Roundtable 3: Vaccine Value Chains – Research & Development – Summary Report

THE AfCFTA AND TRANSFORMATIVE INDUSTRIALISATION ROUND TABLESERIES ROUNDTABLE SERIES

ROUNDTABLE 3: VACCINE VALUE CHAINS – RESEARCH & DEVELOPMENT SUMMARY REPORT 2022 Cape Town

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Contents 1. Background.................................................................................................................................. 2 1.1

Objectives...................................................................................................................... 2

1.2

Speaker Biographies ................................................................................................... 4

2. Presentations............................................................................................................................... 6 2.1

The 2021 UNESCO Science Report........................................................................... 6

2.2

Africa’s research capabilities..................................................................................... 6

2.2.1

Collaboration amongst scientists in Africa...................................................... 8

2.2.2

Skills development................................................................................................ 9

2.2.3

R&D Financing & Partnerships............................................................................ 9

2.3

International R&D Funding and Africa..................................................................... 9

2.4

Making partnerships work......................................................................................... 10

2.5

Supporting healthcare value chains........................................................................12

3. Conclusion...................................................................................................................................15 References.......................................................................................................................................15

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The Nelson Mandela School of Public Governance at the University of Cape Town (UCT) hosted a webinar titled ‘Vaccine Value Chains – Research & Development’ on 23 November 2022. This webinar was part of The School’s African Continental Free Trade Area (AfCFTA) and Transformative Industrialisation Webinar Series. Panellists were invited to share their perspectives on the state of research & development (R&D) in Africa. Topics of discussion included human resources, funding and research capabilities. Panellists also provided recommendations on how the R&D environment in Africa can be improved.

1. Background African countries have a long-standing legacy of outstanding scientific and healthcare research, such as the work leading to the first heart transplant performed in Cape Town, South Africa, in the 1960s and the most recent development of the mRNA COVID-19 vaccine by South African scientists in 2021 (Dutton, 2022). Despite these notable achievements, African countries remained dependent on the developed economies to supply vaccines during the acute phases of the COVID-19 pandemic.

This is somewhat of a setback, especially given the region’s rich history of producing medical innovations. By 2006 (African Union, 2007) African countries were already committing to spend at least 1% of their GDP on research and development.

However, to date, none of the countries have managed to reach this target. This is despite countries like South Africa even implementing tax incentives to drive R&D. Most African countries have an overreliance on international funding for research, leading to potential bias in research agendas that may not necessarily align with local needs and priorities. This concern was also raised by African researchers in an open letter to international funders in 2021 (Erondu et al., 2021).

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This roundtable webinar sought to unpack and understand the R&D ecosystems that currently exist, as well as the challenges experienced by African scientists in conducting scientific research that is essential to public health.

1.1

Objectives

The primary objectives of the webinar were as follows: • To explore missed opportunities during the pandemic and the development of local innovations to address areas, such as cold chain management and local vaccine development.

• Emphasise the importance of African government support of local R&D, such as in financing.

• Encourage collaboration amongst African scientists and the sharing of research data.

• To stress the importance of robust local R&D infrastructure.

• Explore financing of R&D and its impact on research focus.

• Discuss intellectual property considerations for the commercialisation of pharmaceuticals and vaccines.

Vaccine Value Chains – Research & Development • SUMMARY REPORT

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1.2 Speaker Biographies Hani Kim is the Executive Director of the Research Investment in Global Health Technology (RIGHT) Foundation, with 16 years of experience in translational health research as an academic research scientist and at global health R&D funding organizations. She completed her PhD in Lab Medicine and Pathobiology at the University of Toronto, Canada, and post-doctoral training in molecular immunology at the Max-Planck Institute of Immunology, Germany. Hani has published articles on translational medical research and the political origins of health inequity.

Mmoloki Moloi is a Technical Advisor at Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ). He is an experienced quality assurance specialist with a demonstrated history of working in the pharmaceuticals industry (retail, hospital, sales and marketing, warehouse and distribution, and manufacturing). Mmoloki is also skilled in cGMP implementation and

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compliance. He further describes himself as an imaginative and creative strategist interested in managing healthcare, reducing costs, and delivering the best health outcomes.

