Transparency in Nigeria's public pharmaceutical sector: perceptions from policy makers

Pharmaceuticals are critical for the health and well-being of populations. Their access and consumption can be likened to a double-edged sword: on one hand, they alleviate the manifestation of disease but on the other hand, if they are inappropriately used, or worse, counterfeit or substandard, they may be ineffective and even toxic to the individuals who take them [3–5]. As such, it is necessary for countries to adhere to the highest standards of quality in the manufacture, regulation, and distribution of drugs. Because of the many steps involved in the process of regulating drugs, the pharmaceutical system is particularly vulnerable to unethical and corrupt practices. In many developing countries such as the Federal Republic of Nigeria, these vulnerabilities are capitalized on and adherence to such high regulatory standards is severely impaired by a lack of transparency, weak regulatory control, and the preponderance of corruption in the public pharmaceutical sector [6, 7] which negatively impact health outcomes, weaken the nation's economy, and decrease public trust in the government.

Corruption, defined by Transparency International as "the abuse of entrusted power for private gain" [8], was identified as one of the major reasons for the preponderance of counterfeit drugs in Nigeria, in addition to inadequate legislation, ineffective enforcement of existing laws, non-health professionals in the drug business, loose control systems, high cost of drugs, greed, and ignorance [9]. Examples of corrupt practices that facilitated counterfeiting of drugs included extortion of bribes from applicants for drug registration, deliberate over-supply of drug samples for resale, and acceptance of perquisites and material gifts from companies being inspected, to name a few [10].

Counterfeit drugs are defined by the WHO as those that are "deliberately and fraudulently mislabelled with respect to identity and/or source" [6]. Counterfeit drugs fall under the general umbrella of substandard drugs - genuine products which do not meet the quality specifications set for them [10]. Counterfeited drug preparations in Nigeria included those without active ingredients, toxic preparations, expired drugs that were relabelled, drugs issued without complete manufacturer information, and drugs that were unregistered with NAFDAC. Over the past decade and a half, Nigeria struggled to curtail the production and trafficking of counterfeit drugs without adequate infrastructure or the political will to properly enforce legislation and standards.

However, in 2001, under the leadership of Dr. Dora Akunyili as the new Director General of the NAFDAC, the agency underwent dramatic restructuring and reform such as the re-orientation and retraining of NAFDAC staff, establishment of more NAFDAC state offices, refurbishment of drug analysis laboratories, stricter enforcement of drug regulations, public confiscation and destruction of counterfeit drugs, and public awareness campaigns [11]. The aim was to a revitalize NAFDACs mandate to "safeguard the health of the nation". As a result, the circulation of counterfeit drugs was reported to have been reduced by over 80% from what it was in 2001 [12], the amount of drugs unregistered by NAFDAC in circulation was reduced from 68% to 19%, and the production capacity of local pharmaceutical industries increased tremendously [13].

Prior to these reforms, the presence of counterfeit drugs had an obvious and detrimental impact on those who used them inadvertently. In 1990, 109 children died as a result of taking paracetamol syrup produced with toxic ethylene glycol instead of propylene glycol, a tragedy that occurred more than 50 years after its occurrence in the United States [14]. Despite NAFDAC's reported successes, examples of the spread and impact of counterfeit drugs in Nigeria still abound. In 2004, 3 Nigerian hospitals reported cases of adverse reactions from the use of contaminated infusions produced by 4 Nigerian companies [15]. It was confirmed that the infusions were heavily contaminated with microorganisms and 147 of the 149 brands of screened water for injection were found to be unsterile. Many of the other substandard drug products in Nigeria were/are present as a result of bad manufacturing practices and weak regulatory control [10, 16].

This study assesses the level of transparency and potential vulnerability to corruption in four essential functions of Nigeria's pharmaceutical sector: registration, procurement, inspection, and distribution. Registration is the first of these decision points in any pharmaceutical system and is intended to ultimately guarantee a drug's efficacy in treating a specific disease and its safety profile. This process includes labeling, marketing, usage, warning and prescription requirements for the drug. As mentioned earlier, counterfeit drugs in Nigeria include those that were not registered with NAFDAC, those without active ingredients, expired drugs that were relabelled and resold, and drugs issued with incomplete manufacturer information [17]. Baseline studies conducted in 2001 showed that 68% of the drugs available in Nigeria were not registered with the Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) and later reports showed that as at 2004, counterfeit drugs still accounted for 40-50% of available drugs in Nigeria [18, 19].

Procurement exists at the interface between the public system and drug suppliers. The purpose of procurement is to obtain the appropriate amount of drugs in the most cost-effective manner. Procurement involves managing inventory, aggregate purchasing, public bidding, analysis of offers, proper allocation of resources, payments, receipts of drugs purchased, and quality control checks [7].

