Region

Jurisdiction

Regulator

2020-09-29 | DFD/SME/GEN/HSRDIS/01/020

Amended Health Sector Research and Development Intervention Scheme (HSRDIS) Guideline

The Central Bank of Nigeria (CBN) introduced the Healthcare Sector Research and Development Intervention Scheme (HSRDIS) to strengthen the public healthcare system and support the development of new drugs, vaccines, and diagnostics for infectious diseases in Nigeria. The scheme provides grants for R&D activities, with a focus on boosting domestic manufacturing and reducing dependence on imported drug products and vaccines.

Nigeria

Central Bank of Nigeria

Highlights Of The Recommendations Of The Boe:

HIGHLIGHTS OF THE RECOMMENDATIONS OF THE BOE:
	REVIEW OF HSRDIS GUIDELINE
OLD	NEW (AMENDMENT)
1.	Introduction	1.	Introduction
The Central Bank of Nigeria (CBN), as	The Central Bank of Nigeria (CBN), as
part of its policy response to the COVID-	part of its policy response to the
19 pandemic, introduces the Healthcare	COVID-19 pandemic, introduces the
Sector Research and Development	Healthcare Sector Research and
Intervention Scheme (HSRDIS) to help	Development Intervention Scheme
strengthen the public healthcare system	(HSRDIS) to help strengthen the public
with innovative financing of research	healthcare system with innovative
and development (R&D) in new and	financing of research and
improved drugs, vaccines and	development (R&D) in new and
diagnostics of infectious diseases in	improved drugs, vaccines and
Nigeria. Specifically, the HSRDIS is	diagnostics of infectious diseases in
designed to trigger intense national R&D	Nigeria. Specifically, the HSRDIS is
activities to develop a Nigerian vaccine,	designed to trigger intense national
drugs and herbal medicines against the	R&D activities to develop a Nigerian
spread of COVID-19 and any other	vaccine, drugs and	herbal
communicable or non-communicable	medicines/medical devices against the
diseases through the provision of grants	spread of COVID-19 and any other
to	biotechnological	and	communicable or non-communicable
pharmaceutical companies, institutions,	diseases through the provision of grants
researchers, and research institutes for	to	biotechnological	and
the research and development of drugs,	pharmaceutical companies, institutions,
herbal medicines and vaccines for the	researchers, and research institutes for
control, prevention and treatment of	the research and development of
infectious diseases. The Scheme is	drugs, herbal medicines/medical
intended to boost domestic	devices and vaccines for the control,
manufacturing of critical drugs and		prevention and treatment of infectious

vaccines to ensure their sustainable	diseases. The Scheme is intended to
domestic supply and reduce the bulk	boost domestic manufacturing of
manufacturing costs of the drugs, herbal	critical drugs and vaccines to ensure
medicines and vaccines in Nigeria.	their sustainable domestic supply and
	reduce the bulk manufacturing costs of
The Framework outlines the operational	the drugs, herbal medicines/medical
modalities for the Scheme.	devices and vaccines in Nigeria.
	The Framework outlines the operational
	modalities for the Scheme.
2.	Objectives of the Scheme	2.	Objectives of the Scheme
The	broad objectives of Scheme	The	broad objectives of Scheme
include:	include:
2.1 Providing grants for R&D in new or	2.1 Providing grants for R&D in new
revalidation of drug molecule,	or revalidation of drug
phytomedicines and vaccines	molecule, phytomedicines
for the control, prevention and	and vaccines for the control,
treatment of infectious	prevention and treatment of
diseases in Nigeria;	infectious diseases in Nigeria;
2.2 Boosting domestic manufacturing	2.2 Boosting	domestic
of validated drugs (Active	manufacturing of validated
Pharmaceutical Ingredients or	drugs (Active Pharmaceutical
APIs), herbal medicines and	Ingredients or APIs), herbal
vaccines for the control,	medicines/medical devices
prevention and treatment of	and vaccines for the control,
infectious diseases in Nigeria	prevention and treatment of
and reduce the nation's	infectious diseases in Nigeria
dependence on	other	and reduce the nation's
countries for these drugs and	dependence	on	other
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vaccines;	countries for these drugs and
	vaccines;
2.3 Improving the capacity of the	2.3 Improving the capacity of the
biotechnological	and
pharmaceutical companies,	biotechnological	and
institutions, researchers, and	pharmaceutical companies,
research institutes in the	institutions, researchers, and
development of approved	research institutes in the
Nigerian drugs, herbal	development of approved
medicines and vaccines for	Nigerian drugs, herbal
infectious diseases;	medicines medical devices
	and vaccines for infectious
2.4 Supporting capacity of relevant	diseases;
health agencies towards	2.4 Supporting capacity of relevant
attaining WHO Maturity Level
3, a prerequisite for	health agencies towards
manufacturing of vaccines in	attaining WHO Maturity Level
Nigeria;	3, a prerequisite for
	manufacturing of vaccines in
2.5Facilitating partnership between	Nigeria;
academia (researchers,
research institutes and	2.5Facilitating partnership between
universities) and industry into	academia (researchers,
the	and	research institutes and
development of of drugs,	universities) and industry into
	the
phytomedicines and vaccines	and
	development of of drugs,
for the control, prevention and
treatment of infectious	phytomedicines and vaccines
diseases in Nigeria; and	for the control, prevention
	and treatment of infectious
2.6Reduce dependence on	diseases in Nigeria; and
imported drug products

