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Delhi High Court rules on Article 21 and Access to Medicine #healthcare

HC orders government to treat 7-year-old with enzyme disorder for free

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TNN | Apr 18, 2014,

NEW DELHI: Just because someone is poor, the government cannot allow him to die, the Delhi high court remarked on Thursday and asked the government to discharge its “constitutional obligation” by providing free treatment to a patient suffering from Gaucher’s disease.

HC ordered the government to provide enzyme replacement therapy (ERT) to a rickshawpuller’s seven-year-old son who is suffering from the life threatening disease. ERT is a medical treatment to replace an enzyme that is deficient or absent in patients who suffer from such genetic disorder.

Asking the government to move swiftly, Justice Manmohan said “health is not a luxury” and “should not be the sole possession of a privileged few”. HC directed that the child’s treatment be carried out at the All India Institute of Medical Sciences (AIIMS) free of cost.

HC was hearing a plea filed by the father of Mohd Ahmed, who has been suffering from Gaucher disease Type-I. AIIMS had stopped the child’s treatment as his parents were unable to pay medical expenses of Rs 4.8 lakh per month.

Ahmed’s father told HC that he has already lost four children to the disease that is an inherited disorder that affects many organs and tissues. Fat accumulates in cells and organs, and the disease is characterized by bruising, fatigue, anaemia, low blood platelets and enlargement of the liver and spleen.

HC said 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”. Reminding the authorities that Article 21 of the Constitution lays down the obligation for the state to ensure patients have access to life-saving drugs, HC said, “Government cannot cite financial crunch as a reason not to fulfil its obligation.”

“In the opinion of this court, no government can wriggle out of its core obligation of ensuring the right of access to health facilities for the vulnerable and marginalized section of society…,” Justice Manmohan said.

HC also expressed displeasure that the central government does not have any policy measure in place to address rare diseases, particularly those of a chronic nature. “All the central and state schemes provide for a one-time grant for life-saving procedures and do not contemplate continuous financial assistance for a chronic disease such as Gaucher which involves life-long expenditure. There are even no incentives in place for Indian manufacturers to develop local alternatives to orphan drugs (those used for rare and chronic diseases),” the court added.

No government can say that it will not treat patients with chronic and rare diseases due to financial constraint, the court said, adding, “It would be as absurd as saying that the government will provide free treatment to poor patients only for stomach upset and not for cancer/HIV/or those who suffer head injuries in an accident.”

This an important judgment on Article 21, the right to health, intellectual property and access to medicine. The issue in Mohd Ahmed v. Union of India is set out in the first paragraph:

“Whether a minor child born to parents belonging to economically weaker section of the society suffering from a chronic and rare disease, gaucher, is entitled to free medical treatment costing about rupees six lakhs per month especially when the treatment is known, prognosis is good and there is every likelihood of petitioner leading a normal life.”

The petitioner, Mohd Ahmed, was/is suffering from a rare disease, called the “Gaucher Disease”. There is a known treatment – Enzyme Replacement Therapy – which, however, is extremely expensive, and the drugs required for it are manufactured by only three pharmaceutical companies. The reason for the high expense, as the Court explains, is the rarity of the disease – because the disease is so uncommon, pharmaceutical companies argue that they can only recoup their research and development costs by pegging the price at extremely high levels. In the language of IP, such drugs are known as “orphan drugs“.

It was argued on behalf of the petitioner that failing to provide him with treatment would be a violation of his right to health (read into Article 21 via the right to life). On behalf of the Delhi government, it was argued that there were various exceptions to the right to health – in particular, exceptions based upon the resources available to the government, and its own best judgment of what kind of healthcare it would prioritise. What this meant was that no individual person could make an enforceable constitutional claim upon the State for medicine – rather, it was up to the State to allocate its resources in a manner that ensured the best and widest possible healthcare to as many people as possible.

Thus, the basic issue in this case was: (given that the right to health has been read into Article 21), what amount of deference ought a Court accord to the legislature’s determination that the lack of resources do not allow it to provide medical treatment to a particular person? And, as a corollary, does the degree of deference change with the nature of the case, turning upon factors such as the patient’s poverty, the seriousness of the disease, the availability of treatment, and so on.

