National policy for treatment of Rare Diseases in India | UPSC – IAS | Pib
What are Rare Diseases ?
There is no universally accepted definition of rare diseases and the definitions usually vary across different countries. However, generally rare diseases are defined as a health condition of low prevalence that affects a small number of people compared with other prevalent diseases in the general population.
WHO defines rare disease as often debilitating lifelong disease or disorder condition with a prevalence of 1 or less, per 1000 population.
80% of rare diseases are genetic in origin and hence disproportionately impact children.
These are also called ‘orphan diseases’ because drug companies are not interested in adopting them to develop treatments due to low profitability.
The most common rare diseases include Haemophilia, Thalassemia, Sickle-cell Anaemia, autoimmune diseases, etc.
They affect 6%- 8% of the total population in the country. So far about 450 rare diseases have been recorded in India.
Karnataka is the first state to release a Rare Diseases and Orphan Drugs Policy.
The Union Health Ministry termed the current policy “untenable” as the policy was to be implemented under the National Health Mission. (The ambit of the NHM is restricted to primary and secondary health care but rare diseases come under tertiary care).
One-time financial assistance is being provided as an interim measure till a new policy is framed. A committee has been set up to frame a new policy.
Criticism of the move: Why India Needs a policy on rare disease? | UPSC – IAS | Pib
Need for Continuous Treatment: Most of the rare diseases for which treatment is available are progressive. They require continuous support and not just one-time assistance as an interim arrangement can never be a substitute for a policy.
The withdrawn Policy highlighted the measures and steps, both in the short as well as in the long term, that need to be taken to deal comprehensively with rare diseases. The policy sought to strike a balance between access to treatment with health system sustainability.
Pushes Families in Poverty: Its impact on families is often catastrophic in terms of emotional as well as financial burden. 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.
Significant Population Impacted: While there is no registry of rare diseases patients in India (the policy provided for one), according to government’s own estimates there are between 70-90 million patients.
Difficulty in R&D: Rare diseases are difficult to research upon as the patient pool is very small and it often results in inadequate clinical experience. The policy envisaged a R&D framework which cannot be attained through one time financial support.
Not covered under Health Insurance: Private insurance companies treat genetic disorders as pre-existing conditions and, on that ground, exclude them from coverage. Since most rare diseases are genetic, patients are routinely denied insurance cover.
