Read the Conversation
Conversation highlights:
GBMSA has grown from 14 to 17 members under new leadership, attracting companies from across Southern Africa.
Generics currently represent 71% of unit market share in South Africa's private sector and dominate volumes in the public sector, positioning the industry for further growth under NHI implementation.
Local manufacturing faces funding barriers as South Africa has reduced investment incentives in economic zones due to stunted GDP growth, creating challenges for companies seeking capital for facility development.
Harmonization across African markets remains a key priority, with the African Continental Free Trade Area Agreement expected to benefit pharmaceutical companies once implementation roadmaps are clarified.
Patient trust in generics has significantly increased in urban and educated populations, with South African law now requiring pharmacies to offer generic alternatives to patients.
The association is exploring innovative partnerships, including gene and cell therapy solutions, though regulatory frameworks for complex innovations like CAR-T therapy still need development at SAPRA.
EF: You took over as Chairman two months ago at a strategic moment for the industry. What mission did you set for yourself when appointed?
SM: The mission is to strengthen the generics and biosimilar sector in a sustainable way because our work is fundamentally about ongoing access and affordability. I want to move beyond commitments to actual observable outcomes. We've grown from 14 to 17 members since late last year. We've gained interesting new members, and we're actively driving to attract Southern African pharmaceutical entities to join the association, expanding beyond just South African organizations to truly represent Southern Africa as our name suggests.
EF: What role does GBMSA play in South Africa's healthcare landscape, particularly with NHI momentum building?
SM: Part of our mission is to increase access, and NHI aligns with this goal. Governments in countries like ours plan to implement NHI to ensure equitable access across the country. We are willing to closely participate to make it a workable and sustainable solution. Despite ongoing disputes and court cases, once those are resolved, generics and biosimilars will be crucial in enabling government procurement at reasonable, sustainable, and cost-effective prices. This will allow expansion into therapeutic areas beyond current focus areas like treatments for HIV, TB, and oncology, extending solutions across all major therapeutic areas. We intend to play a leadership role in the entire process.
EF: Generics currently account for a significant market share in South Africa. What's at the top of your agenda for growth?
SM: In the private sector, generics currently represent 71%-unit market share and dominate volumes in the public sector as well. With transformation policies like broad-based black economic empowerment in South Africa, there will be policy changes, including the Public Procurement Act, with new regulations that may empower local manufacturers and pharmaceutical companies. We anticipate significantly more generics in the future, becoming even more dominant across all therapeutic areas. However, we still need innovators because without them, we don't have access to the latest technologies; they are tomorrow’s generics. We respect the rules of the game to ensure innovators have sufficient time to demonstrate new solutions that benefit the country and patients. Ultimately, we'll play in spaces where we have talent and can negotiate technology transfers with these companies, particularly thinking about localization with generic companies that have invested in local manufacturing. The outlook is positive for generics growth, and we maintain good relationships across the spectrum because leaders move between originators and generics companies. Further, we currently face issues with certain regulatory practices and a lack of meaningful government incentives for local manufacturing. Future alignment on these will also aid growth for certain members.
EF: How do you see harmonization efforts across Africa affecting your members' expansion opportunities?
SM: Currently, not all our members export to African countries due to various barriers. The African Continental Free Trade Area Agreement is still in its infancy, a product of the African Union, but we hope it will make trade between African countries easier. Pharmaceuticals will likely be the biggest beneficiaries once that roadmap becomes clear, allowing our members to register their products more easily. Hopefully, harmonization will become a reality rather than endless meetings negotiating how it can be done. Our regulatory representative participates in most discussions, driving that agenda. The future is bright, and our role is becoming much clearer. We're also working with associations in North Africa because there are strong pharmaceutical sectors in Egypt, Morocco, and Algeria, beyond just sub-Saharan Africa.
EF: What opportunities do you see for generics and biosimilars companies in South Africa this year?
SM: Generics and biosimilars have significant opportunities to grow at this juncture. During the early days, when originators came first, they became the brands patients got familiar with and requested by name from doctors. We're seeing that change over time. Education driven by generics and other associations has empowered patients to understand that in private healthcare with medical aid, they can get more value from their savings by accepting generics, avoiding co-payments, and helping them sustain their accounts. In the public sector, it increases access and helps South Africans in rural corners without major hospitals or primary care clinics, ensuring there will ultimately be solutions for everyone. Our relevance is becoming greater, and trust in generics and biosimilars, since more of them have been launched in the market and thus prescribed in recent years, has reached a level where patients don't question when pharmacists switch brands in prescriptions. In fact, South African law now requires pharmacies to offer generic alternatives, showing the government understands these medications go through the same regulatory processes for quality standards acceptable for safe and effective patient use.
EF: How do you rate the level of awareness and trust in patients regarding biosimilars and generics?
