The Delhi High Court, on a representation by senior advocate Anand Grover, has directed the National Rare Diseases Committee to make efforts to make cheaper medication available to patients of spinal muscular atrophy, ensure better healthcare for them, and promote indigenous research on medication for the debilitating wasting disease.
—
THE Delhi High Court has directed the National Rare Diseases Committee (NRDC) to speak to companies manufacturing medicines for spinal muscular atrophy (SMA) "to explore the possibility of procuring the medication at a reasonable cost."
Justice Prathiba M. Singh was hearing a petition for making SMA medication available at a reasonable price for treatment of patients suffering from the rare SMA disease.
SMA is a rare neuromuscular progressive genetic disease which affects the nervous system and requires medication intervention on a regular basis.
SMA causes loss of nerve cells called motor neurons and is thus classified as a motor neuron ailment. Most motor neurons that control muscles are in the spinal cord, which accounts for the word 'spinal' in the name of the ailment.
On March 15, 2023, the court empanelled a National Rare Disease Committee while hearing a batch of writ petitions filed by the family members of patients suffering from rare diseases such as Duchenne muscular dystrophy (DMD), Gaucher and Hunter's syndrome.
The court also directed the committee to take all steps needed for implementation of the National Rare Disease Policy, 2021.
Senior advocate Anand Grover, who appeared for the organisation CureSMA India, submitted before Justice Singh that Biogen, Novartis and Roche manufacture medications for SMA.
Grover pointed out that the medication Evrysdi-Ridisplam, manufactured and marketed by Roche, costs ₹6,23,000 per bottle in India. He stated that patients weighing more than 20 kg need roughly 36 bottles of the medicine in a year.
Grover further submitted that the same medicine manufactured by the same company is available at one-tenth the Indian price in countries such as China (₹44,692 per bottle) and Pakistan (₹41,002 per bottle).
He handed over Justice Singh a note in this regard. After perusing the note given by Grover, Justice Singh opined that there is a possibility for the NRDC speaking to these companies in order to source cheaper medication for SMA patients.
While directing the NRDC to speak to the manufacturing companies, Justice Singh emphasised that effective deliberations between the companies and the NRDC, and a positive response from the companies, would have a substantial impact on the lives of children who are suffering from rare diseases.
Advocate Vidhi Jain, appearing for the respondent, Union of India, informed Justice Singh that the NRDC is currently holding deliberations with various companies, including Sarepta and Sanofi, in order to explore the possibility of obtaining medications at a more reasonable price for children affected by rare diseases.
Justice Singh asked the NRDC to file a status report before the next date of hearing on August 3, on the progress made by it in the negotiations with companies manufacturing and marketing medicines for rare diseases.
CureSMA India, for whom Grover appeared, requested the court to direct the Ministry of Health and Family Welfare to negotiate with the pharmaceutical companies and provide at least one approved medicine to all persons living with SMA irrespective of their age or the type of SMA from which they were suffering.
The organisation also submitted that India could negotiate with members of South Asian Association for Regional Cooperation (SAARC) as well to procure cheaper medicine for rare diseases such as SMA from them.
CureSMA India has made several suggestions through its petition.
It has suggested that persons living with SMA should not be left to the mercy of donors on crowdfunding portals as mentioned in the National Rare Disease Policy, as doing so has not helped a single patient till date and violates the patients' privacy.
CureSMA India has pointed out that there have been instances where miscreants have tried to use the personal data of persons living with SMA and make false promises to them for a fee. Access to personal mobile numbers and addresses are available to the public at large through the portal. CureSMA India has suggested that such brazen data sharing must stop.
CureSMA India has pointed out that the National Rare Disease Policy does not specify any timelines for provision of treatment, whereas a majority of these rare diseases are progressive in nature and need to be dealt with sooner than later.
In absence of treatment, the health of SMA patients deteriorates, leading to multiple disabilities over a period of time. Lack of focus on timelines consigns more and more children suffering from SMA to wheelchairs. CureSMA India suggests that the government should be directed to introduce timelines for the provision of medicines in the National Rare Diseases Policy.
CureSMA India has stated that the present classification of diseases in the National Rare Diseases Policy does not address the severity of diseases. The classification is formed on the availability of data which can only be gathered when the process of treatment has started.
It has also been suggested that the price for treatment can only come down through negotiations with pharmaceutical companies and when indigenous research and development in relation to the medications increases.
CureSMA India has also called for GST and other taxes and import duty exemptions on life saving medications.
It has also called for such exemptions on medical devices such as Bipap machines, cough assists, suction machines, oxygen concentrators, orthotic devices such as spinal braces, ankle foot orthosis (AFOs), knee ankle foot orthosis (KAFOs)
CureSMA India has suggested that the exemptions be extended to mobility and assistive devices such as wheelchairs, hoist, transferring wheelchair, gel bases cushions for prolonged seating and several such equipment required by patients and caregivers in day to day lives of a person living with SMA.
Exemptions on custom duty on import of life saving medicines were also suggested.
CureSMA India has pointed out that such exemptions have already been given in a select number of cases involving imports by individual patients or on humanitarian or global access grounds.
CureSMA India has also requested that the Ministry of Health and Family Welfare be directed to consider making supporting organisations such as CureSMA India 'key stakeholders' with access to all policy discussions and meetings related to rare diseases.
It has also requested that the Department of Science and Technology and the Indian Council of Medical Research provide funds to institutes such as Indian Institute of Technology, Kanpur, who are ready to support indigenous research on such rare diseases.
CureSMA India has also requested the government of India to establish 'centres of excellence' on rare disease treatment in all states. It has further requested that the process of enrolment should be streamlined and there should be collaboration with organisations working with SMA patients to ensure proper patient registrations and cashflow.
Finally, the Ministry of Health and Family Welfare has also been requested to consider providing holistic care to all persons living with SMA in India.
Click here to read the High Court Order.