Petro Terblanche has a successful track record of strategically managing technology-based organisations and translating research into innovation. She has extensive experience developing and managing research portfolios for clinical research projects for single and/or combination therapy in medical oncology, and in planning, executing and publishing original research focused on decision support and policy development in environmental health. She was the lead negotiator on several license agreements in food, fine chemicals and pharmaceuticals. She has also been instrumental in creating startup companies for profit and non–profit purposes. She has played a significant role in developing and implementing South Africa’s biotechnology strategy since 1999.

Vaccine Value Chains – Research & Development • SUMMARY REPORT

Richard Gordon is currently the Director of International Business Development at the South African Medical Research Council (SAMRC). Previously, he was the Executive Director of the Grants, Innovation and Product Development groups at the SAMRC, which oversaw the majority of the grant funding and international programs seeking to develop new drug vaccines and medical devices for diseases found in Africa. Richard is currently one of the drivers of the mRNA Hub, which is a Word Health Organisation (WHO) program. He has held several international positions and specialises in establishing innovation-based international research partnerships with funders, international partners and the private sector. Richard completed his PhD at the University of Cape Town and his post-doctoral fellowship at the University of Cambridge.

worked as a Projects and Public Relations Officer for the Medicines Control Authority of Zimbabwe. He holds two master’s degrees, including one in Public Health from Umea University in Sweden and another in Pharmacy from Keele University in the United Kingdom.

Susan Schneegans is a Communications Officer in UNESCO’s Natural Sciences Sector. She has been Editor in Chief of the UNESCO Science Report series since 2004, following her role as deputy editor in the Natural Sciences Sector since 1998. She founded UNESCO’s quarterly magazine, A World of Science, in 2002, and served as the project manager and editor until 2013.

She holds a Master of Arts degree from the University of Auckland in New Zealand.

Shingai Gwatidzo is a pharmacist and medical products regulatory affairs professional. Shingai is currently working as a Technical Advisor at the GIZ. He previously

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2. Presentations 2.1 The 2021 UNESCO Science Report Susan Schneegans presented key findings about Africa from the UNESCO Science Report (‘The Report’) published in 2021.

The Report’s findings indicated that low spending on scientific research remains persistent in Africa; all African countries were among 80% of countries worldwide that invested less than 1% of their GDP in scientific research (UNESCO, 2021).

Between 2014 and 2018, Africa’s share of global expenditure on research and development remained constant at 1.01%.

However, in Sub-Saharan Africa, spending dropped from 0.44% to 0.42%. South Africa recorded the highest scientific research expenditure in Africa after increasing its share from 0.77% in 2014 to 0.83% in 2018, while Egypt was ranked second; it raised its share from 0.64% to 0.72% during the same period.

Much has been written about skilled Africans (including medical practitioners and scientists) emigrating annually overseas for better job opportunities. However, despite this trend, the latest UNESCO report shows that Mauritius had increased its researcher density by 86.3%, followed

by Ethiopia (67.8%), Madagascar (45.4%), Togo (26.3%), South Africa (21.4%) and Uganda (15.8%).

The UNESCO report further showed that South Africa had 3,774 scientific publications, followed by Nigeria (1,600), Ethiopia (305) and Ghana (231), which collectively contributed to more than 50% of Sub-Saharan Africa’s total output on artificial intelligence and robotics in that period.

Several other countries in the region have also made significant progress in publishing scientific research. For exam-

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ple, Cameroon made significant strides in energy research, while Kenya made up 10% of Sub-Saharan Africa’s publications in animal and plant biology. It must be noted that African researchers often struggle to publish in Western journals because reviewers sometimes have little contextual understanding of African environments.

The high cost of registering intellectual property and the lack of a common system are hindering patenting in Africa.

The problem is unlikely to be resolved in the near future, especially as the Pan-African Intellectual Property Organization is taking longer than expected to become operational (Africa, 2021; UNESCO, 2021).

As a result, only 17 000 patent applications were registered in Africa in 2018, equivalent to 0.5% of the global total.

2.2 Africa’s research capabilities Petro Terblanche shared experiences on developing the mRNA vaccine platform in South Africa through collaboration amongst local scientists and academic institutions. The team was able to copy the mRNA COVID-19 vaccine developed by Moderna by accessing publicly available information. This vaccine is being used to validate the platform that has been developed, which will provide an opportunity to develop other vaccines, including a potential TB vaccine.

