A qualitative inquiry on the status and adequacy of legal instruments establishing infectious disease surveillance in Nigeria

Introduction The threat of devastating disease outbreaks is on the rise with several outbreaks recorded across the world in the last five years. The intractable Ebola Virus Disease outbreak in West Africa which spread to Nigeria was a reawakening point. This study aims to review the status and adequacy of the legal framework for disease surveillance in Nigeria. Methods: a mixed methods approach comprising of document reviews and key informant interviews was used in data collection. Methods A mixed methods approach comprising of document reviews and key informant interviews was used in data collection. Results Fourteen key informants from the federal ministry of health (FMOH) and six States were interviewed. Five legal instruments were identified and reviewed. The Quarantine Act of 1926 remains the active National Law on disease surveillance in Nigeria. An Integrated Disease Surveillance and Response Policy (IDSR) was developed in 2005 as the means for achieving the International Health Regulations (IHR). All six states claimed to have adopted the national IDSR policy though none could present a domesticated version of the policy. Key informants were concerned that Nigeria does not yet have an adequate legal framework for disease surveillance. Conclusion The legal instruments establishing disease surveillance in Nigeria require strengthening and possibly enactment as a National Law in order to address emerging disease threats.


Introduction
Infectious disease outbreaks have been known to occur for ages with devastating impact. In 541 AD, grain merchants' from Egypt transported rats infested with an unknown organism at that time into the Eastern Roman Empire causing the Plague of the Justinian period [1]. This outbreak left over 30 million people dead with significant economic impact [1]. Likewise, the black plague of the 14 th century was noted to be responsible for the death of 30 percent of Europe's population, estimated at between 75 and 200 million people [2]. Early in the 19 th century and long before the development of the microscope, an outbreak of another unknown disease in London with a high fatality was traced by John Snow to the water pumps, after he was able to map clustering of cases around some particular pumps [3]. He contained the epidemic by removing the handles of the water pumps stopping people from getting water from the contaminated sources. Lately, emerging and re-emerging infectious diseases are posing threat to human populations with fear of outbreaks of these diseases spreading globally and causing significant morbidity and mortality. The Human Immunodeficiency Virus which was first identified in the 1980s is now a pandemic which though has been well curtailed in its acute form by drugs, remains without a cure [4]. The World Health Assembly (WHA) in 1969 adopted the International Health Regulations (IHR) as its legal instrument for implementing its constitutional responsibility for controlling the international spread of infectious diseases. The IHR was an evolution of the International Sanitary Regulations previously adopted by the fourth WHA in 1951.
The IHR was revised in 2005 with the purpose and scope "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks and which avoid unnecessary interference with international traffic and trade" [5]. Several African countries including Nigeria implement the Integrated Disease Surveillance and Response (IDSR) strategy as their means for meeting the IHR [6]. The IDSR is a strategy that was first proposed in 1998 by the World Health Organization (WHO) Regional Office for Africa as a framework for a coordinated and integrated surveillance and response.
Nigeria has a population of about 180 million people with limited resources to tackle all her health challenges. As a result, health indices in the country are not among the best in the world. Life expectancy at birth is 54.5 years which is lower than the regional average (60 years) and far lower than the global average (71.4 years) [7]. Various factors including mortalities arising from infectious diseases of public health significance contribute to the low life expectancy in Nigeria. Pneumonia and other neonatal infections remain major killers among children while perinatal infections also contribute significantly to maternal mortality. The country has been affected by the outbreak of various communicable diseases in the past. Some notable ones include the Lassa fever outbreak in the 70's, Yellow fever in the 80's, the Avian influenza outbreak of the early 2000s, recurrent Cerebrospinal Meningitis and recently the Ebola Virus Disease (EVD) outbreak following an imported case in 2014 [8][9][10][11][12]. Polio which was also thought to have been at the verge of elimination has again reemerged [13]. The ability to identify and respond to outbreaks promptly thereby limiting their impact rests on the availability and implementation of appropriate laws, policies, processes and systems to help detect the outbreaks early and take action that will mitigate the spread of such infectious diseases. However, the reliability of surveillance systems in the country in this regard has been questioned [10,14,15]. Following the recent EVD outbreak, concerns about the adequacy and outdatedness of laws for disease surveillance in the country have been raised [16]. Thus, it is necessary for an inquiry to be carried out to investigate the adequacy of the legal instruments that guide the surveillance system in the country. The study examines the status and adequacy of national and sub-national legal instruments that govern disease surveillance in Nigeria. The knowledge generated will provide policy makers, public health experts and researchers information useful in advocating for improvement in the legal framework for disease surveillance in the country.

