[Children With Rare Diseases] Delhi High Court Asks Centre To Reconsider Its Stand On Funding Clinical Trials

The Delhi High Court has asked the Centre to take a "more pragmatic view" on its suggestion that the financial support of Rs 50 Lakh per patient for treatment under the National Policy For Rare Diseases could be also considered for covering the expenses likely to be incurred in the clinical trials under which 54 children are already enrolled.

Responding to the observations made by the court in August, the Central Technical Committee for Rare Diseases (CTCRD) in a September 02 meeting observed that the amount is to be released only for "treatment of rare diseases" and the responsibility of conducting a clinical trial of a drug lies on the developer until the efficiency and efficacy of that drug is duly proved.

The Committee said the undertrial drugs would not qualify as treatment and perhaps may not fall within the ambit of support scheme as framed by the central government.

However, Justice Yashwant Varma in the order dated October 18 said that undisputedly all drugs which are being presently administered to the children suffering from rare diseases are "in one sense experimental therapies", adding that even the Centre and AIIMS have conceded that there is a lack of definitive research material on efficacy of the drugs being imported for the purposes of treatment.

"Viewed in that light, the experimental drug which has been indigenously developed would also fall within the same category," said the court.

It added, "The Court is thus of the considered view that the issue would warrant a more pragmatic view being taken bearing in mind the costs involved in the import of drugs which too are untried and untested."

On the other objection raised by the CTCRD that the release of Rs 50 Lakhs per patient is linked to the treatment being undergone in the Centres of Excellence and not all trial sites fall within the list of COEs, the court noted that out of the nine trial sites, at least the Indira Gandhi Institute of Child Health, Bangalore; AIIMS, Delhi and Post Graduate Institute of Medicine and Research, Chandigarh do fall within the category of Centres of Excellence.

"Consequently, the Union, while considering its decision with respect to the ambit of the Office Memorandum of 19 May 2022 afresh and whether its provisions would be applicable to clinical trials, may also consider the release of the grant as envisaged in respect of at least those patients who stand enrolled and form part of the clinical trial which is to be undertaken in the three trial sites noticed above," said the court.

Justice Varma also asked the CTCRD to bear in mind the geographical constraints that may be faced by the patients enrolled in the clinical trial "if the aforesaid restriction" were to be strictly construed.

"However, the aforesaid directions are not liable to be construed as confining the CTCRD in any manner from considering the data which has been collated and placed before the DGCI in the trial phases which have been completed and independently evaluating whether the same would warrant further exploration," said the court.

The court 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 also noted the statement made on behalf of AIIMS stating that the funds for all the petitioners (children with rare diseases) have been received by it and that the process of procurement of necessary drugs and their import has commenced.

An assurance was given to court that AIIMS will take expeditious steps to ensure that the procurement process is completed so that the treatment can commence.

The matter will now be heard on November 29.

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

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