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KMID : 1011120170100020081
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Bioethics Policy Studies
2017 Volume.10 No. 2 p.81 ~ p.114
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Access to Experimental Drugs, Fundamental Rights and Clinical Trials Regulation in Nigeria
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Onyemelukwe Cheluchi
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Abstract
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The Ebola crisis, which claimed many lives in several West African countries, raised many ethical and legal questions. One of the issues it raised when it arrived in Nigeria was the basis and procedure for access to experimental (or investigational) drugs.Elsewhere, particularly in the United States, issues raised with regard to expanded orcompassionate use of drugs for people who would almost certainly die without access to experimental medicines have led to legal actions seeking to establish a right to access experimental drugs. Through an analysis of the use of experimental drugs during the Ebola crisis, this article seeks to investigate the state of the law in Nigeria. Do patients in Nigeria have a legal (not merely charitable) foundation for requesting the use of any available therapy, regardless of the certainty of their efficacy or safety? Is there a right to access experimental drugs in Nigeria? What constitutional rights might provide a foundation for this claim? What is the place of the drug regulatory process in analysing such a claim? This article examines the balance that must be drawn between access to experimental drugs and safety, and interrogates whether there is a constitutionally protected, fundamental right to access experimental drugs in Nigerian law and jurisprudence. It considers the fundamental rights to privacy, to health and life and the constitutional provisions, national legislation and jurisprudence related thereto. It examines the drug regulatory requirements in Nigeria and its current capacity to assist the courts in making the requisite determination. I conclude that it is currently difficult to affirmatively assert an existing fundamental right to access to experiments, though the drug regulatory system may help courts reach a firm decision on the right to experimental medicines. However, Nigeria has yet to develop a formalised approach to experimental drugs. Many issues remain outstanding within the current regulatory framework: the need for informed consent, the place of ethics review, and the coordination of responsibilities between the key regulatory agencies: the National Administration for Food and Drugs Control (NAFDAC) and the National Health Research Ethics Committee (NHREC).
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KEYWORD
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Experimental Drugs, Investigational Drugs, Fundamental Rights, Constitutional Rights, Drug Regulation, Clinical Trials, Nigeria, Nafdac, Nhrec
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