IPR and Public Health: Exploring the Possibility of Local Production of Risdiplam in India

The recent appeal by Rajya Sabha MP Haris Beeran for the Union Health Ministry to endorse the domestic production of Risdiplam has opened a Pandora’s box on the equilibrium between public health and the protection of intellectual property. Risdiplam, a requisite medication for Spinal Muscular Atrophy (SMA), is currently available in a limited supply at an exorbitantly high price of close to ₹6.2 lakh per bottle. While the plan to manufacture the drug locally appears favourable, it poses serious issues of scope, legality, and potential consequences.

Understanding SMA and the Role of Risdiplam

A genetic condition caused by a mutation in the SMN1 gene, SMA is a rare and serious type of muscular dystrophy affecting children throughout their lives. Risdiplam, sold by Roche, provides new hope against spinal muscular atrophy to affected children globally. Yet, the drug that every patient truly needs is not actually affordable. The extremely high cost of this drug has been a point of concern and has led to several issues around it.

A suggestion to the innovators that small-scale local production of Risdiplam is worthy of consideration will be prompted by the emphasis on proponents for the manufacture of the drug locally. This action may lead to a significant decrease in the prices of this particular therapy, bringing down the cost of treatment to as low as ₹3,024 annually, thereby relieving the financial punishment on patients by a sizable measure.

The Legal Angle: Section 100 of the Patents Act, 1970

A pivotal aspect of this discussion is the potential use of Section 100 of the Patents Act, 1970 (hereinafter ‘the Act’). This legal provision allows the government to authorize third parties to manufacture patented drugs in the public interest. This provision has been invoked in the past during public health crises to ensure the availability of life-saving medications.

While the use of Section 100 of the Act appears to be a logical solution for improving access to Risdiplam, its application is not without complexities. Critics of the move often highlight the importance of intellectual property rights in encouraging innovation and the risks of setting precedents that might deter future investments in drug development.

The National Policy for Rare Diseases (hereinafter ‘NPRD’) 2021

The NPRD 2021 provides a framework for addressing challenges associated with the treatment of rare diseases. It emphasizes the need to reduce the cost of treatment by encouraging research, development, and local manufacturing of essential drugs. Utilizing this policy in the case of Risdiplam could align with the government’s broader goal of promoting affordable healthcare solutions.

However, the practical implementation of such measures depends on multiple factors, including the capacity of Indian manufacturers to produce the drug at the required quality and scale, potential legal challenges from patent holders, and the government’s willingness to intervene in cases involving high-cost drugs.

The Case for Local Production: Opportunities and Challenges

Supporters of the initiative believe that fostering local production could achieve multiple objectives. It might lower costs, improve access, and bolster India’s reputation as a global hub for affordable pharmaceuticals. Moreover, it could pave the way for similar measures for other rare diseases, where high-cost treatments remain a significant barrier to care.

On the other hand, there are valid concerns regarding the potential backlash from the global pharmaceutical industry, the ethical implications of overriding patents, and the financial feasibility of producing Risdiplam locally. These factors necessitate a thorough cost-benefit analysis to ensure that any intervention is both sustainable and equitable.

Conclusion

The call for local manufacturing of Risdiplam opens a critical discussion on India’s approach to expensive treatments for rare diseases. While there is no denying the potential benefits of making the drug more affordable, the decision to invoke legal provisions such as Section 100 of the Patents Act must be carefully evaluated.

Balancing public health priorities with the need to protect intellectual property rights is a delicate exercise. Whether local production of Risdiplam is the right path forward depends on careful consideration of legal, ethical, and economic factors. At its core, the debate highlights the importance of ensuring that no one is denied life-saving treatments due to financial constraints. Either through policy interventions, collaborations with patent holders, or innovative solutions, the ultimate goal should be to improve accessibility and equity in healthcare.