Chapter 6
PHARMACEUTICAL SERVICES AND POLICY
Shabir Banoo, Susan Putter, Andy Gray, Shoni Mulibana, Gertrude Mngola
Introduction
South Africa’s National Drug Policy (NDP) was issued in 1996 and appended to the White Paper on the Transformation of the Health System of South Africa in 1997 (Minister of Health, 1997). The NDP set objectives in three broad categories: health objectives, economic objectives and national development objectives. Although the continued relevance of this policy document has been questioned (Gray et al., 2017), it remains the extant national document guiding reform of the pharmaceutical sector. Implementing the NDP has required multiple amendments to existing legislation and has elicited strong reactions. A number of provisions have been subjected to Constitutional Court challenges, including the powers of the medicines regulatory authority’s inspectorate (Mistry, 1998), the licence to compound and dispense (Affordable Medicines Trust, 2006; South African Veterinary Association, 2019), and the pricing interventions (New Clicks, 2006). In addition, the scheduling of cannabis has been the subject of a Constitutional Court judgment (Prince, 2018).
This chapter summarises key events and initiatives in the field of pharmaceutical policy between 2015 and 2020, with particular focus on the ongoing process of health reform, efforts to advance equity, community participation, and the extent to which intersectoral collaboration has been achieved. Four aspects are highlighted: the continuing process of strengthening the national medicines regulatory authority, the selection of essential medicines and efforts to introduce health technology assessment (HTA), efforts to improve the availability and accessibility of medicines in the public sector, and the actions taken to address antimicrobial resistance.
Ensuring the safety, efficacy and quality of medicines
The need to strengthen the National Medicines Regulatory Authority was a prime objective of the NDP. Ensuring effective regulation of medicines and other health products, through strengthening systems and improving performance, has become a priority for governments worldwide (WHO, 2018). The process of reform has been protracted and contested, with multiple Amendment Acts (1997, 2002, 2008, 2015), and one unsuccessful attempt (1998) to replace the Medicines and Related Substances Act (Act 101 of 1965) (the Medicines Act).
The reforms implemented in the 2015–2020 period broadly follow the recommendations of the Green-Thompson Report (2008). The process was again protracted with two Amendment Acts (2008 and 2015) being promulgated in 2017, establishing the new South African Health Products Regulatory Authority (SAHPRA). The new Authority replaced the Medicines Control Council (MCC) in 2018.
The current Medicines Act has been in effect since 1967 and has been amended several times over the years. Both the Law Reform Commission (SALRC, 2016) and the State Law Advisers have expressed the opinion that the existing Act cannot be amended any further, and that a complete replacement Bill is warranted.
Addressing past constraints
The MCC had faced a number of financial and human resource capacity constraints that are common to national medicines regulatory authorities (NMRAs) in low- and middle-income countries (Azatyan, 2009). In particular, the increasing volume of applications for the registration of medicines, with limited resources, resulted in significant delays in the registration of medicines, approval of clinical trials, and other critical regulatory functions (Leng et al., 2016). Regulatory timelines in South Africa were much longer than those in comparable countries and the legislative environment impeded implementation of innovative regulatory pathways, such as reliance on the decisions of other NMRAs (Keyter et al., 2018). These delays had a significant impact on patients’ access to both new and essential public heath medicines. SAHPRA inherited both the backlog and the resource constraints of the MCC at its commencement. It needed, therefore, to address key impediments: under-funding and an inability to retain user fees, limited internal technical and administrative capacity, paper-driven systems, and an over-reliance on part-time, external experts to support routine regulatory activities, including registration decisions.
SAHPRA was established as a Schedule 3A public entity, in terms of the Public Finance Management Act (Act 1 of 1999), functioning outside the public service. The Authority is accountable to the Minister of Health and Parliament through its Board, which has governance, fiduciary and performance oversight responsibilities. Provision is also made for the appointment of the usual Board committees, such as those entrusted with audit and risk responsibilities. The Authority is led by its Chief Executive Officer and has operational and financial autonomy, accountability and responsibility for the regulation of health products. It manages its own staff, and appoints relevant technical advisory committees to support its work.
SAHPRA’s mandate has been extended to include the regulation of medical devices including in vitro diagnostics (IVDs). This poses challenges of coordination with existing provisions in the Hazardous Substances Act (Act 15 of 1973). In addition, SAHPRA has been delegated the responsibility for the regulation of ionizing and non-ionizing radiation-emitting medical devices, and radioactive nuclides. A co-regulatory approach is thus needed with the National Nuclear Regulator, which is itself undergoing legislative reform (Minister of Mineral Resources and Energy, 2021). SAHPRA retains regulatory oversight and control of human and veterinary medicines (including complementary medicines) and clinical trials.
