The Delhi High Court issued 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 Constitution, 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)
“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 access medicine – 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.
A mother with her child sitting on an open rickshaw, also called "van," on the main road near Patra village in West Bengal on July 8, 2013. Malavika VyawahareA mother with her child sitting on an open rickshaw, also called “van,” on the main road near Patra village in West Bengal on July 8, 2013.
PATRA, West Bengal — In this village 30 miles south of Kolkata, three generations of women have depended on Saira Bewa to deliver their babies.
On a languid July afternoon, Ms. Saira, 61, squatted on the mud porch of her house in Patra and narrated the story of how she became a midwife. “When I was a teenager, I used to help deliver calves and goat kids at our home,” said the great-grandmother, who goes by one name (Bewa indicates she is a widow). “That is how it started. Soon, I was helping deliver babies.”
In over 40 years as a dai, as traditional midwives are known in India, Ms. Saira helped deliver scores of babies in this village of 6,500, which has a predominantly Muslim population, armed with a basin of hot water, a blade to cut the umbilical cord and her bare hands.
Women in rural India have traditionally relied heavily on midwives like Ms. Saira, but after decades of stubbornly high mortality rates, in 2005 the Indian government introduced the Jnani Suraksha Yojana program, which offered cash to poor women and those disadvantaged by caste, or their status as tribes, who delivered at a medical facility instead of at home.
The number of institutional deliveries rose dramatically, from about 40 percent of all births in 2005 to over 70 percent in 2009, but the fall in mortality numbers has not been equally pronounced.
With more than 55,000 women in India dying from pregnancy and childbirth-related complications each year, health experts and nongovernmental organizations are now pushing the government to re-incorporate midwives into the strained health care system by training them in modern childbirth practices and equipping them to handle complications.
“Community needs are at a point that if you suddenly remove all of the traditional birth attendants and home-based attendants, there will be no alternate for a lot of people,” said Dr. Rajiv Tandon, a pediatrician and public health and nutrition expert.
A 2013 Unicef-funded study in India documented “serious, persistent gaps in safe delivery capacity at the primary level, especially subcenters and remote primary health centers.”
According to government figures released last month, India’s maternal mortality ratio, or the number of maternal deaths per 100,000 live births, has fallen from 212 in 2007-09 to 178 in 2010-12. But it remains among the highest in the world and still significantly higher than the Millennium Development Goal target of 109, to be achieved by 2015.
A United Nations Population Fund study estimated the number of registered midwives in India in 2008 to be 324,624 and that India would be short 25,620 skilled birth attendants to meet 95 percent of the demand by 2015. Midwives like Ms. Saira are not included in these figures as they fall under the category of traditional birth attendants instead of skilled birth attendants, which includes trained midwives, nurse-midwives and doctors.
For a long time, the Indian government recognized that it did not have enough skilled birth attendants and ran programs to retrain women already doing this work, which was found in one study to improve patients’ use of maternal health services. The emphasis of these programs was on cleanliness, which was seen as generally lacking in deliveries performed by traditional practitioners, who combined their experience with religious ritual and superstition.
But in 2005, the government decided to refocus its efforts to encouraging women to give birth in medical facilities. Himanshu Bhushan, a senior Health Ministry official in charge of maternal health, said a government review clearly showed that a majority of the traditional birth attendants, like untrained midwives, could not identify birth complications, which delayed treatment that could have saved women’s lives.
Even with incentives to give birth in a facility, a 2009 United Nations Population Fund study of five states that fare poorly on maternal and child indicators showed that in Uttar Pradesh 52.5 percent delivered at home and 50.9 percent in Bihar. An overwhelming majority of women who did not have institutional deliveries said they found home births “convenient.”
Saira with her two-year-old granddaughter at her home in Patra village of West Bengal on July 8. Malavika VyawahareSaira with her two-year-old granddaughter at her home in Patra village of West Bengal on July 8.
“Where is the need, unless there is a problem?” was Ms. Saira’s response when asked why women in her village were not going to hospitals.
