The most recent edition of the World Health Organization’s Model List of Essential Medicines was released on 9 July and there are new additions and several important issues for the pharmaceutical industry coming out of it.
The executive summary of the report of the WHO’s Expert Committee provides a good overall summary of the changes, together with some commentary on important global access to medicines issues that companies should consider.
More than 150 countries currently reference the WHO Essential Medicines List (EML) as they develop their own national health systems.
What’s in the new EML?
The newly-minted 2019 EML welcomes 28 new medicines for adults and 23 for children, with 26 new uses for existing medicines, meaning that the list now contains a total of 460 medicines deemed essential by the WHO – the highest number ever.
There are tensions and debates in deciding which medicines are ‘essential’ and for whom – there are many important medicines that do not ever get on the EML.
But the fact that so many medicines have made it on the list is itself indicative of the progress the pharmaceutical industry has made over the years in developing medicines the world needs.
While obviously there are many stories and issues contained in the latest update, a few points are worth highlighting:
- Interestingly, the Expert Committee also rejected 21 out of a total of 65 applications – one-in-three – a reminder that putting an application to the Committee does not mean it is a done deal
- The Committee reviewed and extended its new antibiotic classification system, AWaRe, to other antibiotics and added several antibiotics to the EML
- Several medicines were recommended for anti-tuberculosis medicines, anti-retrovirals and anti-malarials
- The recommendation to list adalimumab, the highest selling medicine in the world by sales, for chronic inflammatory conditions coincides with this medicine going off-patent and a range of biosimilar competitors coming on to the market
- One group of medicines that were rejected for listing were for multiple sclerosis, despite efforts by MS patient groups, with the Committee suggesting that a more comprehensive application might get these medicines over the line next time
- The addition of several new, patented cancer medicines such as nivolumab, lenalidomide and pembrolizumab, triggering debates about the access, affordability and value of such newer medicines
- The recommendation that a committee be formed to look at access, availability and affordability of insulins.
The Expert Committee also made some policy recommendations in its Executive Summary about how to improve access to medicines listed on the EML, including the wider use of biosimilars, expanding the remit of the Medicines Patent Pool, using pooled procurement and tendering, using flexibilities from the WTO TRIPs agreements and using existing policy tools.
As is often the case, some of these recommendations might have merit but others run the risk of having significant adverse consequences for patients in the long run.
More to come on cancer meds
On the launch of this latest update the head of the WHO, Dr Tedros, said “The inclusion in this list of some of the newest and most advanced cancer drugs is a strong statement that everyone deserves access to these life-saving medicines, not just those who can afford them”.
The cancer recommendations are interesting coming on the back of work undertaken by a WHO-formed EML Cancer Medicines Working Group. The Expert Committee suggested that this Working Group continue with an expanded agenda to, amongst other things, look at access to cancer medicines at the national level in the context of universal health coverage.
The words of the WHO Director General, together with the recommendation to expand the remit of the Cancer Medicines Working Group, suggest that this issue is not going to go away any time soon.
But there is a question about what the WHO’s remit is and how far it can go down this path.
Perhaps predictably, the release of the 2019 EML triggered immediate calls from some activists and commentators for these new cancer medicines to be acquired through compulsory licensing now that they had been deemed ‘essential’ by the WHO.
In some ways, the release of the 2019 EML continues an at times acrimonious debate seen around earlier updates where newer, patented medicines are added to the list, triggering animated claims and counterclaims about drug pricing, patents, innovation and the like.
For example, we saw a similar campaign concerning hepatitis C medicines with the release of the 2015 EML update.
Sending the message
One problem with this sort of reaction – that because something is essential and expensive it needs to be compulsorily acquired – is that it sends the wrong signal to pharmaceutical companies.
People in pharmaceutical companies that might be developing the next breakthrough treatment for cancer, a new antibiotic or a cure for Alzheimer’s Disease must sometimes look at these sorts of reactions and shake their heads.
What message does it send to a company if they know the moment their breakthrough new therapy is listed on the EML it is then regarded as fair game for compulsory licensing?
We absolutely need to work on ensuring that everyone around the world gets access to the medicines they need.
Clearly, there is a lot of work that still needs to be done.
But there is a perverse incentive somewhere here that needs to be explored.
Criticising companies, campaigning against their business models and threatening wholesale acquisition of innovative essential medicines effectively punishes companies for developing such therapies in the first place.
As the Access to Medicines Foundation recently noted, pharmaceutical companies have been doing more over the years to improve access to medicines, including through the development of comprehensive access strategies for their medicines, strengthening health systems more broadly, and introducing pricing strategies to provide cheaper medicines for lower-income countries.
This is happening at both the individual company level as well as at the broader industry level.
It would be nice to think that there could be more constructive dialogue between industry and the global health community about companies’ access strategies for their medicines, how other stakeholders like governments, insurers, health experts and patients can support these, and how they can help companies do better.
The release of the 2019 EML provides both a challenge and an opportunity for industry and others to identify constructive future strategies to improve access to medicines for the people of the world.