Treatment Of Rare Diseases | Can Financial Aid Cover Expenses For Clinical Trial Of Experimental DMD Drug? Delhi High Court Seeks Centre's Stand

The Delhi High Court has sought the stand of Central Government on the aspect if financial aid for treatment of children with rare diseases can cover expenses that will be incurred in the second and third phase of clinical trials of the experimental drug Duchenne Muscular Dystrophy (DMD) and treatment of children enrolled in the said trials.

Justice Yashwant Varma was hearing a clutch of petitions concerning children suffering from rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's syndrome. The pleas sought directions to provide them free of cost treatment owing to the reason that the medical treatment involved was very expensive.

The Court was of the view that apart from benefits of cost saving, the trials may lead to the rollout of a readily accessible drug for DMD in the country.

"The imperatives for favorable consideration and exploration of this line would be guided by the stark difference in the price of the trial drug when compared to that of other experimental remedies currently available as well as the possibility of the drug which has been indigenously developed then being adopted for treatment of many more DMD afflicted children in our country and across the globe," the Court said.

In the previous hearing, the Court was apprised that the Centre had issued an Office Memorandum dated May 19, 2022 in terms of which it has been provided that financial support of upto Rs. 50 lakhs shall be provided to patients suffering from any category of rare diseases.

Yesterday, the Court took note of the Office Memorandum and noted:

"The said Office Memorandum envisages the extension of financial support up to Rs.50 lakhs for treatment of patients suffering from any of the rare diseases catalogued in the National Policy for Rare Diseases, 2021. The permission which has been accorded for the clinical trial of the experimental drug is in respect of DMD which has been duly recognized as one of the rare diseases in the National Policy."

While being conscious that the drug was yet to go through rigorous clinical trial to ascertain its efficacy, the Court noted the opinion of AIIMS which had said that the drugs currently being adopted for treatment "may help in attenuating the decline in cardiac and respiratory functions".

"Admittedly, even for those exorbitantly priced drugs there are no long-term clinical studies available and they thus all so remain in the realm of experimental therapies. 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," it said.

The matter will now be heard on September 9.

Earlier, the Court had observed that the treatment of children suffering from rare diseases would not merit being deferred on the ground that long term clinical trial studies are not available or that adequate evidentiary material does not exist.

Case Title: Master Arnesh Shaw v. Union of India & Anr.

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