Personalized Medicine, Omics, and Health Disparities in Cancer: Can Personalized Medicine Help Reduce the Disparity Problem?
Curator: Stephen J. Williams, PhD
UPDATED: 5/24/2026
Europe’s Medicine Access Crisis: What the Latest Data Means for Lung Cancer
This week, EFPIA published its annual WAIT Report. It tracks how quickly medicines approved by the European Medicines Agency reach people across EU member states. The 2025 data, covering 168 medicines approved between 2021 and 2024, makes for difficult reading.
Nearly half of those medicines, 49%, are not available to people in Europe. That figure has risen from 46% in 2019. The share of medicines fully available on public reimbursement lists has fallen from 42% in 2019 to 28% in 2025. A further 17% are only available under restricted conditions, up from 6% six years ago.
The median time from European marketing authorisation to availability across the continent is 532 days. In Germany, the median wait is 56 days. In Romania, it is 1,201 days. That is a difference of more than three years, for the same medicines, approved by the same regulatory body, for people living on the same continent.
For oncology, the trend is moving in the wrong direction. The average time to availability for cancer medicines has increased year on year. EFPIA’s analysis also flags a declining trend in the number of FDA-approved medicines subsequently approved by the EMA, with a particularly steep drop since October 2025.
These are system-level statistics. But behind every number is a person whose treatment options are shaped not by what science has made possible, but by where in Europe they happen to live.
What this means for lung cancer
Lung cancer is the leading cause of cancer-related death in Europe. It is also one of the most rapidly evolving areas of oncology. New treatment options, particularly in molecularly defined subtypes, have transformed outcomes for some groups over the past decade. The pipeline continues to produce results that would have been unimaginable ten years ago.
Yet the treatments that reach people in countries with faster, better-resourced reimbursement systems are the same treatments that remain unavailable or restricted for years in others. EFPIA’s data shows that Germany had 156 of the 168 tracked medicines available. Malta had 22. The gap between the best and worst performing countries in terms of availability was 88%.
This is not a question of what medicine can offer. It is a question of whether health systems, reimbursement frameworks, and pricing negotiations are structured in a way that gets treatments to the people who need them. As Lung Cancer Europe President Debra Montague wrote in her 2025-2026 Annual Report, “it has become clearer that these advancements are not reaching everyone equally.”
What people impacted by lung cancer are telling us
Access to approved medicines is one dimension of a broader picture. Lung Cancer Europe’s own research, drawn from surveys of more than 2,000 people impacted by lung cancer across 34 European countries, consistently shows that the challenges people face extend well beyond whether a medicine has been reimbursed.
Our 9th Report, published in November 2024, found that 40% of respondents did not receive enough information about their diagnosis, treatment, and care. Half received no information about alternative treatment options at all. Nearly nine in ten sought information outside the healthcare system, and one in four either could not find what they needed or encountered information that was inaccurate or unproven. Complex information was identified as the single biggest barrier to meaningful participation in treatment decisions.
Our 11th Report, launched in March 2026, focused on mental health. An average of 89.3% of all respondents experienced significant emotional difficulties following diagnosis. 31% received no mental health support at any point during their care. The burden falls unevenly. People living with small cell lung cancer reported the highest levels of distress, with 66.2% reporting a negative impact on their mental health. 74.3% were never referred to a patient organisation by their healthcare provider. People who had not undergone biomarker testing reported the poorest mental health outcomes of any group surveyed.
There is also a clear geographic dimension to mental health outcomes, one that maps closely onto the geographic inequality in treatment access that the EFPIA data describes. Respondents in Italy, Switzerland, and Denmark reported higher mental health scores. Those in Slovenia, Ukraine, and Greece reported the greatest negative psychological impact.
The pattern is consistent. Where people live in Europe determines not only which medicines are available to them, but the quality of information they receive, the extent to which they are involved in decisions about their own care, and the likelihood that their psychological wellbeing will be supported throughout the course of their illness.
What needs to change
The EFPIA report identifies the causes of these delays as multifactorial: slow regulatory processes, misalignment on evidence requirements, insufficient budgets in member states, and commercial decisions about where and when to launch. There is no single lever to pull. But the trend lines are moving in a direction that demands urgent attention from policymakers, health systems, and all stakeholders with a role in how medicines reach people.
