2. OVERVIEW OF PERFORMANCE
2.1 Service Delivery Environment
In executing its mandate, SAHPRA was challenged through public protests, and it experienced political pressure in areas such as cannabis. In its defence, SAHPRA continuously expressed that its decisions relied on science and evidence. During the public protests, there was minimal disruption to business operations although security measures were enhanced due to safety concerns for staff. SAHPRA requires the continued support from the State to ensure that its autonomy is protected.
Several litigation cases were brought against SAHPRA during the year under review. These cases were primarily challenging the regulatory mandate and powers of SAHPRA, including among others, the application for the approval of the use of Ivermectin, SAHPRA’s decisions on COVID-19 vaccines, classification of cannabidiol and the regulations on complementary medicines. Some of the court cases have been finalised while others are still pending.
The country continues to deal with the COVID-19 pandemic. As a responsive regulator, SAHPRA reduced the time taken to register COVID-19 vaccines to less than three months, where the required standard of data is available, compared to the average of 20 months it takes to approve new medicines/vaccines. SAHPRA did this while continuing to adhere to strict guidelines to ensure the safety of South Africans. The continued receipt of applications electronically has proven to improve the turnaround times as compared to the manual physical submissions.
Seven months into the implementation of the Backlog Clearance Project in March 2020, the COVID-19 lockdown was instituted worldwide. The lockdown resulted in many global research and development, manufacturing and testing facilities operating on skeleton staff. This severely impacted the project as the majority of local subsidiaries and applicants requested long extensions to respond to queries from SAHPRA. As staff members had adapted to the “new normal” way of working, the COVID-19 pandemic posed less challenges than the previous reporting period.
In response to numerous requests from applicants regarding priority review of variations and new applications encompassing vaccines, human immunodeficiency virus, oncology and tuberculosis, SAHPRA approved and implemented the Policy on Priority Review Pathways for medicines. The Policy provides for priority review to facilitate greater accessibility and availability of medicines:
- That address an unmet clinical need in the South African market (novel/innovative medicine/New Chemical Entities).
- That show a major therapeutic advantage in safety or efficacy to existing treatment options.
- For life threatening or seriously debilitating conditions.
- For public health and animal health emergencies.
- For a limited target disease for a patient population (orphan disease).
- In the event of national priorities guided by NDoH.
- Where security of supplies is a concern (guided by NDoH needs) and the Department of Agriculture, Land Reform and Rural Development.
This policy applies to New Chemical Entities, New Biological Medicines, interchangeable multi-source (generic) medicines and Biosimilars for both new registrations and their lifecycle management.
SAHPRA piloted a process which involves the introduction of pre-submission meetings as a first step in the application process. The pilot study was conducted with applications submitted between August and September 2021. Pre-submission meetings were scheduled between SAHPRA and the applicant to discuss the applications to be included in the pilot. The pre-submission meetings provided a common understanding of what supporting documentation is required to evaluate an application as well as resolve any issues before the application is submitted. This resulted in proper planning for submissions and enhanced the management of both timeframes and resources.
To reduce the backlog building up in generic medicine registrations in the Business-As-Usual area, evaluation teams implemented strategies which encompass implementing various forms of reliance that involve making use of assessment reports from recognised regulatory authorities and SAHPRA. This reduced the review timelines of applications.
SAHPRA conducted inspections related to Good Manufacturing Practice, Good Warehouse Practice, Good Clinical Practice, Good Distribution Practice and Good Vigilance Practice (GxPs) as well as inspections related to complaints and matters of regulatory non-compliance. Through co-operation with law enforcement agencies such as the South African Police Service, arrests were made that lead to the prosecution of individuals who contravened the Medicines and Related Substances Act (1965, as amended). Contraventions ranged from illegal importation to illegal manufacturing. Furthermore, through co-operation with the South African Pharmacy Council, SAHPRA witnessed increased actions against registered and unregistered personnel contravening the Pharmacy Act (1974).
Having spearheaded and implementing cannabis frameworks for cultivation of medicinal cannabis to produce scheduled substances, SAHPRA was faced with public protests regarding the limited market for the cannabis plant and its uses. The Cannabis Master Plan, headed by the Department of Agriculture, Land Reform and Rural Development, requires swift implementation so that all economic aspects of the cannabis plant and its uses can be fully realised, with SAHPRA regulating its respective area within its mandate.
With the easing of travel restrictions, local physical onsite inspections increased as full-onsite inspections, or a hybrid method of on-site and remote online inspections were conducted. Several international remote inspections were successfully conducted utilising site readiness meetings to ensure that these inspections were effective. As restrictions on international travel ease for South Africans, plans are to embark on physical onsite international inspections during the 2022/23 financial year.
As part of enhancing the country’s COVID-19 regulatory response, SAHPRA approved the majority of unregistered medicines that treat COVID-19 infections within 24 working hours. Furthermore, SAHPRA continued to provide access to Ivermectin for the treatment of COVID-19 through the controlled compassionate use programme for approved unregistered Ivermectin products. There were quick turnaround times for evaluating clinical trial protocols for vaccines and therapeutics intended for COVID-19. Approved clinical trials were monitored closely for participant safety and well-being. There was an increase in the utilisation of the Med Safety App as a convenient mobile tool for safety reporting of adverse drug reactions to medicines, and AEFIs for vaccines (see Section 3.4.1). The country’s vigilance system was strengthened through the development of a National Vigilance Framework in collaboration with NDoH. To urgently address both awareness about vigilance and the decline in vaccine uptake due to public safety concerns, SAHPRA participated in several campaigns and webinars.