SM: In urban areas and among the educated middle and upper classes, awareness work has been done successfully. We don't get many questions unless someone is biased toward a brand they've used for years. There's still brand loyalty that can never be eliminated. However, newly diagnosed patients are different. Doctors present options upfront, explaining originators versus generics, cost differences, and that they do the same thing. Patients can verify with the regulatory authority and do their own research. Trust levels have really increased there. Where I cannot speak with certainty is in rural corners, where education levels mean people don't understand what doctors give them because some cannot read or write. They take what doctors prescribe, and if those doctors prefer certain brands, that continues. However, if they fetch their medicines from a pharmacy, then usually a generic will be offered if one exists. Organizations like Doctors Without Borders help spread the message that quality medications approved by local regulators should be good enough for the purpose.
EF: With 16 diverse members ranging from multinationals to local companies, how do you adapt to different member needs?
SM: We're structured so the main core setting involves CEOs of member organizations participating in meetings every month and a half, focusing on common challenges. For divergent member interests, we have subcommittees of peers with similar interests. For example, we have a local manufacturing subcommittee with about three local manufacturers among our members. This accommodates those with similar interests without affecting the rest of the group on items that aren't relevant if they're not ready to invest in those spaces. We also have a regulatory subcommittee that attends all regulatory authority meetings and provides feedback and advice on approaches to varying regulations. We maintain a strong relationship with the regulatory authority, meeting regularly, going deeper on systems, challenges, and proposals. We ensure that when members raise issues, we determine how many are affected by the same problems and serve as their collective voice rather than having individual organizations replicate efforts. This proves to be more impactful.
EF: What challenges require the most urgent action in the generics market and local manufacturing environment?
SM: The biggest barrier to localization in South Africa is funding access. Companies wanting to invest require affordable capital and can't rely on commercial banks, so they look for development finance institutions or government subsidies. South Africa created economic zones in all provinces where companies could establish facilities with support packages including pharmaceutical waste disposal, water access, and green energy solutions. However, with the country's stunted GDP growth, South Africa started removing many funds that were available for local manufacturing investment. Skills can be an issue for some, but most of our member companies are from India and already have the skill set. These companies bring in experts who typically stay no more than five years while training qualified locals who lack experience. Over time, these experts return to India, hopefully in bigger roles if they were successful. This helps, but it could be better for members who are purely local because they cannot call on headquarters elsewhere to bring in experts with proven blueprints for new facilities. Members may become more interested in local manufacturing opportunities since our regulator now offers a preference for registration timing of products that will be locally manufactured.
EF: How do you encourage generic companies to embrace innovation beyond traditional manufacturing?
SM: Generic companies are highly innovative, and their innovations benefit from regulatory evaluations that help ensure that, when the product remains the same, but processes improve, these improvements do not compromise steps that would change what the originator offered and may even improve patient compliance through novel dosage regimens. As long as the regulatory authority is aware, dossiers are amended accordingly, and companies have time to explain with technical experts, these innovations are successfully approved for many of our members. We are also seeing different innovations that offer new opportunities for learning and collaboration with regulators as they become more familiar with how to handle them. Many generic companies invest heavily in R&D and develop their own innovator portfolio of patent-protected medicines.
EF: What's your perspective on bringing innovative treatments like diabetes medications to African markets?
SM: When you look at recent blockbuster diabetes treatments, Africa has been left out, not for technical reasons, but because of cost. Many governments are reluctant to commit to these products up front. There’s still a major need for education: for people with diabetes, not just those interested in weight loss. Policymakers often feel they must focus on conditions with obvious, immediate life‑or‑death implications rather than on therapies they view mainly through a weight‑loss lens. It’s a difficult balance, but progress is happening. Many of our members are finding partners, and as patents expire, prices will likely come down in some markets. We’re optimistic that these solutions and innovations will start to reach our health systems.
With limited budgets, African governments inevitably prioritize what they see as the most urgent issues. At the same time, these treatments are now widely discussed, and people have far greater access to information through social media. Patients will increasingly walk into clinics, ask their doctors about these medicines, and request them, even for preventative use. That rising demand will be hard to ignore.
EF: What's your final message to investors and decision-makers about the future of generics in Africa?
SM: Generics have become more relevant and more trustworthy in terms of the products we produce. Patients trust us, and there are opportunities in Africa for further investments outside South Africa. I believe South Africa can play a bigger role if GBMSA members want to start looking at local manufacturing outside South Africa and exporting into Africa, which would help the continent. Harmonization is crucial because registering the same dossier in 50 countries doesn't make sense. We need to work as a continent to find simpler approaches that aren't too expensive but don't compromise quality, with regulators from each country actively involved in creating an almost continental regulatory body. This will fast-track access in many countries beyond South Africa. As innovations keep coming, we'll continue looking at what generics can take over and drive prices down while respecting the role of innovators, because without them, we don't have these products. A stronger generics and biosimilars sector will make healthcare accessible to more people in Africa over time. What threatens our work is that multilateral organizations are recently pulling funding, particularly for HIV treatments that continue to be life-threatening across the continent. Let's make business simpler in the pharmaceutical sector without compromising quality, with all stakeholders playing key roles to educate, invest, and improve access to more patients.
