Tracing the Weaknesses of the Regulatory Framework for Clinical Trial in Nigeria

  • Sani Ibrahim Salihu PhD Scholar, School of Law, Universiti Utara Malaysia
  • Yuhanif Yusof Senior Lecturer, School of Law, College of Law, Universiti Utara Malaysia
  • Rohizan Halim Senior Lecturer, School of Law, College of Law, Universiti Utara Malaysia
Keywords: Clinical Trial, Informed Consent, Ethics, Human Rights

Abstract

Nigeria is one of the developing countries with a very weak and incomprehensive regulatory framework for clinical trials. Past abuses of human subjects in clinical trials and cases of negligence and outright fraud necessitate the need for a stronger legal framework. An outbreak of meningitis in Nigeria in 1996 led to clinical trial of Trovan Drugs by Pfizer, which left many of the research subjects seriously impaired. Some died while some suffered paralysis and brain damage. It was obvious Nigeria has a weak regulatory frame work from the incident that took place in the mentioned above at the Infectious Dieses Hospital (IDH) Kano. Available literatures have also shown that at the time of the trial in Kano, there was no ethics committee to ensure ethics review process and monitor the ongoing trial.

Objectives: This research aimed at examining the Nigerian regulatory framework to bring out its weaknesses. It will also examine the strength and weakness of the current regulatory agencies, and suggest better regulatory framework that will make Nigerians less vulnerable to manipulation and fraud in clinical trials.

Methodology: Library research is used to study both primary and secondary legal resources.

Finding: Lack of standard regulatory body and lack unified legal framework is the cause of failure to protect human subject in Nigeria.

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References

, cap C. 23 laws of the federation of nigeria. Constitution of the federal republic of nigeria 1999, Pub. L. No. Cap C 23 2004 (1999). Nigeria.

Ademiluyi, I. A., & Aluko-Arowolo, S. O. (2009). Infrastructural distribution of healthcare services in Nigeria: An overview. Journal of Geography and Regional Planning, 2(5), 104–110.

Aminu Yakubu1, Morenike Oluwatoyin Folayan2, Nasir Sani-Gwarzo3, Patrick Nguku4, Kristin Peterson5, B. B. (2016). The Ebola outbreak in Western Africa: ethical obligations for care. J Med Ethics, 42.

C., O. (2008). Regulating Research Involving Human in Nigeria: Some Recent Improvement. Health Law Review, 16(4), 36.

Cir., (2d. Abdullahi v Pfizer (2009).

Cohen-Almagor, R. (2011). Physician-Assisted Suicide – A Qualified Endorsement. Health Care, Bioethics and the Law, 4, 116. DOI: https://doi.org/10.2139/ssrn.1754984

Council for International Organizations of Medical Sciences (2002). Geneva.

CR., N. (2012). Remembrance there is Prevention: A brief Review of four Historical Failures to Project human Subject. Journal of Reaserch and Administaration, VXLIII, 99.

Defazio G1, Hallett M, Jinnah HA, B. A. (2013). Development and validation of a clinical guideline for diagnosing blepharospasm. Neurology., 16(3). DOI: https://doi.org/10.1212/WNL.0b013e31829bfdf6

Dowbiggin, I. (2013). From Sander to Schiavo: Morality, Partisan Politics, and America’s Culture War over Euthanasia, 1950-2010. Journal of Policy History, 25(1), 12–41. http://doi.org/10.1353/jph.2013.0000 DOI: https://doi.org/10.1017/S0898030612000334

Erhun Babalola, W. O., & Erhun, M. (2001). Drug Regulation and Control in Nigeria: The Challenge of Counterfeit Drugs. Journal of Health & Population in Developing Countries, 4(2), 23–34. DOI: https://doi.org/10.12927/whp..17597

Etal, A. C. . (2007). Developing Ethical Oversight of Research IN Developing Countries: Case study of Nigeria. Harvard Health Policy Review Spring, 8, 96.

