Roundtable 1 Pharmaceutical Summary Report

THE AfCFTA AND TRANSFORMATIVE INDUSTRIALISATION ROUND TABLESERIES ROUNDTABLE SERIES

ROUNDTABLE 1

FORMULATION MANUFACTURING – VACCINES AND BIOPHARMACEUTICALS SUMMARY REPORT 2022 Cape Town

Linkoping House 27 Burg Road Rondebosch 7700 Cape Town T +27 (0) 21 650 1420 F +27 (0) 21 650 5709 E nelsonmandelaschool@uct.ac.za www.nelsonmandelaschool.uct.ac.za Design: Mandy Darling, Magenta Media

Contents 1. Background and Context .......................................................................................................................... 2 2. Roundtable Objectives..............................................................................................................................4 3. Roundtable 1: Formulation Manufacturing – Vaccines and Biopharmaceuticals........................... 5 4. Summary of Presentations........................................................................................................................ 6 4.1 Introductory Remarks & Welcome Address.................................................................................... 6 4.2 Introduction: Contextualization of the vaccine manufacturing discussion in terms of AfCFTA and what makes this discussion different from others?

How do we become action and implementation orientated?.......................................................... 7 4.3 What practical steps need to be taken to lay the right foundation for a viable network of manufacturers that will serve the African continent as well as markets beyond?.................. 8 4.4 What policy successes and challenges face Africa and what opportunities can be leveraged today to promote vaccine manufacturing?....................................................................... 9 4.5 How can the AfCFTA be leveraged for profitability and growth in African markets?........... 10 4.6 Discussion and Recommendations.................................................................................................12 5. Policy considerations................................................................................................................................13 5.1 Potential for Localization of Vaccine Production Inputs............................................................13 5.2 Opportunities for non-manufacturing countries to participate in the vaccine manufacturing value chain......................................................................................................................13 6. Conclusion...................................................................................................................................................15

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1. Background and Context The Nelson Mandela School of Public Governance at the University of Cape Town, in partnership with the Centre for Competition, Regulation and Economic Development (CCRED) at the University of Johannesburg, launched the AfCFTA and Transformative Industrialisation series in 2020. The main objective of this series was to explore the potential of building regional value chains in pharmaceuticals, agriculture, textiles and clothing, to strengthen policy implementation of the AfCFTA. In 2022, the Nelson Mandela School and its partners sought to make key policy and other actionable recommendations to develop regional value chains in the healthcare and pharmaceutical sector across Africa through leveraging opportunities presented by the implementation of the African Continental Free Trade Agreement (AfCFTA). To this end, a roundtable series on pharmaceutical manufacturing was curated for delivery in 2022.

Many organisations have raised the issues of vaccine equity and the lack of access to vaccines in Africa since the start of the pandemic. Ways to address this inequity, both to meet the needs of the continent during the current pandemic and to create a state of self-sufficiency and competitiveness through local manufacturing, have been debated. Varying solutions have been proposed, some of which will keep the African continent in a perpetual state of external dependency.

National and international responses to the Covid-19 pandemic have further exposed the global asymmetries in installed manufacturing capabilities and industrialization1. This inadequacy, as further revealed by the pandemic has renewed concerns and the genuine commitment to change the narrative of Africa’s lag in industrialization when compared with its peers2.

Pharmaceuticals are ranked the 4th highest category in terms of the value of imports to sub-Saharan Africa in 2018 (World Integrated Trade Solution), amounting to 70% - 90% of the total market in this region. In sharp contrast, the value of exports of pharmaceuticals in the same year was less than 10% of the value of imports3.

An assessment of the vaccine manufacturing landscape in Africa reveals that the situation is dire in comparison to pharmaceuticals. Vaccine production in Africa is currently estimated at around one percent of the domestic need of the continent for routine immunization – this does not include needs for pandemic and outbreak control. There is limited accurate and up-to-date information on the status of existing vaccine manufacturing facilities in terms of their manufacturing capacity, sustainability in terms of business viability, compliance with required regulatory standards and their ability to ensure the security of supply.

In response to this critical and urgent need for vaccines, Heads of State from across the continent met to make a collective commitment of manufacturing at least 60% of Africa’s consumption of vaccines for routine immunization on the continent by 20404. This important task was delegated to the Africa Centres for Disease Control and Prevention (Africa CDC) who facilitated the inauguration of the Partnerships for Africa’s Vaccine Manufacturing (PAVM) in April 2021, together with the establishment of several technical task teams with experts from Africa.

