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Vivian Xie
25 Jun 2024

Women in Pharma: Regulating equity across regional borders

In our monthly series focusing on women in the pharmaceutical industry, we interview leading experts in the pharmaceutical supply and value chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. 

This month’s instalment highlights the work of Frieda M. Shigwedha, Medicines Information and Safety Pharmacist at the Therapeutic Information and Pharmacovigilance Center – Namibia Medicines Regulatory Council. She takes us through the challenges and opportunities in the African pharmaceutical landscape, and how her work as a MIS pharmacist helps to improve healthcare standards, patient safety, and equitable opportunities for all in Namibia and the wider African healthcare region.  

1. Could you please give an overview of yourself and your role? 

My name is Frieda Shigwedha, and I am a pharmacist from Namibia. I currently work as a Medicines Information and Safety (MIS) Pharmacist at the Therapeutics Information and Pharmacovigilance Center (TIPC) of the Namibia Medicines Regulatory Council (NMRC), which operates under the Ministry of Health and Social Services. I hold a Bachelor of Pharmacy (Honours) degree from the University of Namibia, a Postgraduate Diploma in Health Information Systems Management from the Namibia University of Science and Technology, and a certificate in Clinical Trials and Dossier Assessment from the University of the Witwatersrand. I have recently been admitted into a short course on Rational Medicine Use at the University of the Western Cape School of Public Health, and I plan on pursuing further studies toward a master's programme related to my key areas of interest, which include regulatory affairs, pharmacovigilance, health informatics, and pharmacoepidemiology. Despite wearing a couple of hats as a pharmacist, my primary role as a MIS pharmacist involves researching and providing critical information on medicines and related substances, ensuring medicine quality, safety, and efficacy by overseeing regulatory compliance. 

Additionally, I serve as the secretariat for the Regulatory and Local Manufacturing Technical Working Group for the National Medicines Policy Implementation Plan. This role has broadened my perspective on pharmaceutical policy development, governance, and implementation skills. My passion lies in improving healthcare standards and patient safety within Namibia and the broader African region, and I remain committed to being a lifelong learner. 

2. In your role and from your perspective over the last few years, what are some of the biggest challenges affecting the pharmaceutical industry in the African region? 

Over the past few years, the pharmaceutical industry in Africa has faced several significant challenges. One of the foremost issues is the accessibility and affordability of essential medicines. Limited resources, inadequate infrastructure, and economic constraints often hinder the effective distribution and availability of pharmaceuticals in many African countries, and Namibia is not at all an exemption. As a country, we have also witnessed the recalls and withdrawals of key lifesaving medicines from the market, primarily by Big Pharma, and especially for novel drugs that do not have generic medicines yet. This has had a major impact on the health sector, publicly and privately. 

Furthermore, the regulatory frameworks in many regions are still developing, leading to some inconsistencies and delays in approving and monitoring new medicines. However, the critical harmonization and implementation of reliance mechanisms by structures such as the ZAZIBONA initiative has truly been fundamental to ensuring that the process of registering medicines is more efficient.  

Another challenge not to be overlooked is the prevalence of counterfeit, falsified, and substandard drugs. This remains a substantial threat to public health, especially in strenuous economic situations. This problem necessitates stronger regulatory measures, collaborative efforts between the medicines regulator, customs officials, and the national police and security forces and increased and continuous public awareness of the harms posed by using these medicines. 

A significant opportunity in Namibia lies in the establishment of a comprehensive legislative framework for key aspects such as regulatory oversight of clinical trials and medical devices. By addressing this gap, we can develop robust guidelines to enhance the operations of the NMRC. This advancement will greatly improve our ability to ensure the safety and efficacy of new medical products and innovations, ultimately strengthening our healthcare system and fostering public trust in medical advancements. 

3. How do you prioritise an equitable working environment across your various roles, from Medicines Information to Regulatory to Pharmacovigilance? 

Generally, I would be lying if I said I have perfected the art of prioritisation, even with the Pareto principle. But what really helps me is planning and assessing what is urgent and would yield the greatest outcome. I consider myself a leader who is propelled by servitude leadership. However, with time, I have learned that my true strength lies in being a team player. I thrive best in a team and this has encouraged me to learn to trust my colleagues and their abilities. It has also taught me to create opportunities for growth and empowerment through delegation of tasks so that I can focus on my priority areas. Creating an equitable working environment is fundamental to my approach across the various roles, through inclusivity, transparency, and continuous professional development. I try my best to foster a culture where every team member feels valued and empowered to contribute. This includes promoting open communication, ensuring equal opportunities for growth and learning, and maintaining a balance between work and personal life. 

My experience as the secretariat for the Regulatory and Local Manufacturing Technical Working Group for the National Medicines Policy Implementation has also taught me the importance of governance and strategic implementation. This role has required me to develop a governance mindset, learn about pool procurement systems, and draft concept notes for potential funding initiatives. These skills have been critical in ensuring structured and strategic approaches to pharmaceutical policy and operations. 

Additionally, I am passionate about education and for every opportunity I get to teach and empower others with knowledge and skills, it is a way for me to inspire and help add value to the next person. The best way to learn is to impart knowledge through teaching and this is the most fulfilling part of my role as a pharmacy educator. 

