Terms of Reference: Provision of Technical Assistance for Building Local Capacity to Produce Quality Long Lasting Insecticide-Treated Nets (LLINs): Enhancing Local Manufacturing and Supply Chain Management for Health Commodities and Supplies in Nigeria

Nigeria faces a significant burden from both communicable and non-communicable diseases, which strains the healthcare system and hinders economic development. Despite ongoing efforts to address these challenges, the country remains heavily reliant on imports for essential health commodities. This dependency leads to high costs, supply chain vulnerabilities, and inconsistent availability of critical healthcare products. Strengthening local capacity and optimizing supply chain management is essential to improving the accessibility, affordability, and sustainability of healthcare products. This is key to advancing public health.

Market shaping strategies have proven successful in other health sectors by leveraging economies of scale, improving quality control, and enhancing distribution efficiency. Adopting this model for manufacturing and distributing essential health commodities could reduce costs, improve product consistency, and ensure more reliable supply chains. However, transitioning from an import-dependent system to one with a robust local production capacity and an efficient pooled procurement system is a complex process. It requires a comprehensive, multi-faceted approach that addresses manufacturing capabilities, quality assurance mechanisms, supply chain optimization, workforce capacity building, and supportive policy frameworks.

The Presidential Initiative for Unlocking Healthcare Value Chain (PVAC) and the National Malaria Elimination Programme (NMEP), with the support of the World Bank IMPACT, embarked on a project called "Enhancing Local Manufacturing and Supply Chain Management for Health Commodities and Supplies in Nigeria." This project aims to address these challenges through a phased approach that balances short-term and long-term objectives. The strategies for addressing these challenges will include developing and laying the groundwork for local manufacturing of malaria commodities (including ACTs, RDTs, APIs, and LLINs), enhancing production capacity, ensuring compliance with international quality standards, and fostering workforce development. At the same time, the project will focus on optimizing the pooled procurement of imported malaria commodities to improve cost-effectiveness and distribution efficiency. Over the medium to long term, these interventions will strengthen the entire health commodities value chain, create opportunities for economic growth, and support Nigeria's self-sufficiency in critical healthcare products. This comprehensive approach seeks to improve Nigeria's healthcare supply systems' efficiency and resilience while unlocking new economic opportunities within the country's health sector. The project duration is 1 year.

This consultancy aims to provide broad-spectrum technical assistance that will enhance the local production of Long-Lasting Insecticide-Treated Nets (LLINs) in Nigeria.

This assistance involves the conduct of the assessment of existing capacity gaps and institutional strengths across key operational domains like infrastructure, manufacturing processes, quality assurance and quality control (QA/QC) systems, regulatory compliance with both national and international standards (such as NAFDAC, WHO prequalification, and GMP guidelines), supply chain management, and human resource capacity. The consultancy will also explore the manufacturers’ ability to meet current and projected demand for LLITNs, their access to financing and raw materials (including active pharmaceutical ingredients), and their readiness to participate in global health procurement mechanisms. Findings from this assessment will inform strategic interventions aimed at strengthening local manufacturing capacity, enhancing Nigeria’s pharmaceutical self-reliance, and ensuring the sustainable availability of high-quality LLITNs for malaria prevention.

The assistance also includes facilitating partnerships for technology transfer, ensuring compliance with regulatory standards, and supporting policy reforms to create an enabling environment for sustainable production. The consultant/consulting firm will ensure the integration of best practices for policy and implementation and draw from previous experiences in this space to strengthen the framework (both demand and supply) for the local manufacture of quality, and affordable LLINs.

The consulting firm is expected to:

1. Develop recommendations for critical policy and regulatory reforms required for the local manufacturing of LLITNs.

   • Desk review of relevant documents, including existing policies, plans, and partner reports.
   • Analyze the best international practices in manufacturing LLITNs.
   • Evaluate current policy incentives and support mechanisms.

