Child suffering from a rare disease will not be deprived of the treatment because of the high cost of the Medication: Delhi High Court

14 & 38 IN THE HIGH COURT OF DELHI AT NEW DELHI Date of decision: 12th January 2021. W.P.(C) 5315 2020 & CM APPL.19189 2020 MASTER ARNESH SHAW ..... Petitioner Through: Mr. Vivek Chib Mr. Rahul Malhotra Mr. Asif Ahmed Mr. Vikhyat Oberoi and Mr. Manas Tripathi Advocates. M:9899218215) ..... Respondents Through: Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Advocate for R 1. Mr. Satvik Varma and Mr. Tanveer Oberoi Advocates for R 2 AIIMS. UNION OF INDIA & ANR. 38 W.P.(C) 322 2021 & CM APPL.812 2021 KESHAV SHARMA AGE 12 YEARS THROUGH: HIS NEXT FRIEND AND NATURAL FATHER SANJEEV KUMAR Through: Mr. Ashok Agarwal Advocate. ..... Petitioner UNION OF INDIA & ANR. Respondents Through: Mr. Ajay Digpaul CGSC and Mr. Kamal R. Digpaul Advocate for R 1. Mr. V.S.R. Krishna Advocate for R JUSTICE PRATHIBA M. SINGH Prathiba M. Singh J.(Oral) This hearing has been done by video conferencing. Both these matters concern children who are suffering from a rare W.P.(C) 5315 2020 & 322 2021 disease known as Duchenne Muscular Dystrophy 5315 2020 the Union of India through Ministry of Health and Family Welfare has placed on record an affidavit giving details of the various health policies which are under consideration in respect of such rare diseases. As per the said affidavit a Draft Health Policy for Rare Diseases has been released by the government in 2020 which is still in the stage of consultation. The earlier policy of 2017 was kept in abeyance by the government vide notification dated 18th December 2018. This Court vide order dated 7th August 2020 had directed the case of the Petitioners to All India Institute of Medical Sciences which has placed on record a report along with an affidavit reiterating the report. The first report filed by AIIMS is to the effect that the child is unlikely to show improvement with Exondys 51 therapy however a final recommendation in this regard is to be taken by the Central Technical Committee for Rare Diseases Ministry of Health and Family Welfare Govt. of India. The said report has been followed with another affidavit filed on behalf of AIIMS supporting the said earlier report. 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 W.P.(C) 5315 2020 & 322 2021 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. In the Draft Health Policy for Rare Diseases 2020 DMD is recognised as being one of the rare diseases the cost of treatment of which is very high. The said disease has been categorised in group 3 of the Policy which is extracted hereinbelow: “Group 3: Diseases for which definitive treatment is available but challenges are to make optimal patient selection for benefit very high cost and lifelong therapy 3a) Based on the literature sufficient evidence for good long term outcomes exists for the following disorders 1. Gaucher Disease 2. Hurler SyndromeType I]3. Hunter Syndrome (attenuated 4. Pompe Disease diagnosed early 5. Fabry Disease significant end organ damage 6. Spinal Muscular Atrophy 7. MPS IVA 8. MPS VI 3b) For the following disorders for which the cost of W.P.(C) 5315 2020 & 322 2021 treatment is very high and either long term follow up literature is awaited or has been done on small number of patients 1. Wolman Disease 2. Hypophosphatasia 3. Neuronal ceroid lipofuscinosis 4. Cystic Fibrosis 5. Duchenne Muscular Dystrophy ” Insofar as group 3 diseases are concerned the relevant proposal in the Draft Health Policy is contained in paragraph 9 which reads as under: “9. Voluntary crowd funding for treatment 9.1 Keeping in view the resource constraint and competing health priorities it will be difficult for the Government to fully finance treatment of high cost rate diseases. The gap can however be filled by creating a digital platform for bringing together notified hospitals where such patients are receiving treatment or come for treatment on the one hand and prospective individual or corporate donors willing to support treatment of such patients. The notified hospitals will information relating to the patients diseases from which they are suffering prognosis estimated cost of treatment and details of bank accounts for donation contribution through online system. Donors will be able to view the details of patients and donate funds to a particular hospital. This will enable donors from various sections of the society to donate treatment of patients suffering from rare diseases especially those under category III. funds which will be utilized 9.2 The Government will notify selected Centres of Excellence which will be premier Government tertiary hospitals with facilities for treatment of rare diseases. To begin with the following W.P.