Ensuring Global Access to Cancer Medicines: A Generational Call to Action

We are a group of 10 individuals brought together by the Union for International Cancer Control's (UICC) Young Leaders Programme, with a shared goal of reducing the global burden of cancer. We live on six continents and work across the cancer control continuum—from public health, community outreach, clinical care, and survivorship to cancer research, advocacy, and health policy. Our experiences, and those of the cancer communities we serve, are remarkably diverse, and yet our concerns are collective. There have been staggering advances in cancer prevention, diagnosis, and treatment during our lifetime. Yet these remain out of reach for most of the world's population and for many of the communities where we live and work. This is unjust, and it cannot continue. Launched in 2022, the UICC-led Access to Oncology Medicines (ATOM) Coalition aims to bring essential cancer treatment to patients in low- and lower middle-income countries (LLMIC) and offers a chance for our generation to change course.

Cancer is a leading cause of premature death in every country in the world. Although cancer is often thought of as a disease predominantly afflicting people living in what the World Bank classifies as high-income countries (HIC), 70% of all cancer deaths this year will occur in low- and middle-income countries (LMIC; ref. 1). We know—and experience in our daily working lives—that where you live largely determines whether you will develop a certain cancer, as well as have access to timely and quality diagnosis and treatment, and significantly affects your odds of survival (2, 3). Breast cancer, for example, is the most common cause of cancer death in women worldwide and responsible for the deaths of over half a million women living in LMICs each year. In the United States, Canada, and New Zealand, the 5-year overall survival rate after a breast cancer diagnosis is ∼90% compared with only 66% in India and Malaysia, and less than 40% in Nigeria and Uganda (1). For children diagnosed with cancer, the differences are even more stark: 80% will survive a diagnosis of a childhood cancer in HICs compared with only 20% in LMICs (3). Within countries of all income levels, there is often another story of cancer inequity, whereby those who are Indigenous, a racial or ethnic minority, uninsured, older, female, of low socioeconomic status, or live in rural areas and/or are uneducated are often even less likely to receive timely, quality cancer treatment and, as a result, are more likely to die (4).

Two defining features of cancer in many LMICs are the advanced stage of cancer presentation and a higher stage-for-stage case fatality rate compared with wealthier countries (2). Limited access, affordability, and availability of resources for cancer prevention, screening, early detection, diagnosis, treatment, and palliation explain most of the global, regional, and subnational variation in cancer mortality (2). In many HICs, avoidable cancer deaths occur amidst a sea of plenty—in which there are high levels of availability and affordability of both essential and advanced cancer diagnostics and treatment, yet inequitable access and utilization persist (4). In contrast, in many LMICs, the availability and affordability of even basic cancer tests, such as biopsy for diagnosis and hormonal receptor testing in breast cancer, and treatments such as the hormonal therapy tamoxifen and the cytotoxic drug doxorubicin are major issues (2, 5). A recent survey of oncologists from 82 countries estimated that these two key breast cancer medicines were universally available in only 36% of LMICs (5). For the most part, cancer medicines remain prohibitively expensive, mired by patents, trade regulations, and pricing structures that do not account for a country's economic reality, closely resembling the production, procurement, supply chain, and delivery challenges that have shackled the ability of many LMICs to vaccinate their citizens during the COVID-19 pandemic.

