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Meeting highlights:
- Regulatory and Access Challenges: South Africa’s self-care sector faces significant regulatory delays, particularly regarding complementary medicines, which remain unregistered in South Africa. Although the National Department of Health and the South African Health Products Regulatory Authority (SAHPRA) are clearly committed to improving healthcare access and equity, ongoing resource constraints and the complexities of implementing the National Health Insurance (NHI) continue to present substantial challenges.
- Five Strategic Pillars: The Self-Care Association of South Africa’s work is structured around five core pillars: enabling digital self-care, embedding the value of self-care in healthcare policy, improving public awareness (despite limitations on consumer education for certain over-the-counter medicines (OTCs)), advancing environmental sustainability, and delivering value to members.
- Digital and Environmental Innovations: Notable initiatives include the creation of a national OTC online directory in collaboration with SAHPRA, e-commerce guidelines, a pilot for digital-only product information (eliminating paper leaflets) which is in the regulatory planning and approval phase, and a take-back pilot program for expired, unused and unwanted medicines in collaboration with members of the Pharmaceutical Task Group (PTG), the Independent Community Pharmacy Association and DHL.
- Global Collaboration and Advocacy: As part of the Global Self-Care Federation, the Association shares best practices with counterparts worldwide (e.g., Australia, New Zealand, USA, Europe) and supports cross-border regulatory harmonization, particularly in Sub-Saharan Africa.
- Pandemic as a Turning Point: Nicola reflects on the pandemic as a defining moment that accelerated the societal shift from treating illness to promoting well-being and self-care. It also highlighted the power of collaboration across sectors and individuals.
EF: How do you see this year from your perspective? What challenges and opportunities do self-care companies face in 2025?
NB: Across the board, we encounter considerable regulatory challenges and constraints. While I hold great respect for Dr. Semete, the CEO of SAHPRA, and her team, they face numerous obstacles, ranging from financial limitations to human resource shortages. These difficulties inevitably impact the industry, resulting in significant issues such as a substantial product backlog and lengthy registration times for new products.
Take complementary medicines as an example. Regulations were first published in 2013, yet even in 2025, not a single complementary medicine has been registered with SAHPRA. Make no mistake, the intent is there, and those within the SAHPRA environment are doing their utmost. However, regulatory constraints continue to be our most significant hurdle.
While we all unequivocally support the principle of universal health coverage, a closer examination of the proposed NHI Act reveals several significant challenges. In its current form, the NHI is, in my view, fundamentally flawed, introducing a great deal of uncertainty into our healthcare landscape. This uncertainty extends beyond OTC products, affecting all medicines and the broader healthcare system.
We have a large demographic in South Africa for whom access to formal healthcare services is severely limited, whether due to geographic isolation, overburdened public clinics, financial constraints, or systemic inequalities. For many individuals and families, particularly in underserved rural and peri-urban areas, traditional healthcare simply isn’t available or is not realistically accessible. In these cases, self-care isn’t just a supplement to professional care—it becomes the only viable pathway to managing everyday health needs, preventing disease, and maintaining a basic level of well-being. This reality underscores the urgent need to strengthen health literacy, improve access to reliable self-care products, and ensure that self-care is recognised as a formal part of the healthcare ecosystem, and is not an afterthought!
Self-care in more developed countries is not a luxury; it is a right and an accessible option. However, in large sectors of South Africa and across much of Africa, this is not the case. If we recommend to people to eat healthy foods, get their cholesterol tested, and get their blood pressure checked, etc., for many, these are luxuries. They will never have the privilege of accessing these tests, or even of choosing something like fresh produce and whole foods over ultra-processed, cheap alternatives.
The divide within our country is a real challenge. We advocate for self-care on a broader level, not just in the OTC realm. According to the World Health Organisation and advocated by the Global Self-Care Federation, self-care is defined as the ability of individuals, families, and communities to promote health, prevent disease, maintain health, and cope with illness and disability, with or without the support of a healthcare provider. Self-care should therefore underpin healthcare in South Africa, and yet the NHI Act does not explicitly mention self-care or any related terminology. The time has come to reframe the conversation and begin developing self-care policies that support a healthier South Africa.