Africa CDC’s PAVM initiative has motivated at least 9 countries on the continent to start (or plan) multiple initiatives towards expanding domestic manufacturing capacity on the continent, starting with Covid-19 vaccines through

1 Kumar A, Singh R, Kaur J, et al. (2021, November). Wuhan to World: The COVID-19 Pandemic. Front Cell Infect Microbiol. doi:10.3389/FCIMB.2021.596201/FULL 2 The African Continental Free Trade Area. Accessed March 10, 2022. https://www.worldbank.org/en/topic/trade/ publication/the-african-continental-free-trade-area 3 Banga et al., 2020; Conway et al. 2019; UNCTAD. 4 Africa-CDC. (2021). African Union and Africa CDC launches Partnerships for African Vaccine Manufacturing (PAVM), framework to achieve it and signs 2 MoUs. 12th and 13th April 2021. Africa Union-Africa CDC; Africa-CDC. 2021. Partnerships for African Vaccine Manufacturing in Africa (PAVM) –workshop with mRNA vaccine manufacturers and key players: Concept Note. Addis Ababa: Africa Union-Africa CDC.

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Pharmaceuticals, Health Care Value Chains and Health Resilience • SUMMARY REPORT

the establishment of partnerships, and new manufacturing facilities or upgrading existing facilities. These countries include Algeria, Egypt, Ghana, Morocco, Nigeria, Rwanda, Senegal, South Africa and Uganda.

Some of these countries have taken the bold step to manufacture vaccines using newer technologies like the mRNA platform. Other initiatives include the development of novel vaccines using virus-like particle technology platforms.

In addition, the Africa CDC, World Health Organisation (WHO) and Covid-19 Vaccines Global Access (COVAX) have partnered with government and industry stakeholders to set up the first African Covid messenger RNA (mRNA) vaccine technology transfer hub in South Africa.

The PAVM initiative has focused mainly on the mRNA vaccines (Moderna and Pfizer/ BioNTech), and the adenovirus vector platform (AVV) vaccines developed by Johnson & Johnson5,6. These efforts have so far also focused predominantly on the latter part of the vaccine value chain, i.e. fill & finish, which is considered less complex but at the same time creates some level of vulnerability due to the ongoing dependence created by the need to import the drug substance or active for the vaccines.

In addition, due to the urgency of the pandemic and the need to optimize speed and quality, there is limited opportunity to source any of the production input materials required for the

manufacturing of vaccines from local African sources due to stringent regulatory requirements. Changes in the source of production inputs or manufacturing process methods would require regulatory approval and, if significant, could require new clinical trials due to the potential clinical impact on patients.

Other initiatives within the PAVM framework, such as pathways for regulatory harmonisation, tech transfer & IP and R&D for vaccines to be produced in Africa will require the support of the AfCFTA Secretariat to create an enabling environment to establish optimized regional value chains for sustainable vaccines production.

Even though the pandemic has created a high level of momentum to develop local vaccine manufacturing capabilities with urgency, there is also a fair amount of scepticism around African countries’ capabilities to implement and maintain this level of manufacturing infrastructure. There is also the risk of duplication of effort and capabilities across countries which may become problematic in terms of access to markets to consider.

While the current efforts are nested in the global push for access to Covid-19 vaccines on the continent, a holistic, implementable strategy that is African-led is needed to ensure sustainable health security and self-sufficiency in the supply of critical health commodities to its populations.

5 The Johnson & Johnson vaccine is already being manufactured (fill and finish) by Aspen Pharmacare in South Africa 6 Slaoui, M. & Hepburn, M. (2020). Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach. The New England Journal of Medicine. (383;18):1701-1703. https://www.nejm.org/doi/full/10.1056/NEJMp2027405.

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2. Roundtable Objectives This roundtable was the first of a series of discussions hosted by the Nelson Mandela School of Public Governance to make key policy recommendations for the development of regional value chains in the vaccine value chain through localisation, and leverage of the opportunities presented by the implementation of the African Continental Free Trade Agreement (AfCFTA).

