Life Sciences 2024 Comparisons

The key legislation and regulations that govern pharmaceuticals are:

• the Food and Drugs Act (Chapter F32) LFN 2010;
• the National Agency for Food and Drug Administration and Control Act Chapter (N1) LFN 2010;
• the Food, Drugs and Related Products (Registration) Act (Chapter F.33) 2010; and
• the Pharmacy Council of Nigeria (Establishment) Act 2022.

The Food and Drugs Act and the Food, Drugs and Related Products (Registration) Act regulate the manufacture, sale, advertisement and distribution of drugs in Nigeria. The National Agency for Food and Drug Administration and Control Act establishes the main regulatory agency (ie, NAFDAC) responsible for issuing marketing authorisations and product registrations for the sale and distribution of imported and locally manufactured pharmaceuticals in Nigeria.

However, the Pharmacy Council of Nigeria (Establishment) Act 2022 regulates the sale and distribution of pharmaceutical products in Nigeria. 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 Act also establishes the Pharmacy Council of Nigeria (PCN), which is the regulatory agency responsible for the control and supervision of pharmacists and the premises used for the 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, including:

• Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria;
• Guidelines for Pre-Registration Inspection of Pharmaceutical Manufacturing Facilities in Nigeria;
• Good Distribution Practice for Pharmaceutical Products Regulations 2021;
• NAFDAC Guidelines for Contract Manufacturing of Finished Pharmaceutical Products in Nigeria;
• Drug and Related Products Labelling Regulations 2021; and
• Online Pharmacy Regulations 2020.

The legislation governing pharmaceuticals also governs medical devices, so the PCN and NAFDAC are also the major regulators of medical devices. However, he Standards Organisation of Nigeria (SON), the Federal Competition and Consumer Protection Commission and the Nigerian Nuclear Regulatory Authority (NNRA) have also been set up 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 NNRA regulates the use, installation and operation of medical devices that have radiation, including x-ray machines and MRI machines.

However, it is crucial to note that NAFDAC remains the main regulatory authority for medical devices. To this end, it has issued regulations and guidelines to control the distribution, sale and distribution of medical devices, including:

• Drug and Related Products Advertisement Regulations 2021;
• Guidelines for Registration of Medical Devices Made in Nigeria;
• NAFDAC Guidelines for Registration of Imported Medical Devices in Nigeria;
• NAFDAC Guidelines for the Renewal of Certificate of Registration Licence for Imported Medical Devices; and
• Guidelines for Advertisement of NAFDAC Regulated Products.

The following regulatory bodies enforce pharmaceuticals and medical devices laws and regulations:

• NAFDAC is the statutory body that administers the NAFDAC Act and enforces its objectives – it regulates and controls the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs, medical devices, pharmaceuticals and chemicals;
• the PCN is the statutory entity responsible for the control and supervision of pharmacists and the premises used for the manufacture, distribution and sale of pharmaceutical products in Nigeria; and
• the SON is the statutory body responsible for standardising and regulating the quality of products in Nigeria, including medical products – it also oversees the standard of goods imported and distributed in Nigeria.

The SON, the PCN and NAFDAC are all semi-autonomous regulatory entities, 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 that is dissatisfied with the decision of a regulatory body is entitled to request a review of said decision. It is not unusual for decisions of the major regulatory bodies that enforce pharmaceutical and medical device regulation (especially the PCN and NADFAC) to be contested or challenged, generally through the following procedure.

Petition or appeal to the regulatory body

First, an attempt should be made to seek a reconsideration of the regulatory body’s decision, outlining the 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 the party’s right to challenge an unfavourable decision being 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. A pre-action notice must be submitted within one month if a PCN decision is to be challenged.

Court action for judicial review

After taking these steps, 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 for medical devices and pharmaceuticals, as reflected in the laws and regulations in force.

Pharmaceuticals

Pharmaceuticals are not specifically categorised in Nigeria. Although 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, which differ from those for OTC medication.