In its reasoning, the Court found that although a number of countries had specific policies in place to address the problems of orphan drugs, no such policy existed in India (paragraph 38 – 42). Because of the separation of powers, however, the Court could not require the legislature to draft a law or frame a policy. (paras 44 – 45). The only question, then, was the constitutional question: “does the government owe a constitutional duty to provide free medical treatment to the petitioner suffering from a rare and a chronic disease, even though the treatment is expensive and recurring.” (Para 46)

The Court, after referring to Article 21, extensively cited the ICESCR (see Article 12), and General Comment 14 to the ICESCR, which fleshes out in detail the content of the right to health. Citing the prior cases of Paramanand Katara v. Union of India and Paschim Bangal Khet Mazdoor Samiti, the Court held:

“Every person has a fundamental right to quality health care — that is affordable, accessible and compassionate.” (Para 59) The Court conceded that availability of resources was an important factor – and that in light of competing claims like education and defence, it could not “direct that all inhabitants of this country be given free medical treatment at state expense.” (Paras 62 – 63) Nonetheless, crucially – and directly echoing the ICESCR’s jurisprudence, that every right has a minimum core which is not subject to resource constraints and is directly enforceable – the Court held:

“By virtue of Article 21 of the , the State is under a legal obligation to ensure access to life saving drugs to patients. A reasonable and equitable access to life saving medicines is critical to promoting and protecting the right to health. This means that Government must at the bare minimum ensure that individuals have access to essential medicines even for rare diseases like enzyme replacement for Gaucher disease. Availability of a very expensive drug virtually makes it inaccessible.” (Para 68)

And:

“Government cannot cite financial crunch as a reason not to fulfil its obligation to ensure access of 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 for vulnerable and marginalized section of society.” (Para 69)

And, in conclusion:

“Although obligations under Article 21 are generally understood to be progressively realizable depending on maximum available resources, yet certain obligations are considered core and non-derogable irrespective of resource constraints. Providing access to essential medicines at affordable prices is one such core obligation.” (Paragraph 87)

Today’s judgment does two important things. First, it clarifies the content of the right to health under Article 21. One of the signal problems with the Court’s Article 21 jurisprudence over the last twenty years has been the lack of clarity, and a cavalier, laissez-faire approach towards this constitutional provision. By more or less expressly incorporating the ICESCR – with its concomitant principles of what the scope of the right is, what the obligations of the government are (see, e.g., General Comment 14), and the adjudicatory principles of progressive realization, minimum core and non-derogable implementation with respect to the most marginalised sections of society, the Court brings determinate standards to its Article 21/right to health jurisprudence. This would be helpful in future cases involving the right to health.

Secondly, by expressly invoking the constitutional right to health in a case where the driver of inaccessibility is the regime of intellectual property (patent, in this case), the Court lays the foundations of a jurisprudence that has been gaining ground in many countries: the constitutionalisation of IP law. That is to say, although the Court does not deal with IP issues in this case, it makes it clear that the Constitution is relevant. This is important because of a divide within the IP regime: IP maximalists argue that the balance between various rights and interests – the right of the inventor to profit from his work, the interest of the public in fostering more innovation and creativity by protecting inventors’ rights, and the public’s competing right to – are all balancedwithin the IP regime, through inbuilt exceptions such as compulsory licensing. However, of late, there has been a critique of this position. Scholars like Helfer and Birnhack have argued that basic human rights such as the right to free expression and the right to health ought to be invoked to determine the scope of the IP regime and its exceptions. So, for example, when we’re dealing with question of photocopying school/college textbooks, and the question of how much copying constitutes “fair use” under the copyright regime, these scholars argue that the right of free expression and the right to education should be invoked in determining how much use is fair use (as opposed to the traditional analysis, which focuses only on what level of exceptions would foster greatest innovation, without considering problems of individual access (that might be barred because of poverty, unaddressed y the market).

By invoking the specific, individual right to health in a case where medicines have been priced out because of IP, the Court thus opens up the possibility of using constitutional law and constitutional rights in subsequent cases, where IP is implicated much more directly: for example, cases of compulsory licensing, or the scope of S. 3(d). Invoking the right to health, for example, it could be argued that in S. 3(d) of the Patent Act (see here), which denies patents for “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy  of that substance…”and is aimed at preventing evergreening, the term “known efficacy” should be read strictly so as to ensure that essential medicines do not remain perpetually behind exorbitant patent paywalls. Whether that step is taken by the Court in future cases, of course, remains to be seen.

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