The diagnostics industry is facing increasing policy attention. The In Vitro Diagnostic Device Regulation (IVDR) will newly regulate the European approval system, the new EU Health Technology Assessment (HTA) proposal is already on the table and World Health Organization (WHO) has just released the first Essential Diagnostics List (EDL).
Similar concept, Essential Medicines List (EML) has been around for 40 years. Looking at the history of EML what can the diagnostics industry expect?
EDL in nutshell:
- WHO’s list concentrates on 113 in vitro tests mostly in “priority” diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus, syphilis and myocardial infarction
- It aims to provide evidence-based guidance to develop or update national lists of essential in vitro diagnostic tests
- EDL will be updated and reviewed by a group of WHO international experts (Strategic Advisory Group of Experts on In-Vitro Diagnostics) on regular basis (likely 2 years)
- WHO will issue a call for applications to add categories to the next edition
About EML:
- EML facilitates access to affordable medicines, particularly in low-resourced countries
- Essential Medicines Lists have been successful in raising awareness, political will, guide procurement and regulation policies
- More than 156 countries developed their national lists, NGOs and international non-profit organizations also refer to them
- EML contains not only generics, but also newer, innovative cancer medicines (e.g. rituximab, trastuzumab)
3 potential EDL impacts from the industry’s point of view:
Access in the IVD industry is still a relatively new concept, unlike in innovative Pharma, where it has been a widely addressed topic for more than a decade. WHO’s long awaited Essential Diagnostics List will also highlight the importance of broad access to affordable diagnostics solutions in low resourced economies.
It is almost impossible to predict EDL’s overall net impact from the industry’s perspective, but here are three likely measures that could come in the near future:
- Country lists will most likely elevate the relative importance of diagnostics, leading to increased utilization and eventually to smarter spending
- Similar to EML, pooled procurement measures and increased price controls could be also expected
- Certain in-focus disease areas might receive proportionally higher health care budget
One thing is for sure: thanks to WHO’s initiative, patients will benefit rather sooner than later. India is already developing its national list and more countries are likely to follow.
Norbert
p.s. Should you be interested discussing this topic more in-depth, please reach out
Sources:
http://www.who.int/medical_devices/diagnostics/WHO_EDL_2018.pdf
http://www.who.int/medical_devices/diagnostics/Selection_in-vitro_diagnostics/en/