By Biola Lawal
Abuja (Flowerbudnews): NAFDAC Director General, Prof Mojisola Adeyeye has hailed President Bola Tinubu’s bold move to achieve drug and health security for Nigeria through the recently signed health sector Executive Order.
(Hon. Minister of Health and Social Welfare, Prof. Mohammed Ali Pate)
In a special statement saluting the President’s gesture, Prof Adeyeye said that ”the President’s EO underscores his administration’s commitment to transforming Nigeria’s health sector.’:
The NAFDAC Boss noted that ”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’:.
In the statement entitled: NAFDAC JUBILATES AND SALUTES MR. PRESIDENT FOR THE BOLD MOVE TO ENSURE DRUG AND HEALTH SECURITY THROUGH THE EXECUTIVE ORDER (EO) EO, ‘: Prof Adeyeye also acknowledged the active roles and commitment of the Coordinating Minister of Health and Social Welfare, Prof Mohammed Ali Pate, and Coordinating Minister of State for Health and Social Welfare, Dr. Tunji Alausa.
Hon. Minister of State for Health and Social Welfare, Dr. Tunji Alausa)
She praised the Ministers for putting the ”interest of the 200 million plus Nigerians before their own interest.’:
The NAFDAC Boss noted that the EO showed that the Tinubu Administration, was committed to TRANSFORMING NIGERIA’S HEALTHCARE SECTOR BY INCREASING LOCAL PRODUCTION OF HEALTHCARE PRODUCTS
Prof. Adeyeye, a Professor Emeritus of Pharmaceutics and Drug Product Evaluation at the College of Pharmacy, Roosevelt University in Schaumburg, Illinois, USA, Wrote in commendation of President Tinubu’s bold EO;
“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.
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 placing Regulatory Directives (RD) in place to strengthen local manufacturing:
1) 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.
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.
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.
However, 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 in quote.
“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: The EO includes several measures:
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.Relevance to the Nigeria Health Sector Renewal Investment Initiative (NHSRII)
The EO is vital for the NHSRII’s success, addressing key issues:• 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.•
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.•
Enhancing Quality and Innovation: Regulatory harmonization and market shaping will drive innovation and quality improvement in the local healthcare industry.•
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.
Conclusion: 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”. Flowerbudnews
(Prof. Mojisola AdeyeyeDirector General, NAFDAC 29TH June, 2024)
About Flowerbudnews
Established by Hon. Biola Lawal, a former Acting Managing Director of the News Agency of Nigeria (NAN), Flowerbudnews is a consortium of active journalists, media veterans and image makers in both public and private sectors of Nigeria’s media Industry determined to enhance the practice of responsible journalism.
Lawal, on his part, is also a former Honourable Commissioner for Information,Youth, Sports and Culture of Osun state, his home state.
Biola Lawal had also successfully served two tenures as Press Secretary to the ECOMOG Force Commander in Liberia during the Liberian and Sierra Leone Civil wars.
Lawal holds the honour of being the only journalist that served two terms on the ECOMOG international assignment due to his high professionalism and decency)
