Show your account books, Delhi HC asks Centre on rare disease 'burden'

Show your budget allocation and utilisation of the last five years, the Delhi High Court asked the Union Ministry of Health and Family Welfare on January 14, 2020, after the Centre said that assigning funds more than Rs 15 lakh as one-time financial assistance for rare diseases’ patients would be a big financial burden.

The ministry had put out a draft of the national policy for treatment of rare diseases in the public domain on January 13, 2020 for public consultation.

It had first come out with such a policy in 2017 after being ordered by the Delhi High Court to do so. The court had been petitioned by parents of children with rare diseases, who said they were unable to afford treatment for their wards.

The government withdrew the 2017 policy abruptly on November 30, 2018, saying that it needed amendments. The major difference between the earlier policy and the current draft is that the former envisaged the formulation of a corpus fund of Rs 100 crore for treatment, prevention, diagnosis, research and development.

The new draft though has done away with all of it and talks of only one-time financial assistance.

Observing that this arrangement does not sound workable, the court wondered on what basis the corpus was replaced. How would the assistance be provided?

The draft defines three categories of rare diseases patients. The first category are those who require one-time treatment. The second category are the ones who require lifelong treatment but it is not costly. The third category are the ones who require lifelong as well as costly treatment.

The draft says only those who fall in the first category are eligible for financial assistance. The 40 per cent of the population enrolled under Pradhan Mantri Jan Arogya Yojana (PMJAY) would be eligible for treatment under it at government hospitals.

Those falling in the second and third categories would not get any assistance.

“What shall we do? One of the diseases that fall under the third category is Spinal Muscular Atrophy. The cost of drugs for this disease is $750,000 per annum per patient. This is roughly Rs 5 crore per annum,” asks Archana Panda, the head of Cure SMA Foundation of India, a patients’ rights group and also a petitioner in the case.

Prasanna Shirol, co-founder and executive director of Organisation for Rare Disease India told Down To Earth (DTE) that his organisation had asked the government in court as to what will happen to the 200-odd people who had applied under the old policy.

“There are no timelines for anything whatsoever in this second draft too. Neither for financial assistance nor for the digital platform that they want to set up for creating a database. This is what they had done in the first draft. A grand proposal for a corpus fund of Rs 100 crore was put. No deadline was given. It never took off, therefore. And it finally got withdrawn. What reason do we have to not believe that the cycle will not be repeated,” Shirol told DTE. 

On January 14, the court asked the government to come back to it after public consultations have been received. Senior Delhi High Court lawyer, Ashok Agarwal, the advocate for one of petitioners said the next date of the hearing has been fixed as April 28, 2020.

What are rare diseases? 

The World Health Organization defines rare diseases as ‘often debilitating lifelong diseases with a prevalence of 1 or less per 1,000 population’. However, different countries have defined different levels of prevalence, ranging from 1.0 to 6.4 in per 1,000 population.

There is no definition even in the second draft of the national policy. The government justifies this by saying it is not possible to give a definition as there is no epidemiological data. 

All it says is the following:

So far, only 450 diseases have been recorded in India from tertiary care hospitals that are globally considered as rare diseases. The most commonly reported ones are haemophilia, thalassemia, sickle-cell anaemia, auto-immune diseases, Pompe’s disease, Hirschsprung disease, Gaucher’s disease, cystic fibrosis, hemangiomas and certain forms of muscular dystrophies.

Another major change in the current draft is regarding the role of state governments. According to the last policy, state governments had to contribute 40 per cent of the finances. 

The draft says state governments should help such patients with diagnosis, special diets and hormonal supplements. If the state governments wish, they may assist in funding as well. 

Highlighting the challenge of unavailability of treatment, the draft document says that while there are 7,000-8,000 rare diseases, therapies are available for less than five per cent of them.

Even for those diseases for which therapy is available, the drugs are ‘prohibitively expensive’.  This, the government draft says, would drain the health budget of other schemes.

“We do understand that the Union government can’t do it alone. Why can’t it involve state governments, and even ask big philanthropic organisations to come forward? These organisations support various health programmes. The ministry could have easily approached them. Even Corporate Social Responsibility Funds can be involved. These permutations and combinations have to be tried rather than simply throwing in the towel,” Panda said. 

The draft does talk of creating a crowd-funding sort of mechanism. But again, neither the contours have been defined nor are there any deadlines. 

No registry yet

While the government says it can’t define rare diseases in India because of lack of epidemiological data, it had promised to initiate a registry for the same two years ago. Till date, nothing has happened.

The new draft proposes it afresh, tasking the Indian Council of Medical Research once again with the same job with no specific timelines. 

“It is important because we at least have to know the scale properly. Currently, we know it is about 500. The government must have a centralised database — disease-wise and state-wise — of all these patients on the website without revealing their identities. Not only would it help in tracking patients but also if somebody wants to help, s/he can reach out to them,” Panda said. 

In the over 13 months, which the government took to come out with a second draft, 37 children died due to spinal muscular atrophy, Panda said. 

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