This roundtable was hosted and led by African thinkers to develop implementable recommendations to policymakers that will bear fruit quickly to the benefit of member states, as well as improve health security.

Thought leaders and technical experts from around the African continent discussed key questions regarding the practical aspects of the formulation manufacturing part of the vaccine production process. The intention has been to explore opportunities for localisation, including the sourcing of production inputs, roles for non-manufacturing countries to contribute to the value chain and exploring opportunities to create regional value chains.

During the past 18 months, many organisations globally have raised the issues of vaccine equity and the lack of access to vaccines in Africa.

This topic and the various ways to address this inequity both to meet the vaccine needs of the continent during the current pandemic and to create a state of self-sufficiency, health security and resiliency and competitiveness through local manufacturing, have been discussed in various forums, webinars and conferences.

Previous webinars, conferences and discussions focused on the need for Africa to develop its local manufacturing capacity through public-private partnerships, investing in manufacturing infrastructure, technology transfer, etc. However, these discussions and debates stopped short of the practical implementation aspects that will be required to create long term sustainability at a local level, the capabilities required to achieve this and exploring opportunities and natural advantages we have that can be leveraged to enhance efficiencies in the value chain.

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Pharmaceuticals, Health Care Value Chains and Health Resilience • SUMMARY REPORT

3. Roundtable 1: Formulation Manufacturing – Vaccines and Biopharmaceuticals The first roundtable in this series was hosted on 1 February 2022. The session addressed: Formulation Manufacturing – Vaccines and Biopharmaceuticals and was led by Ms Kirti Narsai, an African pharmaceuticals expert and research lead on vaccine manufacturing at the Nelson Mandela School. The manufacturing of

Preclinical development & testing

Clinical development & testing

Vaccine administration to population

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Production process development

Vaccine distribution

vaccines and biopharmaceuticals is a complex process that is quite different to that of small molecules found in pharmaceutical products which require robust quality management systems and strong regulatory systems.

Figure 1: Vaccine production and deployment process7 Scale-up & tech transfer for manufacturing of vaccine active ingredient/drug substance (DS)

Final vaccine product filled into glass vials (fill to finish f2f) under GMP

DS Production under GMP

Sourcing of raw materials & consumables for manufacturing DS

Adapted from Plotkin, S. et al. (2017). The complexity and cost of vaccine manufacturing – an overview. Vaccine.

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4. Summary of Presentations The roundtable comprised three sections, guided by a set of questions posed to pharmaceutical industry experts. Ms Kirti Narsai, the pharmaceuticals research stream leader at The Nelson Mandela School, led the discussions. The session started with introductory remarks by Prof Faizel Ismail, the Director of the Nelson Mandela School. Ms Narsai provided an overview of the theme before introducing the speakers. The list of speakers is provided below: Speaker Name

Title, Organisation CEO, Innovative Biotech Nigeria

Dr Simon Agwale

Dr Paul A Lartey

Pharmaceutical Industry Best Practice Advisor at the National Coordination Center and Senior Consultant for Pharmaceutical R&D at BioBridges in the US CEO-DCVMN

Mr Rajinder Suri

Dr Chidi Nweneka

Global Health and Strategic Management expert; Chair, Advocacy Working Group of the African Vaccine Manufacturing Initiative (AVMI) Social Cohesion and Public Health, Research Stream Lead: Pharmaceutical Manufacturing in Africa, The Nelson Mandela School (UCT)

Ms Kirti Narsai

4.1 Introductory Remarks & Welcome Address Ms Kirti Narsai opened the session by welcoming all participants and speakers to the roundtable. Prof Faizel Ismail delivered the official welcome address. He provided an overview of the Nelson Mandela School and its Pan African approach to strategic policymaking, which includes networks of academics, policymakers, civil society and the private sector. He described the first AfCFTA and Transformative Industrialisation webinar series, which provided the foundation for a dedicated stream of work on vaccine production in Africa.

Covid-19 exposed the asymmetries and inequalities in the global world. The campaign launched by India and South Africa on intellectual property rights for patents was an important step in addressing these inequalities. Over 100 countries supported the call for a waiver on intellectual property rights, pointing to the need for global solutions to health problems that are inclusive. The second area of vaccine access and distribution remains a big challenge. The Global North has accessed vaccines including booster doses for its populations, whilst those from less affluent countries have not been able to do so. The Executive Director of the United Nations AIDS organisation referred to this as “vaccine apartheid”.

