Regulatory systems in Africa – Lessons from the COVID-19 experience and strategies to build back better after the pandemic

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The COVID-19 pandemic has had a huge global impact leading to a dramatic loss of human life and an unprecedented challenge to public health including disruptions on supply of medical products and essential commodities. The emergency caused by COVID-19 has disrupted healthcare systems of all countries, irrespective of their level of income. The pandemic has further exacerbated the substantial inequities in access to health care which has existed for many years between countries. Vulnerable populations have continued to face a higher burden of morbidity and premature mortality due to easily preventable and treatable causes. Their limited access to affordable and quality essential services, as well as underinvestment in primary health care systems, is a major impediment to achieving Universal Health Coverage (UHC).

In response to COVID-19, the search for effective and equitable accessible of quality medical products for its prevention, containment, diagnosis and treatment has served to highlight the critical role regulators play is providing access to quality assured products. The pandemic has led to a sharp increase in global demand for diagnostic kits, personal protective equipment, oxygen plants and concentrators as well as vaccines and therapeutics which need to be rapidly developed, manufactured, and deployed, putting pressure on regulators to innovate and expedite regulatory processes. To address delays in supply, policymakers have recognized an urgent need to strengthen manufacturing capacities on the continent, both for vaccines and other medical products, as part of building back better after COVID-19.

To cope with global supply challenges, regulators across the globe have also had to adopt various regulatory pathways to facilitate approval of the essential medical products and health technologies. Reports show more than a 12-fold increase in regulatory workload in some countries mostly due to medical products designed to prevent exposure to, test for or treat COVID-191. Regulators have had to find ways to support the expedited development and distribution of novel coronavirus-related vaccines, tests, and treatments. The circulation of substandard and falsified medicines and prevalence of unauthorized importation of medical products have exacerbated the challenge for regulators.

More than ever before we have witnessed collaborations between regulators across the globe but also between regulators and scientists/researchers working to accelerate the development, production, and equitable distribution of new COVID-19 essential health technologies as they become available. A common thread in collaborative efforts for regulation is the introduction of increased regulatory flexibility within an international framework that offers consistent standards for meeting quality, safety, and efficacy of medical products. For instance, regulators were called to support the African Union’s goal to attain at least 60% population coverage by facilitating regulatory approval of COVID-19 vaccines through three regulatory pathways that were considered essential to expedite regulatory approval at country levels. In the context of advancing the Pharmaceutical Manufacturing Plan for Africa (PMPA), the AU is taking steps to strengthen research and innovation towards local production of pharmaceuticals and vaccines. The AU is further advancing the Partnerships for African Vaccines Manufacturing (PAVM) Framework to accelerate access to vaccines to the African population. The need to strengthen regulatory systems cannot be overemphasized in terms of speeding up time to approve medical products and subsequent monitoring the safety and quality of products circulating in various markets.

In this regard, the African Medicines Regulatory Harmonization (AMRH) Initiative and its corresponding Technical Committees (TCs) such as the African Vaccines Regulatory Forum (AVAREF) have played a key role in facilitating clinical trial oversight and the joint review of COVID-19 vaccines and subsequent approvals. The African Medical Devices Forum (AMDF) has also played a role of providing regulatory guidance to the AU Member states in the marketing authorization, procurement, donation, and management of sub-standard and falsified (SF) COVID-19 medical device and diagnostic products. Other TCs such as the African Medicines Quality Forum (AMQF) and the African Blood Regulators Forum (ABRF) have been instrumental in providing technical guidance in post-marketing programs and regulation of blood and blood products respectively.

Under the theme “Regulatory systems in Africa: lessons from COVID-19 and strategies to build back better after the pandemic”, the fifth Scientific Conference on Medical Products Regulation in Africa (SCoMRA V) will be held from the 22nd to the 23rd of November 2021. SCoMRA is a broad platform for policy makers, regulators, research community, product developers, manufacturers, and other stakeholders. SCoMRA V will bring together these key stakeholders from the continent and across the globe to reflect on progress, define priorities and set the agenda going forward. It will also provide a platform for stakeholders to share experiences about how they managed various challenges and to draw lessons that will assist in the management of future emergencies and facilitate progress in the continent’s ability to regulate medical products. This event will also provide an opportunity to re-define priorities for the African Medicines Regulatory Harmonization Initiative (AMRH), which serves as the foundation for establishment of the African Medicines Agency (AMA) as per AU Executive Council decision of January 2015.

Strengthening regulatory systems for medical products in Africa through the implementation of harmonized regulatory frameworks and application of work-sharing, reliance and capacity strengthening at national, regional, and continental levels is an integral part of health systems resilience. Health actors, institutions, and populations need to have capacity to prepare for and effectively respond to crises; maintain core functions when a crisis hits; and, be informed by lessons learned during the crisis and reorganise if need be. Ebola outbreak has been a learning point for Africa which has enabled the establishment of Africa-CDC and we see how the continent is now able to manage COVID-19 response including medical products and commodities security.

The conference brings together over 300 participants from African and global organizations involved in regulatory systems strengthening and harmonization and serves as a platform for the discussion and advancement of regulatory sciences in Africa. Participants include:

1. policymakers from ministries responsible for health, finance, trade and industry, research and innovation and other relevant ministries

2. National Regulatory Authorities (NRAs) in Africa

3. other NRAs partnering with Africa

4. researchers

5. academia

6. Ethics Committees/Institutional Review Boards (IRB)

7. clinical trials sponsors; industry representatives

8. Regional Economic Communities (RECs)

9. AUDA-NEPAD

10. AUC

11. WHO

12. AMRH Partners and other non-AMRH partners involved in regulatory work in Africa

13. development partners in health and pharmaceutical sectors in Africa

14. legislatures including national parliaments, regional parliaments, and the Pan African Parliament

15. Patient organizations

16. Media representatives and

17. Other relevant stakeholders.

Overall Objective

The shared objective of the two conferences is to support countries to accelerate patient’s access to safe, efficacious and quality medical products through strengthened regulatory systems and collaborations between NRAs, researchers, academia, procurement agencies, industry and patient organizations.
 

Specific Objectives

1. To reflect on progress in the implementation of the recommendations from SCoMRA IV, held in Zimbabwe from 30 September- 01 October 2019.
2. To reflect on the continent’s regulatory preparedness during public health emergencies to respond to supply chain disruptions.
3. To discuss practical experiences from COVID-19 pandemic on collaborations between regulators and other stakeholders in advancing research and development, and production of vaccines on the continent.