A draft law has been submitted to the state duma for the online trade of RX medicines

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Pepeliaev Group advises that, on 29 July 2022, a draft law was submitted to the State Duma for an experiment to be conducted by introducing remote trading in prescription medicines. 

Principal novelties

The draft law establishes that the experiment will be conducted from 1 March 2023 until 1 March 2026 in Moscow and in the Belgorod and Moscow Regions. 

Before 1 November 2022, the Russian Government and the Russian Ministry of Healthcare should draft the following documents necessary for the experiment: A Regulation on the procedure for conducting the experiment and requirements for medical and pharmaceutical institutions participating in the experiment, criteria for including medicines in the experiment and a list of such medicines, and a form of reporting documents for pharmacies. 

Medical and pharmaceutical institutions may refuse to participate in the experiment by submitting a written application to the regional healthcare bodies.

When selling a prescription medicine remotely, pharmaceutical institutions should ensure the identity authentication of the buyer to whom the medicine is delivered, and ensure that the delivery of the medicine is recorded by drafting and keeping a document which contains, among other details, the buyer’s signature as well. 

The final list of pharmaceutical groups of medicines allowed for sale within the framework of the experiment should be approved by the Russian Ministry of Healthcare in compliance with the criteria for setting up such list as determined by the Russian Government. 

Within the framework of the experiment to be conducted, the remote sale of the following medicines is expressly forbidden:
  • those containing narcotic drugs, psychotropic substances and their precursors;
  • medicines containing potent substances;
  • radioactive medicines;
  • immunobiological medicines;
  • medicines which should be stored at a temperature below 15 degrees Celsius as prescribed by the instruction for the medicine's use;
  • medicines containing alcohol with more than 25% per cent alcohol by volume;
  • those manufactured by pharmaceutical organisations;
  • medicines provided free of charge or with discounts to citizens who are entitled to be supplied with medicines at the expenses of subsidies allocated from the federal budget and the budgets of the constituent entities of the Russian Federation.

Difficulties of construction

The introduction of tools for ensuring patients’ medical secrecy remains an area of concern[1], including information concerning any prescriptions issued to a patient for buying/receiving medicines, as well as the protection of personal data of buyers of Rx medicines. This issue is particularly conspicuous when medicines are delivered that have a narrow list of indications for use and, therefore, make it highly likely that the buyer’s disease can be determined. 
The best way to solve this issue on the part of pharmaceutical organisations would be to document, in the contracts with parties delivering prescription medicines, the obligation of non-disclosure of a patient’s confidential medical information as well as the liability for disclosing such information. 
It would rather be economically infeasible and practically difficult to require that the delivery of a prescription medicine should be proved by the buyer’s signature on a paper document confirming delivery, and that such document should be handed over to a pharmaceutical organisation which provides the prescription medicine. 
Complying with that instruction would result in additional costs relating to the delivery of a document from the buyer of a medicine to the pharmaceutical organisation and to the reservation of premises for the documents to be stored in pharmacies. 

It is also unclear how supervisory bodies will classify violations committed during the experiment (e.g. if there is no buyer’s signature on a way bill) and who among the participants of the experiment will be liable for that (the forwarder, the seller, or both).
The question also remains open of how the new developments in regulation proposed within the framework of the experiment can coexist with the rule of article 67(1) of Federal Law “On the circulation of medicines” (“FZ-61”) according to which information concerning prescription medicines must be set out only in specialised outlets to be used by healthcare and pharmaceutical specialists, as well as how they can coexist with the provisions of Federal Law “On advertising” (“FZ-38”) when ‘classical’ methods are used to promote goods online, including the Recommended section being present on a website, informing users about special offers in relation to prescription medicines, etc.

Since the draft law in question does not envisage a detailed specification of how the experiment should be conducted aimed at the remote retail sales of prescription medicines, it could be expected that the drafts to be prepared by the Russian Government and the Ministry of Healthcare before 1 November 2022 will shed light on law enforcement practice in this field. 

Potential consequences for the market

Currently, there are two models for ordering medicines online in Russia: pre-ordering medicines online and picking them up afterwards in the pharmacy, and the remote sale of OTC medicines which are delivered to one's home. 

The first model existed well before the COVID-19 pandemic and, from the legal point of view, formally fell outside the category of remote sale; the second model started developing after the remote retail sale of OTC medicines was officially permitted when the pandemic broke out[2]; both models are actively used in practice. 

It is expected that the experiment aimed at the remote retail sale of prescription medicines will give a fresh impetus to the evolution of the pharmaceutical market and the optimisation of logistics since it will expand the range of potential consumers, including by making prescription medicines more accessible to patients with reduced mobility and patients who live in remote localities.

However, it should be taken into account that conducting the experiment means that the state-run systems, such as the Healthcare system, the information system for monitoring the movement of medicines (the “ISMMM”), and the information systems in pharmacies must be synchronised. Accordingly, for the experiment to have a successful outcome, it is pivotal to ensure that patients’ personal data is stored securely, that information systems are mutually synchronised and that they are protected from eventual breakdowns, security breaches, etc. The insufficient protection of information systems, along with difficulties in their synchronisation and in ensuring their smooth operation, may adversely affect the accessibility of medicines, especially in a situation when patients who suffer from life-threatening diseases are unable to obtain subsidised prescription medicines. 

Help from your adviser

Pepeliaev Group’s experts are ready to provide any assistance to the participants of the pharmaceutical market, including in adapting processes and documents (among them, contracts) to legislative requirements and minimising the risks that a company faces when participating in the planned experiment. 

[1] See article 13(3) of Federal Law No. 323-FZ “On the fundamentals of health protection in Russia” dated 21 November 2011

[2] Federal Law No. 105-FZ dated 3 April 2020 “On amending article 15.1 of the Federal Law ‘On information, information technologies and on the protection of information’ and the Federal Law ‘On the circulation of medicines’”.

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