- Even among the rare diseases, “Orphan disease” 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.
Policy on rare diseases will attempt to define it:
- The ministry of health and family welfare proposes to task the Indian Council of Medical Research (ICMR) with the project of defining this category of disease, in its new draft policy on rare diseases.
Challenge of the Orphan 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 even recover their research and development costs.
- Treatment is too expensive:
- Even 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.
Should State have an obligation to pay for the treatment of rare diseases:
Courts have usually favoured state providing the treatment:
- Over the past few years, the question of whether the government should pay for the treatment of rare and rarest of rare diseases even reached the court.
- 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.
Courts have also ruled against insurance companies on this:
- 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.
SC ruling on Right to Life:
- 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.
Draft National Policy for Rare Diseases:
- In January, the ministry of health and family welfare released the National Policy for Rare Disease, inviting comments from the public.
- 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 Rs 15 lakh for rare diseases that only require one-time treatment.
Excludes some diseases:
- The draft policy leaves out diseases incurring a recurrent cost to the public exchequer such as Gauchers, Hurlers Syndrome (MPS I), Hunters Syndrome (MPS II) from treatment, 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 tough decisions that have come to be associated with the rarest of the rare diseases.
GS Paper II: Social Issues