Etal, A. P. (2011). . The Ethical and Legal Regulation of HIV-Vaccine Research in Africa: Lessons from Cameroon, Malawi, Nigeria, Rwanda and Zambiya. African Journal of AIDS Research, 10(4). DOI: https://doi.org/10.2989/16085906.2011.646660

Evelyn, S. (1997). Fifty Years Later: The Significance of the Nuremberg Code,”. The New England Journal of Medicine, 337, 1436. DOI: https://doi.org/10.1056/NEJM199711133372006

F., W. A. (2007). Closing the Constant Garden: The Regulation and Responsibility of U.S. Pharmaceutical Companies Doing Research on Human Subjects in Developing Nations. Washington University Global Studies Law Review, 6(3).

GOOD CLIICAL PRACTICE REGULATIOS 2009 C (2009). Nigeria.

Idigbe. (2014). Nigeria: Balancing Access to experimental Drugs with the Constitutional Right to life and the Legal imperative for strict enforcement and compliance with Clinical Trial Laws. Mondaq Connecting Knowledge and People.

J.S, B. (2012). Closing the Gaps in Human Subject Research Law: Regulating Clinical Research Conducted Outside the United State. Anal Health Law, 21(1).

Jan, B. M. & M. (n.d.). Conducting Clinical Trial in the US and Abroad: Navigating the Rise Tide of Regulational Risk.

Jayasuriya, D. C. (1985). REGULATION OF PHARMACEUTICALS IN DEVELOPING COUNTRIES: Legal Issues and Approaches. WORLD HEALTH ORGANIZATION.

Laughton, A. H. (2012). Somewhere to Run, Somewhere to Hide? International Regulation of Human Subject Experimentation. Duke Journal of Comparative & International Law, 18, 181.

M.K, F. (2014). Knowledge of Public Health Ethics among Medical Doctors in Nigeria: A Case Study. South American Journal of Public Health, 2(3), 475.

Murari, G. (2012). Clinical Research and its Condition in India. Journal of Clinical Research & Bioethics, 4(2). http://doi.org/10.4172/2155-9627.1000146 DOI: https://doi.org/10.4172/2155-9627.1000146

N, D. A. (2015). Health Research in the National Health Act: Time for NIMR to Re-strategize in Response to National Health Research Priorities.

Nation, U. INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS (1996).

National Agency for Food and Drug Administration and Control Act (2004). Nigeria.

National Health Act (2014). Nigeria.

Nwabueze, R. N. (2004). Ethical review of research involving human subjects in Nigeria: legal and policy issues. Ind. Int’l & Comp. L.Rev., 14. DOI: https://doi.org/10.18060/17787

Postal, S. W., & Diaz, R. W. (2012). A Remedy in Sight : International Clinical Research Regulation. Journal of Environmental and Public Health Law, 6(1), 1–40. DOI: https://doi.org/10.5195/pjephl.2011.54

Salihu, S. I. (2015). The Dilemma and Challenges in litigation by Victim of Human Rights Violation against Multinational Corporation”. Nigerian Law School Bagauda Law Review.

Singer, P. A. (2008). The Cambridge Textbook of Bioethics. New York: Cambridge University Press. http://doi.org/http://dx.doi.org/10.1017/CBO9780511545566 DOI: https://doi.org/10.1017/CBO9780511545566

Wollensack A F., (2007). Closing the Constant Garden: The Regulation and Responsibility of U.S. Pharmaceutical Companies Doing Research on Human Subjects in Developing Nations. Washington University Global Studies Law Review, 6(3).

Published
2015-12-31
How to Cite
Ibrahim Salihu, S., Yusof, Y., & Halim, R. (2015). Tracing the Weaknesses of the Regulatory Framework for Clinical Trial in Nigeria. Journal of Business and Social Review in Emerging Economies, 1(2), 77-86. https://doi.org/10.26710/jbsee.v1i2.10