In 1977, the World Health Organization (WHO) developed a list of basic, life-saving medicines, known as the Model List of Essential Medicines (EML). This list was meant to satisfy the priority health care needs of all 190-plus of its member countries. A core purpose of the EML is to provide a model to support supply of key essential medicines across countries. A contemporary list of essential medicines is critical to ensure a common global standard of care.
The need to align standards and minimize inequalities became evident during the HIV/AIDS epidemic, when people living in the poorest countries gained access to lifesaving treatments, despite the initial high costs. Adding modern HIV medications to the EML as their efficacy was demonstrated helped contribute to price reductions and stimulated generic production.
Any person, anywhere, at any time, can petition the WHO to add, change or delete a medicine by completing a publicly available application. Each medicine added to, changed or deleted from the EML is approved and selected by the WHO Expert Committee on the Selection and Use of Essential Medicines. Selection criteria include: disease prevalence, public health relevance, evidence of clinical efficacy, safety and relative cost-effectiveness.
The EML needs to be updated to reflect contemporary worldwide medical practice to ensure a global standard of care for chronic conditions such as heart diseases, stroke and other non-communicable diseases (NCDs). It is worth noting that the major causes of premature death have changed significantly since the first list was created; this makes the need for inclusion of medicines that treat non-communicable diseases including cardiovascular even more urgent.
In a 2018 article in the Journal of the American College of Cardiology, we summarized our experience in modernizing the EML, including key criteria and lessons learned towards a global, scalable playbook.
We filed petitions to modernize the EML by focusing our work on heart disease, the world’s biggest killer. Examples of medicines that were recently added as a result of our petitions include cholesterol-lowering statins, modern beta blockers for heart failure and high blood pressure, a blood thinner called clopidogrel and a drug to treat high blood pressure called losartan. But our work is far from done, and we need your help.
We have identified several gaps that still exist and invite you to join us in our work.
Slow adoption of EML medications by individual countries: Adding a medicine to the WHO EML does not guarantee universal access. However, the WHO EML often influences national lists, and may constitutionally guarantee access to such medicines without out-of-pocket costs for patients. Today, only 30 percent of low-income countries, 57 percent of lower-middle-income countries and 50 percent of upper middle-income countries include the four medication classes of aspirin, beta-blockers, statins and ACE inhibitors. We know that adding HIV/AIDS medications on the WHO EML and ensuring a reliable supply to patients were two critical steps to scaling up their adoption worldwide, and we believe the same will be true for chronic diseases.
Networks such as Universities Allied for Essential Medicines, Young Professionals Chronic Disease Network, and the World Heart Federation Emerging Leaders Program are uniquely situated to advocate and act for national-level modernization strategies. One team supported by the World Heart Federation, GLO-PRO, is focusing on a movement t0add essential cardiovascular drugs in sub-Saharan EMLs through adapting a global modernization approach at the country level.
This approach includes creating a process map to identify key actors in the EML decision-making process at the ministerial level. Based on our early results, we have found that certain settings have infrequent (and insufficient) updates to national EMLs. Many of the processes are not publicly available, which makes advancing national level policy petitions difficult.
Access at the “last mile.” Availability and affordability of essential medicines—remains poor in rural, remote and low-resource settings. Statin drug availability is estimated at 36 percent in the public sector across 2,779 outlets in 40 countries. There are approaches that can power access at the last mile to reduce cardiovascular disease burden. Local innovations across the continuum of availability, accountability and adherence can drive impact as seen with the AMPATH model in western Kenya. Longitudinal care, digital tracking and the use of non-physician health workers are vital to ensure that cardiovascular essential medicines are made affordable and available to all, as seen in Argentina, Nepal and elsewhere.
Fixed dose combinations for heart disease: Combination therapy with multiple drugs in a single pill, fixed dose combinations or single pill combinations, is a cornerstone of treatment for conditions such as HIV, tuberculosis and malaria. Combination mediations helped curb anti-microbial resistance, improve adherence and reduce supply chain gaps and inefficiencies. Today, fixed dose combinations, including those that address high blood pressure are critical to scaling up cardiovascular management efforts at the national level.
This type of massive scale up approach is necessary to reach the United Nations Sustainable Development Goals for health improvement, the world target for reduction of cardiovascular mortality, and the World Health Organization indicator for blood pressure control in its 13th Global Programme of Work, and is supported by Resolve to Save 100 million lives. In 2017, the WHO recognized the potential value of fixed-dose combinations, but the medications were not formally added to the WHO EML. These fixed-dose combinations have the potential to reach millions, reduce the number of pills patients take, improve adherence to treatment, and greatly improve logistics, drug supply, training, and supervision, and are now endorsed by several guidelines. These combinations could now improve cardiovascular health at scale. We intend to revisit the petition at global and national levels.
The role of cost and cost-effectiveness: Adding a medication to the WHO EML can successfully drive demand and even make these medications more affordable. In addition, fixed-dose combinations have been shown in various contexts to reduce the cost of medications in comparison with single pill formulations, partly through lower packaging and production costs, and also reduce supply costs. Most importantly, combination formulations improve patient outcomes, reducing avoidable heart attacks, strokes, kidney failure, and death.
While our collective has focused primarily on adding medications to the EML to address the global rise of cardiovascular disease, there is no shortage of conditions to choose from nor shortage of people around the world who can benefit from greater, more affordable access to medicines.
We require concerted action across the entire spectrum—across the axis of access—from global policy all the way to the last mile in order to ensure that these medicines are available and affordable to anyone who needs them. We describe one concrete and necessary step, but welcome collaboration to build, refine and adapt a playbook for expanding access to critical, vital medicines where it matters the most. A key next step is advocating for essential medicines for cardiovascular disease at the national level where many are missing.