In April this year, the World Health Organization’s (WHO) Expert Committee on the Selection and Use of Essential Medicines met for the 22nd time. The biennial meeting’s purpose was the same as ever: to review and update the WHO’s Model List of Essential Medicines (Essential Medicines List, EML).
Since the publication of the first list in 1977, the EML has served as “a model and a guide for countries to help them prioritise the selection of medicines for their own national needs”, in the words of WHO technical officer for the EML Secretariat Bernadette Cappello. For countries all around the world, and especially those that lack the capacity to conduct detailed evidence appraisals for drug procurement themselves, the EML provides an important guide on which to base national essential drug lists and formularies that are best suited to local needs.
“It’s not obligatory for any country to adopt [the EML]; we cannot mandate countries to adopt it,” says Cappello. “However, we are very pleased that so many of them do – there are over 140 countries that have based their own national essential medicines lists on the WHO model list.”
The evolution of the EML
While the EML’s fundamental purpose to act as a guide for global medicine procurement remains the same, its selection criteria have evolved over the decades. A particularly significant shift came about in 2001 – the last time the selection criteria were officially changed – when after a consultation period, the WHO decided that the cost of a medicine shouldn’t prevent its inclusion on the EML if it also met key therapeutic criteria and is deemed to be cost-effective.
For a list that was originally thought of as a line-up of old, off-patent medicines, this was a significant change and has helped drive both the number of drugs included on the list (from 212 in 1977 to 460 today) and discussions around the accessibility of the increasingly innovative treatments included on it.
“There was a time when many thought of the EML just as something designed for health systems in resource-poor settings – basically a list of the cheap, old medicines that least developed countries should have as a minimum,” says Brendan Shaw, principal at healthcare consulting firm Shawview Consulting and adjunct senior lecturer at the University of New South Wales’s Pharmaceutical Management Unit.
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“Since then, however, it has evolved as more medicines have been added to include an increasing number of newer, patented medicines, which has triggered debates about the availability and affordability of these medicines.”
What makes a medicine essential?
To begin with the basics, what exactly makes a medicine essential enough to include on the WHO’s model list?
The EML Expert Committee meets every two years to review and update the model list. Pharma and biotech firms, as well as other groups and even individuals, can submit applications to have a particular medicine included on (or indeed removed from) the list. This year’s update saw the addition of 28 new medicines to the EML, while nine medications were recommended for removal from the list, and 21 applications for the inclusion, change or removal of 31 medicines were rejected.
The process by which the Expert Committee judges medicines for inclusion on the EML is a public one, and as well as peer review the committee takes onboard comments from a wide range of entities before making its recommendations. To make the process more transparent in the future, the EML Secretariat is working on digitising the list and the evidence that has gone into the Expert Committee’s recommendations, and Cappello says the organisation is hoping to make an electronic version of the EML available by the end of 2019.
“[The applications are] published online, they’re reviewed by members of the Expert Committee in the peer review process,” says Cappello. “They’re open to public comment and everything that we receive in relation to an application – so the application itself, the peer reviews, any comments from the WHO technical departments, any comments from public entities or professional bodies – gets published on our website. Those documents form the agenda for the committee to make their recommendations on.”
As for the key criteria behind including or excluding drugs from the list, Cappello explains the balance of evidence the list is aiming for to improve public health. Although the 2001 change means medicines can’t be left off the list purely for reasons of cost, this is still an important factor.
“The criteria that the committee uses to make its recommendations are the public health relevance or the disease burden of the medicine or the condition that it’s intended to treat,” Cappello says. “They have to consider the evidence of efficacy and safety, and also give consideration to the cost and cost-effectiveness of the medicine. Obviously other factors will come into play. It’s primarily an evidence-based list, so if, for example, a medicine meets the criteria of good efficacy and good safety but comes at a very high cost, the high cost won’t necessarily be a reason to exclude it from the list. Availability and feasibility and various other factors are given consideration, but a reason to not include a medicine on the list would primarily be down to the evidence.”
