Personalized medicine and health equity: overcoming cost barriers and ethical challenges

Abstract

Personalized medicine (PM), which aims to tailor healthcare interventions to individual biological profiles, has emerged as a transformative approach in modern medicine. The rapid advancement of digital health technologies is playing an increasingly vital role in enabling this precision-driven model of care. This paper examines the potential of PM to transform healthcare and its implications for health equity, focusing on the cost barriers and ethical dilemmas that hinder its equitable implementation. It argues that while PM holds promise for revolutionizing treatment strategies by tailoring interventions to individual characteristics, the integration of artificial intelligence (AI) is increasingly central to achieving this goal. However, the reliance on advanced technologies, robust datasets, and specialized expertise can exacerbate existing disparities in healthcare access, particularly in low- and middle-income countries (LMICs). The paper discusses the ethical considerations related to unequal access to PM, drawing on ethical theories to examine how these disparities might widen health inequities. It also explores innovative solutions and global health initiatives aimed at improving access, which may help align the benefits of PM with the goal of health equity.

Introduction

The promise and challenge of personalized medicine

The rapid evolution of biomedical data and computational tools is driving transformative changes in healthcare, with personalized medicine at the forefront [1]. Often mistakenly used interchangeably, precision medicine and personalized medicine have distinct definitions. Precision medicine focuses on using the biological or genetic information of specific subgroups to guide medical management decisions [2]. In contrast, personalized medicine takes a broader approach, integrating an individual’s unique genetic, environmental, and lifestyle factors, as well as personal preferences, to deliver care tailored to that person rather than applying a one-size-fits-all model [3, 4]. For the remainder of this paper, personalized medicine will be referred to as PM. PM has generated widespread interest due to its potential to improve diagnostic accuracy, speed up disease prevention, and deliver effective treatments that minimize the need for trial and error. Proponents argue that PM could reduce long-term healthcare costs by focusing resources on specific, targeted therapies [5]. However, implementing this high-tech approach requires significant financial and technological investments, which raises important questions about its accessibility and potential impact on health equity.

The promise of PM to revolutionize healthcare is currently most evident in high-income countries (HICs) where funding, infrastructure, and access to cutting-edge technology are more readily available [3, 6]. For instance, genomics and artificial intelligence (AI)-enhanced diagnostics have enabled these countries to implement PM initiatives that improve outcomes in areas like oncology and rare genetic disorders [7]. Yet, low- and middle-income countries (LMICs), which face systemic healthcare barriers, are largely excluded from these advancements. In many LMICs, healthcare systems are under-resourced, with limited access to basic services and a shortage of medical professionals. These constraints make it challenging to adopt the resource-intensive tools and infrastructure required for PM, potentially creating an uneven global landscape where only affluent populations benefit from these advances [8, 9].

Central to this concern is the cost associated with PM. Precision treatments, particularly those involving genetic profiling, biomarker testing, and AI-driven diagnostics, entail substantial expenses for both development and implementation [10]. The process of drug discovery alone, with its reliance on genomic research and targeted therapies, can be cost-prohibitive, often reaching billions of dollars for a single therapeutic solution. Advanced gene therapies and specialized treatments, such as those in oncology, illustrate this financial burden, as they frequently require not only expensive drugs but also sophisticated diagnostic tools and highly trained personnel [5, 11, 12]. As these high costs trickle down to patients, they can become an insurmountable barrier, particularly in resource-poor settings where even basic healthcare remains a luxury.

While financial constraints present a major hurdle, PM also raises significant ethical questions about fairness and justice. Ethical theories, such as Rawls’ principle of fairness, Kantian ethics, and utilitarianism, provide frameworks to consider these dilemmas. Health equity is the principle that all individuals should have an equal opportunity to achieve their best possible health, free from barriers that may prevent this [13]. Rawls’ “difference principle” suggests that societal inequalities are only justifiable if they benefit the least advantaged [14–16]; applied to PM, this principle challenges the notion of deploying advanced medical treatments that primarily benefit those who can afford them, potentially worsening health inequities. This aligns with the mission of the WHO Commission on Social Determinants of Health (CSDH), which seeks to address the root causes of health inequities [17]. Kantian ethics, with its emphasis on universal human dignity, establishes a moral obligation for healthcare systems to ensure PM is accessible to all individuals, thereby respecting the inherent worth of every person [18]. The ethical tension arises when PM is only accessible to a select few, as this violates the principle of providing equitable access to potentially life-saving treatments. This is why the Kantian framework provides an ethical basis for using a Health Equity Impact Assessment (HEIA). This tool is used to proactively evaluate whether PM policies might disproportionately affect different population groups [19], ensuring they uphold the core mission of health equity.

Similarly, utilitarianism argues for maximizing overall well-being and could suggest that focusing on high-impact, cost-effective treatments might better serve global populations [16]. The ethical tension with PM is whether its high cost is the best use of limited resources to achieve the greatest good for the greatest number of people. This perspective is consistent with the pursuit of health equity by prioritizing interventions that produce the greatest health benefits for the largest number of people. Norman Daniels’s work on “fair equality of opportunity” bridges these theories with practical policy, arguing that access to health is a prerequisite for social participation [20]. This framework directly supports the call for policies that strengthen universal health coverage and prioritize foundational health infrastructure alongside PM advancements. Together, these theories underscore the importance of implementing PM in ways that enhance rather than undermine health equity.

This paper seeks to answer a critical question: Can the promising future of PM coexist with a commitment to health equity? Addressing this requires a comprehensive examination of PM's cost barriers, the infrastructure needed for equitable access, and the socio-political factors influencing healthcare delivery worldwide. To explore the implications of PM, this paper draws on insights using a transdisciplinary approach. It examines perspectives from disciplines such as genetics, global health, ethics, economics, and health policy to gain a comprehensive view. Unlike a traditional interdisciplinary approach, analysing insights from these various fields through a transdisciplinary lens allows for a holistic understanding of PM's potential and the existing challenges beyond simply making unified connections [21]. This approach acknowledges the diversity of viewpoints among different populations and stakeholders, ensuring an understanding of how to adopt PM efficiently and effectively while also addressing existing health inequities.

Through a review of ethical considerations and case studies from both HICs and LMICs, this paper explores how innovative approaches could help bridge the gap between technological advancement and equitable healthcare access. Global health initiatives, supported by policies that emphasize collaboration and shared resources, have the potential to make PM a viable and inclusive approach to healthcare. In addressing these questions, this paper aims to propose strategies that ensure PM does not widen existing health disparities but instead becomes a tool for universal health improvement. By prioritizing infrastructure development, training, and financial investment in LMICs, PM can align with principles of health equity, creating a future where healthcare innovation benefits everyone, regardless of socio-economic status.

