IN THE HIGH COURT OF JUDICATURE AT BOMBAY
ORDINARY ORIGINAL CIVIL JURISDICTION
PUBLIC INTEREST LITIGATION NO. _____ OF 2012
In the matter of Article 14, 21, 16, 39
(e) 45, 47 and 226 of the Constitution
of India
AND
In the matter of Section 84 of the
Patents Act, 1970
AND
In the matter of Drug Price Control
Order 1995
AND
In
the
matter
of
Order
dated
28.01.2009 in Writ Petition No. 16326
of 2006, Hemophilia Federation of
India V/s. Union India & Others of the
High Court of Delhi.
AND
In
the
matter
of
Order
dated
09.03.2011, in Hemophilia Society
Lucknow V/s. Union of India of
Lucknow High Court.
AND
In the matter of proposals dated H
01st October 2010, being proposal no.
241 by SBTC, proposal dated 11th
January 2011, and being proposal no.
2011 by SBTC, and proposal dated
04th July 2011, being proposal no.
16005/11 by NRHM, pending with the
Department
Maharashtra.
1) Vinay Vijay Nair,
)
age 27 years, Occupation Unemployed)
residing at A-10, Dhake Park, Natvar )
Nagar, Road No. 1, Jogeswari East, )
Mumbai – 400060.
)
2) Rupal Ramesh Panchal,
)
age 40 years, Occupation Free Lance )
residing at A-3/4, Mahesh Nagar,
)
S. V. Road, Goregaon (West),
)
Mumbai – 400 062
)
3) Sunil Nivrutti Jadhav,
)
age 40 years, Occupation Service
)
residing at 52 – Anand Estate
)
N M Joshi Marg, Arthur Road Naka )
Chinch Pokli West, Mumbai – 400011)
of
Health,
State
of
4) Selvin Vijay Furtado,
)
age 24 years, Occupation Student
)
residing at Nizar, Opp. Shani Mandir,)
Azad Road, Vasai West,
)
Thane - 401201
)
5) Hemophilia Society Mumbai Chapter )
having their office at 205,
)
Sai Apartment C.H.S.,
)
B. R. Parelkar Road, Parel Village,
)
Mumbai – 400 012
)
…
Petitioners
VERSUS
1) Department of Health,
)
through its Additional Heath Secretary,)
State of Maharashtra
)
having his office at Mantralaya,
)
Mumbai – 400 032
)
2) Controller General of Patents, Designs & Trade Marks
Having their office at
)
Bhoudhik Sampada Bhavan,
)
Near Antop Hill Head Post Office, )
S.M. Road, Antop Hill,
Mumbai-400037
)
)
)
3)The Ministry of Health through its
)
Secretary, having his office at
)
Nirman Bhavan, New Delhi
)
4) Ministry of Chemicals and Fertilizers )
Through its Minister having his office at
A-Wing, Shastri Bhawan,
)
Dr.Rajendra Prasad Road,
)
New Delhi, Delhi-110001
)
)
.... Respondents
TO
THE HONOURABLE CHIEF JUSTICE AND THE HONOURABLE
PUISINE JUDGES OF THE HONOURABLE HIGH COURT OF
JUDICATURE AT BOMBAY
THE
HUMBLE
PETITION
OF
THE
PETITIONERS ABOVE NAMED
MOST RESPECTFULLY SHEWETH:
1. Petitioner No.1, Vinay Vijay Nair, age 27 years, resident of
Mumbai, a qualified Management Professional, currently
unemployed, has been diagnosed with Hemophilia Type A
having developed inhibitor in the body against Factor VIII.
Petitioner No.2 Rupal Ramesh Panchal, age 40 years, is a
Freelance Accountant and a resident of Mumbai and has been
diagnosed with Hemophilia Type B (Factor IX deficiency).
Petitioner No.3 Sunil Jadhav, age 40 years, resident of Mumbai
and working with the Hemophilia Society as a Clerk and has
been diagnosed with Hemophilia Type A (Factor VIII
deficiency).
Petitioner No.4, Selvin Vijay Furtado, age 24
years, female student, also resident of Vasai, Thane district has
been diagnosed with Von Willebrand disorder. The Petitioner
No.5 is a Society registered under the Societies Registration
Act, XXI of 1860. No. 752/1994 of GBBSD of 10/08/1994 with
the Charity Commissioner as Public Charitable Trust Reg. No.