Lung Cancer Europe calls on policymakers and healthcare providers across Europe to treat equitable access to treatment as a priority, not an aspiration. This means faster and more consistent reimbursement processes across member states, a commitment to closing the information gap that leaves too many people without the knowledge to understand and advocate for their own care, and the integration of psychological support as a standard component of the lung cancer care pathway.
The pipeline itself is also under pressure. New data published alongside the WAIT report shows a declining trend in the number of medicines approved by the US Food and Drug Administration that subsequently receive approval from the European Medicines Agency, with a particularly steep drop recorded since October 2025. For people living with lung cancer, where so many treatment advances in molecularly defined subtypes have originated from the global pipeline, a narrowing of what reaches European regulators at all would compound the access inequalities this data already describes.
The medicines exist. The evidence base is growing. The responsibility now is to ensure that what is possible for some becomes available to all.
For PDF report see here: efpia-patients-wait-indicator-2025
*Sources: https://www.lungcancereuropenews.eu/news/europe-medicine-access-crisis-lung-cancer-efpia-2026 EFPIA Patients W.A.I.T. Indicator 2025 (published May 2026); 9th Lung Cancer Europe Report (November 2024); 11th Lung Cancer Europe Report (March 2026); Lung Cancer Europe President’s Annual Report 2024-2025.* ®IQVIA
Original Article
In a Science Perspectives article by Timothy Rebbeck, health disparities, specifically cancer disparities existing in the sub-Saharan African (SSA) nations, highlighting the cancer incidence disparities which exist compared with cancer incidence in high income areas of the world [1]. The sub-Saharan African nations display a much higher incidence of prostate, breast, and cervix cancer and these cancers are predicted to double within the next twenty years, according to IARC[2]. Most importantly,
the histopathologic and demographic features of these tumors differ from those in high-income countries
meaning that the differences seen in incidence may reflect a true health disparity as increases rates in these cancers are not seen in high income countries (HIC).
Most frequent male cancers in SSA include prostate, lung, liver, leukemia, non-Hodgkin’s lymphoma, and Kaposi’s sarcoma (a cancer frequently seen in HIV infected patients [3]). In SSA women, breast and cervical cancer are the most common and these display higher rates than seen in high income countries. In fact, liver cancer is seen in SSA females at twice the rate, and in SSA males almost three times the rate as in high income countries.
Reasons for cancer disparity in SSA
Patients with cancer are often diagnosed at a late stage in SSA countries. This contrasts with patients from high income countries, which have their cancers usually diagnosed at an earlier stage, and with many cancers, like breast[4], ovarian[5, 6], and colon, detecting the tumor in the early stages is critical for a favorable outcome and prognosis[7-10]. In addition, late diagnosis also limits many therapeutic options for the cancer patient and diseases at later stages are much harder to manage, especially with respect to unresponsiveness and/or resistance of many therapies. In addition, treatments have to be performed in low-resource settings in SSA, and availability of clinical lab work and imaging technologies may be limited.
Molecular differences in SSA versus HIC cancers which may account for disparities
Emerging evidence suggests that there are distinct molecular signatures with SSA tumors with respect to histotype and pathology. For example Dr. Rebbeck mentions that Nigerian breast cancers were defined by increased mutational signatures associated with deficiency of the homologous recombination DNA repair pathway, pervasive mutations in the tumor suppressor gene TP53, mutations in GATA binding protein 3 (GATA3), and greater mutational burden, compared with breast tumors from African Americans or Caucasians[11]. However more research will be required to understand the etiology and causal factors related to this molecular distinction in mutational spectra.
It is believed that there is a higher rate of hereditary cancers in SSA. And many SSA cancers exhibit the more aggressive phenotype than in other parts of the world. For example breast tumors in SSA black cases are twice as likely than SSA Caucasian cases to be of the triple negative phenotype, which is generally more aggressive and tougher to detect and treat, as triple negative cancers are HER2 negative and therefore are not a candidate for Herceptin. Also BRCA1/2 mutations are more frequent in black SSA cases than in Caucasian SSA cases [12, 13].
