Feasibility Study for Pharmaceutical Manufacturing Plant Construction — Malawi Health Emergency Preparedness Program

GOVERNMENT OF THE REPUBLIC OF MALAWI

Ministry of Health and Sanitation

REQUEST FOR EXPRESSIONS OF INTEREST

CONSULTING SERVICES – FIRM SELECTION

Country : Malawi

Name of Project : Malawi Health Emergency Preparedness, Response and

Resilience Program

Project ID No : P505187

Assignment Title : Provision of Consultancy Services to conduct a

comprehensive feasibility study for the establishment of

a pharmaceutical manufacturing plant

Reference No. : MW-MOH-527821-CS-QCBS

Date of Issue : 19th March, 2025

• BACKGROUND

The Government of Malawi through the Ministry of Health is implementing the Malawi Health Emergency Preparedness, Response and Resilience project (MHEPRR). The project is financed by the International Development Association (IDA) and Global Financing Facility (GFF) at an estimated budget of US$60 Million. The project aims at consolidating efforts from the World Bank and development partners to provide relief and strengthen health systems against economic shocks, climate disasters, and public health emergencies, aligning with the Government's focus on Pandemic Preparedness and Response after COVID-19. The expected duration for implementation of the Malawi Health Emergency Preparedness, Response and Resilience project (MHEPRR) is 5 years (from 2025 to 2030). This five-year initiative is aimed at strengthening the country’s ability to respond to health crises, particularly those intensified by climate change.

• PURPOSE AND OBJECTIVES OF THE ASSIGNMENT

The purpose of this assignment is to conduct a comprehensive feasibility study for the establishment of a pharmaceutical manufacturing plant at Kameza, Blantyre, Malawi.

2.1. Specific objectives

The specific objectives of the assignment will include the following:

• To assess the technical, financial, economic, regulatory, social and environmental viability of establishing a pharmaceutical manufacturing plant

• To develop preliminary architectural and technical designs for the proposed facility, ensuring compliance with WHO Good Manufacturing Practices (GMP) and both national and international regulatory frameworks.

• To provide a roadmap for alternative investment to support phase two including a Public private partnership arrangement

• DETAILS OF THE ASSIGNMENT

The consulting firm will fully document and assess all the key processes necessary for the establishment of pharmaceutical manufacturing plant including the environmental, social, quality management practices that will enhance responses to health emergencies.

• SCOPE OF CONSULTANCY WORK

The feasibility study will determine the projected costs of establishing a pharmaceutical manufacturing plant in Malawi. It will assess environmental and social impacts, explore regulatory-compliant design options, and analyse market demand both within Malawi and across neighboring countries. The study will also evaluate the plant’s potential economic impact, including profitability and broader industrial benefits. In addition, the study will review existing policies and regulations, assess quality management systems and testing standards, and ensure compliance with national regulations, WHO guidelines, World Bank Environmental and Social Frameworks (ESF), Environmental, Health, and Safety Guidelines (EHSGs), and Good International Industry Practice (GIIP). The consultancy firm will be expected to conduct the following overarching aspects:

• Determine whether the proposed Project is feasible and bankable and is in the best interests of the nation explaining the strategic and operational benefits of the proposed Project for GoM in line with GoM’s strategic objectives and its policies in the sector.

• Consider the critical decision factors for implementing the Project, including possible Public-Private Partnerships (PPPs) as a specific procurement process, which include affordability, value for money, and risk transfer (upon a comprehensive risk assessment process) as they will be applied at every stage of preparing for, procuring, and managing the Project and its implementation agreement.

In addition, the consultancy will conduct the following actions:

(a) Pharmaceutical Sector market assessment:

• Assess the current and projected demand and supply of essential medicines at national and regional (SADC/COMESA) levels.

• Analyse current and future competition nationally and internationally.

• Analyse the potential for export market, pricing structures and distribution channels.

(b) Technical assessment:

• Map existing pharmaceutical manufacturing capabilities in Malawi, including sterile production.

