In the year 2013, a petition was filed in Delhi High Court by the seven-year old Mohammed Ahmed suffering from the rare disease “Gaucher”. It is a hereditary disorder which is caused by the absence of enzyme which breaks down fat and releases energy. The absence of this enzyme leads to fat building all over the body and patients suffer from bone pain and anemia. In some cases, it may also lead to death. Although, this disease can be treated through the replacement therapy of enzymes and the person can lead a normal life under all medications and precautions, however, it can never be completely cured. The cost of therapy is Rs. 6 lakh per dose and has to be administered every month till the patient is alive. Since, his father is a rickshaw-puller and earns daily wages for survival he knocked the door of High Court for help.
Gaucher is one of the 7,000 rare diseases that afflict less than 6% of the global population. Looking at the rare phenomenon of this disease, pharmaceutical companies don’t consider it as an economically viable drug and end up pricing them as high as possible to derive profits. Even these companies don’t invest much on the research of the Orphan Drugs making them almost inaccessible for the weak and marginalised sections of the society.
In order to encourage the pharmaceutical companies to stimulate research for the treatment of rare diseases, the Orphan Drugs Act was passed by the US government in 1983. The law offered different incentives like smaller clinical trials, higher rates of regulatory success, extended exclusivity and tax rebates. Laws on similar line have been replicated in other countries such as European Union, Japan and Australia making it economically viable and commercially attractive for investing in the Research and Development (R&D) of the rare diseases. However, these companies ignore the incentives offered by the government and sell the orphan drugs at inflated prices. Rituximab, an orphan oncology drug, is one such drug in this category which is also the second highest selling drug in the world. The patients of developed country have higher per capita income and also governed by good government health policies hence they can afford them whereas it is completely unaffordable for the patients of developing countries considering their economic status and flaws present in the healthcare policies.
The Delhi High Court gave full attention to the case of Mohammed Ahmed causing lot of stir and scrutiny in the existing healthcare policies governing the nation. Before giving his judgment, Justice Manmohan analysed many other cases which have proved that the right to health and access to healthcare is implicit in Articles 21, 38 and 46 of the Indian Constitution.
He concluded that “every person has a fundamental right to quality health care – that is affordable, accessible and compassionate.” While recognizing the fact that every citizen cannot expect to receive free medical treatment at the state expense he also held the government responsible for not devising favorable policies for ensuring that every citizen can afford the treatment of rare diseases.
The court suggested the government to increase investment in the healthcare sector and formulate best practices and polices related to the treatment of rare diseases. It also confirmed that the act of financial aid treatment of rare diseases will be qualified as a CSR activity. It also directed the state government to arrange treatment for Mohammed Ahmed free of cost at AIIMS whenever he requires it, as per his constitutional right.
Learning lessons from this case, Karnataka became the first state in India to release a Rare Diseases and Orphan Drugs Policy. It recommended to implement the preventive and carrier testing, which is a means of reducing morbidity and mortality. Considering the fact that around 80% of the rare diseases` have genetic connection, it also suggested to the pharmaceutical companies to use genetic testing for accelerating the identification of the critical genes involved in rare diseases.
The state also highlighted about the flaw present in the Insurance Laws of India due which often acts as huge disadvantage for the patients suffering from the rare disease in India. The private insurance companies of India consider the genetic disorders as pre-existing conditions, hence, on that basis doesn’t provide any insurance cover for the same. Since, most of the rare diseases are genetic in nature; hence patients don’t get any support from the existing insurance policy.
The state emphasised on the awareness programmes to combat delay in diagnosis and treatment. It also called for the enactment of an orphan drugs statute to allow for tax breaks, funding and exclusive marketing rights as incentives for orphan drug discovery.
The policy has requested the IRDA (Insurance Regulatory and Development Authority) to re-consider this exclusion from the above mentioned laws and at least provide basic coverage of rare diseases at reasonable premiums.
Fiinovation recommends the other states of India to follow the footsteps of Karnataka to ensure every citizen of India has access to affordable healthcare facilities. The state-led PSUs and private companies can utilize their CSR funds to undertake healthcare initiatives involving rare diseases for extending support to the weak and marginalized sections of the society.
By Manisha Bhatia
Media & Communications, Fiinovation
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