The key pieces of legislation and regulation that govern pharmaceuticals are:
Both the Food and Drugs Act (Chapter F32) LFN 2010 and the Food, Drug and Related Products (Registration) Act (Chapter F.33) 2010 regulate the manufacture, sale, advertisement and distribution of drugs in Nigeria. Meanwhile, the National Agency for Food and Drug Administration and Control (NAFDAC) Act Chapter (N1) LFN 2010 establishes the main regulatory agency (ie, NAFDAC) responsible for issuing marketing authorisations and product registrations for sale and distribution of imported and locally manufactured pharmaceuticals in Nigeria.
The Pharmacy Council of Nigeria (Establishment) Act 2022 regulates the sale and distribution of pharmaceutical products in Nigeria, however. It seeks to control the supply chain of pharmaceuticals and ensure the registration and regulation of premises where pharmaceuticals are sold and distributed, whether such sales are on a large-scale basis or for retail. The Pharmacy Council of Nigeria (Establishment) Act 2022 also establishes the Pharmacy Council of Nigeria (PCN), which is the regulatory agency responsible for the control and supervision of pharmacists, as well as the premises used for manufacture, distribution, and sale of pharmaceutical products in Nigeria.
To reinforce their regulatory oversight, both the PCN and NAFDAC have issued guidelines and regulations on the distribution, advertisement and importation of pharmaceutical products. These regulations include:
The legislation and regulation governing pharmaceuticals also govern medical devices. Thus, the PCN and NAFDAC are major regulators when it comes to medical devices. However, in addition to these regulators, legislation and regulation set up the Standards Organisation of Nigeria (SON), the Federal Competition and Consumer Protection Commission, and the Nigerian Nuclear Regulatory Authority (NNRA) under the Standards Organisations of Nigeria Act 2015, the Federal Competition and Consumer Protection Act 2018 and the Nuclear Safety and Radiation Protection Act 1995 respectively.
Although the SON is responsible for regulating the standards of medical devices, the Federal Competition and Consumer Protection Act 2018 seeks to protect the consumer from exposures from manufacturers. The National NNRA, however, regulates the use, installation and operation of medical devices that have radiation. This would include x-ray machines and MRI machines.
It is, however, crucial to note that NAFDAC remain the main regulatory authority for medical devices. To this end, NAFDAC has issued regulations and guidelines to control the distribution, sale, and distribution of medical devices. This would include:
The regulatory bodies that enforce pharmaceuticals and medical devices laws and regulations are as follows.
The SON, the PCN and NAFDAC are all semi-autonomous regulatory entities, given that they are supervised by the Nigerian federal government through the Federal Ministry of Health and the Federal Ministry of Trade and Investment.
Filing a Complaint
A party who is dissatisfied with the decision of a regulatory body is entitled to petition the same regulatory body for a review of its decision. It is not unusual for decisions by the major regulatory bodies that enforce pharmaceutical and medical device regulation – especially agencies such as the PCN and NADFAC – to be contested or challenged. The following procedure is generally used to challenge decisions by such regulatory bodies.
Petition or appeal to the regulatory body to review decision
First, an attempt should be made to seek a reconsideration of the regulatory body’s decision, outlining grounds for such petition or appeal. There is a statutory time limit of three months for challenging decisions of regulatory bodies; therefore, this petition or letter must be issued to the regulatory body within this timeline in order to avoid a situation where a party’s right to challenge an unfavourable decision is limited and exhausted by operation of law.
Pre-action notice to the relevant regulatory body
Most regulatory bodies that enforce pharmaceutical and medical devices regulations require a party challenging their decision to issue a pre-action notice as a precondition to the commencement of a court action or to seek judicial review. One such example can be found in the NAFDAC Act, which provides that a pre-action notice (or a written notice of intention to commence a suit) must be issued one month prior to the commencement of the suit. There is also a one-month timeframe in which to submit a pre-action notice where a decision by the PCN is to be challenged.
Court action for judicial review of the regulatory body’s decision
After taking the above-mentioned steps mentioned, a party is entitled to proceed to court in order to challenge the decision of the regulatory body. It is crucial to note that the court action must be filed within three months of the date of the decision of the regulatory body, or else the matter will be considered statute-barred.
There are different categories in place for medical devices and pharmaceuticals and this is reflected in the laws and regulations in force.
Categories of Pharmaceuticals
Pharmaceuticals are not specifically categorised in Nigeria. Although the NAFDAC regulates all types of drugs, the NAFDAC Drug and Related Products Advertisement Regulation makes separate provisions for the labelling and advertising of prescription medication. Such provisions differ from those for OTC medication.
Categories of Medical Devices
With regard to medical devices, NAFDAC has adopted the Global Harmonization Task Force (GHTF)’s guidelines – known as the Principles of Medical Devices Classification – for the international classification of medical devices. These classes include:
The higher the risk, the more stringent the regulatory requirements for such class will be.
In Nigeria, clinical trials for pharmaceutical products and medical devices are regulated under the Clinical Trial Regulations 2021, with NAFDAC as the supervising agency. NAFDAC is empowered to review protocols and grant authorisation of clinical trials before they are conducted.
However, the National Health Research Ethics Committee (NHREC) and the Institutional Review Board (IRB) are statutorily expected to provide ethical opinion, which is a precondition for the grant of NAFDAC’s approval of such clinical trials.
The procedure for securing authorisation to conduct clinical trials for pharmaceutical products and medical devices is governed by Clinical Trial Regulations 2021, the Good Clinical Practice Guidelines 2020, as well as the Guidelines for Clinical Investigation for Medicinal Products in the Paediatric Population.
The requirements for applying for approval to undertake a clinical trial are as follows:
Information on clinical trials is accessible to the public; therefore, their status may be ascertainable.
Clinical trial applications filed in Nigeria both for pharmaceuticals and medical devices can be accessed through NAFDAC’s Electronic Clinical Trial Application Platform. Along with the NHREC and the Federal Ministry of Health, NAFDAC also maintains the NCTR, which is accessible to the public. This registry provides information in ongoing as well as completed trials.
There is presently no restriction for using online tools to support clinical trials. for using online tools to support clinical trials under Nigerian legislation have not been updated.
However, in practice, NAFDAC and NHREC have associated online platforms used as a database for clinical trials, which they update with new information on the investigations and upload information peculiar to the trial.
Data resulting from clinical trials may not be considered as personal data under Nigerian law.
Per the provisions of Section 5(10) of the Clinical Trial Regulations 2021, rights of the participant to physical and mental integrity, privacy, and personal data during the clinical trial are protected. The protection of the participant’s data is at the frontier of the clinical trial such that the resulting data and other information made publicly available do not contain any information concerning participants that may be considered personal data.
Where the resulting data includes details that might identify the participants, it is classed as personal data. As such, it can only be published on obtaining the informed consent of the participant to use their personal data.
Transference of Data to a Third Party
In the same vein, such resulting data may be transferred to a third party or affiliate in accordance with the laws that protect such data.
