World Health Organization’s Executive Board (EB) has gotten behind the rollout of an independent evaluation of the agency’s member state mechanism addressing falsified and substandard medical products in order to see how surveillance and enforcement of production standards could be improved.
The initiative, which now needs to go to the World Health Assembly in May, follows in the wake of a raft of recent reports on illnesses and deaths from contaminated medicines – that have been implicated in the deaths of dozens of children in Asia and Africa.
In the EB discussion on Thursday, countries also asked WHO to facilitate the more effective sharing of information on fake and substandard medicines and the necessary expertise to address the problem.
However, member states like Brazil and Thailand, as well as several civil society actors, also stressed that tightening regulations around medicines manufacture should not be designed in a way that exacerbates already existing shortages and restrictions in medicines access in low- and middle-income countries.
“The evaluation should include recommendations aimed at addressing the lack of equitable access to medicines, high drug pricing, supply and demand issues, and regulatory failures, which enable the circulation of quality-compromised medicine,” said Medicus Mundi International and the People’s Health Movement in a statement to the EB.
Other countries, such as Colombia, stressed that their national authorities are just now setting up a medicines surveillance system to regulate drugs. So, reports of the presence of tainted or fake medicines problems doesn’t necessarily mean that overall standards are low – but that enforcement is weak…
“Many countries are only just starting to implement their certification systems, and therefore if they have problems that doesn’t necessarily mean they have low standards that facilitate the proliferation of substandard and falsified medical products. It just means that they’re at an early stage of developing systems to cope with it,” Colombia’s delegate, Sr. Jaime Hernán Urrego Rodríguez, Vice Minister of Public Health, pointed out.
Sharing is caring.
Several member states also called on the WHO to facilitate more sharing of information and the development of technical expertise to detect and take timely action on fake and substandard medicines.
“When we have substandard or falsified medical products, we’re talking about an issue that varies considerably from one country to another depending on the regulatory authority’s capacity to act in different countries and depending on the environment in which it finds itself,” the EB delegate from Senegal stated, on behalf of 47 member states from Africa.
“We therefore would encourage the Secretariat to facilitate the exchange of information, the sharing and pooling of information among states, and also between the global network, with the focal points and other mechanisms and platforms that may exist.”
Contaminated cough syrups responsible for at dozens of deaths
Contaminated cough syrups have been implicated in the reported deaths of hundreds of deaths of children in Asia and Africa over the past decade, including dozens of children in the past year.
At the EB session, delegates from the USA and Botswana highlighted the severity of the fake drugs problem, as evidenced by the proliferation of recent incidents, calling for coordinated action to “address this critical and preventable issue”.
On January 25, the US Food and Drug Administration (FDA) announced that it will join hands with the WHO and other organizations in a joint investigation into the source of these contaminated cough syrups.
In October 2022, the WHO issued a product alert concerning four cough syrup products, contaminated with diethylene glycol (DEG) and ethylene glycol (EG).
“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the alert pointed out. The samples were tested in laboratories in Switzerland and Ghana.
WHO added that the manufacturer of all the four syrups was an Indian company, Maiden Pharmaceuticals Private Limited. These cough syrups were sold in the Gambia. At least 66 children died after consuming the tainted cough syrups, WHO stated, although an investigation into the precise cause of deaths is still going on.
While India said it found no manufacturing malfunction at Maiden Pharmaceuticals, the WHO has not retracted its report.
The WHO also flagged another Indian pharmaceutical manufacturer, Marion Biotech Private Limited, for exporting substandard products laced with DEG and EG to Uzbekistan in central Asia. In a product alert issued in January 2023, the agency said, “Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.” Use of these products has been linked to the recent deaths of 19 children in Uzbekistan.
India, the EB member whose manufacturers have been the focus of many of the complaints, did not present a statement at Thursday’s session.
Don’t set manufacturing standards so high that they impede access
Brazil and Thailand called for the WHO to ensure that the work to advance safe medicines does not invertedly impact access to medicines, by setting the bar too high for the production of medicines by low- and middle-income countries.
“Brazil supports initiatives that promote access to affordable, safe, and quality medical products, including through actions aiming at preventing detecting and responding to substandard and falsified medical products. Actions in this area nevertheless should not hamper the critical work to enable access to medicines through the provision of generic drugs,” Brazil said.
“The requirement to meet manufacturing standards should not become a barrier to access or an excuse to protect the interest of patent holding producers,” added Medicus Mundi International and the People’s Health Movement in their EB statement.
There is a risk that raising manufacturing standards too high – to the levels of the United States or European regulators could boomerang, impinging on the production of generic medicines in Africa and Asia, explained civil society actors at an EB side event on Tuesday evening, sponsored by Knowledge Ecology International.
Rather, WHO Good Manufacturing Practices (GMP), and low- and middle-income countries, such as Morocco, with a good track record of implementing good quality control standards, should be considered as models for emulation, they argued. The WHO GMP is used as the basis for WHO’s Prequalification scheme for medicines and vaccines that are approved by the global health agency for procurement by other UN and UN-Supported agencies.