*Outlines guidelines for intervention scheme

The Central Bank of Nigeria (CBN) has unveiled guidelines for its Healthcare Sector Research and Development Intervention Scheme (HSRDIS) and fixed the maximum limit eligible for development/manufacturing activities at N500 million.

However, under the HSRDIS, the maximum grant limit for research was pegged at N50 million.

In a seven-page circular obtained on its website yesterday, CBN said the initiative was part of its policy response to the COVID-19 pandemic.

It is to finance research and development (R&D) in new and improved drugs, vaccines and diagnostics of infectious diseases in the country.

The scheme is to be funded from the CBN’s developmental component of its N220 billion Micro, Small and Medium Enterprise Development Fund (MSMEDF) and disbursement shall be made to beneficiaries in tranches subject to approved milestones achieved.

The bank stated that the HSRDIS was designed to trigger intense national R&D activities to develop a Nigerian vaccine as well as 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 to boost domestic manufacturing of critical drugs and vaccines to ensure their sustainable domestic supply and reduce the bulk manufacturing cost of the drugs, herbal medicines and vaccines.

The broad objectives of the scheme, according to the CBN, include 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; 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 reducing the nation’s dependence on other countries for these drugs and vaccines.

Others include improving the capacity of biotechnological and pharmaceutical companies, institutions, researchers, and research institutes in the development of approved Nigerian drugs, herbal medicines and vaccines for infectious diseases and supporting capacity of relevant health agencies towards attaining World Health Organisation (WHO) Maturity Level 3. The WHO’s recommendation is a prerequisite for manufacturing of vaccines in Nigeria.

In addition, the objective is to facilitate 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.

The central bank listed activities eligible for consideration under the scheme to include: “Research and development of candidate drugs, herbal medicines and vaccines validated by relevant health authorities for the control, prevention and treatment of infectious diseases; manufacturing of drugs, herbal medicines and vaccines validated by relevant health authorities for the control, prevention and treatment of infectious diseases; red biotechnological R&D in new health technology for the control, prevention and treatment of infectious diseases; research partnership between academia and industry into the development drugs and vaccines for the control, prevention and treatment of infectious diseases; and research and development into validated phytomedicines for the control, prevention and treatment of infectious diseases.”

It added: “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.”

According to the CBN, the research and development timeframe will not be over two years from the date of release of fund, while for development/manufacturing activities, it shall not be more than one year from the date of release of the fund.

“The 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,” it added.

According to the CBN, the composition of the BoE shall be made up of two independent research specialists appointed by the CBN; one nominee from National Agency for Food and Drug Administration and Control (NAFDAC); one nominee from Nigeria Institute for Pharmaceutical Research and Development (NIPRD); one nominee from Nigeria Centre for Disease Control (NCDC); one nominee from Nigeria Institute of Medical Research (NIMR) and one nominee from the Federal Ministry of Health.

The BoE chair is to be appointed by the CBN.

“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.

“The BoE shall evaluate applications and recommend to the CBN. The CBN shall review for documentation adequacy and completeness. Upon approval, the approved grant sum shall be released to the applicant’s account with any PFI of his/her choice. The beneficiary shall submit periodic progress report on the project to the CBN.

“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).

Periodic joint monitoring of research and development activities shall be conducted by the BoE. The framework shall be subject to review from time to time as may be deemed necessary by the CBN,” it stated.