WHO To Review Impact Of Mechanism For Tackling Substandard & Falsified Drugs
Executive Summary
Recent incidents of illness and death caused by contaminated cough syrups show that there is a need to review the “member state mechanism” that is intended to coordinate efforts to tackle poor quality medical products, the World Health Organization says.
An independent review of the World Health Organization’s mechanism for tackling substandard and falsified medical products is to be carried out this year, prompted by the recent discovery of contaminated medicines in various markets and “related preventable deaths,” according to the WHO.
A decision to conduct the review of the “member state mechanism” (MSM) was approved at last week’s World Health Assembly, and will be initiated at the next MSM steering committee meeting later this year, the WHO said.
The MSM was set up by the WHA in 2012 to tackle the problem of substandard and falsified medical “in a transparent and inclusive way,” according to the WHO. Its aim is to protect public health and promote access to “affordable, safe, efficacious and quality medical products,” it added.
The review of the mechanism will reinforce the “urgent” call by WHO director general Tedros Adhanom Ghebreyesus in January for greater vigilance and action in this “important area,” according to the WHO.
Tedros said at that time that over the past four months, countries had reported several incidents of over-the-counter cough syrups for children that had “confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG).”
Those cases were seen in at least seven countries and were associated with more than 300 deaths in three of them, Tedros said. The countries include Gambia, Indonesia, Uzbekistan and Cambodia.
He said that that the WHO was calling on manufacturers, distributors, regulators and governments to take “immediate and coordinated action.”
Drug companies were urged to purchase pharmaceutical grade excipients only from “qualified and bona fide suppliers,” to conduct comprehensive testing upon receipt of supplies before they were used to manufacture finished products, and to “provide assurance of product quality including through certificates of analyses based on appropriate testing results.”
They were also asked to keep accurate and complete records of purchases, testing, manufacture and distribution “to facilitate traceability during investigations in case of incidents.”
The WHA has asked Tedros to report to the WHA’s governing bodies on the outcome of the review of the MSM.
Improving Prevention, Detection And Response
The priorities for the MSM in 2022-23 include strengthening national and regional authorities’ ability to prevent, detect and respond to cases of substandard and falsified products, improve WHO member states’ understanding and uptake of screening technologies, and to “leverage the competencies of relevant stakeholders, including policy-makers, procurers, distributors, practitioners, patients and consumers, and good governance to reduce the burden” of such products.
At the WHA last week, member states “emphasized the support needed to improve their capacity to prevent, detect and respond” to substandard and falsified products “through access to appropriate technologies, including laboratory testing facilities, along with improved oversight on informal markets and advertising, and the online sale of medical products,” the WHO noted.
Countries also said that track-and-trace technologies needed to be implemented for market control and surveillance, and that it was important to ensure formal collaboration among “local and global partners such as law enforcement and customs administrations.”
Member states were “encouraged to align with conventions” aimed at improving legislation and imposing “prohibitive sanctions for wrongful dealing in substandard and falsified medical products,” the WHO added.
The WHO secretariat has been asked to report to the executive board on progress in this area in 2025.