FROM October 28 to November 1, 2024, the African Medicines Regulatory Harmonisation (AMRH) initiative will celebrate its 15th anniversary at the Radisson Blu Hotel in Maputo, Mozambique. This year’s biennial AMRH Week, organised by the African Union Development Agency (AUDA-NEPAD) and the World Health Organisation (WHO), will highlight the achievements in building robust pharmaceutical regulatory systems across Africa.
A foundation for future progress
Themed 15 Years of AMRH as a Foundation for the African Medicines Agency (AMA), this event will explore how AMRH has improved access to high-quality, affordable medicines over the past decade and a half. Launched in 2009, the initiative has transformed fragmented regulatory frameworks into a more harmonised system, paving the way for more efficient healthcare delivery across the continent.
The AMRH initiative has proven vital in meeting Africa’s healthcare needs. With over $200bn in annual financing required to meet the Sustainable Africa Scenario’s energy and climate goals by 2030, the summit also serves as a platform for key stakeholders to discuss the challenges that persist in regulating the region’s pharmaceutical industry.
The gathering will include participants from African Union member states, Regional Economic Communities (RECs), the African Union Commission, AUDA-NEPAD, the WHO, Africa CDC, and numerous development partners.
A crucial time for AMRH
This year’s event comes at a significant moment as the African Medicines Agency (AMA) becomes operational, further enhancing collaboration and regulatory oversight across the continent. AMA builds upon the foundation laid by AMRH, ensuring that safe, effective, and affordable medicines are available to African citizens.
Despite the challenges posed by the Covid-19 pandemic, AMRH has shown resilience. The 2020 AMRH Week was held virtually, focusing on regulatory preparedness during health emergencies. The initiative’s continued success has demonstrated Africa’s commitment to improving healthcare for its people, even amid global challenges.
Key goals of AMRH Week 2024
AMRH Week 2024 will focus on reviewing the progress made since previous recommendations, including adopting technical documents such as continental guidelines and standard operating procedures. Discussions will also address strategies to combat substandard and falsified medical products, which remain a serious issue in many African countries.
Additionally, the event will see the launch of the AMRH Information Management Systems, designed to further streamline regulatory processes across the continent. This system aims to enhance Africa’s capacity to detect and prevent the circulation of substandard medicines.
The week-long programme will include meetings of AMRH technical committees and working groups, focusing on areas such as Good Manufacturing Practices, medicinal product evaluations, and regulatory reforms. The highlight will be the African Medicines Regulators Conference, a closed-door session of national regulatory authorities’ heads. High-profile speakers, including Mozambique’s Minister of Health, are expected to deliver speeches during the opening ceremony.
Strengthening regulatory capacity
As Africa faces increasing pressure to bolster its healthcare systems, stronger regulatory frameworks are critical to meeting ambitious goals such as producing 60 percent of its vaccines locally by 2040. Last year’s AMRH meeting in Accra, Ghana, emphasised the importance of building regulatory systems that can support both vaccine production and access to critical medical countermeasures. Strong regulatory frameworks will also ensure the region is better prepared for future pandemics.
Achieving these goals requires not just political will but financial support. While regulatory systems strengthening has been recognised as essential, there has been a lack of adequate investment to date. AMRH Week provides an opportunity to highlight the need for greater financing, both from domestic sources and international donors, to ensure that Africa’s regulatory systems can meet its healthcare demands.
Building financial independence
One of the critical challenges facing Africa’s regulatory systems is the reliance on donor funding. While organisations like the Gates Foundation and the European Union have provided crucial support, the long-term goal is to move towards a self-sufficient regulatory framework. A key part of this strategy involves implementing industry fees for regulatory review processes, creating a sustainable financial model for national and regional regulatory bodies.
However, such a transition requires significant upfront investment and support. Many African countries currently lack autonomous regulatory authorities capable of collecting and reinvesting fees. Until regulatory systems are sufficiently developed, donor funding remains essential to maintaining the quality of medical products and addressing public health challenges.
To address these challenges, African governments must make a strong case to secure higher levels of domestic financing for regulatory bodies. This would involve demonstrating the economic and public health benefits of effective regulation, such as faster access to quality medicines and the removal of substandard products from the market.
Looking ahead: a unified approach
As new entities like AMA enter the regulatory ecosystem, it is crucial for African nations to align their priorities and ensure that funding is distributed equitably across national, regional, and continental levels. The success of a fee-based system will depend on the industry’s ability to benefit from more efficient regulatory procedures, reducing costs and speeding up the delivery of quality medicines.
In the interim, continued donor support will be critical to sustaining Africa’s regulatory systems. With significant sources of funding like the UK’s aid budget and the World Bank’s Global Medicines Regulatory Harmonisation Multi-Donor Trust Fund no longer available, there is a pressing need for new funding sources, such as development banks and global procurement agencies.
Shaping the future of African healthcare
The African Medicines Regulatory Harmonisation initiative has made remarkable progress over the past 15 years, laying the foundation for the African Medicines Agency and a more harmonised regulatory framework. As AMRH Week 2024 approaches, it presents a unique opportunity to reflect on the achievements to date and chart a path forward that ensures all Africans have access to safe, affordable, and high-quality medical products.
To build on this success, Africa’s leaders, policymakers, and development partners must continue to work together, securing the financial and technical support needed to strengthen the continent’s regulatory systems. Only through a unified approach can Africa meet its healthcare goals and ensure the well-being of its citizens in the years to come.
