CBN Circulars & Publications | |
CBN Circulars & Publications | |
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Wednesday, August 05, 2020 / 08:40 AM / By CBN
/ Header Image Credit: Ecographics
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 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.
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