CBN Circulars & Publications | |
CBN Circulars & Publications | |
1718 VIEWS | |
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Sunday, June 07,
2020 04:05 PM / by CBN/ Header Image Credit: CBN
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.
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.
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 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.
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.
vi. 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 Organisations 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
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