Women in Patra also expressed an unwillingness to be put in the hands of a stranger, especially a man, and voiced fears of knives and of being cut open.
“The ride to the hospital rattles the bones” is how Ms. Saira described a trip in the open rickshaws on unpaved, rocky paths, where ambulances cannot reach, to the nearest bus stop a few miles away. From there, the only options for the poor are overcrowded tempos, the local train or buses to the nearest government hospital equipped to handle deliveries.
Those who can afford it go to the private hospitals, despite the high costs of such care. Those women who make it to the public hospital near Patra complained that they don’t receive the care they needed.
And institutional deliveries by themselves are not necessarily translating into better child care practices.
“We used to think that just because you had institutional delivery breastfeeding will take place,” said Nita Chowdhury, a senior official in the Ministry of Women and Child Development. “But we found that in facility after facility the health worker would urge the mothers to breastfeed their babies, but the mothers refused, saying they wouldn’t do anything till their mother-in-laws were present.”
Saving the lives of mothers and infants would require more than monetary incentives to deliver at a hospital, said Sarah Pinto, anthropologist and author of “Where There is No Midwife: Birth and Loss in Rural India.” Women like Ms. Saira, who enjoy trust within communities, should play an important role, Ms. Pinto added.
A primary health center in Patra village of West Bengal in July, 2013. Malavika VyawahareA primary health center in Patra village of West Bengal in July, 2013.
However, one major hurdle is that traditional midwives are resistant to giving up a lifetime of folk wisdom in favor of clinically proven practices.
For example, Ms. Saira said she insisted that the newborn drink water instead of breast milk in the first hours of birth, a common practice that is particularly harmful in areas where the water is likely to be contaminated. International guidelines recommend that a newborn be breastfed in the first hour of birth and continue to be fed only breast milk for the first six months.
What is especially dangerous to a child’s health is the discarding of colostrum, or the first breast milk produced by the mother, which doctors say is not only wholesome and nutritious, but also builds immunity in children. In Ms. Saira’s village, this first milk, which is thick and yellowish in color, is often discarded because it is believed to be curdled.
Bangladesh, India’s smaller and poorer neighbor, may have some lessons to offer. It is on course to meeting its Millennium Development Goals for maternal mortality, which declined from 830 in 1990 to 194 in 2010. A United Nations Population Fund report credits the reduced mortality rates to the Bangladeshi government’s investments in training community-based skilled birth attendants to provide care for pregnant women and mothers who deliver outside of facilities.
Syeda Hameed, a member of India’s Planning Commission, asserted that the Indian government recognizes the value of traditional midwives.
“It is true that despite the fact that and we have pushed so hard on institutional delivery, many women are still delivering at home,” Ms. Hameed said at a recent conference in New Delhi to promote breastfeeding programs. “These dais are the ones who are a bridge between life and death for them.”
“We are very supportive of not letting go of this institution of midwives,” Ms. Hameed said.
In the absence of a well-trained cadre of community-based midwives who can handle complications and with no government plans to retrain the traditional attendants, rural woman who don’t trust the health care system will remain vulnerable to pregnancy-related deaths.
Midwives in Uttar Pradesh told Ms. Pinto that even though local women were offered incentives to give birth in facilities, the government first needed to follow a popular proverb: “First, you set your house in order and then invite guests.”
This story has been facilitated under the OneWorld-POSHAN Fellowship grant.
Source: Medico Friend Circle List serve
Shared by Jagannath Chatterjee (email@example.com)
Since 2005, the Government of India has launched a series of initiatives like the Janani Suraksha Yojana (JSY) and JSSK to address high maternal mortality, and the SRS surveys over the last decade show that maternal mortality has been steadily coming down in all states including in Jharkhand. In August 2013 a paper examining 23 maternal deaths occurring in one year among young, poor women mostly from tribal communities (including Particularly Vulnerable Tribal Groups (PVTG) in just two blocks of Godda District in Jharkhand was published in EPW (Stairway to Death: Maternal Mortality Beyond numbers, Banerjee et al, Economic and Political Weekly Vol XLVIII no. 31, 2013 Aug 3).
