Health Minister Aaron Motsoaledi. Photo: File
South Africa has launched a pilot national action plan to combat the threat of sub-standard and false medical products that are circulating the market and harming patients’ health.
The initiative is being led by the South African Health Products Regulatory Authority, the World Health Organisation (WHO) and the South African government. If successful it will inform the rolling out of a handbook to UN member states, Health Minister Aaron Motsoaledi said.
“The purpose of this launch is to officially present the developed five-year national action plan on combatting substandard and falsified medical products and to mark the end of the [South Africa’s] WHO pilot on the draft handbook on combatting substandard and falsified medical products,” the minister said.
South Africa was among the first countries globally to develop a National Action Plan to address the production and circulation of sub-standard and fake medical products.
The pilot tested practical arrangements to prevent, detect and respond to substandard and falsified medical products across the supply chain and generated guidelines for a national scale-up. Once completed, it will be rolled out to five other countries and scaled up to other regions.
A 10.5% failure rate was observed on medicine samples in lower to middle-income countries, which caused 186 000 annual childhood deaths due to malaria and pneumonia, research from the WHO shows.
The factors that drive the circulation of unsafe and false medical products include availability where limited stocks are produced in a limited number of locations or in cases where some vaccines require multiple doses.
Affordability is also a contributing factor as only a handful of countries have a universal health coverage index of 80 and above while distribution also ramps up the costs.
Unethical practices and corruption are shown to drive up sub-standard and falsified medical products as well as inefficient administrative structures, where there is poor coordination between distribution channels, logistics and payment.
This is also amplified by poor procurement due to complex supply chains and an overlap between for profit and non-profit sectors, as well as shortages of supply-chain enablers as well as regulations and oversight gaps for different distribution sources, including hospitals.
“Substandard and falsified medical products are a threat to individual lives and the integrity of health systems globally,” Motsoaledi said.
“A significant percentage of substandard and falsified products circulating globally are found in Africa and this presents a serious concern for public health, affecting the attainment of Sustainable Development Goal three, which aims to ensure universal health access for all.”
Sustainable Development Goal three is one of the 17 global goals adopted by all UN member states in 2015 as part of the 2030 agenda for sustainable development.
“A common finding from the WHO global benchmarking tool assessments in various countries is the need to strengthen the market surveillance and control function — which fights the [substandard and falsified medical products],” Motsoaledi added.
The programme was developed by a multisectoral steering committee, which includes the South African Health Products Regulatory Authority as well as technical working groups from government departments, regulators, enforcement agencies, academia and industry.
It also seeks to secure commitment from the department of health and partner departments, strengthen collaboration among stakeholders and engage the media to raise public awareness, the minister said.
The pilot is intended to assess whether this help is clear and user friendly in its structure, language and layout and also whether it offers guidance for developing a national action plan, said Hitti Sillo, the head of regulation and safety in the department of regulation and prequalification at the WHO.
“It also checks whether the different resources adequately support countries in this process … and whether additional examples or tools are needed on how beneficial they will be,” he added.
“It’s a critical action that South Africa has actually agreed to be the pilot and that the lessons will inform the finalisation.”