During the 2021/22 financial year, there was an increase in the number of applications for medical device establishment licences. This increase can be attributed to the following:
- Requirements set by various government departments and healthcare facilities (both private and public) requesting SAHPRA’s medical device establishment licence as a mandatory requirement to service providers.
- Compliance requirements by law enforcement organisations and SAHPRA for organisations importing (port of entry) and selling medical devices in the country.
- The COVID-19 pandemic has led to many organisations selling/distributing medical devices such as COVID-19 test kits, ventilators and masks.
2.2 Organisational Environment
SAHPRA employees are the driving force behind the achievement of the objectives of the Authority. The organisation focused on cultivating and sustaining a high-performance culture under the challenges presented by the COVID-19 pandemic while performing in a hybrid – remote working arrangement.
During the 2021/22 financial year, SAHPRA was able to recruit externally while providing opportunities to internal employees. It was important to ensure that employees grow within SAHPRA, and that key talent is retained.
Staff transferred in terms of the Labour Relations Act 1995 (Act No. 66 of 1995), Section 197 were moved from NDoH to SAHPRA. They were removed from the Public Service Personnel and Salaries Management System (PERSAL) Payroll System and placed on SAHPRA’s SAGE P300 Payroll System.
2.3 Key Policy Developments and Legislative Changes
There were no major changes to the relevant policies or legislation that may have affected SAHPRA’s operations during the period under review.
2.4 Progress Towards Achievement of Institutional Impacts and Outcomes
SAHPRA’s revised 2020/21 – 2024/25 Strategic Plan was approved in January 2021. The revisions were made to the vision, mission, values, and outcome related matters.
2.4.1 Impact Statement
All health products in South Africa meet world class safety, quality, efficacy, and performance standards.
2.4.2 Progress on Outcomes
MEDIUM-TERM STRATEGIC FRAMEWORK PRIORITY 3: EDUCATION, SKILLS AND HEALTH
Effective financial management (1)
1.1 Unqualified audit opinion obtained on the annual financial statements
Unqualified audit opinion obtained
Qualified audit opinion was obtained for the 2020/21 financial year
Financial sustainability achieved through revenue generated and enhanced operational efficiencies (2)
1.2 Total revenue generated from fees in the financial year
Revenue of R230 million generated from fees
Revenue of R169 million was generated from fees
Continuously respond to the needs and expectations of SAHPRA stakeholders (3)
1.3 Percentage of prioritised recommendations from the survey implemented
100% prioritised recommendations from the survey implemented
67% prioritised recommendations from the survey implemented
Out of 3 prioritised recommendations from the survey, 2 (67%) were implemented
A positive and enabling working culture created (4)
1.4 Percentage of the change management intervention implemented
Review of the change management intervention conducted
Out of 13 change management interventions identified, 12 (92%) were implemented
Attract and retain superior talent (5)
1.5 Percentage of positions in the staff establishment filled
100% of positions in the staff establishment filled
96% of positions in the staff establishment filled
Out of 55 budgeted positions, 53 (96%) were filled
Strengthened Information and Communication Technology and digitisation (6)
1.6 Number of business processes digitalised
All business processes digitalised
Section 21 business process was digitised in June 2021
Development of an online application submission system was in progress
Leave application process was digitalised
High levels of organisational operational efficiency and effectiveness in the regulatory function maintained (7)
1.7 Percentage of medicine registrations in the backlog cleared
100% medicine registrations backlog cleared
75% medicine registrations backlog cleared
Out of 3 395 backlog applications for medicine registrations received, 2 557 (75%) were cleared
1.8 Percentage of medicine variation applications in the backlog cleared
100% medicine variation applications backlog cleared
95% medicine variation applications backlog cleared
Out of 3 611 backlog applications for medicine variations, 3 428 (95%) were cleared
1.9 Percentage of New Chemical Entities (NCE) finalised within 360 working days
80% NCE finalised within 360 working days
100% NCE finalised within 590 working days
Out of 246 NCE applications received, 44 (18%) were finalised. Out of the 44 finalised, all 44 (100%) were finalised within 590 working days
1.10 WHO maturity level obtained
WHO maturity level 4 maintained
Based on the WHO provisional assessment report received in November 2021, an Institutional Development Plan was developed to address the recommendations
1.11 Percentage of new Good Manufacturing Practice (GMP) and Good Warehouse Practice (GWP) related licenses finalised within 125 working days
90% of new GMP and GWP related licenses finalised within 125 working days
42% of new GMP and GWP related licenses finalised within 125 working days
Out of 64 new GMP and GWP related licences applications received, 31 (48%) were finalised. Out of the 31 finalised, 13 (42%), were finalised within 125 working days
1.12 Percentage of human clinical trial applications finalised within 60 working days
80% human clinical trial applications finalised within 60 working days
95% human clinical trial applications finalised within 90 working days
Out of 274 human clinical trial applications received, 248 (91%) were finalised. Out of the 248 finalised, 235 (95%) were finalised within 90 working days
1.13 Medical Device registration regulations implemented
50% call-up products registered
19 guidelines to support the medical device registration regulations were drafted