In this context the National Alliance for Maternal Health and Human Rights (NAMHHR) conducted a Fact-Finding Mission (FFM) in Godda district of Jharkhand to explore the status of maternal health services and the role of related social determinants of health. The FFM team visited three villages selected on the basis of different tribal communities, varying distance from the block CHC, as well as different accessibility to roads. The team also visited one Community Health Centre (CHC), one First Referral Unit (FRU) and the Godda District Hospital; where the health providers and managers were asked about their assessment of barriers and challenges.
Godda district is part of the Santhal Parganas division of Jharkhand which is dominated by tribal communities. Sundarpahari is a backward block in Godda. The block has an entirely rural population, with 79% belonging to the Scheduled Tribe category, and more than half the villages are inhabited by particularly vulnerable tribal groups (PVTGs). Nearly 50% of land in Sundarpahari block is forested and hilly and most habitations are not connected to the few roads that exist. The literacy rate in Sundarpahari is 27%, and AHS 2011-12 data indicates that childbirth at home is 75.2% for district Godda.
The team met with a large number of women in three villages of Sundarpahari block who had delivered in the last couple of years; all the women had given birth at home even though some had complications and near-miss experiences. There was also a maternal death in one of the villages. Yet the women did not consider going to the local health facilities as an option, and had no information about JSY or JSSK. Due to local health beliefs and the lack of community outreach, the communities visit local informal practitioners, eg. Dom and Ojha and the RMP. These women did not have access to basic health services such as ANC, and even immunization services for children was unavailable in the case of PVTG communities. The ANMs did not go to the villages for either ante-natal care or for home births; the health sub-centres were not easily accessible for many hamlets in the village, and the VHND was not taking place in even half the villages of this block owing to shortages of human resources and transportation issues. There was no functioning blood storage and transfusion facility in the entire district although a large number of the pregnant women present with high anaemia and comprehensive emergency obstetric care had to be accessed (by those who could afford it) in Bhagalpur Medical College in Bihar. In other blocks where ante-natal care is provided, it is not identifying any danger signs such as anaemia, malnutrition or pre-eclampsia.
In the more remote villages there were no Anganwadi centres (AWC), and the Supplementary Nutrition does not reach the pregnant or lactating women. In other villages, the AWC sporadically provided THR, and even then information that THR is available did not reach all the women. However the PDS (free supply of x kg of grains) was being used by the community even though the concerned distribution centre was far. The PDS does not incorporate the local grains that are richer in nutrients and instead provides the standard cereals that are given all over the country. The traditional food patterns of the tribal communities which were linked to the forests and the robust practice of mixed organic farming has been disturbed by the introduction of PDS grains. Local practices and resources have been ignored and women have been asked to take iron-tablets during pregnancy instead of promoting consumption of local iron rich foodstuff.
Given the geographical situation of Godda district, it is difficult for health services to reach communities located deep in the forests. The tribal communities are seen as ignorant and uneducated, and their practices are looked down upon. The health system has made no efforts to integrate the tribal health system (based on local herbs) and integrate some of the good practices so that the tribal feel less reluctant to use the health facilities. As it stands now, they avoid using government health facilities until matters have gone too far, and then it is usually too late. Different tribal areas and their health problems need to be seriously studied both within Jharkhand and other areas of Tribal communities. The PVTGs or particularly vulnerable tribal groups require socio-cultural studies, to understand their health-related practices and related disruptions which may provide ideas about the underlying reasons for high anaemia and poor health.
The report concludes with a detailed set of recommendations. A preliminary draft of this report has already been shared on 17-18 February 2014 with the senior health officials of the Government of Jharkhand, including the Hon. Minister of Health, the Mission Director NRHM, the Director Health Services, Officer in charge of Reproductive Child Health.
Source: Reprohealth list serve
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