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The lacuna of proper regulation in a particular aspect such as rare diseases can be distressing for that particular group of aggrieved people who fall prey to the diabolical diseases. The occurrence of such diseases is scarce. The treatment of most of them for which the treatment is available is very costly and the price of treatment is exorbitant.
The Government of India had promulgated a National Policy for Rare Diseases in 2017 which was not brought in effect stating that a new policy shall be brought in effect in late 2019 which shall be more thorough, effective, and potent. Concerning the same, National Policy for Rare Diseases 2020 was brought in effect which covered various facets of rare diseases and brought certain action plans.
Before various High Courts, various petitions had have been filed before this policy came into force, impugning the inaction of the state when asked for funds for the treatment of rare diseases.
This article aims to analyze the law laid down for the regulation of rare diseases in India in various legal spheres. Further, it analyzes the government policies and the synchronization of such policies with the law laid down. Furthermore, this paper goes on to address the impediments on the way of addressing the concerns of funding for treatment, diagnosis, and prevention.
Rare Diseases and Health
The health of an individual is his utmost concern and is an integral part of his life. A healthy citizen can work for the betterment of the country and contribute positively to the productivity of the nation. India is a vividly poor nation and the poor of the nation are in the grasp of fatal diseases. Hence, when any rare disease comes on the way, the treatment is a far-fetched thought, even the diagnosis is difficult.
The right to health and medical care is not only the right of a citizen but is also a duty of the state. Article 47 of the Constitution of India provides that the State has an innate duty to raise the level of nutrition and standard of living and to improve public health. Article 41 further places an onerous duty on the state to provide, inter alia, public assistance in case sickness and disablement among others subject to limits of the economic capacity and development.
Health of the individuals is a very important subject for the state. Although, when it comes to Rare diseases, they are 7000 to 8000 in number whereas less than 5% have therapies available as a treatment. Hence, about 95% of the diseases have no available treatment. Also, due to a lack of empirical and epidemiological data, it has been very difficult to define a Rare Disease. It is also an impediment in the way of Research and Diagnosis.
EU has defined Rare Diseases according to the number of patients in a geographical area i.e. when less than 5 in 10000 people.
In India, only 450 diseases have been recorded from the tertiary hospitals that are globally considered as Rare Diseases. This specifically means that due to scarce data, there have been hindrances in pursuing effective and remedy-finding research. Hence, there has been no accepted definition of a rare disease in India. Recent policy by the government on the Rare Diseases creates three groups and allots diseases into these three groups.
- The first group contains Diseases amenable to one-time curative treatment.
- The Second Group contains diseases that require a long time or life long treatment but have a relatively lower cost.
- The third group contains diseases for which definite treatment is available but the therapy is life long and comes at an exorbitant cost.
Right to Health in India
A person has a right to life with dignity, proper health, education, and other basic necessities. All the existing rights must create a better being out of a man. Hence, every individual is obligated to be shown a demonstration of the success of appreciation of his said rights.
Supreme Court has hence enunciated the importance of the right to health of a person which has an innate presence in Article 21 of the Constitution of India. In the landmark case of State of Punjab v. M.C. Chawla, the Supreme Court held that the right to health is integral to right to life and the government has an obligation to extend medical facilities and medical care.
In another case of All India Lawyers Union (Delhi Unit) v. Govt of Delhi (NCT) and Others, the Delhi High Court stated that the Right to Health is implicit in Article 21 of the Constitution of India.
This reasoning started with the principle that the right to life is not mere animal existence but includes the right to liberty, respectable life, livelihood, and a clean environment.
The right to health and medical care has particularly been upheld in cases when the matter is of life and death. In the case of Paramananda Katara v. Union of India, the court held that the preservation of human life is of paramount importance. Hence, every doctor has a professional obligation to extend its services for preserving life. This obligation is total, absolute, and paramount.
The Conundrum of Financial Constraint
The state has to provide facilities to all its citizens and one must not be weighed over another. But in recent decisions of the Supreme Court, the court has averted to an individualistic stance and has provided that every citizen has a right to life which is not just mere animal existence. Hence, the state must protect the citizens from any widespread disease. Recently, the spread of COVID-19 was controlled in India, especially in Kerela by the state authorities.
The ministry of health in the State and the Union Ministry took relevant and rapid action to prevent, control, and mitigate the disease. Hence, the state has a responsibility towards each of its citizens. Moreover, the state has more particular responsibility towards the economically deprived citizens of the state.
