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

1. 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.

2. 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:

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

b. 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.

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

3. 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.

4. 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:

1. 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.

II. 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, retum 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

5. 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 Bills of Quantities.

An external formal stakeholder engagement process will be engaged at this stage to fully inform the external stakeholders of the process and recommendations to date and affording them the opportunity to provide input and or comment for consideration.

5.3 Dissemination workshop

Prepare and submit an electronic copy of a summary of the exercise undertaken; key findings and recommendations to be presented at a project meeting. Workshop to include relevant stakeholders from KUHES, Ministry of Health, Ministry of Education, Public Private Partnership Commision, National Construction Industry Council, Department of Public Works, Pharmacy and Regulatory Authority and relevant organizations.

5.4 Final Feasibility Report

Prepare and submit electronic and three (3) hard copies of a comprehensive consolidated feasibility final report with the respective recommendations addressing comments from KUHES, MOH, PPPC and the World Bank

6. QUALIFICATIONS OF KEY TEAM MEMBERS AND THE FIRM

The following key positions must be filled. The consultant team may propose additional specialist or team members with motivation.

6.1. Team composition or personnel requirements

The tenderer is required to provide personnel who are suited to filling the positions described, on the basis of their CVs (see....), the range of tasks involved and the required qualifications.

The below specified qualifications represent the requirements to reach the maximum number of points in the technical assessment.

Key expert 1- Pharmaceutical Manufacturing expert/Team leader

Tasks of the key expert 1

• Overall responsibility for the advisory packages of the contractor (quality and deadlines)
• Coordinating and ensuring communication with MOH/KUHES, partners and others involved in the project Regular reporting in accordance with deadlines

Qualifications of the key expert 1

• Education/training: minimum of a University degree (Master's) in Pharmacy, Pharmaceutical Sciences, Chemical engineering or related field.
• Language: C1-level language proficiency in English
• General professional experience: 15 years of experience in pharmaceutical manufacturing. pharmaceutical quality assurance, or designing of manufacturing facilities in a stringent regulatory authority or World Health Organization maturity level 3 country.
• Specific professional experience: Demonstrated experience in designing pharmaceutical manufacturing. Familiarity with pharmaceutical WHO maturity levels and stringent regulatory authority.
• Strong analytical and report-writing skills.
• Registered in their country of practice is desirable
• Regional experience. Knowledge of an African country's pharmaceutical manufacturing landscape is added advantage

Key expert 2-PPP Specialist

Tasks of the PPP expert

• Assess PPP suitability and recommend the most appropriate PPP model for the pharmaceutical plant.
• Review legal, regulatory, and policy frameworks for PPP structuring identifying any gaps in the enabling environment for pharmaceutical operations.
• Identify and allocate risks, proposing mitigation measures and a detailed risk allocation matrix.
• Support financial assessments by reviewing affordability, bankability, revenue assumptions, and value- for-money drivers.
• Lead market sounding, preparing investor materials and engaging with potential private partners to test market appetite.
• Prepare PPP sections of the feasibility study, including structuring options, procurement strategy, transaction roadmap, and preliminary term sheet.
• If the project is determined to be viable as a PPP, develop a full transaction plan and prepare procurement documents including draft PPP contract and RFP documents
• Manage stakeholder consultations ensuring alignment between technical, financial, health sector, and government institutions.

Qualifications of the PPP Specialist

• Education/training: Master's degree in Economics, Finance, Business, Engineering, Public Policy, or a related field.
• APMG CP3P certification (highly desirable) and other relevant project finance/procurement training an added advantage.
• A minimum of 15 years' demonstrated experience in providing PPP transaction advisory services/ development of large infrastructure projects on a PPP basis, including extensive experience in project structuring and risk analysis, allocation and management, project agreements; bid process management including preparation of bidding process documentation and post-bid process monitoring. Successful preparation of PPP projects with at least one financially closed project
• Experience working with government PPP units, ministries, or development partners in Africa.
• Key expert 3-Financial/Economic Specialist
• Tasks of the Financial/Economic Specialist
• Financial Modelling: Build and analyse a full financial model (CAPEX, OPEX, revenues, financing. sensitivities) and assess project affordability and bankability of the project.
• Economic Analysis: Conduct an economic cost-benefit analysis (CBA), estimating EIRR, ENPV, cost- benefit ratios, and wider socio-economic impacts.
• Market & Demand Assessment: Assess demand for pharmaceutical products and analyse local/regional market dynamics including market risks specific to pharmaceuticals, such as supply chain dependencies, export potential, and local demand forecasts, to confirm sufficient revenue streams for private sector participation.
• Value for Money (VIM) assessment: Support PPP structuring through VIM analysis comparing PPP procurement models.
• Financial Risk Analysis: Identify and quantity financial risks using sensitivity and scenario testing.
• FCCL Assessment: Evaluate fiscal commitments and contingent liabilities associated with the proposed PPP model, including government payment obligations, guarantees, revenue support mechanisms, and long-term fiscal risks.
• Financing Options: Recommend optimal funding and financing structures to enhance bankability.

