Dr. Francis Moussy (World Health Organisation)

Dr. Francis Moussy

World Health Organisation

Essential Diagnostics List Secretariat

In May 2018, the World Health Organisation led the way in helping to prioritise diagnostics in global health by launching its Essential Diagnostics List (EDL). Dr. Francis Moussy, member of the EDL Secretariat at the WHO and currently leading projects to facilitate the development, access and use of in vitro diagnostics that are suitable for Low-and-Middle Income Countries (LMICs), was instrumental in bringing together this first list. In this Infectious Thoughts interview, we speak with Dr. Moussy about the substantial opportunities heralded by the EDL in reaching important global health goals through improving diagnostics worldwide, including boosting laboratories in resource-poor countries, encouraging innovation and funding towards new and improved diagnostic tools, and engaging nation-states to strengthen their health systems through improvements in diagnostics.

Last month, the World Health Organisation (WHO) launched its Essential Diagnostics List thus providing an essential boost to strengthening global health systems and both national and international coordination on disease diagnosis. What is the WHO's Essential Diagnostics List and what are the main global health challenges that it is seeking to address?

The Essential Diagnostics List (EDL) has been developed by the WHO as a tool to help countries priori-tise diagnostic needs. At the moment, the focus is on in vitro diagnostics rather than diagnostics in a larger sense (for example the list does not include x-rays or any other imaging equipment) however we might extend this to include a wider range of diagnostics in future.

In addition to direct aims such as supporting national governments, we are hoping that the EDL will have far reaching benefits such as helping companies as well as funders worldwide to understand pri-orities in terms of in vitro diagnostics, and bring much needed strengthening of laboratories in developing countries. Overall, we hope that the list will boost the development of new diagnostics – this could have further benefits such as stimulating the local diagnostics production and manufacturing.

The WHO's Essential Medicines List was launched four decades ago and significantly used worldwide since - what have been some of the factors that delayed a similar list for diagnostics and how have these been overcome?

I think that 40 years ago, we simply didn’t have that many diagnostics available and we didn’t hear a lot about in vitro diagnostics even at global health events - the focus was always on medicines and vaccines. It’s only recently that we have started talking a lot about diagnostics, spurred both by advances in technology and advocacy; in fact during this year’s World Health Assembly, many member states explicitly discussed the role and current gaps in diagnostics.

So in the past years, there has really been a growing awareness of the impact of diagnostics not only on healthcare but also in a wider

sense in terms of disease surveillance, monitoring and evaluation, … and this is really changing priorities. Several advocacy papers were arguing the case for such a list and there is a whole new movement around diagnostics which didn’t exits a few years ago.

How will the list be adapted in future as the global disease burden evolves and emergent threats appear? What review mechanisms does the WHO currently have in place to monitor and update the list?

Firstly, we are going to update the list once every year; this means that we have a fast cycle for renewing and expanding the list. In comparison, the Essential Medicines List is updated every two years. On the one hand, we will rely on our committee of 19 experts on in vitro diagnostics to help select the future areas we focus on. In addition, we will also invite comments and feedback from the wider community on the current list as well as suggestions for further areas to be considered for inclusion. In July 2018, we will issue a new call for submission of applications for categories of test to be considered for the second edition of the list. We are fully aware that in vitro diagnostics evolve faster than drug and vaccines, so we are getting input from many multiple sources and we will gather substantial intelligence which will allow us to adapt quite fast to new areas and be more agile.

One way to look at it would be to consider this first list as a single slice of a larger pie. In future years, we will be adding slices of the pie until the pie is complete – then we will have a steady state where we will just be making small adjustments, changes or additions.

Currently, the list contains just over 100 tests – about half of these are basic laboratory tests and the rest are very specialised tests. We focused initially on the diseases where we have a lot of evidence and data at WHO because recommendation for usable tests went through a rigorous and complex evidence-based evaluation process for grading and prioritisation – so in a sense this first list contains the low-hanging fruits which helped to get the list started and we are aiming to rapidly expand this to include other areas such as neglected tropical diseases, non-communicable diseases, anti-microbial resistance… These will be the other pieces of the pie which I mentioned and we will be expanding to these other areas through calls for applications which will be done once a year.

The Essential Diagnostics List will cover a wide range of countries, some of which can be faced with limited resources in terms of laboratory equipment and technician skills. How has the EDL taken this into consideration and has there been an emphasis on tests which can be easily undertaken and interpreted? How suited is the EDL to primary healthcare when resources are low? Can diagnostic companies do more?

The list is global but we realise that needs can be quite specific and resources constrained in low and middle-income countries, particularly at the primary health care level. This is why we felt it was important to distinguish in the EDL the diagnostics for primary health care and, in a separate category, the diagnostics for healthcare facilities where there are clinical laboratories.