Pharmaceuticals and medical devices

General

The legislative framework for circulation of medicines is the Law on Circulation of Medicines, whilst the circulation of medical devices is governed by the Law on Fundamentals of Healthcare.

The main regulatory authority is the Ministry of Health, and the main surveillance authority is the Russian Federal Service for Surveillance in Healthcare (the “Roszdravnadzor”). Some matters such as production of medicines and its licensing also fall under the authority of the Ministry of Industry and Trade.

In recent years, the core aims pursued by the Russian lawmaker and the mentioned authorities have been the following:

· Unification of the regulatory landscape across the EAEU;

· Sustainability of supplies and public access to healthcare products;

· Innovation support;

· Incentivisation of local production;

· Preservation of “soft launch” options for unauthorised products.

The further text addresses the main legal aspects of the circulation of medicines and medical devices in Russia.

Circulation of medicines

Marketing authorisation

A prerequisite of market access for a medicine is getting a marketing authorisation from the Ministry of Health.

Due to the unification of regulatory procedures across the EAEU, the authorisation is carried out at the EAEU level. The applicant can choose the countries of the EAEU (all five or any subset of them) in which the medicine will be authorised for circulation.

For some extraordinary cases a sole country registration is available. It authorises circulation in Russia only. In particular, it remains available for medicines that are in shortage due to economic sanctions against Russia. Though, only a small number of medicines have been registered through this route.

Regulatory and data exclusivity

The Law on Circulation of Medicines guarantees both data and regulatory exclusivity in Russia.

Data exclusivity is the prohibition of unauthorised commercial use of pre-clinical and clinical data provided to the Ministry of Health by an originator within the state registration procedure.

Regulatory exclusivity is defined as a period after authorisation of an original drug during which the Ministry of Health does not accept or review applications for generics registration.

Data exclusivity lasts six years from the date of approval of an original drug. The terms for regulatory exclusivity depend on its type:

· For biological medicines – three years from the authorisation date;

· For other medicines – four years from the authorisation date.

Despite the above, sometimes generic companies evade the regulatory and data exclusivity restrictions by using a gap in EAEU regulations, which do not provide for the same exclusivities as the Law on Circulation of Medicines. However, there have been only a few such cases, and these remain exceptional.

Pricing

The Russian Government approves the essential drug list (the “EDL”) which includes medicines (identified by international non-proprietary names) that are deemed vital for public health. The maximum prices for EDL medicines must be registered with the Ministry of Health. The sale of EDL medicines at a price exceeding the registered one is not allowed.

Prices for medicines not included in the EDL are generally not limited. Such medicines may be sold on the free market pricing; provided, however, the restrictions on monopolistically high (or low) pricing stipulated by the antitrust laws are not breached.

Track & trace system

As a general rule, medicines that are produced in or imported into Russia should be marked with data matrix codes – special codes for tracking the product circulation.

The data matrix codes are issued in the special governmental track-and-trace system, which the manufacturer or marketing authorisation holder must join.

For imported medicines the data matrix code can be labelled either at the manufacturing site located abroad or at the customs warehouse located in Russia.

Introduction into Civil Circulation

Introduction into civil circulation is a special procedure provided by the Law on Circulation of Medicines. In essence, it is close to the procedure of batch (lot) release that applies in many countries, especially in Western jurisdictions. However, the scope of the Russian procedure is broader.

Each batch of a medicine produced in Russia can be put on the market only after the Roszdravnadzor receives the manufacturer’s quality document and the certification of the manufacturer’s qualified person. In respect of imported batches, the importer is responsible for these formalities. The importer is obliged to provide Roszdravnadzor with the manufacturer’s quality document and the certification of the importer’s qualified person.

Furthermore, the first three batches of a medicine that has never been produced in or imported into Russia before shall be tested in accredited laboratories, with the further provision of testing protocols to Roszdravnadzor.

The procedure described above is a general rule. A few exceptions are available when it is needed to facilitate the patient access to medicines.

Licensing

Wholesale and retail sale, storage and transportation of medicines require a pharmaceutical licence issued by a competent healthcare authority.

The production of medicines also requires a licence issued by the Ministry of Trade. The licence conditions include compliance with the Good Manufacturing Practice of the EAEU.