Pursuant to Section 7(6) of the Clinical Trial Regulations 2021, any transfer of ownership of the content of the clinical trial must be documented and the new owner is to assume the responsibilities set out in the regulations. Likewise, Article 3.1(7)(f) of the Nigeria Data Protection Regulation (NDPR) 2019 provides that – prior to collecting personal data from a data subject (in this case, from the participant in the trial) – the data controller (in this case, the person/organisation that is running the study) must inform the data subject of:
Data resulting from clinical trials containing sensitive data may not be shared on the associated platform with third parties unless the participant consented to the use and transfer of their personal data.
By law, the creation of a database containing personal or sensitive data is subject to further protective requirements. Such a database must comply with the Clinical Trial Regulations 2021, as well as the provisions of the NDPR aimed at the protection of sensitive data of the data subject collected on a database.
A requirement of law, for instance, under Article 2.1(1)(I) of the NDPR is that personal data (applicable to the participant’s information used in the trial is collected and processed where consented to by the data subject (the participant in the study) – provided that further processing may be done for archiving, scientific research, or statistical purposes for public interest. Therefore, participants are required to consent to their personal data being uploaded onto a public data base. Section 3 (9) of the Clinical Trial Regulations specifies that the confidentiality of records that could identify subjects must be protected in order to respect their privacy.
In the determination and classification of pharmaceuticals and medical devices, the NAFDAC Act prescribed a number of specific requirements or criteria.
The NAFDAC Act defines a “drug” as any substance of vegetable, animal or mineral origin (or any preparation or admixture thereof) that is manufactured, sold, or advertised for use in:
On the other hand, a medical device is defined as “any instrument, apparatus or contrivance (including components, parts and accessories thereof) manufactured, sold or advertised for internal or external use in the diagnosis, treatment, mitigation or prevention of any disease, disorder, abnormal physical state or the symptom thereof” in humans or animals.
Therefore, products that fall within the scope of these definitions would be assessed and placed in such categories, if considered to be either pharmaceuticals or medical devices.
In Nigeria there are no specific obligations provided for granting marketing licences for biologic medicinal products. As such, the general obligations under the Guidelines must be adhered to.
However, it is to be noted that the National Control Laboratory for Vaccines and Other Biologics (NCLVB) is a specially constituted NAFDAC unit responsible for confirmation of the quality, safety, efficacy and fitness for use of vaccines, biological products, and medical diagnostic devices after analysis/evaluation. This unit may therefore recommend restriction on the marketing of specific biologics based on the review of same.
The NAFDAC Drug and Related Products Registration Regulations 2019 provides that the registration of a drug with NAFDAC will be valid for a period of five years.
Mechanisms for Renewal of Marketing Authorisation
Under the NAFDAC Drug and Related Products Registration Regulations 2019, such marketing authorisations may be renewed. The NAFDAC has published further Guidelines for Renewal of Certificate of Registration for Locally Manufactured Drug Products in Nigeria, in addition to Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria. These guidelines set out the mode of renewal and cover the nature of the application and the supporting documents required – for example, annual licence/premises registration, trade mark registration, Certificate of Pharmaceutical Product (COPP–WHO Format), and notarised declaration. Similar provisions are found in the Guidelines for Renewal of Certificate of Registration for Medical Devices Made in Nigeria, as well as Guidelines for Renewal of Certificate of Registration for Imported Medical Device in Nigeria.
All the above-mentioned guidelines provide that application for renewal must be initiated no later than 30 calendar days before the date the current/valid licence is due to expire. Successful renewal applications for drugs and medical devices, whether locally manufactured or imported, will result in the issuance of a Certificate of Registration with a validity period of five years.
Circumstances in Which Marketing Authorisations May Be Revoked or Withdrawn
Pursuant to Section 7 of the Drug and Related Products Registration Regulations 2019, marketing authorisation may be revoked or withdrawn by competent authorities on the following grounds:
The regulations further provide that, where the registration of drug product is suspended or cancelled, NAFDAC must then withdraw the drug product and cancel it from circulation.
In practice, there is a standard procedure for obtaining marketing authorisation for drugs and all regulated products. Pursuant to the Drugs and Related Products (Registration) Regulations 2019, a drug cannot be imported, distributed, or sold without being registered by NAFDAC.
According to the regulations, a marketing authorisation may be granted through a single application process, as follows.
According to the Guidelines for Registration of Drug Products Made in Nigeria, the procedure for obtaining authorisation entails the following steps.
Procedure for Variation of a Previously Granted Marketing Authorisation
There is a standing procedure for varying a marketing authorisation previously granted by an application to NAFDAC. According to the Drugs and Related Products (Registration) Regulations 2019, such variation can only be made where the product has been previously authorised.
The procedure for variation of a marketing authorisation that has been granted previously begins with the applicant submitting a variation application to NAFDAC with details of the changes to be carried out. This is accompanied by the prescribed fees per the request of NAFDAC. The further requirements depend solely on the type of change requested for.
Such change may be made by:
The applicant who is deemed to hold the Certificate of Registration must not distribute the product until the variation to the authorisation has been assessed and approved by NAFDAC and the product label reflects the change where necessary. However, changes that do not adversely affect the quality of the drug may be made prior to approval by NAFDAC.
Pursuant to Section 6 of the Regulations, the applicant must seek a new application where the variations to be made fall under the following categories:
Transference of Marketing Authorisation
The position of the law on the transference of marketing authorisation is outlined in the relevant NAFDAC laws and regulations.
Pursuant to Section 2(3) of the Drugs and Related Products (Registration) Regulations 2019, once a certificate of registration has been issued, it cannot be transferred, disposed, hired or sold to a third party unless approved by NAFDAC.
Although the guidelines make no recommendation for the appropriate procedure, in practice it may be achievable by applying to NAFDAC with supporting documents.
Section 2 of the Drugs and Related Products (Registration) Regulations 2019 expressly prohibits the sale and distribution of regulated products that are not registered with NAFDAC. This implies that the product must be issued a Certificate of Registration before it can be distributed in Nigeria.
However, Section 2(2) of the referenced regulations allows exceptions and provides that NAFDAC may issue the permits to allow the supply or entry/importation of drugs for the purpose of registration (limited quantity). The exception would also be applicable for the conduct of a clinical trial, a service drug scheme, and for any use in emergency situations resulting from epidemics or disease pandemics, donation for humanitarian interventions, and so on. This exception was explored during the COVID-19 period, during which vaccines were allowed entry for humanitarian reasons owing to the pandemic.
Pharmacovigilance of Pharmaceuticals and Obligations Imposed on the Marketing Authorisation Holder
In regulating and assessing the quality of products, NAFDAC has paved the way for post-marketing surveillance/pharmacovigilance that imposes certain obligations on a Marketing Authorisation Holder (MAH).
For pharmaceutical products, the NAFDAC Good Distribution Practices Guidelines for Pharmaceutical Products outlines the recommendations and principles guiding the distribution of pharmaceutical products in Nigeria. The guidelines highlight the responsibilities of the distributor as endowed by the authorisation issued by NAFDAC.
As imposed by the guidelines, distributors or their agents can only supply pharmaceutical products to those authorised to sell or distribute such products to patients. Such authorisation must be approved and valid before the Marketing Authorisation Holder (MAH) distributes accordingly. Likewise, the guidelines make provisions for a quality management system so that the activities carried out by the distributors and MAHs are compliant with GMP principles.
