NAFDAC Commends President Tinubu’s Bold Move To Ensure Drug, Health Security Through Executive Order
The Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has commended President Bola Tinubu for the bold steps taken in signing an Executive Order (EO) to transform Nigeria’s healthcare sector by increasing local production of healthcare products, reducing costs of healthcare equipment and consumables as well as promoting local investments.
She noted that this initiative, as part of the Nigeria Health Sector Renewal Investment Initiative (NHSRII), addresses longstanding challenges and aims to improve health outcomes for Nigerians.
The DG said with the signing of the Executive Order by the President, the efforts of reforming and transforming the Agency to a stable, strong, effective, efficient regulatory organization she spearheaded in the last six years are paying off.
According to a statement personally signed by NAFDAC DG and made available to journalists, “It has been six years since the Director General of National Agency for Food and Drug Administration and Control (NAFDAC) started the reforms and transformation of the Agency to a well-functioning, strong and stable regulatory Organization.
“Today we can look back at the Executive Order that I am forwarding to you (see below), and say that the efforts are paying off!!!
“On this path, we carried the local manufacturers along with our new Quality Management culture and WHO Global Benchmarking. NAFDAC became accredited for ISO-9001-2015 in 2019, recognized as Maturity Level 3 Agency in Medicines and the Central Drug Control Laboratory in Yaba, Lagos, and became a WHO Prequalified Laboratory.
“Along this path, NAFDAC started putting Regulatory Directives (RD) in place to strengthen local manufacturing:1) Goods Manufacturing Practice (GMP) Road Map in 2018, to ensure our manufacturers are compliant with international standards; 2) Five-Plus-Five RD in 2019, to ensure that the capacity of local manufacturers are maximized by limiting import renewals of medicines that our manufacturers have the capacity to manufacture locally; 3) Pharma Operations Division created in 2019 to ensure better oversight and compliance with regulatory requirements by local manufacturers; 4) Layout Review RD in 2021 to ensure that that from inception when the architectural blueprint is being designed, NAFDAC is part of the design for proper guidance to the manufacturer so that quality is built into the facility design.
Other include 5) Ceiling 34 Regulatory Directive in 2021 to increase the number of medicinal products that cannot be imported into the country because of our local capacity and 6) Hand Holding and Targeted Inspection and Testing of of local manufactured medical devices and in-vitro diagnostics (IVDs) in 2023 to ensure the devices and IVDs conform with international standards.
“Along this path, importers started migrating to local manufacturing or forming partnerships with local manufacturers, thus resulting in a 30% increase in new facilities being built. Confidence continued to build among local manufacturers and they started responding by re-designing their facilities, especially during the pandemic with some intervention of funds from the President Buhari Administration for infrastructural development.”
She said “The perennial and persistent costly challenge of importation of ALL materials needed for manufacturing (except water) by local manufacturers became an open sore. As Director General, my professional heart ached for local manufacturers considering the import duties they have to pay for ALL materials, some packaging materials and equipment. I have advocated for zero tariffs since my assumption of office with a limited moratorium to give local manufacturers industrial breathing space to do what they know how to do best – manufacturing quality medical products.
“Then came the Tinubu Administration, and then the administration of the cerebral Coordinating Minister of Health and Social Welfare, Prof Mohammed Ali Pate, and Coordinating Minister of State for Health and Social Welfare, Dr. Tunji Alausa, who put the interest of the 200 million plus Nigerians before their own interest. Then the unimaginable started happening – giving local manufacturers a chance to excel and be competitive. Then came the Executive Order below as published from the Coordinating Minister of Health and Social Welfare Office.”
The DG quoted the Coordinating Minister of State for Health and Social Welfare, Dr. Tunji Alausa, who said “Revitalizing Nigeria’s Healthcare: President Tinubu’s Bold New Executive Order.
“President Tinubu, GCFR, has signed an Executive Order (EO) to transform Nigeria’s healthcare sector by increasing local production of healthcare products, reducing costs of healthcare equipment and consumables, and promoting local investments. This initiative, part of the Nigeria Health Sector Renewal Investment Initiative (NHSRII), addresses longstanding challenges and aims to improve health outcomes for Nigerians.”
Key Provisions and measures in the Executive Order are 1. Zero Tariffs and Excise Duties: Exempting specified pharmaceutical machinery, equipment, goods, and accessories from tariffs and excise duties to reduce production costs and make healthcare products more affordable.
2. Special Waivers on Pharmaceutical Inputs: APIs, excipients, and other essential raw materials, including those for Long-lasting Insecticidal Nets (LLINs) and Rapid Diagnostic Kits, will benefit from zero tariffs, excise duties, and VAT, lowering the price of essential medicines and medical supplies.
3. Market Shaping: Establishing framework contracts and volume guarantees to stabilize the local manufacturing market.
4. Regulatory Harmonization and Expedited Approvals: Developing a Harmonized Implementation Framework to guide regulatory agencies in streamlining approval processes.
5. Implementation and Compliance: Agencies like the Nigeria Customs Service, NAFDAC, SON, and FIRS are mandated to ensure swift implementation. The waivers and exemptions are valid for two years from the effective date.
On the relevance to the Nigeria Health Sector Renewal Investment Initiative (NHSRII), she said Executive Order is vital for the NHSRII’s success in addressing key issues such as reducing the High Cost of Medicines: By lowering tariffs and providing special waivers, the EO aims to reduce the prohibitive costs of medicines and other pharmaceutical products, making healthcare more affordable for Nigerians, and boosting Local Industry: Encouraging local manufacturing will create jobs, stimulate economic growth, and reduce dependence on imports, ensuring a reliable supply of essential healthcare products.
Others include enhancing Quality and Innovation – Regulatory harmonization and market shaping will drive innovation and quality improvement in the local healthcare industry, as well as strengthening Health Systems – By addressing underinvestment and regulatory challenges, the EO will strengthen Nigeria’s health system, improving service delivery and health outcomes, and enhancing resilience to future health crises.
NAFDAC DG concluded that “The President’s EO underscores his administration’s commitment to transforming Nigeria’s health sector. It aligns with the broader objectives of the NHSRII and the Presidential Initiative on Healthcare Value Chain (PVAC), approved in October 2023. By addressing core challenges and providing a clear path for improvement, this EO sets the stage for a sustainable and high-quality healthcare system for all Nigerians”.