4. What are some of the biggest developments in the African pharmaceutical sector, and how important is a diverse workforce in contributing to these developments? 

The African pharmaceutical sector has seen significant developments, particularly in the local manufacturing of medicines. This shift aims to reduce dependency on imports and enhance self-sufficiency, which is crucial for ensuring drug availability during global supply chain disruptions, something we learned in a tough way during the COVID-19 pandemic. Rome was not built in one day however every effort of progress is a step towards the bigger dream for an Africa which is self-sustainable. Additionally, there is growing investment in regulatory capacity building, with initiatives to harmonise regulations across the continent, such as the establishment of the African Medicines Agency (AMA). 

We are also moving into an exciting time as Namibia where green hydrogen is a primary area of focus. The role of a ‘green pharmacist’ could be significant in this context, ensuring that medicines are produced sustainably, and that patient safety remains a priority. This involves integrating environmental considerations into pharmaceutical practices and promoting the use of eco-friendly processes and materials. 

A diverse workforce is vital to these developments. Diversity brings a wealth of perspectives, innovative ideas, and a broad range of skills necessary to address complex healthcare challenges. A workforce that reflects the diverse populations we serve is better equipped to develop effective and culturally sensitive healthcare solutions, ultimately improving patient outcomes. By embracing diversity, we can foster innovation, drive progress, and enhance the overall effectiveness of the pharmaceutical sector. 

5. What have been some of your highlights working as a woman in the pharmaceutical industry? Have there been any challenges? 

Working as a woman in the pharmaceutical industry has been both rewarding and challenging. One of my highlights has been the opportunity to hold leadership positions, such as serving as the President of the Pharmaceutical Society of Namibia and as a member of the Pharmacy Council of Namibia. These roles have allowed me to advocate for the profession, influence policy, and mentor the next generation of pharmacists. I have also had the privilege of leading initiatives like the #MedSafetyWeek campaign in Namibia with my dedicated and passionate colleagues of an all-female pharmacovigilance center and participating in significant projects aimed at strengthening pharmacovigilance and regulatory systems. Our success as a team is unmatched! 

In many of my roles, such as serving as the secretariat for the Regulatory and Local Manufacturing Technical Working Group for the National Medicines Policy Implementation, I have been pushed to think beyond traditional pharmaceutical roles. Experiences such as my secretariat role have required me to be creative in ways I never imagined possible as a pharmacist, significantly contributing to my personal and professional growth. 

However, the journey has not been without its challenges. Gender biases and stereotypes can create barriers to advancement and recognition. Balancing professional responsibilities with personal commitments is also a common challenge faced by many women in the industry. Despite these obstacles, my experiences have strengthened my resolve to support and empower other women in the field, fostering a more inclusive and equitable industry. 

One of the critical areas I've focused on is expanding the role and scope of pharmacists, especially in terms of pandemic preparedness. During the COVID-19 pandemic, we had to rely heavily on the assistance of the only local pharmaceutical manufacturer to produce the necessary medicines when borders were closed, and it was difficult to import drugs even from South Africa. This experience underscored the importance of local pharmaceutical production and the need for pharmacists to be adaptable and resourceful in crisis situations. 

I am passionate about helping to mold the current and future generations of pharmacists, encouraging them not to be limited by existing systems but to find sustainable and innovative solutions to the challenges facing the pharmaceutical industry. In an ever-evolving fraternity such as the pharmaceutical industry, pharmacists are required to be agile and forward-thinking, and they need to explore roles beyond traditional retail and clinical settings, contributing to various aspects of healthcare and pharmaceutical sciences and improving healthcare for all. 

6. Who are some of your Heroines of Pharma (women in the pharmaceutical industry you admire)?

Oh wow. There are many formidable women within the industry, and my immediate heroine is Fransina Netumbo Nambahu, the current and first female Registrar of Medicines and Head of the Secretariat for the Namibia Medicines Regulatory Council – essentially, my boss. She is a leader who fosters innovation and idea-sharing in the workplace. Since stepping into this demanding role, she has not only embraced change and challenges but tackled them with grace. She has instilled in our team the importance of always prioritising patients as our key stakeholders. Her guidance emphasises teamwork and collaboration to overcome obstacles, ensuring we work more efficiently and meticulously. I call her a ‘firecracker’ because she ignites passion and determination with humility and authority.  

Other leading female figures I admire in the pharma industry, albeit from a distance, include Mrs. Priscilla Nyambayo, Head of Pharmacovigilance and Clinical Trials Unit at the Medicines Control Authority of Zimbabwe; Ms. Mafora Matlala, Pharmacovigilance Manager at the South African Health Products Regulatory Authority; Ms. Lenias Hwenda, Founder and CEO of Medicines for Africa; and Ms. Chimwemwe Chamdimba, Head of the African Medicines Regulation Harmonization Programme at the African Union Development Agency-NEPAD. 


Do you have a story to tell about diversity? If you’d be interested in being featured in our Women in Pharma series, please reach out to [email protected].   

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