Delhi High Court Directs Centre To Constitute National Rare Diseases Fund, Orders Mandatory Monthly Meetings To Monitor Disbursement Of Funds

The Delhi High Court on Friday directed the Union Government to constitute a “national rare diseases fund” and ordered mandatory monthly meetings to monitor disbursement of funds and to identify delays, if any.

Justice Prathiba M Singh directed that the National Rare Disease Committee (NRDC) constituted by the Court on May 15, 2023, shall continue to function for a further period of five years.

“The Union of India shall establish the national fund for rare diseases, for which the sum of Rs. 974 crores, as per the recommendation of the NRDC and pending approval of Ministry of Health, shall be allocated for the financial years, 2024-25 and 2025-26,” the court ordered while pronouncing the verdict.

Justice Singh expressed her confidence that once the fund is created, over the next few years, efforts would be made to reduce the prices of drugs and make them more accessible.

The Court passed the order while disposing of a batch 105 petitions concerning the treatment of children suffering from rare diseases like Duchenne Muscular Dystrophy and Hunter's syndrome.

The petitions sought free-of-cost treatment for the patients, which is otherwise very expensive. The Court has been passing various orders in the pleas from time to time, since 2020.

The directions are as follows:

- Crowdfunding and CSR (corporate social responsibility) funding would also bring in additional funds for tackling rare diseases.

- Union of India ought not to be deterred from accepting the recommendation of NRDC and releasing the Rs. 974 crores.

- Approval for this transfer of said funds to be granted and amounts to be transferred to the National Fund for rare diseases within 30 days by the concerned ministries and competent authorities.

- There should be a mandatory monthly meeting between the Ministry of Health and Centers of Excellence and NRDC to monitor the disbursement of funds and identify any delays. The first meeting should be scheduled within 30 days.

- The said amount should be utilized for providing treatment to all the petitioners who are suffering from Rare diseases.

- The medicines shall be procured by the Ministry of Health at the prices negotiated by the NRDC.

- The NRDF shall be administered by the National rare disease cell, consisting of one or more nodal officers in the Ministry of Health, who shall release the funds for treatment of patients under the national policy for rare disease as directed by the NRDC.

- The fund would not lapse or revert due to under utilization. Monthly reports of utilization of the fund shall be submitted to the NRDC.

- Within a period of three months, the Union of India should develop and operationalize a “centralized national Rare Disease Information Portal” that includes a patient registry, available treatments, nearest COEs and updates on fund utilization. This portal should be accessible to patients, doctors and the general public.

- The crowdfunding platform, which is already operational, shall be under the supervision of the nodal officer Ministry of Health, so that adequate publicity shall be given to that.

- Requisite notifications for granting GST customs waivers and exemptions and the Income Tax Act shall be issued within 30 days.

- Donations for rare diseases shall be added in schedule seven of the Companies Act to enable CSR contribution.

- Union of India shall direct DCGI and CDSCO to create a “dedicated Fast Track approval process” for rare disease drugs and therapies within 60 days. All application for rare disease therapy shall be processed within 90 days from submission.

- The Union of India is directed to expand the number of COEs considering the patient density.

- The DCGI and CDSCO shall coordinate on the issue whether orphan drugs for the treatment of rare diseases ought to be regulated.

- The DCGI and CDSCO are directed to keep a watch out for clinical trials, both global and local, so that more and more patients can be enrolled, especially when the medicines are unaffordable. They may also consider granting exemptions for conducting clinical trials in terms of the extant rules prior to approval or even post factor approval may be explored.

- The Union of India is directed to review its policies relating to local manufacturing or medical equipment.

- The Nodal official who shall be responsible to coordinate between NRDC and Ministry of Health shall be identified and notified within one week.

- The pharmaceutical companies should have a proper distribution network to ensure continuous supplies as per the prices which are agreed with the NRDC.

In her verdict, Justice Singh held that the right to health, which is an integral part of the right to life enshrined under Article 21 of the Constitution of India, cannot distinguish between persons with more prevalent diseases on one hand and rare diseases on the other hand.

“To discriminate between patients suffering from more prevalent diseases and those who suffer from Rare Diseases would also be discriminatory and violative of Article 14 of the Constitution of India. The right to health has to be equally recognized for persons suffering from Rare Diseases,” the court said.

It added that while there is no doubt that the constitutional obligation to provide healthcare rests upon the State, the same is to be balanced with the available constraints. However, the recognition of the right to health and healthcare cannot be completely negated due to these constraints, the court said.

Justice Singh also said that the country ought to strive to provide healthcare to person with rare diseases within the available limitations and in the best possible manner.

“There is gross under-utilization of budgets. The same is obviously not due to lack of patients and lack of medicines, but due to lack of streamlined procedure for ensuring enrollment of patients with rare diseases, evaluation of the said patients, procurement of medicines and administration of the medicines,” the court said.

Earlier this year, Justice Singh had clarified that custom duties and charges shall not be levied on medicines, drugs and therapies for rare diseases.

In November last year, the Court had directed the All India Institute of Medical Sciences (AIIMS) to commence the process of procurement of medicines for children with rare diseases, for whom evaluations have been completed and who are amenable to treatment, as per the fund of Rs. 50 lakhs allocated per patient in terms of the Rare Diseases Policy.

In May last year, Justice Singh had constituted a five-member committee so that the National Policy for Treatment of Rare Diseases, 2017 can be implemented in an efficient manner and also to ensure that its benefits reach the ultimate patients.

The Committee was directed to hold deliberations with companies manufacturing and marketing medicines for Spinal Muscular Atrophy, a genetic rare disease, to explore the possibility of procuring the medicines at a reasonable price.

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