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As part of efforts to reduce medical errors, eliminate treatment failure, eradicate fake reagents and laboratory equipment, advance universal health coverage, address health emergencies, and promote healthier populations, the World Health Organisation (WHO) has published the first edition of the Model List of Essential In Vitro Diagnostics (EDL).

The EDL contains list of 113 diagnostics. Fifty-eight are the routine blood and urine tests: measurements of red and white blood cells, blood sugar, liver enzymes and so on, plus tests for one-time events like pregnancy or transfusion blood-typing.

The remaining 55 are tests for diseases the WHO considers of highest priority: Human Immuno-deficiency Virus (HIV), tuberculosis, malaria, hepatitis B, hepatitis C, Human Papilloma Virus (HPV) and syphilis.

The principles of EDL are the three strategic priorities of the WHO Thirteenth General Programme of Work (2019–2023) (GPW). The EDL is also intended to complement the WHO Model List of Essential Medicines (EML) and enhance its impact.

Besides setting universal standards, the list is meant to encourage countries to build the laboratories needed to do the tests.

It is also meant to give the diagnostics industry — which is far more fragmented than the pharma industry — targets to aim at, which should lower prices.

Titled “World Health Organization Model List of Essential In Vitro Diagnostics First edition (2018), the report was developed and presented by the first Strategic Advisory Group on In Vitro Diagnostics (SAGE-IVD) at the WHO headquarters, Geneva, April 16–20, 2018.

In March 2017, the WHO Expert Committee on Selection and Use of Essential Medicines recommended the development of an EDL, to complement the WHO EML.

To support the EDL and to advise on other in vitro diagnostic (IVDs) initiatives, WHO created SAGE-IVD.

The SAGE-IVD, which includes 19 multidisciplinary members with global representation, held its first meeting from 16–20 April 2018 at WHO headquarters, Geneva.

The SAGE IVD made recommendations for the content, format and implementation of the first edition of the EDL.

The only Nigerian member of the SAGE-IVD and Professor of Haematology, University of Calabar and former Registrar/Chief Executive Officer (CEO), Medical Laboratory Science Council of Nigeria (MLSCN), Anthony Emeribe, told The Guardian that this is the first time, the WHO has published a list of diagnostic tests that it considers essential to every health care system in the world.

“It is foreseen that EDL will be an important tool in increasing access to appropriate, affordable and quality-assured IVDs, particularly where they are most needed to address health priorities.”

The SAGE IVD confirmed a list of general IVD tests that should be available in primary health care settings, and in hospitals and reference laboratories, for routine patient care. The information to select the general diagnostic tests was compiled from existing WHO guidance, guidelines, technical manuals and the priority medical devices lists.

Panel members hope to soon expand the list by adding tests for viruses like flu, antibiotic resistance in bacteria, cancer, heart disease and other ills.

They also hope to add an essential “devices” category to include diagnostic equipment like X-ray and CT scanners, ultrasounds, fiber-optic scopes, automated blood analyzers, PCR machines and so on.

Although many of these tests and devices have been around for decades, there is great variance in the ways diseases are diagnosed in different countries.

Worse, doctors often prescribe antibiotics or other drugs without diagnoses, which can hurt patients and speed drug resistance.

Besides setting universal standards, the list is meant to encourage countries to build the laboratories needed to do the tests. It is also meant to give the diagnostics industry — which is far more fragmented than the pharma industry — targets to aim at, which should lower prices.

If a dozen manufacturers know that a certain type of blood analyzer or CT machine is the global standard, for example, they may compete to make it, driving prices down.

Forty years ago, before the essential medicines list was published, poor countries were largely at the mercy of drug companies — which were often left over from those countries’ colonial periods. Companies frequently offered only the medicines they wanted to sell rather than the most sensible choices.

Meanwhile, a foremost Nigerian virologist and consultant to the WHO, Prof. Oyewole Tomori, has accused the United Nations apex health body of “systematic discrimination at WHO headquarters against Africans.”

Tomori made a letter to the Director General WHO, Dr. Tedros Adhanom Ghebreyesus, dated May 25, 2018, written by one Mr. David Manley, available to The Guardian.

Manley wrote: “Thank you very much for taking the email sent on the 21 April 2018, “Systematic discrimination at WHO headquarters against Africans” seriously and for meeting with African and Caribbean Ministers and Ambassadors during the World Health Assembly about the issue.

“However since then, rumour has it that WHO senior colleagues under you are attempting to stifle the investigation or to sweep the systematic discrimination at WHO headquarters against Africans under the table.

What we need is concrete follow up and a formal investigation into racial discrimination particularly in WHO Emergency Programme (WHE) and in general WHO.

This is the time for honesty and action. Quite shockingly, the email account originally used (manleyd005@gmail.com) has since been blocked by WHO or others and is no longer accessible/ and emails sent to it also bounce.”

Presenting the facts on discrimination, Manley said: “As mentioned in the first email, in 2018, WHO recorded 70 graded emergency and outbreak events. Of these, 75 per cent occurred in Africa 33 grade 1, 27 grade 2 and 10 grade 3. In summary, 75 per cent of all outbreaks worldwide occur in Africa.

“In the past 4 years – WHO/WHE at HQ has only recruited ONE African at a senior level. As of 15 May 2018, there are 408 staff at WHO/WHE headquarters, including eight directors (D1 /D2), 5 P6 and 70 at P5 level. Out of 70 P5 staff only 1 is from Africa.

“In summary - No African director / Only 1 African coordinator / 1 African P5 and 5 P staff out of a staff of 408 (1.7 per cent). According to UN estimates Africa represents 20 per cent of the world’s population whilst at WHO HQ/WHE Africans represent only 1.7 per cent and yet 75 per cent of all emergencies and outbreaks are in the African region.

“In addition since 2014, WHO / WHE HQ has recruited over 2017 (consultants, short-term and fixed term) staff. We only counted five from Africa. How does an organization like WHO justify such appalling statistics?

“Inequitable WHO recruitment policy and malfeasance in office will not attract the best talent in the world.

As also reflected in the recent ‘WHO Culture change Survey’, staff morale and performance is negatively affected when there is an abuse of power and no fair or coherent promotion policy within WHO.”

For the WHO to reach its maximum potential, Manley said, it needs to serve the world in a transparent manner and to not sabotage genuine concerns.

The virologist added: “It would be a shame for your leadership to be tainted by lack of action to address unfair recruitment practices and discrimination against minorities and Africans.

“Please can you urge your senior colleagues to address the issues and not to suppress emails or ‘to shoot the messenger’.

“Thank you to colleagues from the regions (HQ, EMRO, SEARO, WPRO and PAHO) who gave specific examples and evidence on: Racial discrimination, abuse of power, symptoms of sexual harassment, corruption and taking advantage of women and conflict of interest.

“We shall be forwarding the next email with concise and factual examples to the UN Secretary-General and major donors, if there is no active and transparent action to address this very serious issue.


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