The high cost of personalized medicine

Many have envisioned the positive transformation of healthcare through major advancements in science and technology, such as advancements in DNA sequencing tools, AI-assisted diagnostics, and precision treatments. Yet, this vision fails to account for the significant value-added costs required to materialize it. As Lu et al. [5] pointed out, while scientific progress continues to accelerate, it ironically exacerbates core issues like affordability and access disparities that further challenge the delivery of health equity.

The same is true for PM. Despite its advantages in its implementation and integration within clinical practices, one of the major obstacles to this advancement is primarily economic in nature [22]. With many factors contributing to the higher costs associated with accessing its declared benefits, Vellekoop et al. [23] state that PM is significantly found to contribute to higher costs in healthcare and treatment, even though it also improves medical outcomes. Several key factors lead to increased financial burdens for personalized treatments, including the high costs of developing drugs and other therapeutics.

The drug development process involves different stages, each incurring substantial expenses, from preclinical research and drug development to clinical trials. This includes additional costs associated with collaborations between health systems and industry [5]. Over the last few decades, the costs of developing drugs have risen significantly. As research and development efforts have expanded, the prices of these treatments have also begun to skyrocket [24]. Developing new and effective drugs is crucial for tailoring treatments to an individual’s unique genetic profile, which is essential in PM. However, the exorbitant costs required to create a new drug increase further when the costs of failure are included [25], with evidence suggesting that it averages around $314 million USD to $2.8 billion USD [26].

Oncological treatments are a prominent example of the high-cost application of PM. The costs associated with cancer treatments, such as anticancer drugs and gene therapy, continue to increase [27]. Although the costs of these anticancer drugs vary globally, in the United States alone, their prices can reach up to $100,000 USD per year, with many requiring an adjuvant drug for increased efficacy, further driving up cancer treatment expenses [28]. Moreover, cancer drugs are initially introduced in the U.S., establishing high standard market prices that drive up costs worldwide [27].

One example of this is the varying market prices for trastuzumab (Herceptin) for HER2-positive breast cancer, with 440 mg costing up to $1,852.07 USD in Taiwan alone [29]. Similarly, the price of trastuzumab deruxtecan (Enhertu), based on the Canadian Agency for Drugs and Technologies in Health [30], is around $2,440.00 CAD ($1,766.49 USD) per 100 mg, with an estimated annual cost of $165,949 CAD ($120,142 USD) per treatment. In 2015, the UK National Health and Care Excellence ultimately stopped funding trastuzumab due to its high expense, as its retail price amounted to £90,000 GBP ($120,088 USD) per patient [31]. This shows that even with systemic controls in a public system, cost can lead to a withdrawal of access, directly affecting the poor or those without private means. While studies suggest that these cost burdens are evident in HICs [11, 32], they are felt even more acutely in LMICs. For example, in the Philippines, the cost of sourcing this drug alone is enough to drain the entire national budget allocated for other drug acquisitions [33].

In a public healthcare system, inequity arises from the difficult choices that government bodies must make when faced with limited resources and high costs. The decision to fund a single, expensive PM drug may mean not being able to fund other, more widespread public health programs. In the UK, stopping funding for Trastuzumab shows that even in an advanced economy with a public system, cost can lead to a withdrawal of access, affecting those without private means. In a private healthcare system, inequity is more direct. Access to PM is determined by an individual’s ability to pay, creating a divide where affluent populations have priority access to life-saving treatments, while low-resource populations are left with inadequate healthcare options.

Another major contributor to the high costs of personalized treatments is the expense of advanced technologies required for its individualized approach. PM relies heavily on technologies for exploring biomarkers, genetic, and molecular profiling. Meckley & Neumann [34] emphasize that PM strategies are largely driven by these technologies, which can only be feasible with significant financial investments, leading stakeholders to increase personalized therapy prices to achieve substantial returns [11]. Gene therapies targeting specific diseases are also known for their high costs [12].

As Peters et al. [35] demonstrate, LMICs already suffer from underfunded healthcare systems and limited access to health services. Furthermore, the lack of advanced genetic testing facilities, adequate funding, research-focused education, health literacy, and a skilled workforce continues to hinder LMICs in overcoming persistent barriers to health equity [6, 36]. For instance, there is a clear gap in genomic laboratory establishment in LMICs, with countries like Tunisia often relying on external funding, international collaborations, and the need to send samples abroad for high-throughput sequencing [9]. In the Philippines, genome sequencing services are limited to only a few national laboratories [37, 38], and these services come at significantly high costs. Existing geographical barriers also make it challenging to access these facilities [39]. Furthermore, most developing nations face clear inaccessibility to new, life-saving drugs. Challenges such as unestablished drug regulatory programs, logistics, weak health systems, and resource scarcity make acquiring these medications nearly impossible [40, 41].

The need to establish infrastructure and train skilled workers to build capacity for PM in LMICs is another pressing challenge contributing to high costs, requiring substantial financial investments and collaboration [39, 42]. Despite HICs starting to benefit from PM through genetic insights, the reduced costs for next-generation sequencing machines, and support from global organizations like the World Health Organization, many LMICs still cannot afford the necessary infrastructure to implement these innovations effectively [43]. To date, numerous studies detail how LMICs will bear the brunt of the additional financial burden of PM [1, 6, 44–47]. Though HICs struggle to manage the exorbitant costs that come with this evolving healthcare landscape, LMICs are still grappling with existing barriers to accessing adequate treatments to promote health, only to face greater challenges as PM moves farther out of reach.

Most importantly, political and government engagements are crucial catalysts for the adoption of PM in LMICs. Without a strong commitment from leaders and a supportive policy environment, PM is unlikely to move beyond a theoretical concept. Since PM requires significant financial investments, the governments are positioned to provide funding and infrastructure, such as funding for local research and development (R&D) to encourage the development of affordable personalized treatments and building diagnostic facilities [48]. Also, the increasing reliance on collecting and sharing vast amounts of sensitive genomic and clinical data in PM introduces significant challenges related to data privacy and security. A primary concern is the vulnerability of large genomic databases to privacy breaches, as they are attractive targets for cyberattacks. The exposure of this highly sensitive information could have serious consequences for individuals, revealing their health status, disease predispositions, and family history. Beyond direct breaches, the potential for misuse of genetic information by third parties is a critical issue. For instance, insurers or employers could use a person’s genetic profile to make discriminatory decisions, such as denying healthcare coverage [49]. These data privacy and security concerns are particularly acute in LMICs, which often lack the robust legal and regulatory frameworks found in HICs. This absence of comprehensive legislation to protect sensitive genetic data makes it difficult to build the public trust necessary for large-scale PM initiatives and creates ethical dilemmas in international collaborations where data is transferred between countries with different levels of privacy protection [50]. Therefore, strong political and government engagement is a crucial catalyst for the ethical adoption of PM, as governments are uniquely positioned to create and implement the necessary regulations to address these issues [51]. Additionally, as PM requires a skilled workforce, the government can provide education and training among healthcare professionals to effectively integrate PM into clinical practice. They can also lead initiatives to educate the public about the benefits and implications of PM, which is crucial for building public acceptance and encouraging participation in research and clinical trials [52]. Thus, for LMICs to successfully adopt personalized medicine, they must have both the necessary resources and practical, well-defined policies in place.