Medical devices

Registration

Medical devices can be circulated in Russia after their authorisation with Roszdravnadzor. Both the national (sole country) authorisation in Russia and the EAEU authorisation are available. In the latter case, the applicant is allowed to choose from two to five EAEU member states in which the medical device will be circulated.

Unlike medicines, the vast majority of medical devices are registered through the national Russian (sole country) procedure. Only fewer than 100 medical devices have been registered at the EAEU level.

While the strategical aim of the EAEU authorities is to get all the medical devices registered for EAEU, the local authorisation in Russia is expected to be available at least until the end of 2027.

Declaration of сonformity

In addition to the marketing authorisation requirement, some medical devices and their components are also subject to declaration of conformity. Declaration of conformity is a document confirming that the product is in compliance with applicable technical regulations.

Licensing

Only the technical maintenance of medical equipment requires a license. No license is needed for wholesale, retail, storage, transportation, or production of medical devices (save for a few exceptions such as devices containing biologically hazardous agents, sources of ionising radiation, or precious metals).

While the production of medical devices does not require a license, it must comply with quality management requirements. In some cases, the manufacturer’s quality management system must be inspected by organisations subordinate to the Federal Service.

Notification

Before carrying out activities on circulation of medical devices (import, export, sale, transportation, storage, etc.) a company should serve a preliminary notice to Roszdravnadzor. Upon receipt of the notification Roszdravnadzor includes the company in a special public register.

Pricing

The manufacturer’s prices for some implantable medical devices included in a special governmental list (e.g. coronary stents, various prosthetic devices) are subject to the registration with Roszdravnadzor. The prices for other medical devices are not limited by law (provided, the price complies with the applicable antitrust regulations, e.g. not monopolistically high, etc.).

Track & trace system

Some medical devices are subject to marking with data matrix codes to track their circulation. As of today, the data matrix requirements apply only to a few groups of medical devices: hearing aids, coronary stents, orthopaedic shoes, etc.

However, the list of such devices is consistently expanding, and we expect that in the future all medical devices will be subject to the data matrix labelling requirements.

The data matrix codes can be placed on medical devices produced abroad either at a manufacturing site or at a customs warehouse in Russia.

Introduction into сivil сirculation

There is a special procedure of introduction of medical devices into civil circulation.

Once a medical device is released, manufacturers or importers shall provide to the Federal Service certain basic information about the product (e.g. name of medical device, registration data, batch number and quantity, date of production, etc.).

“Soft Launch” options

For companies seeking to “test” the Russian market, the legislation provides an option of importing unregistered medicines and medical devices on a named-patient basis. Such supplies are possible with permission from the Ministry of Health (for unauthorised medicines) or the Roszdravnadzor (for unauthorised medical devices), granted upon the decision of a council of physicians who prescribe an unauthorised product for a particular patient.

This mechanism is supported by significant state financing through the charity fund “Circle of Kindness”. This fund was created by the Government to provide persons under 18 y. o. with vital products for treatment of orphan diseases. To date, the fund purchases products for the treatment of 100 orphan diseases.

Interactions with HCPs and HCOs

Interactions with healthcare organisations (HCPs) are subject to strict limitations in Russia.

Pharmaceutical and medical device companies are prohibited from giving gifts to HCPs (even symbolic ones), entering into agreements on prescription of their products and/or providing samples of products (except for clinical trials). The companies are also not allowed to enter into commercial agreements with HCPs and pay them remuneration except for: (1) clinical trial agreements, (2) agreements for scientific services, and (3) agreements for pedagogical activities. Companies may also reimburse reasonable expenses incurred by HCPs in performing these contracts (e.g. travel, accommodation, etc.).

Charitable donations and educational grants to healthcare organisations (HCOs) are allowed provided that an HCO is a non-profit organisation (most clinics in Russia are public non-profit organisations).

There are two major industry associations operating in Russia: International Medical Device Manufacturers Association (IMEDA) and Association of International Pharmaceutical Manufacturers (AIPM). Both have their own codes of ethics that set rules for interactions with HCPs and HCOs (for example, public disclosure of payments made to HCPs and HCOs). Although formally only official members are required to follow the associations’ codes, in practice these documents have become a standard and are widely adopted by the entire industry.