DRUG COUNTERFEITING AND THE RIGHT TO HEALTH IN NIGERIA

Abstract

The right to the highest attainable standard of mental and physical health includes availability, accessibility, acceptability and quality of prescription drugs. Counterfeit drugs have been described as the most dangerous goods in the market with harmful consequences to citizens’ health. Previous studies have focused largely on prevalence, effects and ways of curbing the menace without addressing the legal issues in drug counterfeiting and the right of victims to remedy. This study was, therefore, designed to examine the legal and institutional framework on drug counterfeiting and the right to health as well as legal issues associated therewith. The Sociological School of Jurisprudence Theory guided the study, while doctrinal and analytical legal research methodologies were adopted. Primary data included the Constitution of the Federal Republic of Nigeria,1999 (as amended), the National Agency for Food and Drug Administration Act, Counterfeit and Fake Drugs Act, all of the 2004 Laws of the Federation of Nigeria. International instruments included the Universal Declaration of Human Rights and the United Nations Guiding Principles for Business and Human Rights (UNGP). Constitutions and legislation of India and Kenya, with high incidents of counterfeit drugs, were purposively examined and case laws were also used. Secondary data included legal texts, journal articles, online and off-line, newspapers and workshop materials. Two key informant interview sessions each were held with lawyers, doctors and pharmacists and two other focused group discussions with patent medicine vendors and victims. Data were subjected to content and comparative analyses. Nigeria’s legal framework on drug counterfeiting is characterised by provisions of some legislation overlapping thereby resulting in loopholes and confusion, while enforcement machinery is not effective. Penalties of imprisonment of a term of three to 15 months and a maximum fine of Five Hundred Thousand Naira are lenient compared to the harm caused and profits earned. While there is no legislation on compensationof victims of counterfeit drugs, the implementation of the law has also been hindered by corrupt personnel and lack of effective enforcement mechanism. Although the UNGP requires states to protect citizens’ right to health, corporations to respect the right, and that victims of violation be entitled to remedy, there is yet no statutory enactment for remediation in Nigeria. Under the common law principle of negligence in tort and product liability, however, a victim of counterfeit drug may be entitled to compensatory damages where he can establish a breach of duty. Kenya regards drug counterfeiting as an intellectual property rights infringement, while India and Nigeria regard it as both public health and intellectual property rights violations. Though there are technological means of detecting counterfeit drugs in Nigeria, the public awareness is low. The unstructured interviews revealed that counterfeit drugs violate the right to health of citizens. Consequently, victims should be compensated. Inadequate legal framework for punishing drug counterfeiting offenders has contributed to the violation of the right of Nigerians to health, without effective remediation for the victims. There is a need for improved public awareness of the means for detecting counterfeit drugs in Nigeria.