In the same vein, once MAHs have been issued with a marketing authorisation, they may be subject to post-marketing obligations to ensure that quality goods are distributed accordingly – hence pharmacovigilance of medical devices, pharmaceuticals and regulated products.
Through the Guidelines for Post-Marketing Surveillance in Nigeria, NAFDAC has made express provision for pharmacovigilance of pharmaceutical products and the necessary steps and considerations to be taken.
Under the guidelines, post marketing surveillance (PMS) planning involves international organisations, procurement organisations, NGOs, MAHs or other persons involved in the distribution of products. As with the MAHs, they must all be adequately trained in the requirements of PMS prior to commencing PMS tasks. As a prerequisite, the training must be based on written standard operating procedures (SOPs). This is mandatory, given that MAHs are obliged to comply to such post-monitoring activities.
During the PMS planning stage, among other things, the quality of the products must be considered. Likewise, the system of distributing and supplying the target medicine is sorted and reviewed to reflect the quality desired. The patient’s exposure to the products is also considered and the effects thereof. The mode of carrying out the pharmacovigilance is also considered in the planning stage.
Pharmacovigilance of Medical Devices and Obligations Imposed on the Marketing Authorisation Holder
On the other hand, pharmacovigilance of medical devices is much more straightforward. The holder may be required to carry out passive and active pharmacovigilance. Passive surveillance calls for manufacturers or MAHs to submit reports to the National Pharmacovigilance Centre (NPC) on adverse events that may occur in carrying out post-monitoring activities.
Active surveillance or pharmacovigilance uses proactive measures to detect and report on adverse events resulting from medical devices authorised for distribution – for example, active follow-up of patients who subsequently used such medical devices, recording of medical events or occurrences, and so on. It may be done prospectively or retrospectively.
Circumstances in Which Obligations May Be Imposed on Marketing Authorisation Holders
There is no express provision in the guidelines regulating pharmaceutical products that allow for specific circumstances in which such obligations are imposed when granting marketing authorisations. However, MAHs and importers and distributors of medical devices are mandated to report to the NPC if certain events occur in which:
The status of third-party access to applications for market authorisation under NAFDAC laws is not apparent.
However, in reality, NAFDAC has executed agreements with each of its staff on the issue of confidentiality. Such agreements, which are contained in the NAFDAC Confidentiality, No Conflict of Interest, Code of Conduct Agreement Form stipulates that information obtained and treated in the course of their duties is to be treated as confidential. The agreement also mandates that “clients” of NAFDAC shall be notified ahead of any disclosure of such confidential information.
This is also mirrored in practice, where access to the records of registration and application are treated as being confidential and not easily accessible by the public.
The legislation and procedures against falsified and illegally distributed medical devices are outlined here.
First, Section (1)1 of the Food, Drugs and Related Products (Registration, etc) Act proscribes import, export, advertisement, sale, or distribution in Nigeria of unregistered drugs and devices. Section 6 of the Act also imposes a fine of NGN50,000 or imprisonment for up to two years (or both) where an individual violates this provision. However, where the offence is committed by a company, the fine is NGN100,000 and the key persons in such organisations would also be individually liable.
Furthermore, by virtue of Section 25 of the NAFDAC Act, if any person contravenes the provision of the Act, the person would be guilty of an offence and liable on conviction to the penalties specified in the regulations.
NAFDAC Drug and Related Products Advertisement Regulations 2021 provides that, if a regulated product is advertised without authorisation, the manufacturer may be liable to sanctions. Where advertised with the knowledge of an officer of the manufacturing company or any person acting in that capacity, they may be severally and jointly liable on conviction to a fine of NGN100,000. The Advertising Regulatory Council of Nigeria Act creates further penalties for broadcasting unauthorised adverts.
The Guidelines for Procurement and the Management of the Mobile Authentication Service (MAS) Scheme in Nigeria 2018 was put in place to combat against falsified medical products.
There are a number of measures to tackle counterfeit pharmaceuticals and medical devices that are worth noting.
Primarily, the Counterfeit and Fake Drugs (Miscellaneous Provisions) Act prohibits any counterfeit or fake drugs from being distributed, imported, manufactured or sold within Nigeria. A similar provision is also found under the Food, Drugs and Related Products (Registration, etc.) Act.
In addition to the above, NAFDAC has adopted the introduction of hand-held devices used for on-the-spot detection of counterfeit medicines. It allows law enforcement agents to conduct screening on sight to identify counterfeits.
In reality, there is significant collaborations between the Nigerian Customs Service as well as the NAFDAC in the implementation of border measure to combat fake and unregistered regulated products.
Primarily, the NAFDAC Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria provides that manufacturing facilities must be inspected and in compliance with GMP and an authorisation to manufacture pharmaceutical products must have been issued by NAFDAC.
NAFDAC approves the manufacture of medicines and related products before consumer use. Per its directive, Good Manufacturing Practice Guidelines for Pharmaceutical Products 2016 regulates the manufacture of these products, and NAFDAC Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria grants authorisation.
Furthermore, the SON has a general mandate to regulate local manufacturing in Nigeria. In furtherance of this, manufacturers of pharmaceutical products are to be authorised by this agency.
Procedure for Obtaining Authorisation of Manufacturing Plants
The NAFDAC Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria prescribes the following procedure that must be undertaken in order for manufacturing plants to obtain authorisation.
In addition, self-inspection is included in NAFDAC’s Guidelines on Good Manufacturing Practice, so as to monitor whether the manufacturers are compliant with the principle in GMP and to make necessary corrections.
For medical devices in Nigeria, wholesalers are held accountable for activities that relate to wholesale. Only co-ordinated wholesale centres (CWC) granted authorisation by NAFDAC may sell and distribute their products.
In the same vein, wholesalers of pharmaceuticals are restricted from selling and distributing their products in wholesale centres unless approved or granted an authorisation by the PCN, which regulates and controls pharmacies and the movement of pharmaceutical products.
Procedure for Obtaining Authorisation for Medical Devices
Wholesale centres may be granted authorisation to engage in wholesale activities in Nigeria by the guidelines and regulations on wholesale.
Since the regulations are non-specific about obtaining authorisation for wholesale distributors of medical devices, the due process for granting a marketing authorisation follows suit.
Procedure for Obtaining Authorisation for Pharmaceuticals
However, for pharmaceutical products, the guidelines posit that CWCs may be granted a permit to sell products by applying to NAFDAC.
According to the procedure stipulated, the applicant may apply for the premises of the wholesale centres to be granted an authorisation by a PCN application form for registration of premises (Form B). Such application must contain the number of premises (not less than 200 centres) and prohibit street trading within the centres.
The application is submitted to the registrar of the PCN with other documents supporting documents/information as prescribed by the PCN. Some of the documents include:
Activities Approved by the Authorisation
The activities approved by the authorisation of medical devices are such that, where granted, pharmaceuticals and medical devices may be sold within or to a country or territory.
For pharmaceuticals, the authorisation enables wholesale centres to sell medicines. However, other provisions may extend the authorisation to food vendors and banks.
Period of Validity of Marketing Authorisation for Wholesalers
There is no standing validity period applicable to wholesalers provided by the regulations. However, a marketing authorisation is valid for five years and may be renewed upon expiration.
