PHM-Exch> Essential medicines require essential diagnostics

Claudio Schuftan cschuftan at
Tue Jun 13 19:57:03 PDT 2017

From: Ken Harvey <ken.harvey at>

Another important post from e-drug.

Essential medicines require essential diagnostics Dr. Madhukar Pai

In a welcome development, 40 years after publishing the first Essential
Medicines List (EML), WHO is poised to begin the development of an
Essential Diagnostics List (EDL). An EDL should help amplify the impact of
the EML. After all, patients need access to both diagnosis and treatment.

Access to critical medicines is important for patients, care providers, and
health systems. It is a key component of Universal Health Coverage (UHC),
and included in Goal 3 of the Sustainable Development Goals.

To improve access to drugs, since 1977, WHO has published a list of drugs
that are considered essential for addressing the most important health
needs globally. This WHO Model List of Essential Medicines is updated every
two years, and the most recent update, the 20th WHO EML, marks the 40th
anniversary of this flagship WHO initiative to expand access to medicines.

The updated, 20th EML lists a total of 433 drugs deemed essential. In an
effort to tackle the growing threat of antimicrobial resistance (AMR), the
20th EML categorises antibiotics into three classes: access, watch, and

Based on the WHO EML, over 100 countries have published their own national
essential medicines list, and use such lists to control drug prices,
prioritize procurement, streamline supply chain, develop guidelines, and
ensure access. India, for example, has published a National List of
Essential Medicines since 1996, with the most recent iteration released in
2015. The National EML in India has been helpful in capping prices of a
variety of products, ranging from cancer drugs to cardiovascular stents.

While the benefits on the EML are well documented, there is much less
acknowledgement of the importance of diagnostics. To get the most impact
out of medicines, we need to target the medicines at the right patient, for
the right condition, at the right time, ideally after an accurate diagnosis
is made. Imagine treating HIV without a diagnosis, or managing diabetes
without access to lab testing. Without diagnosis, good medicines can be
wasted, misused or simply not used.

At long last, four decades after the first EML, WHO is now gearing up to
begin work on the first Essential Diagnostics List. The WHO Expert
Committee on the Selection and Use of Essential Medicines that oversaw the
20th EML, also considered a proposal to establish a model EDL. This
Committee "acknowledged that diagnostic tests are essential to diagnose the
disease or subpopulation for which certain medicines may be indicated, and
to monitor the medication effectiveness or toxicity. Furthermore, often the
diagnosis has important implications for prognosis. The Committee
recognized that Member States and countries might seek advice about which
technologies to prioritize, how to shift from one technology to another,
and which technologies should accompany essential medicines since they are
strongly interconnected."

The Committee also "recognised that the idea of having a Model List of
Essential In Vitro Diagnostics developed and maintained by WHO merits
exploring, using the Model List of Essential Medicines as a "model" for its
process, methodology and transparency." The Committee recommended that "the
EDL list may initially focus on in vitro diagnostics (IVDs), and that the
initial proposed priority areas (TB, malaria, HIV and Hepatitis B & C) may
be appropriate for the first iteration of the list but should expand to
other areas including other antimicrobials and non-communicable diseases as
soon as possible."

In parallel, WHO has begun the process of creating a Strategic Advisory
Group of Experts on In Vitro Diagnostics (SAGE IVD) which will act as an
advisory body to WHO on matters of global policies and strategies related
to IVDs. Among other tasks, the SAGE IVD group provide advice to WHO
Secretariat for the development of the EDL and in line with the work of the
Expert Committee on Selection and Use of Essential Medicines.

There are many potential benefits to an EDL: improving patient care,
helping detect outbreaks, increasing affordability of tests, reducing
out-of-pocket expenses for tests, reducing antibiotic abuse, improving
regulation and quality of diagnostic tests, strengthening accreditation and
quality of laboratories, improving supply chain, and guiding the R&D of new
diagnostic tools.

Thus, member states, as well as global health agencies, should applaud and
support the decision by WHO to develop an EDL, and to create an advisory
group on diagnostics. Both decisions demonstrate a serious commitment by
WHO to recognize the importance of good diagnostics as a way of increasing
the impact of essential medicines, and contributing to UHC.

While WHO has always led the way in developing normative guidelines and
policies on diagnostic tests, and operating a prequalification program on
IVDs, an EDL is an excellent opportunity for the WHO to cement its
leadership role in global health diagnostics. The WHO, however, will need
both resources as well as technical expertise to successfully publish and
periodically update an EDL.

Once the WHO EDL is published, it will give countries a much-needed impetus
to develop national lists of essential diagnostics. India, for example, has
launched a Free Diagnostics Service Initiative, under its National Health
Mission. The Initiative aims at the provision of a package of quality
essential diagnostic services free of cost in all public health facilities.

Hopefully, India and other countries will develop national EDLs, and find
ways to realize the value of a WHO model EDL. Such translation into action
at the country level is critical for any real impact of the EDL to be

e-Med, E-Drug
Bruneton Carinne <carinne.bruneton at>
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