New operating model
SAHPRA has attempted to address its systemic weaknesses by developing a new operating model, relying primarily on in-house technical and administrative staff to manage all regulatory functions, with external technical support being engaged only where needed. Despite a new funding model, which encompasses a fiscal allocation as well as retention of user fees from applications assessed and regulatory functions performed, the Authority remains underfunded and under-resourced. The 2020/2021 SAHPRA Annual Report noted that the audit for that financial year remained qualified, although the number of findings reduced from 88 in the previous year to 23, with only one finding leading to a qualification (SAHPRA, 2021).
The Authority has nonetheless made significant strides through appointing key senior management and technical staff, transforming legacy systems, and streamlining regulatory review procedures, coordination and quality management systems. These interventions have been aimed at preventing the development of new backlogs, and expediting the registration of priority health products. Having completed the transfer of staff from the National Department of Health (NDoH), SAHPRA has prioritised the training and development of new and existing employees. Several key technical and operational positions in new regulatory areas still need to be filled. Significant investments have also been made in new digital platforms such as the Electronic Document Submission System, Digital Variations Portal and the Complementary Medicines Licensing Portal. The development of an integrated Regulatory Information Management System, which will bring all regulatory processes onto one platform with built-in automation, intelligence and reporting capabilities, remains the goal. Key achievements include the provision of a complete medicines register on the redesigned SAHPRA website, and steps to provide a repository of professional information and patient information leaflets for registered medicines.
Meeting global standards
Globally, NMRAs are increasingly focused on improving transparency, information sharing and reliance models, in order to enhance the quality and speed of regulatory decision-making. Amendments to the Medicines Act have enabled SAHPRA to establish information sharing and work-sharing arrangements with recognised NMRAs globally and to advance the development of reliance models. SAHPRA can conduct full reviews of dossiers submitted for registration of medicines, which entail a complete scientific review for safety, efficacy and quality, including Good Manufacturing Practice (GMP). It is also enabled, in relation to applications for multi-source (generic and biosimilar) medicines, to conduct abridged reviews, assessing specific, pre-agreed areas of critical importance. However, it can also conduct verified reviews, validating that an application has been authorised by a recognised NMRA and relying on that decision for key components of the review.
SAHPRA (and the MCC) has been a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 2007, which has enabled it to strengthen the inspectorate function by harmonising GMP standards and processes for inspection of quality systems, promoting networks and information exchange with other NMRAs, and supporting training of GMP inspectors. SAHPRA also has observer status at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), so is expected to contribute to the development of global, harmonised standards.
The WHO has developed a Global Benchmarking Tool to assess the maturity level of NMRAs, as mandated by WHA Resolution 67.20 on Regulatory System Strengthening for Medical Products (WHO, 2014). NMRAs are assigned maturity levels (ML) from 1 (existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement). ML4 is intended to replace the previous designation of stringent regulatory authority, but ML3 and above would be considered WHO-listed authorities. SAHPRA aspires to being assigned ML3 status and is in the process of being assessed. Initial indications of the gaps that will need to be addressed in an institutional development plan have been received and are being considered. One of the key challenges is to revisit the outdated interpretation of the secrecy clause (section 34) in the current Medicines Act (Vawda & Gray, 2017). The chairperson of the Board noted in the 2020/2021 Annual Report that ‘more needs to be done in the field of communication to the public, and this continues to be a prioritised work in progress’ (SAHPRA, 2021).
SAHPRA is supportive of the ratification of the Treaty for the Establishment of the African Medicines Agency, which will require a parliamentary process, but also ‘domestication’ of the African Union Model Law on Medical Products Regulation in a future SAHPRA Bill (African Union, 2019).
Reducing the backlog
Eliminating the backlog of registration applications inherited from the MCC was an urgent public health imperative. The backlog was substantial, with over 16 000 applications, many dating back a number of years. Although comprised primarily of applications for the registration of generic medicines, there were also significant bottlenecks in the completion of post-registration amendment (variation) applications. Previously registered products were not able to be marketed until these variations had been finalised.
SAHPRA’s approach to reducing the backlog took advantage of global and regional regulatory harmonisation initiatives, and in particular the WHO prequalification collaborative procedure. With the financial support of the Bill & Melinda Gates Foundation, a dedicated in-house Backlog Team was established, supported by the Boston Consulting Group. Funding was also secured through a special allocation from the National Treasury, as well as from the US Centers for Disease Control and Prevention (CDC), the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Clinton Health Access Initiative (CHAI). SAPHRA was able to appoint additional external reviewers from a pool of local and international experienced regulatory experts. A phased approach was implemented, with applications prioritised based on public health and unmet medical needs. The team also updated guidelines and redesigned operational and business processes and implemented systems to enable electronic submission, review and tracking of applications, to reduce unnecessary bureaucracy and delays. Through engagement with industry applicants, an ‘opt-in’ process was implemented which allowed applicants to voluntarily withdraw older applications in the backlog that were considered out of date or of less interest. All applicants were required to resubmit updated, consolidated electronic applications within a given timeframe in line with SAHPRA’s new guidelines and requirements. Poor-quality applications were rejected if these did not meet strict predefined administrative or quality criteria.
