WHO Urges Nations to Adopt National Strategies for Diagnostics

In the wake of the COVID-19 pandemic, the World Health Organization has adopted a resolution that has received the backing of MedTech Europe and the Advanced Medical Technology Association (AdvaMed). The WHO recommends that nations across the globe consider development and establishment of diagnostic strategies, including radiology systems and in vitro diagnostics, that would aid in the effort to respond to any future pandemics.

The executive board of the WHO had recommended the measure to the World Health Assembly (WHA) on the basis of a report by WHO director-general, Tedros Adhanom Ghebreyesus. This recommendation was developed from an Oct. 6, 2021, series of papers by the Lancet Commission on Diagnostics, which includes a paper on means for improving access for citizens of all nations. The access paper states that 47% of the global population has little or no access to diagnostics and that more than one million premature deaths due to diabetes, hypertension and other conditions could be alleviated with wider access to testing.

The Lancet paper also states that sustained access to testing in some nations will require that governments prioritize access in programs that will need more than a decade to achieve the goal of universal access. One of the policy issues associated with testing is that it is largely absent from many national strategies for health, according to the Lancet Commission.

In addition to the establishment of diagnostic strategies, the WHO’s recommendations include development of national systems for health technology assessments and development of a list of diagnostics that are essential for that nation and its citizens. Other recommendations include establishment of diagnostic services that can be accessed at sites providing primary care and development of workforces trained in the use of these diagnostic technologies.

WHO recommended further that national authorities consider the rights and obligations encoded in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, and to consider appropriate legislative or administrative measures that would prevent anti-competitive practices that hinder access to diagnostics. The resolution calls for a report on implementation of the resolution when the WHA next convenes in 2025 and for development of regulatory mechanisms in nations where none currently exist.

AdvaMed praised the resolution as highlighting the fact that resilient healthcare systems depend on diagnostics at each stage of healthcare. Thierry Bernard, chairman of the AdvaMedDx board of directors, said, “we applaud WHA’s recognition of the significance of diagnostics and global health.” Bernard, who is also the CEO of Qiagen NV, said the COVID-19 pandemic exemplified the power of diagnostics to aid in the management of infectious disease outbreaks, “underlining their importance in saving lives.”

The Global Medical Technology Alliance (GMTA), which is jointly chaired by AdvaMed and MedTech Europe, stated that diagnostics play a central role in improving, extending and saving lives each day in nations across the globe and in a variety of circumstances. The combination of diagnostics and other products manufactured by the medical device industry, such as ventilators and personal protective equipment, “protect and help treat our loved ones as well as the broader community,” the GMTA statement noted.

The GMTA letter called on WHO to ensure that regulations provide a flexible and responsive environment that facilitates access to diagnostic innovations, adding that GMTA looks forward “to continuing our critical work with the WHO on a broader range of essential medical technologies.”