F17067 Dt. 24/01/1995, set up to further the rights of persons
afflicted with Hemophilia, other than engaging in advocacy and
lobbying. The Petitioner No.5 also undertakes activities
involving the distribution of medical aids for Hemophiliacs
through its parent organization Hemophilia Federation India
situated at New Delhi.
2. Respondent No.1 is the Department of Health, State of
Maharashtra who till date does not have a comprehensive policy
and plan of action for the diagnosis and treatment of
Hemophiliacs most of whom are unable to afford the ensuing
treatment, particularly medication. Respondent No.2 is the
Controller General of Patents, Designs & Trade Marks,
Maharashtra, who grants and renews licenses for drugs
Respondent No.3 is the Ministry of Health and Family Welfare,
Government of India, which has only intermittently responded
to the critical nature of Hemophiliacs across the country.
Respondent No.4 is the Ministry of Chemicals and Fertilizers,
who controls the pricing of the drugs. The Respondents are
responsible towards the fruitful endeavor of a comprehensive
policy and plan of action for the diagnosis and treatment of
Hemophiliacs in the State of Maharashtra.
3. The Petitioners seek to invoke the constitutional jurisdiction of
this Hon’ble High Court, aggrieved by the acts of omission and
commission of the Respondents which has led to the lack of a
comprehensive policy and plan of action, particularly in the
State of Maharashtra, towards the diagnosis and treatment of
Hemophiliacs, which has resulted in a large number of deaths of
Hemophiliacs, in addition to the official apathy to the
debilitating
animal
and
vegetable
existence
of
other
Hemophiliacs in the State of Maharashtra.
THE ISSUE HEREIN: HEMOPHILI
4. Hemophilia is a lifelong bleeding disorder usually inherited but
also emerging sporadically in over one-third of those afflicted
by this debilitating condition. A person afflicted with
Hemophilia faces bleeding inter alia in the joints and muscles. If
not treated promptly and effectively it leads to progressive
damage of joints, nerves and muscles; over time it renders a
person disabled, if not in a fatal condition. Today, it is identified
as a rare incurable, but manageable, hereditary sex-linked
genetic bleeding disorder caused due to the deficiency of
clotting factors.
5. To the layman, Hemophilia is usually described as a bleeding
problem where people afflicted with Hemophilia suffer
prolonged periods of bleeding due to the lack of clotting
agents/factors in the blood. Hemophilia is quite rare, afflicting
0.01% of the population. Being a sex-linked genetic disorder, it
predominantly shows up only in men, furthering its rarity,
bringing into perspective the poor response from state and nonstate actors.
6. While Hemophilia is not contagious, around one-third of known
cases have been attributed due to mutations in the absence of a
family history, referred to as Sporadic Hemophilia. Over time,
a person could be identified as Hemophiliac if he or she
constantly suffers big bruises bleeding into muscle and joints
especially the knees, elbows and ankles. Spontaneous bleeding,
i.e. bleeding inside the body or prolonged periods of bleeding,
for instance during the extraction of a tooth or a simple surgery,
etc. It is pertinent to mention that internal bleedings lead to
swellings, pain, stiffness in the joints and muscles, and over
time admittedly have been one of the most predominant causes
leading to orthopedic disabilities.
7. Sporadic bleedings have been known to be fatal, particularly
when the bleeding afflicts an organ, the abdominal cavity or the
brain.
8. The gravity of the issue herein cannot be downplayed inasmuch
as the complications that arise. In the instance of Mahesh
Suryavansi, who at the young age of 23, was suffering from
frequent bleeding problems, and due to the infusion of infected
wet blood product, he developed Human Immunodeficiency
Virus (HIV) and died due to multiple causes. Mahesh's parents
have a younger son, Nilesh age 22, also a severe hemophiliac.
The parents and the patient himself do not wish to infuse any
wet blood products, even if there is a bleeding episode. The
family is also unable to avail of Factor concentrate because of
economic constraints. Devang Bhanushali, a boy of 15 years,
was declared dead on arrival at K.E.M. Hospital having
complained of a headache. Subsequently, he was diagnosed
with a brain hemorrhage.
Untreated and undiagnosed,
Hemophilia poses one of two outcomes – either debilitating
disability or death.
