Health groups argue Roche’s legal action to block generic supply jeopardises public interest by limiting access to affordable medication.
They have also sought intervention by the government to incentivise generic manufacturers to produce and supply drugs for rare disease patients in India and other low and middle-income countries.
Roche’s patent for Risdiplam is effective until May 2035, allowing the company to charge about ‘6 lakh per bottle.
“The production costs suggest the drug could be made available for a really low cost,” said a health activist, who did not wish to be identified. “The monopoly on the drug could hinder the Indian ministry of health and family welfare’s efforts to benefit from domestic production and competitive pricing through pooled procurement (tendering) strategies.”A Roche spokesperson said, “At Roche, drug innovation and its access to patients is foremost. We are committed to deliver healthcare innovations that significantly improves patient lives in the country while ensuring that as many patients as possible have access to our products.”The spokesperson further said, “Our focus remains on discovering and developing innovative medicines and diagnostics that will change standards of care in the future. At the same time, we are also committed to protect our innovations within the scope of applicable laws in the countries we operate and believe that laws provide sufficient safeguards for protection of innovation.”
The generic production and supply of a rare disease at a fraction of the cost of the originator is a breakthrough that needs to be promoted to meet patient needs in India and across low and middle- income countries, the health groups said in a note highlighting the issue for other diseases such cystic fibrosis, where the patent barriers are similarly overwhelming, with no options for the drug likely to be available to patients in India.