On the other hand, implementing PM in HICs faces multifaceted challenges too, including the substantial high costs and funding required for advanced technologies and therapies [5]; the need for robust data management and infrastructure to handle complex and voluminous data while ensuring privacy and interoperability [53]; the complexities of integrating these approaches into existing healthcare systems, necessitating changes in workflows, guidelines, and reimbursements [54]; significant regulatory and ethical considerations surrounding genetic information, data privacy, and equitable access [55, 56]; a demand for enhanced workforce training and education most especially in genomics and bioinformatics [32]; the imperative of ensuring equitable access across diverse populations within HICs [5]; the necessity of demonstrating clinical utility and cost-effectiveness through rigorous research [57]; and creating secure, standardized systems for data sharing while fostering collaboration between researchers and clinicians to speed up discoveries and enhance the application of research in clinical settings [58].

In this context, these challenges reveal the broader implications PM could have on health equity. As countries worldwide confront existing disparities, compounded by the risks PM may impose, it becomes increasingly clear that health equity must be defined and examined to understand its intersection with the evolving healthcare landscape. This underscores how health equity plays a pivotal role in ensuring that PM is accessible to all, addressing gaps in access, treatments, and outcomes across diverse populations.

Evidence-based personalized care: cost-effectiveness analysis

Understanding the economic implications of PM is paramount given limited healthcare resources and its frequently higher initial costs, such as genetic testing. Cost-effectiveness analysis, utilizing metrics like the Incremental Cost-Effectiveness Ratio (ICER), helps decision-makers assess the value proposition of personalized approaches compared to standard care. The ICER quantifies the additional cost required to gain one extra unit of health benefit, often measured in Quality-Adjusted Life Years (QALYs). QALYs provide a standardized measure combining both the length and quality of life, allowing for comparisons across different interventions [59]. By evaluating the ICER against a willingness-to-pay threshold, stakeholders can determine if the improved outcomes and potential long-term savings offered by PM justify the initial investment, ultimately guiding resource allocation towards strategies that provide the greatest patient benefit within budgetary constraints.

A practical application is using genetic testing to inform the selection of antiplatelet therapy in patients who have received a coronary stent. The upfront cost of genetic testing might be $300 per patient but studies have shown that this personalized approach, by identifying and treating poor responders to standard drugs like clopidogrel with alternatives, can reduce the incidence of major adverse cardiovascular events by 20–30%. This reduction in events translates to significant cost savings from avoided hospitalizations and interventions, resulting in an ICER of approximately $42,000 per QALY gained in some analyses, which often falls below the commonly accepted willingness-to-pay threshold of $50,000–$100,000 per QALY in many developed countries [60]. Similarly, in neonatal diabetes, genetic testing costing around $2,000 can identify patients who can switch from lifelong insulin injections (costing upwards of $5,000 annually) to cheaper oral sulfonylurea drugs, leading to substantial long-term cost savings, estimated at over $30,000 per patient over 30 years, while also improving their quality of life, reflected in a gain of 0.70 QALYs [61, 62]. Moreover, implementing a precision medicine approach using pharmacogenetics for psychiatric patients has shown a cost-to-benefit ratio ranging from 3.31 to 3.59, accompanied by a reduction in direct healthcare costs, including hospitalizations and pharmacotherapy expenses [63]. These examples illustrate how quantifying the ICER and QALY gains through robust data is crucial for making informed decisions about the adoption and reimbursement of PM strategies.

Health equity: definitions and challenges

The pursuit of global health equity remains the central focus of global health initiatives. Health is a significant and fundamental right, yet the challenges to achieving it remain profoundly complex, especially in many developing countries. Definitions of health equity may vary, but with fairness and justice as its main theme, Braveman et al. [13] define it as a principle where all people have equal chances of attaining their best possible level of health, free from barriers that could prevent this. Health equity essentially strives to remove impediments to accessing adequate and efficient healthcare, which hampers individuals’ chances of achieving full health potential [64]. However, due to its transdisciplinary nature, it is prone to various challenges. Several studies [35, 65–67] have shown that issues like resource allocation, policies, and agreements among global communities, as well as systemic factors such as discrimination based on gender, race, and socioeconomic status, hinder health equity, especially in LMICs.

In recent years, the COVID-19 pandemic has further exposed stark disparities in healthcare access worldwide, particularly between HICs and LMICs. Challenges in healthcare accessibility, vaccine procurement, treatments, and lack of essential resources highlight that the world is still far from achieving health equity [68]. Inequities in vaccine distribution are a clear example; Bayati et al. [69] described that vaccine administration was 69% higher in developed countries than in developing countries. Despite global health initiatives by the United Nations to distribute vaccines more widely in LMICs, these efforts were still found to be insufficient [70]. Additionally, the delayed access to vaccines by LMICs resulted in worsened health outcomes, increased infection rates, and higher mortality than in wealthier nations [71]. These disparities underscore how economic status impacts essential health outcomes; even after vaccines became available in LMICs, there remains a significant need to ensure that all countries, regardless of wealth, have fair and easy access to health interventions.

Today, increasing barriers to health equity reveal the limitations of global health initiatives. These disparities have been exacerbated by the challenges of the pandemic, recent economic instability, and escalating political conflicts, leaving LMICs and low-income populations in wealthier countries grappling with food insecurity, housing instability, and limited access to hygiene facilities [72, 73]. Moreover, the global shortage of healthcare workers has only intensified these burdens. The World Health Organization projected that by 2030, a shortfall of 18 million health workers would accelerate in resource-limited countries [74]. Meanwhile, 17% of global healthcare workers are expected to retire in the next 10 years [75].

Younger generations are increasingly deterred from entering the health profession due to factors such as low job status, poor compensation, and better career prospects elsewhere, not to mention the financial burden of nursing training [76, 77], rising living costs [78], and the high costs of medical school [79]. Consequently, numerous studies report that healthcare professionals in LMICs are often motivated to migrate to other countries for better job opportunities, greater job security, and higher salaries compared to their home countries [80, 81]. This migration helps address the shortage of health professionals in many HICs [82] but poses significant threats to the healthcare systems they leave behind. This trend constitutes a substantial loss to already strained public health infrastructures, potentially widening health equity gaps.

Without an adequate workforce, vulnerable populations face even greater risks of inadequate healthcare. Although some argue that LMICs benefit economically from remittances sent by healthcare workers abroad [83], this does not offset the shortage itself. For instance, this shortage limits the capacity to provide essential health services. Haddad et al. [84] explain that nurses are vital to healthcare service delivery, and their absence or shortage results in worsened health outcomes, including increased disease burden and mortality risk. Similarly, Al-Shamsi [85] highlights that the shortage of physicians in low-income countries is a pressing issue, reducing capacity in health emergency response and hindering disease prevention programs.

