According to a report from BIS Research, the global precision medicine market is expected to reach nearly US$217 billion by 2028.  This growth is driven by factors such as the increasing prevalence of chronic diseases, bioinformatics advancements and gene therapy's growing application in rare diseases.

On the other hand, pathogen genomics is instrumental in public health surveillance and responses, helping track disease spread and inform intervention strategies. It has been a cornerstone of the global response to the COVID-19 pandemic. 

The COVID-19 disease is caused by the SARS-CoV-2 virus, and genomic sharing has been critical in identifying and tracking the emergence of many SARS-CoV-2 variants around the world, such as the Alpha, Beta, Gamma and Delta variants.  The initial sequencing and sharing of the SARS-CoV-2 genome by Chinese scientists in January 2020 allowed researchers worldwide to begin developing vaccines.

Indonesia is grappling with a substantial burden of noncommunicable diseases (NCDs), which account for an alarming 76 percent of total mortality. Predominant causes of these deaths include cardiovascular diseases, cancer, diabetes and respiratory disorders. Additionally, the nation ranks among the top in terms of tuberculosis prevalence.

In this context, genomics could prove instrumental in addressing these health challenges that Indonesians face. Genomics could transform the country's healthcare landscape by enabling early detection and disease-specific treatments.

The government has delineated its aspirations for genomics research tailored to the country's healthcare requirements. It has set up a national entity, the Biomedical and Genome Science Initiative (BGSi), and has started initial projects in collaboration with specific hospitals.

However, there is still a need for scaling up these initiatives. The primary tasks on the horizon are the development of a comprehensive genomics policy and regulations and completing their inaugural genome biobank.

Building human capital and enhancing testing infrastructure are other significant challenges to address. These could potentially be overcome by forging joint ventures with international partners. The emphasis should be on leveraging these partnerships to build local capacity and expertise in genomics.

Typically, the legal situation for genomics in any country are determined by a patchwork of legislation and regulations that touch on relevant areas, such as medical practice, research, data protection and bioethics. These can include laws and regulations on patient consent, genetic testing, data privacy and intellectual property. They may also include regulations specific to genomics if they have been developed. 

Indonesia does not have a comprehensive legal framework on genomics, apart from the ministerial regulation that established BGSi. The regulation stipulates that BGSi oversees patient registries for specific diseases, managing the systematic collection, storage and utilization of genomic data. It also governs biobanking operations, which are crucial for storing biological samples used in genomic research.

Additionally, the BGSi manages human whole genome sequencing within the country, a vital component in understanding disease-related genetic variations. Lastly, it says that BGSi is fostering the growth of precision medicine.

The passing of the new Health Law aims to address gaps or ambiguities in the existing legal framework, provide greater clarity and direction and cater to the unique considerations that genomics requires.

Article 338 of the law explicitly recognizes genomics as part of biomedical technologies that are important for supporting health services in Indonesia. The legislation underscores the various stages at which genomics can play a role, from the initial specimen collection to long-term specimen storage and even further to the management and utilization of specimens and associated genomic data.

This extensive process is crucial for advancing scientific knowledge and developing health technology and health services, including precision medicine, an approach for disease treatment and prevention that considers individual variability in genes, environment and lifestyle.

Article 339 explicitly outlines the provisions related to establishing and operating biobanks or biorepositories, which are crucial for genomic studies as they are responsible for safely storing and managing biological samples. Various organizations, both the public and private sectors, can establish these biobanks or biorepositories.

However, they must obtain approval from the government to operate, signifying that these institutions will work under regulatory scrutiny. Moreover, it's mandated that these biobanks or biorepositories keep the biological specimens and related data within Indonesia. This requirement is a critical protective measure to address unauthorized international access or exploitation concerns.

Article 340 establishes the guidelines for transferring and using specimens, data and information beyond Indonesian borders, providing significant relevance to genomic studies, which often require international collaboration. The primary principle underpinning the regulation is the conservation of Indonesia's biological and genetic resources, signifying that any transfer or use of such resources should not compromise Indonesia's control of them.

The transfer and use of these resources, which would encompass genomic data, can only occur under two specific circumstances: when the necessary examinations of specimens, including genomic analyses, are not possible within the country; or for research purposes. Crucially, any transfer of specimens, data or information must be governed by a material transfer agreement designed to ensure a fair and equitable exchange of resources.

However, the law is unclear on the utilization of pathogen genomics for health surveillance. Article 372 only stipulates that health surveillance is a part of outbreak responses and Article 374 further describes that health surveillance is done to identify the characteristic of the diseases causing the outbreak and is carried through systematic and continuous monitoring of the outbreak.

The law should have been clear that pathogen genomics is a part of health surveillance, and the management of pathogen genomics should fall under the principles of Article 338, 339 and 340.

The new Health Law brings meaningful discussions around the dual needs of swift data sharing for public health responses and the imperative to safeguard individual privacy.  Although not very clear, the law can serve as a basis for Indonesia to share pathogen genomics and help prevent future pandemics.

This new law also provides a platform for ongoing dialogue and academic study that could shape practices in genomic data handling within Indonesia and globally.  These conversations are crucial for navigating the complex intersections of privacy, equity and public health needs in the genomics era.

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The writer a PhD candidate at School of Law, Chinese University of Hong Kong,