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Synopsis

The Delhi High Court directed the Centre to release Rs. 5.35 crore to fund clinical trials for the treatment of rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's Syndrome, etc.

Justice Prathiba M. Singh 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 is very expensive. 

Justice Singh noted that the gravity of the issue of rare diseases is yet to be fully recognized, with the involvement of the Department of Biotechnology, MoH & FW, AIIMS, and others, therefore, the Court is monitoring and supervising the treatment of children suffering from rare diseases.

“The Court believes that the development of treatment for children with rare diseases should be considered a 'Nationally Important Project' due to the enormity of the issues confronting these children”, the single-judge bench added.

During the hearing, the court was informed by the Centre that a meeting was held with various ministries, industry associations, and PSUs to educate them about rare diseases and the importance of voluntary donations. It was also informed that the MoHFW had requested that donations for rare diseases be included in Schedule VII of the Companies Act as CSR, but that the MCA had not yet responded.

To this, the Court directed, “In order to ensure that there is a specific recognition of donations for rare diseases this court is of the opinion that the same ought to be included in schedule VII as requested by the MoHFW and the MCA is directed to file an affidavit as to the status of this request”.

Furthermore, the court noted that Hanugen Therapeutics Private Limited, the company that had agreed to conduct the clinical trials with the Biotechnology Industry Research Assistance Council (BIRAC) last year, was unable to begin them due to a lack of funds.

Taking note of the submissions made, the court directed BIRAC to release Rs. 5.35 crore to Hanugen to begin the clinical trials and further directed both to draft a fresh agreement and place it on record.

Earlier, the court suggested the Centre to widely publicize the crowd-funding platform under the National Rare Diseases policy for the treatment of children with rare diseases.

Justice Singh had directed the Centre to prepare a detailed plan for the publicity of the crowd-funding and also directed the same to be communicated to the Public Sector Units (PSUs) as well as corporate entities so that they consider contributing under their Corporate Social Responsibility (CSR) Accounts. Furthermore, the court had directed that there shall be a proper follow-up of these communications and any response shall be placed on record.

In October, a single-judge bench of Justice Yashwant Varma 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. Justice Varma had 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.

In June, the court admitted that there was a lack of research in the course of treatment, which may establish 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 court said then. 

The court's observations 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 which it had been provided that financial support up to 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 then 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.