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Support to Tunisia vaccine and pharmaceutical production strategy

Terms of reference for project management short-term consultant

1. Background

COVID-19 pandemic has exposed the need for every country to ensure an equitable and continuous access to medicines, vaccines, and other health technologies. Strengthening Tunisia’s national production capacity for strategic health commodities, such as vaccines and therapeutics, can improve its health system resilience, contributing to its ability to combat current and future waves of the COVID-19 pandemic as well as other health shocks. It can also generate economic benefits through allowing exports to regional and other international countries. 

Tunisia currently imports all of its vaccines, except for a locally produced BCG vaccine (by Institut Pasteur of Tunisia). While there is a range of public and private institutions as well as biomedical research capacity in Tunisia, this capacity has not been mobilized to produce vaccines. There is a dynamic local production sector for generic drugs, which covers about 65 percent of national needs by financial value. While there is national clinical research capacity, as well as both public and private actors who can engage in vaccine production, the legislative and regulatory environment is not conducive to attracting foreign investors. In this context, the development of a comprehensive national strategy for vaccine and biomedical production is a key first step to enable further investments, as well as diagnosing specific areas where Tunisia’s competitiveness and capacity can be strengthened. 

World Bank is currently supporting Tunisia’s COVID-19 response with a project focusing on the procurement and deployment of COVID-19 vaccines, as well as health system strengthening. The World Bank is also providing technical assistance around different aspects of the health system, and has been requested to provide technical assistance to a government taskforce in developing a national vaccine production strategy. Local production of vaccines (both routine and COVID-19), as well as the use of the mRNA platform for the production of other health commodities, have been identified as national priorities by the Government of Tunisia, with the intention of improving resiliency in the health sector as well as generating economic benefits. 

2. Objectives and scope of work

In order to support the government, a firm will be hired to provide the World Bank health team and the Government of Tunisia national vaccine production taskforce in the following areas: (i) a benchmarking exercise on recent international experiences on vaccine production across different dimensions, as well as international actors who can provide technology transfer to Tunisia; (ii) a feasibility study on the implementation of an mRNA production platform, as well as other vaccine production modalities, in Tunisia; and (iii) the development of an action plan and a national strategy for vaccine production in Tunisia on the basis of the benchmarking exercise and feasibility study. The World Bank is looking to recruit a short-term consultant (STC) to support the work that will be conducted by the firm, as well as support day-to-day project management and coordination activities pertaining to the task, with the objective of ensuring successful and timely implementation of the project.  

The work that will be executed by the firm is as follows:

Task 1: International benchmarking on vaccine production: This task includes the following activities:

