PUBLIC HEALTHCARE FUNDING OF BIOLOGICS: LEGAL FRAMEWORK AND JUDICIAL PRECEDENTS

1. INTRODUCTION

Public healthcare funding of biologics concerns the use of government resources to provide access to biological medicines, including monoclonal antibodies, vaccines, recombinant proteins, insulin, enzyme replacement therapies and gene-based treatments. Unlike conventional chemical medicines, biologics are produced using living systems and often involve complex manufacturing, storage and distribution requirements. Their high prices can make long-term treatment unaffordable for economically disadvantaged patients.

In India, the legal framework involves the constitutional right to life, public health obligations, government healthcare schemes, pharmaceutical regulation and judicial review. Although courts recognise the importance of access to life-saving treatment, the constitutional right to health does not automatically guarantee every patient unrestricted access to every expensive biologic.

2. CONSTITUTIONAL AND STATUTORY FRAMEWORK

A. ARTICLE 21 AND THE RIGHT TO HEALTH

Article 21 of the Constitution protects the right to life and personal liberty. Judicial interpretation has recognised access to necessary medical treatment as an important component of this protection. Articles 14 and 47 are also relevant: Article 14 prohibits arbitrary state action, while Article 47 directs the State to improve public health and nutrition.

B. PUBLIC HEALTHCARE FUNDING

Funding may be provided through government hospitals, publicly financed health insurance, disease-specific programmes, financial assistance schemes and procurement arrangements. Eligibility, available funding, treatment protocols and the division of responsibilities between central and state governments depend on the applicable scheme and governing rules.

C. MEDICINES AND REGULATORY COMPLIANCE

The Drugs and Cosmetics Act, 1940, applicable rules, and the New Drugs and Clinical Trials Rules, 2019, establish relevant regulatory requirements for medicines and biological products. The Patents Act, 1970, including Section 3(d), may affect pharmaceutical patent protection and competition. Price regulation under the Drugs (Prices Control) Order, 2013, and applicable National Pharmaceutical Pricing Authority measures may also influence affordability.

3. RELEVANT CASE LAWS

1. PASCHIM BANGA KHET MAZDOOR SAMITY v. STATE OF WEST BENGAL (1996)

Authority: Direct constitutional authority on public medical care; analogous to biologic funding.

The Supreme Court held that failure by government hospitals to provide timely medical treatment could violate Article 21. The judgment established that the State has a positive obligation to protect life through adequate medical facilities. Applied to biologics, it supports arguments against unjustified denial of necessary treatment within the public healthcare system.

2. STATE OF PUNJAB v. MOHINDER SINGH CHAWLA (1997)

Authority: Direct authority on medical treatment as part of the right to life.

The Supreme Court recognised that the right to health is integral to the right to life. The case supports the principle that government medical-treatment obligations must be assessed consistently with constitutional protections. It does not, however, establish an unconditional entitlement to every costly medicine.

3. MOHD. AHMED (MINOR) v. UNION OF INDIA (2014)

Authority: Direct authority concerning access to expensive treatment for a rare disease.

The Delhi High Court directed free enzyme replacement therapy for a child suffering from Gaucher disease. It emphasised access to life-saving medicines for vulnerable patients and rejected financial constraints as a sufficient justification for abandoning core healthcare obligations. This is particularly relevant to expensive biologics and enzyme replacement therapies.

4. MASTER ARNESH SHAW v. UNION OF INDIA (2021)

Authority: Directly relevant to expensive rare-disease treatment; analogous to broader biologic funding.

The Delhi High Court considered petitions concerning children with Duchenne muscular dystrophy and the affordability of expensive treatment. The proceedings addressed governmental responsibilities, policy implementation and possible funding mechanisms. The decision supports scrutiny of whether authorities have meaningfully considered access to treatment.

5. CONFEDERATION OF EX-SERVICEMEN ASSOCIATIONS v. UNION OF INDIA (2006)

Authority: Direct authority on government healthcare schemes and constitutional review.

The Supreme Court examined the constitutional validity of a contributory medical scheme for ex-servicemen. The judgment recognised medical aid as a component of Article 21 while accepting that governments may structure healthcare schemes through reasonable eligibility and contribution requirements.

6. NOVARTIS AG v. UNION OF INDIA (2013)

Authority: Direct pharmaceutical patent authority; analogous to public funding of biologics.

The Supreme Court rejected Novartis's patent claim concerning a modified form of imatinib because the statutory requirements under Section 3(d) were not satisfied. Although the dispute concerned patentability rather than government funding, it illustrates the relationship between intellectual property protection, pharmaceutical competition and access to medicines.

7. MASTER MEDHANSH JHAWAR v. RAJESH BHUSHAN (2024)

Authority: Directly relevant to rare-disease treatment access and funding mechanisms.

The Delhi High Court considered governmental obligations concerning expensive rare-disease therapies and examined implementation of policy measures, including funding and procurement-related concerns. The proceedings demonstrate the importance of effective coordination between government departments, hospitals and manufacturers.

4. PRACTICAL FUNDING AND COMPLIANCE REQUIREMENTS

Public authorities should establish transparent eligibility criteria, assess clinical necessity, evaluate cost-effectiveness, and maintain reliable procurement and cold-chain systems. Where appropriate, pooled procurement, negotiated pricing, biosimilar competition, risk-sharing agreements and patient assistance programmes can improve affordability.

Funding decisions should provide understandable reasons, use consistent clinical criteria and include review mechanisms. Authorities should also monitor treatment outcomes, adverse events, continuity of supply and expenditure. Manufacturers must comply with applicable quality, safety, licensing and pharmacovigilance requirements.

5. CONCLUSION

Public healthcare funding of biologics requires balancing constitutional duties, clinical need, affordability and responsible allocation of public resources. Indian case law supports meaningful access to essential and life-saving treatment, particularly for vulnerable patients, without creating an unlimited right to every expensive medicine. Transparent eligibility rules, sustainable funding, effective procurement and judicial accountability are therefore central to an equitable biologic-access framework.