now, the rate will be reduced to 15%.
The British government made these concessions to the industry after pharmaceutical giants began withdrawing funding for projects in the country en masse. By November, they had withdrawn over £2 billion ($2.7 billion) in investments due to onerous commitments. Among those taking this step were MSD (Merck & Co. in the US and Canada), Eli Lilly, Sanofi, Novartis, and AstraZeneca.
The Russian Ministry of Health will be granted new powers to conduct medical examinations for drivers
Russia plans to tighten oversight of drivers' health by changing the rules for medical examinations, effective March 1, 2027. Medical reports will be issued with mandatory data exchange between the Russian Ministry of Health and the Russian Ministry of Internal Affairs.
The Russian Ministry of Health will be granted new powers to conduct mandatory and unscheduled mandatory medical examinations for vehicle drivers. The draft Russian government resolution has been published on regulation.gov.ru.
This concerns the procedure for the ministry to exchange information with the Russian Ministry of Internal Affairs regarding the need for a driver to undergo an unscheduled mandatory medical examination, medical reports on the presence or absence of medical contraindications, and information on issued driver's licenses. The process will be streamlined within a unified system of interdepartmental electronic interaction by March 1, 2027.
In July 2025, Russian President Vladimir Putin signed a federal law requiring clinics to report any contraindications to driving to the Ministry of Internal Affairs. Driver's licenses may be revoked based on this information. The rules for revoking driver's licenses for medical reasons will also come into effect on March 1, 2027.
In recent years, several initiatives have emerged in Russia to tighten controls over drivers' health. In 2025, a proposal to label medications that potentially affect driving ability was introduced in the State Duma. Furthermore, work is underway on amendments that will allow the Russian Ministry of Health to compile a mandatory list of medications that drivers are not allowed to take while driving, MV reported. In just five years, 96,000 driver's licenses have been revoked for medical reasons.
Russia is considering delaying the introduction of mandatory vaccinations against four infections
Russia has proposed postponing the inclusion of rotavirus, chickenpox, human papillomavirus (HPV), and meningococcal vaccines in the National Immunization Schedule (NIS) by one to four years. The Russian Ministry of Health has prepared a draft government decree on this initiative, according to RBC.
According to the decree, accessible vaccination against rotavirus will be included in the NIIS in 2029, not 2025; vaccination against meningococcus and HPV will be included in 2027; and vaccination against chickenpox will be added only in 2031. (Currently, these vaccines, with the exception of HPV, are included in the NIIS for epidemiological indications. — Ed.) The decision is based on the need for a full vaccine production cycle in Russia, the ministry explained.
Yan Vlasov, co-chair of the All-Russian Patients' Union, called the government's plans negative, citing delays in protecting the population from dangerous infections and stricter conditions for manufacturers. The incidence of meningococcal infection has doubled in 2025, from approximately 600 cases in 2024 to 1,200 by the summer of 2025.
Chickenpox cases have increased in several regions: since the beginning of 2025, the rate has increased by 67% in Yamal, and more than doubled in Bashkortostan. There have been no spikes in human papillomavirus cases, but a gradual increase has been observed: over the past ten years, the number of infections has increased by 2.5 times. Domestic medications for the prevention of chickenpox, HPV, and rotavirus are not yet on the market.
More than 70% of experts surveyed by the Right to Health company believe that Russia's vaccination policy is insufficiently effective. The key problem is delays in implementing the Strategy for the Development of Immunoprophylaxis of Infectious Diseases through 2035. Postponing important measures in this document increases the risk of spreading life-threatening infections and jeopardizes the national goal of increasing life expectancy to 78 years by 2030.
Experts previously noted that the current vaccination schedule is based on 20th-century demographic assumptions. Rubella vaccination is recommended until age 25, but fewer women are giving birth at this age. Furthermore, the vast majority of adults do not have sufficient antibody titers against measles.
New registered medical devices
We publish a list of new medical devices registered from 11.28.2025 to 12.05.2025
Link to the list: [see table in the attachment]
News