Petro emphasised the need for investment in R&D and further indicated that, at present, R&D is severely under-funded in South Africa, apart from two or three R&D clusters. Similar to other African countries, South Africa spends less than 1% of its GDP on R&D, which is very low compared to countries like South Korea, which spends 5% of its GDP on R&D.

Vaccine Value Chains – Research & Development • SUMMARY REPORT

To reach the target of manufacturing 60% of vaccines on the African continent (Africa, 2021), investments are required in science, engineering and technology. African countries need to focus on strategic planning processes aligned with national healthcare manufacturing priorities to capacitate their R&D capabilities. This is a strategic imperative for both R&D and industrial development.

Governments in Africa have historically prioritised generic medicines manufacturing over investment & funding of R&D. As such, it is not surprising that there is a brain drain of African scientists. One in three African scientists emigrates due to a lack of opportunity and access to appropriate and cutting-edge R&D infrastructure.

Knowledge and use of digital technologies are evolving rapidly, and as a result, one of the fastest-growing fields of research is artificial intelligence and robotics. Globally, at least 34 countries have developed a national strategy for artificial intelligence.

Essentially, digital technologies are transforming society as we know it, spurring the fourth industrial revolution and resulting in many useful innovations that can improve the healthcare sector in Africa. For example, drones collected COVID-19 samples from rural clinics and delivered them to specialised centres for testing in Ghana between April 2020 to June 2021 (Denford, Samar Fatima, Kevin C. Desouza, Gregory S. Dawson, and James S., 2021; Sylverken et al., 2022).

It is projected that by 2030 Africa will make up 25% of the world’s population.

This raises questions about how the African population will be sustained – the consumption of resources, food security, environmental security, and employment creation are all factors that need to be seriously considered with strategic foresight. To address future challenges, investment in education and R&D is crucial, especially for building a manufacturing ecosystem that can provide local products and solutions and reduce Africa’s import

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dependency. Foreign investment needs to be channelled into building local R&D capacity. South Africa, for example, has leveraged international funding to improve its science and technology sector. African governments should also consider matching funding arrangements and strategies for international funding received.

It will be necessary for strategic and targeted investment decisions to be made to avoid duplication across African markets. For example, it is neither practical nor advisable for all countries to develop vaccine manufacturing capabilities. Under the current AfCFTA framework, developing regional value chains (RVCs) where countries develop different complementary production inputs and capabilities would be prudent. Developing regional pharmaceutical RVCs will require visionary leadership.

2.2.1 Collaboration amongst scientists in Africa Currently, there is insufficient collaboration amongst the continent’s scientific community on key strategic priorities for R&D. Since minimal data sharing occurs among African researchers, and travel across the continent can be costly and challenging, further hindering collaboration, it is often more convenient for local scientists to work with European and US organisations and scientists.

The African scientific, research, and technical communities need to make a more concerted effort to strategically engage with each other for further collaboration.

Science and innovation departments across the continent need to drive bilateral dialogues and meetings that facilitate information and data sharing. R&D leaders on the continent need to become intentional about uniting the scientific community. Importantly, active collaborations should focus on creating research and development value that can be translated into economic value.

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Vaccine Value Chains – Research & Development • SUMMARY REPORT

2.2.2 Skills development Education needs to be prioritised, especially education that ensures young people can venture into knowledge-intensive careers. In addition, women, specifically from disadvantaged communities, must be encouraged to study and pursue careers in the sciences, technology, and engineering sectors.

For Africa’s growth and sustainability, it is important to nurture young talent and to create industrial environments which offer secure employment. This will require governments to cooperate and prioritise strategic development and capacity objectives related to R&D. In addition, a multi-party, multisectoral focus is needed to bring young people and women into sustainable careers. We need to avoid situations where graduates with tertiary qualifications struggle to find sustainable job opportunities to build and advance their careers and contribute to the R&D capabilities in Africa.

2.2.3 R&D Financing & Partnerships According to UNESCO, the spending on R&D as a share of GDP has increased globally since 2014, suggesting that spending on research has grown faster than the global economy. However, almost half of this growth (approximately 44%) has been driven by China alone.

