WHO releases Essential Diagnostics List

September 14, 2018 0 By CH Unnikrishnan

Dr Sumit Ghoshal

Several years ago, the World Health Organisation (WHO) published its List of Essential Medicines, which most countries, including India, adopted and modified to create their own National List of Essential Medicines (NLEM).

After lengthy deliberations that began in March 2017, the WHO has taken the initiative further and published a model list which it has named the Essential Diagnostics List (EDL). The list has separate sections for primary and secondary healthcare establishments, and sub-sections for disease-specific laboratory tests.

Thus, the general list in the primary care section mentions commonly used laboratory tests such as haemoglobin estimation and WBC count, clinical chemistry and immune-assays including HbA1c and blood lactate levels, while due emphasis is also given to microbiology (blood and urine). In the disease-specific sub-section are tests for HIV, hepatitis-B antigen, antibodies to HCV as well as various species of Plasmodium and a whole range of tests to diagnose TB.

The highlights of the second section of the list are the tests which should be available in healthcare facilities with a good clinical laboratory at hand. Here the clinical chemistry list incorporates AST-ALT, alkaline phosphatase, serum pH value and blood gases along with BUN-creatinine and several others.

“The disease-specific IVDs (in vitro diagnostic tests) were selected from WHO evidence-based guidelines, which are referred to in the EDL with links to the respective documents. An additional factor considered by WHO was the availability of evidence from the WHO pre-qualification of in vitro diagnostics programme or from other WHO IVD assessment processes, as applicable, which further support the choice of certain diagnostic test categories. Links to relevant documents are provided in the EDL by type of test,” the WHO document says.

In addition to the listing of the individual laboratory tests, the WHO document also provides a number of supporting documents that offer guidelines on how the tests should be conducted. Although the accompanying chart mentions the testing devices and instruments pre-qualified by the WHO, the two processes – inclusion in EDL and pre-qualification are totally independent of each other. Pre-qualification by the WHO is a requirement for those vendors who would like to sell healthcare devices, medicines and other materials for WHO-funded health programmes.

“In order to effectively use the EDL and adapt it to national needs, WHO recognizes that member states will need to consider a variety of factors. These include, among others: local demographics and burden of disease; local disease elimination priorities; local availability of treatments; training and experience of available personnel; local unmet needs and testing gaps; supply chain and transport links; quality assurance capacity; financial resources; information technology capabilities and environmental factors,” the document says.

The 35-page document announcing the EDL was prepared by a Strategic Advisory Group of Experts (SAGE) after wide ranging consultations with healthcare authorities across the world. The draft document prepared by SAGE was then published on the WHO website in late 2017, and comments were invited from stakeholders.

Finally, there was a four-day symposium held at the WHO global headquarters in Geneva from April 16 to 20, 2018, including an open session held on the last day, after which the EDL was published in mid-May.

While this is the first time the WHO has examined the topic of laboratory tests that support therapeutic decisions in hospitals and clinics, the intention is to make this an annual exercise. The criteria for selection of SAGE members for 2019 have already been announced on the WHO website, and applications have been invited by the EDL secretariat. During the next few years, the EDL is likely to be expanded and rationalized, as more and more countries adopt the model list and their experiences are added to the global database.

Whether the EDL would serve the interests of the Indian public or not will depend largely on how the WHO recommendations are used. The primary purpose behind the entire exercise is to ensure that a basic minimum range of laboratory facilities are available in the public health system. This is supposed to happen through a tiered system of local and regional reference laboratories. But in India, the entire diagnostics industry is highly fragmented and poorly regulated (from the standpoint of quality). Hence any effort to create a countrywide network of pathology laboratories is likely to face huge challenges.

Besides, if the NLEM experience is anything to go by, the EDL could also be an instrument for imposing price control on the ubiquitous private healthcare sector. This would ultimately impact the manufacturers and suppliers of diagnostic kits, needles, syringes and other devices, possibly to the detriment of all.