Antibiotic resistance is the third leading cause of death, globally, claiming almost 5 million lives every year, with this projected to increase …
Bridging the Gap: Access to Medicines in Low- and Middle-Income Countries
Bridging the Gap:
Access to Medicines in Low- and Middle-Income Countries
By Stuart Bell, Executive Vice President, Inceptua Early Access & Paul Stanton, Senior Director, Global Strategy, Inceptua Eary Access
Around two billion people (nearly one-third of the global population) lack regular access to essential medicines (1). In some of the world’s poorest regions, particularly parts of Africa and Asia, more than half the population is affected (2). This stark inequity is not just a health crisis; it’s a structural challenge that erodes global development, human rights, and the promise of Universal Health Coverage (UHC).
The Uneven Landscape of Access
The availability of generic medicines, often the most affordable option, varies dramatically by region. A recent multi-region analysis found that public-sector availability of generics ranged from just 37.8% to 68.3%, while private-sector availability was only slightly better, at 42.3% to 77.4% (3). These shortages are not just logistical; they are structural drivers of inequity.
The WHO’s UHC Service Coverage Index, which includes access to essential medicines as a core tracer, reveals the extent of the problem. While high-income countries typically score between 80 and 95, many low- and lower-middle-income countries fall far below, with scores at or under 65. That threshold signals that a country is delivering less than two-thirds of the essential services needed for universal coverage (4). Globally, around 1.5 billion people live in countries with UHC scores at or below this level.
Innovation Without Inclusion
The inequity extends beyond current access to future innovation. Clinical trials and pharmaceutical R&D remain heavily concentrated in high-income countries. While low- and middle-income countries (LMICs) host about 43% of global clinical trials, only 3.6% occur in low-income countries. (5) This means that many new therapies are not tested (or introduced) in the places that need them most.
Early Access Programs: A Practical Bridge
Early Access Programs (EAPs) (also known as compassionate use, expanded access, or managed access) offer a pragmatic, if partial, solution. These programs allow patients to receive promising therapies before full regulatory approval or reimbursement decisions are finalized, and some therapies which may never be approved in that country.
Why EAPs Matter:
- Pre-approval supply: Patients with serious or rare diseases can access treatment months or years earlier.
- Bridging to registration: Real-world data from EAPs can accelerate regulatory and reimbursement decisions.
- Support for HTA: EAPs generate evidence that informs health technology assessments and national formularies.
- Equity for rare conditions: In markets where a full commercial launch is unlikely, EAPs provide a legal, controlled access route.
- Flexible pricing: Programs may offer medicines free-of-charge or at a cost (often set by the manufacturer), bypassing lengthy pricing negotiations.
- Open-ended provision: In some markets, through Early Access mechanisms, it is possible to provide open ended provision, wWhere no commercialization is planned.
The Limits of EAPs
While EAPs can save lives and reduce inequity, they are not a systemic fix. They serve as an interim solution, helping to provide timely access to critical therapies while countries continue to strengthen the infrastructure, financing, and procurement systems needed for long-term, sustainable access.
To maximize their impact, EAPs must be:
- Supported by clear national regulationswith simple application processes.
- Linked to data-sharing agreementsto inform regulators and payers.
- Backed by public–private partnershipsfor logistics and pharmacovigilance.
- Aligned with WHO Essential Medicines Liststo prioritize high-impact therapies.
A Time-Buying Mechanism, not a Cure
EAPs cannot close the global treatment gap alone. But when well-designed, they offer a critical bridge, delivering life-saving medicines faster, generating data for broader adoption, and highlighting where systemic improvements are most urgently needed.
In the long run, equitable access to medicines must be embedded in national health strategies, supported by robust financing, and underpinned by global solidarity. Until then, EAPs remain one of the most practical tools we have to ensure that innovation reaches those who need it most, without delay.
References
1 . https://www.emro.who.int/essential-medicines/strategy-access/
2. Yenet, A., Nibret, G., & Tegegne, B. A. (2023). Challenges to the availability and affordability of essential medicines in African countries: A scoping review. https://pmc.ncbi.nlm.nih.gov/articles/PMC10276598/
3. Oldfield, L., Penm, J., Mirzaei, A., & Prof Moles, R., (2025) Prices, availability, and affordability of adult medicines in 54 low-income and middle-income countries: evidence based on a secondary analysis. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(24)00442-X/fulltext
4. https://data.who.int/indicators/i/3805B1E/9A706Fd
Antibiotic resistance is the third leading cause of death, globally, claiming almost 5 million lives every year, with this projected to increase …
Antibiotic resistance is the third leading cause of death, globally, claiming almost 5 million lives every year, with this projected to increase …