Russians will not be able to import some medications for personal use from abroad unless they present prescriptions from a doctor at customs: a bill on this will probably be adopted before the end of May. Who will be affected by these restrictions?

Photo: Artem Geodakyan/TASS

On Tuesday, May 17, the State Duma in the second reading adopted a bill amending the federal law “On the Circulation of Medicines.” The amendments establish a special procedure for citizens to import medicines containing potent substances.

According to an RBC source, the Duma Committee on Health Protection recommends considering the bill in the third, final reading next Friday, May 20. The amendments will come into force from the day the new law is officially published, that is, probably before the beginning of summer.

The new rules caused a lot of noise. Business ombudsman Boris Titov wrote on his Facebook page that “medicines are not parmesan, not luxury goods, and not even a case when imports can be limited in order to increase domestic production.” “There is a huge shortage of many drugs in Russia, and not all domestic analogues are of high quality. The lives of tens of thousands of people depend on medicines purchased abroad in person. This is a decision against our own citizens, against their health and safety,” Titov wrote.

RBC figured out what will change with the entry into force of the law.

How are medications for personal use currently imported?

All medications, except potent ones, are imported for personal use without interference: Article 50 of the Law “On the Circulation of Medicines” provides for a preferential procedure for importation if it is not for commercial purposes.

You can even import drugs that are not yet included in the State Register of Medicines. There will be no problems with the transportation of falsified and counterfeit medicines - the quality when crossing the border should not be confirmed by a manufacturer’s certificate.

But there is an exception - drugs containing potent substances: they cannot now be imported at all if the purpose is personal use, State Duma deputy Dmitry Gudkov told RBC. According to Article 226.1 of the Criminal Code of the Russian Federation, the transportation of potent or toxic substances across the border of the Customs Union is equivalent to smuggling. The Criminal Code provides for punishment for the transportation of such drugs for individuals - imprisonment for a term of three to seven years, a fine of up to 1 million rubles.

The list of potent and toxic substances for the application of the relevant articles of the Criminal Code was approved by Government Decree No. 964 of December 29, 2007 (last amendments were made in 2013). They are often used to treat serious diseases: for example, benzobarbital is part of drugs that have an anticonvulsant effect on the body, clozapine has an antipsychotic effect, cephedrine is used to treat depressive conditions, etc.

Why did the Ministry of Health propose to change the import procedure?

The Constitutional Court demanded clarification of the rules for importing potent drugs for personal use in July 2015. in 2013 complained about the current legislation of the Russian Federation Two citizens of Kazakhstan who came to a powerlifting tournament in Yekaterinburg , the industry portal Vademecum reported : the athletes were detained at customs for importing anabolic steroids. Despite the presence of accompanying documents - doctor’s prescriptions and receipts, the Kazakhs were accused of drug smuggling.

Fulfilling the order of the Constitutional Court, the Ministry of Health prepared a bill in November last year, and in January 2016 submitted it to the State Duma . The ministry proposed allowing citizens to transport medications containing potent substances that are not psychotropic or narcotic for personal use.

Imported and domestic medicines on the Russian market

RUB 1.1 trillion reached the Russian drug market in 2015

741 billion rubles. constitutes the commercial drug market. Of these, 554 billion are imported medicines

by 13.6% Prices for domestic finished medicines on the commercial market increased , from 69 to 78 rubles . At the same time, imported medicines increased in price by 5.1% - from 215 to 226 rubles.

From three to seven years in prison with a fine of 1 million rubles. individuals can receive, according to the current Criminal Code of the Russian Federation, for the import of potent drugs into Russia from abroad. Drugs prohibited from import include, for example, clozapine and cephedrine, which are used to treat mental disorders, as well as the opioid analgesic tramadol.

By 231 billion rubles. medicinal products were produced in Russia in 2015

Prices for vital medicines produced in Russia increased by 28.9% in 2015. Prices for imported vital and essential drugs over the same period increased by 4.9%

5084 million packages of medicines were sold in Russia in 2015. This is almost 500 thousand packages less than in 2012

Sources: DSM Group, HSE, RNC Pharma

But a citizen crossing the border must have a special document issued by a medical professional, or a certified copy thereof: the name and quantity of the prescribed medicine must be indicated there.

