HC seeks Centre’s stand on assistance to children suffering from rare disease

Justice Yashwant Varma asked the Centre to respond while hearing a bunch of petitions by patients suffering from rare diseases such as DMD and Hunter’s syndrome, seeking direction to the government to provide them uninterrupted free-of-cost treatment in view of the exorbitant treatment costs.

During the hearing on August 5, the High Court was informed by the petitioners that a drug for the treatment of DMD, a condition that causes progressive muscle degeneration and weakness in the victim, had been developed by Dystrophy Annihilation Research Trust. The results of the first stage trial, on an individual, had reportedly shown encouraging results.

The trust was now given the requisite approvals to undertake clinical trials for the second and third phase, for which 54 children had been enrolled. The treatment would entail an outlay of at least ₹20 lakh in the manufacture of doses for each enrolled child.

As per a May 19, 2022 office memorandum of the Ministry of Health & Family Welfare (Rare Diseases Cell), financial support of up to ₹50 lakh could be provided to patients suffering from rare diseases for treatment in any of the Centres of Excellence (CoE) established in eight premier government hospitals across the country.

Justice Varma said he was of the considered view that the financial support envisaged by the Ministry of Health & Family Welfare (Rare Diseases Cell) could be considered as covering the expenses likely to be incurred in the course of administration of the trial drug.

“Apart from the evident benefits of cost saving, the trials may perhaps lead to the rollout of a readily accessible drug for DMD in the country itself,” said Justice Varma.

“All of the aforesaid factors would thus merit consideration of the competent authority in the Union Government which may examine whether the expenses, which are likely to be incurred in the course of administering the drug to the 54 enrolled patients, would stand covered under Office Memorandum of 19 May 2022,” the court stated. It will now hear the case on September 9.