Methods
This article reports part of a larger research effort to investigate the compliance with disease surveillance and notification by private healthcare providers in Nigeria and the factors that may be affecting their performance. A brief description of the entire study has been previously published [17]. The objectives of the entire study are: to examine the legislative/legal framework for routine disease reporting in Nigeria (nationally and sub-nationally) and how it might affect compliance by private providers; to determine the level of

Results
Different legal instruments establishing or reinforcing disease surveillance in the country were identified during the study. Some of the legal instruments were identified during the literature reviews and before the KIIs while some were identified and/or reinforced during the KIIs. In total, six documents were identified and subsequently retrieved and studied. Fourteen key informants were interviewed during the period: two officers from each State (State epidemiologist and State HMIS officer) across the six States of investigation, the national IHR focal person and the NHMIS officer.
The interviews lasted between 20 and 45 minutes. The identified documents during this process are presented in Table 1. following the EVD outbreak of 2014, a Bill to enact a law on cremation of suspected infectious disease cases has been under discussion in the legislature. However, progress to enact the law has been slow. This draft Bill was not available to the research team upon request as it was stated to be a confidential document.

Discussion
Nigeria is a Federation with three tiers of government: the federal government, state governments and the local governments [22]. One Million Lives-Program for Results [28]. However, the effectiveness of this strategy still needs further evaluation. Many of the respondents do not think that Nigeria has adequate laws on disease surveillance which is worsened by the poor implementation of existing laws. This has also been echoed in the literature following the EVD outbreak of 2014 [16]. A Public Health Bill was discovered to be awaiting assent in the Nigerian Senate since 2004.

This Bill sought to establish a Public Health Emergency Planning
Commission with the hope that this institution will improve the responsiveness of the system to public health emergencies. The long delay in finalizing this Bill is a huge challenge to the health sector. However, it was also observed that several other Bills were awaiting review. While the establishment of an agency may provide some opportunities for structured response to infectious diseases, Page number not for citation purposes 6 the unavailability of adequate Laws for the system will make it unable to achieve its goal. A Nigeria Center for Disease Control (NCDC) supported by the US Centers for Disease Control and Prevention (CDC) has been in operation since 2012 [29]. However, this operated as a US CDC supported project of the government.
Early in 2017, the Federal Executive Council (chaired by the President) approved a memo to adopt the NCDC as a standalone government institution and a request has been sent to the legislature for ratification [30]. It is unclear if the effort to establish the NCDC will nullify the public health bill which has been awaiting reading on the floor of the Senate since 2004. Notwithstanding it is noteworthy that information on the NCDC first surfaced in 2008 [29]. The long delay before it received attention is a concern that must be addressed. The IDSR strategy which was developed to implement the IHR is still governed by a policy, the lesser of the two legal instruments. The Quarantine Act predates the IDSR policy and both documents do not necessarily align on diseases that are to be tracked. While many officers interviewed generally agreed that they were implementing the national policy on IDSR since it was adopted at a NCH meeting several years earlier, none could show any document ratifying the IDSR by their State legislature or detailing how IDSR should be implemented in their State by their Ministry of Health. This is a major shortcoming as it has been established that national laws and policies on health do not necessarily bind the States. As such, State specific Laws or policies addressing disease surveillance are necessary to strengthen the commitment towards disease surveillance in each State.

Conclusion
The legal framework establishing disease surveillance in Nigeria requires strengthening and possible enactment as a law to give it the authority it deserves as well as to update it to address emerging Global Health Security challenges. State governments should domesticate policies or laws on disease surveillance to demonstrate buy-in and improve their commitment to its implementation.
Lawmakers and Policymakers need to be educated on the importance of prompt attention to laws on Global Health Security.
What is known about this topic  The threat of devastating disease outbreaks is on the rise globally and countries need an efficient surveillance system for detecting and responding to outbreaks to mitigate their impact;  The first step towards a reliable system is a legal or regulatory framework that establishes and enforces the surveillance system in a country;  Disease surveillance is poor is several low and middle income countries including Nigeria and efforts are required to improve their performance.

What this study adds
 This study provides a snapshot of the status and the adequacy of the legal and regulatory framework which establishes disease surveillance in Nigeria;  It also highlights concerns by key stakeholders that Nigeria does not have an adequate legal or regulatory framework for addressing disease surveillance and those currently available are not being implemented. Technical guideline for the implementation of the IDSR was developed in 2013 and followed the international guidelines released by WHO Regional Office for Africa three years earlier.