Although the NAFDAC Act is unclear on the classification of pharmaceuticals, some guidelines (including the Drug and Related Products Advertisement Regulations 2021) distinguish between prescription medication and OTC products.
Laws Governing Importation and Exportation of Medical Devices
In Nigeria, Guidelines for Registration of Imported Devices in Nigeria provides for the necessary measures taken in importing medical devices. The application will pass through the following five stages.
Laws Governing Importation and Exportation of Pharmaceuticals
A registered pharmacist may apply to import pharmaceuticals once they have completed the National Youth Service Corps (NYSC) programme and presented a discharge certificate to that effect.
The registration is done by a single application process. The applicant must submit an application form (Form B) to the registrar of the PCN through the Director of Pharmaceutical Services in the state where the pharmacy is to be operated.
Alongside the application letter, the applicant must submit the following documents:
Governmental Agencies Enforcing Import Rules
Some of the governmental agencies responsible for enforcing import rules in Nigeria include:
Only a company duly registered in Nigeria is permitted to import pharmaceutical products into Nigeria. Therefore, a foreign company seeking to import drugs into must either set up a Nigerian entity for this purpose or appoint a pharmaceutical company incorporated in Nigeria as its agent for the importation of same. The pharmaceutical company must also comply with the Pharmacy Council of Nigeria (Establishment) Act 2022.
Requirements to Act as an Importer of Record
There are a number of requirements that a company must fulfil before it can be authorised to import pharmaceutical products. These include:
The importation of pharmaceuticals and medical devices are subject to prior authorisation. Such regulated products cannot be imported without authorisation, according to the Drug and Related Products Registration Regulation. The application process is specified under the Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs) and Guidelines for Registration of Imported Drugs, as well as Guidelines for Registration of Imported Medical Devices into Nigeria.
Non-tariff restrictions are imposed upon importation of goods in Nigeria. However, existing non-tariff measures are not specific to medical devices and pharmaceuticals. The issuance of import permits has been made a prerequisite for food, drugs, and other products to be imported into Nigeria so that manufacturers and distributors alike cannot import their products without such authorisation. This applies to all entities – foreign and local – regardless of origin.
There are requirements that must be met before issuing import permits and it may be peculiar to the type of product. In order to import pharmaceuticals into Nigeria, one must apply according to the procedure provided under the Pharmacy Council of Nigeria (Establishment) Act 2022, which requires the applicant to submit an application form to the registrar with related information as prescribed by the PCN. Upon satisfying these requirements, the PCN then issues an import permit that will allow the premises to import goods.
Likewise, NAFDAC issues import permits for regulated products in Nigeria. The due process is outlined according to the Guideline for Approval to Import Products by Government Agencies, International Bodies and Multinational Organisations (including documents needed for the application). Once approved, the permit subsists until December 31st every year and may be renewed on January 1st of the following year.
In order to import laboratory and industrial chemicals into Nigeria, the Guidelines for Issuance of Permit to Import Laboratory and Industrial Chemicals prescribe the requirements and supporting documents involved in applying to NAFDAC for an import permit.
Import permits are also issued by the SON. Under the Nigeria Conformity Assessment Programme introduced by the SON, certain imported products must meet the requirements before importation into Nigeria. The SON may issue a SONCAP certificate for goods to be imported, forming a prerequisite for entry and clearance of imported goods. However, this does not extend to food, drugs, medicine, and medical devices, as the SON has other regulations that cater to those products.
Mode of Restricting Goods Imported
Goods are also prohibited from being imported according to the import prohibition list, which makes provisions for the different classes of goods and products that are not granted entry to Nigeria – thereby alerting distributors and manufacturers in this respect.
The list includes medicaments under Headings 3003 and 3004, which specify the kind of drug products prohibited (eg, penicillin/gentamycin ointments, aspirin tablets, levamisole tablets and syrups).
Likewise, the prohibition list separates some goods based on HS Codes. This is a standardised method used in identifying the traded products – ofr instance, under the list, live or dead frozen poultry have HS Codes 0105.1100-0105.9900, 0106.3100-0106.3900, 0207.1100-0207.3600 and 0210.9900.
In addition to the foregoing, some variation of a product may be exempted. By way of an example, bird eggs are prohibited from importation, with the exception of hatching eggs.
Laws and Regulations Indicating Goods Prohibited from Importation
Primarily, the Customs and Excise Management Act (CEMA) provides for an import prohibition list banning the import of different product categories, with the aim of promoting local industries and the health and safety of Nigerians. The CEMA regulates the goods imported and exported in Nigeria and enforces rules and regulations to this effect.
Besides the import prohibition list, the CEMA further restricts other goods from being imported permanently under Schedule 4 of the Act, such that Customs may enforce its authority as granted under the Act to prevent any activity inconsistent with the provisions as instilled. Some of the goods absolutely prohibited include air pistols, counterfeit or pirated materials, indecent articles or paintings, cowries, second hand clothing, and so on.
Nigeria is a member of the African Continental Free Trade Area (AfCFTA) and accordingly can take the benefit of the trade facilitation provisions therein. The AfCFTA, as created by the African Continental Free Trade Area Agreement on Trade Facilitation, is focused on customs and trade facilitation and aims to ensure free movement of labour, goods and services. It helps to increase profit and contributes to the development of the manufacturing sector.
Nigeria’s involvement is predicted to promote business collaborations with other African countries. The Central Bank of Nigeria is heavily involved in the AfCFTA as stakeholders, unifying the vision for the trade agreement across all sectors.
Nigerian law does not expressly permit the regulation of pricing for pharmaceutical and medical devices. However, the Federal Competition and Consumer Protection Act 2018 prohibits the fixing of a minimum price for resale of goods and services, except in cases of a patent licence.
There are no standing provisions inferring that the price level of pharmaceuticals and medical devices is dependent on the price in foreign countries.
In order to mitigate cost and facilitate the accessibility of expensive pharmaceuticals and medical devices in Nigeria, the government has deployed public funds as a means of reimbursing such cost as envisaged in its laws.
For instance, the National Health Insurance Authority Act 2022 (the “NHIA Act”) addresses healthcare services for Nigerians by mitigating health expenditure for children, pregnant women, physically and mentally challenged Nigerians, or other indigents under the Vulnerable Persons Scheme.
Specifically, Section 11 of the NHIA Act covers healthcare services for indigent and poor persons by the Basic Health Care Provision Fund, which is funded by the consolidated revenue fund of the federal government. This is particular to indigenes who fit the category under the Basic Health Care Provision Fund.
In addition to this, the NHIA Act also makes provisions for states in Nigeria to establish a contributory scheme to maintain health insurance for its citizens. It may be inferred from this law that the cost of medical or pharmaceutical devices incurred by a citizen will be reimbursed through the funds in the scheme. The NHIA Act was passed recently and, as such, its applicability can only be determined after a period of time.
However, the bearing of cost by the government is not exclusive to these circumstances, as it may apply:
Cost-benefit analysis has yet to be applied when determining the price for medical devices and pharmaceuticals in Nigeria. This is because, notwithstanding the overall legal framework in place, Nigeria is yet to make laws and legislation concerning the pricing of medical devices and pharmaceuticals.