As Jensen et al. [68] further discuss, the ability to maintain reliable healthcare systems is fundamental to achieving health equity. Despite numerous initiatives to combat health disparities, the current healthcare landscape in LMICs demonstrates that these countries remain far behind. With PM emerging as a new frontier in healthcare, its promising benefits may have serious implications, potentially making health inequity in developing countries irreconcilable. Multiple studies have already shown how resource-intensive PM is, and to date, its methods are primarily adopted in HICs. As a result, success stories of its implementation have not yet been fully explored in LMICs. PM relies on advanced technology for genomics, diagnostics, and specialized treatments, which require significant investments in new technology and workforce training [86]. Even when genomics has advanced greatly in wealthy countries with immediate infrastructure establishment, its application in low-resource countries remains premature [87].

Although genetics and genomics are being integrated into different levels of healthcare systems, including primary and specialized tertiary care settings [88], it is challenging to integrate them into LMICs. According to Walters et al. [89], most LMICs face major obstacles in integrating genetics into primary healthcare systems. These obstacles often include the absence or limited availability of genetic services, a shortage of skilled human resources, and inadequate facilities, tools, and technology for genetic testing. Furthermore, political and financial barriers, such as insufficient health policies and resources, place restrictions on accessible genetic services, passing financial burdens onto patients, who face high costs for these services.

Given these pervasive challenges, achieving health equity in the era of PM requires reimagined global health strategies. Foundational issues impacting health equity must be addressed to implement PM effectively in LMICs. This demands a comprehensive review of educational approaches, socio-political factors, legislative frameworks, and ethical considerations to overcome primary challenges before transitioning to this new healthcare paradigm. Key initiatives to help bridge this gap include promoting scientific education, particularly in computational methods, genomics, and genetics fundamentals, updating healthcare curricula, and launching health literacy campaigns [56]. Additionally, revisiting and amending health policies to encourage collaborations and resource sharing is essential. In Thailand, for example, Thamlikitkul, L et al. [90] demonstrates how their government has established accessible public and private genetic testing services for cancer across all regions. Their progress in genomic medicine has been facilitated by substantial funding for cancer precision research. Similarly, global health initiatives are shifting toward frameworks for policy reforms in healthcare workforce development, equitable resource allocation, and ethical data sharing [91, 92], all foundational steps for advancing genomics and implementing PM in LMICs.

However, HICs, despite their advanced healthcare systems, also face significant health equity challenges. Socioeconomic disparities are a major concern, as income and poverty, lower levels of education, and precarious employment create barriers to accessing quality healthcare and the resources needed for good health [93]. Racial and ethnic minorities often experience systemic discrimination in healthcare and are affected by historical and ongoing social injustices, leading to disparities in care and outcomes [94]. These inequities are further compounded by issues related to healthcare access and quality, including inadequate insurance coverage, geographic limitations, and systemic problems within healthcare systems, such as a lack of cultural competence [95].

The social determinants of health also play a crucial role. Factors like unsafe housing, food insecurity, and limited transportation create unequal conditions that disproportionately affect vulnerable populations [96]. Specific groups, including immigrants and refugees, LGBTQ+ individuals, and people with disabilities, face unique challenges that contribute to health disparities [92, 97, 98]. Addressing these multifaceted issues requires comprehensive strategies that tackle the underlying social, economic, and systemic factors that drive health inequities and prevent everyone from attaining their full health potential.

Although transitioning to PM is time-consuming and resource-intensive, addressing primary issues, from basic healthcare infrastructure to advanced technologies, can help LMICs establish a sustainable framework for this paradigm. In essence, though PM poses significant risks of exacerbating health disparities, it also creates an opportunity for transdisciplinary collaboration, especially when stakeholders from high-, middle-, and low-income countries join forces to tackle shared challenges. Therefore, it is imperative to consider ethical implications and strengthen efforts to make PM accessible to all, promoting equity in healthcare for the future.

Innovative approaches to aligning personalized medicine with health equity

Emerging technologies and healthcare models

The process of PM has been significantly streamlined by emerging technologies such as AI, specifically machine learning and federated learning, along with high-throughput screening. AI and ML improve disease diagnosis, clinical testing, and treatment personalization by analyzing patient data. For example, these technologies reduce the need for trial-and-error, making diagnostics more accurate and efficient [99, 100]. This ultimately lowers costs and increases the affordability of advanced care [101]. Federated learning, a specialized type of AI, is crucial for inclusion because it allows multiple hospitals to train a single AI model without sharing patient data directly [102]. This ensures that the resulting AI models are more representative of diverse populations and can be applied more effectively to a wider range of people, regardless of where their data is located.

Complementing this, high-throughput sequencing rapidly analyzes genes to identify potential drug targets [103]. This has accelerated drug development and, with automation, has helped lower costs compared to traditional, manual methods [104]. For example, high-throughput screening has been used to analyze tumor samples from 125 pediatric patients, identifying their activated genomic alterations and responses to drug treatment [105]. Integrating high-throughput screening into PM has improved biomarker-driven strategies for treating cancer, while automated testing has reduced costs, streamlining the drug development process.

Decentralized healthcare approaches

While PM has traditionally been associated with high-tech, centralized facilities, the integration of decentralized healthcare models is crucial for addressing its inherent challenges of cost and accessibility, particularly in low-resource settings. Mobile health (mHealth), a model that delivers healthcare through telecommunications on smartphones and wearable devices [106], enables professionals to provide services despite geographical barriers. Through remote monitoring, mHealth facilitates continuous data collection, supporting rapid disease diagnosis, prevention, and management, while also reducing medical errors and overall costs [107].

Similarly, telemedicine has grown substantially, providing essential healthcare services via call and video platforms. In the Philippines, for example, it became a vital access point during the COVID-19 pandemic [108], addressing immediate needs while supporting long-term goals for decentralized healthcare. Telemedicine helps physicians gain a holistic understanding of each patient’s life circumstances and supports PM through customized diagnostic and therapeutic approaches [109]. Studies report high patient satisfaction, largely due to its focus on patient-centered communication, enhanced accessibility, and the involvement of family members or support individuals [109, 110, 111]. This shift toward telemedicine also reduces hospital visits, lowers transport costs, and decreases the risk of hospital-acquired infections [112, 113]. However, barriers to its implementation, such as low connectivity, technology illiteracy, and lack of access to devices, can contribute to healthcare disparities [114], highlighting the need to address these limitations to improve telemedicine’s reliability and accessibility, especially in low-resource communities.

The role of global health initiatives

Finally, global health initiatives are instrumental in making advanced healthcare more accessible. The World Health Organization’s Global Health Initiative (GHI), for example, has been crucial in addressing emerging diseases, malnutrition, and maternal and child health in low-income countries [115]. GHI, in partnership with Gavi, the Vaccine Alliance, uses public-private partnerships and multilateral funding to negotiate lower vaccine prices, making them accessible to vulnerable populations [116]. By 2020, Gavi had introduced 200 new vaccine programs to low-income countries, significantly improving vaccination rates among children and expectant mothers [117]. The profound impact of Gavi on public health through its vaccination initiatives demonstrates how global collaboration can make essential healthcare, including preventative measures, more widely available and affordable.