What constitutes an essential cancer treatment? For patients, any treatment that allows them to improve their odds of survival and quality of life after a cancer diagnosis might be considered essential. However, faced with limited resources, countries and health systems all over the world need to make difficult decisions about what treatments they do and don't cover, and what constitutes value (6, 7). In cancer care, the wide range of treatments, rapid pace of innovation, high prices, and variable clinical efficacy data, which may not be generalizable across contexts, systems, and populations (most cancer medicine trials are still conducted in HICs in predominantly European-ancestry patient populations) make the task of assigning value both philosophically and practically complex (8, 9). To help address this, the World Health Organization (WHO) publishes the WHO Model List of Essential Medicines (EML). Updated every 2 years, the EML currently includes 62 cancer medicines encompassing antineoplastic agents, hormonal treatments, immunomodulators, and targeted therapies (9, 10). The list is used by more than 150 countries to develop their own national essential medicines lists. Essential medicines are intended to be always available, of assured quality, and at prices individuals and/or the health system can afford. The EML considers disease burden, population health impact, efficacy, safety, and comparative cost-effectiveness in making its recommendations. A guiding principle of the list is that cost is not a reason to exclude a medicine if it will make a substantive improvement in population health or disease outcomes (10). The aspiration has long been that if a medicine is deemed essential by the WHO EML, prices should be reduced to improve access in markets where it is unaffordable (9). Despite this, it is estimated that over 50% of cancer medicines listed on the WHO EML in 2021 are unavailable in LMICs (5). Although many countries have made ambitious commitments to universal health coverage, cancer treatments (and diagnostics) are often too expensive to include, at least during initial expansion efforts. Many of those costs are then transferred onto patients and households who must pay for cancer care entirely out of pocket. This often leads to catastrophic expenditure (whereby the cost of the medication absorbs >40% of a household's expenses), impoverishment, and treatment abandonment (2, 11). For example, a study in eight Southeast Asian countries demonstrated that one in two patients diagnosed with cancer is pushed into economic hardship, and one in three households (33%) fell below the national poverty line within a year of a household member being diagnosed (11). A recent international survey of cancer treatments on the EML suggests household affordability is an even greater access barrier than availability in most LMICs (5).

Although the prices of other medicines on the WHO EML have fallen since its inception in 1977, cancer medicines have not followed suit. In 1987, around the same time many of us—the authors of this article—were born, the FDA approved the first antiretroviral therapy (ART) for the treatment of HIV/AIDS. Additional drugs and more effective three-drug combinations quickly followed. They were expensive and available in only a few HICs. As with many scientific breakthroughs for global health challenges, after ART came to market, a wide chasm grew between where the greatest burden of disease and death from HIV/AIDS were—on the African continent and in South and Southeast Asia—and where the treatment was—in North America and Western Europe (12). In 2022, this is often what it feels like to work in global cancer control—to be staring at a gap that gets wider and wider with each new scientific discovery and with each diagnostic test or treatment brought to high-income markets. To see novel targeted and immunotherapies “melt away” advanced colorectal, lung, and skin cancers in Canada but to be faced with the task of treating women with breast cancer in Nigeria who lack access to breast imaging, biopsy, or hormone receptor testing, who cannot afford surgery and chemotherapy, and who live thousands of kilometers from the nearest radiation machine (2).

But we also know that this story can be different. Although we, as a group of UICC Young Leaders, were born in a time when a diagnosis of HIV/AIDS anywhere in the world was a swift and certain death sentence, we grew up in an age where HIV became a manageable chronic illness—if you had access to ART. The differential impact of this access in our communities and countries, and the sweeping social and economic impact of the HIV/AIDS epidemic, shaped many of our lives and our early interests in health care and health advocacy. In fact, it still shapes the health systems and the social and economic circumstances in several of the countries in which we work today. In our lifetime, and from our different vantage points, we have seen how HIV/AIDS activism, politics, and global partnership achieved what many believed to be socially, politically, and economically impossible only two decades ago (12). Antiretroviral medicines once deemed too expensive to purchase and too complex to deliver in low-resource settings are now taken by some 25 million people living with HIV in LMICs, 87% of all people who know their HIV status are on treatment, and 90% of them are completely virally suppressed (13). The cost of ART in LMICs dropped by as much as 99% in the decade between 1996 and 2006 through a combination of voluntary licensing agreements with pharmaceutical companies, generic competition due to the expiry of drug patents, the use of legal flexibilities in international trade rules, tiered pricing based on a country's gross national income, and other innovative financing mechanisms and partnerships (14). Recognizing that affordability is not the same as availability, precipitous falls in the cost of HIV treatment were coupled with the financing and implementation of effective “test and start” diagnostic and treatment delivery mechanisms—including those focusing on the type of “last mile” communities where many of us serve—alongside procurement, regulation, and monitoring processes (15). Similar stories are currently being written for human papillomavirus (HPV) vaccination (against HPV-associated cervical, oral, and anal cancers; ref. 16), hepatitis B virus vaccination (hepatitis B–associated liver cirrhosis and liver cancer; ref. 17), and direct-acting antivirals for hepatitis C (which have transformed treatment of the virus, and associated hepatocellular cancer and cirrhosis). We believe that it is possible to write this story for cancer too. In fact, we have never been closer.