2. Conduct a comprehensive institutional capacity assessment of local manufacturers for LLITN production through stakeholder engagement, facility visits, and assessment

   • Finalize the list of local manufacturers of LLITNs with PVAC and NMEP.
   • Participate in the development and finalization of the assessment tools/questionnaires.
   • Collaborate with the National Malaria Elimination Program (NMEP) and regulatory institutions such as National Agency for Food and Drug Administration and Control (NAFDAC), National Institute for Pharmaceutical Research and Development (NIPRID), and private-sector pharmaceuticals.
   • Conduct site visits and inspections of shortlisted manufacturers, in collaboration with selected stakeholders, to assess facilities, equipment, and quality control measures, verifying compliance with regulatory standards and capacity for producing LLITNs. (The number of local manufacturers will be agreed during preliminary meetings with PVAC)

3. Conduct an analysis of findings and make the raw data available to PVAC and NMEP.

4. Develop a comprehensive report highlighting the findings of the assessment and recommendations on the local manufacturers that have the required capacity to be part of the project.

5. Facilitate the engagement of stakeholders (government agencies, partners, private sector structures, technical partners, etc.) relevant to realizing the goals of this workstream. These stakeholders must understand the Nigerian and international regulatory and LLIN manufacturing landscape.

6. Provide technical support to organize policy dialogues with key stakeholders to develop the implementation framework for priority recommendations.

7. Facilitate stakeholder workshops to validate findings and co-develop a strategic roadmap for local LLIN production.

8. Ensure that appropriate support is identified and provided to the selected LLIN manufacturers in the following (not-exclusive) areas:

   1. Technical support and knowledge transfer directly or through partnerships
   2. Identification of funding gaps and possible funding sources
   3. Establishment of a QA system to ensure compliance with international standards

9. Ensure the quality of all outputs from this LLIN workstream, including the compilation, assessment, and final selection of potential LLIN manufacturers and recommendations for support.

10. Meet bi-weekly with the project team to review progress and collaboratively resolve any identified issues.

There is an urgent need to strengthen Nigeria’s local manufacturing capacity, particularly in the production of Long-Lasting Insecticide-Treated Nets (LLITNs), which remain a cornerstone of malaria prevention in the country. Despite Nigeria’s high malaria burden and increasing demand for LLITNs, the country remains heavily reliant on imports, with challenges such as inconsistent product quality, weak regulatory oversight, and limited local manufacturing capacity posing significant risks to sustainable malaria control and elimination efforts. This consultancy is therefore critical to conducting a comprehensive assessment of the capacity and readiness of selected local manufacturers, identifying systemic strengths and gaps across key areas including infrastructure, regulatory compliance, quality assurance, and supply chain systems, and generating evidence-based recommendations to inform national strategies. In response to this need, PVAC is seeking the services of a qualified consultant to undertake this institutional capacity assessment for the local production of high-quality LLITNs.

This assessment will adopt a mixed-methods approach, combining qualitative and quantitative data collection and analysis to ensure a comprehensive understanding of the institutional and operational capacities of selected local pharmaceutical manufacturers producing LLITNs. The methodology will be structured around the following key phases:

• Inception Phase

  • Conduct initial meetings with the National Malaria Elimination Program (NMEP), PVAC, and other key stakeholders to agree on the scope, objectives, and expected deliverables.
  • Co-develop a detailed work plan including timelines, responsibilities, and deliverables.

• Desk Review and Development of Assessment Tools

  • Review existing policies, strategic documents, partner reports, previous assessments, and international best practices on LLITN manufacturing.
  • Collaboratively develop and validate assessment tools and checklists with input from NMEP, PVAC, and other partners.

• Stakeholder Engagement

  • Conduct Key Informant Interviews (KIIs) and consultations with key regulatory bodies (NAFDAC, NIPRID), professional associations, donors, and industry stakeholders to gather contextual insights and validate findings.

• Field Visits and Capacity Assessment

  • Finalize the shortlist of LLITN manufacturers in consultation with PVAC and NMEP.
  • Conduct structured facility visits to assess infrastructure, manufacturing processes, QA/QC systems, and compliance with national and international standards.
  • Use the finalized assessment tool to collect data across key operational domains including:
  • Infrastructure adequacy
  • Manufacturing technology and processes
  • Quality assurance and control systems
  • Regulatory compliance (NAFDAC, WHO prequalification, GMP)
  • Supply chain logistics (access to raw materials and APIs)
  • Financial capacity and access to capital
  • Human resource availability and technical competencies
  • Production capacity and demand responsiveness
  • Engage local manufacturers’ staff to assess their perspectives on challenges and opportunities related to LLITNs production and scale-up.

• Data Analysis

  • Compile and clean quantitative and qualitative data from site visits, interviews, and documents.
  • Use thematic analysis to interpret qualitative data from KIIs and stakeholder interviews.
  • Apply capacity scoring and gap analysis frameworks to quantitatively assess institutional readiness across predefined benchmarks.