• Conducting a situational analysis and global benchmarking on vaccine production and markets from countries in the Middle East and North Africa, sub-Saharan Africa, and Latin America regions, as well as other middle-income countries where relevant, including the collation of information on vaccine production initiatives following the COVID-19 pandemic. This situational analysis would focus on the financing arrangements, list of involved organizations and partners (e.g. companies involved in technology transfer), type of vaccines, level of production (e.g. bioproduction, fill and finish, secondary packaging), and volumes. This review would focus on all production modalities (not just mRNA but also for other types such as protein subunit, viral vector, and whole virus), not just for COVID-19 vaccines but all vaccines. The assessment would focus on country supply management, bottlenecks, market size, modalities of production (either public-private partnerships, or other modalities). Up to 15 countries can be selected for the benchmarking exercise as relevant. 
• Gathering industry intelligence through the identification of international technical structures/partners (biomedical and other companies) which are able to transfer the required technologies to Tunisia, as well as financial structures/partners who are able to invest in financing the scale up of manufacturing capacity in Tunisia. This would include a mapping of all eligible technical and financial partners who have recently been involved in technology transfer for mRNA vaccines, or other production modalities, with details regarding their capacity, and feasibility for undertaking relevant work in Tunisia. For mRNA production, it would involve a mapping of different structures on the development, control, and production of mRNA technology, including on the design and production of target DNA template, the mRNA production process (transcription of mRNA in vitro), production of liposomes, formulation of the vaccine, and any other steps. This will also include the investigation of the demand of biomedical, pharmaceutical, and other companies to engage in vaccine manufacturing in Tunisia based on incentives, public private partnership (PPP) modalities, and strategic partnerships. The firm would be expected to engage with potential multinational and regional manufacturers who may be interested in setting up local manufacturing capacities in Tunisia, as well as with multilateral stakeholders.  
• Identification of markets and market sizing, focusing on export and purchasing mechanisms that can be utilized for commodities produced in Tunisia. This will include market sizing of vaccine production for different stages (drug substance, transformation, packaging) for any potential vaccines that would be produced in Tunisia, for export to markets both within and outside of Tunisia. This would focus on drivers of demand (target population, coverage, wastage) as well as assessment of any potential unmet need in the market. 
• Assessment of supply chains for vaccines and mRNA products which would be produced in Tunisia, including on market breakdown and integration (vertical and horizontal), identification of problematic supply chain stages (e.g. fill, finish, operation, substance manufacturing), medicines and countries impacted by supply chain challenges, and benchmarking of public private partnerships (PPP) and other modalities applied in different countries. This will also be used to assess Tunisia’s potential dependence on imports from a limited number of international companies for any eventual production.

Task 2: Feasibility of the implementation of an mRNA production platform and other vaccine production modalities in Tunisia: This task includes the following activities:

• Mapping of all public and private entities in Tunisia which can undertake the production of vaccines in Tunisia, including an assessment of their capacity across different stages of production. This would include the local mapping of public and private companies and organizations within Tunisia for production as well as receiving technology transfer.
• Assessment of the governance, economic and regulatory context as it pertains to the manufacturing and export of vaccines in Tunisia, with the identification of enabling factors as well as bottlenecks in production. 

Task 3: Action plan, and inputs to a national strategy for vaccine production in Tunisia. This task involves the drafting of an action plan on the basis of the findings from tasks 1 and 2. It would include recommendations regarding enabling factors as well as bottlenecks to rectify to enable Tunisia to start producing vaccines and other health commodities. The action plan and inputs would indicate the potential comparative advantages and disadvantages of production in Tunisia, and propose a specific way forward regarding the production of vaccines and other health commodities. It would also include an action plan on the implementation of necessary steps that would have to be implemented prior to successful production of vaccines, including the necessary resources and timelines. 

In order to support the work implemented by the firm, the STC will be expected to fulfill the following tasks:

• Support the government of Tunisia taskforce in workplanning, project management, coordination, and other aspects of the project, serving as a liaison between the firm, World Bank, and the government of Tunisia on all aspects of task implementation;
• Monitor the execution of tasks and support follow-ups as needed;
• Following up with the recruited firm and the government of Tunisia taskforce to ensure effective coordination, including ensuring the collection of documents and scheduling of meetings, as relevant;
• Schedule and participate in routine meetings between the firm, government of Tunisia, and the World Bank team;
• Contribute to and review the deliverables conducted by the firm.

3. Qualifications

• Master’s degree in public health, business, management, or a related field;
• At least 5 years of experience in the Tunisian health sector, with a focus on project coordination and management;
• Previous experience on biomedical and vaccine production;
• Experience working with government of Tunisia, particularly the Ministry of Health, as well as with private sector stakeholders in health, is a plus; 
• Fluency in English, French and Arabic is required. 

4. Contract duration, payment, and reporting

The STC will be hired for 20 days, with additional days to be added as needed. The consultant will be asked to submit a timesheet every two weeks keeping track of the meetings and tasks that have been conducted as part of the task. 

The STC will report to Denizhan Duran (Health Economist, HMNHN), and work closely with the World Bank Tunisia health team as well as the vaccine production taskforce led by the Ministry of Health of Tunisia.