The pharmaceutical industry asks the government to instruct the Ministry of Health to speed up the inclusion of new drugs in the lists
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A number of associations of manufacturers and distributors of the pharmaceutical industry are asking the government to instruct the Ministry of Health to expedite the inclusion of new drugs in the lists, including vital drugs purchased at state tenderers (VED). The Ministry has twice postponed consideration of this issue, citing the need to study the possibilities of companies to arrange the issuance and supply of funds, taking into account the new realities in the economy. Uncertainty discourages production planning and discourages new product launches, which manufacturers warn could be one of the reasons for potential drug shortages.
Kommersant obtained a letter dated August 8 addressed to Prime Minister Mikhail Mishustin, signed by five organizations from the pharmaceutical industry, including the Association of Russian Pharmaceutical Manufacturers (ARPM), the Association of International Pharmaceutical Manufacturers and a similar structure uniting EAEU companies. They ask the government to instruct the Ministry of Health to hold a meeting of the commission in September, which would approve drugs for inclusion in the lists for 2024.
The reason for the appeal was the fact that since the beginning of 2023, the ministry has twice postponed consideration of the issue, the last time for an indefinite period. Earlier, the Ministry of Health explained to Kommersant that it was necessary to further study, taking into account the current situation, the possibilities of pharmaceutical companies to produce and supply drugs proposed for inclusion in the lists. The press service of the government confirmed receipt of the letter, specifying that it had been redirected to the Ministry of Health. On August 10, the ministry did not promptly respond to Kommersant’s request.
The lack of clarity, as the authors of the appeal write, does not allow pharmaceutical companies to plan the production schedule and its volumes, and in the case of foreign drugs, their import. Moreover, they note that after the drugs are included in the lists, it takes from six months to a year before they reach pharmacies. Uncertainty with the date of the meetings could negatively affect the provision of patients with medicines and increase the risk of defects, the letter emphasizes. The current situation, the appeal says, also “reduces the pharmaceutical industry’s interest in bringing new drugs to the market.”
The situation is aggravated by the fact that new drugs that are not included in the list of vital ones cannot be purchased at state tenders for beneficiary patients and included in the state guarantee program. Traditionally, new drugs recommended by the commission of the Ministry of Health, the government includes in the lists at the end of the year.
Last year, the list of vital and essential drugs was expanded to include only five drugs instead of 19 approved by the commission, and under the high-cost nosology program (VZN), under which Russians receive expensive therapy, none of the three recommended drugs was included, Pharmvestnik reported earlier. This year, the Ministry of Health has so far approved one drug from the VED list and none from the VZN list. Currently, 28 new drugs and their forms are under consideration. These funds have already passed the examination, are allowed to be examined by the commission, and it may consider them in September, says Alexei Fedorov, an independent expert on public procurement.
“The situation with inclusion in the lists is becoming opaque,” says ARFP General Director Viktor Dmitriev. According to him, the situation is aggravated not only by the possible disruption of production plans, but also by the need to register the maximum price of vital and essential drugs after they are included in the list. With current inflation and a weakening ruble, companies need to understand whether they should include their drugs in the lists at all and at what price, Mr. Dmitriev explains. He attributes the reason for the postponement to the unwillingness of the authorities to guarantee purchases for patients due to lack of funding.
According to RNC Pharma Development Director Nikolai Bespalov, ideally, pharmaceutical companies need to clearly know the required production volumes of drugs six months before actual deliveries. A clear schedule for the revision of the list of vital and essential drugs allows you to effectively organize production planning, they agree in Roche. Although the long-term strategy of this company, they say, takes into account possible changes in internal or external circumstances, including industry regulation.
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