In developing countries, companies spend less on research due to high R&D costs – including infrastructure, equipment, research inputs etc. – and a lack of skills and infrastructure. As a result, most African countries tend to import packaged technologies from abroad rather than develop their own. African governments are recognising the need for R&D, especially in the post-pandemic era. As such, they are trying to make it more attractive for companies to innovate by providing tax incentives and developing tech incubators and technology parks. The number of active tech hubs in Africa has more than doubled between 2016 and 2020, with

every African country now having at least a small number of hubs. However, tech start-ups in Africa face several hurdles, such as a lack of seed capital and the costly task of patenting. For example, according to UNESCO, it costs ten times more to maintain a 30-year patent for ten years in Africa than it does in the UK. Specifically, in South Africa, it costs twice as much.

For African countries’ industrialisation strategies to succeed, companies must be able to protect their intellectual property and have access to seed capital to bring products and innovations to market. At present, overseas investors contribute the most to seed capital, creating further dependency on more developed economies. At the Pan-African level, Africa’s health strategy has been revised to focus on mobilising research and innovation to address health challenges and reduce external dependencies to bring medicines and vaccines to African populations.

2.3 International R&D Funding and Africa Richard Gordon shed some light on the international funding landscape of R&D, highlighting various funders and their funding requirements, and how this influences the type of research that is conducted in Africa. A fundamental issue regarding the international funding of R&D projects is establishing whose priorities are being funded. Unfortunately, many global funders often fund projects that are not viable due to a lack of local knowledge.

Imposing a global view on most health topics can be very misleading, resulting in funding not being efficiently used or allocated. It is important to determine what type of health research will be funded, i.e. whether it is health research or research for health. In addition, identifying whose interests are to be funded is critical, i.e. whether funding is aligned with the international funder’s priorities or local public health needs – these may not always

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be aligned. Local priorities must be the primary focus as opposed to international funder priorities.

capacity building. It is very seldom that the same funder will finance both Capex and R&D.

There is an implicit complexity in applying for research funding. For example, applying for funding from the Wellcome Trust is very different to applying to the Elma or Dell Foundation, the African Development Bank, or USAID. Understanding the links between funders is also essential, as these links may not always be obvious. For instance, the Grand Challenges Program, funded by the Bill and Melinda Gates Foundation, is also linked with the United States Agency for International Development (USAID), the Wellcome Trust, and the South African Medical Research Council (SAMRC). The SAMRC hosts the South Africa Grand Challenges Program and implements collaborative projects with the Wellcome Trust and USAID.

The largest funder of health research in South Africa is the US-based National Institute of Health (NIH) which finances approximately 50% of health research in the country. The Wellcome Trust, a charitable British Foundation, and the Bill and Melinda Gates Foundation are also substantial funders in South Africa.

Another example is that of the European & Developing Countries Clinical Trials Partnership (EDCTP) and the German Development Agency (GIZ) and their link with The Kreditanstalt für Wiederaufbau (KfW) Development Bank, which funds infrastructure while the GIZ funds research implementation. These examples highlight the interconnectedness of some funders as well as the complexity of the funding ecosystem.

There is substantial funding available in Africa, but the challenge is accessing it.

This is further exacerbated by ever-changing funding requirements and priorities.

Furthermore, grant applications can be tedious and challenging to compile and rarely succeed on the first attempt. Approximately one in ten grant applications are successful. To ensure that an application is at least reviewed with seriousness, it is essential to understand the funder’s requirements and priorities and tailor applications accordingly. Some funders focus on capital expenditure (Capex), while others focus on funding research or

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Richard Gordon described a South African Medical Research Council (MRC) project, which is focused on investigating the funding environment in South Africa; the results of this study were published in the South African Medical Journal in 2019 (Barnabé et al., 2020). The top 40 funders by size globally were interviewed to understand how their funding was structured and the type of health research they funded in South Africa, including information regarding diseases of focus such as HIV and TB. Results showed that 50% of the funding came from the US, followed by the UK and then the SA government. Based on the research findings, it was found that most funders do not prioritise monitoring and evaluation procedures to ensure the appropriate use of research funds.

2.4 Making partnerships work Hani Kim of the Right Foundation shared what it takes to develop critical healthcare technologies as a global public good, with a specific focus on innovations developed

by South Korea, and the opportunities available to contribute to the collective endeavour of realising global health equity for all. First, it is necessary to identify the source(s) of global health inequities, which explains the focus on infectious diseases.