“We are witness to a vaccine apartheid that is only serving the interests of powerful and profitable pharmaceutical corporations while costing us the quickest and least harmful route out of this crisis.”8 Thirdly, the inequity in vaccine production across Africa is a great concern. As highlighted earlier in this report, Africa produces one

8 Statement by Winnie Byanyima, Executive Director of UNAIDS, in 2021. Quoted by Sirleaf, Matiangai. 2021. “Omicron: The Variant that Vaccine Apartheid Built.” Just Security. [accessed in March 2022]

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Pharmaceuticals, Health Care Value Chains and Health Resilience • SUMMARY REPORT

percent of its total vaccine consumption. Ninety-nine percent of these vaccines are imported from elsewhere in the world. A similar pattern is evidenced across the pharmaceutical sector as a whole, including access to and distribution of pharmaceutical technologies.

It is important to explore how Africa can produce its vaccine and health technologies and expand manufacturing capabilities. Prof Ismail celebrated leadership on the continent through Africa CDC, which has brought countries together to negotiate and apply pressure on big pharmaceutical companies; and is also driving research through its task force. He stressed the Nelson Mandela School’s commitment to research and dialogue that supports the work of the AfCFTA Secretariat, Africa CDC and other partners. Prof Ismail thanked the speakers and Ms Narsai for dedicating their time to contribute to this research process.

Ms Narsai posited that a new approach to vaccine manufacturing must include non-manufacturing countries and analyse how they can contribute to the value chain by providing either production or service inputs into the value chain to improve efficiency and reduce costs. Additionally, questions need to be asked about where production inputs, equipment and services come from currently, and what is the potential for localisation without hampering the production process. She noted the vaccine stockouts which took place in 2021 were a result of import dependency on production inputs, and therefore it is important to ensure that this does not happen in the future.

She introduced the panel to the roundtable participants. The speaker bios are included in the final section of this report.

4.2 Introduction: Contextualization of the vaccine manufacturing discussion in terms of AfCFTA and what makes this discussion different from others? How do we become action and implementation orientated?

Ms Narsai noted the multiple conversations, which took place in 2021 to address the global challenge of vaccine equity and the lack of vaccine manufacturing capacity in Africa.

Although these dialogues achieved consensus that Africa needed to develop its vaccine manufacturing capacity, the conversations stopped short of translating policy into practical recommendations on how to establish sustainable local vaccine manufacturing capabilities.

She emphasized that the AfCFTA provides an important framework to drive this agenda since other pillars, including Africa’s Pharmaceutical Manufacturing Plan and existing national industrial policies, which prioritised local pharmaceutical manufacturing in many countries have not managed to reach the objectives of sector development and self-sufficiency.

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4.3 What practical steps need to be taken to lay the right foundation for a viable network of manufacturers that will serve the African continent as well as markets beyond?

Dr Chidi Nweneka provided an overview and noted the need to assess the feasibility of such a venture, making informed decisions and a firm commitment to follow through on the process.

He welcomed the enthusiasm from countries and companies willing to start vaccine manufacturing on the continent but highlighted that the practical realities of vaccine manufacturing are complex and go beyond investments in bricks and mortar to establish manufacturing hubs. Dr Nweneka emphasized that there is a need to plan for the long-term and to plan sustainably.

Dr Nweneka stressed the importance of creating an enabling environment for local vaccine manufacturing and he also highlighted the important role that governments play in creating an enabling environment for success, whilst also contributing the necessary resourc-

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es. The role of African governments needs to be clarified in terms of vaccine components.

Comprehensive risk assessment is required due to political instability and policy uncertainty in some countries.

Commitment from state actors reassures the investors that the operating environment is stable, especially in the African context, which is plagued by political instability and policy inconsistency. Investors need this assurance for continuity.

Additionally, governments can promote technology transfer by ensuring that the production of drug substances and other inputs is carried out in Africa. These components are important and should be prioritised over “fill and finish”.

The factories producing drug substances can be hubs for technology transfer. There needs to be an acknowledgement that vaccine manufacturing constitutes a complex process and therefore a realistic appraisal is required.

