Access to Medicines Still Uneven in South-East Asia, Finds WHO Regional Report

The World Health Organization’s report “Access to Medical Products in the South-East Asia Region”, developed in collaboration with the WHO Regional Office for South-East Asia, the National Institute of Health Research and Development (Indonesia), the Institute of Public Health (Sri Lanka), and the Indian Council of Medical Research, offers a comprehensive examination of how the region’s nations are striving to ensure that lifesaving medicines, vaccines, and medical technologies reach everyone who needs them. The report captures a complex landscape of achievements and ongoing struggles, from India’s world-class generic drug industry to the smaller nations still dependent on imports. Despite notable progress toward universal health coverage, deep inequities remain, largely shaped by regulatory weakness, affordability challenges, and market inefficiencies. The WHO frames equitable access not as a privilege, but as a moral and developmental obligation fundamental to achieving the Sustainable Development Goals (SDGs), particularly SDG 3 on health and well-being.

The Uneven Terrain of Access and Affordability

Home to over a quarter of the global population, the South-East Asia Region (SEAR) remains marked by stark contrasts in access to medical products. Countries like India, Thailand, and Indonesia have developed strong domestic pharmaceutical sectors, while others, such as Bhutan, Nepal, and the Maldives, depend heavily on imported medicines and diagnostics. The report underscores that availability alone is not enough; affordability and quality assurance are equally vital. High out-of-pocket spending continues to plague most SEAR countries, with many households facing catastrophic health costs for essential medicines. Weak procurement systems, fragmented supply chains, and a lack of pooled purchasing mechanisms often lead to inflated prices. WHO recommends strengthening public procurement practices, ensuring transparency in pricing, and adopting pooled buying systems that can drastically reduce costs and improve supply predictability. The report stresses that access inequities are not just economic failures but reflections of systemic governance gaps that demand political attention.

Regulating for Trust and Quality

One of the report’s most crucial insights is that access without quality can be dangerous. Regulatory systems, the report notes, are the backbone of trust in health care. Yet in much of South-East Asia, regulatory capacity remains limited. According to the WHO’s benchmarking, most national regulatory authorities are still operating at Level 2 maturity, meaning they have foundational systems but lack the full ability to perform oversight effectively. India’s Central Drugs Standard Control Organization (CDSCO) and Thailand’s Food and Drug Administration are cited as regional leaders, while countries like Myanmar, Timor-Leste, and Bhutan are still building basic surveillance and licensing frameworks. A chart in the report vividly depicts this disparity. WHO advocates for regional harmonization through the South-East Asia Regulatory Network (SEARN), a mechanism to align standards, promote information sharing, and facilitate mutual recognition. Strengthening regulatory science and embracing digital tools like e-registration and pharmacovigilance databases are presented as essential steps toward eliminating substandard and falsified products.

Innovation, Intellectual Property, and Public Interest

The report delves deeply into the interplay between innovation, intellectual property rights (IPR), and access. It urges governments to balance the protection of innovation with the right to health. The document reaffirms the importance of flexibilities under the WTO’s TRIPS Agreement, which allow countries to issue compulsory licenses or import generics in public health emergencies. Thailand’s experience in using these provisions to expand access to antiretroviral drugs is held up as a model of political courage. However, the WHO warns that new trade and investment agreements increasingly include “TRIPS-plus” provisions that could limit such flexibilities and raise medicine prices. It calls for health impact assessments before signing any new trade deals, ensuring that economic interests do not overshadow public health imperatives. Innovation, the report argues, must serve people, not just profits, and must be guided by the principles of equity and sustainability.

Beyond Medicines: Devices, Diagnostics, and the Fight Against Counterfeits

Expanding the lens beyond pharmaceuticals, WHO explores the underdeveloped regulatory systems for medical devices and diagnostics, describing them as “the silent enablers of modern healthcare.” Unlike medicines, devices in many SEAR countries are poorly classified, allowing substandard products to flood markets. India and Thailand are singled out for pioneering device-specific legislation, but the region as a whole lacks harmonized frameworks. The report emphasizes that strengthening post-market surveillance and regional coordination could improve both safety and efficiency. Another major concern is the proliferation of substandard and falsified (SF) products, which WHO estimates account for up to 10% of circulating medical products in low- and middle-income countries. A regional map in the report reveals clusters of SF incidents along trade corridors between India, Myanmar, and Thailand. The WHO Global Surveillance and Monitoring System (GSMS) is credited with helping track and disrupt illegal supply chains, yet weak enforcement remains a recurring obstacle. The report calls for digital traceability systems and cross-border data-sharing to safeguard patient trust and public safety.

A Call for Regional Solidarity and Systemic Reform

In its closing chapters, the report strikes a tone of measured optimism. It praises the region’s progress in developing policy frameworks, strengthening regulatory institutions, and improving manufacturing capabilities. However, it warns that without sustained political will, investment, and cooperation, gains may not be sustainable. The WHO advocates for a “whole-of-system” approach, one that integrates affordability, innovation, and quality into a single policy vision. It also frames access to medical products as an expression of regional solidarity, urging governments to act collectively to ensure no country is left behind. In its final lines, the report makes a moral appeal: access to safe, effective, and affordable medical products is not merely a technical matter, but a test of social justice and governance. Ensuring that right, it concludes, is the truest measure of a region’s commitment to health equity and human dignity.