To prevent shortages, the Ministry of Health has begun collecting data on drugs that are not available in Russia and friendly countries. On March 18, the agency, on behalf of Deputy Prime Minister Tatiana Golikova, asked its chief freelance specialists to discuss possible options for replacing such drugs with regional counterparts. This follows from a letter dated March 21, sent to the regions by one of such specialists – clinical pharmacologist of the Ministry of Health Vladimir Petrov. Vedomosti got acquainted with his copy. The existence of such a document was confirmed by a source in the State Duma and two representatives of pharmaceutical companies.
The representative of the Ministry of Health also confirmed the sending of the letter by the department. According to him, this work is carried out so that the regions in case of, for example, logistics violations, know in advance what to temporarily replace drugs. All pharmaceutical manufacturers continue to work on the Russian market, deliveries are on schedule, and the agency sees no reason for a shortage of some groups of drugs, the interlocutor added. Representatives of Golikova’s staff and the Association of Clinical Pharmacologists, whose president is Petrov, did not respond to Vedomosti’s request.
The content of the letter is partially confirmed by the information published on the website of the Russian government. It says that the regional authorities should analyze the prescribed drugs from the list of essential and essential drugs (ZNVLP) and together with the territorial offices of Roszdravnadzor to clarify their availability in manufacturers’ warehouses and wholesale, and then ensure the availability of pharmacies in the pharmacy.
“The letter from the Ministry of Health is about interchangeability within the therapeutic group,” Evgeny Nifantyev (United Russia), a member of the State Duma’s Committee on Industry and Trade, told Vedomosti. – Clinical pharmacologists will be able to give clinical recommendations on which antibiotic or viral drug can be replaced by another.
And pharmacists and pharmacists have the authority to offer drugs exclusively on the basis of the active substance, ie only direct generics.
Compiling such lists of analogue drugs, the Ministry of Health is working for the future, as foreign pharmaceutical companies continue to supply vital drugs to Russia, says the director of development of the analytical company RNC Pharma Nikolai Bespalov. At the moment, only the American company Lilly has refused to import a drug for the treatment of erectile dysfunction cialis, Kommersant reported earlier. Sergei Shulyak, General Director of the DSM Group analytical company, believes that the Ministry of Health’s approach in advance is correct: if there is a shortage, it will be too late to prepare. But Bespalova was surprised that this work goes down to the level of subjects, and regional specialists are collecting information about possible analogues. In his opinion, it would be appropriate if this was done by a federal agency.
In the letters of the Ministry of Health and Petrov, the possible deficit may mean, first of all, the lack of original drugs (patented drugs created on the basis of a new pharmaceutical formula), Bespalov and Shulyak believe. Experts found it difficult to name the exact share of such drugs on the Russian market. Patients with oncological, as well as cardiovascular and rare diseases are most sensitive to the disappearance of original drugs, Bespalov notes. He also mentions people with HIV.
Cancer patients are not yet complaining about drug problems, but they are very worried about it, says Olga Goldman, director of the Clear Morning psychological care service for cancer patients. According to her, the profile foreign pharmaceutical manufacturers have been contracted for the year ahead and do not plan to interrupt deliveries yet. She refers to the results of communication with representatives of companies, but she did not name them. Goldman acknowledges that delays in the treatment of cancer patients directly affect the likelihood of their recovery, and the possible shortage of original drugs will inevitably affect the effectiveness of therapy, including due to side effects that are difficult to stop.
The latest drugs of recent generations are often a success in the treatment of oncology, “14 high-cost nosologies” (hemophilia, cystic fibrosis, etc.) and orphan diseases (such as Lenegra’s disease or progressive familial heart block), confirms Shulyak. The rest of the effectiveness of drugs of previous generations still remains high. “We have a lot of generics in the country that people continue to be treated with,” he added.
The government can also compile a list of analogues to organize their supply to other manufacturers from friendly countries or localize their production in Russia, says Bespalov. He believes that these companies may be given simplified market access. If there is a mass exodus of foreign pharmaceutical manufacturers from Russia, the mechanism of urgent centralized procurement of specific drugs, which operated during the coronavirus pandemic, simply will not work, he said. According to Bespalov, companies from China, India, Brazil and South Korea could become Russia’s potential pharmaceutical partners in analogue drugs.
Russia will be able to establish its own production of medicines if foreign companies stop supplying, Minister of Industry and Trade Denis Manturov said on March 27 on Russia 1 TV channel. According to him, the country is ready to purchase drugs in a civilized manner, but he reminded of the existence of a mechanism for compulsory licensing of drugs. Earlier, Prime Minister Mikhail Mishustin signed an order giving Pharmasynthesis the right to produce a one-year analogue of the antiviral drug remdesivir under the brand name Remdeform without the permission of the American Gilead Sciences.
The share of Russian medicines in the total volume of the pharmaceutical market in 2021 was 61.2% in physical terms (5.2 billion packages), said a representative of the Ministry of Industry and Trade. According to him, from the list of vital drugs, which includes 808 items, domestic pharmaceutical companies have the technological ability to produce within the country on a full cycle of 404.
Maria Glukhova participated in the preparation of the article