WHO List of Essential Tests Gets An Upgrade

Today, the World Health Organization (WHO) published two lists that are critical for global health: the 21st WHO Model List of Essential Medicines (EML), and the 2nd WHO Model List of Essential Diagnostics (EDL). The purpose of these lists is to help countries prioritize critical health products that should be widely available, accessible, and affordable throughout health systems, especially in low- and middle-income countries (LMICs)

As countries gear up to deliver on their pledge to deliver Universal Health Coverage (UHC), it is critical for them to ensure access to essential products, including tests, vaccines, and medicines. Tests are particularly crucial for UHC, since quality healthcare depends on our ability to detect conditions, and ensure appropriate treatment. Tests are also critical to ensure optimal use of essential medicines, to detect outbreaks, and to have robust surveillance systems for antimicrobial resistance and pandemics.

“As countries move towards universal health coverage and medicines become more available, it will be crucial to have the right diagnostic tools to ensure appropriate treatment.” Mariângela Simão, Assistant Director-General for Medicines and Health Products, WHO, Geneva.

 In a 2016 post in Forbes, I had, along with colleagues, offered 10 reasons for the creation of an essential diagnostics list. Thankfully, WHO developed and published the first Essential Diagnostics List in 2018. I had the privilege of participating in the advisory group of experts that developed and updated the EDL.

What is in the list?

The first list covered a limited number of priority diseases. The second list released today has expanded to include more noncommunicable and communicable diseases.

The 2nd EDL consists of 122 test categories presented as follows:

• 46 general IVD tests that can be used for routine patient care as well as for the detection and diagnosis of a wide array of disease conditions;
• 69 IVDs intended for the detection, diagnosis and monitoring of specific diseases. The first EDL listed tests for the following WHO priority disease areas: HIV, TB, malaria and hepatitis B and C as well as syphilis and human papillomavirus infection. The second EDL extends the diseases to include gonorrhea, Chlamydia, cholera, leishmaniasis, schistosomiasis, dengue, zika, influenza, and blood cultures for bacterial and fungal sepsis. In addition, the list includes several noncommunicable diseases (NCDs), with an extensive new section covering cancer tests (e.g. solid tumours such as colorectal, liver, cervical, prostate, breast and germ cell cancers, as well as leukemia and lymphomas) as well as a new section on anatomical pathology to facilitate cancer detection in general; and
• 7 test categories intended for screening of blood donations, to ensure safer blood transfusions.

The second EDL is presented by health care facility level in two tiers: 1) Community and health settings without laboratories; and 2) Health care facilities with clinical laboratories. WHO has plans to keep the list updated on an annual basis, and the 3rd edition of the EDL is expected in 2020. While the current list includes only in-vitro diagnostics (IVD), I hope future lists will go beyond IVDs and cover other essential diagnostic technologies such as blood pressure monitors, x-rays, ultrasound, and electrocardiograms.

How to make the list work?

WHO model lists are intended to provide guidance to countries. For example, the WHO Model List of Essential Medicines has guided and inspired over 150 countries to develop their own national lists and use them in their healthcare delivery strategies. The same approach is necessary for the EDL to have an impact – every country that has a national EML must develop a national EDL.

Thankfully, countries are starting to adapt and develop their own national EDLs, with India leading the way. Based on national disease burden and health system capabilities, countries can modify and adapt the WHO EDL to suit their priorities and needs.

To ensure essential tests are made available in the health system, it is important to make sure they are incorporated into national UHC benefits packages. When tests are not acknowledged as an essential component of the UHC package, they get little attention, budget, and support for implementation. If tests are not explicitly listed in national health plans or benefits packages, there is no mechanism for procurement, supply, and reimbursement.

Once national lists of essential tests are drafted and included in UHC packages, countries would need to invest in tiered, connected, efficient laboratory networks, which include sample transportation and referral systems. For decades, LMICs have neglected laboratories and have prioritized medicines over tests. The consequences of under-investment in diagnostics and laboratories are clear. The laboratory infrastructure in most low- and middle-income countries is very weak. Even simple tests are missing in many health facilities in LMICs.

It is not shocking, therefore, that diagnosis is the biggest gap in the cascade of care. This is true across a range of communicable (e.g. tuberculosis, HIV, hepatitis C) as well as non-communicable diseases (e.g. diabetes, hypertension, cancer). 

While the traditional approach of pushing medicines at the cost of tests might have worked in the past, it definitely cannot work in the UHC era. All countries need to invest in laboratories and make sure tests are available at all levels of the health system (community, primary, secondary and tertiary care).

Can the diagnostics industry help?

The IVD industry, which has received the WHO EDL positively, can play a key role here and support laboratory strengthening in LMICs as a key global health activity. The IVD industry can also improve access to essential tests via special access programs for LMICs (e.g. concessional pricing for rapid molecular TB testing, and HIV viral load testing). Currently, special access programs are mostly limited to a few priority infections. This needs to change, as LMICs increasingly battle NCDs, and will need to diagnose a wide range of non-communicable diseases.

The right to diagnosis

As I have argued before, the global health community must reject the mindset that simple, rapid tests and empiric treatments are “enough for poor countries.” Policy makers in LMICs need to start investing in diagnostic tests and laboratories. Donors and funders must go beyond test procurement and invest in laboratories and health systems. And patient advocates and civil society must demand better access to early and accurate diagnosis as a basic right.

All patients deserve to know their diagnosis, regardless of where they live or what they earn. Implementing the WHO EDL within the UHC agenda is the surest way to ensure this.

Disclosure: I served on the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) group that developed and updated the Essential Diagnostics List. I have no financial or industry interests in any diagnostic company or product.

Madhukar Pai

Forbes