Treatment Of Children With Rare Diseases Cannot Be Deferred Due To Unavailability Of Long Term Clinical Trial Studies: Delhi High Court

The Delhi High Court has 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.

Justice Yashwant Varma was 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.

While admitting that there is a dearth of authoritative research material which may indicate or establish the long term outcome of the treatment protocols presently being followed, the Court observed:

"…..That, however, should not detract from the right of the patients to undergo the treatment options which are currently available and are being administered to similar patients across the globe even if they be viewed as experimental therapies."

The development came after the Court had earlier asked All India Institute of Medical Sciences (AIIMS) to examine medical records of children suffering from Duchenne Muscular Dystrophy (DMD) in order to frame a recommendation of whether commencement of treatment is likely to yield any results.

Accordingly, the recommendations of the AIIMS Expert Committee were placed on Court's record wherein the Expert Committee had opined, with respect to some of the petitioners, that the administration of the drug may help in attenuating the decline in cardiac and respiratory as well as ambulatory functions.

"Although the Committee has further gone on to observe that there is presently no evidence which may suggest that the administration of the drug would stop the disease from progressing and that long term outcomes are unknown, the Court is of the opinion that treatment to the aforenoted patients would not merit being deferred on the ground that long terms clinical trial studies are not available or that adequate evidentiary material does not exist," the Court said.

The Court was further 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.

"In view of the aforesaid and the communication of 25 May 2022, let AIIMS forward its proposal for commencement of treatment to the petitioners aforenoted to the competent officer in the Ministry of Health and Family Welfare, Government of India," the Court said.

The Court further directed the competent authority in the Department of Biotechnology to explore and file a response in the present writ petition disclosing other generic norms of treatment that may be under development in respect of children suffering from rare diseases.

The matter will now be heard on August 5.

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

Click Here To Read Order