Ethical considerations in the push for personalization

The pursuit of PM raises several ethical dilemmas, particularly regarding unequal access to cutting-edge treatments. Personalized therapies often come with high costs, limited availability, and a need for sophisticated infrastructure, which risks concentrating the benefits of these innovations in high-resource settings. This leaves low-resource countries with inadequate healthcare options, exacerbating health disparities between wealthy economies and LMICs. This divide raises questions about the fairness of personalized treatment applications in the global context and highlights the need to explore the theoretical foundations of these ethical dilemmas to assess the tension between PM and health equity.

One of the primary ethical dilemmas is the unequal access to personalized treatments between populations with different economic standings. Treatments like gene therapies, tailored pharmaceuticals, and personalized diagnostics often require extensive financial resources and advanced healthcare infrastructure, which are typically lacking in LMICs. As a result, affluent populations have priority access to life-saving treatments, while low-resource populations are left with inadequate healthcare options.

Various classical and ethical theories offer unique perspectives on the distribution of healthcare resources. From a utilitarian perspective [16], healthcare policies should aim to maximize overall well-being. Advocates of this view might argue that PM, though expensive, could still be justified if it results in significant health gains for the greatest number of people [118, 119]. However, a utilitarian approach may also prioritize treatments that benefit a larger number of individuals in low-resource settings with common, preventable diseases rather than focusing on costly, niche treatments for individuals in high-resource settings. Marseille and Kahn [16], note that, while utilitarianism has its limitations, it values cost-effectiveness and often supports achieving the most health benefits without exceeding available financial resources. In this context, utilitarianism would prioritize solutions that produce the greatest health impact, such as focusing on public health infrastructure before PM.

On the other hand, Rawls’ theory of justice, specifically the “difference principle” [120], challenges the ethical justification of any healthcare innovation that worsens existing inequalities. This theory posits that inequalities are acceptable only if they benefit the least advantaged members of society [15]. In this case, developing and implementing PM in a way that risks exacerbating health inequalities would be unethical. From a Rawlsian standpoint, PM must be equally accessible to all, with priority given to disadvantaged communities before benefiting those in high-resource settings [14]. Kantian ethics on universality and respect for persons [18] similarly critiques healthcare systems that offer specialized treatments only to those who can afford them. This approach implies a moral obligation for healthcare systems to ensure equitable access, respecting the dignity and rights of every individual [121].

Immanuel Kant’s ethical theory aligns closely with the capabilities approach proposed by philosophers Martha Nussbaum and Amartya Sen. This theory emphasizes the importance of providing individuals with the opportunity to fulfill their potential [122]. In the context of PM, this theory would argue that access to healthcare technologies should not depend on economic factors or resource availability. Instead, governments and institutions should foster environments that enable everyone to achieve their full potential on a global scale. This approach advocates for equal opportunities for all individuals to benefit from PM, encouraging global health policies to be reformed to promote health equity and well-being.

Modern theories of distributive justice, as developed by Norman Daniels, emphasize the ethical imperative to ensure “fair equality of opportunity” in health [14]. This theory asserts that health disparities that prevent individuals from fully participating in society are unjust. In the context of PM, this ethical framework challenges any approach that allows technological advances to widen the gap between vulnerable low-resource populations and high-income groups. It argues that access to personalized therapies and treatments should be distributed equally to promote equitable health opportunities. This perspective supports the idea that technology should be optimized to improve health outcomes for all [123].

These ethical considerations are particularly relevant to address whether personalized healthcare should be prioritized in high-resource economies first. Proponents of this approach argue that these regions can serve as testing grounds for optimizing health treatments due to their resource availability. However, this approach is ethically problematic, as it risks fostering “technological elitism” and widening global health gaps, creating a “biomedical apartheid” that gives high-income populations greater advantages in accessing these technologies over poorer countries. Moreover [124], emphasize that genetic diversity within certain geographic or ethnic groups is more pronounced than between racial categories. Hussein et al. [125] argue that applying PM in regions like Africa requires a more nuanced approach due to the continent’s vast genetic diversity and environmental variation. This view is corroborated by Drake et al. [36], who highlights that genomic advance in high-resource countries cannot represent the entire global population.

From a utilitarian perspective [16], prioritizing high-resource settings might still be justified if the long-term goal is to create scalable, cost-effective treatments that can eventually be applied globally. However, a Rawlsian or capabilities-based approach would demand that healthcare systems ensure equitable access from the outset, enabling the least advantaged populations to benefit from these technologies simultaneously with wealthier populations [14]. This highlights the need for existing governing bodies, global health leaders, and institutions to provide an ethical framework that emphasizes fair distribution and commits to mobilizing strategies that promote health equity in PM.

A critical reassessment of how to manage current ethical dilemmas and healthcare advancements in line with justice, equity, and universal human dignity is essential for all stakeholders involved. This calls for strategic efforts to mitigate existing health disparities and reinforce health policies that balance the distribution of personalized medical interventions. Strengthening collaborations can support the development of PM that serves individuals across socio-economic backgrounds, paving the way for a more inclusive and just healthcare system in the future.

The importance of ethical frameworks in PM is often acknowledged but there is often a lack of concrete guidance on how to operationalize them across diverse cultural and policy landscapes. This is a significant challenge, as ethical considerations are not universal and can vary substantially depending on societal values, norms, and legal structures. To move beyond generalities, we need to focus on developing practical strategies that facilitate the application of ethical principles in real-world settings. Ethical frameworks must be adapted to the specific cultural, social, and political contexts in which PM is being implemented. This requires cultural sensitivity, recognizing and respecting diverse cultural beliefs, values, and norms related to health, illness, and the use of genetic information [126]; policy alignment, aligning ethical frameworks with existing legal and regulatory frameworks, as well as healthcare policies [127]; and socioeconomic considerations, addressing socioeconomic disparities that may affect access to and the benefits of PM [128]. Operationalizing ethical frameworks also requires active participation from all stakeholders, including public engagement, healthcare professional education, industry collaboration, and patient involvement [129]. Furthermore, it involves developing practical tools and mechanisms to support implementation, such as ethical review boards, clear ethical guidelines and protocols, decision-support tools, and mechanisms for monitoring and evaluation [127, 129]. By taking these steps, we can move beyond simply acknowledging the importance of ethics and begin to effectively integrate ethical considerations into the practice of PM across diverse cultural and policy contexts.

Case studies: successes and shortcomings

While the theoretical benefits of PM are clear, real-world examples highlight both the promise and the profound challenges related to health equity. By examining a few representative cases, we can see how ethical and structural issues play out in different settings.