9. It is the Petitioner’s case that in the absence of adequate
accessible mechanisms for diagnosis of Hemophilia and
reasonably tried and tested treatments, Hemophiliacs continue
to be undiagnosed and untreated. This is in spite of the
Government of Maharashtra being seized of the issue herein.
DIAGNOSIS
10.Ideally, newborns should be screened for Hemophilia as its
accurate diagnosis is essential for its effective management,
particularly as Hemophiliacs may not have bleeding symptoms
until the age of one or later when they begin crawling and
walking. Hence, newborns should be screened through the
activated Partial Thromboplastin Time (PTT) Test.
Even
expecting mothers are not spared the dilemma of this affliction,
requiring prenatal diagnostics to be undertaken when there is a
history of Hemophilia in either of the families of the expecting
child. This calls for enhanced protocols to be followed.
11.In the face of this essential diagnosis not having been
undertaken, over 95% of Hemophiliacs in India today do not
know the cause of their recurring health concerns or disability.
12.Of the existing 11,200 Hemophiliacs in the State of
Maharashtra, approximately only 2,500 exist on the Registry of
the State Blood Council, State of Maharashtra. (The population
of Maharashtra is 11.23 crores, as per the 2011 National Census,
with a 0.01% prevalence of Hemophilia).
TREATMENT
13.The treatment of Hemophilia has evolved from reinforcing the
loss of clotting factors by injecting blood and thereafter
transfusing fresh frozen plasma and cryoprecipitate. While there
is no cure for Hemophilia, Hemophiliacs can lead normal
healthy lives with adequate and proper treatment. It is also
pertinent to mention here the risk that blood and wet blood
products (derived from blood) carry with them, afflicting a large
number of Hemophiliacs with HIV, Hepatitis C or B Virus. This
has resulted in evolution to recombinant Anti-Hemophiliac
Factors (AHF), which are artificially produced without any
human blood.
14.It is important to mention here that the National AIDS Control
Organisation (NACO) has accepted vide letter dated 29.9.2010,
that the patients receiving multiple transfusions (i.e. patients of
Thalasaemia, blood cancer, hemophilia etc) are at high risk for
acquiring transfusion transmitted infections including HIV, in
response to information sought under the RTI Act by Mr Kumar
Shailendra, Executive member of Hemophilia Federation
(India), New Delhi. A photocopy of dated 29.09.2010 issued by
NACO is annexed herewith and marked as EXHIBIT A.
15.Fiscals of treatment for Hemophilia are only telling of the
sordid inaction and apathy of the Respondents herein. On
average, a Hemophiliac patient would require 10,000 to 20,000
units of Factor VIII or IX concentrate. Plasma-derived product
is available to him at Rs.20/- per unit while a recombinant is
available
at
Rs.35/-
per
unit,
effectively
requiring
a
Hemophiliac to pay anything between Rs. 4,00,000 to Rs.
7,00,000 every year for the respective product. It is pertinent
here to mention that the aforesaid figures do not factor in
contingencies like surgery, accident or spontaneous bleeding.
16. a) Petitioner No.1, Vinay Vijay Nair, has been diagnosed with
Hemophilia Type A, having developed inhibitor in the body
against Factor VIII. The normal dosage and Factor VIII
replacement are unable to prevent bleeding. He either requires
FEIBA (Factor Eight Inhibitor Bypassing Activity) Concentrate
or Factor VIIa - (Activated Factor VII) which are prohibitively
costly i.e. each unit cost Rs.50 per unit and Rs.43,000 per
Milligram respectively. Vinay requires the infusion of at least
4,000 to 6,000 units of FEIBA or 6 mg of F VIIa per bleeding
episode, costing approximately Rs.3,00,000 per episode.
b) Petitioner No.2, Rupal Ramesh Panchal, age 40 years, has
been diagnosed with Hemophilia Type B (Factor IX Deficiency)
infected with HCV, which has resulted in lowering immunity
and increasing the bleeding tendency. He requires at least 5,000
units of Factor IX per bleeding episode costing Rs.1,00,000.
c) Petitioner No.3 Sunil Jadhav, age 40 years, has been
diagnosed with Hemophilia Type A (Factor VIII deficiency). He
requires at least 2,000 units of Factor VIII per bleeding episode,
costing Rs.40,000.
d) Petitioner No.4, Selvin Vijay Furtado, age 24 years, has been
diagnosed with Von Willebrand disorder. She requires at least
2,000 units of Von Willebrand Factor per bleeding episode
costing Rs.40,000. This explains the financial burden faced by
each person with hemophilia.
