Ethical and Regulatory Issues in Genetic Research Collaboration between Global Pharmaceutical Industry and Low- and Middle-income Countries
Sharawy, Iman;
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. Lowand
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 lowand
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 noncollaboration.
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.
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. Lowand
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 lowand
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 noncollaboration.
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.
Other data
Title | Ethical and Regulatory Issues in Genetic Research Collaboration between Global Pharmaceutical Industry and Low- and Middle-income Countries | Authors | Sharawy, Iman | Keywords | Genetic research collaboration, Global Pharmaceutical Industry, Low- and Middle-income Countries, COVID-19, Research Ethics | Issue Date | 17-Feb-2022 | Publisher | Springer Nature (Research Square for the preprint) | Journal | preprint (posted online) | DOI | https://doi.org/10.21203/rs.3.rs-1319747/v1 |
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