Draft Policy on Rare Diseases and the Role Played
by IMA and HCFI
Dr KK Aggarwal
President CMAALO, HCFI and
Past National President IMA
The Indian government has
come up with a new draft National Policy for Rare Diseases, 2020,
which highlights “scarce resources” to provide financial support for treatment
of rare diseases. The draft policy proposes to set up a registry under ICMR to
create a database and provide financial assistance of up to Rs 15 lakh to Ayushman
Bharat beneficiaries for rare diseases that require a one-time treatment
in tertiary hospitals only.
The government plans to
notify certain medical institutes as Centers of Excellence for Rare Diseases.
To begin with, these will include Delhi’s All India Institute of Medical
Sciences and Maulana Azad Medical College, Chandigarh’s Post Graduate Institute
of Medical Education and Research, Mumbai’s King Edward Medical Hospital,
Lucknow’s Sanjay Gandhi Post Graduate Institute of Medical Sciences, and three
others.
The draft policy also
categorises rare diseases under three categories based on clinical experiences
and treatment availability.
Category 1: Disorders amenable to one time
treatment (curative) : Prioritise
funding for this category as one time treatment cost
ranges from 5 – 20 lacs, which is much less compared to long term therapy, treatment
outcome is good, facilities for treatment are available in both private and
public sector with good expertise and outcome Funding should also include
support for follow up therapy and ceiling on existing funding limit should be
made flexible. Examples are certain
immune deficiency disorders that can be cured with treatment, and certain
diseases Tyrosinemia, Fabry’s disease and Maple Syrup Urine Disease, which
require kidney or liver transplants.
Category 2: Disorders requiring long term/life-long
therapy: Cost of therapy for most disorders in this category
is prohibitive and families cannot afford it without some support
Category 3: Disorders for which no known
therapy is currently available but requires supportive care (
Supportive therapy is the only available option, Need to provide care and support services)
Role of IMA and HCFI
1.
From 2014 to
2017 during my tenure as HSG and later National President IMA we had been
fighting about this issue.
2.
2015: hhttps://ordindia.org/uncategorized/indian-needs-extra-health-budget-for-rare-diseases/
27th Feb 2015. IMA stand that more budget is required.
3.
2016: http://blogs.kkaggarwal.com/2016/12/rare-diseases-and-rare-drugs/
as HSG IMA I wrote this to all the government agencies. Should CRS,
insurance companies and government subsidy under one roof be the answer for
such diseases and drugs?
4.
2018: July 17, Policies for management of
rare diseases and their treatment a must in India: http://blogs.kkaggarwal.com/2018/07/policies-for/
5.
Based on our
and many other NGOs efforts the health ministry had formulated a national
policy on treatment of rare diseases in 2017, which envisaged the setting up of
a corpus fund with an initial amount of ₹100 crore towards funding
treatment of rare genetic diseases, but this never picked up due to budget
constraints.
6.
The draft
policy does not provide financial assistance to rare diseases that require
lifelong treatment like Gaucher’s Disease, Hurler Syndrome, Wolman Disease. Treatment
for some of these diseases may vary from ₹10 Lakhs to more than ₹1
crore per year. For these diseases, the government has sought alternate funding
mechanism like setting up a digital platform for voluntary and corporate
donations.
7.
This policy is also based on our persistent efforts
at Heart Care Foundation of India. HCFI filed a
representation with Hon’ble Delhi High Court requesting the Hon’ble Court to
direct the Central Government as well as the State Government to follow the
suggestions / directions as given by this Hon’ble Court judgment dated
17.04.2014 in the matter titled as “Mohd. Ahmed (minor) versus Union of India
& Others, Writ petition (Civil) No. 7279/2013. The said representation
converted into PIL was duly accepted and disposed off vide order dated 15th
July, 2019 whereby the government has been asked to consider the same. As per the high court directions “All government hospitals could have a
separate CSR/ Charitable entity/account wherein donations can be received. The donations could be subject to an audit.”
8.
In the US, the
Orphan Drugs Act provides incentives to drug manufacturers to encourage them to
manufacture drugs for rare diseases, and similar incentives are also provided
in the UK and certain other developed countries
No comments:
Post a Comment