Russia will tighten responsibility for the import of unregistered drugs: what will change

“The exclusion of the unimpeded import of medicines that have not passed clinical trials into the country will have a positive impact on the development of the market”

The bill, which introduces not only administrative, but also criminal liability for the import of unregistered drugs and medical devices from the so-called “WHO list”, was approved by the State Duma in the first reading. How it will affect our lives, “MK” learned from the experts.

Corresponding amendments to the Administrative and Criminal Procedure Codes were submitted for consideration last spring. Until now, we have provided for penalties only for the production, sale or import into Russia of falsified, low-quality or unregistered medical devices and medicines that were not recommended or simply approved for use by the World Health Organization. Now they want to remove this exception, since the legislators considered that in this form the article decriminalizes the import and sale of medicines and medical devices, the safety of which has not been confirmed in our country. And, therefore, there is no possibility “to make informed procedural decisions if the facts of the circulation of unregistered medicines or products are revealed.” At the same time, the authors of the initiative draw attention to the fact that, de jure, the WHO does not compile any special lists of unregistered, but recommended medicines and medical devices. And this situation gives rise to temptations for various violations.

Legislators are sure that with the help of the new wording they will be able to limit the “gray import” into the country of medicines and medical products of dubious origin, the safety of which has not been confirmed. At the same time, the Ministry of Health has already reported that the innovation will not affect ordinary citizens in any way: they will still be able to import medicines into Russia for personal use, provided that they can confirm the indications for their use. And verbally they assure that, if necessary, the import of unregistered drugs, for which a shortage is predicted, or drugs against COVID-19, is possible.

“There are still provisions in the current legislation that exempt from liability for the illegal import of medicines and medical devices, if they are included in the WHO recommendations,” says Victoria Presnyakova, director of the SRO Association of Independent Pharmacies, head of the Alliance of Pharmaceutical Associations. “In fact, this is a list of essential medicines by their international generic names (active ingredients) without reference to a specific brand of drug and its manufacturer, the organization is quite average, and rarely updated (last changed in 2021) Countries use it as a basis when developing their lists. Russia is going its own way in this matter.The exclusion of the unhindered import of unregistered drugs into the country that have not passed clinical trials will have a positive impact on the development of the market.However, it must be borne in mind that the draft law does not establish procedures for controlling the import of unregistered drugs for whether chnogo application. We do not have any registers where it would be recorded how much, in what volume and how often a person imported this or that drug. This means that this option of crossing the border of a drug can also contribute to the entry of unregistered drugs with unconfirmed quality sold on the Internet into the market.”

And yet, many experts note that the new law will block the supply channels for drugs that are not registered in Russia for needy patients by foundations and volunteer organizations. For example, until now they have been importing life-saving drugs, the manufacturers of which have not applied for registration in Russia. First of all, this concerns orphan (rare) diseases. For example, cystic fibrosis. So far, these volunteers have been saved from liability (the fine is up to 100,000 rubles, criminal liability involves up to 5 years in prison) only by the very exception in the law regarding the same “WHO list”. And soon the situation may change radically.