(synthetic and herbal) and	2.6 Reduce	dependence	on
vaccines for the control,	imported	drug products
prevention and treatment of	(synthetic and herbal) and
infectious diseases in Nigeria.	vaccines for the control,
	prevention and treatment of
	infectious diseases in Nigeria.
3. Eligible Research and Development	2. Eligible Research and Development
Activities	Activities
Activities eligible for consideration under	Activities eligible for consideration
the Scheme shall include:	under the Scheme shall include:
i.	Research and development of	i.	Research and development of
candidate	drugs,	herbal	candidate	drugs,	herbal
medicines	and vaccines	medicines medical devices and
validated by relevant health	vaccines validated by relevant
authorities	for the control,	health authorities for the control,
prevention and treatment of	prevention and treatment of
infectious diseases;	infectious diseases;
ii.	Manufacturing of drugs, herbal	ii.	Manufacturing of drugs, herbal
medicines	and vaccines	medicines medical devices and
validated by relevant health	vaccines validated by relevant
authorities for the control,	health authorities for the control,
prevention and treatment of	prevention and treatment of
infectious diseases;	infectious diseases;
iii.	Red biotechnological R&D in new	iii.	Red biotechnological R&D in
health technology for the control,	new health technology for the
prevention and treatment of	control,	prevention	and
infectious diseases;	treatment of infectious diseases;
iv.	Research partnership between	iv.	Research partnership between
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academia and industry into the	academia and industry into the
development drugs and vaccines	development	drugs	and
for the control, prevention and	vaccines for	the control,
treatment of infectious diseases;	prevention and treatment of
	infectious diseases;
v.	Research and development into
validated phytomedicines for the	v.	Research and development into
control, prevention and treatment	validated phytomedicines for the
of infectious diseases; and	control,	prevention	and
	treatment of infectious diseases;
NOTE: Candidate vaccines undergoing	and
pre-clinical testing or trials shall not be
eligible for consideration under this	NOTE: Candidate vaccines undergoing
Scheme. However, candidate vaccines	pre-clinical testing or trials shall not be
undergoing clinical testing or trials shall	eligible for consideration under this
be eligible for consideration under the	Scheme. However, candidate vaccines
Scheme if considered to have high	undergoing late preclinical and early
potentials to cross the clinical trial stage	clinical testing or trials shall be eligible
and prospects of scale by the BoE.	for consideration under the Scheme if
	considered to have high potentials to
In applying for the grant, the applicant	cross the clinical trial stage and
shall be required to have conducted	prospects of scale by the BoE.
pre-clinical testing of the candidate
drugs, herbal medicines and vaccines,	In applying for the grant, the applicant
and obtained certification from relevant	shall be required to have conducted
health authorities for further research	pre-clinical testing of the candidate
and development.	drugs, herbal medicines/medical
	devices and vaccines, and obtained
Special consideration shall be given to	certification from relevant health
candidate drugs, herbal medicines and	authorities for further research and
vaccines with high scientific merit	development.
against	emerging infections	and
contribute to the development of the	Special consideration shall be given to
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Nigerian vaccine.	candidate can	drugs,	herbal
	medicines medical devices	and
For this purpose, a Body of Experts (BoE)	vaccines with high scientific merit
shall be constituted from the academia	against emerging infections and
and industry to review validated	contribute to the development of the
research proposal submitted and	Nigerian vaccine.
recommend for financing,	as
appropriate. The BoE shall meet	For this purpose, a Body of Experts (BoE)
regularly to appraise the research and	shall be constituted from the academia
development project and submit	and industry to review validated
progress reports to the CBN.	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	4.	Funding
The Scheme shall be funded from the	No Amendment
Developmental Component of the
Micro, Small and Medium Enterprise
Development Fund (MSMEDF).
5.	Grant Limit	5.	Grant Limit
i.	Research activities: Maximum of	No Amendment
N50.0 million.
ii.	Development/Manufacturing
activities: Maximum of N500.0
million.
NOTE: Disbursement under the Scheme
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shall	be made to	beneficiaries in
tranches subject	to	approved
milestones achieved.
6.	Research	and	Development	6.	Research	and	Development
Timeframe	Timeframe
i.	Research activities: Not more than		No Amendment
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	7.	Body of Experts
The Body of Experts (BoE) shall be	The Body of Experts (BoE) shall be
responsible for the review and	responsible for the review and
evaluation of submitted research	evaluation of submitted research
proposals, as well as recommend for	proposals, as well as recommend for
financing	R&D projects with high	financing	R&D projects with high
potentials to contribute to the	potentials to contribute to the
development of the Nigerian vaccines	development of the Nigerian vaccines
for infectious diseases. The composition	for infectious diseases. The composition
of the BoE shall be as detailed below:	of the BoE shall be as detailed below:
i.	Two (2) independent research	i.	Two (2) independent research
specialists appointed by the CBN;	specialists appointed by the CBN;
ii.	One (1) nominee from National	ii.	One (1) nominee from National
Agency for Food and Drug	Agency for Food and Drug
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Administration and Control	Administration and Control
	(NAFDAC);
(NAFDAC);
iii.	One (1) nominee from Nigeria	iii.	One (1) nominee from Nigeria
Institute	for	Pharmaceutical	Institute	for Pharmaceutical
Research	and	Development	Research and Development
(NIPRD);	(NIPRD) :
iv.	One (1) nominee from Nigeria	iv.	One (1) nominee from Nigeria
	Centre	for Disease
Centre	for	Disease	Control	Control
(NCDC); and	(NCDC); and
v.	One (1) nominee from Nigeria	v.	One (1) nominee from Nigeria
	Institute of Medical Research
Institute	of Medical Research	(NIMR)
(NIMR)
NOTE: The Chair of the BoE shall be	vi.	One (1) nominee from National
appointed by the CBN.	Biotechnological Development
	Agency (NABDA)
	NOTE: The Chair of the BoE shall be
	appointed by the CBN.
8.	Modalities	8.	Modalities
i. The applicant(s) shall submit its i.	The applicant(s) shall submit its
application,	with with	relevant	application, with	relevant
documentation of validation from	documentation of validation from
relevant health authorities, trial	relevant health authorities, trial
results, patent registration details (if	results, patent registration details (if
any) and development timetable	any) and development timetable
to the Body of Experts (BoE).	to the Body of Experts (BoE).
ii. The BoE shall evaluate applications	ii. The BoE shall evaluate applications

