"Ethical and Regulatory Issues in Genetic Research Collaboration between Global Pharmaceutical Industry and Low- and Middle-income Countries"

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Abstract Background:The global pharmaceutical industry (big pharma) is responsible for production, and distribution of drugs. Big pharma revenues have been growing markedly totaling about 1.27 trillion U.S. dollars in 2020. Low- and middle-income countries spend only 1.46% of their Gross Domestic Products (GDP) on research and development necessitating collaboration with big pharma. Genetic research require access to sophisticated laboratories, large-scale genotyping facilities, bioinformatics and statistical expertise which cannot be afforded by low or middle-income countries. Consequently, most of the genetic research is conducted in high-income countries and big pharma. Main body: This paper has three aims: the first aim is to identify ethical and regulatory issues related to genetic research collaboration of big Pharma with low and middle-income countries. The second aim is to explain the impact of non-collaboration of big pharma with low and middle-income countries. The third aim is to propose a future ethical and regulatory framework for genetic research of big pharma with low- and middle-income countries. To accomplish these aims the big pharma revenue and spending was outlined, the necessity of genetic collaboration was highlighted and the resultant ethical and regulatory gaps were elaborated. The COVID-19 mRNA vaccine was mentioned as an illustration for non-collaboration. Then a future ethical and regulatory framework for genetic research of big pharma with low- and middle-income countries at the international, national and research ethics committee levels was proposed.Conclusion:This paper identified several ethical and regulatory issues related to genetic research collaboration and non-collaboration of big Pharma with low and middle-income countries followed by proposing a future ethical and regulatory framework for collaboration at the international, national and research ethics committee levels.

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