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IN THE HIGH COURT OF DELHI AT NEW DELHI
Prathiba M.Singh, J.
Master Arnesh Shaw - Appellant
Versus
Union Of India & Anr. - Respondents
W.P. (C) No. 3682 of 2021, 3689 of 2021, 3706 of 2021, 3707 of 2021, 3729 of 2021, 3737 of 2021, 10782 of 2020, 322 of 2021, 1491 of 2021, 1511 of 2021, 1611 of 2021, 3859 of 2021, 3662 of 2021, 5315 of 2020; C.M. Appl No. 4291 of 2021, 812 of 2021, 33828 of 2020, 11277 of 2021, 11269 of 2021, 11229 of 2021, 11153 of 2021, 11179 of 2021, 11230 of 2021, 11647 of 2021, 4600 of 2021, 4331 of 2021, 4332 of 2021, 11103 of 2021, 11104 of 2021, 11105 of 2021, 19189 of 2020
Decided On : 23-03-2021
Rare Diseases - Treatment and Funding - Draft National Policy for Rare Diseases, 2020 - WP(C) 5315/2020, WP(C) 10782/2020, WP(C) 3682/2021, WP(C) 3689/2021, WP(C) 3706/2021, WP(C) 3707/2021, WP(C) 3729/2021, WP(C) 3737/2021, WP(C) 322/2021, WP(C) 1611/2021, WP(C) 3859/2021, WP(C) 1491/2021, WP(C) 1511/2021, WP(C) 3662/2021 - The court discussed the Draft National Policy for Rare Diseases, 2020, and issued directions for finalization and notification of the policy, establishment of a National Consortium for Research and Development on therapeutics for Rare Diseases, and creation of a Rare Diseases Fund managed by AIIMS for treatment and funding of patients suffering from Rare Diseases.
Fact of the Case:
The Petitioners, mostly children suffering from Rare Diseases, sought free treatment and therapies due to the exorbitant costs. The court called for the finalization of the Draft National Policy for Rare Diseases, and proposals for crowdfunding to meet the costs. It also constituted an expert committee to explore treatment options and indigenization of therapies.
Finding of the Court:
The court found that the exorbitant costs of drugs and therapies for Rare Diseases should not deprive patients of treatment, emphasizing the fundamental right to health and healthcare. It directed the finalization and notification of the Draft National Policy for Rare Diseases, establishment of a National Consortium for Research and Development, and creation of a Rare Diseases Fund for treatment and funding.
Issues: Exorbitant costs of treatment for Rare Diseases, finalization of the Draft National Policy for Rare Diseases, establishment of a National Consortium for Research and Development, and creation of a Rare Diseases Fund.
Ratio Decidendi: The fundamental right to health and healthcare under Article 21 of the Constitution necessitates ensuring treatment for Rare Diseases despite exorbitant costs. The court directed the finalization and notification of the Draft National Policy for Rare Diseases, establishment of a National Consortium for Research and Development, and creation of a Rare Diseases Fund.
Final Decision: The court issued directions for the finalization and notification of the Draft National Policy for Rare Diseases, establishment of a National Consortium for Research and Development on therapeutics for Rare Diseases, and creation of a Rare Diseases Fund managed by AIIMS for treatment and funding of patients suffering from Rare Diseases.