Essential medicines: pricing and patents
As the EML has evolved to include innovative, expensive drugs with patent protection, debates around patient access have come with them. After all, what’s the use of listing a drug as an essential medicine when its price will be prohibitive for most health systems? The clear implication is that listing an expensive drug on the EML should prompt some action to reduce its cost.
Since 2001, a range of innovative medicines have been added to the EML for the treatment of conditions such as tuberculosis, hepatitis C and cancer. In many cases, the inclusion of high-cost drugs on the list has prompted healthy conversations between countries and the industry to create or improve access programmes and tiered pricing, or agree on voluntary licensing schemes.
Twelve antiretroviral therapies (ARVs) for HIV were added to the list after 2001, despite most of these therapies being deemed too expensive for inclusion in 1999, and the EML listing helped to prompt a massive push to lower costs and improve access to ARVs in developing countries.
“[EML listing] can be a very strong incentive and a strong motivator, I guess, for countries and industries to engage with each other about how they might approach making medicines affordable in different markets,” says Cappello.
But from the industry perspective, some have expressed concerns that the pricing conversations spurred by EML listing have become overly antagonistic towards drugmakers.
While being included on the EML is in one sense a commercial opportunity for companies with the relevant drugs to engage with more markets, the potential threat of compulsory licensing – explicitly acknowledged by the World Trade Organisation’s Doha Declaration on the TRIPS Agreement and Public Health in 2001, which noted flexibilities in the way global patent protection rules can be interpreted by member states to promote public health and drug access – makes it a double-edge sword.
“Currently, the debate around each EML update usually involves activists and others trying to embarrass pharmaceutical companies and criticise the business model,” says Shaw. “The EML could be a catalyst for a broader constructive discussion about things like access programs, lower medicine prices for low-income countries and how to develop health systems so the medicines can get to patients. That would be a good discussion instead of the diplomacy by press release we sometimes see with each update of the EML. The risk is that the criticism and potential commercial risk around each EML update could dissuade companies from getting involved. That would be bad for patients.”
Collaborating to meet global health goals
Having a certain focus on cost – even if it’s not the deciding factor that it used to be – makes absolute sense for the EML, given that its goal of improving access to essential medicines has an inherently economic component.
But should pharma and biotech companies be a bigger part of the process? While Cappello notes that industry stakeholders are welcome to submit comments related to their applications and attend the open session on the first day of the biennial Expert Committee meeting, Shaw argues that the industry should be consulted more extensively.
“An example during the last EML update was the process around the Cancer Medicines Working Group,” he says. “This influential group and its subgroups advised the Expert Committee on a range of important cancer medicine policy and pricing issues but had no representation from industry. This was unfortunate. The WHO might have been concerned about industry conflicts of interest but, frankly, everyone has conflicts of interest to manage, including some others who were members of those groups.”
It’s certainly true that a collaborative and multilateral approach will be necessary to continue the world’s progress towards key public health goals, whether it’s improving access to medicine or supporting the development of health systems in lower-income countries. While public suspicion of the pharma industry and its motives has skyrocketed in recent years, simply heaping blame on companies for not slashing prices after EML listing could have a suppressive effect on the private sector’s R&D investment for future treatments, which would run counter to the initiative’s global goals.
While it’s completely understandable that the WHO – which operates for the benefit of its member states, not the private sector – would be wary about giving industry an official seat at the EML table, stiff-arming the companies whose investment has created so many of the medicines on the list may be throwing the baby out with the bath water. Deeper engagement would have to involve compromise from the private sector, and Shaw acknowledges that companies “should be doing more to understand how the EML works”, but industry may have more important contributions to bring to the process without having undue influence.
“While industry would have to be prepared to adopt innovative models, others would have to accept that companies being profitable is part of the solution for global health, not part of the problem,” Shaw says. “That might be heretical to some, but the reality is we’re not going to achieve the global health goals we have set ourselves if we don’t constructively engage and partner with the medicines industry.”