It is then important to understand which infectious diseases need R&D funding.

Vaccine Value Chains – Research & Development • SUMMARY REPORT

Three criteria that are prioritised by most funders1 include: a. Identifying diseases that disproportionately affect lower-middle-income countries in terms of disease burden and mortality; b. Identifying areas where there are insufficient commercial incentives to attract R&D by the private sector; and, c. Identifying diseases where there is a need for new or approved technology, such as vaccines, therapeutics, or diagnostics.

It is equally important to recognise gaps between the identified needs and the current global R&D effort. For example, for neglected diseases that satisfy the above criteria, there is some funding available, largely driven by the public sector or donor

funding from various governments. There is R&D support, but it mostly prioritises the development of new medicines, with very little focus on the development of vaccines or diagnostics. The South Korean Government has been recognised by the global community for its contribution to developing essential health technologies as a global public good. The government prioritised efforts to make public investments to support R&D, especially in areas without sufficient commercial incentives.2 The Right Foundation3 emphasises that funders understand the critical importance of focusing on the local context to guide R&D. The Foundation deeply values the perspectives and insights of partners in low-middle income countries, and recognises that to maximise the impact of vaccines (and all critical health technolo-

1 Funders include (but are not limited to) the NIH, Bill & Melinda Gates Foundation, Drugs for Neglected Diseases Initiative (DnDi).

2 Korean life sciences partners have contributed in the last decade or so across different health tools; although the Korean Life Science Community is still quite small, it has actively engaged in global health R&D. In addition to supplying vaccines during the COVID-19 pandemic, Korean manufacturers contributed to supplying a range of COVID-19 test kits. For instance, according to a report published in 2020, diagnostic tests from 66 Korean companies were exported to over 100 countries in just the first half of 2020.

3 The Right Foundation is a Korean nonprofit that was established in 2018 through a public-private partnership. It was primarily funded by the Korean Ministry of Health and Welfare, with the Bill and Melinda Gates foundation as the second largest donor, as well as 5 Korean companies.

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gies) requires reflecting on the needs of the end-users, which must be incorporated in the product development process and product characteristics. As such, the best approach for obtaining local insights is through engagement with experts that live and understand local issues. Collaboration must continue with local partners even after products are manufactured, to ensure the sustainable impact of the products as well as their integration into the local public health system. Genuine collaboration is rooted in fairness and solidarity to exchange skills and knowledge, and co-develop health products and tools.

Currently, 42 projects are being funded by the Right Foundation without a specific disease focus. The only stipulation is that the projects represent a source of global health inequities and are committed to equitable access. Grantees are required to commit to product pricing prior to funding to ensure that the products and/or tools being developed, whether it is a vaccine or diagnostic, or therapeutics, are supplied to low-middle-income countries at an affordable price.4 Another condition for funding relates to licensing. If the developer or the manufacturer will not supply products to governments, they must be committed to issuing non-exclusive licenses to other manufacturers so that those products can be manufactured locally to help solve health problems.

2.5 Supporting healthcare value chains Shingai Gwatidzo of the Deutsche Gesellschaft für Internationale Zusammenarbeit (German Development Agency [GIZ]) shared about the agency’s work with private sector companies, institutions and various other entities aimed to contribute to the production of medical and pharmaceutical products within the Southern African Development Community (SADC) region.

4 Affordable pricing in this context refers to affordability by governments to achieve large-scale public procurement for their populations.

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Vaccine Value Chains – Research & Development • SUMMARY REPORT

The Support to Industrialisation & Productive Sectors (SIPS) project is an EU and German Federal Ministry of Economic Cooperation and Development-funded Project. It has two mutually reinforcing focus areas: studying the policy and regulatory environment implemented by the SADC secretariat, and examining private sector participation in value chains. The GIZ collaborates with private sector companies across two value chains, antiretroviral (ARV) and COVID-19. The main focus in both areas is on skills development, innovative manufacturing, access to markets, certification, access to finance, and contributions towards research and development.

Mmoloki Moloi, a Technical Advisor from the GIZ, shared insights regarding the GIZ’s work in innovative manufacturing.