Medical Devices

NAFDAC has adopted the guidelines of the Global Harmonization Task Force (GHTF) for the international classification of medical devices, known as the Principles of Medical Devices Classification. These classes include:

• Class A for low risk (eg, cholesterol, uric acid test system, surgical instruments, bandages, surgical cameras);
• Class B for low-to-moderate risk (eg, surgical lamp, surgical mask, electric hospital bed);
• Class C for moderate-to-high risk (eg, condom, x-ray unit, syringe, contact lens); and
• Class D for high risk (eg, pacemaker, defibrillator, HIV blood donor screening, stent, intraocular lens).

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. NAFDAC is the supervising agency and 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 an ethical opinion, which is a precondition for the grant of NAFDAC’s approval of a clinical trial.

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 and 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.

• Application form – every organisation that wishes to undertake a clinical trial must fill out and submit an application form, along with supporting documents and a completed checklist, containing details of the study, the organisation conducting the trial and the technical details of the pharmaceutical or medical device being tested, as well as other relevant details.
• Protocol – certain protocols are required under the regulation, including investigation of approved trial sites and facilities used for clinical trial, processing of data of trial participants (patient information leaflet), signed declaration by the sponsor or principal investigator and co-investigators and persons of interest, informed consent of participants, and proof of indemnity or insurance certificate.
• Ethics Committee approval – after observing protocol measures, the Ethics Committee is set up only for specific matters that ensure the risks to the participants are equally managed. It operates under a valid certificate issued by the NHREC, and members of the Ethics Committee must not have any interest in the trial.
• Registration – upon completion of the application form, submission of other supporting documents and observance of protocol measures, the applicant for clinical trial will then be registered with the Nigerian Clinical Trial Registry (NCTR) or the Pan-African Clinical Trial Registry, and the evidence must be submitted to NAFDAC.

Information on clinical trials is accessible to the public, so their status is ascertainable.

Clinical trial applications filed in Nigeria 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 and provides information on ongoing and completed trials.

There is currently no restriction on using online tools to support clinical trials. However, in practice, NAFDAC and the NHREC have associated online platforms used as a database for clinical trials, which they update with new information on the investigations and upload information particular to the trial.

Data resulting from clinical trials may not be considered as personal data under Nigerian law.

Section 5(10) of the Clinical Trial Regulations 2021 protect the rights of the participant to physical and mental integrity, privacy and personal data. 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 and can only be published if the participant has provided informed consent 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:

• the fact that the data controller intends to transfer personal data to a third party, another country or an international organisation; and
• the existence or absence of an adequacy decision by the National Information Technology Development Agency (NITDA), which indicates whether another country satisfactorily protects personal data.

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 and with the provisions of the NDPR aimed at the protection of sensitive data collected on a database.

For instance, Article 2.1(1)(I) of the NDPR requires that personal data (applicable to the participant’s information used in the trial) is collected and processed where consented to by the data subject, 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 database. 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 prescribes a number of specific requirements or criteria. It 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:

• the diagnosis, treatment, mitigation or prevention of any disease, disorder or abnormal physical state (or the symptom thereof) in humans or animals;
• restoring, correcting or modifying organic functions in humans or animals;
• disinfection or the control of vermin, insects or pests; and
• contraception.

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 the granting of marketing licences for biologic medicinal products; the general obligations under the Guidelines apply.

However, the National Control Laboratory for Vaccines and Other Biologics (NCLVB) is a specially constituted NAFDAC unit responsible for confirming the quality, safety, efficacy and fitness for use of vaccines, biological products and medical diagnostic devices after analysis/evaluation. This unit may recommend restrictions on the marketing of specific biologics based on the review thereof.

The NAFDAC Drug and Related Products Registration Regulations 2019 provide that the registration of a drug with NAFDAC will be valid for five years.

Renewal of Marketing Authorisation

The NAFDAC Drug and Related Products Registration Regulations 2019 state that marketing authorisations may be renewed. 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 – eg, 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 and the Guidelines for Renewal of Certificate of Registration for Imported Medical Devices in Nigeria.