SAHPRA planned to clear the backlog within a two-year period. The 2020/2021 SAHPRA Annual Report showed that 78% of the backlog had been cleared by March 2021 (SAHPRA, 2021). Of 5 320 applications for the registration of medicines, 2 819 (53%) had been finalised. Of 7 440 variation applications, 7 185 (96%) had been cleared. Of 38 new GMP licence applications, 29 (74%) had been issued. Of these 29 new GMP licences, 17 (59%) were issued within 125 working days of receipt of an application.
The approach taken by SAHPRA to clear its inherited backlog of work required a fundamental re-engineering of its procedures and processes, and this new methodology and approach was also introduced into SAHPRA’s ‘business as usual’ work.
Strengthening post-market surveillance
SAHPRA is responsible for the monitoring, detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems. An important aspect of pharmacovigilance comprises the systems and processes that holders of certificates of registration employ to ensure that safety-related data is collected, analysed and reported, with mitigations, corrective and preventive actions where required. SAHPRA aims to strengthen capacity within the inspectorate to assess the pharmacovigilance systems of holders of certificates of registration against established guidelines. By 2020, out of the 86 health product safety signals identified, all 86 (100%) had been investigated and finalised (SAHPRA, 2021). Of the 86 health product safety signals actioned, 37 (43%) were actioned within 20 working days.
With the numbers of new products, new technologies and new manufacturers continuously expanding, there is an urgent need to focus on a strengthened approach to post-marketing surveillance and vigilance to ensure that medicines and medical devices are safe and of good quality once introduced into the marketplace. Proactive post-market surveillance is required to reduce the risk of substandard or falsified medicines entering the local market. SAHPRA does not operate its own quality laboratory, and relies on contracted capacity. It also does not yet report on the number of products identified as potentially problematic.
Leveraging lessons learned from the COVID-19 pandemic
The introduction of the various information technology initiatives has allowed employees to work remotely during the COVID-19 pandemic and has resulted in increased productivity for core business activities. SAHPRA has made significant strides in partnering with relevant stakeholders to reach the public through its public awareness programmes, including providing information on new therapeutics, regulatory approaches for various health products as well as health products safety. The Authority’s redesigned website, use of social media and other communication tools has positioned it as a trusted source of information. The key contributions have been the use of rolling reviews, tied to reliance on section 21 approval, to enable conditional access to COVID-19 vaccines even as the data required for full registration were being developed and submitted. SAHPRA approval has also enabled access to quality-assured IVDs, protecting the health system and the public from exposure to sub-standard products.
Medicines selection and health technology assessment
In the period 2015–2020, the public sector has continued to rely on the existing structures for the selection of essential medicines. The NDoH Essential Drugs Programme (EDP) provides the secretariat for the ministerially appointed National Essential Medicines List Committee (NEMLC), which is supported by three expert review committees, each focused on a level of care (combined primary health care (PHC) and adult hospital, paediatric hospital and tertiary/quaternary care). The NEMLC continually updates and refines the national Essential Medicines List (EML) and Standard Treatment Guidelines (STGs). The selection of essential medicines is based on assessment of available evidence for efficacy, safety, cost-effectiveness and
affordability. The EML is organised and published per level of care (primary, secondary and tertiary/quaternary), and lists those medicines that should be available in the public health system. There are associated STGs for primary and secondary levels of care, providing guidance to health care professionals. In the 2015–2020 period, updated editions of the Paediatric Hospital EML/STGs were issued in 2017, of the Adult Hospital EML/STGs in 2019, and of the Primary Health Care EML/STGs in 2020. Rather than being issued in printed form,these documents are available on the Knowledge Hub (https://www.knowledgehub.org.za/) and also as a mobile application.
Challenges and lessons from COVID-19
One of the ongoing challenges to the entire medicines selection process is fiscal federalism. Although developed at the national level, the EML/STGs are not automatically applicable in the provinces. They remain subject to agreed cooperative governance provisions, as negotiated in the National Health Council. However, the NDoH has limited leverage, except where specific programmes (such as the antiretroviral treatment programme) are funded by conditional grants from the national budget. The provinces retain considerable autonomy in relation to expenditure funded from the equitable share allocation from the fiscus. The other major challenge is the coordination of selection and procurement processes. Although individual chapters of the EML/STGs are now updated, once approved by NEMLC, rather than waiting for an entire ‘book’ to be completed that does not address the problem of the set tender cycles for particular medicine types or therapeutic groups, newly selected medicines may not be available immediately, and medicines that have been replaced or removed from the EML/STGs may still be subject to ongoing contractual commitments to procure. In response to the COVID-19 pandemic, a sub-committee of the NEMLC was created and a process of rapid reviews developed (Leong et al., 2020). These rapid reviews, which are now produced by the NEML Ministerial Advisory Committee (MAC) on COVID-19 therapeutics, are placed in the public domain (http://www.health.gov. za/covid-19-rapid-reviews/) and inform the development of the national guidelines for the management of COVID-19. The rapid review process enabled the refinement of an evidence-to-decision (EtD) framework, which documented the basis for each recommendation. Elements considered in the EtD were the scale of health benefits and harms and the certainty of the evidence for each element, the resource implications, equity considerations, acceptability and feasibility (Leong et al., 2021).