Inspection of ports of entry and establishments such as local drug manufacturing sites is another crucial function of the Nigerian pharmaceutical sector. The majority of drugs in the country are imported from other countries in Asia such as India and China. Currently, there are 92 pharmaceutical companies producing only approximately 30% of Nigeria's internal drug supply [15]. Between 2001 and 2005, 30 Indian and Chinese pharmaceutical companies and 1 Pakistani company who were confirmed to be manufacturing counterfeit drugs were banned from exporting drugs to Nigeria [15]. Inspection of establishments occurs at the local and international level, where NAFDAC participates in ensuring Good Manufacturing Practices (GMP) of all establishments involved in the manufacture, sale, storage and distribution of drugs [20].

Distribution of drugs in the pharmaceutical sector involves allocating, transporting, and storing drugs appropriately at all times. Some medications have specific storage requirements such as refrigeration and secure facilities to minimize the risk of theft and other unethical practices. For this to occur, it is critical that information moves through each step of the system to control inventory and deliveries.

The study was conducted from May to August 2007. The methodology is based on the WHO Assessment Tool of Medicines Regulatory Systems, 2007, which provided both qualitative and quantitative information on the level of transparency and susceptibility to corruption in each of the four functions of the public pharmaceutical sector: registration, procurement, inspection (of ports and establishments), and distribution. The assessment tool is currently being used in over 25 countries as part of the ongoing WHO Good Governance for Medicines Program.

Standardized questionnaires containing both open and closed-ended indicator questions adapted from the WHO assessment instrument [21, 22] were used for each of the four functions. Fourteen semi-structured interviews were conducted in person by one of the study authors with key policy makers and stakeholders (furthermore referred to as key informants)representing both the public and private sector of the pharmaceutical system. Key informants included officials at NAFDAC and other government organizations, officials in non-government organizations, individuals who worked within the profession of pharmacy, and officers in judicial/law and order [see Additional File 1]. The key informants were selected purposefully according to their expertise and extent of involvement in each of the four functions, according to the relevance of their department to the area being researched, and based on their job description and institutional or corporate affiliation.

Certain questions ask a respondent to what extent they agree to a statement. For such questions, the number of responses was tallied and the most frequent response was presented. The scale below was used to qualify the responses:

Strongly disagree

Disagree

Undecided

Agree

Strongly Agree

Not Applicable

Don't Know

Lastly, open ended questions were used for the purpose of obtaining additional information or perceptual information that could not be adequately collected via structured questions. The open ended questions also allowed key informants the opportunity to provide additional qualitative information that could help confirm findings from the closed ended questions or could also highlight areas that may not have been covered.

It is important to note that in pharmaceutical sector, or any other public system for that matter, identifying corruption is a not an easy task for a number of reasons. Firstly, individuals being interviewed may be reluctant to admit that corruption or any form of institutional weakness exists for fear of being directly implicated or for fear of reprimand. In addition, actual corruption and institutional inefficiency may be indistinguishable and often, inefficient systems can facilitate corruption or corruption can be hidden by inefficient systems [21]. Bearing this in mind, these questions and this scoring system are not intended to measure actual corruption. Rather, the point is to identify areas where potential vulnerability to corruption exists due to various deficiencies in governance and institutional weaknesses. Also noteworthy is the fact that the scores reflect the situation in the field at the time of the study. Since then, it is possible that steps may have been taken to address some of these deficiencies.

The most pervasive institutional weakness identified from this study was the lack of explicitly documented conflict of interest guidelines for any of the four functions of the pharmaceutical sector. Many other weaknesses stemmed from this deficiency. Thus, the primary recommendation would be to establish clear and well-documented conflict of interest (COI) guidelines for personnel of NAFDAC, the National Drug Law Enforcement Agency (NDLEA), and other public officials in the pharmaceutical sector. When conflict of interest guidelines are present and consistently administered, the promulgation of corrupt practices may be limited. Nigeria can model its COI guidelines after those of public drug systems of other countries, for example, the conflict of interest guidelines for the Common Drug Review by the Canadian Agency for Drugs and Technologies in Health [32]. In addition to developing COI guidelines, the Nigerian government also needs to ensure consistent application of the guidelines, which may involve the establishment of penalties for breaching COI principles. This would be a relatively low cost initiative to implement and one that has potential to result in some significant improvements in the system.

