Impact of Legislative Changes on the Availability of Medicines and Pharmacovigilance Activities

Research output: Types of ThesisDoctoral Thesis

Abstract

Access to medicine is a universal human right; however, it is still a global problem. In the present study, we chose the regulatory system of drug registration of the largest Latvia neighbouring country, the Russian Federation (RF), as the object of research, which in 2010, underwent radical changes leading to regulatory pathway burden; these changes impacted the availability of drugs and pharmacovigilance activities. As of now, there are pharmaceutical manufacturers from Latvia and other European Union (EU) countries that have important markets in the RF; it would be helpful for them to have a scientific insight into the regulatory processes and enhance their medicines registration process. The study is also important for state decision makers to plan changes and predict their potential impact.
Until the change in legislation, the RF tried to follow the world-recognized guidelines of the United States (US) and European drug registration legislation. In turn, after the introduction of the new pharmaceutical law (NPL) in 2010, a unique legal system was created that did not correspond to either the US or the European practice. In this study, for the first time, legislation performance has been statistically evaluated and study confounders controlled based on the number of authorized medicines and pharmacovigilance reporting activities. Before the NPL, 20836 drugs and 5000 food supplements (FS) were registered. After NPL, 16,409 drugs in the State Medicines Register vs. 9500 FS were noted. The fall was −21.25%. Additionally, before the NPL, in 2008, drug MAs issued per year were 3043, whereas the number was 1092, two years post intervention in 2012. The difference was −1975 MAs/year and difference-in-differences, assuming the FS trend of 1978. The fall was obvious at −64.11%. The reported adverse drug reactions before the NPL, in 2008, were 0.042 per 1000 inhabitants, whereas two years post-intervention of the NPL, in 2012, the number reported was already 0.120. The difference was 0.079 reports/year. Although differences-in- differences, assuming the EU trend, still showed negative performance at −1.224 reports, the increase recorded in the reporting activity in Russia in 2012 was 185.71%, whereas in the EU it was 117.51%.
Conclusion. Despite the intention of synchronizing the marketing authorization system with the best international practices, the RF still has its own peculiarities. The implementation of the NPL and consequential administrative reforms during the observational period led to reduced access to medicines. In contrast, the drug safety monitoring system succeeded, which was ensured by the implementation of an international approach and the
system not being exposed to administrative turmoil.
Original languageEnglish
QualificationDoctor of Medicine (Dr.med.)
Awarding Institution
  • University of Latvia
Supervisors/Advisors
  • Purviņa, Santa, First/Primary/Lead supervisor
  • Krieviņš, Dainis, Second/Co-supervisor, External person
Award date23 Mar 2021
Place of PublicationRiga
Publisher
Publication statusPublished - 23 Mar 2021

Field of Science

  • 3.1 Basic medicine

Publication Type

  • 4. Doctoral Thesis

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