In Conversation with Dr. Boitumelo Semete-Makokotlela

Pretoria, 18 June 2025

Meeting highlights:

• Crisis-Driven Resilience and Standards: SAHPRA maintained strict scientific standards and operational integrity during the COVID-19 pandemic, focusing on responsiveness without compromising safety or quality, while also strengthening collaboration with national and international stakeholders. 
• Support for Local Manufacturing and Strategic Vision: A major 2025 priority is to release a draft policy that supports local manufacturers and transitions from reactive crisis management to long-term strategic planning, including preparation for AI and advanced therapies. 
• The Impact of U.S. Funding Withdrawal on Research: The sudden halt in U.S. funding has destabilized South Africa’s clinical research capacity, forcing a pivot toward innovation, technological solutions, and broader collaboration to sustain progress. 
• Future Skills Development and Biomedical Talent: South Africa faces a shortage of technical expertise that is needed to regulate emerging technologies. SAHPRA is collaborating with universities to enhance capacity through joint academic-regulatory programs, preparing for future innovations. 
• Call for Pan-African Collaboration: In light of reduced donor funding, Dr. Semete advocates for stronger regional coordination through SADC and AU structures, urging African countries to share strategies and resources instead of acting in isolation. 

EF: What are you most proud of in your five-year tenure leading SAHPRA, and what do you consider the key highlights of this period? 

BS: We did a lot, but I would say it falls into three main areas, considering where SAHPRA (South African Health Products Regulatory Authority) was at the time—we had just been established after moving on from the Medicines Control Council. So, things changed a lot operationally. We were no longer the same organization, even physically—we had moved to a different building when COVID 3hit. Later, we had to find and move into our own rented space. 

What I am most proud of is the resilience of our team. Despite all the changes, we were still able to focus on our COVID-19 response strategy. The second thing I am proud of is our collaboration with expert committees and the academic community nationwide. It was a time of great uncertainty, and those partnerships were truly crucial. I am proud of how well we collaborated, not just with them, but also with other national regulatory authorities. We needed that support. And finally, we were always committed to being responsive, but never at the cost of safety, quality, or effectiveness. Even though we worked quickly and put in long hours, we never compromised on scientific standards. We stayed strict but also adaptable. 

EF: What are your top priorities for SAHPRA in 2025? 

BS: One of our top priorities is currently supporting local manufacturers. We are about to release a draft policy that outlines our plan for doing so, and we are really excited about it. Around the world, governments are increasingly focusing on self-sufficiency, particularly in light of reduced U.S. funding and a broader trend toward inward focus. So, it makes sense for us, as the regulator, to ask: how can we support our local manufacturers? Not by excluding others, but by implementing systems that give local players a fair advantage. That is a big priority for me. 

Another important focus for me is strategy. In my first five years, I was constantly dealing with urgent issues—always reacting rather than planning. Now, I have the space to think strategically. We need to assess the current state of the health sector and ensure we are prepared. That means strengthening our regulatory systems and ensuring SAHPRA remains a strong and relevant authority. Just because we are strong today does not mean we will stay that way unless we continue to adapt to changes. A lot is happening, including the development of advanced medicinal therapies and the integration of AI in medical devices. We need to ask ourselves how we will respond to these developments and make sure we align with global best practices. One thing that has changed for me is that I am starting to think more about the legacy I want to leave. I am now halfway through my sixth year, and I want to use the remaining four years with a clear purpose and direction. 

EF: Where does South Africa currently stand in attracting clinical research, and what additional steps can be taken to strengthen its position? 

BS: If we had spoken back early in January, I would have had a very different answer. We still have a strong clinical research community, with great people, resources, and infrastructure, but this is now under threat because the U.S. government has withdrawn funding. That funding supported numerous studies and significantly enhanced our capacity, so losing it will undoubtedly have a substantial impact. 

The quality of our researchers and our work will continue to draw international interest. We cannot replace the funding we previously received from the U.S., but some research activities will continue with alternative funding sources. This situation is a crisis—almost like a pandemic—because it hit suddenly and affected many countries. We didn’t have time to prepare. On January 27th, we got the notice, and that was it. We needed a phased withdrawal, but instead, it was abrupt. Still, we cannot let this crisis go to waste. It is pushing us to think differently and form new kinds of partnerships. We will need more collaboration across different sectors to answer big research and innovation questions, especially since we now have to do more with less. 

