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Should the State pay for treatment of rare diseases?

Treatments for rare diseases are often not developed, because pharma companies aren’t able to recover research and development costs, and when treatments are developed, they are extremely expensive

Updated: Feb 14, 2020 18:19 IST

By Shyel Trehan,

In the absence of a policy on orphan diseases, patients have been forced to knock on the doors of the courts (Biplov Bhuyan/HT PHOTO)

The Supreme Court of India categorises the “rarest of the rare” cases for possible imposition of the death penalty. Of late, courts have dealt with a different category of “rarest of the rare”, and it is in the context of diseases. The commonality among both the categories is the decision between life and death. And the disease in question is known as the orphan disease. What would cause a disease to acquire the moniker “orphan”? In the world of rare diseases, it connotes diseases that are even rarer than rare. In the United States, it is a disease that afflicts less than one in 200,000 people. In India, we don’t have a definition of orphan diseases just yet, and the ministry of health and family welfare proposes to task the Indian Council of Medical Research with the project of defining this category of disease, in its new draft policy on rare diseases.

Orphan diseases present multiple challenges to the public health system. Pharmaceutical companies don’t have satisfactory commercial incentives to develop treatments because the small number of patients does not present an opportunity to recoup their research and development costs. For this reason, where treatments have been developed, the price of the treatments is astronomical. For instance, for the treatment of Gaucher’s Disease, only three companies in the world manufacture lifesaving enzyme-replacement therapy, which costs anywhere between ~7 lakh to ~10 lakh per dose, with each patient requiring a dose every one or two months. The treatment is lifelong, and the inability to receive it could mean death.

The question then is, does the State have an obligation to pay for it? Over the past few years, this agonising decision, the one between life and death, has entered courtrooms in India. In the case of Mohd Ahmed v. Union of India & Ors, the Delhi High Court held that the right to life under Article 21 of the Constitution includes the right to health, and “because someone is poor, the State cannot allow him to die”. The court found a breach of the patient’s constitutional rights and ordered delivery of State-sponsored treatment. Similar cases are pending a final decision in Karnataka and Kerala.

More recently, the Delhi High Court revisited the issue, in cases filed by patients suffering from rare diseases, against the Employees State Insurance Corporation (ESIC). The HC ruled that the administrative circulars seeking to exclude genetic diseases were issued by the ESIC in a manner contrary to the ESIC Act. Once again, patients received treatment through court orders.



The Supreme Court (SC) has long held that Article 21 imposes an obligation on the State to preserve life. In the cases of Parmanand Katara v. Union of India and Paschim Bangal Khet Mazdoor Samity v. State of West Bengal, the SC emphasised the fact that providing adequate medical facilities for people is an essential part of the obligations undertaken by the government of a welfare State. As things stand today, there has been no dilution of the principles laid down in these judgments. A plea to the contrary was made to the HC in the Mohd Ahmad case and summarily rejected.

So where are we at, as a country, in our position on State-sponsored treatment for rare diseases? Until earlier this month, the government did not have any official policy on the matter. Having nowhere to turn to, patients suffering from orphan diseases, knocked at the doors of the courts.

On January 13, the ministry of health and family welfare released the National Policy for Rare Disease, inviting comments from the public by February. The policy takes positive steps towards data collection, identification of diseases, dissemination of information and prenatal counselling and screening. It also provides for treatment for up to ~15 lakh for rare diseases that only require one-time treatment.

However, diseases incurring a recurrent cost to the public exchequer such as Gauchers, Hurlers Syndrome (MPS I), Hunters Syndrome (MPS II) find themselves excluded from treatment under the policy altogether, citing resource constraints.

It is likely that the draft policy, if finalised in its current form, will find itself the subject of legal challenge. It is also likely that it will once again fall to the courts to make the agonising decisions that have come to be associated with the rarest of the rare diseases.

Shyel Trehan is an advocate who practises in the Delhi High Court, and the Supreme Court of India. She is a graduate of National Law School of India University, Bangalore, and Columbia Law School
The views expressed are personal

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