Each month, the SLD International Senior Lawyers Committee convenes a one-hour presentation on a timely, international legal topic of interest and invites all members of the SLD to attend. The Committee is co-chaired by Bob Lutz and Aaron Schildhaus. The November meeting was held in cooperation with the ABA Section of International Law, Seasoned Lawyers Interest Network.
The following notes were compiled by Robert Brown and Alan Gutterman, Vice Chairs, and Ellie Webb, and describe the presentation on November 18 by Bruce A. McDonaldmoderating a discussion with Vladislav Ugryumov on Russia’s pharmaceutical industry and its development of COVID-19 vaccines.
Russia Pharma Profile
On the status of the Russian pharmaceutical industry, the 2019 annual volume is around 890 billion rubles with a projected expansion by 2030 of 150%. Other estimates put the volume of the Russian pharmaceutical market in 2018 at 1,682bn rubles ($25bn) with an annual growth rate of 2.6%. The industry in Russia is largely dependent on import trade, causing a push by the government for increased national security through the national medicine supply. One of the dominant Russian pharmaceutical companies, OTCPharm, is largely an online retail for over-the-counter medication unavailable in physical stores; the online purchase of drugs directly by consumers has temporarily authorized drug sales because of the COVID-19 pandemic.
On the topic of data protection in Russia, Ugryumov described existing regulation on the issue. Russia provides at least six years of protection with exclusive right to clinical data submitted to the government for drug approval. In addition, companies ethically must publish their clinical data in medical journals, but a 2015 decision in the Russian Intellectual Property Court limited the protection of data to undisclosed data. This case limited the generic manufactures from supporting competing applications.
Legal Development RegulatoryActions
Ugryumov also enumerated several current initiatives in legislation and regulation, such as legal amendments, elimination of antitrust immunity, limiting patent protection, changes in the issuance of compulsory license without a court order, deregulating parallel imports, and more. In terms of participants creating pharmaceutical policy, stakeholders include the Federal Antimonopoly Service, the Federal Intellectual Property Service (“Rospatent”), the Ministry of Health, Ministry of Economic Development, and drug developers and producers.
Among those stakeholders, there are two camps on prioritizing competition or intellectual property protection, dividing the Federal Antimonopoly Service and the Ministry of Health in one group and Rospatent and Ministry of Economic Development in the other. The grounds required for compulsory licensing are a national emergency or extreme urgency with clear and vital health needs, or a strong societal interest in access to patented invention. Alternatively, the patent owner could fail to practice the invention, or abuse economic power in violation of antitrust laws, or different owners holding multiple patents.
With respect to current events, Ugryumov provided updates on the Russian COVID Vaccine. In August of 2020, the Ministry of Health provisionally registered the vaccine made by Binnopharm in Zelenograd. This vaccine has been approved for a small number of vulnerable people but cannot be approved for widespread use until more trials are successfully completed. The approval of the Ministry of Health has been criticized because of a failure to show safety and efficacy in a large group, as it was tested in only 76 people, but the Minister of Health disagrees.
Ugryumov described three Coronavirus therapies in more depth: Afivavir, Coronavir, and Remdesivir. Afavir has not yet completed large-scale trials but has begun selling in 6 countries with 23 more coming soon, but the vaccine variant failed to gain approval in Japan because of the lack of sufficient testing. In addition, there are three therapeutics and two are available in pharmacies, which are all variants of an anti-flu medication developed in 2014. Coronavir was approved in September 2020 after the completion of a phase 3 trial with 160 patients, and it has begun sales in pharmacies for patients with mild to moderate infection. This therapy is also a variation of the anti-flu medication favipiravir, and the trial showed a reduction in recovery by 4-8 days.