Health groups and treatment activists argue that patent monopolies in rare diseases are restricting access to affordable medication, especially for patients in low- and middle-income countries (LMICs).
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- Roche’s Legal Action: Roche has filed for a permanent injunction to prevent Natco Pharma from producing a generic version of Risdiplam, a drug for Spinal Muscular Atrophy (SMA), citing patent infringement.
- Pricing Disparity: Roche charges approximately ₹6 lakh per bottle for Risdiplam, while production costs suggest it could be made available at an estimated ₹3,024 annually.
- Patent Duration: Roche’s patent for Risdiplam extends until 2035, which limits competitive pricing and access to more affordable generics.
- Roche’s Argument : Roche emphasises its dedication to healthcare innovation and improving patient lives, while maintaining that protecting its patents is essential to sustain future medical advancements.
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Spinal Muscular Atrophy (SMA)
- SMA is a genetic disorder causing muscle weakness and atrophy.
- Cause: Mutation in the SMN1 gene, leading to deficient survival motor neuron (SMN) protein.
- Types: Four types (Type 1–4) based on onset and severity, with Type 1 being the most severe.
- Symptoms: Muscle weakness, poor motor function, respiratory issues, and difficulty swallowing.
- Treatment: Nusinersen, gene therapy and supportive care.
- Inheritance: Autosomal recessive; parents carry one copy of the mutated gene.
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Health Group and Activist Concerns
- Public Interest at Risk: Health groups argue that Roche’s monopoly on Risdiplam limits affordable access, posing a risk to public interest and patient health.
- Impact on Local Healthcare Strategies: This monopoly may hinder the Indian Ministry of Health and Family Welfare’s efforts to utilise domestic production and pooled procurement strategies to bring down treatment costs.
What is Rare Disease?
- A rare disease is a health condition of low prevalence that affects a small number of people compared with other prevalent diseases in the general population.
- India accounts for one-third of the global rare disease incidence, with over 450 identified diseases.
- Example-Spinal Muscular Atrophy and Gaucher’s disease, Mucopolysaccharidosis type 1 and Whipple’s disease.
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Issues with Other Rare Disease
- Cystic Fibrosis (CF) Drug Access: Patent restrictions have blocked access to CFTR modulators (elexacaftor/tezacaftor/ivacaftor) for cystic fibrosis treatment in India.
- Vertex Pharmaceuticals, the patent holder, hasn’t registered the drug with the Indian FDA, forcing patients to import it individually at an annual cost of ₹1 crore, making it unaffordable for most.
- Generic production of these modulators has begun in Argentina, but Indian patients cannot access it due to ongoing patent restrictions.
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Pros and cons of Patent Monopolies for Rare Diseases
| Pro |
Con |
- Incentivizes Innovation: Patents provide a strong incentive for pharmaceutical companies to invest heavily in research and development (R&D) for rare diseases, which often have smaller potential markets.
- Protects Investment: Patents allow companies to recoup their significant R&D costs, ensuring a return on investment and encouraging further innovation.
- Encourages Competition: While patents grant temporary monopolies, they also foster competition among companies to develop better treatments and lower costs over time.
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- High Drug Prices: Patent monopolies can lead to high drug prices, making treatments inaccessible to many patients, especially in low-income countries.
- Limited Access: Exclusive rights granted by patents can restrict access to life-saving medications, particularly for patients in need.
- Barriers to Generic Competition: Patents can delay the entry of generic drugs, which are typically more affordable, further limiting patient access.
- Potential for Abuse: Patent holders may engage in anti-competitive practices, such as evergreening, to extend their monopoly and maintain high prices.
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Way Forward
- Price Controls: Implement stringent price controls on rare disease treatments to make them affordable for patients.
- Compulsory Licensing: Utilize compulsory licensing to allow generic manufacturers to produce affordable versions of patented drugs.
- Health Insurance Coverage: Ensure comprehensive health insurance coverage for rare diseases to alleviate financial burdens on patients.
- Financial Incentives: Provide financial incentives to generic manufacturers to encourage the development and production of affordable rare disease treatments.
- Regulatory Support: Streamline regulatory processes for generic drug approval to expedite access to affordable medications.
- Global Collaboration:
- International Partnerships: Foster international collaborations to share knowledge, resources, and clinical expertise in rare disease research and treatment.
- Global Access Initiatives: Support global initiatives aimed at expanding access to affordable rare disease treatments, particularly in low- and middle-income countries.
November 6, 2024
