Delhi High Court
Master Arnesh Shaw vs Union Of India & Anr. on 12 January, 2021
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:14.01.2021
16:24:40
$~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)
versus
UNION OF INDIA & ANR. ..... 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.
38 AND
+ W.P.(C) 322/2021 & CM APPL.812/2021
KESHAV SHARMA AGE 12 YEARS THROUGH:
HIS NEXT FRIEND AND NATURAL FATHER
SANJEEV KUMAR ..... Petitioner
Through: Mr. Ashok Agarwal, Advocate.
versus
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-
2/AIIMS.
CORAM:
JUSTICE PRATHIBA M. SINGH
Prathiba M. Singh, J.(Oral)
1. This hearing has been done by video conferencing.
2. Both these matters concern children, who are suffering from a rare
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Signing Date:14.01.2021 14:51
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SINGH NAYAL
Signing Date:14.01.2021
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disease known as Duchenne Muscular Dystrophy (hereinafter referred as
"DMD"). The drug for this particular condition is stated to be at an
experimental stage and is currently being manufactured by a company called
Sarepta Therapeutics, USA. The relief sought in these petitions is that the
government should be directed to ensure that the Petitioners are provided
free treatment for this disorder, as the drug is exorbitantly expensive and is
not affordable by the Petitioners.
3. In W.P.(C) 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 (hereinafter, "AIIMS"), 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
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By:PRATHIBA M SINGH
Signing Date:14.01.2021 14:51
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SINGH NAYAL
Signing Date:14.01.2021
16:24:40
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.
5. 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 (Type I & III (without
significant neurological impairment)
2. Hurler Syndrome [Mucopolysaccharidosis
(MPS) Type I] (attenuated forms)
3. Hunter Syndrome [MPS II] (attenuated
form)
4. Pompe Disease diagnosed early (Both
infantile & late on set)
5. Fabry Disease diagnosed before
significant end organ damage
6. Spinal Muscular Atrophy
7. MPS IVA
8. MPS VI
3b) For the following disorders for which the cost of
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By:PRATHIBA M SINGH
Signing Date:14.01.2021 14:51
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:14.01.2021
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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 "
6. 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 share
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 funds, which will be utilized for
treatment of patients suffering from rare diseases,
especially those under category III.
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
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By:PRATHIBA M SINGH
Signing Date:14.01.2021 14:51
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:14.01.2021
16:24:40
institutes would be notified as Centers of
Excellence for Rare Diseases:
1. All India Institute of Medical Sciences, New
Delhi.
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,
Hyderabad
6. King Edward Medical Hospital, Mumbai
7. Institute of Post-Graduate Medical Education
and Research, Kolkata
8. Center for Human Genetics (CHG) with 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.
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
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By:PRATHIBA M SINGH
Signing Date:14.01.2021 14:51
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:14.01.2021
16:24:40
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.
10. List on 28th January, 2021.
PRATHIBA M. SINGH
JUDGE
JANUARY 12, 2021/dk/Ak
Signature Not Verified
Digitally Signed
By:PRATHIBA M SINGH
Signing Date:14.01.2021 14:51