All the above-mentioned guidelines provide that an 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.

Revocation or Withdrawal of Marketing Authorisations

Pursuant to Section 7 of the Drug and Related Products Registration Regulations 2019, marketing authorisations may be revoked or withdrawn by competent authorities if:

• the ground of registration happens to be false;
• the conditions of registering the drug product have been breached;
• the standard of quality in the paperwork of the registration has been contravened;
• the product is ineffective for its primary purpose;
• the premises where the drug product or part thereof is manufactured – or kept on behalf of the Certificate of Registration Holder (“the Holder”) – contravene the provisions of current Good Manufacturing Practice (cGMP);
• the Holder has given notice to NAFDAC in writing of any intentions to suspend product registration for a period not exceeding the validity of the certificate of registration; and
• the registration is inchoate based on the information supplied.

The regulations further provide that, where the registration of a 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 a 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.

• The applicant must submit an application form, along with relevant documents as prescribed by NAFDAC, including a clear description of the product and all technical and administrative information relating to the product. The applicant must pay the fees prescribed by NAFDAC, which may be done at any time in the course of applying for registration.
• NAFDAC may ask the applicant for further information in order to reach a decision about the application if deemed necessary. Once satisfied, NAFDAC issues a Certificate of Registration, which subsists for five years until renewal.
• NAFDAC then publishes the list of registered products on its official website, thereby notifying the registration status.

According to the Guidelines for Registration of Drug Products Made in Nigeria, the procedure for obtaining authorisation entails the following steps.

• Dossier application – the applicant must submit a dossier of the drug product for screening as a prerequisite for registration.
• Application letter – this allows the applicant to submit an application for the registration of the products, which is processed on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal. A separate application must be made for each product and addressed to the Director General of NAFDAC. Other documents are attached and the original copies will be made available on request. These documents include:
1. the Certificate of Incorporation or any evidence of registration of the business of the applicant in Nigeria;
2. a legal manufacturing agreement/contract;       
3. any evidence showing that the trade mark or brand name of a drug has been registered under Class 5 in the name of the trade mark owner at the Trademarks, Patents and Designs Registry;
4. a copy of the superintendent pharmacist's valid annual licence to practise;
5. a copy of the valid Premises Retention Licence for the facility;
6. a certificate issued by GMP or any evidence of a successful inspection by any regulatory authority; and
7. an artwork or product label that complies with the Drug and Related Products Labelling Regulations.
• Product approval meeting – the Food and Drug Registration Committee then holds an approval meeting to determine whether the drug or product has satisfied the requirements.
• Issuance of Certificate of Registration – upon approval of the product, an electronic Certificate of Product Registration is issued to the applicant and subsists for a period of five years unless renewed.

Procedure to Vary a Marketing Authorisation

There is a standing procedure to vary a marketing authorisation previously granted by 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 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 on the type of change requested.

Such change may be made by:

• annual notification;
• immediate notification;
• minor variation; or
• major variation.

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:

• change of the Active Pharmaceutical Ingredient (API);
• inclusion of an additional API in a multi-component product;
• removal of one API from a multi-component product;
• change in the strength of one or more APIs;
• change from an immediate-release product to an extended or delayed-release dosage form or vice versa;
• change from a liquid to a powder for reconstitution or vice versa; and
• changes in the route of administration or other changes as prescribed by NAFDAC.

Transference of Marketing Authorisation

The position of the law on the transference of a 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 issued, a certificate of registration cannot be transferred, disposed of, hired or sold to a third party unless approved by NAFDAC.

Although the guidelines do not recommend any 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 a product must have a Certificate of Registration before it can be distributed in Nigeria.

However, Section 2(2) of the 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 or a service drug scheme, and for any use in emergency situations resulting from epidemics or disease pandemics, donation for humanitarian interventions, etc. 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 (MAH)

In regulating and assessing the quality of products, NAFDAC has paved the way for post-marketing surveillance/pharmacovigilance that imposes certain obligations on a MAH.

