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
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