What happened to the Russian hospice?
Hospice "House with a Mayak" accused of non-compliance with the rules of turnover
Kommersant found out that the complaint about possiblethe violation was reported to the Ministry of Internal Affairs on September 29 - even before the House with Mayak bought the first drug on September 30. They came to the medical facility with a check on October 27. The head physician of the hospice, Grigory Klimov, admitted errors in the logging, but clarified that they had already been eliminated.
Everything was in order with the medicines, butthe basis for the administrative protocol was shortcomings in the keeping of accounting journals. Under the relevant article, the hospice faces either a fine of up to 400 thousand rubles, or suspension of work for up to 90 days.
Why it happens?
The media often write about criminal cases initiated byfor the import of medicines to Russia from abroad. It seems that this only happens to illegal drug dealers, but the customs service can pay attention to any drug that is transported across borders.
All transportations of this kind are regulated by the Law on the Circulation of Medicines. Russians regularly encounter problems when importing a number of medicines, for example:
- Tramal... Import into the country is prohibited.It is used for pain relief of cancer patients, in the postoperative period, for injuries, for pain due to myocardial infarction, during painful medical procedures.
- Bupropion... Not on the banned list, but there is more than one criminal case for transporting it.
- Kaffetin... Limited, can only be transported for personal use with a certificate.
- Merida... Import to Russia is prohibited.
- Retabolil... Import to Russia is prohibited.
- Dinitrophenol (DNP). Import to Russia is prohibited.
- Zolpidem... Limited, can only be transported for personal use with a certificate.
- Modafinil... Import to Russia is prohibited.
The fact is that not all the necessarydrugs enter the Russian market. To sell drugs in Russia, manufacturing companies need serious resources: according to experts, the registration procedure for a drug can take one and a half to two years, moreover, one of the requirements for registering a new drug is to conduct clinical trials in Russia, which takes three more -five years and requires huge investments. Considering that government procurement of innovative expensive drugs rarely shines, it may not be profitable for pharmaceutical companies to invest in registration and preparation for it.
In addition to preparing and translating documentation,necessary to bring a drug to the market (it takes thousands of pages), for example, a GMP certificate (good manufacturing practice, or good manufacturing practice - rules that control the production and quality of drugs) is required.
The certificate is issued based on the results of the inspection(which is also paid by the manufacturer). Since 2017, the countries of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia) have uniform GMP standards, that is, the results of an inspection of one country are recognized in others. The same agreement is in force between the US and the EU countries - this avoids duplication of inspections.
But in order for the drug produced in the EU to be brought to the Russian market, experts from Russia must carry out an inspection for compliance with GMP standards.
In addition, in 2020, Russia becamemandatory new labeling of medicinal products - it will allow tracking the movement of packaging from the factory to the hands of the buyer and should provide additional protection against counterfeiting.
To introduce the new labeling, the companynew equipment will be required - according to the head of the Federal Service for Surveillance in Healthcare Mikhail Murashko, it will cost the manufacturer from 2 to 10-12 million rubles.
Who is being treated with "controversial" drugs?
- Cancer patients
Cancer patients in most cases suffer frompain due to the growth of cancerous tumors, less often from anticancer treatment. Sometimes the pain syndrome has nothing to do with the disease and its treatment. At later stages, pain can only be relieved by more effective means. Often, only strong painkillers for cancer at the last stage are able to alleviate the condition. Here the trick is most effective:
At various stages of pain syndromevarious groups of funds are used. Medicines can be non-narcotic and narcotic. The first group includes analgesics (some of them are available only by prescription). The second group includes opiates, which also have varying degrees of effect.
- Mental and psychological disorders
In April 2019, on the Russian woman Daria Belyaevaa criminal case was opened over the fact that she bought an antidepressant from a Polish online pharmacy. Although the drug is not registered in Russia, it is not prohibited - but it is a derivative of the stimulant ephedrone, which is included in the list of substances prohibited for circulation in our country.
The key difference between antidepressants andPotential addictive surfactants are that antidepressants do not cause an immediate effect - a person who chooses to use them will not get instant euphoria, as it does with ordinary drugs. Moreover, in the first week of taking antidepressants, a person’s condition, as a rule, is slightly worse - a huge number of side effects of such drugs are associated with this.
Usually antidepressants start acting - andonly for patients with depression or another disorder - two to three weeks after the start of treatment. Antidepressants cannot improve the mood of a healthy person, especially to the extent that it occurs when taking drugs.
Potentially addictive surfactants, such as, for example, amphetamine or heroin, on the contrary, change the mood and mental state of healthy people as soon as the substance reaches the brain.
How is this problem abroad?
As the Chinese practice shows, not soit is difficult with the help of market mechanisms to create such economic conditions in the country so that domestic drugs are no less competitive in the eyes of consumers than foreign drugs. To do this, it is enough to create conditions in which our own laboratories, state-of-the-art equipment, long-term research, high-tech production, investments, personnel, logistics and, most importantly, the most modern medicines at low prices will appear.
For example, the Chinese government went straightthe opposite way. Finding that from 2006 to 2016 none of the 426 new drugs began to be sold in China, it canceled import duties on drugs, reduced the VAT on drug production to 3%, reduced the registration period of drugs to 3 months, increased the punishment for unlicensed copy production drugs and allowed the conclusion of long-term contracts for the supply of drugs.
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