Delhi High Court Comes To Rescue Of Rare Disease Sufferers; Directs Notification Of National Policy Of Rare Diseases
The Delhi High Court recently directed the Central government to issue notification of National Health Policy for Rare Diseases on or before March 31, 2021.
The interim order was passed by the Single Bench of Justice Prathiba M Singh in relation to petitions concerning children suffering from rare diseases. The Bench also directed setting up of National Consortium for Research, Development and Therapeutics for Rare Diseases.
Comprehensive directions were passed by the Court After considering the report of an expert committee and the affidavit of the Ministry of Health & Family Welfare, the comprehensive directions were passed for setting up of a Rare Diseases Committee at AIIMS for the examination of applications for treatment and funding with respect to rare diseases.
It was also directed that once an application is received directly at AIIMS, a decision has to be taken by the Committee within two weeks. In case an application is received through other institutions notified under the Policy, the decision has to be taken by the Committee within four weeks.
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 January 28, 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 March 02, 2021 the Bench constituted a Committee to report on the aspects related to National Health Policy For 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 recognized 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.
Noticing that there is shortage of funds for the scheme, the court said that the entire unspent budget allocated for rare diseases for the past three years shall be immediately moved into the Rare Diseases Fund. The court said that AIIMS shall be the nodal agency for management and supervision of this Fund.
Earlier this year, the Court had opined that right to health and healthcare was a fundamental right, and therefore, finalisation of the policy on rare diseases could not be kept pending indefinitely. This led to constitution of a nine-member Committee to deal with issues being faced by persons suffering from rare diseases.
The court stated that the Consortium shall consist of the Department of Biotechnogy, ICMR, CSIR, other related ministry and departments, and hence, they will conduct R&D for development of indigenous treatment, manufacturing of drugs and inclusion of persons in clinical trials.
The government may consider for increase of the budget for rare diseases for the upcoming financial year, said the court.
As per the Court's directions, the Policy shall be placed before it, and the petitioners before it can make a representation to the Committee. The matter is placed for next hearing on April 19, 2021.