(C) 5315 2020 & 322 2021 institutes would be notified as Centers of Excellence for Rare Diseases: 1. All India Institute of Medical Sciences New 2. Maulana Azad Medical College New Delhi. 3. Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow. 4. Post Graduate Institute of Medical Education and Research Chandigarh. 5. Centre for DNA Fingerprinting & Diagnostics 6. King Edward Medical Hospital Mumbai 7. Institute of Post Graduate Medical Education and Research Kolkata 8. Center for Human Geneticswith Indira Gandhi Hospital Bengaluru The cost of treatment of patient in these centres of excellence will be met out of donations received through the online digital platform mentioned in Para 8.1 above” 7. As per the above draft policy in view of the constraint of governmental resources and competing health priorities the government proposes that it cannot fully finance the treatment of all high cost rare diseases but the gap can be filled by seeking donations from prospective individuals or corporate donors who are willing to support the cost of such diseases. Thus the government has recognised that DMD is a rare disease and has also recognized the fact that patients in general may not be able to afford its treatment. The Government thus proposes that it shall explore crowd funding as an option to address affordability concerns. 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 W.P.(C) 5315 2020 & 322 2021 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 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 crowd funding 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. 9. Let a report in respect of the above two directions be placed on record at least 2 days before the next date. List on 28th January 2021. PRATHIBA M. SINGH JANUARY 12 2021 dk Ak W.P.(C) 5315 2020 & 322 2021 

Summary: Merely because of the exorbitant price of a drug or treatment, children suffering from a rare disease cannot be deprived of the treatment. This decision was taken by Delhi High Court for the petitioners who were suffering from a rare disease known as “Duchenne Muscular Dystrophy (DMD)”. Delhi High Court gave this judgment in the case of Master Arnesh Shaw and Master Keshav Sharma vs. Union of India [W.P.(C) 5315/2020 &amp; CM APPL.19189/2020 and W.P.(C) 322/2021 &amp; CM APPL.812/2021] by the single bench of Hon’ble Justice Pratibha M. Singh. In the above-cited case, Natural guardians of the petitioners had approached the court stating that the petitioner children are suffering from a rare disease named Duchenne Muscular Dystrophy(DMD) and they contended that disease is very rare and the treatment/ drugs are only manufactured in the USA company called Sarepta Therapeutics. Being aggrieved by the exorbitantly expensive prices of the drug, petitioners had filed petitions in the High Court seeking directions on the Union of India, Ministry of Health and Family Welfare to ensure that they are given free treatment for the disorder as they cannot afford the heavy prices at which the drug was being sold. Reading the petitions, the High Court had given orders on 07.08.2020 directing AIIMS to submit a detailed report considering the health conditions of the petitioners. Report submitted by the AIIMS suggested that the child was unlikely to show any improvement with the treatment being given to him with Exondys 51 therapy and it was recommended in the report that the case should be taken by the Central Technical Committee for Rare Diseases, Ministry of Health. The HC observed that the Right to Health and Healthcare is a fundamental right under Art. 21 of the Constitution and therefore mentioned that even though the treatment is costly, no child of the country will be deprived of it, even if there is a small window of improving their chances of survival or even providing a better quality of life. HC Bench directed that:- And Hence, HC opined 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” and it was directed that the Union of India shall implement and notify the draft policy and also consider crowdfunding option in the meantime for the successful treatment of the petitioners. HC directed that the Ministry of Health and Family Welfare should finalize the implementation of the Draft Health Policy for Rare Diseases, 2020 at the earliest.