The import of medicines not registered in the Russian Federation can become a crime

The State Duma of Russia adopted in the first reading a draft law on administrative and criminal liability for the importation into the country of drugs and medical products that have not been registered in Russia. Such import will be prosecuted, even if the drugs are recommended by the World Health Organization. Previously, the corresponding administrative and criminal articles were not applied to drugs that are not produced in Russia and approved by the WHO. They concerned only falsified medicines.

The authors of the bill argue that even with WHO approval, the safety of foreign drugs has not been confirmed.

The administrative penalty for importing unregistered medicines is a fine for individuals from 70,000 to 100,000 rubles, for individual entrepreneurs and enterprises – several times higher. In the case of criminal punishment, citizens may face from three to five years of imprisonment, in the presence of aggravating circumstances – up to 12 years.

As noted by Sota, the bill may affect new and experimental drugs developed abroad, which may be vital for Russian patients.

• In Russia, there is also a “grey” market of drugs delivered from abroad by courier services and individuals, when the original drugs are not available in Russia or are much more expensive than generics not registered in Russia – analogs produced in other countries under license. For example, generic drugs for the treatment of hepatitis C – a potentially fatal disease – are produced in India and are an order of magnitude cheaper than the original ones. They are not registered in Russia, although the expensive original is registered. The latest drugs for the treatment of oncological diseases and HIV infection, which have not yet been registered in the country, gene therapy drugs and many others are privately imported into Russia.