For pharmaceutical products, the NAFDAC Good Distribution Practices Guidelines for Pharmaceutical Products outline the recommendations and principles guiding the distribution of pharmaceutical products in Nigeria, highlighting the responsibilities of the distributor as endowed by the NAFDAC authorisation.

As imposed by the guidelines, distributors or their agents can only supply pharmaceutical products to those who are authorised to sell or distribute such products to patients. Such authorisation must be approved and valid before the 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, a MAH 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, which 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 with such post-monitoring activities.

During the PMS planning stage, the quality of the products must be considered among other things. 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 and the effects thereof are also considered, as is the mode of carrying out the pharmacovigilance.

Pharmacovigilance of Medical Devices and Obligations Imposed on the MAH

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 MAHs

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:

• the marketed devices may have caused death or serious injury; or
• a malfunction of the marketed device may cause death or serious injury should it recur.

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 are contained in the NAFDAC Confidentiality, No Conflict of Interest, Code of Conduct Agreement Form, which 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 are not easily accessible by the public.

The legislation and procedures against falsified and illegally distributed medical devices are as follows.

First, Section (1)1 of the Food, Drugs and Related Products (Registration, etc) Act proscribes the import, export, advertisement, sale or distribution in Nigeria of unregistered drugs and devices. Section 6 of the Act 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, any person who contravenes the provisions of the Act would be guilty of an offence and liable on conviction to the penalties specified in the regulations.

The NAFDAC Drug and Related Products Advertisement Regulations 2021 provide that a manufacturer may be liable to sanctions if a regulated product is advertised without authorisation. If such advertisements are made with the knowledge of an officer of the manufacturing company or any person acting in that capacity, such individuals 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 the broadcasting of unauthorised adverts.

The Guidelines for Procurement and the Management of the Mobile Authentication Service (MAS) Scheme in Nigeria 2018 were put in place to combat falsified medical products.

A number of measures to tackle counterfeit pharmaceuticals and medical devices 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) Act.

In addition, NAFDAC has introduced hand-held devices for on-the-spot detection of counterfeit medicines, allowing law enforcement agents to conduct screening on site to identify counterfeits.

In reality, there is significant collaboration between the Nigerian Customs Service and NAFDAC in the implementation of border measures to combat fake and unregistered regulated products.

The NAFDAC Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria provide that manufacturing facilities must be inspected and comply with GMP, and must have received NAFDAC authorisation to manufacture pharmaceutical products.

NAFDAC approves the manufacture of medicines and related products before consumer use. The Good Manufacturing Practice Guidelines for Pharmaceutical Products 2016 regulate the manufacture of these products, and the NAFDAC Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria grant authorisation.

Furthermore, the SON has a general mandate to regulate local manufacturing in Nigeria; 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 prescribe the following authorisation procedure for manufacturing plants.

• Application for inspection – an application for Pre-Production Inspection should be made and submitted on the company’s letterhead to the director of the Drug Evaluation and Research (DER) Directorate, along with supporting documents.
• Payment for inspection – a payment invoice for the inspection is collected from the DER Directorate. The applicant may visit www.remita.net to generate a Remita invoice before printing out a copy of the invoice and paying at the nearest bank. An official receipt is issued by the Finance and Accounts Section.
• Schedule of inspection – the facility is scheduled for inspection at a convenient date, with the following documents provided during the inspection:
1. the site master file;
2. the current annual licence to practise of the superintendent and production pharmacists issued by the PCN;
3. letters of appointment and acceptance of key officers;
4. credentials of the key officers (minimum qualification should be first degree in the relevant disciplines);
5. job descriptions for key personnel;
6. validation master plan for the facility;
7. documentary evidence showing the qualification of production and laboratory equipment;
8. documentary evidence showing the analytical method validation/verification;
9. documentary evidence showing the water system validation (where applicable);
10. a list of production and quality control equipment and their identification numbers; and
11. any other relevant documents.

