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Patient groups and organisations in favour of accessibility and affordability of lifesaving medicines to all, has welcomed the Delhi High Court’s order rejecting Swiss Pharma major Roche’s appeal seeking an injunction against Natco Pharma in a case concerning the spinal muscular atrophy (SMA) drug risdiplam.
Seba PK, one of the two persons living with SMA who intervened in the case opposing the injunction, expressed relief and hope and said: “I'm greatly relieved to hear this news."
"With the reduced price, the government will now be able to purchase and provide the medicine for several years using the Rs. 50 lakhs fund under the National Policy for Rare Diseases. This is a huge relief for me and my friends living with SMA,” added Seba.
Purva Mital, another intervener on behalf of people living with SMA stated “We are deeply grateful to the judiciary for delivering a verdict that prioritizes life, compassion, and justice; a decision that will help save the lives of countless SMA patients and offer hope where it is needed most.”
The Working Group on Access to Medicines and Treatment has welcomed the Delhi High Court’s order rejecting pharmaceutical corporation Roche’s appeal seeking an injunction against Natco Pharma in a case concerning the drug risdiplam.
The decision paves the way for introduction of an affordable generic version of risdiplam by Natco Pharma, significantly improving access to this
life-saving treatment for patients across India, it opined.
The decision is significant given the striking price difference between the two versions of the drug. Roche’s risdiplam currently costs Rs. 6.2 lakh ($6982) per bottle. Since it has to be taken lifelong, the cost makes it unaffordable to most families.
Whereas Natco’s generic version
is expected to cost around Rs. 15,900 ($179) per bottle reducing the price by as much as 97 per cent, it added.
Third World Network (TWN) has been supporting SMA patients including the patient group patients living with spinal muscular atrophy (SMA), with their legal representations before the Indian Court, said that the division bench upheld a previous Court decision issued last March against a stop-order Swiss company Roche had launched against Indian generic manufacturer Natco for patent infringement of the drug risdiplam. The Court said there were legal grounds to believe that the patent could be revoked for not being new.
Chetali Rao, scientific researcher with TWN, the Court's decision sends a message to pharmaceutical companies. “Today’s decision underscores a simple truth, evergreening is not innovation. When patents on life saving drugs are allowed to be evergreened through minor modifications to emulate a new invention when clearly there is none, it delays generic entry and keeps prices high forcing patients to unaffordable treatment,” she said.
Currently, in India, risdiplam costs $81,000 per year for an adult patient. Consequently, patients cannot access the medicine on their own and the government is also not able to offer enough for India's over 5,000 patients currently living with SMA and 3,200 children born every year with the disease.
K M Gopakumar, senior researcher, TWN, said that other countries should seize this opportunity and promote access for the many SMA patients around the world.
“They can source generic risdiplam from India if risdiplam's patents are not valid in their countries or consider issuing a compulsory license,” he said.
The Working Group averred that access to life-saving medicines should not depend on the people’s ability to pay and urged the Central government to take proactive steps to procure the generic version of risdiplam under the National Policy for Rare Diseases to facilitate timely and equitable access to this life saving medicine.
It also extended its gratitude and appreciation to senior advocate Anand Grover and Advocate Rajeswari for their dedicated representation of the SMA community and continued advocacy for the right to health and access to affordable medicines.
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