While universal health coverage is essential to building an equitable health system, current structural and resource challenges mean we are still far from achieving it.
EF: How are you helping to shape the narrative and raise awareness about the basic changes people can make to take care of themselves and support this shift toward prevention?
NB: The Self-Care Association of South Africa is internally and member-focused, i.e. B2B, while our members are more externally focused. Five years ago, we came together to define five key pillars that now underpin everything we do. The first, although not unique to us, is enabling self-care in a digital world. We spent considerable time exploring the real needs and gaps faced by consumers or patients. One clear issue was the traditional paper leaflet included in medicine product packaging. These leaflets are often lost, discarded, or printed in fonts so small they are unreadable to many. When the leaflet is missing or the font is too small to read, consumers or patients often turn to Google and similar platforms for dosage information. However, the information they find may not always be accurate or directly relevant to the specific medicine they are using. For example, some products sold in South Africa may appear identical to those with the same brand name in the United States, but they can have different formulations or dosage instructions. This can easily lead to consumer confusion and incorrect use. In addition, the limited information provided on the packaging often fails to give consumers the full guidance they need.
So, we asked ourselves: What can we do about this? After some brainstorming, we came up with the idea of building an OTC online directory to provide consumers with accurate, accessible product information. We approached SAHPRA with the concept, and they were very supportive. Fast forward to today, and the directory is now live.
Together, we developed a platform that allows each pharmaceutical company to access a dedicated backend where they can upload the latest patient information leaflets, package inserts, product images, and other relevant details for all their OTC products. The system also enables them to generate a QR code, which is now required by SAHPRA to be included on promotional and advertising materials and can be used across various platforms.
It is a wonderful initiative. What started as an OTC-focused project has now expanded to include all SAHPRA-registered medicines. The original intention was to cover OTC SAHPRA-registered medicines only, but it now also includes prescription medicines. By the end of this year or early next year, every SAPHRA-registered medicine on the South African market will be available on the site, which is super exciting. Only once all the prescription-only medicines have been loaded will this section go live.
The second initiative we undertook in the digital space was the development of e-commerce guidelines. As more OTC medicines are being sold online, it's clear that there is currently very little regulatory direction in this area. While global platforms like Amazon have largely set the standard, we are still working to catch up. To address this, we’ve been collaborating with SAHPRA to draft clear, practical guidelines. For example, when a retail pharmacy sells OTC medicines on its website, a QR code should be available for customers to scan, giving them immediate access to accurate and up-to-date product information. The same standard should apply to platforms like Takealot and Amazon South Africa in the case of Schedule 0 medicines.
While our organisation primarily operates in the B2B space, we are actively pursuing initiatives that deliver value to consumers, healthcare professionals, SAHPRA, and both our members and non-members. We are currently collaborating with pharmacy software providers to develop an integrated solution that enables pharmacists to automatically generate and print product-specific QR codes that take the consumer or patient directly to the SAHPRA online directory. These codes will be included on pharmacy-generated labels affixed to dispensed packs, enhancing access to critical product information.
The second strategic pillar focuses on embedding and unlocking the value of self-care within the broader healthcare system. Globally, numerous economic studies have demonstrated that self-care contributes significantly to health outcomes and system sustainability. These analyses have quantified its impact, assigning tangible monetary value to self-care interventions, highlighting their role in reducing healthcare costs, improving patient autonomy, and alleviating pressure on clinical resources.
The Global Self-Care Federation conducted a comprehensive study across 155 countries, including South Africa, revealing that self-care practices result in an estimated annual savings of $120 billion. Beyond cost savings, the study highlighted that self-care empowers individuals to manage minor health issues more effectively, reducing the burden on healthcare systems. Crucially, there is significant economic value in maintaining wellness. Preventing illness not only improves quality of life but also boosts productivity and reduces absenteeism, further reinforcing the case for integrating self-care into health policy and system design.
