CENTRAL BANK OF NIGERIA

Healthcare Research And Development Grant Guidelines

CENTRAL BANK OF NIGERIA

Healthcare Research And Development Grant Guidelines

1. Introduction

The Central Bank of Nigeria (CBN), as part of its policy response to the COVID-19 pandemic, introduces the Healthcare Sector Research and Development Intervention Scheme (HSRDIS) to help strengthen the public healthcare system with innovative financing of research and development (R&D) in new and improved drugs, vaccines and diagnostics of infectious diseases in Nigeria. Specifically, the HSRDIS is designed to trigger intense national R&D activities to develop a Nigerian vaccine, drugs and herbal medicines against the spread of COVID-19 and any other communicable or non-communicable diseases through the provision of grants to biotechnological and pharmaceutical companies, institutions, researchers, and research institutes for the research and development of drugs, herbal medicines and vaccines for the control, prevention and treatment of infectious diseases. The Scheme is intended to boost domestic manufacturing of critical drugs and vaccines to ensure their sustainable domestic supply and reduce the bulk manufacturing costs of the drugs, herbal medicines and vaccines in Nigeria. The Framework outlines the operational modalities for the Scheme.

2. Objectives Of The Scheme

The broad objectives of Scheme include:
2.1 Providing grants for R&D in new or revalidation of drug molecule, phytomedicines and vaccines for the control, prevention and treatment of infectious diseases in Nigeria; 2.2 Boosting domestic manufacturing of validated drugs (Active Pharmaceutical Ingredients or APIs), herbal medicines and vaccines for the control, prevention and treatment of infectious diseases in Nigeria and reduce the nation's dependence on other countries for these drugs and vaccines; 2.3 Improving the capacity of the biotechnological and pharmaceutical companies, institutions, researchers, and research institutes in the development of approved Nigerian drugs, herbal medicines and vaccines for infectious diseases; 2.4 Supporting capacity of relevant health agencies towards attaining WHO
Maturity Level 3, a prerequisite for manufacturing of vaccines in Nigeria; 2.5 Facilitating partnership between academia (researchers, research institutes and universities) and industry into the research and development of drugs, phytomedicines and vaccines for the control, prevention and treatment of infectious diseases in Nigeria; and 2.6 Reduce dependence on imported drug products (synthetic and herbal) and vaccines for the control, prevention and treatment of infectious diseases in Nigeria.

3. Eligible Research And Development Activities

Activities eligible for consideration under the Scheme shall include:
i. Research and development of candidate drugs, herbal medicines and vaccines validated by relevant health authorities for the control, prevention and treatment of infectious diseases; ii. Manufacturing of drugs, herbal medicines and vaccines validated by relevant health authorities for the control, prevention and treatment of infectious diseases; iii. Red biotechnological R&D in new health technology for the control, prevention and treatment of infectious diseases; iv. Research partnership between academia and industry into the development drugs and vaccines for the control, prevention and treatment of infectious diseases; v. Research and development into validated phytomedicines for the control, prevention and treatment of infectious diseases; and NOTE: Candidate vaccines undergoing pre-clinical testing or trials shall not be eligible for consideration under this Scheme. However, candidate vaccines undergoing clinical testing or trials shall be eligible for consideration under the 3 Scheme if considered to have high potential to cross the clinical trial stage and prospects of scale by the Body of Experts (BoE). In applying for the grant, the applicant shall be required to have conducted preclinical testing of the candidate drugs, herbal medicines and vaccines, and obtained certification from relevant health authorities for further research and development.

Special consideration shall be given to candidate drugs, herbal medicines and vaccines with high scientific merit against emerging infections and contribute to the development of the Nigerian vaccine.

For this purpose, a BoE shall be constituted from the academia and industry to review validated research proposal submitted and recommend for financing, as appropriate. The BoE shall meet regularly to appraise the research and development project and submit progress reports to the CBN.

4. Funding

The Scheme shall be funded from the Developmental Component of the Micro, Small and Medium Enterprise Development Fund (MSMEDF).

5. Grant Limit

i. Research activities: Maximum of N50.0 million.

ii. Development/Manufacturing activities: Maximum of N500.0 million.

NOTE: Disbursement under the Scheme shall be made to beneficiaries in tranches subject to approved milestones achieved.

6. Research And Development Timeframe

i. Research activities: Not more than two (2) years from the date of release of fund.

ii. Development/Manufacturing activities: Not more than one (1) year from the date of release of fund.

7. Body Of Experts

The Body of Experts (BoE) shall be responsible for the review and evaluation of submitted research proposals, as well as recommend for financing R&D projects with high potential to contribute to the development of the Nigerian vaccines for infectious diseases. The composition of the BoE shall be as detailed below:
i. Two (2) independent research specialists appointed by the CBN;
ii. One (1) nominee from National Agency for Food and Drug Administration and Control (NAFDAC);
iii. One (1) nominee from Nigeria Institute for Pharmaceutical Research and Development (NIPRD);
iv. One (1) nominee from Nigeria Centre for Disease Control (NCDC)
v. One (1) nominee from Nigeria Institute of Medical Research (NIMR) and; vi. One (1) nominee from the Federal Ministry of Health NOTE: The Chair of the BoE shall be appointed by the CBN.

8. Modalities

i. The applicant(s) shall submit its application, with relevant documentation of validation from relevant health authorities, trial results, patent registration details (if any) and development timetable to the Body of Experts (BoE).

ii. The BoE shall evaluate applications and recommend to the CBN
iii. The CBN shall review for documentation adequacy and completeness; iv. Upon approval, the approved grant sum shall be released to the applicant's account with any PFI of his/her choice.

v. The beneficiary shall submit periodic progress report on the project to the CBN.

NOTE: The CBN shall have proprietary right over all financed R&D outcomes or products. Equally, licensing protocol for the mass manufacturing of developed drugs, phytomedicines and vaccines shall be defined by the BoE in accordance with the World Health Organisation's current Good Manufacturing Practices (cGMP).

9. Monitoring

Periodic joint monitoring of research and development activities shall be conducted by the BoE. 10. Amendments The Framework shall be subject to review from time to time as may be deemed necessary by the CBN. 11. Enquiries and Returns All enquiries and returns should be addressed to:
Director, Development Finance Department, Central Bank of Nigeria, Abuja.

May 2020 Abbreviations

APIs	Active Pharmaceutical Ingredients
BoE	Body of Experts
CBN	Central Bank of Nigeria
cGMP	Current Good Manufacturing Practices
HSRDIS	Healthcare Sector Research and Development Intervention Scheme
MSMEDF	Micro, Small and Medium Enterprise Development Fund
NAFDAC	National Agency for Food and Drug Administration and Control
NCDC	Nigeria Centre for Disease Control
NIMR	Nigeria Institute of Medical Research
NIPRD	Nigeria Institute for Pharmaceutical Research and Development
WHO	World Health Organisation