The Law on the Introduction of Amendments to Certain RF Laws Concerning the Prevention and Liquidation of Emergency Situations has now come into force, amending several laws related to the circulation and registration of medicines and medical devices in Russia.
Together with other recent changes to the Law on Circulation of Medicines and the Law on Fundamentals of the RF Citizens' Health Protection, this law addresses the regulatory approval process in the following ways:
- the registration of medicines for the treatment of dangerous diseases and prevention of emergency situations, including covid-19, will be conducted in accordance with a special procedure approved by Resolution 441, dated 3 April 2020 and effective as of 14 April 2020; and
- the registration of medical devices for diagnostics and treatment of covid-19 will be accelerated, the specifics of which may be further regulated by the government.
Further, Resolution 441 is aimed at accelerating the process to register medicines to treat covid-19 and its related symptoms.
The general term of registration is a maximum of 20 days. Further, the scope of studies to confirm the medicines' safety and efficacy has been substantially reduced. However, these registrations are conditional on successful post-registration monitoring.
With regard to foreign applications, the simplified procedure is based on Russia's process for expediting the registration of orphan medicines. No additional local clinical studies are required where an applicant provides a summary report on efficacy and safety in accordance with the foreign country's framework for clinical studies. However, the provision of pre-clinical studies is mandatory. Further, a medicine should be tested on at least one type of a large species of animal to prove that it is safe for humans.
In the case of registering a combination of several earlier registered medicines, it is sufficient to provide a review of scientific publications for inclusion in the registration dossier instead of trial results.
Under the expedited procedure, foreign applicants can register covid-19-related medicines without conducting local trials or including additional confirmation of safety and efficacy, provided that relevant medicines have already received marketing authorisation in the United States, Canada and the European Union (other countries may be added to this list). This registration takes five business days and is valid until 1 January 2021.
It is also possible to obtain an interim permit for the import and turnover of certain series (batches) of foreign registered medicines that are not analogous to an active substance in Russia instead of obtaining local marketing authorisation. This permit is also valid until 1 January 2021.
The Ministry of Health has issued interim recommendations, including Resolution 441, which allows hospitals to use off-label medicines. Under this, liponavir/ritonavir, which was initially registered for the treatment of HIV, can be used in a combined covid-19 treatment.
On 25 March 2020 the Ministry of Health issued a letter to medical device manufacturers and distributors with regard to the availability of expedited procedures for the registration of medical devices for covid-19 diagnostics. This stated that the accelerated procedures were likely to include technical, clinical and toxicology tests. It also referred to the availability of free-of-charge consultations that may be organised between applicants and the Research Institute for Medical Techniques in Ekaterinburg, as well as with other accredited centres, in order to facilitate the registration process.
Further, on 26 March a law came into effect enabling the Russian government to establish maximum wholesale prices and retail mark-ups. This relates not only to medical devices and medicines previously included in the vital medicines lists and purchased primarily through state procurement tenders, but also to other medicines and devices of critical importance to be identified and added to it. Moreover, this list will include price monitoring, in which the costs of listed items will be frozen for 90 days.
As of 3 April 2020, over-the-counter medicines can be sold online by properly licensed pharmacies and delivered directly to customers. However, prescription medicines or medicines not registered in Russia cannot currently be sold online. These measures are reportedly aimed at preventing the sale of overpriced medicines, including those with no proven effect for treating covid-19. The scope of online sales may be extended to certain types of prescription medicine; draft regulations for this are currently under review by the government.
On 27 March the Ministry of Health reported that the organisation responsible for federal oversight – the Centre for Strategic Planning and Management of Biological Risks – has begun serial production of a test system for diagnostics called AmplyTest SARS-CoV-2, which was recently registered by the Russian Health Surveillances Agency. The system uses the polymerase chain reaction method. The initial plan is to produce at least 10,000 tests per day, which could be increased to 50,000 per day. Several other test systems were approved by the Russian Health Surveillance Agency between February and early April 2020, including Smartlifecare real-time tests, developed jointly by Russia and Japan.
It is therefore anticipated that covid-19 diagnosis tests will be primarily available for specialised medical organisations. They will also be available for medics in cases of severe symptoms or for the purposes of testing Russian citizens returning from abroad and ordered to self-isolate. Private Russian labs have recently been granted limited permission to conduct paid tests for willing individuals, however patients experiencing severe symptoms or those returned from abroad can only be examined and tested by state health emergency services or at specialised state hospitals.
These government regulations will be in force until 31 December 2020, although it may be that the above-mentioned accelerated registrations are further extended subject to corresponding amendments to the Law On Circulation of Medicines (61-fz) and/or relevant Eurasian Economic Council regulations. It is currently unclear if and how patent protection or data-exclusivity issues will be affected by government regulations or other legal acts aimed at the registration and circulation of covid-19-related medicines and devices.
Meanwhile, prospective applicants should note that data exclusivity in Russia has been granted for a new medicine but not for administration devices or other types of medical device (eg, diagnostic tests). The Law on Circulation of Medicines provides four years of data exclusivity for chemical medicines (when it is impossible to file an application with the regulator for the registration of the medicine), plus two years of marketing exclusivity (when it is possible to apply but the generic cannot be introduced to the market). For biological medicines and vaccines, three years of data exclusivity plus three years of market exclusivity apply.
This article first appeared on IAM 23 April 2020
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