Carel Bouwer - Managing Director, Clinigen, South Africa

Conversation highlights:

• Strategic Partnerships: Clinigen’s vision includes partnering with multinational, small, medium, and large companies to provide access to innovative drugs in Southern and East Africa.
• Ethical Distribution: Clinigen aims to be the partner of choice for companies seeking ethical distribution of their products while ensuring regulatory and quality compliance.
• Therapeutic Expertise: Clinigen specializes in various therapeutic areas and is expanding into new fields such as Women’s Health, Hematology, and Urology.
• Addressing Unmet Needs: The company prioritizes tackling gaps in areas like oncology, hematology, cell and gene therapy, hospital lines, and antimicrobial resistance.
• Combatting Antimicrobial Resistance: Clinigen supports initiatives in South Africa to responsibly manage treatments and prevent the escalation of resistance challenges.
• Tech-Driven Solutions: Leveraging technologies and AI, Clinigen monitors product availability, provides alternatives during shortages, and collaborates with companies and patients across territories.
• Attracting Investment and Talent: Clinigen highlights its exceptional talent and expertise to attract resources and increase regional investment.
• Ethical Leadership: Carel Bouwer aims to leave a legacy of ethical, responsible business that adds value to lives while fostering growth, enjoyment, and development within the organization.

‍EF: What trends do you observe, and what are your priorities for 2023?

CB: I am highly passionate about my work in South Africa and within the company, and I believe our vision at Clinigen encompasses two important aspects. Firstly, we aim to partner with multinational, small, medium, and large companies that may not have a presence in South Africa or focus on all therapeutic areas. We offer our local affiliate capabilities to ensure access to innovative drugs that are currently unavailable in the country.

Our focus also lies in addressing the availability of unlicensed medicines, an area I am particularly passionate about. Through regulatory pathways, we strive to make these medicines accessible in South Africa. Additionally, we are expanding geographically into new territories, such as Kenya, where we have recently opened an affiliate. Our goal there is to facilitate access and licensing of products that are currently unavailable, and we already have products in the regulatory process. Furthermore, we are actively involved in supplying unlicensed medicines to areas and territories where treatments are currently not available. By pursuing these initiatives, we are working towards our vision of expanding access to vital medicines in South Africa and beyond.

Ensuring ethical access to products has become a key focus for many multinational companies. We aim to be the partner they seek, providing front-end support and ticking all the boxes to ensure ethical access. This includes ensuring compliance with regulatory and quality requirements for the products. Additionally, we work towards raising awareness among doctors, healthcare providers, and patients about the availability of these innovative treatments and drugs in their respective territories.

EF: How do you formulate strategies to select your partners, and which therapeutic areas do you perceive as having the highest growth potential, particularly as you expand into Kenya?

CB: We currently have established units in several therapeutic areas, including Oncology, Hematology, Neurology, Hospital Injectables, Infectious Diseases, and Substance Abuse. However, we are also expanding into new areas, such as Women's Health, Hematology, and Urology, with product lines in the process of registration. Our focus is on oncology, rare diseases, and hospital injectable lines, particularly in addressing antimicrobial resistance and providing access to innovative drugs licensed in other regions.

When partnering with companies, we adopt a wide approach tailored to their needs. We are offering both niche and affordable treatments based on their needs within specific therapeutic areas. We are flexible in our approach, tailoring proposals to suit their requirements, whether it is in distribution, pharmacovigilance, medical affairs, regulatory, or marketing and distribution services. We aim to provide the services that are most helpful and aligned with their preferences.

EF: How do you perceive the evolving role of oncology in Africa, especially considering the disparities in breast cancer survival rates compared to Europe?

CB: The approach to disease varies based on individual needs and priorities. In the field of oncology, there has been a significant global focus on developing treatments for various types of cancers, including personalized approaches such as gene therapies.

Cell and gene therapy is a major focus for our company and within our group globally.  We offer a diverse range of treatments through unlicensed terms and managed access programs. Our goal is to work with partners and improve access to these treatments for patients through compassionate grounds or paid arrangements.

As these treatments become more available and accessible, our ethical responsibility is to ensure that patients with specific diseases can access them. We achieve this by implementing patient support programs and aiding where needed. In our portfolio, we currently offer treatments for breast cancer and strive to support patients through various support programs, enabling them to access the best available treatment for their disease on a global scale.

For us, access programs involve working with various companies on new initiatives. When a product is not licensed, we have a range of options to offer. When a product is licensed, we engage with medical funders and reimbursement companies to ensure they recognize the value that the treatment provides to patients and understand how it can reduce overall general medical expenses. We work on business plans, create global value dossiers, and facilitate market access for companies that require these functions. Additionally, if a company is willing, we can explore joint agreements with organizations offering patient support programs, allowing for copayments that make treatment more affordable for patients who would otherwise be unable to access it.

EF: What specific priorities and opportunities do you identify in South Africa that could potentially benefit companies, particularly in terms of unmet needs?

CB: Our primary areas of focus are oncology, hematology, and the advancement of cell and gene therapy, which currently lacks availability. We also prioritize hospital lines and addressing the issue of antimicrobial resistance by exploring new antibiotics and intravenous treatments. We actively seek out products, including discontinued molecules, that fulfill emerging needs or address bacterial susceptibilities.

Additionally, we have a strong emphasis on rare diseases, participating in initiatives and fundraising events through our involvement with the Rare Disease Society. We strive to make treatments accessible and affordable for patients who face high costs or limited access. Furthermore, we extend our efforts to post-clinical trial supply and the provision of treatments for niche diseases. Our approach encompasses both disease-specific considerations and the availability of biological therapies in therapeutic areas where there is a demand within our country.

EF: Do you believe that initiatives addressing antimicrobial resistance, such as the fund raised by Thomas Quinney from IFMA, have the potential to be implemented in South Africa?