Initiatives to Combat Health Disparities in SSA
Multiple initiatives are being proposed or in action to bring personalized medicine to the sub-Saharan African nations. These include:
H3Africa empowers African researchers to be competitive in genomic sciences, establishes and nurtures effective collaborations among African researchers on the African continent, and generates unique data that could be used to improve both African and global health.
There is currently a global effort to apply genomic science and associated technologies to further the understanding of health and disease in diverse populations. These efforts work to identify individuals and populations who are at risk for developing specific diseases, and to better understand underlying genetic and environmental contributions to that risk. Given the large amount of genetic diversity on the African continent, there exists an enormous opportunity to utilize such approaches to benefit African populations and to inform global health.
The Human Heredity and Health in Africa (H3Africa) consortium facilitates fundamental research into diseases on the African continent while also developing infrastructure, resources, training, and ethical guidelines to support a sustainable African research enterprise – led by African scientists, for the African people. The initiative consists of 51 African projects that include population-based genomic studies of common, non-communicable disorders such as heart and renal disease, as well as communicable diseases such as tuberculosis. These studies are led by African scientists and use genetic, clinical, and epidemiologic methods to identify hereditary and environmental contributions to health and disease. To establish a foundation for African scientists to continue this essential work into the future work, the consortium also supports many crucial capacity building elements, such as: ethical, legal, and social implications research; training and capacity building for bioinformatics; capacity for biobanking; and coordination and networking.
The World Economic Forum’s Leapfrogging with Precision Medicine project
This project is part of the World Economic Forum’s Shaping the Future of Health and Healthcare Platform
The Challenge
Advancing precision medicine in a way that is equitable and beneficial to society means ensuring that healthcare systems can adopt the most scientifically and technologically appropriate approaches to a more targeted and personalized way of diagnosing and treating disease. In certain instances, countries or institutions may be able to bypass, or “leapfrog”, legacy systems or approaches that prevail in developed country contexts.
The World Economic Forum’s Leapfrogging with Precision Medicine project will develop a set of tools and case studies demonstrating how a precision medicine approach in countries with greenfield policy spaces can potentially transform their healthcare delivery and outcomes. Policies and governance mechanisms that enable leapfrogging will be iterated and scaled up to other projects.
Successes in personalized genomic research in SSA
As Dr. Rebbeck states:
Because of the underlying genetic and genomic relationships between Africans and members of the African diaspora (primarily in North America and Europe), knowledge gained from research in SSA can be used to address health disparities that are prevalent in members of the African diaspora.
For example members of the West African heritage and genomic ancestry has been reported to confer the highest genomic risk for prostate cancer in any worldwide population [14].
PERSPECTIVEGLOBAL HEALTH
Cancer in sub-Saharan Africa
- Timothy R. Rebbeck
See all authors and affiliations
Science 03 Jan 2020:
Vol. 367, Issue 6473, pp. 27-28
DOI: 10.1126/science.aay474
Summary/Abstract
Cancer is an increasing global public health burden. This is especially the case in sub-Saharan Africa (SSA); high rates of cancer—particularly of the prostate, breast, and cervix—characterize cancer in most countries in SSA. The number of these cancers in SSA is predicted to more than double in the next 20 years (1). Both the explanations for these increasing rates and the solutions to address this cancer epidemic require SSA-specific data and approaches. The histopathologic and demographic features of these tumors differ from those in high-income countries (HICs). Basic knowledge of the epidemiology, clinical features, and molecular characteristics of cancers in SSA is needed to build prevention and treatment tools that will address the future cancer burden. The distinct distribution and determinants of cancer in SSA provide an opportunity to generate knowledge about cancer risk factors, genomics, and opportunities for prevention and treatment globally, not only in Africa.
References
- Rebbeck TR: Cancer in sub-Saharan Africa. Science 2020, 367(6473):27-28.
- Parkin DM, Ferlay J, Jemal A, Borok M, Manraj S, N’Da G, Ogunbiyi F, Liu B, Bray F: Cancer in Sub-Saharan Africa: International Agency for Research on Cancer; 2018.
