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LATEST NEWS UPDATES | Onus on the state-Sagnik Dutta </title>
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A Delhi High Court verdict says the State government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases.
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A Delhi High Court verdict says the State government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases.
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<h1 class="cat-box-title">Onus on the state-Sagnik Dutta</h1>
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Published on</span><span class="text-date"> May 6, 2014</span>
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<div style="text-align: justify">-Frontline</div><div style="text-align: justify"> </div><p style="text-align: justify"><em>A Delhi High Court verdict says the State government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases. </em></p><p style="text-align: justify">SEVEN-YEAR-OLD Mohammed Ahmed Khan looked on helplessly as his father, Sirajuddin, narrated the sordid tale of the loss of four of his children to Gaucher's disease, a rare genetic disease that requires lifelong, exorbitantly expensive enzyme replacement therapy. Sirajuddin, a rickshaw puller, earns Rs.250-300 a day. His children were turned away by government hospitals between 2005 and 2012 as he could not pay for their treatment. Mohammed Ahmed is his last hope.</p><p style="text-align: justify"><em>Delhi High Court case</em></p><p style="text-align: justify">A petition filed before the Delhi High Court in November last year alleged that the denial of treatment to the petitioner (Mohammed Ahmed Khan) on account of the failure of his parents to pay the exorbitant costs of the treatment violated the right to life guaranteed under Article 21 of the Constitution. The petition made the Union of India, the Government of Delhi and the All India Institute of Medical Sciences (AIIMS) respondents in the case. Mohammed Ahmed was admitted to the Department of Paediatrics at the AIIMS in a critical state with Gaucher's disease type 1. In this disease, the body does not produce an enzyme called glucocerebrosidase, which leads to a build-up of harmful substances in the liver, spleen, bones and bone marrow and prevents the normal functioning of cells and organs. Mohammed Ahmed required enzyme replacement therapy at a cost of Rs.4.8 lakh a month, according to a certificate issued by the Genetic Unit of the Department of Paediatrics. The hospital refused him treatment as his father could not afford it. Following some assistance from the Directorate of Health Services, Government of Delhi, in July 2013, the AIIMS began the treatment the next month. However, on November 15, the hospital asked the family to bring in money for further treatment as the funds received from the government had already been utilised. The petition asked for uninterrupted treatment free of cost for the patient. It stated that the government hospitals where Sirajuddin's four other children had been admitted were mute spectators to their unfortunate deaths, which happened mainly because he was not able to afford the treatment.</p><p style="text-align: justify">Ashok Aggarwal, who heads a Delhi High Court-appointed committee monitoring the admission of persons from economically weaker sections to private hospitals and who argued for the petitioner in the High Court, further stated: "At present, the AIIMS is providing treatment to 16 people suffering from the same disorder. Of them, 11 patients are government servants or related to government servants and five are being funded by international NGOs [non-governmental organisations]."</p><p> </p><div style="text-align: justify">On April 17, in a landmark judgment in the Delhi High Court, Justice Manmohan ruled that the State government had a constitutional obligation to provide free treatment to the child in this instance at the AIIMS and stated that the government was bound to ensure that poor and vulnerable sections of society had access to treatment for rare and chronic diseases, such as Gaucher's disease. The court upheld the right to health and access to health care as part of the right to life guaranteed under Article 21. Accordingly, every person has a fundamental right to quality and affordable health care.</div><p> </p><p style="text-align: justify">What makes the problem very complicated is the lack of affordable medicines manufactured by generic pharmaceutical companies. A rare disease, usually a genetic disorder, is one that affects less than 0.1 per cent of the population and is usually present throughout the lifetime of the affected person. According to an estimate of the Organisation for Rare Diseases India, a group of eminent leaders in health care, NGOs, doctors and government bodies, about 70 million people in India suffer from such diseases, which include haemophilia, primary immunodeficiency in children and lysosomal storage disorders, such as Gaucher's disease and Pompe disease, genetic conditions in which the metabolic system is unable to digest fats and proteins.</p><p style="text-align: justify">In the absence of affordable medicines, state funding is the only avenue for poor patients suffering from such diseases. Mohammed Ahmed's case highlights the lack of a viable policy on a recurring financial assistance to such people. Ashok Aggarwal pointed out that the issue was linked to a lack of adequate funding for public health programmes: "Though health is a State subject, there is no legislation explicitly recognising a right to public health at the State level. In 2009, Assam enacted a Right to Public Health Act, but it only mandated the State government to pay in case of an emergency." In recent times, some States have made feeble attempts to set aside funds for the treatment of rare diseases. The recent budget of Karnataka proposed to set up a special treatment unit at the Indira Gandhi Institute of Child Health in Bangalore.</p><p style="text-align: justify"><em>Lack of policy</em></p><p style="text-align: justify">This case has highlighted the lack of a viable policy at the national and State levels to address the concerns of patients suffering from lifelong genetic disorders. On February 28, the Ministry of Health and Family Welfare submitted to the Delhi High Court that it had not been possible to devise a viable policy for financial assistance on a recurring mode on a long-term basis for the entire lifetime of patients suffering from lysosomal storage disorder. In the present case, the court steered clear of formulating any policy for the treatment of such diseases. It observed: "Keeping in view the concept of separation of powers as incorporated in the Constitution, this court cannot direct Parliament to enact a Central legislation on Right to Public Health or with regard to rare diseases or orphan drugs, even though the same may be eminently desirable."