The promise of health technology assessment
Health technology assessment has been defined as ‘a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle’ (O’Rourke et al., 2020). The definition also states that the ‘purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system’. Health technology assessment has been identified as a key enabler of universal health coverage (UHC) (Wirtz et al., 2017). Although expected to be an important part of the process for determining the benefit package for National Health Insurance (NHI) in South Africa, HTA processes in South Africa remain fragmented (Siegfried et al., 2017; Wilkinson et al.,
2022). The National Health Insurance Bill (Bill 11 of 2019), which is currently before Parliament, makes mention of various structures that will rely on HTA. The description of the Benefits Advisory Committee (to be entrusted with developing ‘detailed and cost-effective treatment guidelines’) and the Office of Health Products Procurement (tasked to ‘determine the selection of health-related products to be procured’, ‘develop a national health products list’ and ‘coordinate the supply chain management process and price negotiations for health related products’) has been described as confusing (Gray & Vawda, 2019). Further, it was pointed out that the Bill defines ‘health-related products’ as excluding medicines and medical devices, but that ‘health products’ are not defined, whereas ‘health goods’ are, and appear to include medicines and medical devices. Lastly, the Health Care Benefits Pricing Committee must ‘recommend the prices of health service benefits to the Fund’. Section 38(4) of the Bill describes the selection process as follows: ‘The Office of Health Products Procurement must support the Benefits Advisory Committee in the development and maintenance of the Formulary, comprised of the Essential Medicine List and Essential Equipment List as well as a list of health-related products used in the delivery of health care services as approved by the Minister in consultation with the National Health Council and the Fund’. Congruence with the proposals made by the Competition Commission’s Health Market Inquiry (HMI) in 2019 is also unclear (Competition Commission, 2019). The HMI proposed an independent supply-side regulator for health care, as well as an Outcome Measurement and Reporting Organisation (OMRO). The OMRO is described as ‘a platform for providers, patients and all other stakeholders in the provision of healthcare to generate patient-centred and scientifically robust information on outcomes of healthcare’.
This last proposal highlights a key weakness of current medicines selection and nascent HTA processes – the lack of provision for public participation. The same could be said of SAHPRA, which is endeavouring to communicate more directly with the public, but has as yet not explored the potential role of patients, patient organisations and the general public in regulatory processes. Transparency has an inevitable and virtuous consequence, namely, increased demands for access and engagement, and a ‘voice’ in decision-making processes.
The NHI Bill also includes consequent amendments to other legislation. One of the proposed amendments would change the definition of the Single Exit Price (SEP) in section 22G of the Medicines and Related Substances Act from the only price at which manufacturers shall sell medicines ‘to any person other than the State’ to read ‘to the National Health Insurance Fund …. or any other person’. This change, if effected, would have enormous consequences for the current strict separation between state stock procured on contract and private sector medicines.
Ensuring availability of essential medicines in the public sector
The first health objective in the 1996 NDP was ‘to ensure the availability and accessibility of essential drugs to all citizens’. Significant successes have been achieved in expanding access to treatment and care services for priority public health diseases, including HIV, through task shifting initiatives (see Chapter on National Health Programmes).
An ongoing challenge for the country is ensuring that its workforce is capacitated to handle the demands of service delivery in a changing environment with a large disease burden. The ongoing shortage of pharmacy personnel in the country, particularly in the public sector, has created significant challenges for the delivery of pharmaceutical services, with supply chain disruptions, long waiting times and delays becoming the norm, especially at high-volume facilities. Whilst it is unlikely that the human resources issues in pharmaceutical services will change appreciably in the near future, strategies are needed to ensure the best possible utilisation of existing pharmacy personnel to provide quality pharmaceutical services.
The NDoH has implemented a number of initiatives aimed at addressing some of these challenges, including implementation of core standards for service delivery, improving coordination of district health services, strengthening PHC services, and integrating the management of chronic diseases. In addition, current initiatives to strengthen the medicines supply chain, implement information management systems, and centralise medicine distribution and dispensing, are also intended to improve availability and access to medicines. These strategies are closely aligned with government’s universal health care objectives under the planned NHI. The NDoH continues to encourage engagement with private sector providers and partners to support efforts at developing best practice service delivery models, particularly for chronic disease patients.