In the United States, PM has led to significant advancements, particularly in targeted cancer therapies. However, this progress illustrates key structural and ethical challenges. The high cost of PM diagnostics and therapies often places them out of reach for many, even with insurance. This creates a two-tiered system where advanced, life-saving treatments are primarily available to those with robust financial resources, directly violating Rawls’s “difference principle” by failing to benefit the least advantaged [14–16]. The economic structure of the healthcare system creates a barrier that undermines the goal of universal access.

On the other hand, the Philippines provides a compelling example of how a developing nation is attempting to leverage decentralized healthcare models to improve access. The country has successfully integrated telemedicine to provide essential healthcare services, particularly during the COVID-19 pandemic. This has been a crucial step toward PM because it allows for customized diagnostic and therapeutic approaches that consider a patient’s unique circumstances, even without in-person visits [108]. Despite these benefits, the document highlights significant barriers to the implementation of telemedicine, such as low connectivity and a lack of technological literacy, which can lead to healthcare disparities [114]. A Kantian ethical perspective would argue that healthcare should be universally accessible. However, without addressing these foundational issues, the promise of telemedicine and PM remains elusive for a large portion of the population.

Moreover, many African countries provide a stark example of the foundational structural barriers that hinder the adoption of PM. The document notes that these nations face underfunded healthcare systems, a shortage of skilled medical professionals, and limited access to basic services [41]. For instance, the lack of genomic laboratory establishment means that countries like Tunisia must often send samples abroad for high-throughput sequencing. Furthermore, there is a “brain drain” where highly trained professionals leave for better opportunities in high-income countries, further straining local healthcare systems [130]. This situation creates a significant ethical dilemma, as the inaccessibility of advanced treatments can be seen as a form of “biomedical apartheid” that widens the global health gap. The lack of resources and political will, as well as the high cost of technologies, mean that the benefits of PM remain largely out of reach, making it challenging to achieve health equity in these regions.

We also mentioned Gavi, the Vaccine Alliance, as a successful example of a global health initiative. Gavi operates through public-private partnerships to negotiate lower prices for vaccines, making them accessible to vulnerable populations and low-income countries [116]. The ethical implication here is one of utilitarianism, where the focus is on maximizing the greatest good for the greatest number of people [16]. Gavi’s approach demonstrates that by prioritizing collective well-being and establishing a cooperative framework, it is possible to bypass market failures and ensure that life-saving medical innovations reach those who need them most [117].

Most importantly, highlighting the disparity in PM between HICs and LMICs is essential to achieving health equity. A comprehensive approach addressing the social, economic, and political factors that impact the healthcare system is needed. In addition, opportunities such as external research funding and government collaboration with non-profits or private corporations could jumpstart the implementation of PM in LMICs, providing them with funds, healthcare worker training, and access to advanced diagnostic technologies. Through collaborative efforts and innovative partnerships, it is possible to implement PM even in low-income countries, ultimately improving health outcomes and access to new therapeutics.

Proposals for policy and structural changes

To address the disparity between PM and health equity, policy changes are necessary to ensure that healthcare services offered by PM are accessible and affordable, especially for LMICs. Bridging the gaps between current health inequities and the potential of PM requires a collective effort from socio-political stakeholders and healthcare professionals. Existing global health initiatives can be expanded and improved to better address and adapt to local needs and resources, supporting equitable access to personalized care.

For example, the International Consortium for Personalized Medicine (ICPerMed) is composed of experts who aim to foster initiatives focused on healthcare system improvement, medication market access, and patient empowerment [131]. Since its launch in 2016, the consortium has created and developed numerous action plans, frameworks, and funding roadmaps designed to support both local and international research, education, and innovative solutions. This collaboration across different sectors promotes and helps accelerate the development and implementation of PM. In 2020, ICPerMed outlined five key perspectives as a framework to guide PM initiatives over the next 10 years with the goal of achieving both PM and health equity. These perspectives include promoting individual and community mobility, engaging the healthcare workforce actively, integrating PM practices, expanding health-related data, and ensuring economic sustainability to support improved PM approaches [132].

ICPerMed also suggests specific strategies, such as developing IT solutions for big data collection, management, and sharing, as well as providing comprehensive education and skills training for everyone, including healthcare providers. According to Pastorino et al. [133], the collection of patient data in healthcare is the first step toward improving disease prevention and patient care quality. Big data, encompassing patient information from electronic health records, genomic testing results, prescriptions, and imaging results, is now an integral part of PM, helping improve efficiency, reduce diagnostic errors, and lower treatment costs (Badr et al., 2024). To execute this vision and overcome the barriers between PM and health equity, the following recommendations should be considered:

Educational reform

Educational institutions in HICs are actively reforming their academic and training programs to incorporate PM, preparing future healthcare professionals to use a patient’s unique genetic information and data for tailored prevention and treatment. This shift requires a unified approach that integrates diverse fields like genetics, bioengineering, and information technology. Unlike traditional practices, PM demands cross-disciplinary collaboration to enhance precise treatments, provide a comprehensive understanding of patient needs, and strengthen the modern global healthcare system [134].

Academic programs are being redesigned to provide a strong foundation in genetics and genomics, data analysis, and practical application. This ensures the development of a well-rounded and skilled workforce capable of optimizing healthcare outcomes through PM.

For example, Yale University launched a new graduate program in 2022, offering a Master of Science in Personalized Medicine and Applied Engineering. This program reflects the need to build capacity among the next generation of healthcare and engineering professionals focused on improving personalized patient care [135]. Similarly, in the US, initiatives like the Precision Medicine Initiative’s All of Us Research Program have spurred significant curriculum changes. Leading institutions like the University of Florida and Vanderbilt University Medical Center have established new departments and degree programs, including master’s and fellowship tracks, specifically for PM [136–138].

In the United Kingdom (UK), the Genomics England Initiative and the 100,000 Genomes Project have been major catalysts. Medical schools and Health Education England have collaborated to create comprehensive training programs to upskill the entire healthcare workforce—from general practitioners to specialists—in genomic medicine [139]. Moreover, several UK universities, including the University College London [140] and the University of Edinburgh [141], now offer post-graduate programs in precision medicine. This continuous effort to integrate genomics, pharmacogenetics, and bioinformatics into curricula and specialized training programs is crucial for both new and existing health professionals [142].

In contrast, educational reforms for PM are still in their infancy and largely underdeveloped in LMICs. This is mainly due to a lack of initiatives from local institutions, limited funding, and insufficient infrastructure. According to Yamey [130], implementing reforms in LMICs is often halted due to the lack of political will or interest. This can be due to a focus on addressing more immediate public health challenges and a general hesitation to invest in new, complex fields. In many cases, health policy decisions are driven by political considerations rather than data on effectiveness and cost.