The second most important recommendation is for better allocation of financial and other resources by NAFDAC and investing in up-to-date technology to assist officers in their work. Purchasing vehicles for inspectors of would halt the practice of having manufacturing companies transport inspectors to and fro manufacturing sites. This would not only reduce the safety risk to the inspectors, it would also limit the potential for enticement and regulatory capture. Purchasing video cameras and electronic alarm systems for drug storage sites prior to distribution would greatly enhance security and accountability for procured products. However, it is acknowledged that the greater problem of the nation's erratic power supply may impede the immediate implementation of an electronic security system. Acquiring camcorders and other battery-operated devices to aid remote inspections and on-the-spot testing of drugs would increase the accuracy of the inspection process. Purchasing mobile GSM phones for officers in the field or on the road would greatly improve communication between departments. More modern laboratory equipment would also enable better detection of counterfeit drugs. Identifying the most worthwhile ventures to allocate investments into can be determined by regular diagnostics of the pharmaceutical system.

A third recommendation is to place greater emphasis on human resources. This involves hiring qualified personnel and re-training current staff. Short staffing was a particular problem in drug inspection at the ports and this is problematic given that the ports are a porous entry point for counterfeit drugs and with fewer staff, more counterfeit products are likely to be missed. In addition, an enhanced salary and benefit package for current NAFDAC officers would help shield them from tempting offers made by desperate companies, however, this would be contingent on an increase in budgetary allocation to the NAFDAC from the Federal Government.

Fourthly, the local pharmaceutical industry may benefit from incentives which favour registration of high-quality locally manufactured drug products over foreign imports. One of NAFDAC's mandates is to "strengthen confidence in made-in-Nigeria products" so processes that favour local drug manufacturers in the long term could result in a more responsive and accountable industry which ensures higher quality of locally-made products and would also stimulate the nation's economy. The establishment of such initiatives would require initial investments into Nigeria's manufacturing facilities so that they are in line with WHO Good Manufacturing Practices as a starting point.

To further restore confidence in the Nigerian drug industry, closer monitoring of patent and proprietary medicines dealers is recommended to ensure that they do not distribute drugs they are not authorized to. This could be in the form of both routinely scheduled and impromptu inspections of their facilities. As well, the suppliers of their products should be verified and more closely monitored by inspectors to ensure that they are legitimate, compliant with NAFDAC regulations, and that their products are quality controlled. Some respondents went as far as calling for the abolishment of sale of drugs by non-pharmacists altogether. The immediate feasibility of the latter is questionable, however, given that many rural areas in Nigeria do not have pharmacists or even any formally-trained health care professionals.

A sixth recommendation is for public availability of internal/external audit results of drug regulatory agencies. Apprehension about public scrutiny may provide an incentive for all agencies to ensure that their processes are well-documented and consistent, and that they are fully compliant with the standard operating procedures set out for them. This measure would increase transparency as well. Auditors may benefit from occasional collaborations with foreign partners such as the WHO, the United States Food and Drug Administration, and Health Canada, among others, thus increasing the validity, reliability, and thoroughness of audits and providing a means for external monitoring and evaluation of the audit process. In accordance with the theme of public accountability, the area of drug registration suffered from a lack of public availability of documentation describing the terms of reference or criteria for member selection of the committee that decided which drugs would be approved for registration. Being able to assess these documents publicly would also improve transparency and with increased transparency, there is a lower potential for inefficiency and/or corruption [21].

To reinforce transparency and accountability of the inspection process, it is also recommended to regularly rotate inspectors to different sites. An explanation given for not rotating inspectors was that greater lengths of time spent at a particular port increased the expertise of the inspectors there. Furthermore, respondents demanded that some inspection units should be decentralized into the various local government areas as opposed to remaining primarily in state capitals. This places inspectorate offices much closer to their jurisdictions and this will quicken response times as well as reduce inefficiencies created by gaps in communication between local, state, and federal bureaucracies. The establishment of inspectorate offices in local government areas is in fact part of a 10 year rolling plan of NAFDAC.

Global attention to the battle against counterfeit drugs is increasing. The WHO fact sheet on counterfeit medicines refers to them as "an enormous public health challenge" and reports that drug counterfeiting is the greatest in regions with legal oversights and weaknesses in regulatory control of pharmaceuticals [33]. The fact sheet predicts a greater than 90% increase in counterfeit drug sales by the year 2010.

Despite this global trend, Nigeria stands out as a country that has acknowledged its problem and made some degree of progress in dealing with counterfeit drug production and trafficking. Much this success can be attributed to stronger leadership and political will within NAFDAC and greater public awareness of the problem. However, there is still much work to be done. Greater institutional robustness and appropriate checks and balances are necessary to ensure a sounder, more effective, and more transparent pharmaceutical system in Nigeria. These study findings and recommendations will hopefully enable Nigeria evaluate the operating structure of their pharmaceutical sector, capitalize on its strengths, and institute necessary reforms to address its deficiencies.