Director of the State Budgetary Institution Research Institute of Healthcare Organization and Medical Management of the Moscow Department of Health, David Melik-Guseinov, claims that European countries have established a similar control mechanism over potent drugs. For example, for crossing the EU border with Corvalol in your luggage, you can be arrested if you don’t have documents for the medicine with you, he assured.

How can you tell if there will be problems with transporting a particular drug?

There will be no problems with drugs purchased in foreign pharmacies without prescriptions, say Melik-Guseinov and Nikolai Bespalov, development director of the analytical agency RNC Pharma.

According to their data, drugs containing potent substances in Russia are generally used by a small number of people: Melik-Guseinov talks about hundreds of patients, Bespalov – about dozens. Difficulties may arise for athletes who use potent drugs not as medicine, but as doping, says Melik -Guseinov: “Of course, it will be more difficult for them to get a prescription. We are talking about thousands of people in this category.”

Exactly what documents will be needed to transport such drugs will become clear later: perhaps you will only need a prescription, perhaps a prescription and a receipt, explains Bespalov, while this data has not been published. In his opinion, Russians will be able to receive prescriptions from both Russian doctors and foreign specialists. At the same time , you most likely will not have to use translators from the servants, since prescriptions are usually written out in Latin.

But, as Titov writes, “restrictions on mandatory prescriptions and notarized translations are an extra blow to citizens’ wallets during a crisis.”

Why do Russians bring medicines from abroad?

According to DSM Group, the volume of commercial imports of drugs into Russia in 2015 amounted to almost 554 billion rubles. But the Russians themselves export a small number of medicines from abroad - their volume is not noticeable for the market, Melik-Guseinov insists.

In principle, only 7–10% of the population travel abroad, says the head of the Association of Russian Pharmaceutical Manufacturers, Viktor Dmitriev. Basically, people buy medicines produced in other countries because they trust less what is sold in Russia, he says. Moreover, according to him, almost all such drugs are over-the-counter. “Sometimes patients believe that a drug brought from abroad is better than Russian, although it may be the same medicine,” agrees Melik-Guseinov.

Some medicines are cheaper abroad than in Russia, so Russians tend to buy them there, Gudkov adds.

Who is against imported drugs?

Veronica Skvortsova,

minister of health

“We are grateful to foreign companies that come to Russia with technology transfer, but it is important for us that this is a full production cycle, starting with the substance <…>. We need the substance for the immunobiological drug to be prepared on the basis of strains that are confirmed by our internal epidemiological studies and characterize the Russian population.”

Sergey Chemezov,

head of Rostec

“We set ourselves the task of making full-cycle production. Such factories are already operating: for example, “Fort” near Ryazan. Then the state transferred the largest vaccine manufacturer, FSUE Microgen, to the management of Rostec. We plan to create other production sites. Thus, we are forcing competitors to do full-cycle production here in Russia, instead of simply importing, packaging and bottling [essentially ready-made medicines].”

Dmitry Medvedev,

prime minister

“As for import substitution, there are no doubts here; of course, to the extent possible, we must go out to produce our drugs, naturally, giving priority first of all to effective means, but with the understanding that we must provide ourselves with these drugs, especially since Research in this area is ongoing.”

Dmitry Morozov,

General Director of Biocad company

“Now the country is undergoing global changes in the work to provide people with medicines. Thanks to the support of the Ministry of Industry and Trade, the Ministry of Health and the Ministry of Economic Development, Russian pharmaceutical companies are creating a powerful technological platform for the production of domestic innovative drugs and successful competition in the global pharmaceutical market. Now we can produce not only high-quality generics, but also innovative drugs that have no analogues in the world.”

Mikhail Murashko,

Head of Roszdravnadzor

“The import substitution process is active. Today, in packages, in the absolute quantity of drugs produced, this [share] already exceeds 60%. In financial terms, this figure is somewhat lower, since domestic drugs save money for medical organizations - it’s a little more than 25%.”

Vladimir Shipkov,

Executive Director
Associations of International Pharmaceutical Manufacturers

“We put the interests of patients, not manufacturers, first. No one knows from which country the drugs will be imported, under what conditions they were produced and stored, and in what language they will be labeled. No one knows this, and no one is responsible for their production, handling and storage.”

Across the border - with a prescription: how the procedure for importing medicines into Russia is changing