The Code of Ethics for Pharmacists mandates dispensing pharmacists to refrain from dispensing drugs that may endanger the patient. A pharmacist should also not dispense drugs to a patient if they believe it is not necessary for the patient to use the drug. The code is enforced by the Pharmaceutical Society of Nigeria.
There are specific rules for medical apps. The PCN’s Online Pharmacy Regulations 2020 is the extant law on medical applications, and it covers the extent to which medical apps are accessed via the internet.
The Online Pharmacy Regulations 2020 did not define “medical devices” and “medical apps”. However, medical devices cover a wide range of medical equipment, whether used online or offline. Thus, medical apps may be considered as medical devices. However, not all medical devices are medical apps, as not all medical devices can be accessed online.
Medical devices have been defined as any instrument that is produced or sold ‒ whether internally and externally ‒ for the diagnosis or treatment of a disease in humans or animals. Thus, where a medical app is used for any of the foregoing, it may be considered a medical device.
According to the Rules of Professional Conduct for Medical and Dental Practitioners in Nigeria, telemedicine is recognised in professional practice in Nigeria and seen as an opportunity to include computer and telecommunication technology in the medical profession. Telemedicine aids the process of requesting and practising medicine at a distance.
As a result of telemedicine, physicians and those who provide medical attention may do so electronically and manage patient care effectively. This is not restricted, as there is room for specialist consultation and any form of medical attention sought out through the web across various industries and fields of medicine and dentistry.
In addition, specific conditions and criteria are deemed necessary to improve telemedicine in Nigeria. Section 22 of the Code of Medical Ethics expressly provides that – in order to avoid legal action –registered practitioners bear full responsibility for ensuring they act in compliance with rules on the following matters:
In the same vein, the Code of Medical Ethics emphasises specific rules to be followed when processing data electronically. Practitioners must ensure that personal information is secure. This includes any information/data stored on a database and sent or received by fax, computer, email or other electronic means. Likewise, the security of the information must be ensured before connecting to a network.
The regulations also provide that practitioners must ensure that data sent is not accessible to any party other than the intended recipient. They should also be informed about the likelihood of their emails being intercepted by internet hackers.
The same is envisaged in the NDPR, which provides for the electronic processing of patients’ data to be carried out only with the consent of the patient. Article 1.3 of the NDPR sheds light on consent of the data subject (the patient in this instance) as an indication that the patient agrees to the processing of their personal data. Personal data in this context includes health-related information of the patient, which must be stored and sent with their informed consent.
Likewise, Article 2.6 of the NDPR entails that extra security measures must be taken in the electronic space to protect personal data of the patient – for example, setting up firewalls, restricting access to only authorised persons, data encryption, and other measures for handling patients’ data.
There are special rules guiding the advertisement of medical devices on online platforms. These rules are the NAFDAC Drug and Related Products Advertisement Regulations 2021 and the PCN’s Online Pharmacy Regulations 2020.
The Drug and Related Products Advertisement Regulations 2021 provides that, after obtaining the Certificate of Registration, an application for advertisement approval must be submitted to NAFDAC. Both regulations provide that only medicine that can be bought without a prescription can be advertised publicly, meaning that only OTC should be advertised online publicly (see 8.5 Online Sales of Medicines and Medical Devices).
For adverts on online portals, the applicant may be required to submit the script, artwork and storyboard used in the advertisement. The same applies for any publication on radio, print, by SMS or pre-recorded messages.
Also, the Online Pharmacy Regulations 2020 makes regulations for pharmaceutical service providers who are based online. This covers all registration requirements but, specifically, makes provisions for granting licences. According to the regulations, online pharmaceutical service providers must be registered with the PCN.
Pursuant to Section 2, such licence is applied for by an application letter to the registrar of the PCN through the superintendent pharmacist in charge of online pharmaceutical services. The application is submitted with the documents/related information prescribed by the PCN. Some of these documents include:
In addition, once granted, the licence may subsist for a year such that it expires on December 31st every year and may be renewed on January 1st the following year.
Electronic prescriptions are allowed and regulated in Nigeria. Section 11 of the PCN’s Online Pharmacy Regulations 2020 provides that pharmaceutical service providers may dispense prescription-only medicines (among others) electronically. Such pharmaceutical service providers are internet-based and must do so within the confines and provisions of the regulations and subsidiary legislation.
According to the regulations, a system must be put in place to ensure that the prescription orders for drugs are legitimate. Likewise, there must be a system to regulate the validity of the prescription from a professional before it is dispensed.
In addition to the foregoing, the regulations restrict prescribing drugs based on telephone or online medical consultations as it may be difficult to authenticate their validity. This extends to restricting the quantity of prescribed drugs that can be ordered or sold online.
Online sale of medicines and medical devices is permitted in Nigeria, subject to the provisions of the law. The PCN’s Online Pharmacy Regulations 2020 provides that, in the online sale of medicines, the following requirements must be complied with:
The law also makes a distinction between prescription and non-prescription drugs, whereby it provides that only non-prescription drugs should be sold or prescribed online. Prescription drugs are drugs that are considered safe and effective when used under the care and instructions of a doctor. Non-prescription drugs, such as OTC medication, can be used with or without the prescription of a doctor.
As mentioned in 8.3 Promoting and/or Advertising on an Online Platform, pursuant to Section 12(2) of the Drug and Related Products Advertisement Regulations 2021, prescription drugs are prohibited from being advertised through television, radio or any online media. They are only advertised in scientific journals, health newsletters strictly accessed by professionals, and other means as approved by NAFDAC.
There are no express electronic health laws in Nigeria. However, there other relevant provisions that address the subject matter. Health records, like any other records of personal or sensitive data, are regulated under the NDPR
Of course, medical personnel utilising electronic health records continue to be bound by duty of confidentiality, as well as the duty to secure medical records under the Medical and Dental Practitioners Act and The Code of Medical Ethics in Nigeria (Rules of Professional Conduct for Medical and Dental Practitioners).
Regulation of Health-Related Information as Sensitive Data
Notably, the regulation of health-related information as sensitive data depends on the importance of the data. The NDPR defines sensitive personal data as any data relating to religious or other beliefs, health, race or ethnic background, sexual orientation, and political views. Thus, health-related information is classed as sensitive data in Nigeria.
The National Health Act 2014 also provides that the health records must be kept safe by the holder in order to prevent any authorised access. This implies that health records are considered sensitive. Thus, health-related information that reveals personal data will be classed as sensitive.
Stricter Regulations for Health-Related Information
Health-related information is often subject to stricter regulations, as it qualifies as sensitive personal data. Such stricter regulations may include the need to conduct a Data Protection Impact Assessment (DPIA). According to NITDA regulations, the holder of such health-related information may request the submission of such DPIA or mandate the appointment of a Data Protection Officer (DPO).
Special Requirements for Cloud Platforms
There are presently no special laws on the transfer and storage of sensitive data of patients on cloud platforms.
The NDPR, however, considers sensitive personal data to be of a critical nature and therefore special requirements apply. Before such personal sensitive data can be transmitted to cloud, the cloud platform must comply with the requirements for handling personal sensitive data as outlined in the NDPR (eg, collection of data, using the data for the purpose for which it was obtained, and appointment of DPO).
