Drug registration is the responsibility of NAFDAC under the Registration and Regulatory Affairs Directorate [see Additional File 3 for an organogram of the subdivisions of NAFDAC]. Responsibilities of the directorate include the registration of drugs, foods and bottled water; auditing, monitoring and reporting on clinical trials; post-registration surveillance; and advertising control of regulated products . Drug registration received the lowest score, an average rating of 5.8, indicating that this is the area most vulnerable to corruption in Nigeria's pharmaceutical sector.
There is an up-to-date list of registered pharmaceutical products in the country which provides the minimum level of information about the products. Clearly documented procedures and standard forms exist and are publicly available for applications for drug registration. There is written documentation with well-defined standard operating procedures for assessors on how to process applications and there is a formal appeals process for applicants who have their applications rejected. A fixed committee composed of directors of various NAFDAC departments, directors within the Federal Ministry of Health, and officers of the Registration and Regulatory Affairs Directorate of NAFDAC assesses applications for drug registration.
The rating given to drug registration was diminished by a combination of factors. There are no documented timeframes for processing applications as this has not yet been standardized. The only publically available timeline for registration processing is a 3 month timeframe indicated on the NAFDAC website .
There was no available documentation to support the selection and functioning of members of the committee that assesses applications. There was no documentation to support the requirement of any specific professional qualifications, technical skills, work experience, or research experience as criteria for membership of the committee. Documentation was lacking to describe the composition and terms of reference of the committee or the length of time that an individual could serve as a committee member. Also, guidelines for the committee's decision-making process as well as the decisions themselves were not required to be made publicly available. Written documentation that defines the committee's membership, composition, and terms of reference has been identified by the WHO's Good Governance for Medicines Programme as a tool to increase transparency and decrease vulnerability to corruption .
Guidelines to limit how and where registration officers meet with applicants were lacking and there were no written guidelines on conflict of interest. The only semblance of such guidelines was in the form of a declaration of assets which all civil servants complete upon commencement of employment with the government. This is vastly inadequate to address further conflicts of interests that may arise during the course of a registration officer's term. Screening of regulatory employees for conflicts of interest has been identified as a tool to lower the risk of corruption in the drug registration process and allow the regulatory authority to act impartially .
Bribery, offering of material gifts and favouritism occur commonly. Respondents reported that difficult living conditions in Nigeria sometimes lend officers to temptation. Indeed bribery is a common practice in Nigeria and has been identified as one of the leading causes of the rampancy of counterfeit medicines [22, 9]. The process was so rampant that when Dr. Akunyili took over as Director General of NAFDAC, she fired a large number of NAFDAC officials . However, each registration officer is not a sole decision maker therefore the potential for inducement may not affect decisions largely. Moreover, companies cannot readily alter lab results which are definitive criteria that determine approval for registration, limiting the extent of a company's influence on drug registration.
Respondents in community pharmacy cited the registration of patent and proprietary medicines dealers (non-pharmacists who are authorized to distribute specific over-the-counter medications outlined in the Essential Medicines List) as an avenue for infiltration of counterfeit drugs because many of these dealers operate in rural areas where regulation of their activities is difficult and many still sell medications that they are not permitted to sell .
Respondents also indicated that the registration process still does not address one of the root causes of counterfeiting in Nigeria: the fact that non-professionals (i.e. non-pharmacists) are still largely in control of retail pharmacy. It was reported that some pharmacies are owned by rich businesspersons who wish to cut corners and maximize profits by importing and selling substandard products. These individuals hire pharmacists as a front solely to obtain licensure to open and operate pharmacies. Using their wealth and influence, they often attempt to intimidate their way through normal regulatory procedures. At times, some of these syndicates are discovered and the individuals responsible are prosecuted, but the practice is apparently still prevalent .
