Leading regulations through excellence and evidence-based decision-making

‘Chaos’ and ‘disruption’ are the best words that encapsulate how COVID-19 impacted the world, our country and SAHPRA.

In spite of concerted efforts to fight the COVID-19 pandemic, it is still a threat. However, thanks to our efforts and those of other role players in South Africa, the continent and the world at large, it is subdued. As the regulator of national health products, SAHPRA was at the core of the South African national response strategy for a pandemic that wreaked havoc within both South Africa and the world.

SAHPRA had to continue ramping up its operations and its business processes in order to address the areas of need. This involved staff recruitment to bolster much-needed capacity and also streamlining digital processes. All COVID-19 related applications for vaccines, therapeutics and in vitro diagnostic tests remained a priority for the authority.

As vaccines offered the proverbial saving grace, SAHPRA had to be responsive to the regulation of vaccines, as well as to monitor all reports on adverse reactions to the vaccines and other health products. SAHPRA, together with various stakeholders, implemented a Med Safety App and launched it successfully. Following the launch of the Med Safety App, a microsite was created for regular reporting of adverse events following immunisation (AEFIs) as well as adverse events of special interest (AESIs) after vaccination. SAHPRA led the pack by playing a decisive role in making evidence-based decisions and monitoring the adverse effects of COVID-19 related health products.

The national scientific community must be applauded for championing several COVID-19 clinical trials, ranging from therapeutic to vaccine trials. In total, SAHPRA authorised 52 therapeutic trials and 23 vaccine trials during the 2021/22 financial year. These approvals were finalised in record time, due to the extended hours worked by both the internal team and external evaluators in an effort to support the national and global endeavours to fight the pandemic.

When a pandemic of mammoth proportions makes its appearance, partnerships and knowledge exchange are key interventions. SAHPRA forged several partnerships nationally, regionally and globally: regulators such as the United States Food and Drug Administration (USFDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) as well as participation in global harmonisation programmes and associations such as the International Coalition of Medicines Regulatory Authorities (ICMRA), the WHO, and the African Vaccine Regulatory Forum (AVAREF) proved to be most beneficial. Furthermore, SAHPRA’s internal and external experts as well as committee members participated in collaborative review processes with the WHO and AVAREF for a number of the vaccines.

SAHPRA also recognises the need to build capacity not only in South Africa, but also on the African continent. The need to ramp up capacity in regulatory sciences was echoed by many African regulatory authorities, the WHO and the African Medicines Regulatory Harmonisation (AMRH) initiative. To this end, a number of SAHPRA’s staff received training in a variety of regulatory functions to ensure that SAHPRA’s skill sets remain on par with global standards.

While science-based efforts were progressing, there was an emerging threat that sought to undermine these efforts. Fake news and a lack of science-based information began circulating on, especially, social media platforms and this gained traction with lightning speed. SAHPRA engaged media proactively and held 10 webinars on priority issues and used this as a platform for public engagement of the functions of the regulator. SAHPRA’s social media platforms were also abuzz to debunk myths and to present credible scientific evidence. Apart from many media appearances, SAHPRA also created videos and infographics to convey information in a palatable format. SAHPRA media spokespersons were trained on engaging the media and the public on various media and social media platforms to disseminate vital information optimally. Partnerships with entities such as PATH, the National Press Club, the Government Communication and Information System (GCIS), Daily Maverick, Bhekisisa, and the Solidarity Fund proved to be most favourable.

During the 2021/22 financial year, SAHPRA had realised a significant year-on-year increase in fee income generated which amounted to R169 million from R87 million in the 2019/20 financial year. The increase in revenue generation was mainly due to the impact of the revised Fee Gazette issued in December 2020.

An accounting surplus amounting to R28 million was posted for the 2021/22 financial year compared to a deficit of R19.6 million in the prior year resulting in an increase in our net asset position. We will be continuing as a going concern for the foreseeable future due to the strong cash position held at year end and the material liabilities that relate to revenue received in advance which will be recognised in future financial periods.

A strong focus was placed on strengthening governance and internal control processes resulting in an unqualified audit for the 2021/22 financial year as well as the implementation of consequence management processes in an effort to build a culture of accountability plus the capacitation of the Supply Chain Management Unit, thereby limiting the risk in the supply chain management area.

As we look forward to the year ahead, there is much work to be done; however, strong foundations in innovation, monitoring and evaluation processes are steadily progressing. We are also firmly working towards growing capacity within the organisation. We aim to continue engaging, collaborating and growing new partnerships in the global fight against the COVID-19 pandemic.

I must express my deep gratitude to the SAHPRA team for their unwavering support and dedication as they work under extraordinary circumstances and at equally extraordinary times in order to execute their duties with gusto.

I must also thank the SAHPRA Board for providing me with significant guidance in terms of strong governing frameworks, policies, and practices. Where required, they provided technical and legal guidance to the team, yet in doing so remained absolutely clear of their fiduciary roles and duties.

Dr Boitumelo Semete-Makokotlela

Chief Executive Officer

31 August 2022