In addition, self-inspection is included in NAFDAC’s Guidelines on Good Manufacturing Practice, 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, the guidelines for pharmaceutical products posit that CWC 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 supporting documents/information as prescribed by the PCN, including:

• a photocopy of the annual licence to practise/application for retention of name on the Pharmaceutical Register (Form J);
• any evidence of the payment of inspection and registration fees as prescribed by the PCN;
• a contract of agreement between the superintendent pharmacist and employer;
• the company’s Certificate of Incorporation;
• a certified true copy of the Articles and Memorandum of Association;
• a certified true copy of particulars of directors issued by the Corporate Affairs Commission (CAC);
• a letter of undertaking by the superintendent pharmacist;
• a letter of undertaking by the managing director of the company handling the management of pharmaceuticals to the superintendent pharmacist; and
• evidence that the board of directors includes a registered and licensed pharmacist on the board of directors.

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

The regulations do not provide for a standing validity period applicable to wholesalers. 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.

Medical Devices

In Nigeria, the Guidelines for Registration of Imported Devices in Nigeria provide for the measures to be taken when importing medical devices. The application will pass through the following five stages.

• Submission of the application – a written application for the registration of imported medical devices should be made on the company’s letterhead paper to the Director-General of NAFDAC. It must indicate the name of the brand and associated product and be submitted with a separate application form for each product.
• Import permit – after the documents are screened, an import permit is issued while the products are submitted for vetting.
• Submission of products for laboratory analysis – laboratory samples are submitted with payment evidence, certificate of analysis and evidence of submission for vetting.
• Product approval meeting – after they have been reviewed and deemed to satisfy the requirements of GMP for the production facility and laboratory analysis of product, the requested documents are presented for approval. Product labels that do not comply with the restrictions will be re-sent with the compliant artwork, along with a commitment letter from the manufacturer undertaking to ensure compliance.
• Issuance of notification – the approved products are issued a Notification of Registration or Listing, which is valid for a period of five years, while those yet to be approved receive compliance directions.

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 through 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.

The following documents must be submitted alongside the application letter:

• a photocopy of the annual licence to practise/application for retention of name on the pharmaceutical register (Form J);
• inspection and registration fees as prescribed by the PCN;
• the legal agreement between the superintendent pharmacist and the employer;
• the company’s Certificate of Incorporation or evidence of registration of business for a pharmacist-owned retail premises;
• a certified true copy of the Articles and Memorandum of Association;
• a certified true copy of the particulars of directors issued by the CAC;
• a photocopy of the NYSC discharge or exemption certificate;
• a letter of undertaking by the superintendent pharmacist;
• a letter of undertaking by the managing director handling the management of pharmaceuticals to the superintendent pharmacist;
• a pharmacists' inter-state movement form (where applicable); and
• the current annual licence of the pharmacist director.

Governmental Agencies Enforcing Import Rules

The governmental agencies responsible for enforcing import rules in Nigeria include:

• NAFDAC ‒ the key regulatory authority for drugs and medical products in Nigeria, as well as the import thereof;
• the SON – through the use of Harmonised Systems (HS) Codes for the examination of goods at the nation’s entry points, the SON has been in line with international best practices aimed at reducing conflicts to the bare minimum; and
• the Nigerian Customs Service – by statute, Customs are empowered to enforce custom rules, including rules of importation and any prohibition thereof through officers allocated in different units.

Only a company duly registered in Nigeria is permitted to import pharmaceutical products into Nigeria. A foreign company seeking to import drugs must either set up a Nigerian entity for this purpose or appoint a pharmaceutical company incorporated in Nigeria as its agent for the importation. The pharmaceutical company must also comply with the Pharmacy Council of Nigeria (Establishment) Act 2022.

