In a breakthrough for Spinal Muscular Atrophy (SMA) patients, the Delhi High Court has opened the door for access to a generic version of the patented drug, Risdiplam, at a fraction of the cost marketed by the Swiss pharmaceutical corporation, La Hoffman Roche.
Roche had earlier sought to prevent the introduction of a generic version of Risdiplam, citing patent infringement. However, patients battling SMA highlighted the negative impact on their deteriorating health resulting from a lack of access to Risdiplam due to its "exorbitant cost" and the desperate need of letting low cost generic versions enter the market.
Seba P.A. and Purva Mittal, two young women battling SMA, said that at a time when a medicine that can stop progression of SMA already exist, "it is unethical to let patients die simply because they cannot afford to purchase the medicine.” The Delhi High Court order on Tuesday opened the way for Indian drugmaker Natco Pharma Ltd to manufacture Risdiplam in India while refusing to allow a suit by Swiss pharma giant Roche seeking to restrain Natco Pharma Ltd against manufacturing the drug for the rare disease. This will hopefully bring relief to SMA patients in India, both children and adults, a high percentage of who were unable to access high-cost Risdiplam and thereby remained without effective treatment for years.
Spinal Muscular Atrophy (SMA) is a rare genetic neuromuscular condition, affecting one in 7,000 people in India and is the leading genetic cause of infant mortality. It is a rare genetic condition that causes muscle weakness and affects a child's ability to crawl, walk, sit, and control head movements.
At present, as per official figures, there are over three lakh children with SMA in India. And this being a debilitating disease which has no cure, the only approved drug, Risdiplam, marketed under the name ‘Evrysdi’, "must be made available at affordable prices in India especially in the public interest as public health considerations take precedence," Justice Mini Pushkarna reportedly said.
She further added, "A drug which is the only one available for treatment in India for a rare disease, its availability to the public at large at very economical and competitive prices, is a material factor which a court will consider.”
Roche's patent for Risdiplam expires in May 2035. However, taking a note of that, the court refused to grant the pharma company, an injunction, saying that its "intention is to monetise the drug." Lawyers arguing for making the generic version of the drug available, said that in pharmaceutical patent enforcement cases, public health considerations must take precedence and that the reasoning of the court will go a long way in facilitating affordable access to medicines for rare diseases. They also urged Natco Pharma to supply the generic drug without delay, at a price accessible to patients and hoped, that the "ministry which implements the National Policy for Rare Diseases, will ensure that the life-saving drug reaches all SMA patients in need”
Since early 2021, courts have been addressing petitions related to SMA, advocating for local production and generic competition to address the high cost of treatments driven by patent monopolies. There are three types of treatment for SMA patients: gene therapy Zolgensma, which costs ₹17 crore, and two other drugs — Nusinersen (₹87 lakh) and Risdiplam (₹6.2 lakh per bottle). In a statement, Seba mentions her treatment cost as ₹2,03,840 for one bottle of Risdiplam, and with an annual requirement of 30 bottles, the total yearly cost of her treatment reaches ₹61,15,200. This is above the ₹50 lakh limit per patient set by the government under the National Policy for Rare Diseases.
ALSO READ
- Who owns ‘bro code’—a Delhi-based alcohol firm or ‘90s kids pop culture?
- 'The Bads of Bollywood' in legal trouble: Sameer Wankhede files case against Aryan Khan and Red Chillies Entertainment in Delhi High Court
- Delhi HC questions Priya Sachdev Kapur’s bid for sealed-cover asset disclosure
- Sunjay Kapur will dispute: Delhi High Court orders widow Priya Sachdev to list all of late husband’s assets
- Delhi HC denies bail to Umar Khalid, Sharjeel Imam, and others in riots conspiracy case, four years of incarceration raises questions
Alpana Sharma, founder director of CureSMA, a parent-led advocacy group that helps those suffering from spinal muscular atrophy, welcomed the decision saying it was "the absolute need of the hour."
As a parent to her 12-year-old son Aarav, she is proud that her son is no longer just known by his SMA condition, rather, he is popular for his exceptional performance in science, mathematics and Cyber Olympiads, his dedication to academics as an above average student and his friendly and cheerful demeanour.
Aarav suffers from spinal muscular atrophy (SMA) Type 2, a rare genetic and progressively degenerative disease. Back in 2018, Sharma, as a part of the Parents of SMA children support group, led the campaign urging the government to provide Risdiplam to all SMA patients in the country. Now, with the generic versions of Risplidam to become available soon, parents of SMA children say they're celebrating their "second victory."