The rollout of Covid-19 vaccines in South Africa is viewed with more than a little scepticism in many quarters. Potentially corrupt Covid-19 spending has already cost the country billions of rand according to law enforcement agencies.
The erosion of trust has meant the management of vaccine distribution is already under severe scrutiny – a situation that needs to be remedied quickly if the rollout is to prove effective. According to experts, one way to achieve this is by following the lead of the world’s leading pharmaceutical companies.
According to internationally-recognised life science experts Greg Reh and Hanno Ronte, writing on online platform PharmaBoardroom.com, vaccine manufacturers like Oxford/AstraZeneca, Moderna, and Pfizer/BioNTech displayed almost unprecedented transparency about their respective vaccine trials.
This had the effect of being “a great win for public trust”. The other key component to restoring the public’s faith are the supply chains themselves. Dr Juanita Maree, chairperson of the South African Association of Freight Forwarders (SAAFF), readily acknowledges these chains have been exposed to bribery, cronyism, nepotism and embezzlement in the past.
However, she has every reason to believe corruption can not only be avoided, but stamped out entirely when it comes to vaccine distribution.
Her belief stems from the fact that operators in the extended supply chain have created a Standard Operating Procedure (SOP) for the clearance process of international imports of the Covid-19 vaccines.
The SOP was being sent to South Africa’s partially state-owned vaccine manufacturer Biovac and Business for South Africa for adoption, Dr Maree says. “Covered in the SOP is the scope, background, prerequisites, and escalation information regarding the import processes.”
On the face of it, removing corruption at the supply chain stage is relatively simple. Dr Maree advocates for a monitoring of the end-to-end distribution chain once the vaccines arrive in South Africa, coupled with the creation of a dedicated tariff heading in order to monitor the export and transshipment cycles.
She also suggests the risk engine is improved once the vaccines reach the country.
In order for this strategy to be effective, it is essential that adequate amounts of the vaccine are secured by government, and delays are avoided at all costs. “We have to maintain the integrity of the cold chain,” Dr Maree says.
South African reality
South Africa’s tragic reality is that to date, the checks and balances required to implement successful procurement, distribution and administration plans have all too often been ignored.
Muhammad Ali, CEO of ISO training, consulting and implementation specialist WWISE, is all too aware of South Africa’s questionable track record in this regard. “If the procurement process is not independently audited, most of the tenders are awarded to companies that have employees in the public sector who have a personal advantage of being awarded the tender,” he says.
“The full legal requirements of the tender requirements are not always aligned, such as a valid tax clearance, or accredited BBBEE certificate and even unaccredited ISO Certifications.”
The fact is, most organisations do not have quality controls in projects aligned to ISO 9001, the standard that defines the requirements for a quality management system.
“There is poor quality in verifying documents and reports and validating the actual design. This can cause sub-standard work, which can impact clients requiring services. Often legal requirements are simply bypassed,” Ali says. South Africa needed to change its thinking in terms of certifications, particularly when it came to an issue like vaccines.
“Laboratories need to consider accreditation with South African National Accreditation System (SANAS) or Southern African Development Community Accreditation Services (SADCAS) to ISO 17025 (testing and calibration of medical laboratories) and/or ISO 15189 (quality management competency for medical laboratories).
“This justifies that the laboratory providing tests and research on the vaccines are following the correct methodologies with no shortcuts on quality control.”
In terms of eliminating corruption within the various systems, ISO 20400 Sustainable Procurement is key. This provides guidance to organisations, independent of their activity or size, on integrating sustainability within procurement.
“ISO 20400 Sustainable Procurement is aligned to the Public Financial Management Act. No ISO management system will be effective if the legal requirements are not embedded in the policies and procedures of the organisation’s systems,” Ali explains.
Another important apparatus is ISO 37001, which specifically is designed to tackle bribery. It assists an organisation to identify and mitigate weaknesses with extra controls “whether they are automated or verified and validated by two independent bodies which are alternated regularly”.
Thankfully, traditionally the medical industry has been strict in respect of medical devices and ensuring these meet international standards.
ISO 13485 Quality Management in Medical Devices is the most common medical device quality management standard regulatory standard in the world.
Ali says: “The South African Health Products Regulatory Authority (SAHPRA), Health Professional Council of South Africa and South African Pharmacy Council, along with the department of health and all its subsidiaries, have made it clear to any organisation looking to trade with the public or private sector the ISO 13485 is a pre-requisite before a licence is obtained for PPE and your laboratory is accredited to ISO 17025 and ISO 15189.”
He stresses that entities implementing ISO management systems should not see them as a cost, but an investment that allows for a structured approach in doing business. “In turn a culture of quality will be embedded among the employees and suppliers and expectations will increase among clients. That drives continual improvement.”