Additionally, a significant lack of awareness, training, and education among healthcare providers and the general public presents a major barrier to redesigning educational systems [143]. Even when some training is available, it can lead to a “brain drain” where newly trained experts in PM leave for better-funded positions in HICs, further hindering local progress. Strong hesitancy among medical practitioners regarding the adoption of PM is also evident. Often overlooked in traditional medical education, recent literature notes that only 21% of discussions on the principles of PM are included in medical school curricula [144]. This likely contributes to the lack of awareness and doubts surrounding the application of PM in clinical practice.

Thus, reforming medical curricula to introduce the principles and concepts of PM is essential. In addition, other allied health programs play a crucial role and must also incorporate education on the effective application of PM into their focus and practices. Within this evolving landscape, healthcare workers must be able to meet the demands of the modern healthcare system. Even Spanakis et al. [145] suggest that nursing education should adapt to the changing healthcare environment by advancing expertise in genomics, mathematics, statistics, ethics, and information and communication technologies. This approach will ensure that safe, well-informed, and effective personalized nursing care can be delivered. Similarly, introducing these transdisciplinary foundational courses at an early stage in nursing education will support the expansion of nursing roles in personalized healthcare.

Finally, implementing health literacy campaigns to promote public awareness can also improve perceptions of PM. These campaigns encourage community engagement and openness to professional healthcare, helping remote communities understand and reduce misconceptions about medical interventions, ultimately promoting better health [146].

International collaboration

In promoting global health equity, international collaborations are essential. Establishing strong relationships between governments, experts, and international organizations is recommended to accelerate equitable access to PM. Multilateral agreements between developed and developing countries can foster inclusive progress through resource sharing in technology, knowledge, and innovations. Global initiatives like ICPerMed illustrate this potential by creating a platform for dialogue to drive advancements in personalized healthcare. Additionally, partnerships between countries that have already integrated PM into their healthcare systems can support those still facing adoption challenges through exchange programs and training, where both sides benefit from gaining insights into potential challenges in PM and how to address them efficiently.

Resource allocation and research and development

For many countries, the cost of PM is the most challenging barrier to overcome. Addressing this challenge requires a comprehensive approach. While the long-term solution involves economic evaluation and a reassessment of priorities in government resource allocation, immediate actions are also essential.

Governments are encouraged to prioritize funding for the healthcare sector, along with research and development, to improve strained healthcare systems, particularly in LMICs. Partnerships with private sectors are equally important to accelerate innovative solutions. Industry stakeholders, policymakers, and other governing bodies serve as primary facilitators who can mobilize and ease the implementation of PM. The health and well-being of the community must, and should always, be the top priority. Existing global health initiatives from international organizations, such as ICPerMed and the World Health Organization, offer frameworks that can serve as practical guidelines for governments and other key stakeholders to take action. These initiatives can help build a more resilient healthcare system and achieve health equity.

Yet, political will and supportive government policies are the most critical factors for implementing PM in LMICs. Without a strong political commitment, PM is often viewed as an unaffordable luxury, overshadowed by other pressing health concerns. A government’s role is to place PM on the national health agenda by creating a strategic roadmap that prioritizes key areas, invests in essential infrastructure like genomic data centers and biobanks, and develops the necessary workforce through funded educational programs. This political resolve is also vital for attracting and managing external resources, enabling effective partnerships with international organizations and the private sector to accelerate research, build local capacity, and secure funding.

Furthermore, a government’s commitment is essential for establishing the regulatory and ethical frameworks required to govern PM. Policymakers must create clear pathways for the approval of new PM technologies and enact robust data privacy laws to prevent genetic discrimination and protect sensitive patient information. This includes developing ethical guidelines for informed consent and ensuring that PM technologies are accessible to all citizens, regardless of their socioeconomic status. By taking these decisive steps, governments can build the necessary foundation for a resilient healthcare system, turning the promise of PM into a reality that benefits the entire population and promotes health equity.

However, changes in political leadership, resource allocation, and healthcare priorities can critically undermine the adoption of PM in LMICs. Since PM requires sustained, long-term investment, a shift in government can abruptly stall or reverse progress if a new administration does not share the same vision. This political instability can lead to the diversion of crucial funds, leaving expensive infrastructure underutilized and causing a “brain drain” as trained professionals seek more stable opportunities elsewhere. Furthermore, a new government might reprioritize healthcare toward more immediate, broad-based interventions, framing PM as an inaccessible luxury and weakening the ethical and regulatory frameworks necessary for its responsible and equitable implementation. Ultimately, a lack of political continuity erodes the trust of international partners and private investors, making it difficult to secure the sustained support needed for PM to succeed.

To address the instability caused by changes in political leadership and priorities, the adoption of PM must be institutionalized, its funding diversified, and public and expert advocacy strengthened. This means establishing a semi-autonomous national PM agency and enacting bipartisan legislation to embed PM as a permanent part of the national healthcare framework, making it less vulnerable to political turnover. Simultaneously, a robust and resilient funding model can be built by moving beyond sole reliance on government budgets, forging legally binding public-private partnerships, and securing long-term support from international and philanthropic organizations. Finally, cultivating a strong base of public and expert support through awareness campaigns and a coalition of advocates will create a non-partisan mandate for PM, ensuring its long-term viability and protecting it from short-term political shifts [147].

Maximizing new technology

Technology has become an indispensable tool for positively transforming healthcare and addressing significant challenges and barriers [148]. The hallmarks of PM rely on technological innovations and advancements. Tools like AI and ML help streamline the work of healthcare providers, easing the considerable burden this new approach places on an already strained healthcare workforce. Effective data utilization is crucial in PM, but concerns over data security persist among various stakeholders [149, 150]. To address these concerns while maximizing technology’s potential, federated learning offers a privacy-preserving approach. Rather than sharing raw data, federated learning allows healthcare systems to build and refine predictive models collaboratively by processing data locally on devices, ensuring that sensitive patient information remains secure and never leaves its original location [151].

More recently, technology has effectively expanded the reach of healthcare services. Telemedicine and mHealth exemplify how technology can bridge PM and health equity by facilitating accessible interactions between providers and patients. This approach enables people from underserved locations and the broader community to access specialized care more easily. As technology continues to evolve, harnessing its full potential can significantly enhance the inclusivity of PM personalized medicine, promoting better health outcomes across diverse populations.

Bridging the gap between health equity and PM requires a multi-faceted approach, involving policy reform, educational development, international collaboration, and strategic technology use. Socio-political stakeholders must prioritize equitable access to PM, especially in low-resource populations where health disparities are often more pronounced. Building on GHIs like ICPerMed fosters collaborative efforts that support patient empowerment and sustainable healthcare practices. Reforms in educational curricula and government legislation promote learning, innovation, and more accessible healthcare. Partnerships across the globe are also essential; building meaningful relationships can enhance and facilitate the implementation of PM through resource sharing. Finally, the strategic use of technology like federated learning can streamline complex processes, reduce healthcare system strain, protect patient data privacy, and broaden healthcare access by removing geographical barriers to equitable care.

