Expert workshop on new developments in ensuring access to medicines, vaccines and other health products

Medicines for Africa had the honor of contributing to an Expert workshop on new developments in ensuring access to medicines, vaccines and other health products hosted by the United Nations Deputy High Commissioner for Human Rights, OHCHR, Mme Nada Al-Nashif,. We were asked to provide a critical view on the efforts of the African Medicines Agency and the Africa Centre for Disease Control (Africa CDC) as well as comment on the Mpox health emergency, pandemic preparedness and other emerging issues for the region. We made the following remarks at the expert workshop. 

Introduction

1.     Excellencies, distinguished guests, ladies and gentlemen. Thank you for the opportunity to join this conversation and offer some practical insights on advocating for access to medicine of assured quality and strengthened medicine manufacturing in Africa, the main challenges, risks and opportunities for enhanced regional cooperation.

2.     I was also asked to provide a critical view on the efforts of the AMA and/or CDC and since the workshop focused on new developments, to comment on the Mpox health emergency, pandemic preparedness and other emerging issues for the region.

3.     Let me start by sharing with you 3 important facts. More than 90% of medicines consumed by Africans, and 99% of its vaccines, are imported, and because historically, the focus has been on increasing the availability of medical products, the quality of the medicines being made available was neglected As a consequence of this neglect, Africa accounts for the biggest share of counterfeit medical products circulating in the world at least 42% which lead to half a million Africans losing their lives each year due to substandard falsified medications.

4.     We are worried. So apart from the challenges of limited availability of medicines, as Medicines for Africa, we are worried about the quality of medicines that Africans are taking, an issue we believe to be an urgent challenge that needs to be put front and centre at the heart of every conversations about improving access to medical products in Africa. Like the WHO said in the morning, access to substandard and counterfeited medications that do harm to patients is no access at all. Because our mission at Medicines for Africa is to improve access to medicines of assured quality, we are tireless advocates for making quality assured medicines the norm.

Progress and Developments

Let me start with the Developments in Local Production of Medicines, Vaccines, and Medical Products in Africa. Since the COVID-19 pandemic, Africa has seen significant developments in local production of medicines, vaccines, and medical products:

1.     Vaccine Manufacturing Initiatives: Countries like South Africa (Biovac and Aspen Pharmacare), Senegal (Institut Pasteur de Dakar), and Rwanda have made strides in establishing vaccine manufacturing facilities. Partnerships with global manufacturers, like Pfizer-BioNTech and Moderna, have enabled local production.

2.     African Medicines Agency (AMA): Operationalization of the AMA has improved regulatory harmonization and quality standards across the continent.

3.     Tech Transfer and Licensing: WHO’s mRNA technology hub in South Africa is transferring vaccine technology to multiple African countries.

4.     Infrastructure Investment: Investments in biomanufacturing hubs, supported by international agencies like the African Development Bank and the African Union, are expanding capacity.

5.     Policy Support: Governments have introduced incentives such as tax breaks, public-private partnerships, and funding for R&D.

6.     Pharmaceutical Manufacturing Growth: Countries like Nigeria, Kenya, and Egypt are scaling up pharmaceutical production with domestic and international collaboration.

These efforts will help to reduce dependency on imports and enhance Africa's healthcare resilience towards the accelerated disease outbreaks that we are witnessing.

In terms of Regulatory Strengthening: African Medicines Agency (AMA)

1.     The AMA, established in 2021, is a key regulatory institution aimed at harmonizing medicines regulation and ensuring the availability of high-quality, safe, and effective medical products across the continent. It is expected to contribute to pandemic preparedness efforts by aligning pharmaceutical regulation standards across the continent, ensuring faster approvals for vaccines, therapeutics and other infection, prevention and control products like diagnostics and medical devices.

2.     The African Medicines Agency (AMA) is almost operational, with the board in place and its office HQ now waiting for the Director General of the agency. The organization has been able to attract significant investment from partners and the number of countries that have ratified the AMA treat continues to grow.