Importer of Record

A company must fulfil a number of requirements before it can be authorised to import pharmaceutical products, including:

• providing evidence of business incorporation with the CAC, showing that the company is registered in Nigeria;
• complying with the provisions of the Pharmacy Council of Nigeria (Establishment) Act 2022; and
• disclosing a suitable warehouse or storage facility where such drugs can be kept, bearing in mind the storage method prescribed for such drug.

The importation of pharmaceuticals and medical devices is subject to prior 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 the Guidelines for Registration of Imported Drugs, as well as the Guidelines for Registration of Imported Medical Devices into Nigeria.

Non-tariff restrictions are imposed on the 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 neither manufacturers nor distributors can import their products without such authorisation. This applies to all entities – foreign and local – regardless of origin.

Certain requirements must be met before an import permit is issued, which may be peculiar to the type of product. In order to import pharmaceuticals into Nigeria, one must follow the application 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 in 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.

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 for laboratory and industrial chemicals.

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 SON Conformity Assessment Programme (SONCAP) certificate for goods to be imported, forming a prerequisite for the 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.

Import Prohibition List

Goods are also prohibited from being imported if they are on 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). It also separates some goods based on HS Codes. This is a standardised method used in identifying the traded products – for instance, under the list, live or dead frozen poultry has HS Codes 0105.1100-0105.9900, 0106.3100-0106.3900, 0207.1100-0207.3600 and 0210.9900.

Some variation of a product may be exempted – eg, bird eggs are prohibited from importation, with the exception of hatching eggs.

Laws and Regulations Prohibiting Importation

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. Goods that are absolutely prohibited include air pistols, counterfeit or pirated materials, indecent articles or paintings, cowries and second hand clothing.

Nigeria is a member of the African Continental Free Trade Area (AfCFTA), as created by the African Continental Free Trade Area Agreement on Trade Facilitation, so benefits from the trade facilitation provisions therein. The AfCFTA 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 a stakeholder, 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.

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:

• where the patient makes contributions to the National Health Insurance Scheme; and
• through other health insurance schemes organised by the State ‒ eg, Health Maintenance Organisations.

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 that dispensing pharmacists must 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 govern medical applications, and cover the extent to which medical apps are accessed via the internet.

They do not define “medical devices” and “medical apps”, but medical devices cover a wide range of medical equipment, whether used online or offline, so 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 for the diagnosis or treatment of a disease in humans or animals, whether internally or externally. Therefore, a medical app may be considered a medical device if it is used for any such means.

According to the Rules of Professional Conduct for Medical and Dental Practitioners in Nigeria, telemedicine is recognised in professional practice in Nigeria and is 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:

• confidentiality;
• professional competence;
• legal and registration status of the specialist being consulted;
• reliability of the equipment used;
• patient management; and
• referral of patients timeously.

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, including 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 states that extra security measures must be taken in the electronic space to protect personal data of the patient – eg, setting up firewalls, restricting access to authorised persons only, data encryption and other measures for handling patients’ data.

There are special rules guiding the advertisement of medical devices on online platforms: 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 provide 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.

The Online Pharmacy Regulations 2020 make regulations for pharmaceutical service providers who are based online, covering all registration requirements but making specific 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 submitting 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, which include:

• the current annual licence of the superintendent pharmacist;
• a photocopy of the registration licence of the current premises;
• evidence of the payment of fees as prescribed by the PCN;
• the letter of appointment of the superintendent pharmacist;
• the legal agreement between the superintendent pharmacist and the employer;
• the Certificate of Incorporation of the company or evidence of business name registration for pharmacist-owned retail premises;
• certified true copies of the Articles and Memorandum of Association;
• certified true copies of CAC documents showing the names and particulars of directors;
• the NYSC discharge or exemption certificate;
• an undertaking by the superintendent pharmacist;
• an undertaking by the managing director of the online company handling management of the business for the superintendent pharmacist; and
• policy documents including procedures and processes for all operations of the internet services.