and recommend to the CBN	and recommend to the CBN
iii. The	CBN shall review	for	iii. The CBN shall review	for
documentation adequacy and	documentation adequacy	and
completeness;	completeness;
iv. Upon approval, the approved	iv. Upon approval, the approved
grant sum shall be released to the	grant sum shall be released to the
applicant's account with any PFI of	applicant's account with any PFI
his/her choice.	of his/her choice.
v. The beneficiary shall submit	v. The beneficiary shall submit
periodic report on the project to	periodic report on the project to
	the CBN.
the CBN.
NOTE: The CBN shall have proprietary	NOTE:	Inventions arising from	HSRDIS
	financed
right over all financed R&D outcomes or	research	ano
products. Equally, licensing protocol for	development projects must be
the mass manufacturing of developed	eported to CBN that funded
drugs, phytomedicines and vaccines	Individua
shall be defined by the BoE in	esearchers	and
accordance with the World Health	pharmaceutical manufacturers
Organisation's	current	Good	are to retain substantial (80%
Manufacturing Practices (cGMP).	devices, herbal medici
	accines made
	unded research. Inventors are
	expected	for	paten
	protection	ensure
	commercialization	upor
	licensing	for	the	benefit
	public health.
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9.	Monitoring	9.	Monitoring
Periodic joint monitoring of research and	No Amendment
development activities shall	be
conducted by the BoE and periodic
progress reports submitted to the CBN.
10.	Amendments	10.	Amendments
The	Framework shall be subject to	No Amendment
review from time to time as may be
deemed necessary by the CBN.
11. Enquiries and Returns	11. Enquiries and Returns
All enquiries and returns should be	All enquiries and returns should be
addressed to:	addressed to:
Director,	Director,
Development Finance Department,	Development Finance Department,
Central Bank of Nigeria,	Central Bank of Nigeria,
Abuja.	Abuja.
May 2020	September, 2020