Regulatory stringency and adaptability in the time of Covid-19
Dr Boitumelo Semete-Makokotlela
As the entire world ushered in 2020, no one had any idea how life, businesses, governments, and nations would be disrupted. The “normal” that we were so familiar with got eroded rapidly as the pandemic gripped society with deadly force.
Health regulatory authorities were not exempt. In fact, they were caught in the eye of the proverbial storm. We all found ourselves having to grapple with adapting to the fast pace of change that was unprecedented. Our age-old practices, approaches and in some instances, regulations, were now being challenged.
Specifically, as the South African Health Products Regulatory Authority (SAHPRA), a newly established schedule 3A public entity from the previous Medicines Control Council (MCC), with a newly appointed CEO with only two (2) months into the role, found itself at the heart of South Africa’s response to the COVID-19 pandemic.
The authority which had a number of manual processes had to, like many others, transform its business processes within a few weeks to ensure that as an essential service, it continues to operate efficiently and remains relevant. The pandemic made it necessary to move away from the “business-as-usual” mode to changing the face and the pace of its operations. SAHPRA was forced to embrace 4IR and to venture into the digital space.
SAHPRA had to be more responsive than ever. What has previously been characterised as a rigid regulatory authority with lengthy approval timelines had to undergo a “facelift” and be flexible and operate through high levels of efficiencies to keep up with the dynamic and fast paced changing landscape.
Furthermore, the organisation had to strengthen its external communication to deal with areas of miscommunication and “fake news” around the role of the regulator. It became apparent that regular communication of the role of the regulator in the health sector and clear public education and engagement programmes will be critical.
Throughout this period of executing its regulatory oversight in the areas of medical devices, in vitro diagnostic tests, medicines, clinical trials, and vaccines targeted at the management of Covid-19, SAHPRA had to ensure that it remains stringent, making science-based regulatory decisions without any undue influence from any parties. This was done over and above the other health product needs that the country demanded, outside of Covid-19.
The regulator had to leverage on the wealth of scientific skills and expertise that South Africa is endowed with. Collaborating with a range of stakeholders, primarily the academic scientific community, was critical to its success and the regulatory prowess it displayed.
Key learnings have been gleaned by this African regulator, that is on a transformation journey to be among the leading regulatory authorities in the world, aligned with international best practices, yet being locally relevant.
It will no longer be business as usual for the authority. As it positions itself for success, these key aspects will be part of its ethos going forward:
1. As SAHPRA strengthens its internal capabilities, partnership with the country’s scientific community will be pivotal. It is apparent that the country’s regulatory strength is not just the regulator’s internal skills sets and capacity, but also the national scientific stature.
2. As SAHPRA retains its scientific and regulatory stringency, rigidity will have no place in the future of the regulator. Responsiveness to the ever-changing external landscape will be critical.
3. The complexity and frequency of health challenges that the world faces is ever increasing, requiring that SAHPRA strengthens its regional and international partnerships in an effort to leverage on the global knowledge base available to it.
4. The era of taking many years to register health products is over at SAHPRA. The high rate of advances in medicine development and the complexity of diseases necessitates that SAHPRA is efficient, to ensure timely access to innovative and life-saving health products.
5. SAHPRA will have to ensure that it is an enabler of the local health sector development and innovation value chains. The pandemic and the associated lockdowns have spurred a renewed intention by the country to develop health products locally. Thus as a regulator, while remaining true to our core mandate of ensuring safe, quality and efficacious health products, we will need to review our process and ensure that we are an enabler and not a barrier in the health sector.
Not adapting to this change and ever evolving external landscape will be detrimental for the regulator. While SAHPRA adapts, regulatory stringency will remain core to its fabric.
* Dr Boitumelo Semete-Makokotlela is the CEO of the South African Health Products Regulator.
** The views expressed here are not necessarily those of IOL.