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, with Section 11 of the PCN’s Online Pharmacy Regulations 2020 providing that pharmaceutical service providers may dispense prescription-only medicines (among others) electronically. Such pharmaceutical service providers are internet-based and must dispense 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.

The regulations also restrict the prescription of 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 sales of medicines and medical devices are permitted in Nigeria, subject to the provisions of the law. The PCN’s Online Pharmacy Regulations 2020 provide that the following requirements must be complied with in the online sale of medicines:

• policies must be in place to guarantee the legitimacy of the drugs;
• such drugs must not be sold without confirming that they were prescribed by a licensed officer;
• telephone or electronic medical consultation should be reduced; and
• the quantity of medicines to be sold or prescribed online must be reduced.

The law also makes a distinction between prescription and non-prescription drugs, providing that only non-prescription drugs should be sold or prescribed online.

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, but there are 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 a duty of confidentiality and a 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

This 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 provides that health records must be kept safe by the holder in order to prevent any authorised access, implying that health records are considered sensitive. Thus, health-related information that reveals personal data will be classed as sensitive.

Stricter Regulations

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).

Cloud Platforms

There are currently no special laws on the transfer and storage of sensitive data of patients on cloud platforms.

However, the NDPR considers sensitive personal data to be of a critical nature and therefore special requirements apply. Before such personal sensitive data can be transmitted to a 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 a DPO).

Transfer and Storage of Sensitive Data on Cloud Platforms

There are currently 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 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, etc.

The National Office for Technology Acquisition and Promotion Act assists in the filing of patents and innovations applicable only to government-funded research, as well as in the private sector.

Nigerian legislation on patents has some shortcomings in terms of pharmaceuticals and medical devices:

• there are no provisions on the infringement of second and subsequent use patents for pharmaceutical products;
• there is no provision for term extensions for pharmaceuticals;
• there is no specific means of applying for a patent term extension for pharmaceuticals in Nigeria; and
• there is no requirement for pre-launch action to “clear the way” in market entry.

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 a 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.

Nigerian patent laws do not currently provide for term extension for pharmaceuticals. The 20-year lifespan of a patent is sacrosanct, subject of course to the payment of an 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 strictly amount to patent infringement. However, the plaintiff may be entitled to explore a quia timet action through a patent infringement action in order to prevent the issuance of such authorisation that would result in infringement.

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 that:

• there is a threat of serious infringement;
• potential harm will be caused if the injunction is refused;
• irreparable harm will be caused if the injunction is not granted; and
• it will suffer more injury if the injunction is not granted.

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:

• lack of novelty of the subject matter of the patent;
• prior publication of the subject matter of the patent;
• defence of previous use;
• the subject matter of the patent is not patentable;
• ambiguity of the claims;
• insufficiency of the claim;
• inability to work the subject matter of the patent; and
• the description of the invention or claim does not conform with the provisions of the Patent and Designs Act 1971.

Compulsory Licences

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 the economy.

The Patent and Designs Act 1971 provides the requirements for the issuance of compulsory licences 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 the court that:

• they have approached the patentee for a licence and were unable to secure one within a reasonable time;
• there is a deficiency in the invention and, as such, assure the court that they will rectify the deficiency;
• the patent has not been worked on as required;
• if it has been worked on, the extent of the work is not reasonable considering the nature of the product;
• the patented article has hindered the operations of patented inventions in Nigeria; and
• the refusal by the licensee has hindered industrial commercial activities in Nigeria.

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 the subject of compulsory licences and the Minister may permit the 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:

• the licensee notifies the patentee of the infringement;
• the patentee refuses to act on the infringement; and
• the licensee files a copy of the notice to the patentee with the registrar.

Remedies

Under patent law in Nigeria, the following remedies are available to the plaintiff:

• injunctions restraining the other party from further infringement of the patent right;
• damages to compensate the owner or inventor of the patent right;
• declaration of the patent of a plaintiff as valid where such relief is sought by the plaintiff;
• account of profits made from infringement; and
• delivery up of infringed products.