He referred to a case whereby the GIZ is supporting a company based in South Africa to venture into active pharmaceutical ingredient (API) manufacturing. This partnership will help facilitate the entry of the South African firm into the API manufacturing market. Additionally, another company is being supported to pilot the production of dolutegravir (DTG), which is used as the first-line treatment of HIV. The GIZ also supports capacity building for African pharmaceutical manufacturers in Good Manufacturing Practice (GMP), an international standard for pharmaceutical manufacturing, which is critical for companies to adhere to in order to enter global markets and global procurement systems.

Most African academic institutions focus their training on hospital and community pharmacy and place less emphasis on industrial pharmacy. To address this, a satellite fellowship program has been developed at the following institutions: The University of Zambia, Kilimanjaro School of Pharmacy, and the University of Witwatersrand, alongside private sector companies. The SADC Secretariat is also a stakeholder in the fellowship program.

The program aims to provide a bridge and

platform for pharmacists within the region to enhance their knowledge in industrial pharmacy. The need for skills and capacity building within the region is critical, to ensure that the relevant skills and competencies are available.

Shingai Gwatidzo shared some insights into the GIZ’s role within the COVID-19 value chain in supporting local private-sector companies to produce commodities needed for the prevention, diagnosis and treatment of COVID-19. Fourteen grants, ranging from 50,000 to 200,000 euros, were provided to seven member states in the SADC region. The funders targeted innovative projects focused on personal protective equipment, sanitisers, hospital disinfectants, ventilators and other ancillary equipment.

Projects have been identified to support healthcare-related activities, including vaccine production and vaccine ecosystem projects in South Africa, Ghana, Senegal and Rwanda. The GIZ is also focusing on supporting the development of a vaccine ecosystem or vaccine-enabling environment, which relates to products for vaccine administration and management and patient clinical management.

In addition, to grant financing the GIZ provides technical support, with a specific focus on business management skills and opportunities for networking to enable access to new commercial markets. Assistance is also being provided to private companies within the SADC region to better prepare for future pandemics. The GIZ provides a 75% contribution towards the overall project budget, and the private sector funds the balance.

In terms of R&D projects, the GIZ works with various institutions across the region.

For example, in South Africa, the GIZ is involved in a project between the Central University of Technology (CUT) and the University of Free State to develop a respirator mask, and with the University of Cape Town to develop a ventilator.

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CPT Pharma, an API manufacturer based in South Africa, is working on developing WHO-recommended APIs and securing a Medicines Patent Pool license for production. Other innovative GIZ-supported projects in the region include the development of diagnostics. Companies are supported from the R&D phase, to bring their products to the clinical study readiness phase and then to commercialisation, which is a long and complex process.

Call for proposals for projects related to vaccine production, for example, the production of adjuvants, stabilisers, excipients, preservatives and vials, especially towards securing a sustainable supply of inputs, was unsuccessful due to a skills and capacity deficit. Nevertheless, these components remain critical for vaccine production. This outcome further highlights

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one of the reasons that the availability of raw materials, specialised components and equipment in the region remains challenging. Feasibility studies are, therefore, being conducted to determine the capabilities that are required within the region to be able to produce these necessary raw materials and various specialised components locally.

Another challenge is the certification of medical devices, a requirement that ensures high quality, safety and effectiveness, as the regulatory framework is still relatively weak. There is work underway towards ensuring that national medicines regulatory agencies within the SADC region can regulate medical devices appropriately, and this includes new product development research.

Vaccine Value Chains – Research & Development • SUMMARY REPORT

3. Conclusion Despite much progress and pockets of excellence in innovation and R&D capabilities, Africa still lags behind other developing countries in terms of R&D focus, prioritisation and financing. International funding support for various R&D initiatives across the value chain will aid in developing African R&D capabilities further. However, African governments and policymakers must prioritise the following to develop R&D capabilities: a) skills development, especially focusing on youth participation

in developing the pharmaceutical value chain; b) R&D infrastructure must be prioritised to reduce Africa’s brain drain; c) local institutions need to finance R&D to ensure that initiatives and projects are aligned with local health priorities; and, d) improving the cross-border movement of people will contribute toward improved cooperation and collaboration amongst African scientists which will, in turn, enhance research outputs.

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