17.Advocacy by various Chapters across the country has helped in
provoking proactive responsive action by State authorities in the
states of Assam, Andhra Pradesh, Haryana, Rajasthan, Tamil
Nadu, Uttarakhand and Kerala, where Hemophilic patients are
now provided AHF free of cost.
18.The Hon’ble High Courts in Delhi, Patna, Lucknow and Jammu
and Kashmir have directed the concerned state authorities to
make available the life saving drug AHF to hemophilic patients,
free of cost. Hereto annexed and marked as EXHIBIT B are the
Orders of the High Courts of Delhi, Patna, Lucknow and Jammu
and Kashmir.
19.It is also relevant to point out that the Ministry of Railways,
Government of India vide order dated 26.3.03 letter no. 2003/H1/9/1(Misc) has decided that Railway Hospitals should list all
Persons with Hemophilia (PWH) as Railway beneficiaries and
provide AHF to them as and when needed, directed them to
keep suitable quantities of AHF in all Railway hospitals where
PWHs are registered, for this purpose. Further, the Central
Government Health Scheme also supplies its employees and
their family members with Hemophilia Treatment with
recombinant AHF, free of cost.
20.It cannot be the case that the State of Maharashtra has not been
seized of the issue of the inability of Hemophiliacs to access
affordable treatment. Subsequent to extensive lobbying in the
light of numerous deaths by the Petitioner-society herein, the
Department of Health vide its proposal dated 01st October 2010
proposal no. 241 for Rs. 24.82 crore, sought to put into place
Phase I of its extensive action plan to combat Hemophilia. For
reasons best known to it, it subsequently revised its proposal by
proposal dated 11th January 2011 proposal no. 2011 for Rs.
92.77 crore prepared and submitted to the Additional Health
Secretary by SBTC, where it also sought to address other bloodrelated concerns including Thalassemia and sickle cell anemia.
Fiscals were further revised by the Director of NRHM Mumbai,
putting into place a District Response System which included
spreading awareness and treatment. Proposal no. 16005/11
dated July 4 2011 proposal for Rs. 92.77 crore for treatment and
50.59 crore for prevention of blood disorders, was prepared and
submitted to the Additional Health Secretary by the Director of
NRHM Mumbai. Hereto annexed and marked as EXHIBIT C
is a copy of the proposal made with the state concerned. This
dithering and re-working of proposals has been felt only too
well over the last three years. During this period, at least 35
PWHs in and around Mumbai have passed away and the rest are
progressively becoming disabled in the interregnum due to the
lack of treatment. Hereto annexed and marked as EXHIBIT D
are the various representations that have borne no response or
action from the State Government.
21.Aggrieved by the inaction of the Respondents, particularly the
Department of Health, State of Maharashtra, the Petitioner seeks
to approach this Hon’ble Court on the following grounds which
are without prejudice to one another.
GROUNDS
a) That the denial of medical treatment including affordable
medication to hemophiliacs is a violation of their Right to
Life as guaranteed under the Constitution.
b) That the denial of medical treatment including affordable
medication to hemophiliacs is a violation of their Right to
Equality as guaranteed under the Constitution of this
country.
c) That the landmark Delhi High Court Order in Writ Petition
No. 16326 of 2006 has made AHF more accessible and
economically viable for persons suffering from hemophilia,
particularly for persons who do not have means to avail of
the drug.
d) That the Universal Declaration of Human Rights, 1948 vide
Article 25(2) assures that everyone has the right to a standard
of living, adequate for their health, including medical care,
sickness and disability.
e) That Article 39(e) of the Constitution (within the Directive
Principles of State Policy) urges the State to secure the
health and strength of its workers. In several judgments, the
Hon’ble Supreme Court has practically accepted the right to
health as a part of fundamental right by saying "A healthy
body is the very foundation for all human activities in a
welfare state; therefore, it is the obligation of the state to
ensure the creation and the sustaining of condition congenial
to good health".
f) That, as per the World Health Organisation, AHF is an
essential medicine for PWHs.
g) That the Ministry of Health, Government of India has
included AHF in its essential medicine list, as published on
its website.
h) Given the exponential pricing of AHF, the Respondent State
Authorities ought to have listed AHF in the list of drugs
covered under the Drug Price Control Order.
i) That the Respondent State ought to have invoked the
Compulsory Licensing provisions under the Patents Act,
1970 so as to make available affordable medication to
Hemophiliacs in India.
j) That the Respondent State Authorities ought to have put into
place a comprehensive Policy and Action Plan on the
treatment of Hemophilia.
k) That given the gravity of the issue involved herein, the
Respondent State Authorities ought to have supplied free
AHF to every hemophiliac as and when the need arises.
