Government biomarker governance accountability

Introduction

Government biomarker governance accountability refers to the legal and institutional responsibility of public authorities when they collect, analyse, store, share, or use biological markers for governmental purposes. Biomarkers may include genetic information, physiological indicators, disease markers, biochemical measurements, and other biological data capable of revealing information about an individual’s health or biological characteristics. Their use can support public-health surveillance, disease prevention, environmental-health monitoring, epidemiological research, and medical policy. However, government control over such information raises significant concerns relating to privacy, autonomy, discrimination, data security, informed consent, and misuse of state power.

Accountability requires that government agencies using biomarkers operate under clearly defined legal authority and remain subject to constitutional, administrative, judicial, and institutional oversight. A government cannot rely merely on the scientific value of biomarker information; it must demonstrate that its collection and use are lawful, necessary, proportionate, transparent, and connected to a legitimate public objective.

Legal basis of government biomarker accountability

Government biomarker governance generally rests upon principles of legality, necessity, proportionality, purpose limitation, data minimisation, confidentiality, and procedural fairness. Before collecting biological information, an authority should identify the statutory basis for the collection and explain the purpose for which the information will be used.

In India, Article 21 of the Constitution provides the central constitutional foundation because the Supreme Court has interpreted the right to life and personal liberty to include a constitutionally protected right to privacy. In Justice K.S. Puttaswamy (Retd.) v. Union of India (2017), the Supreme Court recognised privacy as a fundamental right and emphasised legality, legitimate state purpose, and proportionality when the State interferes with privacy. This reasoning is particularly important for biomarker governance because biological information can reveal highly intimate characteristics of an individual.

The accountability principle also requires procedural safeguards. Government agencies should maintain rules concerning who may access biomarker databases, how long information can be retained, when information can be disclosed, and what remedies are available to individuals whose information has been improperly collected or used.

Privacy and informational autonomy

Biomarker governance directly engages informational privacy because biological information can provide insights into an individual's health, genetic characteristics, disease susceptibility, or other sensitive attributes. The government therefore has a heightened responsibility to prevent unnecessary surveillance and unauthorised disclosure.

In Puttaswamy, the Supreme Court recognised informational privacy and individual autonomy as important dimensions of privacy. The judgment provides a constitutional framework for evaluating governmental collection and processing of sensitive personal information.

Similarly, in PUCL v. Union of India (1997), concerning telephone interception, the Supreme Court established safeguards against arbitrary governmental surveillance. Although the case did not concern biomarkers, its principle is relevant: intrusive governmental information-gathering powers require legal authority and procedural safeguards.

Proportionality and legitimate governmental objectives

Government biomarker programmes may sometimes pursue legitimate objectives, such as controlling infectious diseases, monitoring occupational exposure, or conducting population-level health research. Nevertheless, the existence of a public-health objective does not automatically justify unrestricted biological-data collection.

The proportionality principle requires an assessment of whether the measure has a legitimate objective, whether it is rationally connected to that objective, whether less intrusive alternatives are available, and whether the benefits outweigh the rights infringement.

The Indian Supreme Court's decision in K.S. Puttaswamy (Aadhaar) v. Union of India (2018) is particularly relevant. The Court examined extensive governmental collection and use of personal and biometric information and applied constitutional principles concerning legality, necessity, and proportionality. The judgment demonstrates that technological efficiency cannot by itself justify unrestricted governmental collection of personal information.

Consent, public interest and exceptional collection

Consent is an important principle in biomarker governance, particularly for research. However, government programmes may sometimes operate under statutory authority or compelling public-health requirements where individual consent cannot be the sole legal foundation. In such circumstances, stronger safeguards become necessary.

For example, compulsory collection may potentially be justified in narrowly defined circumstances involving serious public-health risks, but the government should establish clear statutory authority, scientific justification, limited collection, confidentiality protections, and independent oversight.

The Jacobson v. Massachusetts (1905) decision in the United States is historically significant for public-health law. The U.S. Supreme Court recognised governmental authority to adopt certain compulsory measures to protect public health. However, modern biomarker governance requires applying such public-health authority alongside contemporary constitutional and data-protection principles rather than treating Jacobson as unlimited governmental power.

Data security and institutional responsibility

Accountability also extends beyond the initial collection of biomarkers. Government institutions must protect biological databases against unauthorised access, cyberattacks, accidental disclosure, and secondary uses that were not contemplated when the information was collected.

A comprehensive accountability framework should therefore include:

• clearly defined statutory authority;
• limited and specified purposes;
• minimum necessary data collection;
• secure storage and encryption;
• access controls and audit trails;
• restrictions on third-party disclosure;
• defined retention and deletion periods;
• independent regulatory or ethical oversight;
• transparency and reporting requirements; and
• effective remedies for unlawful processing.

Government officials should also be accountable where biometric or biomarker information is misused. Administrative responsibility, disciplinary mechanisms, judicial review, and compensation can operate as important safeguards.

Equality and discrimination

Biomarker information may create risks of discrimination if government agencies use biological characteristics to classify individuals. For example, biomarker-based risk classifications could potentially affect access to public services, employment-related government decisions, insurance-linked programmes, or eligibility for benefits.

Article 14 of the Indian Constitution requires equality before the law and protection against arbitrary state action. Consequently, biomarker classifications must have a rational and constitutionally defensible basis and cannot be used merely because technological systems make such classification possible.

Judicial review and remedies

Judicial review provides an important accountability mechanism. Courts can examine whether a biomarker programme exceeds statutory authority, violates fundamental rights, lacks procedural safeguards, or imposes disproportionate restrictions.

The broader constitutional principles developed in Maneka Gandhi v. Union of India (1978) are also relevant because governmental action affecting personal liberty must satisfy standards of fairness and non-arbitrariness. When combined with the privacy jurisprudence of Puttaswamy, these principles create a strong framework for challenging arbitrary biomarker surveillance or processing.

Conclusion

Government biomarker governance accountability requires balancing legitimate public interests with individual privacy, autonomy, equality, and dignity. Biomarker information is particularly sensitive because its collection can expose biological and health-related characteristics that individuals may reasonably expect to remain private. Government agencies should therefore operate under clear legislation, strict purpose limitations, proportionality requirements, robust security standards, independent oversight, and accessible remedies.

Indian constitutional jurisprudence, particularly Justice K.S. Puttaswamy v. Union of India (2017) and Puttaswamy (Aadhaar) v. Union of India (2018), provides a strong foundation for such accountability. PUCL v. Union of India (1997) further demonstrates the importance of procedural safeguards for intrusive information-gathering by the State. Collectively, these principles support a governance model in which scientific and public-health objectives cannot override constitutional limitations, and governmental biomarker programmes remain continuously answerable to law, courts, regulators, and affected individuals.