3.     The AMA plays a critical role in enhancing the capabilities of national regulatory authorities (NRAs) to safeguard product quality and safety, enabling them to respond more effectively during health emergencies and to coordinate their actions to minimize risks to populations. Efforts to harmonize regulatory standards are making great progress towards improving quality of medical products with most countries working towards regulatory development and eight national regulatory authorities are now operating at level 3 maturity for either medicines or vaccines on the WHO global benchmark - which means that they are stable, well-functioning and well-integrated regulatory systems capable of providing effective oversight of medical products within their jurisdiction. This is a critical step towards strengthening Quality Assurance and reducing substandard or counterfeited medical products.

4.     We have seen an increase in vaccine manufacturing. Countries like Kenya, Egypt, and Nigeria have invested in expanding local production facilities for essential medicines and diagnostics, but pharmaceutical manufacturing remains an unfinished business whilst medical devices are all but neglected both in terms of regulation and local production.

5.     There are many opportunities for the AMA but one of its challenges at the moment is the slow paces of its operationalization in the face of climate driven acceleration of disease outbreaks. Like the Africa CDC, much of the AMA’s funding appears to be coming from external sources with very little indication what African governments are investing to ensure a sustainably financed institution.

Now onto the efforts of the Africa CDC and the African Medicines Agency efforts.

Africa CDC

The Africa CDC, established in 2017, has played a central role in pandemic preparedness and response during the Covid-19, the ongoing mpox outbreak and in coordinating the more that 200 outbreaks reported to have occurred on the African continent in 2024. It has made notable progress including in:

1. Rapid Response Mechanisms: During COVID-19, the Africa CDC coordinated testing, vaccination, and logistics, showcasing its growing capacity to manage health crises.

2. Pathogen Genomics Initiative: Strengthened disease surveillance and genomic sequencing to identify emerging threats like Mpox and COVID-19 variants.

3. Regional Collaboration: Facilitated partnerships for vaccine production, including technology transfers and support for local manufacturing.

4. Continental Frameworks: Developed initiatives like the Africa Joint Continental Strategy for COVID-19 and the Partnerships for African Vaccine Manufacturing (PAVM).

5. The Africa CDC declared a new public health order but efforts to implement this new order seems to have stalled in large part because of reliance on external funding sources to drive it. In 2024, the African CDC made history by declaring a public health emergency of continental concern but that declaration also revealed weaknesses in its preparations for outbreak responses such as anticipating access needs for infection, prevention control products.

6. The Mpox outbreak underscores the importance of strong health systems and regulatory frameworks. By fully operationalizing the AMA, empowering the Africa CDC, and investing in local manufacturing, Africa can secure the health of its people and achieve sustainable development.

What’s next

To capitalize on this progress, African countries must continue to address structural inequities and systemic inefficiencies. Here are actionable recommendations to enhance access to medicines from a right-to-health perspective:

1. Stop the neglect of quality: Access to medicines that are of poor quality and could harm patients no access at all and the idea that medicines destined for African markets should be subject to a lower quality standard violates the human rights of Africans. All stakeholders need to put quality at the centre of all conversations about improving access to medicines by Africans and commit to making quality medicines the norm.

2. Accelerate AMA Operationalization: Governments must prioritize funding and leadership appointments for the AMA, ensuring it can harmonize regulatory standards and expedite medicine approvals.

3. Strengthen Local Manufacturing: Invest in biomanufacturing and innovation hubs, leveraging partnerships like the WHO’s mRNA Technology Transfer Hub in South Africa. Countries like Rwanda and Ghana, establishing mRNA production facilities, are models to emulate.

4. Secure Sustainable Funding: Increase domestic funding for critical health security initiatives and reduce reliance on external donors in order to continue strengthening health systems and key public health institutions like the Africa CDC and AMA.

5. Enhance Pandemic Preparedness: Develop frameworks for equitable vaccine access, focusing on local production and procurement to ensure security of supply.

6. Strengthen Regional Cooperation: Promote data sharing, resource pooling, and joint procurement mechanisms to strengthen collective resilience.

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