This year, the UICC established a new and ambitious global partnership, the ATOM Coalition (18). The coalition's goal is to increase the availability and affordability of cancer medicines and diagnostics in LMICs and to increase country capacity and coordination to deliver these to patients who need them (Fig. 1). Although the ATOM Coalition is not the first initiative attempting to address access issues, it is the first to bring together many major stakeholders globally across the public and private sectors to act on both supply- and delivery-side challenges (Table 1). This includes the pharmaceutical, biotechnology, and diagnostic companies AstraZeneca, Becton Dickinson, BeiGene, Bristol Myers Squibb, Gilead, MSD, Novartis, Roche, Sanofi, and Thermo Fisher Scientific; the Medicines Patent Pool that negotiates with patent holders for voluntary licenses that permit lower cost manufacturers to distribute patented medicines in LLMICs and patent pooling; and organizations already working at the country level on access to medicines and cancer capacity building, such as The Max Foundation, Project ECHO, the American Society for Clinical Pathology, Direct Relief, the IDA Foundation, and others. As part of its work, the ATOM Coalition will support countries to systematically identify and address needs, gaps, and challenges at the systems level that limit availability and affordability, and aim to develop and implement sustainable, scalable access solutions. Many of the upstream barriers patients and health systems face accessing cancer medicines start beyond national borders and, as with ART, relate to international trade and intellectual property law, patents, licensing, regulation, manufacturing, and supply chains. At the country level, proper handling, supply monitoring, forecasting, and quality assurance are crucial, as is having the cancer and health system infrastructure in place to initiate, monitor, and complete a treatment course. The strength of the coalition includes the long-standing relationships, infrastructure, and track record that individual stakeholders already have both with countries and in many cases with each other, and its ability to act as a single negotiating mechanism rather than on a country-by-country, organization-by-organization, or drug-by-drug basis. New financing and licensing mechanisms will be needed to lower the price of cancer medicines still on patent, as well as new medicines as they come to market including via voluntary licensing agreements with the Medicines Patent Pool (an official observer to the ATOM Coalition) that opened up access to HIV, hepatitis B, and tuberculosis medicines. However, some 70% of the cancer medications currently listed on the WHO EML are older off-patent therapies (9). Increasing local and regional production of cheaper generic and biosimilar medicines is one of the most pressing actions to address availability and affordability of those drugs already on the EML (9). Strengthening procurement, supply management, and quality assurance within a country's health system is then required to get medicines to patients.

Medicines are of course only one tool in the cancer control armamentarium and cannot close the cancer care gap on their own. Without affordable, available, and timely diagnostic tests—for example, those that stratify breast cancer by hormone sensitivity (e.g., estrogen receptor/progesterone receptor) and the targetable oncogene HER2/neu or identify targetable mutations in lung cancer [e.g., EGFR mutations for tyrosine kinase inhibitor (TKI) use] to ensure patients get the type of treatment they need—many of the medicines on the EML cannot be deployed safely or effectively (19). To address this, the coalition is also engaging a range of public and private stakeholders involved in the development and delivery of cancer diagnostics, biotechnology, and genomics. In addition, effective cancer treatment requires the coordinated delivery of multiple interventions within a population and health system, which go far beyond supplying medications. Although surgery is the mainstay of curative treatment for many solid malignancies, including breast, gastric, liver, and colorectal cancers, safe oncologic surgery is still not available in many parts of the world (20). Radiotherapy, which is unavailable or inaccessible in many LMICs, is critical for the treatment and locoregional control of many high-burden cancers and serves as an important means of palliating symptoms when curative treatment is not possible (21). Pathology and imaging are required for diagnosing and staging all cancers and for treatment planning but again, these critical services are often underdeveloped or out of reach for most patients (22). To realize the full potential of the ATOM Coalition, countries and the international community will need to address each of these pillars of cancer control at subnational, national, and international levels and along the cancer continuum. This includes prevention, screening, and early detection efforts; expansion of universal health coverage to ensure that the costs of cancer treatment are not borne by individual patients and their families; and investment in human resources, national and regional governance, and health systems leadership.

