This article was first published in Kompas on 25 Mei 2025 and has been translated using AI.
As long as there is political will, strong regulations, and maintained public ethics, ethical, open, sovereign, and fair collaboration can be realized.
In early May 2025, the Indonesian Minister of Health, Budi Gunadi Sadikin, conveyed three main reasons why Indonesia was willing to be the location for the M72/AS01E tuberculosis (TB) vaccine trial (Kompas, 9/5/25).
The reasons are, first, to more quickly ascertain the compatibility of the vaccine with the genetics of the local population. Second, to ensure that Indonesian scientists are directly involved in the development of vaccine manufacturing technology. Third, to enable faster vaccine production by Bio Farma.
The Minister of Health’s statement seemed to try to dispel concerns that Indonesia was merely being used as a testing ground.
Two days earlier, on May 7, 2025, President Prabowo Subianto received a visit from Bill Gates and revealed that since 2009, the Gates Foundation has provided grants totaling more than 159 million US dollars (approximately 2.62 trillion rupiah) to Indonesia.
Most of the funds (119 million USD) are allocated for the health sector, including the procurement of vaccines and strengthening the vaccine production capacity by Bio Farma. Additionally, 5 million USD is allocated for the agriculture and technology sectors, and more than 28 million USD for cross-sector social programs such as education and poverty alleviation.
The question arises, is the TB vaccine trial related to, or even a condition (conditionalities) of, the grant from Gates?
One perspective views the two as interconnected, and therefore the narrative needs to be explored more deeply. Another perspective sees them as separate: the clinical trial of the vaccine is solely a matter of health technicalities, and there is no need to link them, especially since tuberculosis has become endemic in this country and needs to be addressed promptly.
Those who are not naive understand that under this sky, there is no matter that is purely technical, even when it involves the complexities of science such as health, including vaccine technology. At the very least, there are always ethical issues present, which can serve as an entry point to delve into the matter, rather than falling into a pro-con narrative, let alone simply supporting or opposing it.
Rational, but not automatic
The Gates grant has indeed made a significant contribution to the development of vaccine production capacity in Indonesia. With this support, Bio Farma is able to produce approximately two billion doses of polio vaccine per year, used in 42 countries and reaching over 900 million people.
Currently, the Gates Foundation supports the development of a tuberculosis vaccine that is planned to be tested in Indonesia, as well as a micronutrient supplementation program for pregnant women that will be launched soon.
The M72/AS01E vaccine was actually developed by Glaxo SmithKline (GSK) with the support of Aeras and the International AIDS Vaccine Initiative (IAVI) since the early 2000s. In 2020, this effort was taken over and continued by the Gates Medical Research Institute (Gates MRI) until the phase III clinical trial stage, with funding support from the Gates Foundation and Wellcome Trust.
Although the three reasons given by the Minister of Health are rational, it is important to read them more deeply and critically.
First, in biomedical science, it has been found that the immune response to vaccines can vary depending on the host genetics—the genetic characteristics of the recipient population. A study by Oberemok et al (2021) showed that genetic variations in the HLA (Human Leukocyte Antigen) gene and immune cell receptors can affect the level of a vaccine’s ability to stimulate effective antibodies.
This difference serves as an important scientific basis for the necessity of cross-regional and population clinical trials. This is where Indonesia’s relevance as a trial location lies: the country has high genetic diversity due to geographical and ethno-demographic factors, making it a representative model (for example, for Southeast Asian populations). This approach is known as precision public health, a health strategy based on local data and population characteristics.
For example, the clinical trial of the Sinovac Covid-19 vaccine in Bandung in mid-2020. Bio Farma collaborated with Padjadjaran University to conduct a phase III trial involving 1,620 volunteers. The results of this study provided contextual data that served as the basis for the national vaccination policy at that time.
Another example is the phase III clinical trial of the malaria vaccine RTS,S/AS01 by GSK, which involved more than 16,000 children in eight African countries from 2009 to 2014. The results showed that the efficacy of the vaccine varied significantly between 27% and 50%, depending on the testing region. This variation occurred due to differences in the genetic structure of malaria parasites in each region, as well as differences in human immune responses.
Therefore, without local testing, the effectiveness of the vaccine could be overestimated or underestimated if it solely relies on data from other populations. However, the benefits—in the case of the tuberculosis vaccine—are not automatic: they can only be achieved if Indonesia secures full rights to access data, freedom for scientific analysis, and the space to integrate it into national health policies.
Without such guarantees, we merely become a research location that distributes risks, without control over the outcomes. History shows that in many cases of global clinical trials, the country where the trials are conducted does not always receive a share of the intellectual results or production rights of the developed technology.