Dr Nweneka identified effective collaboration as one of the keys to overcoming bottlenecks in the localisation of vaccine manufacturing.

He added that implementation is imperative to effective collaboration. Partners in the implementation process must each bring something

Pharmaceuticals, Health Care Value Chains and Health Resilience • SUMMARY REPORT

to the table to: facilitate innovation, improve chances of effective knowledge and technology transfer, reduce the risk of duplication of activities and unhealthy competition, promote optimal resource utilisation and creation of an ideal environment for consistent supply of inputs for vaccine manufacturing, and promote collective bargaining with established vaccine manufacturers.

Funding remains a challenge. African entrepreneurs and philanthropists should partner in initiatives to promote vaccine manufacturing.

One way to do this is through education. To date, sensitisation has taken place, but not the education of potential African manufacturers.

Identification of skills gaps and how to fill these gaps by building a resource base supported by African capital will be key.

Dr Nweneka reiterated the role of non-manufacturing countries in contributing to the value chain. He described a spider web of actors, who can play different complementary roles.

For example, one scenario could be where Nigeria may have a manufacturing plant that produces finished products, while research and development can be hosted in another country with strong research capacity; clinical trials can be carried out in other countries with the capacity to support this activity. Production of the media for the drug substances used in vaccines can also be produced off-site in other countries.

4.4 What policy successes and challenges face Africa and what opportunities can be leveraged today to promote vaccine manufacturing?

In this way, there is potential for multiple countries to play a role in the value chain across the continent. He pointed out that similarly, Boeing and Airbus manufacture parts in different locations and bring them together at their assembly facilities. Countries with assembly facilities and those contributing to production can have co-ownership of the final products.

This would provide an incentive for vaccine manufacturing. It would also help to address concerns from new investors, where there are strong players already active in the market.

A good example of co-ownership includes the production and clinical trials for the Simcoe Muskoka vaccine in the Gambia. Although the Gambia did not produce the vaccines and do not have vaccine manufacturing facilities, it offered an environment which was conducive to conducting clinical trials. The Gambia now has co-ownership of the vaccine and can receive the vaccine. A similar approach can be adopted more broadly in terms of vaccine manufacturing in Africa.

In looking ahead, it is necessary to have comprehensive conversations with multilateral institutions already operating in Africa, including UNICEF, GAVI and other partners. Agreements need to be put in place.

Dr Paul Lartey drew from decades of experience in pharmaceutical manufacturing to identify the successes and challenges confronting Africa. He pioneered the establishment of a company in Ghana to address drug access problems in Africa. The vision was to set up the entire value chain comprising the discovery, development and manufacturing of drug substances (APIs) and finished dosage forms.

Good manufacturing practice means full compliance with regulations to ensure that the drugs produced adhere to the required quality assurance standards and requires more than the design and construction of a facility. It also includes the equipment used, the people and the behaviour of the teams involved, all of which are equally important.

It is challenging to employ highly trained people who understand Good Manufacturing Practise (GMP).

Dr Lartey pointed out that graduates from the continent with specialisation in chemistry, biochemistry, chemical engineering and other fields worked to their advantage. Graduates were recruited directly out of university or college and additional training was provided on the job to build their knowledge and experience in the industry. This worked very well in developing the appropriate skills needed in the industry.

This initiative was further developed through strategic partnerships to develop good manufacturing practice skills training. At the time, UNIDO was driving initiatives on the local manufacture of antiretroviral drugs on

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the continent. Through partnerships with UNIDO and the The Deutsche Gesellschaft für Internationale Zusammenarbeit GmbH (GIZ), AUDA-NEPAD, Dr Lartey and his team established a training course that focused on pharmaceutical technology.

He stressed the importance of establishing good relationships amongst key stakeholders, including pharmaceutical regulators and pharmaceutical manufacturing associations for advocacy.

In terms of local pharmaceutical manufacturing, Dr Lartey identified four key challenges. The first relates to infrastructure including access to electricity, water, and effluent treatment, which were lacking. Addressing these challenges proved difficult. Secondly, the market dynamics of working in small economies exposed what an integrated economy can do for emerging economies. For example, Nasdaq meant product registration costs were much lower in Ghana and Nigeria. Thirdly, barriers to regulation especially in registering products from English-speaking to French-speaking African countries proved near impossible.