Monitoring and improving medicine availability
Between 2015 and 2020, a number of reforms were implemented, aimed at improving the availability of medicines at public sector health establishments. These included the establishment of the National Surveillance Centre (NSC), the introduction of the Stock Visibility System (SVS) and the roll-out of the RxSolution stock management system.
The NSC was conceptualised in 2015 to provide visibility of medicine availability throughout the public sector supply chain, coupled with key performance indicators. Medicine availability is measured at various levels in the supply chain – provincial depots, hospitals, community health centres and PHC clinics. Data is also monitored at Centralised Chronic Medicine Dispensing and Distribution (CCMDD) service providers, as well as other health establishments that provide services on behalf of the public sector. To assist in monitoring and evaluating the performance of suppliers, medicine availability is monitored at the level of the pharmaceutical manufacturers who are contracted via transversal contracts to supply medicines to the state. Given the
variety of systems operated in different provinces, the NSC needs to draw on a variety of data sources, shown in Table 6.1. One of the supply chain challenges highlighted by the introduction of the NSC is the lack of a uniform set of master data relating to the medicines used in the public sector. The Medicine Master Data System (MMDS), which is under development, will provide a centralised, uniform set of data to support improved efficiencies at all levels and facilitate visibility via the NSC.
Table 6.1 Medicines availability data sources
Facility type
Supplier Management (PAT, Age Analysis)
Provincial warehouses
Hospitals, community health centres and some PHC clinics
PHC clinics
CCMDD and other providers of health care services on behalf of the state
Data source
RSA Pharma (supported by CHAI)
MEDSAS, gCommerce, Oracle, PDSX
RxSolution and other electronic stock management systems (ESMS)
SVS
Various ESMS in use by service providers
The information in the NSC is visualised on 154 dashboards, including an integrated dashboard which consolidates all provincial medicine availability views. Users are able to drill down to district and facility level, per province, and can also access the supplier performance dashboard. Root cause analyses can be undertaken to determine reasons for stock shortages identified and apply escalation procedures at health establishment, district/sub-district, provincial or national level, to enable appropriate action where needed. Escalation processes include confirmation of whether the medicine is actually on the formulary of the relevant health establishment, whether an order has indeed been placed, whether stock can be borrowed from another health establishment or whether an alternative medicine is available for use. The NSC is thus able to support effective and informed decision-making, including mitigation of challenges related to medicine availability across the supply chain. Accountable process owners are able to monitor medicine availability routinely and take preventive and corrective action as needed.
Reporting to the NSC has been included in the Annual Performance Plan of the NDoH, with targets related to the number of sites reporting being monitored. In addition, reporting is aligned to the Ideal Clinic framework. By the end of 2020, 3 783 facilities were reporting stock availability to the NSC. There was also an increase in NSC reporting compliance, improving from 80% in November 2019 to 93% in September 2020. Enhanced utilisation of the NSC was one of the unexpected outcomes of the COVID-19 outbreak, with stakeholders embracing the ability to use the NSC to monitor availability of medicines used in the management of COVID-19 as well as those used in the management of chronic conditions, while also providing data to support supply chain planning. In the absence of patient-level consumption data, optimised minimum and maximum stock levels are being calculated and loaded onto RxSolution and SVS.
The SVS was developed to monitor medication stock on hand at PHC level and is a web-based tool with a mobile application used to capture and monitor medicine availability. The tool is an early warning system to support better management of stock availability for essential medicines, particularly those used in HIV and tuberculosis. Each health establishment using the system is allocated a smartphone with the application pre-loaded. The application is designed to work even in remote areas. The data captured is synchronised in real time to a cloud-based server, where it is available to view on the designated SVS web portal by approved users as well as being visualised on the NSC. The portal generates automated emails and short messages (SMSs) that enable web users at all levels of the supply chain to monitor and manage medicine availability at facilities under their control. The SVS was first introduced to 703 sites in 2014, increasing to 3 321 by 2020.
A key finding highlighted in the 2010 Medical Products Technical Task Team (MPTTT) report was that South Africa lacked the capacity to determine a national pharmaceutical budget necessary to address its health needs (MPTTT, 2010). In 2018, the NDoH commenced with the development of a new demand planning process and set of tools, which aimed at improving future medicine demand modelling at national and provincial levels, and the forecasting that underpins the tender system. The new approach was first rolled out in two provinces, with an additional two provinces using the new process in 2019. Challenges relating to pharmaceutical budgets were again highlighted at the Presidential Health Summit held in 2019. One of the immediate actions identified was ‘to ring-fence pharmaceutical budgets and insulate them from being overridden to avoid budgets being redirected to non-medical expenditure which result in stockouts’ (Presidency, 2018). Although some progress has been achieved in the budgeting process for medicines, limited progress has been made in ring-fencing the pharmaceutical budget as recommended by the Presidential Summit Commission.