Transfer and Storage of Sensitive Data of Patients on Cloud Platforms
There are presently no special laws on the transfer and storage of sensitive data of patients on cloud platforms. Nevertheless, under the NDPR Regulations 2020, the data controller must ensure that the sensitive data of patients is transferred to cloud platforms and stored in line with the NDPR.
The Draft National Cloud Computing Implementation Strategy is an indication that a proper legal framework specifically designed for cloud computing will soon be established.
Patent protection in the pharmaceutical and healthcare industry is not lost in thought as it is duly regulated and managed in Nigeria. The Patents and Designs Act 1971 is the legal framework for patent-related matters such as registration, procedural steps for application, and so on.
The National Office for Technology Acquisition and Promotion Act assists in the filing of patent and innovations only applicable to government-funded research, as well as in the private sector.
Nigerian legislation on patent has some shortcomings in terms of pharmaceuticals and medical devices, including that:
There are also no specific requirements for patents for pharmaceutical and medical devices in Nigeria.
In Nigeria, second and subsequent medical uses of a known product are generally unpatentable in respect of product patents, as such patent would not be considered novel. Patents are granted for either inventive activities or improvements in either products or processes. Under the Patents and Designs Act 1971, an invention results from inventive activity “if it does not obviously follow from the state of the art, either as to the method, the application, the combination of methods, or the product that it concerns, or as to the industrial result it produces”. This is clearly not the case with second and subsequent medical uses of a known product.
Nonetheless, this may apply where known product is used in respect of a “novel process”. Processes are also the subject matter of patents and, as such, the patentability of second medical uses of a known product may be explorable under this regime. This is yet to be tested, however.
As regards the infringement of second and subsequent patents of pharmaceutical products, there is no express provision on second patentability of drugs.
Currently, the Nigerian patent laws do not provide for term extension for pharmaceuticals. The 20-year lifespan of a patent is sacrosanct, subject of course to the payment of annuity.
Pharmaceutical or medical device patent infringement entails the reproduction and exploitation of the subject matter of the patent. This would include making, importing, selling, or using a product or stocking the pharmaceutical or medical device for sale or use without the approval, assignment or consent of the owner of the patent right.
Seeking a marketing authorisation does not strictu sensu amount to patent infringement. However, the plaintiff may be entitled to explore a qua timet action through patent infringement action in order to prevent the issuance of such authorisation that would result in infringement.
The threat of infringement may be actionable under a qua timet action. The court may grant the patentee a quia timet injunction upon application in order to prevent such threatened infringement from occurring.
Although the Patent and Design Act 1971 does not make specific requirements for a threat of infringement in the case of imminent infringement, a party may fall back on the equitable relief of a quia timet injunction. To be entitled to such a relief, a party must prove:
There are no specific defences to patent infringement of medical devices and pharmaceuticals. However, under the law, general defences are available to a party that has allegedly infringed a patent right, including:
Compulsory Licences for Pharmaceuticals and Medical Devices in Nigeria
There is a compulsory licensing regime under the Patent and Designs Act 1971, which allows a party to seek the compulsory licensing of patents that have not been worked to the benefit of economy.
The Patent and Designs Act 1971 provides the requirements for issuance of compulsory licenses either by the court or by an order of the Minister in the Federal Gazette. Where leave to obtain a compulsory licence is made through the court, the Patent and Designs Act 1971 provides that the applicant must show to the court that:
Where the request for compulsory licences is made to the Minister, it is expected that the Minister will have issued a declaration stating patented products and processes that may be subject of compulsory licences and the Minister may permit importation or exploitation of the subject matter of such products.
Under the Patent and Designs Act 1971, the patentee may bring proceedings for patent infringement. Likewise, a patent licensee may do so in circumstances where:
Remedies Available for Patent Infringement
Under patent law in Nigeria, the following remedies are available to the plaintiff:
Procedure for Patent Infringement Actions
The action for infringement typically goes to trial after service of documents and processes according to a procedure that entails the following steps.
Patent Invalidity as a Defence
The invalidity of a patent may be raised as a defence by a defendant to an action for patent infringement. Such defendant is entitled to raise it in the Statement of Defence and file a separate petition for nullification of such patent. Said petition may be consolidated within the action for infringement to the extent that, if the court finds that the patent was invalid, the court action for infringement will be dismissed.
A generic product to be launched and potentially distributed would be allowed market entry in accordance with the NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products. However, based on the current case law, there is no requirement for pre-launch action to “clear the way”.
There is a procedure in place for obtaining marketing authorisations in Nigeria under the guidelines. However, unlike the requirement for confirmation of trade mark ownership, the rules do not require a similar confirmation that the applicant is the patent holder or duly licensed.
Other than IP laws, there are other regulations and laws in place that may be utilised to combat counterfeiting of pharmaceuticals and medical devices in Nigeria. Some of these regulations and legislations include:
Under Nigerian law, the general restrictions that apply to other products may apply to medical devices and pharmaceuticals. These restrictions include the following:
Specifically, Section 12 of the Trade Mark Act proscribed the registration of a single chemical element or single chemical compound as a chemical or preparation.
Restrictions on Importation of Pharmaceuticals or Medical Device Products From Other Countries
Nigerian trade mark laws do not expressly prohibit parallel importation. However, it has been noted that parallel importers often violate trade mark laws with regard to disclosures as to country of origin, labelling, etc. Parallel imports are therefore dealt with for violation of such laws.
Furthermore, when a drug is to be imported into Nigeria, one of the requirements for the processing of NAFDAC registration is that an importer obtains power of attorney from the manufacturer. By requiring such power of attorney before registration for the purposes of importation, NAFDAC whittles down the likelihood of parallel importation.
The Business Facilitation and Miscellaneous Provisions Act 2022 provides that the trade dress (packaging), shape and design of a trade mark is protected. The Patent and Designs Act 1971 also protects the trade dress or trade design of a product, which may extend to a medical or pharmaceutical device.
The trade mark or patent of a pharmaceutical and medical device covers its trade dress (shape, colour and commercial look) to the extent that, once such device has been registered, it will enjoy all the trade mark protection guaranteed under the Trade Mark Act and the Patent and Designs Act.
This protection is also available under the common law of passing off. Passing off is a tort that prevents a manufacturer from misrepresenting goods or services as that of another. This avails a party even where the trade mark is not registered.
Data exclusivity is essential to legal practice as well as the protection of medical devices and pharmaceuticals.
Although there is no specific provision for protecting data gathered for pharmaceuticals and medical devices in Nigeria, Section 3 of the Food, Drugs and Related Products (Registration) Act provides that information disclosed while applying for registration to NAFDAC cannot be shared without the written consent of the person who supplied the information or unless instructed by NAFDAC or for the purpose of a proceeding. This applies both to medical devices and pharmaceuticals in Nigeria.
Difference Between Chemical Drugs and Biologics
There is a notable difference between chemical products and biologics.
Under Section 18 of the Chemical and Chemical Products Regulations 2020, “chemical products” refers to a substance formed by a chemical reaction to yield one or more products such as cleaning chemicals, paint, adhesives, wood preservatives and polishers, and agrochemicals.
