Institute Report
Key Access Pathways and Bottlenecks for Medicines in LMICs
Data Insights into Recently Launched and Established Medicines
Jun 24, 2025

Report Summary:

Access to medicines is a cornerstone of equitable healthcare and a critical determinant of health outcomes, particularly in low- and middle-income countries (LMICs), which are home to over 80% of the global population. These countries face a disproportionate burden of both communicable and non-communicable diseases, making timely access to effective treatments essential for improving population health, reducing mortality, and addressing health disparities.

Ensuring the availability of both recently launched medicines and established essential medicines in LMICs is a matter of public health and a key factor in achieving global health equity and meeting national health targets and international development goals, such as Universal Health Coverage (UHC) and the United Nations Sustainable Development Goals (SDGs). However, significant barriers — ranging from regulatory challenges and reimbursement to supply chain inefficiencies and national infrastructure and capacity — often limit access to these medicines, delaying or denying treatment to millions of patients. Addressing these challenges and bottlenecks is vital for fostering healthier, more resilient communities worldwide.

This report evaluates select access pathways for two types of medicines in 18 LMICs. One, the “recently launched” analyses focus on medicines first launched globally between 2013 and 2022. Two, the “established” analyses focus on a selection of medicines from the 2023 version of the WHO Essential Medicines List (EML) excluding - among others - the “recently launched” entries. The analysis examines several factors that influence drug availability and accessibility: whether these medicines are registered locally, included on national essential medicines lists, reimbursed by healthcare systems, or sold in-country. The number of countries with quality data varies for each measure.

By identifying gaps in these areas, the study highlights potential bottlenecks in the drug access process that may contribute to inequities both within and across nations. These findings aim to provide key data to support discussions around these bottlenecks as well as success stories and inform strategies to improve access to essential and recently launched medicines.

Key Findings:

  • While four of 14 LMICs analyzed have registered over half of the established medicines and all countries have over 100 registrations from the sample, recently launched medicines are not widely registered in these LMICs. The exceptions are Brazil (293) and Mexico (200) where 40% and 34% respectively of the 593 recently launched medicines are currently registered.
  • None of the analyzed 17 National EMLs (NEMLs) contains a significant number of recently launched entries, where only three NEMLs have more than 10 recently launched medicines. Six of the 17 analyzed NEMLs contain more than 50% of the established drugs, noting that the established sample is based on a selection of drugs listed on the WHO EML.
  • Reimbursement of recently launched medicines is uncommon in LMICs. Of ten reviewed countries, the reimbursement lists of only two include over 100 (of 593) recently launched medicines each, while the other LMICs’ lists include less than 30 each. Additionally, from the 217 medicines on at least one reimbursement list, most (66%) are found in only one country, while 4% are in the lists of over half of the seven LMICs analyzed.
  • The number of medicines sold varies significantly across the analyzed countries, with 0-34% range for the recently launched and 19-52% range for the established analyses. Five countries saw sales of over 100 of the 593 recently launched medicines. In parallel – apart from one country – all LMICs saw sales of over 100 of the 477 established medicines. On the lower end, in four countries either no recently launched medicines were sold or only one or two had reached them.
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