Affordability and funding barriers

Affordability is one of the key barriers to access. However, there are many root causes behind this challenge, depending on where the inability to pay comes from (i.e., at the system or at individual level) and what aspect of care is unaffordable (i.e., the product itself, health insurance, etc.).

High out-of-pocket costs – In some countries, particularly LMICs, national payer institutions may not have enough resources to cover the full cost of healthcare services, leaving patients with the burden of paying for their treatment themselves. In private-based markets, insurance may be strongly exclusive, making it even more difficult for low socioeconomic-status groups, who may not benefit from broad coverage and have limited or no coverage for some healthcare services, such as specialized treatments or procedures.

Prohibitive cost of diagnosis – High costs of diagnosis can raise barriers for patients to access the treatments they need. For example, precision medicine may require genomic testing, a complex and specialized type of diagnostic testing that analyzes a patient's genetic material to identify potential disease risk, genetic mutations, or other factors that may impact their response to treatment. These tests can be costly, ranging from hundreds to thousands of dollars per test.

Prohibitive indirect costs – Receiving healthcare services often involves additional costs, such as transportation, childcare, time off work, and other related expenses. For example, the cost of transportation to a medical appointment or taking time off work can be prohibitive (especially in cases where treatment requires multiple appointments or procedures), leading to missed appointments and delayed care. This particularly impacts low socioeconomic-status groups, for whom the relative financial and logistical burden might be greater, as well as people living in remote areas, for whom the time and cost to physically access services are more important.

Healthcare delivery system barriers

Insufficient healthcare delivery systems and infrastructure create barriers to access, even if the drug is registered and reimbursed in a given country. For this reason, it is critical to ensure that the underlying challenges related to the healthcare system itself are understood and addressed to ensure patients are prescribed and can access treatment. Barriers include:

Lack of or insufficient healthcare infrastructure – The lack of appropriate facilities and trained clinicians or specialists needed to deliver treatment is a systemic challenge in low-resource settings, which creates inequity across countries, but also within countries, as rural populations are often far from hospitals or specialized centers of care.

Lack of advanced capabilities and competencies – Healthcare systems may not be equipped with advanced technologies to be able to treat patients using the latest advances in medical innovation. For example, the expansion of precision medicine in LMICs has been limited because these countries often lack advanced diagnostic capabilities (e.g., genomic testing).

Complex and uncoordinated healthcare systems – Healthcare systems are often challenging and time-consuming for patients to navigate (i.e., obtaining an appointment, finding the right clinician, ensuring communication between practitioners, etc.). This is often due to the fragmented nature of health system organization and lack of data sharing between facilities, but can result in patients not seeing the right specialist, the specialist not having the correct information to make a proper diagnosis, or patients giving up altogether, reducing the benefits patients can derive from care.

Patient-level barriers

Patients’ backgrounds and behaviors can raise major barriers to access, potentially influencing patients’ willingness and/or ability to connect to the healthcare system and receive the care they need.

Lack of trust – Mistrust and distrust of the healthcare system and medical professionals can drive patients to delay or avoid seeking care. Persistent stigma related to race and ethnicity, gender, sexual orientation, or socioeconomic background results in unwillingness from concerned patient groups to engage with the health system. For example, the stereotype that Black people have a higher pain tolerance leads to racial biases in pain assessment and negatively affects pain management for Black patients².

Lack of understanding and awareness – Poor health literacy, referring to a patient’s ability to understand common healthcare communications (such as prescription instructions or test results)³, leads in most cases to delayed treatment, suboptimal outcomes, or missed care opportunities, and is persistently associated with low socioeconomic status (SES). In fact, once people become ill, chronic conditions are more likely to persist and progress in people with low SES backgrounds⁴. Another challenge is lack of treatment adherence. Glaucoma, for instance, requires rigorous treatment practices (i.e., daily eye drops), with nonadherence leading to disease progression and blindness in the long term, without triggering any short-term symptoms.

Limited autonomy – Certain pathologies can diminish a person’s autonomy (e.g., cause cognitive and/or physical difficulties) or affect populations with already limited autonomy (e.g., children or the elderly), creating challenges for patients to reach healthcare facilities or adhere to treatment regimens. The lack of available caregivers to accompany patients to visits and support them with treatment compliance may be an aggravating factor. For example, Parkinson’s disease, which highly affects elderly people, causes motor difficulties and a loss of autonomy in daily life, leading to a strong dependency and high burden on caregivers⁵.

Drug and treatment design barriers

The treatment design itself can present significant access hurdles.

Narrow indications – When developing a medication, pharmaceutical companies study a limited set of conditions and diseases. Consequently, indications for which treatments are approved may not cover all patients who could potentially benefit from them. Additionally, indications might remain understudied among certain patient groups, resulting in safety and efficacy evidence gaps, and ultimately to HCPs’ reluctance in prescribing the treatment. For instance, comorbidity exclusion criteria in clinical trial participation makes it challenging for clinicians to determine how to interpret trial findings in people with multimorbidity.

Burdensome protocol of treatment – Treatment burden (e.g., high frequency of administration, lengthy protocol duration, significant adverse effects, etc.) can create substantial hurdles as well. For instance, age-related macular degeneration (AMD) commonly affects older patients with limited autonomy, but the treatment protocol imposes a constraining schedule and frequent injections, therefore intensifying patients’ dependency on caregivers. These factors put patients’ ability to properly adhere to the treatment at risk, potentially leading to suboptimal outcomes.

Health system institutional barriers

The peculiarities of health system institutions may intensify access challenges in LMICs. Institutional barriers can lead to pharmaceutical companies encountering difficulties, delays, or an inability to launch products in LMICs.

Lack of regulatory framework – In LMICs, healthcare systems can have limited regulatory resources and capabilities, resulting in undefined or unclear access guidelines. In addition, launch processes may not be standardized or adapted for innovative therapies. This creates an uncertain and lengthy regulatory environment, which is rendered even more challenging given pharmaceutical companies’ often limited resources and capabilities in these countries (e.g., small local subsidiary with limited expertise). This can cause pharmaceutical launches in LMICs to be delayed, postponed, or abandoned.  

Absence of patent protection policies – Restrictive patent filing and granting procedures (e.g., limited patent coverage, strict patent application requirements), a lack of patent protection enforcement (e.g., suboptimal judicial system capabilities, no linkage mechanisms), and compulsory licensing (e.g., domestic industry favoring) may create reluctance among pharmaceutical companies to launch innovative medicines, compromising patients’ timely access to safe and effective medicines.

Protectionism laws favoring local manufacturers – In certain countries, pharmaceutical launch is conditioned to country requirements regarding manufacturing: local production (i.e., relocation of the manufacturing line locally, with or without tech transfer) can be a mandatory condition. The need to build additional manufacturing capabilities constrains pharmaceutical companies and launches as it requires massive investments.