22.The Petitioners state that they have not filed any other Petition
in respect of the subject matter in this Hon’ble Court or in any
other High Court or in the Supreme Court of India.
23.The Petitioners state that they have no other alternate
efficacious remedy but to approach this Hon’ble Court and the
reliefs as prayed for if granted shall be complete.
24.The Petitioners are residents of Mumbai and have their offices
in Mumbai as do the Respondents. As the cause of action has
arisen within the State of Maharashtra, this Hon’ble Court has
jurisdiction to entertain and try this Petition.
25.The Petitioners will rely on documents a list whereof is annexed
hereto.
26.There is no delay or laches in filing this Petition.
27.The Petitioners have paid the required court fee of Rs._______
to this Petition.
28.The Petitioners have not received any caveat from the
Respondents as on date of filing of this Petition.
PRAYERS
29.The Petitioners therefore pray that:
a) That this Hon’ble Court be pleased to issue a writ of
mandamus or any other appropriate writ, order or direction
in the nature of mandamus directing the Respondents to
ensure that all persons afflicted with Hemophilia are
provided with the necessary treatment free of cost.
b) That this Hon’ble Court be pleased to issue a writ of
mandamus or any other appropriate writ, order or direction
in the nature of mandamus directing the Respondents to
provide for mandatory screening of newborns to ensure the
early diagnosis of those afflicted with Hemophilia
c) That this Hon’ble Court be pleased to issue a writ of
mandamus or any other appropriate writ, order or direction
in the nature of mandamus directing the Respondents to
bring all types of Anti Hemophilic factors (i.e. Factor VIII,
Factor IX, FEIBA, Activated Factor VII and Von Willebrand
Factor) medicine under the Drug Prices Control Order, 1995.
d) That this Hon’ble Court be pleased to issue a writ of
mandamus or any other appropriate writ, order or direction
in the nature of mandamus directing the Respondents to
invoke Compulsory Licensing as per the provisions of
Section 84 of the Patent Act 1970, to undertake the
manufacture and distribution of Hemophilic Drugs
e) Pending hearing and final disposal of this petition in this
Hon’ble Court be pleased to direct the respondents to ensure
that all persons afflicted with Hemophilia are provided with
the necessary treatment as and when required, free of cost.
f) Pending hearing and final disposal of this petition in this
Hon’ble Court be pleased to direct the respondents to
provide for mandatory screening of newborns to ensure the
early diagnosis of those afflicted with Hemophilia
g) Pending hearing and final disposal of this petition in this
Hon’ble Court be pleased to direct the respondents to
provide necessary treatment as and when required free of
cost to hemophiliacs.
h) Pending hearing and final disposal of this petition in this
Hon’ble Court be pleased to direct the respondents to bring
all types of Anti Hemophilic factors (i.e. Factor VIII, Factor
IX, FEIBA, Activated Factor VII and Von Willebrand
Factor) medicine under the Drug Control Order
i) Pending hearing and final disposal of this petition in this
Hon’ble Court be pleased to direct the respondents to invoke
Compulsory Licensing as per the provisions of Section 84 of
the Patent Act 1970, to undertake the manufacture and
distribution of Hemophilic Drugs
j) Ad interim reliefs as per Prayer clause (e) to (i)
k) For such further and other reliefs as this Hon’ble Court may
deem fit and proper in the circumstances of the case.
l) For costs of this Public Interest Litigation;
Petition drawn by:
Petitioner
Advocate
VERIFICATION
I, Vinay Vijay Nair, aged 27 years, residing at A-10, Dhake Park,
Natvar, Nagar, Road No. 1, Jogeswari East, Mumbai – 60, do hereby
state and solemnly declare that what is stated in paras No. ______ is
true to my own knowledge and whatever is stated in remaining paras
no.____ to _____ is stated on information and belief which I believe to
be true.
Solemnly declared at Mumbai )
on this day of April 2012
Identified by me
GAYATRI SINGH
Advocate for the Petitioners
)
Petitioners