Legal proceedings against the Ministry of Health: lessons for Russia's drug registration system
The recent decision by the Arbitration Court of the City of Moscow, which recognised as illegal the actions of the Ministry of Health of the Russian Federation in relation to the registration of an Indian antibiotic using forged documents, underlines the need for reform of the pharmaceutical regulatory system in Russia.
The case concerned the company “Jodas Expoim”, which submitted a fake letter of consent from an Indian company holding the rights to the substance of the drug “Biapenem”.
Thus, we are currently observing the following main problems in drug registration
- Lack of transparency in the process. Gaps in the legislation allow the registration of generics and drug analogs without taking into account patent claims. This leads to conflicts between pharmaceutical companies and government agencies.
- Verification of the authenticity of documents. The Ministry of Health has limited ability to verify submitted documents, leading to abuse by applicants and, ultimately, potential health risks to consumers.
- Interaction with third parties. The lack of clear rules for interaction with companies that do not hold registration certificates raises doubts about the decision-making criteria.
Gaps in the legislation allow the registration of generics and analogs without taking into account the rights of third parties to original medicines.
Commenting on the case for Izvestia ("The News"), Maksim Vaskin, senior lawyer at MAGENTA Legal, identified the following areas for potential improvement
- Strengthening the verification of documents. The Ministry of Health must either expand its powers or establish cooperation with competent authorities to verify the authenticity of submitted documents.
- Establish transparent regulations. Developing clear rules for dealing with third parties will help to minimise the risk of decisions being made on the basis of forged documents.
- Appeal mechanisms for patent holders. The introduction of a system of early challenges to drug registrations could reduce the number of disputes and increase the confidence of the international community.
The need for reform
The current situation highlights the fragility of the existing system and the need to reform drug registration procedures. Strict oversight and clear regulations will not only strengthen legal mechanisms, but also create favourable conditions for protecting the rights of pharmaceutical companies and developing the market. These steps would enhance the reputation of the Russian regulatory system and minimise the risk of litigation.
MAGENTA Legal lawyers provide services to pharmaceutical companies, including representation in arbitration courts for commercial disputes and disputes with government agencies, as well as consulting in other areas of Russian law.
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