ET Bureau Jan 14, 2020, 10.05 AM IST

The government will provide a meagre one-time financial assistance of Rs 15 lakh to patients suffering from rare diseases. The decision comes as the government comes up with a new draft policy for the treatment of rare diseases, more than a year after it withdrew the earlier policy that promised an initial corpus fund of Rs 100 crore for the treatment of patients with rare genetic diseases. As an alternate, it has proposed creating a funding mechanism through setting up a digital platform for for individuals and corporate donors to contribute to the treatment cost of patients with rare diseases.

In its draft rare diseases policy 2020, the government has proposed a financial support of up to Rs 15 lakh under the umbrella scheme Rashtriya Arogaya Nidhi for those that require a one-time treatment. Justifying the scrapping of earlier corpus, it has said that since resources are “limited”, the policy makers had to make a choice of prioritising certain set of interventions over others. “In resource-constrained settings, it is pertinent to balance competing interests of public health for optimal outcome for the resources allocated. The appropriate choice is then to support those interventions that would provide more number of healthy life years for given sum of money while simultaneously looking at the equity i.e. interventions that benefit poor who cannot afford healthcare are prioritised. Hence any policy on rare diseases needs to be informed by the available scarce resources and the need for their utmost judicious utilization for maximizing the overall health outcomes for the whole of society measured in terms of increase in terms of healthy life years,” it said. The draft of the proposed policy has been put up for comments on the health ministry’s website.

The proposed policy will be submitted before the Delhi High court on 14 January. The government started working on the new policy after several patients and the health groups dragged it to the Delhi High Court when they failed to secure the promised financial assistance under the National Policy for Treatment of Rare Diseases, cleared in 2017.

On 8 February last year, the Delhi High Court gave the government nine months to come up with a revised policy after the Centre admitted that it had overlooked certain important factors in devising the earlier policy. In the draft policy, the government has listed rare diseases in three categories grouping them depending upon their severity.

Experts blame the government for their callous work on the new draft.“Policy has adopted a very narrow scope limited to diseases listed in 3 categories, essentially purging diseases not listed such as for which no treatments currently exist. The policy ought to have addressed need for R&D for these diseases. Instead of a sustainable model to finance treatment, the policy speaks of competing interests in allocating public health resources for “maximizing the overall health outcomes for the whole all of society” as the primary justification for scrapping of the corpus that existed under the previously notified policy,” said Malini Aisola, co-convenor, All India Drugs Action Network (AIDAN).

According to the government, so far only about 450 diseases have been recorded in India from tertiary care hospitals that are globally considered as rare diseases. The most commonly reported diseases include Haemophilia, Thalassemia, Sickle-cell Anaemia and Primary Immuno Deficiency in children, auto-immune diseases, Lysosomal storage disorders such as Pompe disease, Hirschsprung disease, Gaucher’s disease, Cystic Fibrosis, Hemangiomas and certain forms of muscular dystrophies.

Archana Panda, cure SMA foundation of India said that the policy is an “eyewash” and of no use to Spinal Muscular Atrophy community where medicines are astronomically priced and children are lost every month. “Looks like govt is okay with our kids dying. Clearly there is lack of intent to provide life saving drugs to patients n parents,” she said.

Adding that,“Finally the much awaited policy is out but as usual it has disappointed most of the rare disease community patients mainly those where cost of treatment is high. As expected, govt will only provide 15 Lacs one time financial help for group1 diseases which have one time cure. It appears that entire policy is drafted to justify that govt cannot provide treatment due to high cost as it is resource constraint country. It admits there is lack of awareness among primary care physicians, , lack of adequate screening and diagnostic facilities in India”.

Few government hospitals like AIIMS, MAMC, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Post Graduate Institute of Medical Education and Research, Chandigarh, Centre for DNA Fingerprinting & Diagnostics , Hyderabad and King Edward Medical Hospital, Mumbai are listed to be notified centre of excellence.

The government has proposed support for undertaking screening and diagnosis amongst high-risk pregnant women as well as amongst suspected cases of rare diseases reporting to government facilities. According to the newly proposed policy, for prenatal diagnosis, tests like Amniocentecis and/or CVS testing would be offered to those pregnant women in whom there is a history of a child born with a rare disease. Also, for newborns, neonatal screening has been proposed amongst newborns with a family history of a rare disease (with confirmed diagnosis).