The Delhi High Court has consituted a nine-member Committee to deal with issues being faced by persons suffering from rare diseases such as Duchenne Muscular Dystrophy (DMD), Hunter’s syndromes, in a time-bound manner (Master Arnesh Shaw vs UOI).
A single-judge Bench of Justice Prathiba M Singh directed the Committee to submit a report on:
– How to immediately provide treatment and therapy options to patients suffering from DMD, Hunter’s syndromes and other rare diseases.
– Steps to be taken to indigenize the development of the therapies in India, and reasonable timelines required to be followed.
– Whether accelerated approval processes can be considered especially in view of the research currently being undertaken in India for DMD?
– Immediate concrete proposals for crowdfunding of the costs of treatment for children with rare diseases.
The Court was dealing with petitions concerning children suffering from a rare disease.
The Court also directed the Central government to state on affidavit its budget for health in the last five years and whether the unused budget, if any, can be used for the purpose of treatment of the petitioners or the indigenous development of therapies for the treatment of rare diseases.
In view of the affidavit filed in the matter, the Court observed that the Central government’s clear stand appeared to be that until the policy on rare diseases gets notified and the e-platform for crowdfunding is created, there could be no crowdfunding that can be explored.
It noted that nonetheless, orally, the representative of Ministry of Health, Union of India had informed that a communication was sent to four organisations to arrange for funding for treatment of the patients in question.
Based on the affidavits submitted by other parties, the Court recorded that various organisations and companies were presently conducting clinical trials in respect of DMD therapies.
The Court accordingly opined that the feasibility of accelerated approval processes ought to be examined and the Centre ought to explore the confidential proposal which is being put forward by one M/s Sarepta Therapeutics for the purpose of making the therapy available for children who are suffering from DMD.
The matter would be heard next March 15.
Earlier this year, the Court had directed the Central government to give a specific timeline with respect to finalisation and notification of the Draft Health Policy for Rare Diseases, 2020.
The Court had opined that finalisation of the policy could not be kept pending indefinitely since human lives were involved.
Advocates Ashok Aggarwal, Kumar Utkarsh, Vivek Chib, Rahul Malhotra, Asif Ahmed, Manas Tripathi represented various petitioners.
ASG Chetan Sharma with Standing counsel Ripudaman Bhardwaj, Ajay Digpaul, Amrita Prakash appears for Centre.