In contrast, although NAFDAC Act does not define biologics, it refers to products derived from living cells or animal tissues – thereby differentiating them from chemical products, which are formed from chemical solutions.
As a result of the COVID-19 pandemic, the commercialisation and distribution of medicines was handled differently. The following special regulations or guidelines were issued in relation to the commercialisation or distribution of medicines and medical devices in order to respond to the COVID-19 crisis.
The applicability or enforcement of rules on the commercialisation and distribution of medicines in Nigeria was not relaxed. It was enforced by responsible agencies of the Nigerian federal government.
Special measures were employed to regulate clinical trials in Nigeria. NAFDAC issued the Clinical Trial Regulations 2021 to provide clarity and purposeful measures in relation to ongoing clinical trials. With regard to specific matters, Section 3(16) made provision for investigations by NAFDAC into the trial sites and facilities to be used in order to ensure they meet the standard required under the regulations.
The regulations also catered to the rights of the participants in the trial. Section 5 provides that the investigator must inform the participant on all due processes and aspects of the trial to be conducted (including the review of the participant by the Ethics Committee) and that this must be done prior to the participant’s involvement in the trial.
Special Regulations Issued in Relation to COVID-19 Treatments or Vaccines
NAFDAC issued special regulations in relation to COVID-19 treatments, including Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 Vaccines 2020. This included the requirement for external review of the marketing authorisations granted to manufacturing plants – a deliberate provision that caters to COVID-19 vaccine applications. NAFDAC also released guidance notes to sponsors of clinical trials during the COVID-19 pandemic as part of the procedure.
Certain protocols were updated following the emergence of COVID-19 and other regulations were set in order to facilitate emergency approvals for medical devices and pharmaceuticals needed for the cause.
On record, NAFDAC allowed emergency approvals of pharmaceutical and medical devices via a circular dated 9 April 2020. This regulatory pathway was created specifically for COVID-19.
The pathway provides that such emergency approval must meet with the following criteria:
There were no specific instances where NAFDAC was flexible in granting certifications to manufacturers owing to the COVID-19 pandemic. However, NAFDAC granted the emergency conditional use of COVID-19 vaccines through Emergency Use Authorisations, which simplified the bottlenecks for authorising vaccines needed to prevent COVID-19 in people over the age of 18.
Some import restrictions were set in place for medical devices following the COVID-19 pandemic. On 24 March 2020, the federal government of Nigeria introduced an import duty waiver on medical equipment, medicines, personal protection equipment, and other medical necessities required for the treatment and management of COVID-19 in Nigeria effective from 1 March 2020 until 31 December 2020.
There were import restrictions in relation to medicines and medical devices during the COVID-19 as a result of the national and global lockdown. Nigeria could not produce medicines for export, even though most of the drugs were imported.
Digital healthcare forms an integral part of the healthcare industry and this was made more practical as a result of the COVID-19 pandemic. However, the Nigerian authorities appear not to have adopted any measures to facilitate digital health innovation or digital transformation.
Notwithstanding the measures taken to adapt to the COVID-19 pandemic, the Nigerian government has not announced any intention to issue compulsory licence for Covid-19-related treatments or vaccines. However, the Nigerian Patent and Designs Act 1971 allows the Minister to issue compulsory licences for patented products declared to be important for public health. A compulsory licence may also be granted by a court upon application by an interested party/entity.
Liability exemptions regarding COVID-19 vaccines were not adopted in Nigeria.
There existing provisions for granting authorisation to manufacturing sites were adapted in response to the COVID-19 pandemic. However, no clear provisions appear to have been introduced with regard to manufacturing sites as a result of COVID-19.
Following the emergence of COVID-19, changes were made to the system of public procurement of medicines and medical devices in Nigeria.
The Bureau of Public Procurement (BPP) introduced the Guidelines on the Conduct of Public Procurement Activities. According to these guidelines, an emergency procurement plan must be prepared for all projects specific to the COVID-19 pandemic and uploaded into the Nigeria Open Contracting Portal (NOCOPO), where it will be accessed by the BPP in order to qualify for funding from the federal government.
A notable change was made to the system for public procurement activities as a result of COVID-19. Instead of the previous rigorous process of placing advertisements in two national dailies and the Federal Tenders Journal, as was standard practice, the emergency procurement plans were only uploaded directly to the website.
In addition, the standard “No Objection” requirement required prior to the emergency procurement plan was no longer mandated as a result of the COVID-19 pandemic. Instead, procuring entities were allowed to respond and act on the emergencies at hand before providing a detailed report to the BPP later.
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jee@jee.africa www.jee.africaIntroduction of New Healthcare Insurance Regime
In 2022, the Nigerian federal government introduced the National Health Insurance Authority Act (the “NHIA Act”) to govern health insurance and make health insurance coverage mandatory for all residents in Nigeria. The NHIA Act replaces the defunct National Health Insurance Scheme Act 1999 and seeks to integrate the various state insurance schemes that have been established all over Nigeria. The new law also seeks to provide a tighter regulatory framework for governing Health Maintenance Organisations (HMOs) in Nigeria. The NHIA Act established a new regulator (the National Health Insurance Authority), which has now replaced the defunct National Health Insurance Scheme.
Overview of the National Health Insurance Authority Act
One important positive effect of the NHIA Act would be broadening the health insurance industry in Nigeria, in view of the mandatory requirement for all residents to obtain health insurance under a State Health Insurance and Contributory Scheme. State Health Insurance and Contributory Schemes are health insurance schemes established by state governments in Nigeria.
The new law further prescribes that the National Health Insurance Authority shall establish a scheme for the employees of the Federal Civil Service and other relevant groups. This implies that the National Health Insurance Authority would be responsible for regulating the sector and organising health insurance schemes for residents not covered under the respective State Health Insurance and Contributory Scheme, especially where such persons are members of the Federal Civil Service.
The general statutory requirement for residents to obtain mandatory health insurance coverage with the State Health Insurance and Contributory Scheme would not, however, bar residents from taking supplementary healthcare coverage from private HMOs. Indeed, the NHIA Act provides that the healthcare coverage under the State Insurance and Contributory Scheme would be a basic minimum package of care in line with the guidelines for the implementation and administration of the Basic Health Care Provision Fund. The basic minimum package provides a very low coverage in the region of USD28; hence, it is anticipated that residents may adopt supplementary schemes with HMOs that provide private health insurance services in order to obtain a better coverage.
The new law also makes provision for vulnerable and indigent persons that may not have the capacity to make contributions under the mandatory scheme. The NHIA Act provides that every State and Federal Capital Territory Scheme shall provide coverage for vulnerable persons under the various schemes through the Basic Health Care Provision Fund and other sources and would not require payment of premiums for such coverage. The NHIA Act defines the persons within the vulnerable group to include “children under five, pregnant women, the aged, those who are physically and mentally challenged, and the indigent”.
