The suspension of the National Policy for Treatment of Rare Diseases (NPTRD) has come as a rude shock to families and patients affected by a rare disease (defined by the World Health Organisation as one that affects less than 1 in 1,000. Definitions vary nationally).
A travesty
On November 30, 2018, the Centre filed an affidavit in the Delhi High Court stating that the current policy for rare diseases needed to be reframed due to challenges in implementation and costs. The Union Health Ministry termed the current policy “untenable” as the implementation of the policy was moved out of the Public Health Division to the National Health Mission (NHM). Since the ambit of the NHM is restricted to primary and secondary health care, rare diseases (which come under tertiary care) cannot be served. The Ministry is sure to have known beforehand that rare diseases cannot be treated under the NHM. A flimsy reason such as this reflects a lack of intent and a political unwillingness to ensure health justice.
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The NPTRD was approved in May 2017 on the orders of the Delhi High Court. The Government of National Capital Territory, Delhi had also appointed an interdisciplinary committee to look into the challenges of rare diseases. The recommendations of the three major committees and sub-committees were used to formulate policy going beyond just treatment and suggesting measures towards awareness, prevention, research and development of therapies and orphan drugs and issues of health insurance. The policy set out a road map for the immediate treatment of affected patients along with concrete implementation mechanisms. It recommended the setting up of a technical-cum-administrative committee (at the Central and State levels), and an immediate corpus of funds (₹100 crore) for treatment. The policy also stated the role of the Union Health Ministry by suggesting that a rare disease cell should be set up within the Ministry and headed by a joint secretary. When the policy clearly outlined the Ministry’s role, it is unclear why implementation was moved to the NHM. The affidavit filed by the Centre states that no corpus of funds was created under the NHM.
Instead of shifting implementation of the policy and the creation of the fund to the NHM, the Ministry should have followed the policy recommendations and created a national rare disease cell, similar to the blood cell. While the blood cell is a part of the NHM, a national rare disease cell should have been a part of the Ministry, as recommended. To coordinate policy implementation across all States, a State rare disease cell under the State Ministry of Health and Family Welfare could have been set up. Instead, there was no action ever since the current policy came into being in May 2017, in turn affecting patients and families. According to the Organisation for Rare Diseases India (ORDI), in Bengaluru, six patients have died waiting for their applications for treatment to be approved.
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An interim arrangement of one-time financial assistance for treatment of patients below poverty line is no solution. The exorbitant cost of treatment per patient, which ranges anywhere from ₹25 lakh and ₹4 crore per year, is out of reach even for middle-class families. In India, out-of-pocket health-care expense is a key driver of poverty, and more so in families with those affected by a rare disease, as they have to run from pillar to post for diagnosis and treatment. The government must understand the financial burden of rare diseases and extend help to all patients.
The Constitution of India has provisions guaranteeing the right to the highest attainable standard of physical and mental health. The suspension of the current policy is a travesty of health justice. Since the Ministry has neither specified a deadline for a new policy nor made clarifications on the formation of the 10-member policy committee, it is a sign of the government’s shaky commitment towards the plight of rare disease patients.
Dr. Namitha Kumar is Research Director, Centre for Health Ecologies and Technology, Bengaluru