A certain medicine called Risdiplam by Roche Pharmaceuticals, for patients of spinal muscular atrophy (SMA) costs Rs 72 lakhs a year in India. A case in this regard has been going on in the Kerala High Court for a while now. On 22nd the Central government submitted an affidavit in response to a complaint filed by the petitioner.
"The government is basically just shrugging its responsibility from providing life-saving treatments to people when it is the people's right to life-saving medicines. We know the prices can be brought down and the production cost is only Rs 3,000 and there are companies in India who can make it and will make it at a fraction of the cost at which Roche is making now," says Jyotsna Singh.
However, the government's argument is that because it is such an expensive medicine, it will take crores of rupees if the government were to provide it to all patients suffering from SMA in the country.
In the affidavit, the Central government acknowledges the staggering cost of SMA therapies—ranging from Rs 50 lakh to Rs 8 crore per patient annually, with gene therapies costing between Rs 9 crore and Rs 30 crore per patient. This results in an unbudgeted national expenditure of Rs 6,400 crore to Rs 34,000 crore each year.
The government argues that such costs are beyond its financial reach. Activists though, maintain that it is up to the government to allow generic production in the country and bring the price down, thereby making it available to everyone in need. This approach leaves patients and families without a sustainable path to life-saving treatments. It also fails to inquire about the transparency of pharmaceutical pricing.
The government, in its affidavit, also contests the efficacy of Risdiplam on adults, maintaining that it is more effective on children than on adults. The affidavit notes that "on examination of the patient, the Rare Disease Committee of SAT Hospital, CoE, Thiruvananthapuram has not recommended to incur expenditure on the patient as the Committee has opined that the drug is more beneficiary for younger children and since in older individuals the death of the involved cells has already occurred, the benefit of the drug is theoretically less."
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The patient here represents thousands of other SMA patients in India. Saifullah Khalidi, an adult in his 30s who was present in a media briefing arranged by the Working Group on Access to Medicines and Treatments, suffers from SMA.
Khalidi contests the government's stance, saying, "Instead of shifting the burden on patients and their families, the Ministry of Health needs to look for ways and means to reduce the cost of Risdiplam. This is a matter of equity and compassion."
SMA impacts individuals differently depending on the severity of their condition. However, it is universally marked by progressive muscle weakness and loss of function.
Over 8,500 people, ranging from newborns to those over 60 years of age, have received treatment with Risdiplam.
"Data from trials for Risdiplam reinforce long-term efficacy and safety profile in some of the most severely affected people with SMA type 2 and 3. This trial included people with advanced disease, and not just kids," says Chetali Rao, a legal and pharma expert working on rare diseases.
SMA activists believe that even as the high prices of SMA treatment/medicines remain, "it does not absolve the responsibility of the government from its moral and constitutional obligations."
The government, say activists, is empowered with effective law and policy tools and therefore should facilitate the availability of Risdiplam at an affordable price using those tools. Section 100 of the Indian Patents Act empowers the government to issue a government-use license to facilitate affordable generic production.
"It is also a well-known fact that Indian companies possess the ability to produce the generic version of Risdiplam. The Ministry of Health should act swiftly and not push the lives of thousands of SMA patients to the edges," says patient Khalidi.