Procurement of pharmaceuticals is under the mandate of Nigeria's Ministry of Health. The Ministry purchases a limited number of therapeutic classes of medications, namely anti-retrovirals, artemisin therapy for malaria, narcotics and controlled substances, vaccines, sulfadoxine, and anti-tuberculosis drugs. Procurement scored 8.9, indicating this area of the pharmaceutical sector has a low vulnerability to corruption. This is commendable particularly given the economic importance of this area and given that in many developing countries, drug procurement procedures are inefficient, non-transparent, and often corrupt . This high score may be due to the fact that the Ministry procures a few therapeutic classes of drugs which do not account for a majority of total drug procurements.
The process for procurement is competitive, documented, and well-defined (a concise manual on public procurement reform in Nigeria exists in print). Drugs are purchased using tenders (both international and local), except vaccines which are purchased through UNICEF or are donated. Objective methods are used to determine the quantity of pharmaceuticals needed using calculations that incorporate consumption data, population growth, projectional studies etc.
The criteria for membership and functions of the tender committee are clearly defined and are differentiated from that of the procurement office: the tender committee is made up of an Evaluation Committee and the Ministerial Tenders Board, which are responsible for evaluating supplier qualifications, inviting those who qualify to bid and determining which suppliers receive contracts. The procurement office, also known as the Budget Monitoring and Price Intelligence Unit (BMPIU) or the "Due Process" team, manages the tender process and finalizes the certificate of award and certificate of payment for the tender.
Procurement information is publicly available. Tenders are advertised in at least two national newspapers and in the Federal Tenders Journal. The bidding process and opening of applications for pre-qualification are also publicly accessible. Contracts are awarded to bidders who are pre-qualified and technically evaluated, but most importantly, who can execute the contract at the lowest cost. Some bidders, out of desperation, may quote prices unreasonably lower than fair market value. In such cases, contracts are awarded to bidders with the second lowest financial costs. There is a formal appeals process for applicants who have their bids rejected.
Management information systems to report problems in procurement exist in the form of written reports from the central medical stores where drugs are kept upon arrival. These include tracking records of the products ordered and delivered, records of quality assurance information, and evidence of communication between the procurement office and the central medical store when problems arise. A Monitoring and Evaluating Unit is tasked with reporting on the performance of suppliers, and works with the NAFDAC Inspectorate to ensure adequate packaging, labeling, potency, etc. of the products. Unsatisfactory performance has resulted in certain suppliers being blacklisted. Names of blacklisted companies are published routinely in public alert notices. Consignments are routinely inspected and samples analyzed upon inspection. The procurement process undergoes regular audits both internally (by the Internal Audit Unit of NAFDAC) and externally (by the Auditor General's office).
Bidders at times attempt to bribe procurement officers based on how they "sized them up". This type of activity was reported as being infrequent particularly because the procurement process is so open and because no single officer is a sole decision maker. In addition, more rigorous enforcement of regulations by NAFDAC has led to a higher calibre of bidding companies (prior to this, any local manufacturer had a shot at bidding regardless of the quality of their operations).
As with drug registration, there is also a lack of written conflict of interest guidelines. This is concerning because the potential for corruption exists if members of the tender committee have vested interests in companies offering bids. Another weakness is a lack of evidence to suggest public availability of audit results. As discussed previously in registration, lacking conflict of interest guidelines and publicly available reports decreases transparency in the system and increases the vulnerability to corruption.
Inspection of Ports
Nigerian ports of entry include airports, seaports and its national borders. The inspection of these ports offers unique operational challenges and multiple organizations undertake the activity. NAFDAC inspectors, present at all these ports, are assisted by the National Drug Law Enforcement Agency (NDLEA), the Nigerian Ports Authority (NPA), as well as other organizations. The decentralization of inspection, resulting in varying regulations and standards results in this area receiving a modest score of 6.4, the second lowest score of all the areas.
