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South African Health Technologies Advocacy Coalition

Call to the Government of South Africa to fully Ratify the African Medicines Agency Treaty

As the South African Health Technologies Advocacy Coalition (SAHTAC), a network of over 20 organizations, we write to urge the South African government to ratify the AMA Treaty. We believe it is a historic opportunity for South Africa to be at the forefront of shaping the future of access to medicines and economic progress across the continent.

By October 2021, fifteen countries had signed and ratified the AMA treaty to set up the African Medicines Agency, a specialised health agency of the African Union (AU).The agency was officially established on 5 November 2021. To date 27 AU Member States have fully ratified the AMA Treaty. Tanzania is the latest country to have ratified the treaty (November 2023), a country which like South Africa has WHO accredited Maturity Level 3 (ML3) National Regulatory Authority (NRA). The time is now to join other AU member states, including those with ML3 status NRAs (Tanzania, Egypt and Ghana) and ratify the treaty.

We are aware that the South African Cabinet signed the treaty in 2022. It was tabled before the National Assembly and referred to the National Council of Provinces for consultation. We however call on the Portfolio Committee on Health to expedite this process and complete the formal ratification, and ensure that South Africa engages, influences and leads the early conversations in the operationalization of AMA aimed at improving regulatory oversight and heightened economic prosperity on the continent.

The main objective of AMA is to harmonize the regulatory landscape and move Africa towards a single integrated block, especially when it comes to highly regulated medical products. Similarly, AMA will enhance standards, improve ease of movement of medical products that meet accepted international standards, promote local production, encourage innovation, and ease introduction into the African market. All these efforts will ensure that products regulated within member states and across the continent are of the highest quality and are safe and efficacious.

Here are four key reasons why it is critical for the South African government to show full support for AMA.

1. Strengthened Regulatory Oversight
AMA provides South Africa the opportunity to be part of a unified regulatory system for medical products in Africa. By joining AMA, South Africa can contribute its sought-after expertise and resources to help develop a robust regulatory system that ensures the safety, efficacy, and quality of medical products. The South African Health Products Regulatory Authority (SAHPRA) is one of five medicines agencies on the continent that have the expertise and maturity level to be a leader in approving medical products in Africa for Africans. This streamlined process would accelerate access to life-saving treatments, and significantly limit the proliferation of substandard and falsified medicines and medical products.

2. Enhanced Access to Medicines
As a country that grapples with healthcare disparities, South Africa’s involvement in AMA will contribute to improved access to essential medicines for its citizens. Through harmonized regulations and collaborative efforts, AMA aims to expedite the approval of new medical products and innovations, especially those addressing prevalent diseases in Africa such as HIV/AIDS, malaria, and tuberculosis. This could significantly contribute to improving overall access to quality products, hence increased quality of care. resulting in improved public health outcomes and overall reduced reliance on imported goods. AMA will ensure the faster release of innovative products to the market.

3. Research and Development Collaboration
By ratifying AMA, South Africa can further catalyze research and development efforts. Collaboration with other African nations could lead to shared expertise, pooled resources, and co-funded initiatives that foster innovation in healthcare and pharmaceuticals. This collective approach can ultimately drive the development of novel treatments and therapies, elevating South Africa’s status as a leader in medical research.

4. Economic Benefits
Ratifying the treaty isn’t just about medicines regulations; it’s also about boosting economic growth. South Africa’s participation could attract foreign investment, encourage local pharmaceutical production, and create jobs in research, manufacturing, distribution, and regulatory affairs. Additionally, a more efficient and harmonized regulatory system would reduce the barriers for pharmaceutical companies to enter multiple African markets, enhancing trade and economic cooperation. AMA will contribute to the increased economic integration of the African continent. The African Continental Free Trade Area (AfCFTA), which came into effect June 2020, has dramatically reinforced economic integration. AMA will also lead to increased trade and investment by ensuring simplified, less fragmented processes and shorter timelines for pharmaceutical product registration.

By ratifying the AMA treaty, South Africa can contribute its strengths, collaborate with fellow African nations, and create a brighter future for its citizens. Let us embrace this opportunity to make a lasting impact on healthcare, research, and prosperity for generations to come.

Thank you for your attention to this important public health issue and we look forward to receiving your position. We are available to meet with the committee at a suitable time as advised by the secretary to further explain our call to action, respond to questions and reiterate the importance of AMA.

SAHTAC Secretariat

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