Finally, access to capital is difficult to secure, especially borrowing for construction.

Today’s environment provides the following opportunities: to start, awareness that Africa needs industrial growth has translated into the establishment of industrial parks, with the necessary infrastructure (electricity, water and transport systems). The AfCFTA expands the market potential for products. Regulatory barriers have been addressed by the African Medicines Regulatory Harmonisation (AMRH) to some extent by establishing the African Medicines Agency. Once fully operational, this will enable companies to register medicines in one country and distribute them across the continent without experiencing any problems.

With regards to access to capital, the Federation of Pharmaceutical Manufacturers Association negotiated with the African Union, to establish a fund for African pharmaceutical development.

This was endorsed by the Executive Council of the Specialised Technical Committee on Health, with the AUC and AUDA-NEPAD. The pandemic necessitates the reactivation of this fund for the pharmaceutical sector.

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4.5 How can the AfCFTA be leveraged for profitability and growth in African markets?

Dr Simon Agwale identified specific areas hampering productive practices on the continent and provided strategies on how to overcome these barriers. He talked about the hesitancy amongst vaccine manufacturers to invest due to high costs which run into the millions of US dollars. Secondly, he observed that sustaining manufacturing on the continent requires thinking outside the box – with a model that goes beyond “fill and finish”. Sustainability will also need a focus on upstream processes such as drug substance manufacturing. Technology transfer must take place from experienced manufacturers to those at the local level, bridging the finance gap by creating advanced purchase commitments.

Like Dr Lartey’s presentation, Dr Agwale stressed the need to establish collaborative partnerships to aid the manufacturing process.

This approach proved helpful in the production of the Human Papillomavirus (HPV) vaccine to prevent cervical cancer. This platform has also been used to develop Ebola and Covid vaccines.

The virus-like particle allows manufacturers to work with different variants simultaneously. In developing the vaccines, the move to commercialisation would require further testing and clinical trials.

Vaccine manufacturing facilities must be designed based on the manufacturing process that is developed for a specific vaccine. The establishment of these facilities has also benefitted from international partnerships including with Merck KGA which specialises in the supply of manufacturing equipment. Other partners have provided capital investment, resources, knowledge, and technology transfer using a plug and play approach, where the facility is developed remotely and then shipped to the final location, once completed. This model will be used until the facilities in Nigeria are fully operational.

An important area includes the development of surveillance tools, which are needed for detecting and monitoring different diseases on the continent. Partnerships with AfroMedics have helped with the detection of multiple diseases simultaneously.

Pharmaceuticals, Health Care Value Chains and Health Resilience • SUMMARY REPORT

Mr Rajinder Suri provided an external assessment of the opportunities. On the backdrop of the Covid-19 pandemic, Mr Suri said, “any adversity brings with it an opportunity.” He stated that Africa’s population of over 1.38 billion and a GDP growth of over USD 2.5 trillion gives Africans an opportunity to manufacture for Africa in Africa. The current vaccine demand translates to over USD 1 billion and is expected to triple in the next decade to USD 5 billion. This huge opportunity considers the vaccine inequities, and the unique support through political will, research, regulators and technology. The environment is conducive for vaccine manufacturing grounded on four pillars, namely: 1) Technology, 2) Infrastructure, 3) Investment: Access to Capital, and 4) People: Human Resources.

He cast sight beyond Covid-19 to plan for future pandemics and diseases by promoting effective technology transfer. He reiterated Dr Agwale’s point about platform technologies for the manufacture of various vaccines and also endorsed the move away from a sole focus on “fill and finish” facilities. Mr Suri also asked who will design and build the facilities that are required to do this and confirmed the complexities of building vaccine facilities.

Mr Suri agreed with the need for timely and sustained investments. He identified the relevance of innovative funding mechanisms that allow for recovery and pay-back in the long term. He pointed out that a competent workforce is the most important pillar and gives life to the shells that are facilities. Universities and biotech institutions need to provide expertise along with all parts of the value chain including production, quality control, quality assurance, engineering and regulation. In addition to formalised education, additional training within the facilities is also important.

He talked about the affordability and quality of vaccine products from India, and how the Indian experience provides useful learning points.