Respondents indicated that the provision in the regulations for inspection at the ports is comprehensive, well-defined, and available to the companies involved in the importation of drugs. There are also well-defined written Standards of Practice (SOPs) for NAFDAC inspectors on how to conduct inspections. Guidelines for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are well-defined and are discussed in detail under Inspection of Establishments. The assistance from NDLEA and NPA inspectors at the ports further strengthens the ability of port authorities to discover irregularities. Collaborating with NAFDAC by providing both expertise and greater manpower also increases accountability for inspection findings.
A principal weakness was the absence of written conflict of interest guidelines except for the incomprehensive "declaration of assets" form. Ports of entry are highly susceptible to the influx of counterfeit drugs and any laxity in vigilance of inspectors, which may be created by potential conflicts of interest, would seriously jeopardize progress in the battle against counterfeit pharmaceuticals.
Despite well-written regulations for port inspections, including well-defined SOP, respondents also highlight the prevalence of regulatory capture, the unethical practice where government officials who are supposed to act in the interest of the public are influenced by those that they are meant to be policing and engage in the very same unethical practices and behaviours that are supposedly being regulated . The inconsistency in the written mechanisms or procedures to prevent regulatory capture between inspectors and suppliers thus leaves an open window for corrupt practices like the offering of bribes for inspectors to allow counterfeit products in.
According to respondents, anecdotes of bribery - the offer of material gifts, shares and investments in companies - are common at the ports. Companies have also been reported to become aggressive and threatening when deficiencies in their products are identified. Staffs at the ports are sometimes overwhelmed by the sheer volume of work and may inadvertently allow counterfeit drugs slip through, especially since there may be only one NAFDAC inspector at a time at a given port.
The NAFDAC claims that it cannot afford to have more than one inspector on the field, and there is heavy reliance on the presence of officials from other inspecting agencies to reduce strain. The propensity for regulatory capture is further exacerbated by the limited specificity in criteria needed for inspectors, including lack of specification of work experience or previous references in the field, an oversight which can result in employing inspectors who are inexperienced, less competent, and potentially more susceptible to inducement. The absence of any evidence of an internal review mechanism for the inspection procedure also causes concern, as it enables inefficiencies to be overlooked and allows counterfeit drugs to slip through the cracks.
Inspection of Establishments
A country with high capital and sufficient infrastructure, Nigeria has a vibrant local drug manufacturing capacity. The role of NAFDAC in enforcing good manufacturing practices among local drug manufacturers is the inspection of establishments. Although improving under the current NAFDAC administration, inspection of establishment received a score of 7.0, indicating marginal vulnerability to corruption.
Written guidelines that classify and define the Good Manufacturing Practices (GMPs) are available, outlining potential types of deficiencies and subsequent actions to be taken by the Inspectorate. A company may also seek an 'advisory inspection,' where a standard fee is paid to NAFDAC for advice from an inspector on GMP requirements and for recommendations of measures to improve GMP compliance at that site. To reinforce the emphasis on GMP, training programs for inspectors are routinely organized enabling them to travel overseas to countries where majority of manufacturing sites are compliant with GMP.
There are detailed SOPs and checklists for inspectors on how to conduct various kinds of inspections. Inspections are conducted in teams and are peer-reviewed under a well-structured chain of command. Inspectors (and sometimes re-inspections) are rotated on a scheduled system but inspectors remain within the same geographical area. The rationale for this is that inspectors can become more familiar with the idiosyncrasies of manufacturers in that geographical area, which increases their level of expertise. The process is subject to both an internal review and external audits. There is also a formal appeals process for companies who wish to contest the inspection findings however, claims must be supported by clear scientific evidence.
Like the inspection of ports, the score for the inspection of establishments was hampered by the absence of written guidelines on conflict of interest. Respondents explained that conflicts of interest seldom truly affect the results of an inspection because inspections are conducted in teams of at least two individuals per site who undergo debriefing with a unit head and sign an inspection register after each inspection, thus no individual is the sole decision-maker. Written guidelines however, are necessary to ensure complete transparency as conflicts of interest can still exist in the presence of multiple checkpoints. Unless there are specific and comprehensive guidelines describing what constitutes conflict of interest and the process for controlling it, these conflicts will be addressed inconsistently or may even remain unaddressed, at the cost of transparency and accountability.