CB: The implementation of antimicrobial resistance strategies is applicable in Africa, too. We have received training and guidance from a professor who specializes in this area. With increased global travel and close interactions between individuals, there is already resistance to new antibiotics in our country, which originated from specific diseases or other countries.

This issue is evolving rapidly. While it is crucial to have innovative treatments, it is equally important to exercise responsibility in treating patients to prevent the escalation of resistance problems.

EF: What is your perspective on the growth of local companies in South Africa and their potential expansion across Africa, considering initiatives such as Africa's focus on mRNA and the goal to achieve 60% vaccine manufacturing in South Africa within the next five years?

CB: It is indeed exciting, and South Africa possesses a wealth of knowledgeable individuals and expertise. We have the capabilities to offer manufacturing and develop services that extend beyond our country's borders. South Africa can serve as a center of excellence and a knowledge hub for the development and manufacturing of new products, particularly those that are challenging to produce or are limited to certain regions. This allows for increased accessibility across the continent.

We witnessed a similar trend during COVID, where local manufacturing of COVID-19 vaccines was conducted. This potential extends to various therapeutic areas. Our focus is on the services and partnership sectors. We have a local workforce that provides services to global pharmaceutical and pharmacovigilance companies, as well as customer service, technology, IT, and data-related fields.

EF: How do you perceive the implementation of technologies and AI in healthcare, specifically regarding the integration of AI and data in healthcare practices in South Africa?

CB: Yes, it is a fascinating field, and I believe it will have a significant impact on the healthcare industry in South Africa moving forward. We have been working on databases to monitor the availability of certain product molecules and APIs in different regions. This allows us to understand the potential consequences of shortages. We are heavily focused on building a comprehensive database and utilizing artificial intelligence to collaborate with companies and patients across various territories.

Our goal is to address the needs arising from shortages by creating a platform where individuals can search for specific products and access information on their availability and location. This platform enables us to swiftly respond to demands and ensure timely product implementation. It has become an important aspect of our work. Additionally, as a global group operating across different continents, having visibility into various spheres helps us identify trends and be proactive in preventing shortages or disease outbreaks in our territory, fostering synergies within our organization.

EF: How do you foresee Clinigen's role in expansion into Africa, particularly in relation to the National Health Insurance (NHI) discussions in South Africa? Additionally, what significance do you place on maintaining trust and fostering long-term collaborations with the right partners?

CB: Yes, the National Health Insurance (NHI) has been a topic of extensive discussion and is on the verge of becoming law. We are preparing ourselves for its implementation while continuing to offer a wide range of products and services to companies and entities in need. It will be a challenging yet crucial time, and we remain committed to South Africa. Our operational entities will grow and expand, and we will increase our investments in the country.

Despite the obstacles faced in the South African environment, such as power outages, political interactions, and currency devaluation, we recognize the need for local expertise to handle these issues on behalf of companies. We ensure that assets are managed effectively to extract the maximum value while ensuring accessibility to patients across different territories. The NHI presents opportunities for us to find solutions and work collaboratively with the National Department of Health, contributing to the betterment of the country's health system.

EF: What specific types of investments do you anticipate for Africa, and how do you articulate your pitch to attract resources and foster increased investment in the region?

CB: When we engage with clients and showcase our resources, our main selling point is the exceptional talent within our organization. Our people are our most valuable asset. We have a diverse mix of experienced individuals as well as innovative and younger talent who bring fresh perspectives from various industries and sectors. The value they bring is immeasurable, and their expertise and relationships with healthcare providers across the country are invaluable. It is something that cannot be easily replaced or quantified. This aspect is crucial to our success in delivering our services and ensuring the success of the assets we handle in the country and other territories we operate in.

EF: How do you effectively attract young people to pursue careers in the healthcare industry, considering the evolving expectations of the younger generation?

CB: We frequently encounter and address this in our own environment, particularly when working with ambitious individuals. However, the fact that we are addressing the unmet needs in the pharmaceutical and medical fields in Africa already plays a significant role in our employee engagement. We celebrate the successes of our diverse portfolio from our companies, which includes pharmaceutical devices and products ranging from generics to niche therapies, including rare diseases. Sharing patient stories pays homage to the industry professionals and acknowledges their valuable work with us.

For us, this is important. We also strive to find innovative ways to keep our employees engaged and their minds stimulated. We believe in their personal and professional development, and we actively encourage them to share their ideas and aspirations for their own growth. We have an open-door policy that extends from me to the global CEO, where open discussions are welcomed. Whether it is seeking advice, brainstorming, or pitching new ideas, we embrace and support our employees' initiatives as they work toward achieving their objectives.

EF: How do you envision your legacy being remembered, considering the challenges faced in the healthcare industry over the past few years and your continued dedication to delivering healthcare products?

CB: The legacy I aspire to leave behind is that of being an individual with an open and trustworthy approach. Conducting business ethically and responsibly, especially when it comes to the well-being of patients and healthcare providers whom we support and assist.

My utmost priority is to add value to people's lives and enable their personal growth. Witnessing others achieve success brings me great satisfaction. Therefore, the legacy I aim to create involves being innovative, responsible, and fostering a sense of enjoyment and growth within our organization.

In the pharmaceutical and healthcare industry, we are currently experiencing exciting times. However, it is crucial to acknowledge the immense responsibility that accompanies these advancements. Ethical conduct is of utmost importance as we strive to ensure that every medication entering the country and reaching patients complies with rigorous regulatory and quality standards.

It is our duty as pharmaceutical industry professionals to implement these regulations diligently. While we embrace new and innovative approaches to drug supply, our ultimate goal is to foster the growth of healthcare and improve patients' quality of life through innovative treatments.