Asia’s rise as a clinical trial region is often presented as a success story, and there is truth in that. The region offers large and diverse patient populations, growing scientific capacity, lower trial costs than the United States or Europe, and disease profiles that are highly relevant to global health needs.
Malaysia, too, is seeking to position itself as a serious and credible regional hub with links to domestic manufacturing. But a harder question now demands attention: when more clinical trials come to Asia, will the people of Asia gain fair and affordable access to the medicines they help test? Once we accept that Asia is becoming central to clinical research, a second question follows - can the region also become more influential in shaping the terms on which research is conducted and translated into care? Put differently, success must result in securing fairer access, stronger benefit-sharing and more credible post-trial obligations for the populations where the clinical trial is taking place.
At the opening of the recent Clinical Research Malaysia (CRM) “Trial Connect Conference”, Health Minister Datuk Seri Dr Dzulkefly Ahmad set the right benchmark when he reminded participants that “Science must act in the name of humanity. Science without humanity loses its purpose”.
That reminder matters because Asia’s centrality to clinical research is increasing just as its health needs are changing rapidly. Asia and the Pacific are home to about 60 per cent of the world’s population, around 4.7 billion people, and the region is ageing quickly. By 2050, the number of people aged 60 and above is projected to reach around 1.3 billion, placing much greater pressure on long-term care, medicines access and health financing.
This means the region’s health challenge is no longer mainly episodic care. It is increasingly about sustained access to treatment for cancer, diabetes, cardiovascular disease, kidney disease and other chronic conditions. For Malaysia, these are not distant trends. They mirror domestic realities and rising fiscal pressures on the health system.
In this setting, clinical trials are not a side issue. They are part of a bigger question: how countries secure timely, safe and affordable access to health technologies in a world of concentrated supply chains, geopolitical uncertainty and high treatment costs.
Structural gap
The access problem is structural and systemic. It is shaped by the interaction of intellectual property rules, regulatory barriers such as data exclusivity, pricing practices, trial contracts, uneven manufacturing capacity and weak post-trial access arrangements.
The Covid-19 experience made this painfully clear. Public funding and scientific cooperation helped produce vaccines, diagnostics and therapeutics at unprecedented speed, yet access remained highly unequal. Wealthy countries locked in early supply through purchasing power and contracts, while many countries in the global South faced delayed, partial or donation-dependent access, even as they contributed pathogens, genomic data, clinical trial participants and research infrastructure.
This same imbalance appears in the clinical trial system more broadly. A cross-sectional analysis of 172 medicines approved by the US Food and Drug Administration between 2015 and 2018 found that five years after approval, only about one quarter had obtained marketing authorisation in all the countries where pivotal trials had been conducted. More than half of the medicines targeted cancer, cardiovascular disease or diabetes, conditions that account for about 60 per cent of deaths worldwide, 80% of which are in LMICs. While high-income countries have experienced improvements in physical access to the medicines they help test over time, no meaningful gains were observed for upper- or lower-middle–income countries in trials.
If countries and communities contribute patients, data and infrastructure, but the resulting products remain unaffordable or unavailable, then the system is not delivering equitable benefit-sharing.
Post-trial Access Obligations
This is where ethics and access converge. In many low- and middle-income settings, patients may join trials partly because routine care cannot offer similar treatment, monitoring or specialist attention. In those circumstances, the quality of consent still matters, but voluntariness is shaped by the broader access environment as well.
Some scholars describe this as structural coercion: not coercion in the narrow sense of overt force, but a situation in which financial constraints, personally and within the system, result in lack of alternatives and constrain real freedom of choice. If a patient joins a trial because the public system cannot provide standard care or best-available treatment, then ethical review cannot stop at the consent form alone. It also has to ask what background conditions are shaping the decision to participate.
The ethical issue does not end when a trial closes. This is where post trial access becomes critical. In oncology, immunology and rare diseases care, stopping a beneficial treatment at the end of a study can have serious consequences for participants. Post-trial access, therefore, cannot be treated as a charitable add-on. It must be a design obligation.
Trial protocols should state clearly who will provide continued access, for whom, for how long, through what financing mechanism and through what pathway into the health system if the product proves beneficial. Sponsors should also undertake responsibility for registering successful products in the countries where trials took place.
Malaysia and the region
Malaysia’s own framework already points in the right direction. The country’s 5th edition Guideline for Good Clinical Practice states that it should be read alongside the Declaration of Helsinki, which, together with the CIOMS Guidelines, offers stronger guidance on benefit-sharing, vulnerable groups, post-trial access and the justified use of placebos.
ICH-GCP remains important, but it should be understood as a minimum operational standard, not as the full ethical horizon. It is valuable for trial management, documentation, monitoring and data integrity, but it does not, by itself, answer the harder distributive questions raised by trials conducted in low- and middle-income settings. The ICH itself is an institution initiated and still largely controlled by the industry associations and regulators of the United States, Europe and Japan. Ethics committees and regulators should therefore look beyond procedural compliance and require clear provisions on trial-related injury compensation, placebo justification, protection for vulnerable groups and financed post-trial access plans.
Malaysia also has limited continuity mechanisms, including compassionate use and named-patient pathways, to support access to investigational products before market registration. These are useful, but they are not enough. The wider challenge is to move from case-by-case continuity to structured planning for affordability, supply and uptake in the public health system.
Funding arrangements are central to this discussion. Much of the region’s product-development research is still financed through standard patent-based commercial models, in which the sponsor pays for the trial and retains substantial control over data, intellectual property and eventual pricing. Under that model, post-trial access can easily become secondary to registration strategy and market positioning. However, other models are possible.
If Asia and the Pacific is becoming more central to global clinical trials, then the region should also become more central to defining what a responsible research ecosystem looks like. That means stronger ethical review, clearer post-trial obligations, more transparent funding structures, greater use of public-interest financing, stronger regional cooperation, and a deliberate effort to connect research with affordable access and domestic productive capacity. Patients in the region should not be treated merely as participants in the production of evidence. They are rights-holders, and their contribution should be matched by fair access to the health technologies they helped make possible.
> Karina Yong is a senior lawyer and researcher at Third World Network