Article 41 of the Constitution of India provides that the state shall make provisions for securing the right to public assistance in cases of sickness, old age, and disablement. But these provisions are subjected to the limits of economic capacity and development.
However, earlier, Indian Courts have enunciated their decisions in favor of the State considering the argument of financial constraint.
In the case State of Punjab & Ors. vs. Ram Lubhaya Bagga, the court held that it cannot interfere in the policymaking decisions of the state. It can only interfere when such a policy is arbitrary or violative of any constitutional, statutory or any other provision of law. The court enunciated that the government forms its policy on the basis of several factual circumstances and expert opinions and reports, evaluating the resource constraints and other constraints.
The court recognized the state’s limited resources and that spending must be done only to the extent it is feasible. This applies to the medical facilities too.
In the case of Confederation of Ex-servicemen Associations and Ors. vs. Union of India & Ors., the Court encountered the conundrum of financial restraint and the Right to Health again. The issue before the court was whether the State can ask the retired defense personnel to pay an amount of contribution to getting medical facilities by becoming a member of such Scheme.
The argument was raised that the scheme violated the right to health which is an integral part of Article 21 of the constitution of India. To this, the court stated that a contributory scheme which is reasonable i.e. a one-time payment is required of a reasonable amount cannot be held to illegal and arbitrary. Though the court further stated that the right to medical aid is a fundamental right of the ex-servicemen but the state has to look after the needs of its employees and it is limited by financial constraint and has limited means.
Thus, in light of law laid down, such a scheme was held to be in accordance with the law and it was further held that getting free and full medical facilities is not a part of the fundamental right of ex-servicemen.
Hence, from the perusal of the abovementioned case laws, it can be deduced that the court considers the financial constraint. But the consideration of the same has a limit. This limit is set by the fundamental right to life.
Changing Dynamics in Precedents
In the case of Mohd. Ahmed (minor) v. Union of India and Ors., the Delhi High Court held that:
“Just because someone is poor, the State cannot allow him to die. In fact, the Government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases, like Gaucher especially when the prognosis is good and there is a likelihood of the patient leading a normal life. After all, health is not a luxury and should not be the sole possession of a privileged few.”
The court held that certain obligations are core and non-derogable and hence cannot be done away with.
This is a very interesting angle taken by the High Court. In this case, the court has analyzed the previous judgments, and categorically laid down its logical reasoning behind the judgment. The difference in Mohd. Ahmed (Minor) case is that the child suffers from Gaucher Disease and devoid of treatment, the child shall succumb to death. Gaucher disease is amenable to treatment but is very costly. Despite this, the court has ordered the state to bear the charges of the treatment.
In another case of Lysosomal Storage Disorders Support Society v. State of Karnataka, Karnataka High Court directed the centre and the state to infuse Rs. 6 crores into funds for free medical treatment of 45 patients suffering from Lysosomal Storage Disorders.
Though these precedents are a sigh of relief for the patients, Lysosomal Storage Disorders can be costly. There are around approximately 40 disorders, some of which can be treated by enzyme replacement therapy. But, ERT is very costly and cannot be afforded even by the middle-class people let alone the poor.
Combating the Conundrum of Financial Constraint
In the National Policy for Rare Diseases, Ministry of Health and Family Welfare has come up with the idea of crowdfunding. The effect of crowdfunding in India increases when it is connected emotionally. And, thus, this will cause an enormous assist to patients of rare diseases. Now, we look at the problem from the perspective of competition in the Industry.
India does not recognize any regulation or provisions for promotion of competition among the companies producing the drugs or treatment of rare diseases. There are other countries which do the same. Since there are only 5% of rare diseases that can be treated, we need to analyze the possibilities of adjusting a reasonable price for an orphan drug.
In the United States of America, the Orphan Drug Act was enacted for, inter alia, facilitation of the development of drugs for rare diseases and conditions. The act recognizes the problems of financial constraints and impediments on the way of production of drugs for the treatment of such rare diseases. These drugs are also referred to as “Orphan Drugs”.
European Union has given 10 years of market exclusivity to the drug producing company when the drug is an orphan drug or when treatment is for a rare disease.
Moreover, India needs to invest in research and development for curative as well as early diagnostic methods. Further research is needed in innovative delivery systems and repurposing drugs.
Authored by: Vagish Yadav
 (1997) 2 SCC 83.
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W.P.(C) 7279/ 2013, High Court of Delhi at New Delhi, Judgment dated 17.04.2014
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