INNOVATIVE METHODS FOR COUNTERACTING PHARMACEUTICAL CORRUPTION IN THE PRECLINICAL RESEARCH AND CLINICAL TRIALS PHASE: THE SEARCH FOR COMMON INTERNATIONAL STANDARDS
The issue of preventing and combating corruption at the stages of preclinical research and clinical trials of medicines is very relevant, because the quality, impartial, objective and reliable research depends on the safety and quality of the investigational medicinal products, and ultimately the lives and health of the large number of patients who will receive these medicinal products.
Materials and Methods.
The materials of this article are current ethical and international legal norms for conducting preclinical research and clinical trials of medical products, The following methods such as doctrinal, comparative-legal, structural-functional, method of informational search, and system-analytical method are applied.
Analyzing the reports of international organizations, such as WHO, Transparency International, and others, current law, including the jurisprudence of different countries of the world, the current scientific doctrine of combating corruption in the pharmaceutical sector, as well as by questioning relevant experts, we can conclude that corruption offenses at the stage of preclinical research and clinical trials, medicines are and remain a significant problem, which seriously violates human rights to health.
Substantial reduction of pharmaceutical corruption problems in the preclinical research and clinical trials phase can be achieved by building a system of drug research using the following methods of counteracting corruption: banning direct funding for drug research by those research clients research and the creation of special public institutions engaged in the organization of such research; monitoring and comparing research results; transparency and accountability of research; digitization of research and management processes; revitalization of civil society institutions; internal organizational compliance of anti-corruption requirements of pharmaceutical companies, research institutions, and regulatory bodies; WHO monitoring activities. In doing so, this system should be at the heart of an international treaty in order to harmonize research standards at international and national levels.
- 2020-11-12 (2)
- 2020-11-02 (1)