Later this year and into the next, we will undertake local research to assess and quantify the financial impact of self-care within the South African healthcare system. By establishing cost savings in rand terms, we aim to build an evidence base that informs policy development and underscores the economic value of self-care. Demonstrating these benefits through empirical data will be instrumental in advancing our strategic agenda and securing broader support for embedding self-care into healthcare frameworks.
The third strategic pillar is advancing the practice and acceptance of self-care in South Africa. As mentioned, we operate primarily as a B2B organisation, and we are deeply invested in empowering consumers to take greater responsibility for their health. One of the current regulatory challenges we face is the restriction on consumer awareness for Schedule 2 medicines, which are available OTC, but require pharmacist dispensing within a pharmacy setting.
Presently, communication about these products is limited to the information provided on or in the packaging itself. We view this constraint as a fundamental barrier to public health literacy. Educating consumers is essential, not only to foster responsible self-care but also to enable more meaningful and informed conversations between consumers or patients and pharmacists. This is incidentally permitted for Schedules 0 and 1 medicines.
Our aim is to build awareness that encourages consumers to ask better questions, understand their options, and participate more actively in their healthcare decisions. Pharmacists will, as always, retain full discretion over dispensing. However, we continue to advocate for regulatory reforms that allow for responsible awareness-building.
We are currently engaging with SAHPRA on this matter and appreciate their openness to dialogue. Our hope is that updated guidelines around consumer communication for Schedule 2 products will be published soon.
An important component of this pillar involves our pursuit of a Section 36 exclusion from the current prohibition on sampling complementary medicines. As an industry, we have formally applied for this exclusion to allow for regulated consumer sampling of low-risk health products, such as basic vitamins, minerals, and herbal supplements.
We strongly believe that consumers should have the opportunity to make informed, evidence-based decisions based on firsthand experience. Allowing sampling under prescribed conditions will empower individuals to assess the safety, tolerability, and effectiveness of complementary medicines before making a long-term commitment. This initiative is ultimately designed to promote responsible self-care and ensure that consumers are equipped to make choices that are right for their health and well-being.
The fourth strategic pillar focuses on advancing environmental sustainability within the healthcare landscape. One of the key initiatives under this pillar is a national medicine take-back programme designed to support the safe disposal of expired, unwanted, and unused medicines. This project was initially championed by the Self-Care Association of South Africa and presented to the PTG, of which we are an active member. It received unanimous support and is now progressing with strong momentum.
We have partnered with the Independent Community Pharmacy Association and DHL, one of our member organisations, to roll out a pilot programme in the Western Cape, launching across 100 participating pharmacies. Each pharmacy will be equipped with designated dry and wet bins to facilitate environmentally responsible disposal by consumers. While some pharmacies currently accept returned unwanted, expired, and unused medicines, the burden of disposal falls on pharmacists, an unsustainable practice we aim to address.
Our intention is to establish an accessible and well-structured system that enables proper disposal, prevents pharmaceutical waste from ending up in landfills or water systems, and demonstrates our commitment to doing what is right for people and the planet.
The second initiative within this pillar is the Paper to Pixel pilot, which reflects our commitment to modernising healthcare packaging and reducing environmental waste. We are working closely with SAHPRA and are currently navigating the regulatory approval process.
This pilot aims to replace the traditional paper patient information leaflet (PIL) with a QR code on the packaging of selected OTC medicines. The QR code will redirect consumers/patients and healthcare professionals to the product-specific page within the SAHPRA online directory, offering convenient access to up-to-date and detailed information.
In tandem, we plan to retain only English on the product packaging, removing the second language requirement. This approach effectively frees up valuable space on the pack, allowing us to incorporate additional printed guidance that enables safe and informed product use, even for consumers who may not be able to access digital resources at the time. Mechanisms to access a printed version of the leaflet for those who want or need this are being investigated.
This initiative aligns with our broader sustainability goals while prioritising consumer empowerment and healthcare accessibility.
We are thrilled to have seven pharmaceutical companies actively participating in the pilot, all of whom share our commitment to innovation and responsible self-care.
