Overview
Recently, the Delhi High Court directed the National Consortium for Research, Development and Therapeutics for rare diseases to give recommendations on funding of clinical trials for Duchenne muscular dystrophy (DMD) , a rare disease. The Ministry of Health and Family estimates that approximately 72 to 96 million people in India are suffering from rare diseases. WHO defines a rare disease as “ a disease with a prevalence of 1 or less, per 1000 population as a rare disease”. Rare diseases are generally connected with genetic aberration therefore children in early age are more prone to it. Demographically, in India the prevalence of rare disease is uneven. For instance, Tamil Nadu reports higher records of Duchenne Muscular Dystrophy. Whereas β-thalassemia is higher in the states of Punjab, West Bengal, Odisha, Andhra Pradesh and Gujarat.
Due demographic disparities and comparatively smaller market major pharmaceutical companies hesitate in spending their resources for the development of drugs for rare diseases and drugs that are available in the market are inaccessible due to exorbitantly higher prices. Eg. A single dose of Spinal Atrophy Muscular (SMA) drug cost INR 16 crore in India. Therefore, accessing affordable and quality treatment for rare diseases is a big challenge.
To address problems related to treatment of rare diseases, the Ministry of Health introduced National Rare Disease Policy 2021. This policy classifies the rare diseases into three groups and introduces financial assistance for its treatment.
Group 1
Disorders amenable to one-time curative treatment
Group 2
Diseases requiring long term / lifelong treatment having relatively lower cost of treatment and benefit has been documented in literature and annual or more frequent surveillance is required:
Group 3
Diseases for which definitive treatment is available but challenges are to make optimal patient selection for benefit, very high cost and lifelong therapy.
The policy talks about providing one time financial assistance up to Rs 20 lakh under Rashtriya Arogya Nidhi and Pradhan Mantri Jan Aarogya Yojna only for the disease falling under Group 1. However, for Group 2 and 3 diseases the policy stressed upon generating funds through crowdfunding wherein the Government can also fill the gaps in reaching the required funds. However, in May 2022, the policy was changed and promised financial assistance of Rs 50 lakh for diseases falling under all the categories. To date around 500 patients are registered under the policy but not a single one received funds yet for treatment. Therefore, question arises whether India’s national policy on rare disease a non-starter ?
Government Obligation and Right to Health
Treatment for rare diseases involves high cost. India’s healthcare policies focus more on improving existing infrastructure and to fund the welfare schemes. Therefore, the lack of funds is a ground that the government often takes for not financially supporting treatment of rare diseases to an extent. Due to this financially backward population of the country suffers a lot. The Supreme Court of India in Common Cause Vs Union of India also observed that:
“Right to health is a part of Article 21 of the Constitution. At the same time, it is also a harsh reality that everybody is not able to enjoy that right because of poverty etc. The State is not in a position to translate into reality this right to health for all citizens”.
In a democratic country, the Government is a legal guardian of its citizens and has an obligation to provide better healthcare and treatment. Delhi High in Master Arnesh Shaw vs GNCT held that
“This Court is of the opinion that just because of the exorbitant price of the drug or treatment, patients, especially children, suffering from a rare disease ought not to be deprived of treatment for their condition”
The Right to life including the Right to Health and Access to Medicine is a fundamental right guaranteed under Article 21 of the Constitution of India read with Articles 39(e). The Supreme Court of India in State of Punjab Vs Ram Lubhaya Bagga (1998) 4 SCC 117 held that – The Right of every citizen to life under Article 21 cast obligation on the state. This obligation is further reinforced under Article 47, as it is for the state to secure health to its citizens as its primary duty. (Also see Paschim Banga Khet Mazdoor Vs State of West Bengal (1996) 4 SCC 37, Pt Parmanand Katara 1989 AIR 2039 and Confederation of Ex-Servicemen (2006) 8 SCC 399).
India also has obligations under international legal instrument to such as WHO) Constitution (1946), Universal Declaration of Human Rights (1948), International Covenant on Economic, Social, and Cultural Rights (ICESCR) of 1966, General Comment 14 (2000), WHO Medium Term Strategic Plan for 2008-2013.
However, right to health is a far-fetched dream that cannot come true until major policy changes are taken.
Conclusion
To attain the highest level of health coverage in India certain policy decisions are required. Government should explore mechanisms to generate funds through various ways including waiving of taxes, directing and incentivising corporate houses and making national policies that cater the demand of affordable health care and treatment.
1. Corporate Social Responsibility : Rare disease policy 2021, talks about sourcing funds from corporate donors. However, it’s not possible until firm steps are taken by introducing amendments under CSR rules directing mandatory contribution of some amount of CSR funds in healthcare especially for treatment of rare diseases. The Hon’ble Delhi High Court in Mohd Ahmed (Minor) Vs Union of India 2014 SCC OnLine Del 1508, stressed upon generating the funds including through Corporate Social Responsibility (CSR), and held that
69. Government cannot cite the financial crunch as a reason not to fulfill its obligation to ensure access to medicines or to adopt a plan of action to treat rare diseases. In the opinion of this Court, no government can wriggle out of its core obligation of ensuring the right of access to health facilities………. by stating that it cannot afford to provide treatment for rare and chronic diseases.
2. Taxes and Tariffs: Pricing of the drug depends upon several factors, including Tariff (import duty) and Taxes, that are among the two major components. The UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, in its report also urged the UN member countries to refrain from taxing essential medicine. Nonetheless, it’s not the case and many countries including India levy hefty taxes and import duty even on life-saving drugs. This certainly makes medicine inaccessible further. In the past Government the competent authority waived off 23 % Import Duty and 12 % GST from Zolgensma thus treatment of five months old Teera Kamat became possible after when the remaining amount came from different sources.
3.Universal Health Coverage : WHO defines Universal Health Coverage (UHC) as “people have access to the full range of quality health services they need, when and where they need them, without financial hardship”. In 2018 on similar lines the Government of India also introduced the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana with the aim to provide financial assistance of Rs 5 lakh per family per year for secondary and tertiary care. Although it’s not enough to treat complex medical problems, it is a welcome step, however we can expect some future improvements.
4. Incentivise Corporate. The Government should incentivise corporates who engage in providing assistance in drug discovery and Research and Development (R&D) of treatment for rare disease, by giving some tax rebates, and other forms of benefits.
Rohit Kumar is an advocate of the Supreme Court of India. Views are personal.