Delhi High Court Constitutes Committee To Finalise Draft Health Policy For Rare Diseases
The Delhi High Court, given the absence of a policy to deal with patients suffering from rare diseases, has constituted a Committee to finalize a Draft National Health Policy for Rare Diseases (“National Policy”).
The Policy aims at lowering the incidence and prevalence of rare diseases based on an integrated and comprehensive preventive strategy encompassing awareness generation and screening programs to prevent births of children with rare diseases, and, within the constraints on resources and competing health care priorities, enable access to affordable health care to patients of rare diseases which are amenable to a one-time treatment. The Policy was formulated earlier in July 2017 but was kept in abeyance vide non- statutory Gazette Notification dated 18th December 2018, till a revised version of the National Policy was issued. In November 2018, an Expert Committee was constituted by the Ministry of Health & Family Welfare (“MHFW”) to review the Policy and draft a National Policy. The Expert Committee submitted a report titled ‘The Draft National Policy for Rare Diseases, 2020’, and the same was put up in the public domain for comments from stakeholders. The National Policy is likely to be finalized by 31st March 2021, and a digital platform will also be created that will be operational by 31st March 2021.
“Considering the fact that for the last more than three years, there has been no policy to deal with patients suffering from rare diseases, the Ministry of Health & Family Welfare (“MHFW”) is now directed to finalise and put in public domain, the National Policy on or before 31st July, 2021. Simultaneously, since the said policy also contemplated voluntary crowd funding for treatment, the creation of a digital platform is also essential to enable patients like the Petitioners to avail of funding for medicines and treatment. Considering the urgency in the matter, the digital platform is also directed to be made operational on or before 31st March, 2021.”, the Bench directed.
The present issue arose from a petition filed by the petitioner suffering from Duchenne Muscular Dystrophy (DMD) praying for issuing directions to AIIMS & Central Government to treat the same by procuring Exondys-51 (eteplirsen) Injection developed in the USA.
“As per estimates, there are more than 5 lakh patients suffering from Duchenne Muscular Dystrophy (hereinafter ‘DMD’) and if genetic therapy is to be provided to all such patients in India, the current cost of such therapy is approximately Rs.6 crores per year per child”
On 28.01.2021, the Court on considering the exorbitant price of the drug and the treatment passed the following directions:
(1)A specific timeline shall be provided by the Secretary, Ministry of Health and Family Welfare, in respect of the finalisation and notification of the Draft Health Policy for Rare Diseases, 2020.
(2)Insofar as the Petitioners, who are suffering from DMD, are concerned, the Secretary - Ministry of Health and Family Welfare would proceed in terms of the draft policy and explore crowdfunding, including through prospective individuals, corporate donors and independent foundations, which exist to fund such treatments. The Ministry shall in addition also contact the company M/s Sarepta Therapeutics, USA, which publicly advertises that it provides financial support/ medication in deserving cases, as is evident from their website. The Ministry shall come up with a proposal, with respect to the same, within the next 10 days.
Thus, vide order dated 02.03.2021 the Bench constituted a Committee to report on the following aspects related to National Health Policy For Rare Diseases:
- How to immediately provide treatment and therapy options to the Petitioners and similarly situated patients suffering from DMD, Hunters 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 thereof.
- 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 Single Bench of Justice Pratibha M Singh further directed for holding the first meeting of the Committee on 5th March 2021 at 3.00 p.m & submitting a report to this Court on or before 12th March 2021. The Union of India was also directed to file an affidavit specifying the budget for health in the last five years and whether any part of the budget has been unused and can be used to treat the Petitioners or the indigenous development of therapies for the treatment of rare diseases.
“Patients suffering from a rare disease ought not to be deprived of treatment owing just to the exorbitant price of the drug or treatment required for the said rare disease. The Court had considered the fact that the Right to Health and Healthcare falls within the ambit of the Right to Life, as recognised by the Supreme Court. As such, the Right to Health and Healthcare being a fundamental Right under Article 21 of the Constitution of India, it is imperative that the society in general, and the authorities in particular, ensures that such a right of a patient is safeguarded and not compromised, even with a small window of improving their chances of survival or bettering their quality of life” , the Court observed.
The matter is now listed for March 15,2021.
Case Title: Master Arnesh Shaw v. Union of India & Anr