• Reporting and Validation

  • Draft a comprehensive assessment report detailing:
  • Current capacity of each manufacturer across operational domains
  • Identified gaps and institutional strengths
  • Recommendations for regulatory and policy reform
  • Suggested manufacturers with the capacity to participate in the project.
  • Share raw data and findings with PVAC and NMEP in appropriate formats (e.g., Excel datasets, summary briefs).
  • Present preliminary findings in a stakeholder validation workshop to ensure feedback and consensus-building.
  • Finalize the report incorporating stakeholder feedback and submit both the narrative and data outputs.

• Capacity Building

  • Provide training services to selected manufacturers based on identified capacity gaps.
  • Facilitating partnerships for technology transfer from established manufacturers within and outside Africa to selected local manufacturers
  • Ensure compliance with regulatory standards and supporting policy reforms to create an enabling environment for sustainable production.
  • Facilitate the integration of best practices into policy development and implementation
  • Drawing from previous relevant experiences, facilitate the development of frameworks for the local manufacture of quality, and affordable LLINs across supply and demand streams.

The expected outcomes include:

• An inception report outlining the agreed scope of work and implementation approach.
• A technical document presenting key recommendations to strengthen LLITN manufacturing in Nigeria.
• A validated assessment tool/questionnaire for assessing local pharmaceutical manufacturers.
• A final assessment report detailing key findings, capacity gaps, and strategic recommendations.
• A cleaned and finalized dataset from the assessment, ready for analysis and dissemination.
• List of 1st batch LLIN manufacturers (at least 3) and a pipeline of recommended 2nd batch local LLIN manufacturers
• List of manufacturers that are ready for local LLIN production.
• Detailed map of funding opportunities
• Technical assistance reports
• Local manufacturing policies with an integrated local LLIN support mechanism.

The selection process will follow a Limited Consultant Qualification-Based Method (LCQBM). Under this approach, interested consultants will submit proposals in response to the Terms of Reference (TOR) issued by PVAC. As part of the evaluation, consultants / firms must demonstrate their relevant experience and qualifications in managing similar projects. Only the most qualified consultant/ firm with the required qualification/ expertise would be considered.

The following are the expertise required from the applying consultant / firm:

• Global Health Experience: Strong background in malaria epidemiological studies, prevention and control strategies, as well as global health programs, demonstrated experience conducting quality assurance/quality control assessments in pharmaceutical settings with experience in implementing large-scale public health interventions around LLIN development in LMICs with special interest in West Africa.
• Clinical Research Expertise: In-depth knowledge, experience and skills in epidemiological and molecular biological research with special interest in the development and evaluation of affordable LLINs as well as managing large clinical trials and its associated regulatory and certification requirements.
• Experience in LLIN Development: Expertise in the research, formulation, and manufacturing processes for LLINs, including clinical trial design and implementation.
• Stakeholders Engagement and Coordination Capabilities: Proven ability to manage multi-sectoral projects, coordinate with governments, NGOs, INGOs, donors, research institutions and private sector partners in malaria prevention and control.
• Innovative Financing: Excellent background in innovative financing for healthcare service delivery and development especially in the management of malaria in Africa.
• Regulatory Knowledge: Have a wide experience working with national and international regulations for LLIN production approval, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), WHO prequalification and NAFDAC regulatory requirements.
• Capacity Building: Experience in training and mentoring teams in clinical research, LLIN development.
• Local Context Knowledge: Familiarity with Nigeria’s pharmaceutical sector, policies, and health system. Experience working with or engaging regulatory bodies such as NAFDAC, WHO, or NIPRID is an added advantage.
• International Context Knowledge: Understanding of international health systems, and regulatory landscapes. Familiar with the operational challenges in Africa especially regarding healthcare needs and distribution challenges. Able to influence the local LLIN manufacturing landscape along the lines of international best practices.

2 months -- May to December, 2025

Interested organizations are expected to submit the following documents:

1. Technical Proposal: The technical proposal should include:

• A clear methodology that demonstrates expertise in managing this project.
• A track record and experience in implementing similar projects
• At least 3 references from similar projects

2. A valid CAC certificate (or equivalent)

3. Financial Proposal -- including clear budget narratives.

All required documents should be sent to [email protected] on or before May 19^th, 2025. Proposals sent after this date will not be considered.