Rare Diseases: Delhi High Court Calls For Plan To Publicize Crowdfunding Platform Among Top Companies, PSUs For CSR Contributions

The Delhi High Court on Friday called for preparation of a plan to publicize the crowdfunding platform, which has been setup under the national policy for rare diseases, among top private companies and public sector undertakings (PSUs) for receiving their contributions under Corporate Social Responsibility (CSR).

Justice Prathiba M Singh was hearing a clutch of petitions concerning children suffering from rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's syndrome. The pleas seek directions to provide them free of cost treatment, which is otherwise very expensive.

Noting that the court had directed setting up of a crowdfunding platform by the Centre under National Rare Diseases Policy on March 23, 2021, Justice Singh said:

"The said crowdfunding platform is operational, however, it appears that the same requires to be publicized in order to attract funding from the general public and corporate entities as also PSUs."

While directing the Centre to prepare a plan for its publicity, the court ordered that details relating to the crowdfunding platform be communicated to the "Navratna PSUs and at least the top 10 private companies in India" so as to enable them to consider contributing under their CSR accounts.

"There shall be proper follow up of these communications. Any responses received shall be placed on record," the court said.

Justice Singh also sought response of the Centre through the Ministry of Health and Department of Biotechnology on the data regarding the number of patients in respect of whom the Centres of Excellence have recommended treatment.

The court also sought data in respect of the number of patients to whom amounts have been disbursed to the Centres of Excellence and the timelines being followed by the Ministry in approving the same.

Observing that despite repeated orders the patients with DMD rare diseases have not started receiving their treatment, the court directed AIIMS to file a response on the expected timeline for receiving medicine and its administration in such cases.

The court was also apprised that a memorandum of understanding (MOU) was entered between BIRAC and Hanugen Therapeutics Private Limited on January 8, 2021. 

As per the said MOU, the company (Hanugen Therapeutics Private Limited) is to conduct a multicentric study for therapeutic evaluation in respect of DMD patients. The court noted that in terms of the agreement, 50% of the fund for the said study is to be contributed by the Centre whereas the other 50% fund is to be contributed by the company itself.

While the total approved amount for the study is Rs. 9.24 crores, the court was informed that only the first tranche of Rs. 1.41 crores has been released, adding that there was shortage of funds.

During the hearing, the company's representatives appeared before the court and stated that the phase two and phase three trials of the therapy has been approved by the DCGI and that they have enrolled 54 patients for conducting the two trials. The court was however apprised that the commencement of the trial has been delayed due to the lack of funds.

Noting that DMD is a rare disease which is prevalent in a large number of patients in India, Justice Singh said that the indigenous development of therapy is extremely crucial "in order to avoid investment on expensive medication which is also not easily available in India."

"The same is in fact imported from US and thus, if the trial which is approved is allowed to be completed and if it is successful, the same could act as a major solution for patients suffering from DMD in India," the court said.

Accordingly, the court directed the company's officials to place on record an affidavit giving the details of the funding, the patients, DCGI approval and the manner in which the phase two and phase three trials are to be conducted, within a period of one week.

The court also directed Centre's counsel to obtain appropriate instructions as to whether a sum of Rs. 5 crores can be released on an urgent basis in order to enable the company to commence the clinical trials.

The matter will now be heard on December 22.

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

Citation: 2022 LiveLaw (Del) 1160