One clear lesson from HIV/AIDS is that investment in one part of the access equation can catalyze the growth of other components, and even entire health systems, when civil society demand, political will, financial and human resources, and underlying motivations align (12). One caution is that a singular focus on distributing medicines for a condition can distort health resource distribution and prioritization, especially when this occurs outside existing health systems. Because government prioritization and commensurate investment are key to ownership and sustainability, the ATOM Coalition will prioritize partnering with countries already committed to or engaged in improving cancer control.

Although the ATOM Coalition and the partnerships it has created represent an enormous stride forward in global cancer control, we are realistic about the challenges such initiatives face in increasingly complex national and global geopolitical and economic contexts. A recent example is the COVAX initiative, which aimed to accelerate the development and manufacture of COVID-19 vaccines and act as a global risk-sharing mechanism for pooled procurement and fair and equitable vaccine distribution for every country in the world (23). This included 92 LMICs that, through a Gavi (the Vaccine Alliance)-supported innovative financing mechanism, were to have access to donor-funded vaccines and country-delivery supports. Although COVAX successfully distributed over 1 billion vaccine doses, it fell significantly short of its target, and many of the LMICs it aimed to support had to find alternative ways to obtain vaccines. The enthusiasm for global solidarity that heralded the arrival of the COVAX initiative was tested during its subsequent implementation. Challenges faced included a lack of early financing for the initiative, hoarding of vaccines by HICs procured through direct bilateral agreements with pharmaceutical companies outside the COVAX mechanism, export restrictions on key vaccine components coupled with a lack of regional suppliers and manufacturers, and a reliance on an aid-financed mechanism for vaccine procurement in LMICs rather than intellectual property waivers and technology transfers to facilitate production outside of high-income regions (24). One of the main lessons of COVAX, which should be applied to all global initiatives, is that good intentions are not enough. Global solidarity must be hard-wired into the design, financing, and risk-pooling mechanism of coalitions such as the ATOM Coalition. Local ownership is key to implementation and sustainability. Success must be measured not in commitments but in actions. In fact, the ATOM Coalition is already translating its ambition into concrete outcomes. The announcement of the first-ever public health–oriented voluntary license of a cancer drug [the BCR/ABL TKI nilotinib for chronic myeloid leukemia (CML)] in October 2022 shows the promise and power of public and private sector collaboration (25). In HICs, patients with CML receiving TKI treatment achieve similar life expectancies to the age-matched general population (26). Despite being on the WHO EML, these treatments have been out of reach for most patients in LLMICs. Under the umbrella of the ATOM Coalition, the agreement between ATOM Coalition partners Novartis and the Medicines Patent Pool represents an exciting milestone for the cancer community and signals a real opportunity for more companies to consider engaging voluntary licenses to expand access to cancer medicines.

As the next generation of cancer advocates, professionals, and leaders, we stand committed to realizing a future for our patients and communities in which cancer diagnostics, medicines, and treatments are available, affordable, and accessible to all—a future where countries can develop, procure, produce, and deliver essential cancer medicines for their populations on an equitable footing, as partners in the global creation, dissemination, and delivery of cancer knowledge, resources, and care. We call upon patients, caregivers, civil society, political leaders, industry, private and public institutions, and the wider cancer and health community to commit to delivering on the goals of the ATOM Coalition. We are optimistic that within our lifetime we can end unjust and unnecessary differences in access to cancer care within and between our countries, leaving no one behind.