Qualifications of the Financial/Economic Specialist

• Master's degree in Finance, Economics, Accounting, Business Administration, or a related field.
• Minimum of 10 years in analyzing PPP financial viability, economic appraisal and developing financial models for projects
• Demonstrated experience in dealing with capital market institutions, such as investment banks, global insurance and guarantee products, etc., and experience in raising funds for similar PPP projects until financial close and successful contract award with at least one financially closed PPP project.
• Familiarity with PPP fiscal risk analysis, including FCCL assessments.
• Experience with public-sector projects, PPP units, IFIs, or development-financed studies is an advantage.

Key expert 4- Architect

Tasks of the key expert 4

• Be co-lead with the key expert 1.
• Support the responsibility for key expert the advisory packages of the contractor (quality and deadlines)
• Coordinating and ensuring communication with MoH/KUHES, partners and others involved in the project
• Support regular reporting in accordance with deadlines
• Lead in designing the Pharmaceutical plant with ecofriendly environmental safeguards
• Navigate Pharmaceutical Regulatory Compliance when designing the facility

Qualifications of the key expert 4

• Education/training: minimum of university degree (Master's) in Architect or Civil Engineering.
• Language: C1-level language proficiency in English
• General professional experience: 15 years of experience in designing pharmaceutical manufacturing and associated works, or designing of manufacturing facilities in stringent regulatory authority or WHO maturity-level-3.
• Specific professional experience: Demonstrated experience of in designing pharmaceutical manufacturing.
• Familiarity with pharmaceutical WHO maturity levels and stringent regulatory authority in an eco-friendly environment.
• Registered with appropriate professional bodies in their country of practice
• Strong analytical and report-writing skills.
• Regional experience: Knowledge of an African country's pharmaceutical manufacturing landscape is added advantage

Expert: Environmental and Social Impact Assessment Expert:

• Master's Degree in environmental science or related degree
• 10 years post graduate experience in Environmental and Social impact assessments and implementation supervision.
• Must be registered with the relevant regulatory body in their country or Malawi
• Applied experience doing work on environmental and social safeguards for multilateral organizations on pharmaceutical projects, knowledge of WB ESF or IFC PS is an added advantage.
• Knowledge of Malawi's legislative requirements and GIIP in the manufacturing industry sector. Knowledge with World Bank Environmental and Social Safeguard Policies
• Ability to communicate with stakeholders at multiple levels.
• Fluent in Chichewa an additional benefit

Expert: Quantity Surveyor Specialist

Required skills and qualifications

• Bachelor's degree in quantity surveying, construction management or a related field. A master's degree is preferred but not essential.
• Professional membership or certification in quantity surveying or construction management preferably RICS
• 15+ years of experience in quantity surveying or cost consulting, preferably in the construction industry. Sound knowledge of construction industry practices, regulations and standards.
• Proficiency in cost estimation and cost management techniques.
• Familiarity with contract administration and legal aspects of construction projects
• Understanding general contracting, package contracting, value-based project and loading margins and lumpsum in large construction projects.
• Experience working with AutoCAD and validating quantities from the given drawings.

7.2 Required qualifications for the firm

• Be a registered firm operating under either international regulations or the rules of the Government of Malawi
• Have a minimum of 10 years' experience and have undertaken at least 3 consultancies in pharmaceutical construction in stringent regulatory country or WHO maturity-level 3 countries
• Experience in developing countries.
• Be conversant with government systems.
• Have an established team that has all relevant expertise and skills to carry out the assignment.
• Have the ability to clearly communicate, both oral and written in English. Local dialects is an added advantage.
• Have the ability to generate clear and concise reports and communicate content effectively.
• Be able to propose additional expertise
• Have undertaken at least 3 feasibility studies for construction projects.
• Have an established team that has all relevant expertise and skills to carry out the assignment.
• Have the ability to transfer knowledge to the nationals and KUHES staff

8. SELECTION METHOD

The Consultant shall be selected in accordance with the Quality and Cost Based Selection (QCBS). The attention of interested Consultants is drawn to Section 1, paragraphs 1.9 of the World Bank's "Procurement Regulations" Selection and Employment of Consultant under IBRD Loans and IDA Credits and Grants by World Bank Borrowers (Procurement Regulations"- Consultant Guidelines), setting forth the World Bank's policy on conflict of interest.

Further information can be obtained at the address 9 (a) below during office hours from 08.00 to 12.00 and 13.00 to 16.30 hours local time, except on Weekends and Public Holidays

9. SUBMISSION OF EXPRESSION OF INTEREST

Expression of Interest, clearly marked on the outer envelope with Eol name and reference number must be delivered to the address at 9(b) below and deposited in the tender box located at Ministry of Heath, 2nd Floor at or before 16:00 hours local time on 2nd April, 2026

9 (a) Address for Clarifications and Further Information

The Chairperson
Internal Procurement and Disposal of Assets Committee,
Ministry of Health
Procurement Unit - Malawi Health Emergency Preparedness, Response and Resilience Program (MHEPRRP)

Ground Floor, Room No. 17
Capital Hill Circle,
Lilongwe, Malawi.

Attention: Procurement Specialist
Email: andrewngwend@gmail.com
cc: lingonda@gmail.com, pit.tenders@mheper.mw

9 (b) Address for Submission of Expression of Interests

The Chairperson
Internal Procurement and Disposal of Assets Committee,
Ministry of Health Headquarters,
Tender Box: Second Floor,
Capital Hill Circle,
Lilongwe, Malawi.