Comment by Academician Andrey Kaprin on cancer morbidity and mortality forecasts

Due to the great interest of the media in the forecasts of morbidity and mortality from ZNO, as well as the issues of drug provision of the industry, we publish a comment by the chief oncologist of the Ministry of Health of Russia, Academician of the Russian Academy of Sciences Andrey Kaprin and the official position of the Ministry of Health of the Russian Federation

– Our Institute named after P.A.Herzen has been conducting an oncoregister for 75 years, and we know the state of affairs with morbidity, mortality, prevalence of all types of oncological diseases in the country and regions. Over the past 10 years, the incidence of malignant neoplasms has increased
by 23.7 percent, while the mortality rate has practically not changed over the same time, we manage to keep it at the level of 197.9 cases per 100 thousand population. According to WHO, the incidence worldwide will grow and will be 18-20% plus by 2030. The main weapon against cancer remains early detection and prevention of diseases. Unprecedented large funds have been allocated for these purposes within the framework of the state program to combat oncological diseases, including for the purchase of medicines, especially for the regions. Within the framework of the program, a new screening concept has already entered into force, which will cover almost the entire population in order to pass the necessary studies on the detection of malignant neoplasms of common localizations in due time. This is a very large-scale and costly project, but the state goes to these costs precisely so that we can notice and neutralize the cancer in time.

In total, 1 trillion rubles is provided for the program of combating oncological diseases until 2024.And I believe that the program, its purposeful implementation will help to significantly improve the system of medical care, and will give impetus to the development of our own production of pharmaceuticals and necessary equipment,” said Andrey Kaprin.

Also in connection with the speech of the Director of the Institute of Hematology, Immunology and Cell Technologies of the NNPC DGOI. Dmitry Rogachev Alexey Maschan informs the Ministry of Health of Russia:

FSBI NMIC DGOI im. Dmitry Rogachev of the Ministry of Health of the Russian Federation is one of 24 national medical centers of the Ministry of Health of the Russian Federation, which, as part of the execution of a state task funded from the federal budget, are assigned certain tasks in terms of drug provision:

– analysis of lists of provision of necessary medicines (ONLS) and vital and essential medicines (VED), with the presentation of an analytical report, including an assessment of existing documents and proposals for their updating;

– collection and analysis of information on the use of off-label drugs and unregistered medicines and medical products, the need for the development of medicines and medical products under the import substitution program with the submission of proposals on these issues;

– calculation of the current and projected annual demand for medicines purchased within the framework of existing state support measures, taking into account the standards of medical care and clinical recommendations (treatment protocols), with the submission of proposals on these issues.

At the same time, it should be noted that an important tool guaranteeing the quality, effectiveness and safety of medicines is their state registration and subsequent pharmacovigilance.

«..This also applies to drugs for chemotherapy — they either disappear altogether, or they are replaced by generics that are completely untested in clinical studies…”

The Ministry of Health of the Russian Federation makes a decision on the state registration of a medicinal product based on the conclusion of an expert organization after conducting the necessary examinations of the quality, safety and effectiveness of the medicinal product, containing an unambiguous conclusion about the quality, safety and effectiveness of the registered medicinal product for medical use, regardless of the country of manufacture. When registering any reproduced medicines, all quality control indicators are monitored. For reproduced drugs in dosage forms for oral administration, bioequivalence studies are required, characterizing the equivalence of the pharmacokinetic parameters of the drug to the reference drug. The regular requirements of the Russian Federation on these issues are harmonized with the relevant approaches of the European Medical Agency, the US regulatory system, and also accepted by all regulators of the member countries of the Eurasian Economic Union.

In addition, it is legally established that the production of medicines must comply with the requirements of good manufacturing practice of the Russian Federation (GMP). The corresponding conclusion is issued by the Ministry of Industry and Trade of Russia, including in relation to foreign manufacturers of medicines.

In addition, in accordance with Article 52.1 of the Federal Law “On the Circulation of Medicines” (put into effect in November 2018), manufacturers of medicines or organizations importing medicines into the Russian Federation, at least one year before the planned suspension or termination of the production of medicines or their import into the Russian Federation notify Roszdravnadzor and the Ministry of Industry and Trade of Russia about this. This information is sent to the Ministry of Health of Russia.

With regard to the import of unregistered medicines, we note that currently, within the framework of the current legislation of the Russian Federation, the import of unregistered medicines by citizens for personal use is allowed, while in the presence of appropriate medical documents, the import of narcotic and psychotropic drugs is possible, as well as when prescribing specific medicines to patients for vital indications, the import of these drugs by legal entities is possible if the presence of a permit issued by the Ministry of Health of Russia.

At the same time, it should be noted that the Ministry of Health of the Russian Federation sent a request to the main freelance specialists of the Ministry of Health of the Russian Federation on 13.09.2019 to provide until 26.09.2019 the needs for 2020 in medicines included in the list of VED. Based on the results of the information received, meetings will be held with manufacturers and chief freelance specialists, including, if necessary, with the participation of the Ministry of Industry and Trade and Roszdravnadzor, on the issue of ensuring the collected needs.

Due to the possibility of limiting the supply of a particular drug produced by foreign manufacturers to the Russian market, the Ministry of Health of Russia is creating a working group with the participation of Roszdravnadzor and the Ministry of Industry and Trade to promptly respond to market fluctuations. The Working Group will prepare long-term plans for import substitution, as well as promptly develop and take measures to introduce alternative approaches and treatment regimens.

As already reported, the Ministry of Health of the Russian Federation has prepared appropriate changes to the procedure for determining the contract price, in order to minimize the risks of incorrect formation of the minimum possible unit price of the drug planned for purchase, taking into account the proposals of the expert community regarding prices that may not be taken into account.

Currently, the draft order “On approval of the procedure for determining the initial (maximum) price of the contract, the price of the contract concluded with the sole supplier (contractor, contractor), the initial price of a unit of goods, work, services in the procurement of medicines for medical use” is undergoing a public discussion procedure.

“..The simplest drugs of accompanying therapy also disappear. For example, 10 percent sodium chloride…”

The medicinal product sodium chloride, p-p 10% is not included in the State Register of Medicines, is a drug of pharmacy manufacture. The requirements for the rules for the manufacture and quality control of this drug are set out in the Order of the Ministry of Health of the Russian Federation No. 751n dated October 26, 2015 “On approval of the Rules for the manufacture and release of medicines for medical use by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities”.

In accordance with Article 56 of Federal Law No. 61-FZ of 12.04.2010 “On Circulation of medicines”, the manufacture of medicines by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities is carried out according to prescriptions for medicines, according to the requirements of medical organizations.

In accordance with the Rules of pharmacy manufacture, a 10% sodium chloride solution is subjected to thermal sterilization and after completion of manufacture, a shelf life of 90 days is set.

Press service

FSBI “NMIC of Radiology” of the Ministry of Health of Russia