A recently released report found inefficiencies in a key World Health Organization program that assesses the safety and quality of health products in low- and middle-income countries, stating that the organization needs to provide greater clarity. While WHO is pushing back on some of the report’s assertions, the researchers are standing by their findings.
Many procuring aid organizations, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, and national governments in low- and middle-income countries, or LMICs, rely on WHO’s prequalified health products, such as medicines, in vitro diagnostics, vaccines, and products that seek to control disease vectors. WHO prequalification of a certain product can help expedite their approval and uptake in countries.
The report is published by the Global Health Technologies Coalition and the Duke Global Health Innovation Center. At a webinar last week hosted by GHTC and Duke, Dr. Rogério Gaspar, director of regulation and prequalification at WHO, said parts of the report contain “misrepresentations and factual errors.”
But researchers behind the report are standing by their recommendations on the need for greater clarity and efficiency of the WHO’s prequalification process.
“One striking finding continues to be the lack of full and clear understanding, across multiple external stakeholder groups, of the nuances and details of the various [WHO prequalification] pathways and timelines,” Dr. Krishna Udayakumar, founding director of the Duke Global Health Innovation Center, said in a written response to Devex.
He said a key recommendation is that the WHO ensure more transparency and engagement with stakeholders, including product developers and manufacturers. Udayakumar added that researchers will continue to work with WHO to get more feedback and data, and “stand ready to amend any aspects of the report if warranted.”
“To be clear, we do not see ourselves at odds with the WHO PQ team. Open, public dialog and disagreement is welcomed, and important, to move critical discussions forward,” he said.
What the report found
Researchers studied 26 prequalified health products, reviewed publicly available information on the WHO’s prequalification program, and conducted interviews with 24 people — including product developers, product development partners, and experts in global regulations, regulations in LMICs, and the WHO prequalification and regulatory system.
They found that the scope and process of the WHO’s prequalification work are not always clear to outsiders, including product developers. One interviewee, for example, believed that the program only covers generics or existing products that are being used for new purposes, when the program also does reviews of new products such as vaccines.
WHO has prequalified 1,125 generic and novel medicines, in vitro diagnostics, vaccines, and vector control products since 1987 — when it began conducting assessments — according to the report.
It’s also unclear to some whether a product can be prequalified even if no WHO guidelines exist yet for that product’s usage. Others commented on the unclear timelines for getting products prequalified by WHO.
Based on its findings, the report recommended that WHO improve communication regarding prequalification to provide “greater clarity” to those who want to engage with the process, along with a public database that includes the complete timeline information of all products under prequalification.
It also advised that WHO expand the use of its “living” guidelines beyond COVID-19 therapeutics and drug-resistant tuberculosis treatments, in hopes this would expedite opportunities to prequalify other health products.
“To be clear, we do not see ourselves at odds with the WHO PQ team. Open, public dialog and disagreement is welcomed, and important, to move critical discussions forward.”
— Dr. Krishna Udayakumar, founding director of the Duke Global Health Innovation CenterIn addition, WHO should provide more opportunities for feedback on its processes and strategy, “beyond annual manufacturers meetings,” and advocate for member states to allow the organization to hire more permanent staff and reduce reliance on consultants, the report said.
Pushback
During the webinar last week, Gaspar congratulated GHTC and Duke for the report, but raised some issues that he said stemmed from a lack of communication, “partly” on WHO’s part. While he doesn’t blame the researchers, given they only relied on publicly accessible data, he said “the data do not represent in most cases what is really the reality of the prequalification exercise.”
He raised concerns that the report’s review focused on just 26 out of the 1,125 products prequalified by WHO as of April 2022. He also said some data cannot be made public because it contains information on communication and reporting by manufacturers and regulators.
In addition, he said WHO consultants are not permitted to provide information to product developers, in response to a text in the report that refers to manufacturers interacting with WHO consultants.
“We have procedures to avoid this. And if the report and the researchers found evidence of this, we need to be informed,” he said.
Jamie Bay Nishi, executive director of GHTC, told Devex that if more and more countries are expected to rely on WHO’s assessments for a wide range of health products, there needs to be a better understanding of the process and a way to beef up WHO’s core staffing to handle the demand.
About the author
Jenny Lei Ravelo@JennyLeiRavelo
Jenny Lei Ravelo is a Devex Senior Reporter based in Manila. She covers global health, with a particular focus on the World Health Organization, and other development and humanitarian aid trends in Asia Pacific. Prior to Devex, she wrote for ABS-CBN, one of the largest broadcasting networks in the Philippines, and was a copy editor for various international scientific journals. She received her journalism degree from the University of Santo Tomas.