Challenges and lessons from COVID-19
COVID-19 has placed additional pressure on the public sector medicines supply chain. Among the factors that impacted the supply chain were the lockdowns in countries such as India and China from which many medicines, medical devices, active pharmaceutical ingredients and excipients used in the manufacture of medicines are imported. An additional challenge was the uncertainty early in the pandemic regarding which medicines would be required for the management of COVID-19 at the various levels of care. Patients at most risk of complications from COVID-19 needed continued access to medicines, with minimal visits to health establishments. The NDoH worked with various implementing partners including the USAID-funded Global Health Supply Chain – Technical Assistance programme, CHAI, and the Africa Resource Centre to respond to changes in the demand for medicines. The first step was to establish a preliminary list of items required for the management of patients presenting with COVID-19, as well as those items where supply challenges were being experienced or were anticipated. Critical care specialists provided input regarding global and local trends and insight into the selection of medicines. The national COVID-19 EPI modelling team provided data on expected patient projections. These inputs were brought together to add a volume lift to the standard baseline forecasts already prepared for all nine provinces. The first demand forecast was published by the end
of March 2020. The forecast was updated weekly until the situation stabilised, and then every two weeks thereafter, based on three components – anticipated medicine requirements, patient projections, and baseline demand forecasts. These were adjusted to take the number of sector patients into account and the duration of hospital stay, updated as new information became available. By the beginning of April 2020, a replenishment planning tool was in use to determine the shortfall in supply of COVID-19 priority items as well as those medicines needed by patients with chronic diseases. An important consideration was that in many instances patients were recipients of multi-month dispensing, as more patients were placed on the CCMDD programme and the length of validity of a prescription was extended to 12 months by means of an exclusion notice published in terms of section 36 of the Medicines Act. The output from the tool was a replenishment plan at the national and provincial levels. This model informed the volumes of medicines that needed to be sourced to fulfil the forecasted demand, taking the stock-on-hand at depots and health establishments and supplier pipeline into account. The recommended orders were shared with provinces to help inform the orders that the provinces needed to place on suppliers. In cases where supply was severely constrained, allocations per province were done. By the end of April 2020, COVID-19 dashboards were published on the NSC providing stakeholders with information about the availability and location of medicines on the COVID-19 priority list. Reporting compliance was also monitored carefully with follow-up taking place as needed. These interventions resulted in a steady supply of medicines in the country despite the challenges caused by the pandemic.
The Centralised Chronic Medicines Dispensing and Distribution Programme
Several early initiatives to improve access to chronic medicines were piloted and implemented in a number of provinces, including using spaced, fast-lane appointments, where chronic medications were pre-dispensed for a patient on an appointment schedule or delivered to a location closest to the patient. Both the Western Cape and Gauteng provinces had also implemented centralised dispensing units (CDUs) that distributed packaged medicines to health facilities for collection by patients (Magadzire et al., 2015).
With funding from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), the NDoH implemented the CCMDD programme in 2014, initially in the 11 NHI pilot districts. The programme was aimed at increasing access to medicines, particularly for patients on chronic medication, while decongesting public sector clinics. The programme was implemented as an NHI initiative, with centralised dispensing operations and distribution contracted to private providers. Packaged medicine parcels were distributed for collection to a health facility via a fast lane or adherence club (facility pick-up point (PUP)), or other convenient external PUP identified in the community or at private sector pharmacies (Liu et al., 2021).
The CCMDD can be characterised as a form of differentiated service delivery. HIV treatment programmes have been challenged to manage an increasingly diverse group of patients’ needs as national guidelines have evolved. The need to ensure both long-term adherence and retention in care demands differentiated service delivery options that suit the needs of patients. The CCMDD programme was expanded as a national programme in 2016, in eight provinces and 46 districts, excluding the Western Cape. More importantly, it was implemented as part of the minimum package of interventions to support linkage to care, adherence and retention in care based on
patients’ needs and context. By October 2019, there had been a significant increase in the number of public health establishments enrolled on the CCMDD programme (3 436 in total) and 2 037 external PUPs, with 2.99 million registered patients, of which 2.07 million were active. A total of 76% of active patients were on antiretroviral therapy and 24% on medicines for non-communicable diseases. As more alternative external PUPs are contracted, patients are provided with more convenient options for collecting their medicines closer to their homes or places of work. The CCMDD programme also offers opportunities for patients to have their medicine parcels delivered to their homes, either through a contracted bicycle model or by a community health worker as part of the Ward-Based Outreach Teams (WBOTs).
A further two technological innovations supporting differentiated service delivery models have been trialled – the remote automated dispensing unit (Pharmacy Dispensing Unit or PDUTM) and smart locker systems (e.g., Collect & GoTM and ‘Pelebox’).