In fact, data from tests is often not returned transparently or published without meaningful collaboration with local scientists. This highlights the importance of careful negotiation and a national legal framework that is not myopic: protecting long-term interests rather than merely pursuing short-term benefits.
Power relations in the medical world
Second, we cannot turn a blind eye to the global political context. In critical medical anthropology literature, this practice is called biomedical colonialism: when developing countries are used as test sites by pharmaceutical companies in developed countries, but are not really involved in the research or sharing the benefits (Petryna, 2009; Sariola & Simpson, 2011).
This is in line with the classical dependency theory (Frank, 1967), where Southern countries continue to be in a subordinate position to the centers of power in knowledge and capital.
A tragic case occurred in Kano, Nigeria, in 1996. During a meningitis outbreak, Pfizer was testing an experimental antibiotic on children using the drug Trovan. Without adequate informed consent, and with controversial results, the case sparked lawsuits and became a symbol of the inequality in global medical research.
Is Indonesia ready to bear that risk?
Becoming a trial location means being the first party to bear the uncertainty—both regarding the efficacy of the vaccine that has not yet been fully proven, as well as the possibility of serious side effects that were not detected in preclinical phases or previous trials. These risks are systemic and inherent in every phase of late-stage clinical trials.
Therefore, if Indonesia is indeed willing to be a test site, the government must have a strict protection system: a strong legal framework for informed consent, an independent ethical mechanism, oversight of clinical trials by competent national authorities, and a fair compensation scheme for affected test subjects. Without all of that, Indonesia’s involvement will actually reproduce exploitative relations as criticized as biomedical colonialism.
Moreover, if the testing protocols and licensing agreements are conducted in a closed manner without the participation of civil society and public oversight, the potential for the abuse of scientific power and capital will increase significantly.
Therefore, the government must be transparent about whether all prerequisites, testing protocols, and licensing agreements are in place, or still in progress. Open communication with the public is key to ensuring transparency and accountability as fundamental principles of any global health cooperation.
Collaboration ethics
Third, rather than being trapped between political cynicism and technocratic optimism, Indonesia can take a constructive middle path: ethical collaboration based on transparency, sovereignty, and justice. This approach is not only morally necessary, but also fits the framework of accountability for reasonableness in public health policy ethics (Daniels, 2000).
He emphasized the importance of procedural accountability and the inclusion of affected parties in every decision regarding public health. This is in line with the international research guidelines of the Council for International Organizations of Medical Sciences (CIOMS) and WHO (2016), which stress that the participation of developing countries in global health research must be accompanied by maximum protection of the rights of research subjects and the strengthening of local capacities.
In that spirit, the involvement of Indonesian scientists should not be limited to the role of technical field implementers. First, they must be given a strategic role in designing test protocols, determining methodologies, and independently analyzing the results. Second, this involvement is necessary to ensure that scientific decisions are not only made externally (by those requesting the tests) but also reflect local interests and contexts.
Three, the publication of all test protocols and their results transparently so that the medical community and civil society can independently assess the benefits and risks, rather than merely accepting the official narrative.
Justice must also be reflected in commercial and technological aspects. Technology transfer agreements and production licenses must be designed to be fair and binding, so that we do not merely become a market or a base for cheap production, but also have ownership over the knowledge and economic benefits generated.
Lastly, it must be remembered: protection for test subjects cannot be negotiated. Those participating in trials must receive legal guarantees and long-term medical support, including adequate compensation in the event of unanticipated side effects.
The experience of the Ebola vaccine trial by Merck in Guinea in 2015, the results of which were published in 2016, serves as an example that ethical and equitable collaboration is possible. Scientists and local governments were not only involved but also played a role in the direction of the research and the distribution of its results. This demonstrates that the involvement of developing countries in medical innovation does not have to occur from an inferior position.
As long as there is political will, strong regulations, and maintained public ethics, ethical, open, sovereign, and fair collaboration can be realized.
Therefore, there is nothing wrong with Indonesia’s participation in the development of global health technology. Science and innovation are indeed universal and must continue to grow across national borders. This is a prerequisite for the advancement of human civilization. However, healthy participation is only possible when built on the foundation of equality, not compliance.
We must remember: the people of Indonesia are not merely statistical figures or anonymous bodies in academic journals. They are citizens whose rights must be protected, not sacrificed in the name of progress.
Vaccine trials are indeed an inseparable part of medical innovation. However, innovation that is not accompanied by fair protection, transparency in the process, and certainty of benefits for all parties will only prolong the history of inequality in a new guise. If we are not careful, Indonesia is not accelerating its steps towards progress, but rather opening the door to a new form of scientific colonialism.
