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Synopsis

The Delhi High Court directed the Centre to take a more pragmatic approach to extend financial assistance to patients suffering from rare diseases, based on its proposal to support up to Rs. 50 lakhs per patient for "treatment" of rare diseases.

A single-judge bench of Justice Yashwant Varma was hearing a batch of petitions concerning children with rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's Syndrome, etc. The pleas prayed for directions to provide the children treatment, free of cost, as the medical treatment for such diseases was very expensive. 

As per the meeting of the Central Technical Committee for Rare Diseases (CTCRD) held on September 2, 2022, the CTCRD has proceeded to observe that, in accordance with the guidelines and procedures for extending financial assistance to patients suffering from rare diseases, it is of the opinion that support of up to Rs. 50 lakhs per patient is to be released for the treatment of rare diseases.

The CTCRD has stated that the responsibility for conducting a clinical trial of a drug rests solely with the drug developer until the drug's efficiency and efficacy are proven. So, it has been decided that drugs under trial would not qualify as treatment and may not fall within the scope of the Union's support scheme.

However, the Court noted that undisputedly, all drugs currently administered to children suffering from rare diseases are experimental therapies in some way and that it is evident from stands taken by the Centre and AIIMS while noting the various drugs currently being imported, contended that there was a lack of definitive research material that could demonstrate the efficacy of the drugs being used for treatment. “The indigenously developed experimental drug would also fall into the same category,” the court added.

The Court, thus, opined that the issue would warrant a more pragmatic approach, given the costs involved in the import of drugs, which are also untried and untested.

On the other issue raised by the CTCRD on the release of Rs. 50 Lakhs per patient being linked to the treatment being undergone in Centres of Excellence (CoE) 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 CoE.

Consequently, the court stated that the Union, while reconsidering its decision on the scope of the Office Memorandum of May 19, 2022 and whether its provisions would be applicable to clinical trials, may also consider releasing the grant in respect of at least those patients who have enrolled and are part of the clinical trial to be conducted in the three trial sites mentioned above.

The court added that if the aforementioned restriction is strictly construed, the CTCRD may also consider the geographical constraints that patients enrolled in the clinical trial may face.

“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,” the court stated.

Furthermore, the court noted that counsel for AIIMS submitted that the necessary funds for all petitioners have been received and that the process of procuring and importing the necessary drugs has already begun and he also assured that expeditious steps will be taken to ensure that the procurement process is completed so that treatment can begin.

Accordingly, the court listed the matter for November 29, 2022.

Earlier, in June, the court admitted that there was a lack of research in the course of treatment, which may establishing long term outcomes of the treatment protocols being followed. However, that would not detract from the right of the patient, to receive such treatment. 

The observations of the court were made after the All India Institute of Medical Sciences (AIIMS) examined the medical records of children suffering from rare diseases. The AIIMS Expert Committee recommendations were placed before the court wherein the committee had opined that the administration of the drugs may help in the decline in cardiac as well as ambulatory functions in some of the Petitioners. 

The Court was further apprised of the issuance of an Office memorandum dated May 19, 2022 in terms of which it has been provided that financial support upto Rs. 50 lakh would be given by the government, under the Umbrella Scheme of Rashtriya Arogya Nidhi, to those who suffer from rare diseases as listed. 

The Court had also directed the competent authority in the Department of Biotechnology to explore other generic forms of treatment that may be under development and may warrant consideration. 

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