He added that partnerships between existing manufacturers with tested facilities are necessary to pass on knowledge and expertise. Mr Suri listed some of the partnerships between manufacturers, including those that help with planning for manufacturing facilities. Instead of shifting all vaccine manufacturing to local facilities, Mr Suri argued that a list of critical vaccines should be provided. The identification

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of raw materials and their providers needs to be planned to ensure viability. In his words, “buy local first”.

Finally, he alluded to the call for sustainable manufacturing practices. Similar to other speakers, he reinforced the importance of collaboration in knowledge sharing, the splitting of vaccine manufacturing across different facilities, and the production of equipment such as refrigerated transport and facilities.

Symbiotic relationships amongst manufacturers of key inputs need to prioritise local products versus imports to cut costs and build across the value chain.

4.6 Discussion and Recommendations Utilising varying technologies There are advantages to using varying platform technologies for the development of novel vaccines as they provide an opportunity to develop for the future, without limiting the focus on single viruses and mitigating the risk of duplication of capabilities. Technological flexibility means investments go further, creating room for further innovation. Using well-established vaccine platforms also provides many advantages to local manufacturers to allow for timely interventions as viruses and diseases change.

The People Matter Ms Narsai asked how educational institutions and policymakers can make sure people are trained and provide human resources for sustainable local manufacturing. Mr Suri stressed the need for industrialised training which covers upstream and downstream

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production, solution formulation, procurement, regulation and quality control. These aspects of industrialised training must be streamlined in tertiary education programmes with an integrated internship to apply their learning before uptake into good manufacturing practice facilities. Dr Lartey noted that public institutions and industry can provide scholarships within schools of pharmacy. In-house company training must complement formal education to remain relevant. To this end, Dr Nweneka underscored the need for the industry to partner with academic institutions.

The Role of Policymakers and the Enabling Environment All speakers mentioned the importance of an enabling policy environment. Dr Lartey pointed to the existence of policies and lack of funding to support local manufacturing. He lamented the lack of an enabling environment, underpinned by unsustainable funding. Dr Nweneka noted that the implementation of effective partnerships will also help to ensure quality control and uptake of pharmaceutical goods by other African countries. Genuine political commitment and leadership are required to get this off the ground. Policies protecting the market and supporting initiatives towards localisation are required.

The Opportunity: Vaccine Manufacturing Inputs There are more than 200 components or production inputs required in the vaccine manufacturing process to produce vaccines.

Partnerships across experienced and emerging manufacturers will help to promote the production of these components on the continent. Collaboration agreements should be put in place after identifying a core list of components to start with.

Pharmaceuticals, Health Care Value Chains and Health Resilience • SUMMARY REPORT

5. Policy considerations The ability of Africa to produce vaccines locally is heavily reliant on two variables, which are: • Talent: this requires innovative thinking and initiatives in developing appropriate work-ready programs through partnerships between academia, governments, multilateral organisations, civil society and the private sector. It also requires leveraging technology and existing as well as new infrastructure as much as possible to ensure that an enabling environment is created to develop and retain talent on the continent.

• Centres of Excellence: the presence or establishment of centres of excellence where hands-on experiences and training are given precedence over theoretical knowledge only.

5.1 Potential for Localization of Vaccine Production Inputs It was noted by the speakers that approximately 200 production inputs are required in the vaccine manufacturing process, many of which are currently imported, creating another external dependency in the value chain. Localization of these production inputs will create further opportunities for the creation of regional value chains and potentially the creation of new businesses and industries to support the value chain. Potential opportunities can be described as follows:

Local sourcing of raw materials: • This is to mitigate the need to incur excessive freight costs and associated tariffs and duties, and therefore lower the overall cost of production.

• To encourage this, policies that encourage local sourcing of production inputs should be implemented and/or incentivized.

Policy Certainty: • This is a critical consideration for investor confidence and should outlive changes in administration at a local level.

• This will require legal and constitutional

assurances to ensure that there is perpetuation in governments’ regulations and policy implementation at national, regional and continental levels.

Collaboration: • There is the need for extensive collaboration amongst existing manufacturers in the establishment of manufacturing capabilities, which will allow for knowledge and technology transfer.

• However, existing manufacturers may need some kind of assurances in the form of royalty payment agreements. This will serve as an incentive to them, giving them the assurance of profitability and continuing partnership.

Robust multilateral cooperation: • Collaboration among African countries to ensure a strategic distribution of the manufacturing value chain across several countries.

