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Should the state pay for the treatment of rare diseases? – analysis


The Supreme Court of India classifies the “rarest of the rare” cases by possible imposition of the death penalty. Lately, the courts have treated a different category of “the weirdest of the weird”, and it is in the context of diseases. The coincidence between both 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 nickname “orphan”? In the world of rare diseases, it connotes diseases that are even more rare than rare. In the United States, it is a disease that affects less than one in 200,000 people. In India, we still do not have a definition of orphan diseases, and the Ministry of Health and Family Welfare proposes to entrust the Indian Medical Research Council with the project to define this category of disease, in its new draft policy on rare diseases

Orphan diseases present multiple challenges for the public health system. Pharmaceutical companies do not have satisfactory commercial incentives to develop treatments because the small number of patients does not present an opportunity to recover their research and development costs. For this reason, where treatments have been developed, the price of treatments is astronomical. For example, for the treatment of Gaucher disease, only three companies in the world manufacture life-saving enzyme replacement therapy, which costs between ~ 7 lakh to ~ 10 lakh per dose, and each patient requires one dose each or two months. The treatment lasts a lifetime and the inability to receive it could mean death.

The question is, then, does the State have the obligation to pay it? In recent years, this agonizing decision, the one between life and death, has entered the courts of 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 violation of the constitutional rights of the patient and ordered the delivery of a state-sponsored treatment. Similar cases are pending a final decision in Karnataka and Kerala.

More recently, the Delhi High Court reexamined the issue, in cases presented by patients suffering from rare diseases, against the Employee State Insurance Corporation (ESIC). The HC ruled that administrative circulars that sought to exclude genetic diseases were issued by the ESIC in a manner contrary to the ESIC Law. 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 emphasized the fact that providing adequate medical facilities for people is an essential part of the obligations assumed by the government of a welfare state. As things stand today, the principles established in these trials have not been diluted. In the Mohd Ahmad case, a statement contrary to the HC was made and summarily rejected.

So where are we, as a country, in our position on the state-sponsored treatment for rare diseases? Until the beginning of this month, the government had no official policy in this regard. Having no one to turn to, patients suffering from orphan diseases knocked on the doors of the courts.

On January 13, the Ministry of Health and Family Welfare published the National Policy for Rare Diseases, inviting public comments in February. The policy takes positive steps towards data collection, disease identification, information dissemination and prenatal counseling and screening. It also provides a treatment of up to ~ 15 lakh for rare diseases that only require a single treatment.

However, diseases that incur a recurring cost to the public treasury, such as Gaucher, Hurlers syndrome (MPS I), Hunters syndrome (MPS II) are excluded from treatment under the policy altogether, citing limitations of resources.

It is likely that the draft policy, if finalized in its current form, is subject to a legal challenge. It is also likely that once again it will fall to the courts to make the agonizing decisions that have been associated with the rarest of rare diseases.

Shyel Trehan is a lawyer who practices in the Superior Court of Delhi and the Supreme Court of India. He graduated from the National Law School of the University of India, Bangalore and the Columbia Law School.

The opinions expressed are personal.

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