- Chinula L, Moses A, Gopal S: HIV-associated malignancies in sub-Saharan Africa: progress, challenges, and opportunities. Current opinion in HIV and AIDS 2017, 12(1):89-95.
- Colditz GA: Epidemiology of breast cancer. Findings from the nurses’ health study. Cancer 1993, 71(4 Suppl):1480-1489.
- Hamilton TC, Penault-Llorca F, Dauplat J: [Natural history of ovarian adenocarcinomas: from epidemiology to experimentation]. Contracept Fertil Sex 1998, 26(11):800-804.
- Garner EI: Advances in the early detection of ovarian carcinoma. J Reprod Med 2005, 50(6):447-453.
- Brockbank EC, Harry V, Kolomainen D, Mukhopadhyay D, Sohaib A, Bridges JE, Nobbenhuis MA, Shepherd JH, Ind TE, Barton DP: Laparoscopic staging for apparent early stage ovarian or fallopian tube cancer. First case series from a UK cancer centre and systematic literature review. European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 2013, 39(8):912-917.
- Kolligs FT: Diagnostics and Epidemiology of Colorectal Cancer. Visceral medicine 2016, 32(3):158-164.
- Rocken C, Neumann U, Ebert MP: [New approaches to early detection, estimation of prognosis and therapy for malignant tumours of the gastrointestinal tract]. Zeitschrift fur Gastroenterologie 2008, 46(2):216-222.
- Srivastava S, Verma M, Henson DE: Biomarkers for early detection of colon cancer. Clinical cancer research : an official journal of the American Association for Cancer Research 2001, 7(5):1118-1126.
- Pitt JJ, Riester M, Zheng Y, Yoshimatsu TF, Sanni A, Oluwasola O, Veloso A, Labrot E, Wang S, Odetunde A et al: Characterization of Nigerian breast cancer reveals prevalent homologous recombination deficiency and aggressive molecular features. Nature communications 2018, 9(1):4181.
- Zheng Y, Walsh T, Gulsuner S, Casadei S, Lee MK, Ogundiran TO, Ademola A, Falusi AG, Adebamowo CA, Oluwasola AO et al: Inherited Breast Cancer in Nigerian Women. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2018, 36(28):2820-2825.
- Rebbeck TR, Friebel TM, Friedman E, Hamann U, Huo D, Kwong A, Olah E, Olopade OI, Solano AR, Teo SH et al: Mutational spectrum in a worldwide study of 29,700 families with BRCA1 or BRCA2 mutations. Human mutation 2018, 39(5):593-620.
- Lachance J, Berens AJ, Hansen MEB, Teng AK, Tishkoff SA, Rebbeck TR: Genetic Hitchhiking and Population Bottlenecks Contribute to Prostate Cancer Disparities in Men of African Descent. Cancer research 2018, 78(9):2432-2443.
Other articles on Cancer Health Disparities and Genomics on this Online Open Access Journal Include:
Gender affects the prevalence of the cancer type
The Rutgers Global Health Institute, part of Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, New Jersey – A New Venture Designed to Improve Health and Wellness Globally
Breast Cancer Disparities to be Sponsored by NIH: NIH Launches Largest-ever Study of Breast Cancer Genetics in Black Women
War on Cancer Needs to Refocus to Stay Ahead of Disease Says Cancer Expert
Ethical Concerns in Personalized Medicine: BRCA1/2 Testing in Minors and Communication of Breast Cancer Risk
Ethics Behind Genetic Testing in Breast Cancer: A Webinar by Laura Carfang of survivingbreastcancer.org
Live Notes from @HarvardMed Bioethics: Authors Jerome Groopman, MD & Pamela Hartzband, MD, discuss Your Medical Mind
Testing for Multiple Genetic Mutations via NGS for Patients: Very Strong Family History of Breast & Ovarian Cancer, Diagnosed at Young Ages, & Negative on BRCA Test
Study Finds that Both Women and their Primary Care Physicians Confusion over Ovarian Cancer Symptoms May Lead to Misdiagnosis
2012pharmaceutical
sjwilliamspa