• The collaboration will also involve a joint agreement on the extent of the involvement of the different countries.

• It will also deliberate on the determination of the physical location of the manufacturing installations and that of the accessorial services. This approach engenders a sense of co-ownership and as such helps to increase the ease of market penetration and the overall success of the venture.

• It will also help to reduce the chances of the duplication of tasks and allow for the maximization of meagre resources.

5.2 Opportunities for nonmanufacturing countries to participate in the vaccine manufacturing value chain Out of the 55 countries in Africa, the majority of countries will be classified as ‘non-manufacturing’ countries in terms of their vaccine

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manufacturing capabilities. However, there are opportunities for these countries to participate in the value chain by leveraging natural advantages and/or through the development of new capabilities to provide services and/or production inputs into the vaccine value chain.

Some examples of such opportunities are listed below: • Provision of production inputs into the vaccine value chain: » For instance, traditional fermentation processes can be incorporated.

This process can be introduced to the production of bacteria that can be genetically modified. The general module of membrane antigens (GIMMA) can produce up to 100million doses of vaccines9. These processes will cost less and can be fine-tuned to meet up with regulatory standards1.

• Production materials like active pharmaceutical ingredients (antigen preparations like mRNA materials, virus-like particles, live attenuated viruses e.t.c.), excipients (pharmaceutical grade water, solvents, diluents, preservatives e.t.c) and packaging materials (vials, ampoules, rubber stoppers, labels).

• Provision of infrastructure elements into the vaccine value chain. » Manufacturing Equipment: such as bioreactors, filtration units and freeze driers that are critical to vaccine production are imported. They are externally sourced. » Good Manufacturing Practice (GMP) compliant production facilities are imported and assembled in Africa. The continent does not currently have the capacity to produce such equipment. » Cold chain facilities are required to keep vaccines within a limited temperature range to maintain efficacy throughout the entire supply chain. This is especially important because some parts of Africa do not have an uninterrupted power supply. These facilities include cold rooms, refrigerators, refrigerated vehi-

cles, and cold boxes.

• Provision of services into the vaccine value chain: » Training: ~ This involves arming professionals with the requisite skillsets necessary to function effectively at various points in the value chain. The process of educating and training people must be detailed and thorough because of the intricacies involved in vaccine production. The focus of education should be industrialized training and can be achieved through educational institutions as well as training programs and workshops organized by international agencies. ~ Human resources such as research personnel, machine operators, engineers, quality control, and quality assurance officers, bioengineers and production officers.

• Technical skills and knowledge requisite for vaccine production are currently not available on the continent. » Research and development: ~ To introduce novel processes best suited for Africa using local resources.

This is especially for diseases that are endemic in the continent. In addition, the countries can undertake the invention and production of raw materials, active pharmaceutical ingredients (APIs), excipients, packaging materials, and storage materials that will be used to produce vaccines that are safe and efficacious. This can be done in basic research laboratories to form a foundation for subsequent processes of vaccine manufacturing.

• Clinical trials in countries that have resources to support them.

This gives such countries a right to co-ownership of the vaccine.

9 Gerke C, Colucci AM, Gainnelli C, Sanzone S, Vitali CG, Sollai L. (n.d.). Produstion of Shigella sonnei vaccine based on generalized mosules for membrane antigens (GMMA), 1790GA. PLoS ONE (2015) 10e0134478 doi:101371/journal.pone.0134478

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Pharmaceuticals, Health Care Value Chains and Health Resilience • SUMMARY REPORT

6. Conclusion An Africa that is self-sufficient in vaccine production will require an extensive range of collaboration, critical appraisal, in-depth risk assessment, governmental involvement, local capacity building and continued policy implementation.

As healthcare innovation progresses and public health is confronted with multiple unexpected shocks, as demonstrated by the current pandemic, there is a need for Africa to focus on an agile approach to scarce manufacturing resources and design them to ensure that they are adaptable and fit for purpose for multiple needs in the future & minimize the potential for redundancy.

Advances in technology can be leveraged to create opportunities for both manufacturing and non-manufacturing countries in Africa to contribute toward efficiencies in the value chain and therefore contribute towards enhancing competitiveness through approaches such as continuous manufacturing, environmental sustainability, artificial intelligence and quality by design.

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