Procedure for Patent Infringement Actions

The action for infringement typically goes to trial after the service of documents and processes, with the following steps.

• The claimant files a writ of summons at the Registry of the Federal High Court accompanied by a statement of claim, list of witnesses, copies of document to be relied on at the trial, list of exhibits, and written statements made under oath by witnesses.
• The defendant files a statement of defence in response to the plaintiff within 30 days, along with a list of its witnesses and written testimonies, and the documents to be relied on. The defendant may also file a counterclaim.
• The plaintiff may file a reply upon receipt of the defendant’s filing within 14 days.
• After service of all processes, parties may explore discoveries and interrogatories in order to obtain relevant evidence and admissions from either party.
• Upon the close of pleadings and interrogatories, the matter is scheduled for trial. Parties to the action give evidence and file final addresses, which are later adopted.
• Upon adoption, the court enters a judgment within three months.

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 regulations and laws in place that may be utilised to combat the counterfeiting of pharmaceuticals and medical devices in Nigeria, including:

• the National Agency for Food and Drug Administration and Control Act 2004;
• the Food, Drugs and Related Products (Registration) Act 1993;
• the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act 2004 (Chapter 34);
• the Customs and Excise Management Act 2004 (Chapter 45);
• the Standards Organisation of Nigeria Act 2015; and
• the Merchandise Marks Act.

Under Nigerian law, the general restrictions that apply to other products may apply to medical devices and pharmaceuticals, including:

• only distinctive trade marks are registrable;
• a mark that is deceptive or scandalous, contrary to law or morality, or in any way disentitled to protection is not registrable; and
• a mark that contains prohibited words and/or symbols (such as names of chemical substances), use of the Coat of Arms of Nigeria or use of any emblem or title such as President or Governor without the appropriate authority is restricted.

Specifically, Section 12 of the Trade Mark Act proscribes the registration of a single chemical element or single chemical compound as a chemical or preparation.

Restrictions on Importation of Pharmaceuticals or Medical Devices

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 are 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, which is a tort that prevents a manufacturer from misrepresenting goods or services as those 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 to NAFDAC for registration 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 to both 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 the 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.

The commercialisation and distribution of medicines were handled differently throughout the COVID-19 pandemic, with the following special regulations or guidelines being issued in response to the crisis.

• In 2020, NAFDAC released a newsletter (Vol 3, No 2) that discouraged the use of falsified chloroquine. NAFDAC also discouraged the commercialisation or distribution of unregistered hand sanitisers.
• There were cautionary notices with regard to various drugs claimed to be used to treat COVID-19.
• The Presidential Task Force on COVID-19 issued guidelines covering various areas, including:
1. expedited/emergency approvals for products;
2. limited GMP inspections for local facilities;
3. alternatives to GMP for foreign facilities when inspections could not be undertaken owing to the pandemic travel restrictions;
4. applications for the registration of products deemed to have urgent public health impact to be processed and given conditional and limited approvals; and
5. encouraging the use of email and other electronic platforms when interacting with NAFDAC.

The applicability and enforcement of rules on the commercialisation and distribution of medicines in Nigeria were not relaxed, and continued to be overseen by the 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 of all due processes and aspects of the trial to be conducted (including the review of the participant by the Ethics Committee), prior to the participant’s involvement in the trial.

Special Regulations

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 a 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 the necessary medical devices and pharmaceuticals.

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 and provides that such emergency approval must meet the following criteria:

• previous registration and approval by the relevant regulatory authorities (eg, the European Medicine Agency);
• registration by the regulatory authority in the country of production;
• declaration of conformity; and
• validation/performance evaluation/clinical evaluation report.

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 cleared the bottlenecks for authorising vaccines needed to prevent COVID-19 in people over the age of 18.

Some import restrictions were put 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 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 licences 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.

The 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 which 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.

In another notable change, instead of the previous rigorous process of placing advertisements in two national dailies and the Federal Tenders Journal, as was standard practice, emergency procurement plans were only required to be 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.