FOREWORD BY THE CHAIRPERSON
National regulatory authorities ensure the legal and regulatory compliance of the drug development process including clinical development, licensing, registration, manufacturing, marketing, labelling and safety monitoring of health products. This means that the pharmaceutical industry is of necessity one of the most highly regulated industries worldwide. Whenever I am asked to give the elevator speech about the importance of a health products regulatory authority, the easiest pitch is to ask people if they trust the medicines they buy from a pharmacy, or the antibiotic they give to their sick child, or the anaesthetic they are given before life-saving surgery. If the answers are yes, then the important role of the South African Health Products Regulatory Authority (SAHPRA) is quickly understood. The past three years of the Coronavirus Disease (COVID-19) pandemic has taught the world tough lessons about what’s required to respond to a pandemic. Social responses, behavioural change, and the rapid development of medicines and vaccines were all urgently required. Having a skilled, principled, and effective regulatory authority has proved critical during this time of crisis. From the early efforts to approve diagnostics, to the ongoing efforts to approve COVID-19 vaccines against the backdrop of changing variants, SAHPRA has continued to deliver for South Africans.
In September 2021, the new SAHPRA Board was established, composed of members who had served on the inaugural SAHPRA Board complemented by new members. The legislation requires that five of the fifteen Board members have specific skills associated with good governance while the other ten members have technical skills associated broadly with medicines regulation. One of the many lessons learnt from the COVID-19 pandemic is the challenge of introducing colleagues to each other through virtual platforms. The Board has grappled with this challenge and is maturing into a dedicated group of experts committed to the ongoing development of a well governed, effective, and ethical regulatory authority. This shared vision is being realised by the dedicated efforts of the Chief Executive Officer (CEO), Dr Tumi Semete, supported by her executive team, staff and SAHPRA’s many external experts.
The lack of access to COVID-19 vaccines in the early phases of the pandemic resulted in a call from the African Union (AU) for the development of local vaccine manufacturing. Initiatives led by the AU with the World Health Organization (WHO) and the Department of Science and Innovation, have supported the establishment of new national manufacturing hubs. What is often not understood is that the success of the pharmaceutical industry depends on the effective oversight of a competent national regulatory authority that is able to independently confirm that health products are safe, effective and of good quality.
Neither foreign investors nor the WHO will support new manufacturing sites unless the national regulator can enforce predetermined global standards. The old language used by the WHO to describe the capabilities of national regulatory authorities was limited to the word ‘stringent’ applied only to high-income country’s national regulators. Until recently, the WHO had no mechanism to grade the competency of other less well-resourced national regulators. In the newly introduced WHO system, all regulatory authorities can apply to be objectively assessed for their maturity level which ranges from one to a maximum of four. SAHPRA is in the process of applying for a maturity level three which includes the ability to regulate vaccine manufacturing.
The COVID-19 pandemic has shown that South Africa’s academic and commercial institutions can advance public health rapidly through innovation in the development of medical products including new vaccines, diagnostics, and therapeutics. To support this, SAHPRA has developed the capacity to evaluate clinical trials rapidly and carefully, to fast-track the evaluation of new health products, and to undertake post-marketing surveillance. These new processes allowed rapid access to many urgently required COVID-19 products. The systems developed for the COVID-19 emergency are now being adapted for the post emergency setting so that other products required for new and ongoing priority public health needs can be more efficiently reviewed.
As with any newly founded institution, SAHPRA has had to capacitate itself so that it can address old problems as well as newly emerging challenges. The Backlog Project, started in 2019, aimed to clear the queue of 16 000 products awaiting evaluation that was inherited from the old Medicines Control Council. Independent funding was secured, and a dedicated Backlog Project management structure was implemented. The Backlog Project has changed the way that dossiers are evaluated by using proven techniques to accelerate reviews, and by sharing product evaluations with other regulatory authorities. After two years of dedicated work by the secretariat and external evaluators, the Backlog Project is now on track to be completed by December 2022. The strategies used in the project are regarded as best practice and are being introduced into the ‘Business as Usual’ department. In addition, next year will see the implementation of an ambitious plan to enhance the efficiency of SAHPRA’s systems through digitisation. These initiatives are being undertaken in close consultation with industry to ensure that new approaches achieve the aim of maintaining quality review while increasing efficiency. Both are essential if the country is to achieve the economic and public health ambitions of a stronger national health products’ industry.
Another responsibility of the regulator is communication. Regulatory authorities of high-income countries have huge departments dedicated to public communication and safe use of health products. Currently SAHPRA has a small Communications Department, but it has nonetheless prioritised public messaging to professionals and the public, covering issues such as SAHPRA’s COVID-19 response, vaccine safety, codeine abuse, and public interest issues relating to regulatory functioning. Over the next year, the ambition is to implement an expanded communication strategy and to identify priority issues for communication, such as the dangers of overusing antibiotics in both human and veterinary medicine.
SAHPRA is a young institution that has many more challenges ahead of it. This includes the development of appropriate oversight for medical devices, complementary medicines, cannabis, and radiation control. The emerging issue of ‘One Health’ that addresses the interface between animal and human health is another priority area for SAHPRA. The regulatory framework for veterinary medicines must be reviewed by SAHPRA and its veterinary colleagues, to ensure that it protects both animal and human health and addresses the emerging concern of antimicrobial resistance.
Regulatory structures that fairly enforce legislation are an essential component of a healthy democracy. I am confident that with the combined efforts of the executive leadership team, the SAHPRA staff and the Board, priority areas will be addressed and SAHPRA will continue along the path of becoming a world-class regulatory authority.
Professor Helen Rees
Chairperson: SAHPRA Board
31 August 2022