The PDUTM, developed and piloted at fixed sites in Gauteng and the Free State by Right to Care, used robotic automation integrated with cloud-based information systems, SMS messaging and telepharmacy support. The system enabled real-time dispensing of prescriptions and allowed public sector patients to collect their chronic medication from any of a number of conveniently located sites in shopping malls, with extended access to services provided after hours, including weekends and public holidays (Firnhaber et al., 2018). Despite high levels of satisfaction from users, the technology was best suited to high-volume facilities and urban centres given the infrastructure requirements (trained support staff, logistics and IT systems, network and electricity) needed and dependence on high utilisation rates for cost-efficiencies (Strydom et al., 2018).
Integrated smart lockers, implemented by Right-ePharmacy and Technovera, were also expanded to facilitate collection of safely stored, pre-dispensed medicine parcels under the CCMDD programme. Patients receive a one-time-PIN (OTP) via SMS, enabling access to the locker. Smart lockers were also COVID-19 friendly in that patients do not have to queue or wait to collect their medicine parcels and support personnel are not required.
The scale-up of the Ideal Clinic Realisation and Maintenance (ICRM) programme also introduced a package of services to improve process flows at facilities as well as quality of clinical care. Scheduling of patient appointments enabled pre-dispensing of patients’ prescriptions which could be supplied from the facility pharmacy, a dedicated CDU or by the CCMDD programme.
The NDoH has embarked on a re-branding campaign intended to improve awareness of the CCMDD programme, making it more relatable to a larger audience. The campaign was branded DABLAPMEDS, a colloquial term for ‘shortcut’, making reference to CCMDD as a timesaving method for chronic medication collection.
Overall, the CCMDD programme has adapted quickly to resolve some of the early implementation problems. However, infrastructure challenges such as network and connectivity issues continue to hamper implementation of web-based platforms to enable online patient registration at health facilities, electronic submission of prescriptions and scanning capability for medicine parcels received and issued at collection points. Additionally, improved systems for prescriptions renewal, multi-month dispensing, expanding differentiated delivery programmes for rural communities and better regulation of private pharmacies to ensure confidentiality and flexible collection times are still needed.
Learning from the COVID-19 response
During the COVID-19 pandemic, the NDoH expanded the eligibility criteria for differentiated models of care to strengthen linkage, adherence and retention in care. Extending the validity of chronic medicine prescriptions during this period enabled reduced visits to health facilities, limiting contact and protecting both patients and health care workers. Patients were also encouraged to collect their medicine parcels at external collection points, including through expanding availability of smart collection lockers, as these remained accessible during lockdown periods.
Addressing antimicrobial resistance
Despite the publication of the WHO Global Strategy for Containment of Antimicrobial Resistance (AMR) in 2001, the slow and fragmented implementation of the recommended interventions in countries continue to contribute to the inadequate response of slowing the spread of AMR (WHO, 2001). Nonetheless, the publication of the Global Action Plan (GAP) has improved the visibility of AMR on a global scale (Leung et al., 2011).
South Africa’s National Action Plan, the Antimicrobial Resistance National Strategy Framework 2018–2024, has embraced a ‘One Health’ approach in an attempt to overcome the fragmented approach in human and animal health, across the public and private sectors (NDoH, 2017). The 2018 strategy updated a 2014 version, incorporating the South African Veterinary Strategy 2016–2026, developed by the then Department of Agriculture, Fisheries and Forestry. An intersectoral Ministerial Advisory Committee (MAC) on AMR was appointed, which drew from both human and animal health sectors. The MAC-AMR established Surveillance, Education, One Health Stewardship, and Infection Prevention and Control Technical Working Groups.
An example of multisectoral action was provided by the efforts to improve the use of colistin, a last-resort antimicrobial used in both human and animal health (Mendelson et al., 2016). A multisectoral, multidisciplinary working group was established in 2016 co-chaired by the MAC-AMR and MCC chairpersons. The working group reviewed the use of colistin in both humans and animals and made various recommendations, including supporting restricting the use of colistin only on the basis of laboratory-confirmed sensitivity testing. The South African Veterinary Council, at the time, also warned veterinarians that any conduct contrary to these recommendations would be considered unprofessional conduct.
