In the created difficult conditions, it is impermissible luxury not to use and doom quality and safe medicines to spoilage. The law enforcement practice of suspension of circulation of drugs due to the identification of comments on production is such that the drug waits for the resumption of circulation in the warehouse until the identified comments are eliminated. Correction of comments is confirmed by repeated (control) inspection of production. Today, on-site inspection has become impossible due to quarantine restrictions. Accordingly, drugs deprived of circulation are waiting for the expiration date getting "dusty" in warehouses. Is it right and prudent? Of course not, especially since patients who interrupted therapy suffer from this.
“In my opinion, this situation is easy to fix. For this, it is necessary to conduct serial monitoring of all drugs stored in warehouses with suspended circulation. Moreover, studies to be carried out on a voluntary basis and at the expense of the owner of the product. If quality and safety are confirmed, these drugs must be allowed to be sold,” Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers, suggested during an online conference of a working group of the Federation Council Committee on Social Policy on preparing proposals for legislative regulation of drug use issues: “Rare rules": Prospects for the development of legislation on the protection of public health.
According to the head of the ARPM, these measures will help ensure the continuity of patient care, maintain the “old” price of drugs, free up storage for new drugs and maintain the manufacturer’s financial stability.
In addition, taking into account the difficult situation in the budget sphere of some subjects, the ARPM supports the proposal to transfer to the federal level procurement of drugs for 17 orphan diseases. It is necessary to verify the databases for these categories of patients and coordinate the financial support of the process. It is planned that this work will be completed in 2021-2022. This is necessary because the regions cannot cope with financing of the treatment of rare diseases on their own, which critically affects the condition of patients.
“Within the framework of a single state tender, it is easier for a supplier to work with one buyer than with 85. In addition, centralizing public procurement saves budgetary funds by increasing the volume,” Victor Dmitriev explained.
The meeting participants drew attention to the need to address the issue of the possibility of redistributing drugs between regions with a change in the number of patients. This issue is relevant for many regions. To date, the federal center has the authority to monitor the movement and accounting of drugs. And that means there is the possibility of ensuring interregional drug interactions.
During the meeting, many interesting proposals were made to solve the problem of orphan diseases. The committee began to deal with this problem in 2008. Russian legislation did not have the very concept of “orphan diseases”, and the purchase of expensive drugs for the treatment of patients with rare diseases lay on the regional budgets. Thanks to the principled position of the Federation Council in 2011, it was possible to include a separate article on rare “orphan” diseases in the new legislation on protecting the health of citizens,” said Tatyana Kusayko.
The keynote speakers were Elena Maksimkina, Director of the Department of Drug Supply and Regulation of Medical Products Circulation of the Ministry of Health of the Russian Federation, Valery Ryazansky, First Deputy Chairman of the Social Policy Committee of the Federation Council, Director of the Federal State Budget Scientific Institution “Medical Genetics Scientific Center named after Academician N.P. Bochkov”, chief specialist in medical genetics of the Ministry of Health of the Russian Federation Sergey Kutsev and others. The meeting of the working group was attended by representatives of the Russian Ministry of Health, the MHIF (Mandatory Health Insurance Fund), and regional authorities. It was the online mode that brought together about a hundred participants at one round table.
ARPM Press Service