These concerted efforts can substantially ease the gradual removal of existing barriers to health, building capacity for a more resilient and accessible healthcare system. With full commitment and consistency in implementing these strategies, the healthcare landscape can transform, making PM and health equity a reality for all, regardless of socio-economic status or geographical location.

Conclusion

Promising new paradigms in healthcare lose their value when they cannot serve all individuals equitably. To move toward a balanced future, we must address a critical question: can these advancements coexist with a commitment to health equity? This paper has highlighted several challenges hindering the full realization of PM and the risks it poses in potentially increasing health disparities. LMICs, in particular, face numerous healthcare barriers, and the added demands of PM, such as high costs, robust infrastructure needs, and capacity requirements, further complicate accessibility. Without intervention, PM may remain an advantage for countries with strong economies, leaving LMICs to grapple with an even greater healthcare equity gap.

To address this issue, transdisciplinary stakeholders must make decisions to ensure that PM is implemented with health equity at its core. Figure 1 illustrates transdisciplinary approaches to establishing PM in healthcare with a central focus on health equity. Achieving this goal requires concerted efforts from policymakers, industry, world leaders, and healthcare providers to mobilize and strategically develop sustainable solutions that create a more inclusive landscape for PM adoption. These efforts include significant financial investments, strong partnerships, and ethical frameworks to enhance the capacity of LMICs. Expanding education and training, leveraging innovative technologies, and enacting legislation to maintain accessible and affordable PM services will also help mitigate disparities while maximizing the benefits of this healthcare advancement. Achieving health equity within PM requires meaningful collaboration and sustained efforts from all stakeholders.

Fig. 1.

Transdisciplinary framework for equitable PM . This transdisciplinary framework for health equity in PM positions health equity as the core guiding principle for the realization of equitable personalized healthcare. The model divides its five interconnected pillars into foundational and practical elements essential for building an inclusive and resilient healthcare system. On the left side, policy and reform and education and training represent foundational elements that equip healthcare providers and other stakeholders with the necessary knowledge, awareness, and skills to implement accessible PM. Policy reforms help remove financial and regulatory barriers, while targeted education develops a skilled workforce and enhances public health literacy. On the right side, technology and innovation and collaboration offer practical solutions to directly support the delivery and accessibility of PM, addressing ongoing challenges in health equity through advanced tools like AI and big data, alongside resource-sharing partnerships between governments, industry, and organizations. At the top, PM integrates these foundational and practical elements to ensure precision diagnostics and treatments reach diverse populations. Together, these five pillars create a comprehensive, transdisciplinary approach to align PM with health equity, fostering an inclusive and sustainable global healthcare system

While this paper centers on health equity within PM, it is important to acknowledge existing barriers that continue to obstruct low-resource populations from accessing healthcare. Often overlooked in favor of new innovations, these challenges must be recognized and addressed. If current issues are not resolved, an already strained healthcare system will be unable to integrate PM effectively, calling for immediate action from global stakeholders. Figure 2 explores the relationship between PM and health equity, highlighting key areas where disparities persist and opportunities for improvement exist. Future studies must focus on practical and innovative solutions that address the financial and infrastructural limitations faced by LMICs. Developing frameworks to make PM sustainable and more affordable is essential. Health equity can then be achieved, putting the vision of improved health for everyone within reach.

Fig. 2.

Conceptual tensions between PM and health equity. This infographic illustrates the promise of PM in tailoring treatments through genomic and lifestyle data, contrasted with the systemic barriers to equitable access, including high costs and ethical dilemmas. It highlights how cost burdens and uneven infrastructure can exacerbate health disparities, underscoring the need for justice-centered policies and global collaboration to align innovation with equity

The three themes: justice and resource allocation, trade-offs between benefit and access, and societal responsibility are the most salient ethical considerations because they are directly addressed and interpreted by the ethical frameworks in the document. Justice and resource allocation are fundamental, as the high cost of a single PM drug can drain an entire national healthcare budget, which is unjust from a Rawlsian perspective. The document highlights the trade-off between benefit and access with the example of the UK's National Health Service (NHS) stopping funding for trastuzumab, which forces a choice between providing significant benefits to a few and ensuring broader access to care. Finally, the theme of societal responsibility is established by Kantian ethics, which implies a moral duty to provide universal access, and Norman Daniels’s work on fair opportunity, which frames access to health as a prerequisite for social participation. These frameworks transform the ethical debate from an issue of individual choice to a collective obligation.

Lastly, this analysis of PM through the lenses of Rawls’s “difference principle,” Kantian ethics, and utilitarianism reveals a central ethical tension: PM's potential for immense benefit is currently at odds with the goal of achieving health equity. The current trajectory risks creating a “two-tiered” healthcare system where only the wealthy can access life-saving innovations, thereby undermining the principles of justice, universal dignity, and the greatest good for the greatest number. The core dilemmas revolve around how to manage the high costs of PM without diverting resources from foundational public health services, and how to balance providing significant benefits to a few with ensuring equitable access for all. To navigate these ethical challenges, we suggest a multi-faceted approach centered on actionable policy recommendations. This includes policies that lower the cost of PM to ensure equitable access, strengthening universal health coverage and foundational health infrastructure as a prerequisite for social participation, and integrating ethical evaluation tools like the HEIA into the policymaking process. By embedding these ethical considerations, there would be a more just and equitable path for PM.

Limitations

We recognize several important limitations that may affect the scope and applicability of our findings. Foremost, this research is predominantly theoretical in nature, relying extensively on secondary literature rather than incorporating original empirical data. Although we have drawn upon a wide range of interdisciplinary sources and global case studies to construct a robust and multifaceted analysis, the absence of first-hand data collection limits our ability to validate the practical relevance and effectiveness of the proposed strategies. This limitation underscores the need for future empirical studies that can test and refine these recommendations in real-world settings.

Furthermore, our exploration of PM implementation across different socio-economic contexts remains largely conceptual. This includes the potential limitations of applying Western-centric ethical frameworks, such as those of Rawls and Kant, to diverse cultural and political contexts within LMICs, where different values and social structures may require alternative ethical considerations. While we have aimed to identify key considerations and potential challenges, further research is required to critically examine how these approaches perform within specific cultural, political, and healthcare environments, particularly in LMICs, where resource constraints and infrastructural disparities may significantly influence feasibility and outcomes.

Author contributions

Conceptualization by K.K.Y.F., A.E.C.A., M.J.T.T.; funding acquisition by H.R.K.; methodology by K.K.Y.F., A.E.C.A.; project administration by N.A., H.R.K., M.J.T.T; writing—original draft preparation by K.K.Y.F., A.E.C.A. N.M.A.T.M., M.C.B.; writing, review and editing by N.M.A.T.M., N.A., H.R.K., M.J.T.T.

Funding

The publication of this article was funded by Multimedia University, Malaysia.

Data Availability

No datasets were generated or analysed during the current study.

Declarations

Ethical approval

Not applicable.

Competing interests

The authors declare no competing interests.