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The World Health Organization's (WHO's) prequalification program is a key actor in the global health ecosystem and an important driver of expanding product access, but despite recently announced improvements to make the program more efficient and transparent, structural challenges continue to undermine its capacity to play a transformative role in quickly accelerating access to a whole spectrum of health products, especially novel technologies, in low- and middle-income countries.

February 20, 2024 by Philip Kenol & Marissa Chmiola

Over the course of the COVID-19 pandemic, more than 1 billion vaccine doses were delivered to the world’s poorest countries via the World Health Organization (WHO)-backed COVAX vaccine sharing scheme. While much attention has gone to evaluating the successes and shortcomings of this effort in the wake of the pandemic, far less has been directed towards the WHO program that helped facilitate the introduction of these vaccines and other technologies by certifying their safety and efficacy—a program that deserves equally nuanced examination.  

For decades, the WHO prequalification (PQ) program has played an essential role in accelerating access to health products in low- and middle-income countries (LMICs) by reviewing their safety, efficacy, and quality. It is a stamp of approval that clears the way for multilateral agencies to procure drugs, vaccines, diagnostics, and vector control products, and it guides emerging regulatory agencies that might otherwise lack the capacity to conduct independent reviews. But despite the program’s critical role in the global health ecosystem, it has been plagued by both operational and procedural challenges that create unnecessary delays. 

External stakeholders highlight pain points in the PQ program

That paradox is on full display in an independent evaluation released last fall of the WHO Department of Regulation and Prequalification, which oversees the PQ program. The assessment lauds the PQ program’s successes in expanding global access to products, especially during the COVID-19 pandemic; however, it also highlights the need for increased communication and collaboration between the PQ department and key stakeholders in the public health ecosystem, including product developers, national regulatory authorities, procurers, and other WHO departments. It also notes how manufacturers who apply for PQ are especially keen to have more visibility into PQ decision timelines and roadmaps for the release of related technical standards and guidelines. 

Stakeholders also unanimously highlighted the limited resourcing at WHO headquarters as a key constraint across the PQ department. According to the evaluation, the department’s resources have remained stable between 2018 and 2022 (from 114 staff members in December 2019 to 115 in December 2022). However, the scope and the workload across all teams have increased substantially over the same period.

This assessment echoes recommendations from a 2022 report from GHTC and the Duke Global Health Innovation Center, which also urged PQ to increase visibility into anticipated timelines for decision gates throughout the review process so developers can better anticipate communication and decision-making. The report also recommended that the PQ program be more transparent in publicly disclosing information on how it is performing against these targets, as well as provide access to regularly updated public databases with complete milestone information on all prequalified products. 

Moving towards greater efficiency and transparency 

Fortunately, recent moves by WHO suggest the agency is beginning to take this feedback seriously and pursue remedies. Alongside the release of the evaluation, WHO announced the forthcoming launch of a new electronic portal for processing PQ applications. The portal promises a one-stop shop for applicants to file applications and relevant documents, receive status notifications, and track and respond to requests—offering them a real-time picture of their application status. This portal should also drive major efficiency improvements, as applications are currently processed manually, meaning that WHO staff handled the more than 1,000 PQ applications received in 2022 without automated support mechanisms. For national regulatory agencies, particularly those involved in WHO’s Collaborative Registration Processes—which allow for regulators to rely on evaluations carried out by WHO and other participating stringent regulatory authorities to accelerate their regulatory decision-making—, the portal provides a single location where they can also access all relevant information and documents in tandem with WHO. Importantly, the portal will also capture process-related milestones in greater detail and integrate with the WHO website, which we hope will allow PQ to improve reporting and transparency.

While, unfortunately, the intended January 2024 launch of the portal has been delayed to the second quarter of the year, the rollout of the portal should be a welcome step toward a more effective, efficient, and transparent PQ program.

A new path forward for novel products?

Alongside pursuing operational improvements to processing applications, it is also vital that WHO reevaluate the PQ process itself to ameliorate bottlenecks that delay access to critically needed new technologies. 

Our 2022 report identified the interplay between the PQ process and the release of WHO treatment and use guidelines as one such process area ripe for change. Currently, WHO PQ procedure states that before a product can complete the PQ process and be listed, the product must already be featured in published WHO policy guidelines that recommend its use in clinical practice or public health policy. Stakeholders with whom we spoke identified this sequence as an obstacle and a source of delay for the PQ of novel products since the committees that develop guidelines, which operate outside the PQ process, will not release them until the clinical data upon which the guidelines are based are formally published in peer-reviewed literature, which can often take some time. 

During the COVID-19 pandemic, WHO proved these functions could occur more flexibly and in parallel. For example, WHO released regularly updated “living guidelines” for COVID-19 therapeutics as new clinical evidence emerged and, in 2022, released interim guidance for novel shorter-course treatments for drug-resistant tuberculosis. WHO PQ also initiated and advanced PQ review of the COVID-19 antiviral known by the brand name Paxlovid before related guidance was released, ultimately announcing the PQ of the product on the same day as the living guidelines for COVID-19 therapeutics were updated to recommend its use. There is an opportunity for WHO to more broadly adopt lessons from this experience by both expanding the use of interim or living guidelines and redefining the process for prequalifying novel products so PQ and guidelines development can occur more in parallel. We hope PQ will pursue this opportunity with haste, as it could be a potential game changer and significantly reduce the timelines for product evaluation, helping products ultimately reach patients faster. We also urge member states to adopt policy changes and provide the PQ program with the resources it needs to meet its growing scope and demands.

Despite some of its constraints, the PQ program remains a key cog in the global health ecosystem and an important driver of improved product access. There are indications that WHO and other key stakeholders have realized that changes must be made, as the current structures are weighing down the program's ability to quickly facilitate access to critical technologies, especially novel products. By implementing changes to make the application and review process more user-friendly and efficient and the procedure itself more streamlined, we believe the program can better deliver on its mission to make high-quality essential medical products available to all who urgently need them.

About the authors

Philip KenolGHTC

Philip manages the coalition’s multilateral policy analysis and advocacy work. He develops and implements outreach strategies to the various United Nations agencies and other multilateral organizations to ensure that the coalition is advocating a more about this author

Marissa ChmiolaGHTC

Marissa manages the development and implementation of the coalition’s communications activities, overseeing GHTC’s digital presence, media outreach, events, publications, and internal communication practices. She also manages GHTC's monitoring, evaluation, and adaptive learning and donor more about this author