The MAC-AMR established two National Training Centres in 2016 to provide health care workers with practical tools required to set up antimicrobial stewardship (AMS) structures, and provide an alternative to the conventional model that relied on infectious disease specialists or clinical microbiologists (Brink, 2017). The AMS model adopted in South Africa needed to take account of the application of task shifting, specifically nurse prescribing at PHC level (Chetty et al., 2019). Guidelines have been published, providing implementers with practical tools to establish robust AMS programmes using quality improvement methodologies (NDoH, 2017b; NDoH, 2018; NDoH, 2019; NDoH, 2019b). Provincial AMR workshops have provided an opportunity for shared learning, encouraging adoption and implementation of best practices. An online AMR module has been targeted at health care workers in both the public and private sectors, in both human and animal health. Engagement is continuing
with all statutory health councils to develop standardised AMR training programmes in the undergraduate curricula for all health care professionals in human and animal sectors, to address the knowledge gaps identified (Chetty et al., 2019). Under the leadership of the MAC-AMR, the Infection Prevention and Control (IPC) working group was established to update the National Infection Prevention and Control Policy and Strategy (2007) and align it to the WHO core components. In 2020, the National Health Council approved the IPC strategy framework, and the practical manual developed to guide health care workers to successfully implement IPC in clinical settings.
South Africa has well-developed surveillance systems for AMR. Programmes operated by the National Institute for Communicable Diseases (NICD) include the Group for Enteric, Respiratory and Meningeal Disease Surveillance in South Africa (GERMS-SA) and the Centre for Healthcare-Associated Infections, Antimicrobial Resistance and Mycoses, which tracks blood culture isolates at sentinel sites for Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species (the ESKAPE pathogens). The NICD has published these data as percentage-resistance heat maps, disaggregated to provincial and district levels. Consolidation of public and private sector data at national level has been prioritised by the MAC-AMR, and memoranda of understanding have been concluded between the NDoH and private sector laboratories. South Africa contributes some resistance data to the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS). Some antimicrobial consumption data were provided in 2017 (Shellack et al., 2017), and included in a national report produced in 2018, disaggregated by AWaRe (access, watch and restrict) category (NDoH, 2018). South Africa has not yet provided antimicrobial consumption data to GLASS. COVID-19 has exposed the limitations of existing antimicrobial consumption surveillance, with only national data on volumes of antimicrobials (such as azithromycin) being easily accessible (Leong et al., 2021). Disaggregating data to provincial, district and facility level, especially across both the public and private sectors, remains challenging.
In order to raise awareness of AMR and mitigate inappropriate antimicrobial use, the NDoH added the World Antibiotic Awareness Week (WAAW), now World Antimicrobial Awareness Week (WAAW), to the South African health calendar, which runs from 18–24 of November every year. Through the UK–SA twinning programme, a collaboration with Public Health England, the NDoH launched the Antibiotic Guardian campaign, with a South African-specific website (www.AntibiocGuardian.com/ South-Africa) developed to host pledges specific to the South African context for human health and veterinary professionals. In 2019, the Minister of Health took a public pledge to become an antibiotic guardian.
Summary and Recommendations
As described in this chapter, the process of reform of the pharmaceutical sector, first initiated with the publication of the NDP in 1996, continues apace. Fundamental changes have been made to the operating model of the NMRA, with the establishment of SAHPRA in 2018. Several innovations have been introduced to improve the visibility of medicines availability in the public sector, but these remain invisible to the general public. That there is still concern about stockouts is evident from civil society efforts, such as the Ritshidze reports on the performance of the public health sectors in all of the provinces apart from the Western Cape (https://ritshidze. org.za/). The limitations of existing methods are evident in the paucity of data, at disaggregated and patient level, regarding antimicrobial consumption. Antimicrobial consumption in the agricultural sector remains poorly characterised. As efforts progress to rewrite the Medicines Act, attention will need to be paid to the appropriate regulation of medicines used in animals. The following specific recommendations in the areas of focus are offered:
SAHPRA: The Authority remains severely underfunded for its expanded mandate and the demands of maturity level 3. Overcoming the constraints of lack of access to specialist regulatory expertise will demand greater use of reliance models, especially for the assessment of applications for the registration of complex new chemical and biological entities. The legislative reform process needs to be accelerated, specifically to address the relationship with the NDoH, the necessary amendments to the Hazardous Substances Act, the co-regulatory approach to be applied with the National Nuclear Regulator, and the regulation of medicines for animal use (in veterinary care and in agriculture). Intersectoral coordination will be key. An equity focus is needed, especially in relation to methods to prioritise particular applications and ensure that they are expedited. Improving transparency of the entire regulatory enterprise is essential.
Medicines availability: Although there have been major advances made in relation to visibility of medicines availability data in the public sector, consideration needs to be paid to how these can be made patient-accessible and patient-friendly.
Access to chronic medication: The CCMDD programme has enabled a differentiated service delivery approach to chronic medication supply. The programme will need to continue evolving, making it more equitable, in particular for rural areas. However, as the division between state and private stock is altered by NHI, the very raison d’être of a centralised dispensing model will need to be carefully considered.
AMR: South Africa’s national action plan is well designed, on paper, but requires additional financial and human resources to be effectively implemented. Securing funding through the National Treasury is key and developing a business case for AMR is urgently needed. Particular attention needs to be paid to developing routine data systems that can report on antimicrobial consumption at all levels, and across both the public and private sector, in human and animal health.
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