JUDGMENT
Prathiba M. Singh, J. - The Petitioners in these cases, who are mostly children, are suffering from the following Rare Diseases:
| Rare Diseases | Petitioners | Age | Writ Petition Number |
| Duchenne Muscular Dystrophy (hereinafter, DMD)
| 1) Master Arnesh Shaw | 7 years | WP(C) 5315/2020 |
| 2) Master Aviraj Garg | 4 years | WP(C) 10782/2020 | |
| 3) Master Harshit Soni | 16 years | WP(C) 3682/2021 | |
| 4) Master Dhananjay Bharadwaj | 11 years | WP(C) 3689/2021 | |
| 5) Master Khushwant Bhardwaj | 7 years | WP(C) 3706/2021 | |
| 6) Master Aarav Garg | 5 years | WP(C) 3707/2021 | |
| 7) Master Manish | 8 years | WP(C) 3729/2021 | |
| 8) Master Chirag | 6 years | WP(C) 3729/2021 | |
| 9) Master Shourya Maru | 7 years | WP(C) 3737/2021 | |
| 10) Master Keshav Sharma | 12 years | WP(C) 322/2021 | |
| 11) Master Lakshya Kumar Goya | 8 years | WP(C) 1611/2021 | |
| 12) Master Siddharth Swarnkar | 9 years | WP(C) 3859/2021 | |
| MPS II (Hunter Syndrome)
| 1) Master Medhansh Jhawar | 2 years | WP(C) 1491/2021 |
| 2) Master Kenit Jhawar | 3 years | WP(C) 1511/2021 | |
| Hippel- Linau | 1) Payel Bhattacharya | 41 years | WP(C) 3662/2021 |
2. It is the case of the Petitioners that the medicines and therapies for all these Rare Diseases are exorbitantly expensive, and directions ought to be issued to the Respondents i.e., the Union of India and its Ministry of Health and Family Welfare, All India Institute of Medical Science (hereinafter, "AIIMS"), as well as the GNCTD, to provide continuous and uninterrupted treatment to the Petitioners, free of cost.
3. On 17th August, 2020, notice was issued in WP(C) 5315/2020, to the Respondent- Union of India, and a counter affidavit had initially been called for from the Union of India. An affidavit was placed on record in W.P.(C) 5315/2020 stating that various health policies are under consideration by the Union of India, in respect of such Rare Diseases. As per the said affidavit, a Draft National Policy for Rare Diseases has been released by the Government in 2020, which was in the stage of consultation. The said draft policy of 2020 was preceded by an earlier policy of 2017 which was kept in abeyance vide notification dated 18th December, 2018.
4. On 12th January, 2021, this Court had observed that the various Rare Diseases have been grouped by the Union of India, in their Draft National Policy for Rare Diseases, as Group 1, 2 and 3. Further, the draft policy also prescribed the manner in which each of the said diseases was to be dealt with.
5. This Court after considering the matter observed as under:
"....4. This Court is of the opinion that just because of the exorbitant price of the drug or treatment, patients, especially children, suffering from a rare disease ought not to be deprived of treatment for their condition. The draft policy of the government, which was introduced in 2020 for consultation, has still not seen the light of the day. Considering the fact that 'Right to Health and Healthcare? is a Fundamental Right which has been recognised by the Supreme Court to be a part of the 'Right to life? under Article 21 of the Constitution, it is incumbent on society in general and authorities in particular to ensure that the life of such children is not compromised, even if there is a small window of improving their chances of survival or even providing a better quality of life.
......
8. This court is of the opinion that the finalisation of the Draft Health Policy for Rare Diseases cannot be kept pending indefinitely, especially when common human lives are at stake. The earlier Policy having been kept in abeyance, it is incumbent for the Government to finalise and notify the Policy at the earliest. Accordingly, it is directed as under:
(1) A specific timeline shall be provided by the Secretary, Ministry of Health and Fami
The fundamental right to health and healthcare under Article 21 of the Constitution necessitates ensuring treatment for Rare Diseases despite exorbitant costs, and the government's obligation to fina....
The court affirmed that the right to health, as part of the fundamental right to life under Article 21, requires timely access to treatment, especially for children with rare diseases.
The court mandated that the government ensure timely treatment and funding for patients suffering from rare diseases, establishing a comprehensive framework to facilitate compliance with health polic....
The central legal point established in the judgment is the need to facilitate the conduct of clinical trials, streamline the manufacturing and trials process, and ensure the implementation of the Nat....
The Court emphasized the need for efficient decision-making by the COE Committee and expressed concern over lapsing budgets and non-release of funds for the treatment of children suffering from Rare ....
The court emphasized the urgency of establishing a national policy for rare diseases, mandating timely action by the government for funding and treatment provisions.
The court emphasized the need for immediate treatment and funding for rare diseases, and referred the matter to the National Consortium for comprehensive recommendations.
The government has an obligation to invest in research for indigenous therapies, and the court can direct the commencement of treatment and release of funds for rare diseases treatment under the Rare....
Facilities for treatment of rare diseases would not be in place in the State in the near future without judicial interference.
The fundamental right to health and healthcare under Article 21 of the Constitution encompasses the responsibility of the government to ensure the availability of treatment for rare diseases, despite....
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