An Enabling Environment for Local Production of Vaccines, Therapeutics and Diagnostics in Africa

One of the goals of Agenda 2063 of the African Union is “healthy and well-nourished citizens”, aspiring to the health and well-being of Africans. [1] In this regard, Africa CDC has launched Africa’s New Public Health Order [2] with a focus on five core pillars, namely:

  1. Strengthen African institutions for public health
  2. Expand manufacturing of vaccines, diagnostics, and therapeutics
  3. Invest in the public health workforce and leadership programs
  4. Increase domestic investment in health
  5. Action-oriented respectful partnerships

The new approach to Africa’s public health response is intended to strengthen Africa’s health systems making them more effective and resilient to meet the health needs of Africa’s 1.3 billion people.

To expand the capacity and capability of Africa to manufacture vaccines, diagnostics, and therapeutics, an enabling environment is needed in terms of policy, regulation, tariffs, incentives, qualified human resources, infrastructure, and macroeconomic and political factors. Integration of investments in local manufacturing capacity on the continent to achieve interdependence of countries is also critical to ensure optimal use of limited resources.

Regulatory capacity, capability and harmonization have been significant needs in African health markets. For regulations to be enablers rather than barriers to investment in local production, they must be guided by strong policies that promote access to quality, safe, efficacious and affordable medicines, vaccines and medical devices.

The World Health Organization (WHO) measures regulatory capacity and capability using a Global Benchmarking Tool (GBT) to evaluate and categorize regulatory systems into four levels of maturity. Maturity level 1 (ML1) indicates that some basic elements of a regulatory system exist, and progression is expected towards ML4 at which a system is said to be “operating at an advanced level of performance and continuous improvement”. [3] A country requires a minimum maturity level of ML3 to produce and supply vaccines. As of November 2022, only five African nations had attained ML3 (South Africa, Egypt, Ghana, Nigeria and Tanzania), with none having achieved ML4. [4], [5]

Regulations that are coordinated and harmonized across regions ease market entry and therefore promote access to medicines. Joint assessment of regulatory applications as well as mutual recognition of common regulatory practices and standards across countries has been implemented by some Regional Economic Communities (RECs). An example is the East African Community Medicines Regulatory Harmonization (EAC MRH) initiative that harmonizes regulation across seven national medicines regulatory agencies. As of April 2022, the EAC MRH initiative had recommended marketing authorization of 89 products evaluated through a joint scientific assessment procedure. [6]

By developing common standards and regulations, the newly set up Africa Medicines Agency (AMA) is set to harmonize and improve regulation of essential medical products and technologies, thus facilitating African states to respond to public health threats more efficiently and swiftly. AMA will coordinate on-going regulatory systems, strengthen and harmonize efforts of the African Union-recognized RECs, Regional Health Organizations (RHOs) and Member States, provide regulatory guidance, and complement and enhance collaboration that contribute to the agency’s objectives. [7] The role of AMA is complementary to the African Continental Free Trade Area (AfCFTA) that is set to ease movement of goods and persons within a 1.3 billion consumer market, and is sure to boost trade in pharmaceutical goods and services. [8]

Other enablers of expansion of local manufacturing include providing incentives for capital investment such as tax breaks and free trade zones, investing in competency-based training of human resources, and ensuring sound macroeconomic factors. This constellation of factors combined with responsive policy and regulatory frameworks will set up Africa to be increasingly self-reliant in its manufacture and supply of health products and technologies

AHB Symposium Session

In this session of the AHB Symposium 2023, a distinguished panel of experts drawn from private sector, governments, non-governmental organizations, and development partners will discuss the key drivers that will create an enabling environment for expansion of local production of vaccines, therapeutics and diagnostics. The report of this session should act as a useful guide to private sector on the priority products for local production, as well as guide governments, non-governmental organizations, and development partners on how to implement enablers for private sector to invest in local manufacturing in Africa.

Reference

[1] African Union, “Agenda 2063: The Africa we want,” [Online]. Available: https://au.int/en/agenda2063/overview. [Accessed 15 February 2023].

[2] CDC, Africa, “Call To Action: Africa’s New Public Health Order,” 21 September 2022. [Online]. Available: https://africacdc.org/news-item/call-to-action-africas-new-public-health-order/. [Accessed 15 February 2023].

[3] World Health Organization, “WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products, Revision VI,” 10 May 2021. [Online]. Available: https://www.who.int/publications/i/item/9789240020245. [Accessed 15 January 2023].

[4] World Health Organization, “South Africa’s vaccine regulator reaches new WHO level to ensure safety, quality and effectiveness,” 5 October 2022. [Online]. Available: https://www.who.int/news/item/05-10-2022-south-africa-s-vaccine-regulator-reaches-new-who-level-to-ensure-safety-quality-effectiveness. [Accessed 15 February 2023].

[5] World Health Organization, “List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4),” 1 April 2022. [Online]. Available: https://www.who.int/publications/m/item/list-of-nras-operating-at-ml3-and-ml4. [Accessed 15 January 2023].

[6] World Health Organization, “List of Medicinal Products Recommended for Marketing Authorization Through The Eac Joint Scientific Assessment Procedure,” April 2022. [Online]. Available: https://www.eac.int/mrh#:~:text=The%20East%20African%20Community%20(EAC,medicine%2C%20vaccines%20and%20medical%20devices.. [Accessed 15 February 2023].

[7] African Union, “African Medicine Agency (AMA) Treaty,” 5 May 2020. [Online]. Available: https://au.int/en/pressreleases/20200205/african-medicine-agency-ama-treaty. [Accessed 15 February 2023].

[8] AfCFTA, “About The AfCFTA,” [Online]. Available: https://au-afcfta.org/about/. [Accessed 15 February 2023].