Inspectors at manufacturing sites are often presented with gifts from companies and there is an ill-defined demarcation between a "benign" offer of material goods and an attempt at inducement of an inspector by a company. Equally problematic is the fact that inspectors who visit manufacturing sites are transported there with vehicles from the company being inspected under what is referred to as a "partnership" with the companies. Not only is this a potential avenue for corruption, this poses a significant safety risk to the inspectors. Respondents have also indicated that it is not uncommon for inspectors to be impersonated. In addition, GMP guidelines are currently not publicly available but a committee is working on making them more accessible to companies being inspected.
The functions of the Inspectorate sometimes overlap with the Food and Drugs Department of the FMoH and the Pharmacists Council of Nigeria (PCN). The Inspectorate works with the Enforcement Directorate of NAFDAC to close down problematic sites including pharmacies. The PCN as the organization responsible for registering pharmacies used to have a major role in their inspection but NAFDAC has somewhat subsumed this responsibility and even has the right to shut down pharmacies. Respondents mentioned anecdotally that on some occasions, NAFDAC officers tend to be overzealous and have confiscated or destroyed legitimate drugs in addition to counterfeit ones. Some suggested that this was because not all officers are pharmacists and as such may not have detailed product knowledge.
Distribution of drugs received one of the highest scores with an average rating of 8.9 which indicates a low vulnerability to corruption. Distribution here refers to the movement of drugs procured by the government to the sites where they are needed (i.e. central medical stores, hospitals, etc.). The distribution of narcotics and psychotropic substances falls under the Narcotics and Controlled Substances Directorate of NAFDAC . Retail distribution of drugs to pharmacies and private and proprietary medicines stores is not as well regulated.
Inventory management models are adequate and are monitored regularly (usually weekly or at least monthly). Products are shelved according to therapeutic class and stock records are reconciled with physical counts weekly. Appropriate security management systems such as security personnel, restricted access to storage facilities, and monitored entry and exit of products are in place.
Audits are conducted yearly by the NAFDAC Internal Audit Unit, the Auditor General, and independent auditors. The system is monitored and evaluated on an ongoing basis by reviewing inventory records, return and disposal records etc. For vaccines, monitoring and evaluation is done quarterly by three parties: NAFDAC officials, UNICEF Vaccine Security Officers, and WHO Officers in each state. There is a fairly effective manual system to track the movement of drugs from warehouses to healthcare facilities, although the system may benefit from becoming computerized. Communication between distribution points is relatively effective, particularly given the popularity of GSM mobile telephones over the seldom functioning land lines in businesses, institutions, and government establishments.
Security management systems could be strengthened by technology like alarm systems for security breaches and video cameras to monitor storage areas. Monitoring and evaluation are hindered by unexplained high staff turnover rates at municipal levels and the lack of adequate equipment for telecommunication in certain rural areas. Coding of government drugs could also be improved - aside from the NAFDAC registration number that all government-approved drugs are given, there is no special designation assigned to drugs purchased by the FMoH.
Rural areas pose a big challenge to drug distribution. Many lack electricity, well-established telecommunication networks, and certain technology like generators to provide backup power supply and WHO recommended fridges for the storage of thermolabile medications. As well, equipment is poorly maintained once supplied. Fuel scarcity also hinders the ability to transport drugs to more rural locations in a timely manner.
The retail distribution of drugs has been described as chaotic  and is considered virtually unregulated. Pharmacies and private and proprietary medicines stores are able to procure drugs in bulk from local drug manufacturers . In addition, prescription and non-prescription drugs are sold on the open market . This creates an entry point for counterfeit medicines into the pharmaceutical market.