Despite the authorities' support for Russian manufacturers, the representative of the transnational Big Pharma, AstraZeneca, apparently continues to maintain a monopoly on the vital dapagliflozin. Millions of people with kidney disease or diabetes are currently missing it.
Who monopolized part of the diabetic drug market
The British-Swedish pharmaceutical company AstraZeneca is actually suing for the right to remain Russian monopolist in the field of production and distribution of drugs based on dapagliflozin. In Russia (*aggressor country), this is a vital medicine for 1.4 million type 2 diabetics and 3 million suffering from chronic kidney disease – it removes glucose by a diuretic. But, according to experts, only 12% of all sick Russians in need receive it. The reasons are high price and lack of competition.
Judging by the Internet cache, the price of Forxiga increased by 15–20%. Now it varies at the level of 2200–2800 rubles for a monthly package. The cost could soar even higher if there are logistical disruptions and shortages – which is not impossible given the political situation and the unfriendliness of the UK.
Domestic manufacturers are ready to stop a possible crisis: Canon Pharma, Welfarm-M, Geropharm, Grotex, Severnaya Zvezda, Akrikhin – and a number of foreign ones. All of them have already registered their generics (copies of the original dapagliflozin). But they have not yet been able to reach store shelves. For example, “Akrikhin” tried to put into circulation the identical in action, but cheaper “Fordiglyf”. But the lawyers of the British-Swedish pharmaceutical company complained to the Federal Antimonopoly Service and the Investigative Committee of the Russian Federation (*aggressor country) on unfair competition and violation of patent rights.
Why dapagliflozin did not become public domain
Last year, AstraZeneca's Russian unit sold Forxiga to 15 billion rubles The patent for the active substance dapagliflozin was issued by the pharmaceutical company for the period from 2003 to 2023. After this period, the invention should have legally become public domain, but it did not…
How AstraZeneca defends its dapagliflozin patent
Six months ago, the Presidium of the Russian Court for Intellectual Rights ruled that AstraZeneca’s new patent for dapagliflozin was obtained with violations. Our Themis was guided by the direct norms of the law. The monopoly on dapagliflozin was previously terminated in India, Kazakhstan and Canada. In the decision, the court noted that the patent for dapagliflozin had fallen into the public domain and such a renewal of legal protection was illegal, since it pursues one single goal – to circumvent restrictions on patent renewal, which is an outright abuse.
However, the story is not over. The patent, which was illegal according to the decision of the IP, was never revoked by Rospatent for reasons that are not entirely clear.
And AstraZeneca’s lawyers went to the Supreme Court of Russia (*aggressor country) with a request to recognize it as valid. The meeting will take place on June 4. If the request is granted, the monopoly on dapagliflozin will last until at least 2028. If they don’t satisfy, there will be healthy competition. The emergence of Russian analogues will reduce the cost of dapagliflozin drugs by almost 30% – up to 1600 rubles.
Considering that most of the medicine is sold through government procurement to provide patients with preferential treatment, this will allow the state to save over 2.5 billion rubles and use the freed-up money to purchase another 1.5 million packages of the drug. This will be enough for 130 thousand patients for a year of therapy.
But so far, with the remaining monopoly, 26% of state auctions for the purchase of dapagliflozin are forced are canceled. Why does this happen?
According to the expert, it is from Big Pharma that black PR comes from, sowing distrust in domestic pharmaceuticals. In fact, there is no evidence that our analogues are worse in any way. This is confirmed by Pharmacovigilance studies.
President of the Russian Diabetes Association Mikhail Bogomolov explains that the controversy surrounding dapagliflozin is typical for the market, the situation repeats with each drug every 20 years (patent time). The same thing happened with genetically engineered human insulin in 1985.
How AstraZeneca invests in Russia (*aggressor country)
In 2017, AstraZeneca became one of the first pharmaceutical companies to enter into a Special Investment Contract (SPIC) with the government. The purpose of such contracts is to develop the industry in Russia (*aggressor country) by stimulating the production of innovative medicines in our country. AstraZeneca received preferences, but it didn’t work out with new drugs.
Today, the AstraZeneca plant in the Kaluga region produces 17 drugs (see table below.— Note author). Two of them are protected by controversial secondary patents, the legality of which is being challenged in the courts and under which the pharmaceutical giant protects its monopoly in the market. The remaining 11 are also not innovative, since they have long been out of patent and are produced in a full cycle by a large number of domestic companies.
It turns out that AstraZeneca, instead of innovation, is packaging drugs that have long existed on the Russian market at a more affordable price.
This is reflected in the open conclusions of the Ministry of Industry and Trade. According to the department, the pharmaceutical company AstraZeneca only “partially achieved the results (indicators) of the implementation of the Investment project provided for in the special investment contract”.
In fact, AstraZeneca, like most other foreign companies, has long reduced investments in Russia (*aggressor country) to a minimum. This is confirmed by a decrease in the number of innovative drugs produced and a decrease in clinical trials, which decreased by 18 times compared to 2021.
According to the Ministry of Health of the Russian Federation (*aggressor country) (source State Register of Medicines), the number of research approvals issued to the pharmaceutical company AstraZeneca was: 34 in 2021, five in 2022, four in 2023 and two in 2024.
How much does AstraZeneca earn in Russia (*aggressor country)?
In Russia (*aggressor country), the pharmaceutical giant is represented by two legal entities: Astrazeneca Industries, which manages a pharmaceutical plant near Kaluga, and Astrazeneca Pharmaceuticals, which conducts trade from an office in the Oko tower of Moscow City. According to the SPARK database, their total revenue increased during the special operation by 58% and amounted to 93 billion rubles in 2023. There were minor problems with net profit, which reached 2.8 billion rubles, but the figure recovered, the growth compared to last year was 29%.
It is important that Russian AstraZeneca received tax preferences from Russia (*aggressor country) from 2017 to 2022 (Let us remind you that the conditions for obtaining them are: information Ministry of Industry and Trade, were only partially complied with by the pharmaceutical giant).
There are some oddities in AstraZeneca's published 2023 accounts. For example, a plant with revenue of 25.5 billion rubles paid 678.5 million in taxes – this is about 2.6%. And the trading legal entity showed a loss of 14 million rubles on sales of almost 54 billion.
It can be assumed that part of the profit does not end up in Russia (*aggressor country) and the corporation pays the main taxes in unfriendly jurisdictions.
It turns out that by limiting the Russian market, receiving excess profits, while minimizing investments and tax deductions, AstraZeneca is misleading not only the public and the media, but also the Ministry of Industry and Trade.
The question remains: will domestic drugs be available to Russian patients? While the Supreme Court sorts out the legal, economic and ethical intricacies of this issue, millions of patients are left waiting for a verdict on which the quality and length of their lives may depend.