LAST WEEK, POLICE in Moscow detained Elena Bogolyubova, who ordered a parcel with an anticonvulsant drug necessary for her terminally ill child. The woman was charged with the smuggling of psychotropic substances – but a couple of days after the situation was widely publicized, the case was still not opened.
This is not the only high-profile story with a similar plot over the past few months. For example, in April, a criminal case was opened against a Russian woman Daria Belyaeva due to 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 on the territory of our country.
Why does the question of importing drugs even arise?
The situation in which patients will need to import medicines seems to be something out of the ordinary, but this is not so rare: not all the necessary medicines reach 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 be unprofitable for pharmaceutical companies to invest in registration and preparation for it.
In addition to the preparation and translation of the documentation required to bring a drug to the market (it takes thousands of pages), it is required, for example, to have a GMP certificate (good manufacturing practice, or good manufacturing practice – rules that control the production and quality of drugs). 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 United States and the EU countries to avoid 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, new labeling of medicines will become mandatory in Russia – 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 implement the new labeling, the company will need new equipment – 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.
In such conditions, it becomes simply unprofitable to enter the Russian market: the manufacturer is doomed either to increase prices, or must hope for very large sales volumes. It is even more difficult in situations when it comes to drugs for orphan (rare) diseases. It is not surprising that the withdrawal of manufacturers from the Russian market is associated, among other things, with economic reasons. What is happening also affects patients: for example, an antidepressant, due to which a criminal case was brought against Daria Belyaeva, was sold in Russian pharmacies until 2016 .
What import is considered illegal and how is it punished for it
In such a situation, patients take different measures – including trying to bring drugs on their own. The law allows you to do this: anyone can bring from abroad for personal use a batch of drugs worth up to ten thousand euros, with the exception of strong and narcotic substances. Complicating matters is the Federal Law 532 adopted in 2015, which introduced several articles into the Criminal Code, including 238.1 – “Circulation of counterfeit, substandard and unregistered drugs, medical devices and circulation of counterfeit dietary supplements.” The article places counterfeit medicines and “falsified biologically active additives” with unregistered drugs on a par – it prohibits the production, sale or import of all these categories “on a large scale” (in excess of 100 thousand rubles). But the fact that a medicine is not registered in Russia does not mean that it will be counterfeit or substandard – these are, with a high probability, drugs that have undergone clinical trials and are used in other countries.
Illegal import may be followed by a criminal penalty, up to imprisonment for a term of three to five years with a fine of five hundred thousand to two million rubles. In addition, there is article 6.33 of the Administrative Code , which regulates the circulation of unregistered drugs , which does not fall under the criminal article. For citizens, it implies a fine of 70 to 100 thousand rubles.
Even experts are lost with the answer to the question of how to confirm that drugs were imported for personal use and not for sale – for example, a situation when a person brought drugs to himself and his wife, in theory, can be considered a sale. “For safety reasons” it is advised “to have medical documents with you (prescription, conclusion of a council of doctors, etc.), which confirm that you or your relative need the medicine personally”. But getting such a document can also cause problems. “We do not prescribe drugs that are not registered in Russia. This is an instruction from the Ministry of Health, says Svetlana Romanova, head of the outpatient department of chronic hepatitis at the St. Petersburg AIDS Center. “But we can have a conversation with the patient, talk about modern methods of treatment, mentioning non-commercial names.”
Another possible way of acquiring a drug not registered in Russia is to obtain permission from the Ministry of Health: it is given on the basis of a decision by a council of doctors of the clinic where the patient is being treated, and a federal medical institution, which must confirm that the patient needs this particular drug. Similarly, help patients get medicines, for example, charitable foundations. In addition, pharmacies that do this on a commercial basis have the opportunity to obtain permission from the Ministry of Health . True, experts from charitable foundations note that this is a difficult procedure and not all patients manage to undergo it. In addition, doctors may be afraid to make recommendations for unregistered drugs in writing, rather than making oral recommendations.
What Happens to Buying Psychotropic Substances
Cases of criminal prosecution under Article 238.1 are relatively rare – for example, in 2015, when the law came into force, four people were convicted under it , three of them were suspended. At the same time, a case under 238.1 will not necessarily be initiated against a person who bought an unregistered drug – its effect does not apply to the sale and import of psychotropic substances. Such a situation happened with the Muscovite Ekaterina Konnova against whom a drug trafficking case was opened. The woman’s son has esophageal atresia – a severe congenital condition; he has regular epileptic seizures. Against the boy’s convulsions, Konnova used injections of the tranquilizer diazepam, but then, due to the fact that the injections had to be done too often, she decided to switch to microclysters of the drug, which she bought from her hands on the Internet. In Russia, this form of medicine is not registered – only tablets and a solution for injections. Diazepam circulation in the country is limited – it can be purchased strictly according to the doctor’s prescription, in a licensed pharmacy. The woman says that over time, the effect of the drug began to decrease. Due to financial difficulties, she decided to sell the remaining microclysters at a lower price – 650 rubles against the initial 1000. Last summer, the woman met with the buyer, after which she was detained by operatives – the buyer was a police officer. A few days after the story hit the news, the case was dropped .
In a similar situation, but so far without an optimistic ending, Daria Belyaeva , who was detained in April at the exit from the post office , found herself in a similar situation . A resident of Yekaterinburg ordered the antidepressant bupropion from a foreign online pharmacy; she decided to try it because other drugs did not work to her full extent – she was diagnosed with schizotypal personality disorder. Bupropion is not included in the list of substances prohibited for circulation in Russia, but, according to an expert from the Ural Customs Administration, it is a derivative of ephedrone, which is included in the list of prohibited substances. At the same time, according to experts, it is impossible to obtain a substance from a preparation .
Until 2016, bupropion was included in the state register of medicines in Russia, but then it was excluded – which is why it cannot be bought in Russian pharmacies. It is not the only drug for psychiatric disorders widely used in the world that is difficult to obtain in Russia. “The problem of drug unavailability in psychiatry due to Russian drug policy is acutely felt in the treatment of ADHD, depression and opioid addiction,” says Dmitry Frolov, psychiatrist, psychiatrist-narcologist at the Mental Health Center. – In ADHD, the main pharmacological treatment, according to modern recommendations, is psychostimulants. For example, amphetamine and methylphenidate, as well as modafinil and armodafinil – the latter two with no evidence of a risk of abuse. In addition to ADHD, these drugs are used for refractory depression that does not respond to standard treatment, especially when there is severe apathy and decreased activity. For heroin addiction, methadone is used to treat withdrawal symptoms and to support substitution therapy. In addition to methadone, buprenorphine is used for the same purpose. They can also be used to phase out opioid use. ”
Elena Bogolyubova, who ordered a parcel with the anticonvulsant drug clobazam for her son (the boy has an incurable genetic disease), like Daria Belyaeva, was detained at the post office. The package with the drug was arrested, but after a few days the case was not opened . In this regard, the Ministry of Health issued clarifications on the import of drugs unregistered in Russia. The ministry explains that it is possible to import and export a limited amount of narcotic drugs or psychotropic substances to Russia if the patient has medical documents that confirm that they were discharged to an individual. Getting a prescription for a drug that is not officially sold in Russia remains the task of patients.