The Ethical Dilemma of Patent Rights in India's Healthcare System

public health AND patent rights IN India

Access to life-saving medicines has long been a moral and legal issue in India. The debate between protecting intellectual property and ensuring affordable healthcare resurfaces whenever rare diseases require costly patented drugs. The case of Spinal Muscular Atrophy (SMA)—a severe genetic disorder affecting muscle control—shows how patent laws can collide with the right to life and health.

1. What is SMA and why is it important?

SMA is a rare genetic disorder caused by mutations in the SMN1 and SMN2 genes. It leads to muscle weakness, breathing difficulties, and in severe cases, early death. India records a high number of SMA cases among infants, making equitable access to treatment a public health necessity.

2. What treatments exist for SMA?

Recent scientific advances have produced therapies that can slow or stop the disease. Zolgensma (a gene therapy) and Risdiplam (an oral drug marketed as Evrysdi) are effective but extremely expensive—costing between ₹6 lakh and ₹18 crore—making them unaffordable for most Indian families.

3. Why are these drugs so costly?

Pharmaceutical companies hold patents that give them exclusive rights to manufacture and sell these drugs. This monopoly allows them to set very high prices, leaving patients dependent on either government aid or private crowdfunding.

4. What is the government’s role in such situations?

Under Article 21 of the Constitution, the right to life includes the right to health. The National Policy for Treatment of Rare Diseases (NPTRD) 2021 offers limited financial support—up to ₹50 lakh—but this is far below the actual treatment costs.

5. What does India’s patent law say?

India’s Patents Act, 1970 protects innovation but also safeguards public health. Section 84 allows the government to issue compulsory licences when a patented drug is too expensive or unavailable. This lets other companies produce affordable generic versions.

6. Has compulsory licensing been used before?

Yes. In 2012, Natco Pharma received permission to manufacture Sorafenib Tosylate (a cancer drug patented by Bayer). Its cost dropped from ₹2.8 lakh to ₹6,000 per month—an international milestone for affordable healthcare.

7. What happened with Risdiplam in India?

Natco Pharma proposed a generic version of Risdiplam at ₹15,900 per bottle—about 90% cheaper than Roche’s price. Roche sued for patent infringement. The Delhi High Court initially upheld public health concerns but later proceedings delayed access, revealing how legal battles can obstruct life-saving care.

8. What ethical dilemma does this raise?

The SMA case poses a serious question: should corporate profit take precedence over human survival? Denying access to essential drugs violates both constitutional rights and moral responsibility.

9. What can be done now?

The Union Government should invoke compulsory licensing for Risdiplam and similar therapies. Parliament can pass a resolution supporting affordable generics, and state governments must coordinate with health departments and patient groups for sustainable rare-disease care.

10. What lesson does the SMA case teach India?

It shows that patents must serve humanity, not restrict it. Ensuring affordable treatment is not charity—it is the state’s constitutional and ethical duty.

Synopsis

India’s SMA crisis highlights the tension between public health and patent rights. While innovation deserves protection, life-saving drugs priced beyond reach threaten the right to health. By using compulsory licensing and firm policy action, India can reaffirm its leadership in affordable medicine and uphold the principle of health justice.