Business

CBN approves N550M intervention to fund research, Development activities

By Foster Obi

The Central Bank of Nigeria is making available a maximum grant of N550m intervention funding for Healthcare Research and Development activities.

A statement by the Bank said  the  Scheme  shall  be  funded  from  the  Developmental  Component  of  the  Micro,  Small and Medium Enterprise Development Fund (MSMEDF).

The maximum grant limit for Research activities is put at N50.0 million while Development/Manufacturing activities, N500.0 million. The Bank noted that the disbursement under the scheme shall be made to beneficiaries in tranches subject to approved milestones achieved. While the timeframe for Research activities is not more than two (2) years from the date of release of fund, that of Development/Manufacturing activities should not be more than one (1) year from the date of release of fund.

According to the Bank, eligibility for consideration under the Scheme shall 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; Research  and  development  into  validated phytomedicines  for  the  control, prevention and treatment of infectious diseases.

The Bank noted that candidate  vaccines  undergoing  pre-clinical  testing  or  trials  shall  not  be  eligible   for   consideration   under   this   Scheme but added however that   candidate   vaccines   undergoing clinical  testing  or  trials  shall  be  eligible  for  consideration  under  the Classified as Confidential 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  pre-clinical 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 statement noted.

The statement said that “The 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 providing grants  for  R&D  in  new  or  revalidation  of  drug  molecule,  phyto medicines 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  Classified as Confidential reduce  the  nation’s  dependence  on  other  countries  for  these  drugs  and  vaccines; 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.”

Others are, “Supporting  capacity  of  relevant  health  agencies  towards  attaining  WHO  Maturity Level 3, a prerequisite for manufacturing of vaccines in Nigeria; 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 Reduce  dependence  on  imported  drug  products  (synthetic and herbal) and  vaccines for  the  control,  prevention  and  treatment  of  infectious diseases in Nigeria.

“ 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: Two (2) independent research specialists appointed by the CBN;. One (1) nominee from National Agency for Food and Drug Administration and Control (NAFDAC);  One  (1)  nominee  from  Nigeria  Institute  for  Pharmaceutical  Research  and  Development (NIPRD);  One (1) nominee from Nigeria Centre for Disease Control (NCDC)v. One (1) nominee from Nigeria Institute of Medical Research (NIMR) and, One (1) nominee from the Federal Ministry of Health.

The statement notes that the Chair of the BoE shall be appointed by the CBN. As regards modalities,  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).  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 Bank added that the Framework shall  be  subject  to  review  from  time  to  time  as  may  be deemed necessary by the CBN.

Pix: CBN Governor, Godwin Emefiele