On the creation of a pharmaceutical safety system in the Russian Federation

Authors

  • Ivan M. Chizh FSAEI HE I.M. Sechenov First MSMU MOH Russia (Sechenov University) 8 Trubetskaya St., building 2, Moscow 119991, Russia Author
  • Elena Yu. Lemeshenko FSAEI HE I.M. Sechenov First MSMU MOH Russia (Sechenov University) 8 Trubetskaya St., building 2, Moscow 119991, Russia Author
  • Andrey B. Goryachev FSAEI HE I.M. Sechenov First MSMU MOH Russia (Sechenov University) 8 Trubetskaya St., building 2, Moscow 119991, Russia Author
  • Oleg N. Afanasiev FSAEI HE I.M. Sechenov First MSMU MOH Russia (Sechenov University) 8 Trubetskaya St., building 2, Moscow 119991, Russia Author

Keywords:

history of health care, pharmaceutical safety, pharmaceutical industry, medicines, drug provision

Abstract

This article analyzes the formation and development of a pharmaceutical safety system in the Russian Federation, which was designed to protect the population and health organizations from threats arising in the production, distribution and consumption of pharmaceuticals. The most difficult period was 1991–1998, which was characterized by a sharp decline in the pharmaceutical industry’s economic potential in connection with the transition to new, market-based management mechanisms and the lack of an adequate regulatory framework for pharmaceutical management. A second period began after the adoption in 1998 of the federal law On Medicines, in which for the first time the priority of state control and regulation of production, manufacturing,quality,  efficiency,  and  safety  of  medicines  was  declared.  However,  opposition  from  the  pharmaceutical  industry  and  the inertia of  state authorities in developing a regulatory legal framework detailing federal law provisions did not achieve positive results. Therefore, in 2009, the “Strategy for the development of the pharmaceutical industry of the Russian Federation for the period until 2020” was approved, marking the beginning of the modern period of improving the pharmaceutical safety system.
he new federal law On the distribution of Medicines (2010) with the necessary set of normative legal acts and the “Strategy for the provision of medicines to the population of the Russian Federation for the period until 2025” (2013) set out a sequence of tasks for solving problems concerning the country’s medicinal independence and providing the population with the necessary pharmaceutical products. In general, it is noted that the level of pharmaceutical safety has increased in Russia. The authors point out that the concept of “pharmaceutical safety” has undergone changes and currently presupposes not only a patient’s personal safety when using medicines, but also the country’s medicinal independence.

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Published

2018-04-30

Issue

Section

Articles

How to Cite

M. Chizh, I., Yu. Lemeshenko, E., B. Goryachev, A., & N. Afanasiev, O. (2018). On the creation of a pharmaceutical safety system in the Russian Federation. History of Medicine, 5(2). https://historymedjournal.com/HOM/index.php/medicine/article/view/208