Distance trade in medicines – how it is developing in Russia
The possibility of online trade in over-the-counter (OTC) drugs has been discussed in the Russian pharmaceutical industry for quite a while, but the decision would probably not have been made so quickly and hastily if it had not been for the spread of the new coronavirus infection.
On March 17, 2020, a presidential decree introduced the possibility of selling some over-the-counter drugs online. Prescription drugs are still prohibited to be sold online. In accordance with this decree, pharmacies that have a licence for pharmaceutical activities and a permit from Roszdravnadzor have the right to sell online.
In order to implement this Decree, Federal Law No. 105-FZ of 03 April 2020 was published on 3 April 2020 and entered into force, amending Federal Law No. 61-FZ of 12 April 2010 “On Circulation of Medicines”. (hereinafter referred to as the “Law on Circulation of Medicines”) and to Federal Law No. 149-FZ of 27 July 2006 “On Information, Information Technologies and Information Protection”.
In accordance with these amendments, pharmacies are not allowed to sell over the Internet:
- prescription medications;
- narcotic and psychotropic preparations;
- alcohol-containing medications with a volume fraction of ethyl alcohol exceeding 25%.
All other drugs that are not subject to the ban can be purchased through the Internet and arranged for home delivery.
For the online retail sale of medicines, pharmacy organizations will need to obtain a special permit, as only those with a license for pharmaceutical activities and a permit from Roszdravnadzor will be entitled to carry out remote trade in medicines. Obtaining a permit takes up to 5 working days from the day Roszdravnadzor receives an application and the necessary documents. A register of permits issued will be posted on the agency’s website. In case of violations on the part of a pharmacy organization and in a number of other cases, the permit can be revoked.
In accordance with amendments to the Law on Circulation of Medicines remote sale of prescription drugs may also be permitted during Epidemics. The Government has additional powers in this regard due to the spread of coronavirus infection. It will be able to use them until December 31, 2020, inclusive. However, in any case, it will be impossible to remotely sell narcotic and psychotropic drugs, as well as alcohol-containing drugs with a volume fraction of ethyl alcohol exceeding 25%.
On May 16, 2020, the government of the Russian Federation, by Resolution No. 697, approved the rules for issuing permits for remote retail sale of medicines, their implementation, and delivery to citizens (“The Rules”).
According to the Rules, acceptance of orders for medicines for remote sale can be carried out through the website, mobile application, by phone of the ordering service / reference service, or through another structural unit of the organization.
The Rules define the requirements for a pharmacy organization to be able to sell drugs remotely to citizens. In particular, the organization must have: an appropriate pharmaceutical license for a year or more, at least ten places of pharmaceutical activity in the Russian Federation, adequate equipment (places) for storing orders, a website / mobile application, its own courier service or a contract with a delivery service which ensures proper temperature conditions for medicines, and an electronic payment system and / or mobile terminals that allow you to pay for goods at the place of service.
In the course of their activities, pharmacies will be required to register remote orders and delivery of medicines, as well as to enter information on medicines paid for (dispensed) and received by the purchaser into the drug monitoring system.
The delivered order will be able to be accepted by the buyer, and in his absence, by another person who will be able to present a receipt or other document confirming the conclusion of the contract, payment for the order, or execution of its delivery.
Among other things, the Rules regulate the obligations of the pharmacy company when accepting orders, the moment of concluding the agreement with the buyer, requirements for packaging of medicinal products at delivery, the order of their delivery, the obligations of the buyer when receiving the order, and other issues.
For violation of the Rules by companies their sites will be blocked if the owners of the site will not delete them themselves.
Federal Law No. 89-FZ of April 1, 2020 establishes administrative liability for the sale of counterfeit medicines online. Penalties for violation for officials and individual entrepreneurs will range from 150,000 to 600,000 rubles, and for legal entities from 2 to 6 million rubles.
For legal entities and individual entrepreneurs, an additional punishment may be imposed in the form of administrative suspension of their activities for up to 90 days.
Federal Law No. 95-FZ of 01 April 2020 establishes criminal liability for the same acts committed on a large scale, that is, when the cost of medicines exceeds 100,000 rubles. Criminal liability measures include forced labour up to 5 years, with possible deprivation of the right to hold certain posts for periods up to 3 years, or deprivation of liberty untill 6 years, with a fine up to 2.5 million roubles, with possible deprivation of the right to hold certain posts up to 4 years.