The initiative is already attracting global interest, highlighting South Africa’s leadership in progressive healthcare and sustainable packaging reform.
The fifth and final pillar focuses on delivering tangible value to our members. This includes providing support in navigating regulatory and operational challenges, whether with SAHPRA, Port Health, SARS, or the Pharmaceutical Economic Evaluations Unit, etc. We also offer targeted training in key areas such as regulatory compliance, environmental stewardship, and other industry-relevant topics. In addition, we prioritise keeping our members informed and up to date with the latest developments, ensuring they are well-equipped to operate effectively in a rapidly evolving landscape.
EF: Why is it important for you to be part of the Global Self-Care Federation, and how are you working beyond borders to push the self-care agenda in South Africa?
NB: The benefits of our global membership are substantial. On a personal level, and ultimately for the benefit of our members, it allows me to engage directly with my international counterparts to exchange best practices, insights, and solutions. Just this morning, for instance, I reached out to my colleagues in New Zealand and Australia to set up a meeting to discuss shared regulatory challenges and areas of alignment. These kinds of cross-border conversations are invaluable in helping us stay ahead and shape more effective strategies locally.
The level of knowledge sharing and mutual support within the global self-care network is truly remarkable. Over time, you build strong relationships with peers around the world, and together, we’re able to advance the broader self-care agenda. While our markets may differ in size and structure, we face many of the same challenges and can learn a great deal from one another. The Global Self-Care Federation acts as a central hub, almost like a ‘mothership’, bringing us together at least once a year to reconnect, exchange ideas, troubleshoot common issues, and reflect on what’s working and what is not. Between these meetings, we stay closely connected through regular collaboration on platforms like Teams, Zoom, email, and even WhatsApp. It’s an invaluable network.
We’re also actively involved in the Global Self-Care Africa Committee, which is focused on accelerating the adoption of self-care across sub-Saharan Africa. The committee’s work centers on policy advocacy, regulatory support, capacity building, and digital innovation. Several representatives from our member companies contribute to this important work. A key priority is regional harmonisation and the sharing of best practices. For instance, the OTC online directory we developed in South Africa could easily be adapted and implemented in other countries. We’re able to offer a complete blueprint, demonstrating how it was built and allowing other nations to white-label the model to suit their local context. It’s a practical example of how collaboration can deliver real value across borders.
These are exactly the kinds of conversations we need to have more often, about how we, as a region, can support one another meaningfully. There are countries in sub-Saharan Africa where regulatory agencies have the expertise, but not always the financial or operational resources to implement systems at scale. This isn’t about capability, it’s about capacity. We have a responsibility to collaborate and share what works. For example, SAHPRA is already engaged in important harmonisation efforts. When we come together on a global platform, as part of a united voice, we gain greater credibility and are more likely to influence the broader policy agenda than if any one country speaks alone.
EF: You are now in your 10th year leading the association. When you look back on these years, what moments stand out the most for you?
NB: For me, the defining moment was the COVID-19 pandemic. I was involved in the Business for South Africa initiative, which brought together private sector expertise and resources to support the national response. It was a remarkable effort, one that revealed both the best and the worst of human nature. People from across sectors and backgrounds stepped forward, offering their time, money, and skills without hesitation. I was humbled by how many CEOs, business leaders, and professionals said simply, “I’m here—tell me how I can help.” That kind of unity and generosity made a profound impact on me.
It also reinforced the value of collective action and highlighted the importance of self-care in a new light. During the pandemic, we saw a fundamental shift—from a system focused primarily on treating illness to one that began to prioritise overall well-being. People started exercising more, eating better, and taking active steps to care for their physical and mental health, not just for themselves, but for their families too.
While some of those behaviours may have faded slightly over time, for many, the shift was lasting. It ushered in a new paradigm where self-care is no longer viewed as optional or secondary. It has become central to how people think about health. For our industry, that evolution has been incredibly encouraging to witness, and we believe the momentum will continue. It’s no longer just about treating illness; it’s about sustaining well-being.