Now, everyone must be more creative and innovative in their work approach. That includes embracing new technology, which can help us save time and resources. For example, we are now exploring how technology can automate routine tasks, enabling our teams to focus on more complex work, such as advanced assessments and dossier reviews. This shock, combined with advances in technology, will lead us to new and improved ways of working. Some of the most brilliant ideas emerge from challenging times. In two years, we will look back and realize that this experience pushed us to make changes we would not have considered otherwise, such as how COVID-19 made remote work the new normal. 

EF: How can South Africa balance investing in cutting-edge medical innovations with essential healthcare access? 

BS: This is where strong, forward-thinking leadership matters in an organization. You will not always get it right, because there are urgent needs—medicines like adrenaline (epinephrine) that are essential for the country and were critical during COVID-19. In contrast, things like stem cell therapies might seem more like a ‘nice to have’ for a specific group of diseases. However, if you are a visionary leader, you must create space for conversations about future innovations—what is happening globally what others are already doing and how these technologies could be developed locally and included in the health system. The good news is that, in regulation, we do not always have to start from scratch. By the time new therapies reach us, they have often already undergone review by the U.S. FDA or Europe’s EMA, allowing us to learn from their processes and adapt. 

The real challenge is whether we have the right skills in our country to keep up. And that is where we are lacking. For example, when it comes to regulating medical devices, especially those involving software, we often lack a sufficient number of developers or biomedical engineers with the necessary background. These professionals typically work in other industries, as the field is not large here due to a lack of a substantial local manufacturing base. That means we have to think creatively about how we attract and train people. One of the things we are planning is to build partnerships with universities, such as Stellenbosch University, which has a strong biomedical department. We want to work with them, explain what skills we need, and create joint programs. That could include honors, master’s, or PhD students spending time at SAHPRA to get real-world experience. This requires a long-term vision. We must invest in developing future skills, even though it takes time and may divert attention away from today’s urgent tasks. But if we wait until these technologies are already here, we will be too late. 

EF: What final message would you like to share on behalf of SAHPRA regarding the future of healthcare in South Africa and Africa in 2025? 

BS: We are living in truly challenging times, but with that comes a real opportunity to think differently. It is an opportunity to innovate—whether that involves forming new partnerships, refining our processes, or managing our people. Although we are facing this disruption, we remain part of a global community. Therefore, whatever changes or strategies we develop, they must not only focus on local needs. I understand that the political focus might be very local right now, but in terms of health, there are no borders. Diseases and health challenges do not stop at national boundaries. That means we have to take a broader view. Even our local manufacturers are not just making products for South Africa—they are thinking globally. Therefore, when we regulate their products, we also need to consider international standards, as their products are intended for the global market. One key takeaway from this entire situation is that it has prompted us to reassess how the public and private sectors collaborate. We can no longer afford to have these two sectors operating separately or out of sync with each other. That is no longer sustainable. 

Organizations like NGOs, which were severely impacted by the pandemic, can position themselves to bring diverse stakeholders together. They can unite people who face the same challenges, bringing different strengths and perspectives to solve them. I would like to see new types of partnerships emerge—ones where the public and private sectors truly work together. Because if we continue to work in silos, we are setting ourselves up for failure. However, if we can pool our knowledge, resources, and shared goals, I believe we can emerge from this stronger than before. 

EF: How do you view the current shift from donor-funded projects to domestically funded health systems in Africa? 

BS: For Africa, especially since there is USG funding across the continent, it is crucial to acknowledge that many countries are attempting to address these challenges independently. But why can’t we, as SADC heads of state or health ministers, come together and fully understand the impact of what has happened? We should explore ways to collaborate and maximize the benefits of our combined resources and expertise. However, I worry that if each country focuses solely on its response, we’ll not make real progress. Instead, we need to say for example: Zimbabwe, Botswana, Zambia, Namibia, Lesotho, Swaziland—join the conversation with South Africa. Let us learn from what each of us is doing. Maybe something one country is doing could benefit another. If there are genuine opportunities to collaborate through SADC, then we should certainly take advantage of them. A regional structure is already in place. We need to utilize it more effectively to plan our recovery from this period, with clear goals, well-defined plans, and robust action, whether through SADC, the African Union, or other regional bodies, such as ECOWAS. 

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