On July 29, the Government introduced Bill No. 173061-8 "On Amendments to the Federal Law "On the Circulation of Medicines" in order to conduct an experiment on the retail sale of medicines for medical use, prescription medicines, remotely"1 (hereinafter – the Bill).
In the period from March 1, 2023 to March 1, 2026 in Moscow, Belgorod and Moscow regions, the Bill proposes to conduct an experiment on the implementation of remote retail sale of prescription medicine (including prescription issued in electronic form). The list of medicine and criteria for the formation of such a list will be established by the Government of the Russian Federation2. At the same time, the experiment will not use medicines that are available free of charge or at a discount to citizens who have the right to receive medicines at the expense of the state.
Participants of the experiment3:
- authorized federal executive authority of the Russian Federation (hereinafter – the Ministry of Health);
- authorized executive authorities of the subjects of the Russian Federation;
- medical and pharmacy organizations that meet the requirements additionally established by the Government of the Russian Federation
At the same time, such requirements cannot be lower than the criteria for organizations engaged in remote retail sale of medicines available without prescription4. So, in any case, the following documents will be required:
- license for pharmaceutical activity;
- permission to carry out retail sale of medicines for medical use remotely.
The procedure and rules for issuing permits for remote retail sale of prescription medicines, as well as the requirements for the delivery of goods under such contracts, are subject to approval by the Government of the Russian Federation5.
It will be possible to refuse to participate in the experiment. Any medical organization selected and approved by the Ministry of Health as a participant in the experiment in accordance with the requirements established by it will be able to submit a written statement of withdrawal to the Ministry of Health6.
Pharmacy organizations and persons delivering medicines will be required to identify the recipient. In case of refusal to submit information or discrepancies in the documents, the medicine will be returned to the seller7. This obligation generates some unresolved issues, since a registered prescription for a medicine is a special category of personal health data8, for which the consent of the primary source, that is, the subject of such data or his duly authorized representative, is required9. The circle of persons involved in the chain of delivery of prescription medicine order, the definition of the operator of personal data, the applicable mechanics of collecting the consent of personal data subjects and processing of that information require further clarification.
The receipt of the medicine will be confirmed by a cash receipt and the signature of the person indicated in the prescription (legal representative, authorized person) on the receipt document for such medicine in the form approved by the Ministry of Health10.
Control over this experiment will be carried out by the Federal Service for Supervision in the Field of Healthcare11. In case of detection of a violation of the law committed during the experiment, participants may be subject to administrative12 and criminal13 liability.
Drafts of all documents to be adopted for the implementation of the experiment must be submitted by November 1, 202214.
2 paragraph 2 of article 55.1 of the Bill
3 paragraph 3 of article 55.1 of the Bill
4 paragraph 1.1 of article 55 of the Federal Law "On Circulation of Medicines" dated 12.04.2010 N 61-FZ
5 paragraph 4 of article 55.1 of the Bill
6 paragraph 7 of article 55.1 of the Bill
7 paragraph 8 and paragraph 9 of article 55.1 of the Bill
8 paragraph 1 of article 10 of the Federal Law No. 152-FZ "On personal data" dated 27.07.2006
10 paragraph 10 of article 55.1 of the Bill
11 paragraph 12 of article 55.1 of the Bill
12 article 6.33 and article 6.34 of the Code of the Russian Federation on Administrative Offenses No. 195-FZ of 30.12.2001
13 article 235 of the Criminal Code of the Russian Federation No. 63-FZ of 13.06.1996
14 The list of regulatory legal acts of the President of the Russian Federation, the Government of the Russian Federation and federal executive authorities subject to invalidation, suspension, amendment or adoption in connection with the adoption of the Federal Law "On Amendments to the Federal Law "On Circulation of Medicines" for the purpose of conducting an experiment on the retail sale of prescription medicines for Medical Use medicinal product, by remote method" (URL: https://sozd.duma.gov.ru/bill/173061-8?ysclid=l6auiwzxs793547326#bh_note)