Despite the penetration of HMOs, which generally provide health insurance coverage in Nigeria, barely 10% of the Nigerian population has health insurance coverage. As such, the majority of Nigerians are restricted to making out-of-pocket payments for healthcare. The new NHIA Act therefore brings some hope to more than 80 million Nigerians who do not have any form of healthcare coverage. HMOs are also expected to play a greater part in the new healthcare regime by taking on a new role as third-party administrators for the various State Insurance and Contributory Schemes, in view of the logistical difficulties that are associated with administering a health insurance scheme. Given that HMOs already have systems in place in various states, integration with the state schemes is all that would be required.
In light of the additional functions granted to HMOs, it is hoped that those acting as third-party administrators to State Insurance and Contributory Schemes consider introducing healthcare insurance packages that allow residents to enjoy various degrees of healthcare coverage that go beyond the basic minimum package, thereby enabling residents to comply with the mandatory requirement to obtain health insurance under the state scheme. This would also provide residents with an acceptable healthcare package subject to the standard or expectation of each resident.
Main players under the National Health Insurance Authority Act
The major players to emerge under the new law are:
The National Health Insurance Authority is clearly the main regulator under the new regime, whereas the State Health Insurance and Contributory Schemes are saddled with the responsibility of administering their schemes and healthcare packages and ensuring that the mandatory contribution is made by residents within their respective regions in order to enforce the law. HMOs are providers of private health insurance schemes. Third-party administrators are entities that perform administrative functions on behalf of State Health Insurance and Contributory Schemes in order to facilitate the implementation of the state health scheme or functions as required by the National Health Insurance Authority. MHAs are associations that exist to represent large groups when negotiating packages with relevant insurance schemes and healthcare providers for the benefit of their own members.
New dispute resolution mechanisms
Enforcement of the NHIA Act is expected to drive more healthcare coverage and lead to investments in the sector. It is also hoped that the dispute resolution challenges faced by the sector will be reduced as the NHIA Act now provides that disputes between players should first be referred for mediation and conciliation before resorting to arbitration. In the event that arbitration fails, parties will then be expected to explore litigation in line with the Constitution of the Federal Republic of Nigeria.
Outlook
Increased demand for healthcare coverage, due to the mandatory contributions under the NHIA Act, is expected to expand health service delivery. Hopefully, this will encourage further investments in – and improve the quality of – Nigerian healthcare.
Introduction of New Pharmacy Regulatory Regime
The Nigerian government introduced a new regulatory regime under the Pharmacy of Nigeria (Establishment) Act 2022. This new law aims to bring remarkable changes to the Nigerian pharmaceutical landscape in a bid to sanitise a market that has been plagued by the free-market distribution of drugs and related exposure to counterfeiting and drug abuse.
Overview of the Pharmacy Council of Nigeria (Establishment) Act 2022
The Pharmacy Council of Nigeria (Establishment) Act 2022 has now opened the pharmaceutical business to non-pharmacists, with statutory limitations, in an attempt to drive more investments in the sector. The new law provides that a company or a foreign company shall not own or operate a chain retail or community pharmacy unless such company has a Nigerian pharmacist or pharmacists who solely or jointly own not less than 40% of the company on its board of directors. This implies that non-pharmacists or investors can own up to 60% of a pharmaceutical-focused company in Nigeria.
The Pharmacy Council of Nigeria (Establishment) Act 2022 has now extended regulatory control to online distribution establishments, as there was previously no regulation in respect of online pharmacy practice. The new law requires any person who carries on the practice of pharmacy – whether online or on-site – to obtain certification for retention of the name of such online or physical pharmaceutical establishment. As well as providing extensive regulatory control, the new law criminalises the operation of pharmacies by persons who are unlicensed as pharmacists.
Regulatory supervision has now been entrusted to the Pharmacy Council of Nigeria (PCN). This statutory entity will be responsible for new licensing and registration regimes for pharmacists, pharmaceutical businesses and pharmaceutical premises (which include hospital premises, along with premises where manufacturing, importation, wholesale and retail are carried out) in Nigeria. The PCN will also be responsible for the discipline of any erring pharmacists and sanctioning offending pharmaceutical companies when violation occurs.
Guidelines for registration of pharmaceutical retail, distribution and importation premises
In order to register a new premises for the retail, distribution and importation of pharmaceutical products, the following documents shall be submitted to the Registrar of the PCN:
Guidelines for the registration of a pharmaceutical manufacturing premises
In the case of a pharmaceutical company that intends to engage in manufacturing, the above-mentioned requirements would also apply. However, such manufacturing entity must also provide the following documents in order to satisfy the licensing or registration requirements:
Guidelines for registration of online pharmacies or drug distribution channels
Online drug channels or pharmacies must also be licensed. Pursuant to Regulation 2 of the Online Pharmacy Regulations 2021, in order to obtain the requisite licence, an application for registration submitted to the PCN by the superintendent pharmacist should be accompanied by the following documents:
The online pharmacy is required to display the name and qualification of the superintendent pharmacist and all other personnel involved in the operation of the pharmacy. In accordance with Regulation 3 of the Online Pharmacy Regulations 2021, the physical location of the pharmacy must also be displayed online. Upon registration of the Internet-Based Pharmacy (IBP), the pharmacy will be eligible for the PCN’s registered online pharmacy sites emblem (ROPSE).
Implementation Of Traceability Of Pharmaceutical Products
In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) is the statutory entity responsible for the regulation and control of the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents (collectively known as regulated products). In 2022, NAFDAC issued guidance on the master data attributes required to make pharmaceutical products traceable in Nigeria.
Given that the burden of regulating drug distribution, sale, use and security rests on NAFDAC, the regulatory entity developed a Five-Year Traceability Implementation plan in line with its national strategy to achieve supply chain visibility and strengthen its pharmacovigilance activities against the scourge of substandard and falsified medicines and medical devices. Traceability is expected to become fully operational in the Nigerian pharmaceutical supply chain by the end of the year 2024.
At the centre of NAFDAC’s strategy on traceability is the plan to adopt a common business language that trading partners involved in the drug distribution value chain – from the manufacturer down to the dispenser – would use to identify, capture and share information about pharmaceutical products and how they move along the supply chain. In so doing, the plan is to ascertain the source, location and site(s) for drugs supplied within Nigeria.
To this end, NAFDAC has now published a list of master data attributes that marketing authorisation holders must share. “Master data attributes” have been defined in the Guidance on Master Data Attributes for Pharmaceutical Products as “attributes or characteristics of an item, entity or location that is created by the owner of that item or entity”. Marketing authorisation holders would be required to share legal, function and location master data with NAFDAC, including:
A good portion of this data is already provided to NAFDAC by marketing authorisation holders. However, it would appear that the collection and collation of this data is an attempt to update NAFDAC’s records – especially considering that it only recently adopted a digital framework for the registration of regulated products.
Changes to Counterfeit Medical Products Legislation
The Counterfeit Medical Products, Fake Drugs and Unwholesome Processed Foods (Prohibition And Control) Bill 2021 (the “CFU Bill”) was introduced in Parliament (ie, the Nigerian National Assembly) on 9 November 2021 to repeal the existing Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous) Provisions Act. The CFU Bill is now at third reading stage, in which a final decision will be taken by the Nigerian House of Representatives to pass the CFU Bill and refer it to a joint parliamentary committee and the Nigerian Senate for passage.
The key changes proposed in the CFU Bill are as follows.
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