I am pleased to present the 2023-24 Annual Report for SAHPRA which is mandated by the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to regulate all health products and their use in South Africa. Like the rest of the world, South Africa is still recovering from the COVID-19 pandemic and is struggling with a weakened economy and political uncertainty. This has impacted SAHPRA both financially and in terms of staff morale. Despite this, SAHPRA has delivered on its mandate to ensure that health products for human and veterinary use are safe, efficacious and of good quality. SAHPRA’s portfolio of responsibilities is many and varied. Throughout COVID-19 pandemic, SAHPRA played a critical role in facilitating the emergency licensure of health products and is currently supporting the Department of Health’s emergency response to the current Mpox outbreak, ensuring access to critical therapeutics and vaccines. SAHPRA also managed to work on new horizons such as cannabis licensure, digitisation and regional harmonisation initiatives. Further objective demonstrations of SAHPRA’s growing effectiveness include an unqualified audit (2022/23), a reduction of irregular, fruitless and wasteful expenditure and a revised structure for service fees, which is in progress.
During the 2023/24 financial year, SAHPRA had six outcomes addressing Priority 3 of the country’s Medium-Term Strategic Framework, “Education Skills and Health”, which are:
Reduced funding from National Treasury for the 2023/24 financial year, put SAHPRA under enormous financial constraints. To address this, cost containment measures were introduced, including a reduction in operational costs and new staff hires, as well as an increase in revenue collection. Despite the challenging environment, SAHPRA achieved 68% of its annual targets while spending 100% of its reduced budget allocation, complemented by significant third-stream funding earmarked for specific projects.
The Board, which is in its second term, has had a major focus on good governance and ensuring that SAHPRA’s strategic plan is fit for the purpose of achieving the regulator’s ambitions. This ambition has been supported by the Minister of Health, Dr Joe Phaahla, who has appointed the responsible DDG to sit on the SAHPRA Board.
The post-COVID period has increased the global understanding of the importance of developing competent regulatory authorities in low- and middle-income countries, especially in the African region. SAHPRA is regarded as a leading African regulator, and it works closely with other African and global regulators, the newly emerging African Medicines Agency, and the World Health Organisation (WHO).
In the 2023/24 financial year, SAHPRA signed a Memorandum of Understanding (MoU) with the Medicines Control Authority of Zimbabwe (MCAZ). In August 2023, the Africa Centre for Disease Control and Prevention (Africa CDC) donated equipment worth USD 750 000 to SAHPRA to support its regulatory functions relating specifically to vaccine manufacturing. Using its new accreditation process, the WHO awarded SAHPRA the status of Maturity Level 3 for vaccine production, and SAHPRA has the short to medium-term ambition of improving its WHO competency level.
Challenges faced by the Board
In 2023 the Board had some governance challenges, which were addressed through significant Board engagement supported by the Minister of Health and the Department of Health. Throughout this period, the Board worked closely with the CEO and the executive team, and this constructive and respectful relationship continues. The Board and its committees work well and effectively with their respective secretarial support teams. In 2023, an independent review of Board functions was undertaken, resulting in helpful recommendations, many of which have been addressed and others which continue to be acted upon. Some of the suggestions included enhancing the use of technology, such as digitisation, and more operational considerations, which have been significantly addressed by the appointment of a new and experienced Board Secretary.
Worldwide, the importance of regulatory authorities has grown over the past ten years. The scope of work for SAHPRA has expanded to include complementary medicines, medical devices, radionuclides, and a renewed focus on a regulatory framework to support local manufacturers. A major strategic change has been the utilisation of reliance mechanisms and harmonisation initiatives. These approaches allow alignment between regulatory authorities regionally and worldwide, thus optimising regulatory efforts and aligning global thinking in licensing and clinical trial approvals.
A new opportunity will be the use of artificial intelligence (AI). SAHPRA has recognised that AI will enhance its functioning by optimising operational processes, but it will also create new challenges. New medical devices requiring regulatory approval will include AI in their development and implementation. Worldwide, there are yet to be blueprints for how such devices will be reviewed, approved and monitored, and this will be a global challenge that SAHPRA will tackle in partnership with other regulators in the years to come.
For the MTEF period, SAHPRA has the following targets under core business:
These are ambitious targets which, if achieved, will increase SAHPRA ‘s recognition as a world-class African regulator.
SAHPRA has grown in stature and competency since its inception seven years ago. As a new statutory entity that started afresh based on the work of its predecessor, the Medicines Control Council, the path has sometimes been challenging. However, SAHPRA is in a sturdy space as it grows to fulfil its legal mandate for South Africa and address the new challenges regulators worldwide are tackling. My sincere appreciation goes out to all the Board members who have worked with incredible dedication on the Board and its committees. The Board is only as good as its supporting executive team. Thanks to the CEO, Dr Tumi Semete, who has been outstanding in her role, ably supported by a committed and competent executive team, and to Advocate Mpho Mphelo, the newly appointed Board Secretary. I suspect that the importance of a health products regulatory authority was not fully appreciated until the COVID-19 pandemic hit the world in 2020, but the importance of an independent, evidence-based regulator is now recognised as a critical pillar for an effective health service.