• Identify the required equipment/infrastructure and technology

• Develop a procurement and implementation plan

• Review quality control and assurance requirements

• Evaluate raw material sourcing local vs imported materials

• Evaluate human resource capacity for pharmaceutical manufacturing and propose a training pipeline in partnership with KUHeS.

• Propose governance structure for the project

• Requirements on patents

• Timeframe and deliverables

(c) Regulatory and policy environment:

• Assess the legal and regulatory requirements in Malawi PMRA, MEPA, Occupational Health and Safety, Labour, quality standards, and related sector legislation .

• Benchmark Malawi’s regulatory regime against regional and international systems (e.g., cGMP AMA, WHO prequalification, US FDA, EMA, SADC harmonization frameworks and AU Model Law on Medical Products and Regulation).

• Assess the regulatory requirements in the regional market ( SADC, COMESA, EAC) for entry of local products, including mutual recognition or harmonization initiatives that may facilitate cross-border trade.

• To assess the cost and timelines and procedures associated with obtaining necessary permits, licenses and approvals.

• To review ISO certification, WHO pre-qualification and other internationally recognized quality assurance schemes.

(c) Financial and Economic assessment:

• The main aim is to assess project and financial viability. Specifically, to conduct profitability analysis; net present value, internal rate of return, return on research capital, and payback period

• Assess the capability of the project to service debt

• Risk assessment by conducting sensitivity and scenario analysis

• Assessing potential financing structure, including public-private partnerships.

• Evaluate the macro-economic factors that can affect the project

• Provide advice on the Project, including all the detailed financial, technical and legal work, as required, to prepare and enable the Contracting Authority to procure the proposed Project as a PPP.

(d) Preliminary Architectural and Technical Designs:

• Prepare functional layouts of manufacturing zones (including sterile production, warehousing, quality control laboratories, utilities, and cold chain facilities).

• Incorporate infrastructure needs such as water purification, waste treatment, energy efficiency systems, and occupational safety.

• Prepare a detailed Bill of Quantities (BoQ) for construction and equipment procurement.

• Cleanroom design and construction: Consultants specialize in designing and building cleanrooms to meet specific classification requirements (e.g., ISO 14644).

• Containment solutions

(e) Environmental and Social Impact Assessment (ESIA):

• Assess environmental implications, occupational health and safety, and community engagement.

• Develop recommendations for sustainable pharmaceutical effluent and waste management, air quality, energy and resource consumption, biodiversity or vegetation of the selected site, labour practices, community engagement and public health.

• Identify both enhancement and mitigation measures in line with national and international standards.

• Craft an Environmental, Social and Governance (ESG) strategy in line with World Bank guidelines

• DELIVERABLES

The output from the consultancy will include architectural designs, a preliminary bill of quantities, and a comprehensive, bankable project document to support financing efforts. The following are the key deliverables associated with this assignment:

5.1 Inception Report

This should include a detailed plan of work, methodology, proposed schedule, details of the facilities to be visited and stakeholders to be engaged and schedule of activities based on an initial desk top review including license/permit requirements.

5.2 Needs assessment and Solutions Options Analysis

As part of the FS, the consultant is expected to undertake a comprehensive demand study that will provide the basis for the scoping of the project and forecasting of revenues. As part of the needs assessment exercise, stakeholder consultations are expected to be undertaken so as to receive input from a range of parties that may have an interest on the project. In addition, the consultant will undertake a willingness to pay investigation, which should cover all economic and social segments of potential users and influencers so as to receive their input in the pricing of services to be rendered by the proposed project.

As part of the solutions options analysis and the Value for Money assessment, the TA will analyse all perceivable approaches to procuring the Project, both in terms of PPP arrangements and other forms of traditional public procurement, public ownership and management of the facility

5.3 Draft mid-term (interim) Report

Draft Feasibility Study Report covering all aspects of the study including procurement process assessment (inc. PPP), procurement plan.

Various legal, technical, financial and environmental due diligence investigations and comprehensive risk analysis process including market sounding

Detailed financial assessment including modelling, financing, affordability and value for money assessment including profitability of the proposed manufacturing plant, the preliminary architectural and Technical designs and the Detailed Bi