</p><p> </p><div style="text-align: justify">Further, the recently revised rules of corporate social responsibility also make it difficult for pharma companies to donate money for the treatment of such diseases under their CSR schemes. During the hearing of the case, Shyel Trehan, amicus curiae for the case, submitted notifications issued by the Ministry of Corporate Affairs on February 27 that stipulated that CSR activities could not include activities undertaken by a company in pursuance of its normal course of business. Trehan stated that as a result of the present rules a pharmaceutical or medical device-manufacturing company would not be able to donate its drugs, devices, implants, etc., to the needy.</div><p> </p><p style="text-align: justify">The courts have largely been sympathetic to the question of the obligations of the state towards the health concerns of the poor. In Parmanand Katara vs Union of India (1989), the Supreme Court, while ruling on the right of every injured citizen to be brought for treatment, observed that the preservation of human life was of paramount importance. In Paschim Banga Khet Mazdoor Samity vs State of West Bengal (1996), the Supreme Court held that the state had a constitutional obligation to provide adequate medical services to the people. It observed that the state could not ignore its constitutional obligations on account of its financial constraints.</p><p style="text-align: justify">In the present case, the High Court was sympathetic to the plight of the child and his family. In an order on February 12, the court observed: "In the present case the right to life of a small child must be given utmost priority irrespective of the rarity of the disease, especially when a known treatment is available for the same. Cost of the treatment should not be an impediment as far as the life of a child is concerned. Being a welfare state, it is the constitutional obligation of the state machinery to do whatever it is necessary to preserve human life in a time bound manner." The court also directed the Ministries of Health of the Union of India and the State government to hold a meeting to look into the issue of a possible policy to treat such patients. Affordable treatment is not available for these diseases because generic pharma companies do not have incentives to invest in research and development in the area of rare diseases.</p><p style="text-align: justify">Some countries have provided drug companies with special incentives to promote research in the area. In the United States, the Orphan Drug Act passed in 1983 provides various incentives, including seven-year market exclusivity and tax credits for up to 50 per cent of the costs for clinical trials, for the research and development of drugs to treat orphan diseases (that is, rare genetic disorders). The European Union also provides similar incentives. But in the Indian context, it is not yet clear whether such incentives will necessarily ensure greater involvement of pharma companies in the area.</p><p> </p><div style="text-align: justify">Swaraj Paul Barooah, a researcher at the University of California, Berkeley, who specialises in intellectual property rights issues, highlighted the reasons for the lack of affordable treatment for genetic diseases: "On account of the small clientele, pharma companies do not have enough incentive to carry out research and development of rare diseases. Even if the patients are rich, the sale of drugs by itself does not yield substantial returns. The Orphan Drug Act in the United States has promoted innovation in treatment for rare diseases. In some countries the treatment of rare diseases is sponsored by the government. In the Indian context, given the limited resources of the government, it is a difficult choice between providing funds for expensive treatment for rare genetic diseases and making available quality heath care for other diseases. It is difficult to quantify suffering and then create hierarchies between diseases."</div><p> </p><p style="text-align: justify">The difficult question facing both the state and the courts at present is whether to approach the issue of medical aid to people suffering from a rare disease merely on the logic of numbers or to take a more holistic view of the constitutional obligations of the state towards the health and overall well-being of people.</p>
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<br><a href="http://www.frontline.in/social-issues/general-issues/onus-on-the-state/article5950781.ece" class="re" target="_blank">Frontline, 16 May, 2014, http://www.frontline.in/social-issues/general-issues/onus-on-the-state/article5950781.ece</a><div class="clear"></div>
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<h1 class="cat-box-title">Onus on the state-Sagnik Dutta</h1>
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Published on</span><span class="text-date"> May 6, 2014</span>
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<div style="text-align: justify">-Frontline</div><div style="text-align: justify"> </div><p style="text-align: justify"><em>A Delhi High Court verdict says the State government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases. </em></p><p style="text-align: justify">SEVEN-YEAR-OLD Mohammed Ahmed Khan looked on helplessly as his father, Sirajuddin, narrated the sordid tale of the loss of four of his children to Gaucher's disease, a rare genetic disease that requires lifelong, exorbitantly expensive enzyme replacement therapy. Sirajuddin, a rickshaw puller, earns Rs.250-300 a day. His children were turned away by government hospitals between 2005 and 2012 as he could not pay for their treatment. Mohammed Ahmed is his last hope.</p><p style="text-align: justify"><em>Delhi High Court case</em></p><p style="text-align: justify">A petition filed before the Delhi High Court in November last year alleged that the denial of treatment to the petitioner (Mohammed Ahmed Khan) on account of the failure of his parents to pay the exorbitant costs of the treatment violated the right to life guaranteed under Article 21 of the Constitution. The petition made the Union of India, the Government of Delhi and the All India Institute of Medical Sciences (AIIMS) respondents in the case. Mohammed Ahmed was admitted to the Department of Paediatrics at the AIIMS in a critical state with Gaucher's disease type 1. In this disease, the body does not produce an enzyme called glucocerebrosidase, which leads to a build-up of harmful substances in the liver, spleen, bones and bone marrow and prevents the normal functioning of cells and organs. Mohammed Ahmed required enzyme replacement therapy at a cost of Rs.4.8 lakh a month, according to a certificate issued by the Genetic Unit of the Department of Paediatrics. The hospital refused him treatment as his father could not afford it. Following some assistance from the Directorate of Health Services, Government of Delhi, in July 2013, the AIIMS began the treatment the next month. However, on November 15, the hospital asked the family to bring in money for further treatment as the funds received from the government had already been utilised. The petition asked for uninterrupted treatment free of cost for the patient. It stated that the government hospitals where Sirajuddin's four other children had been admitted were mute spectators to their unfortunate deaths, which happened mainly because he was not able to afford the treatment.</p><p style="text-align: justify">Ashok Aggarwal, who heads a Delhi High Court-appointed committee monitoring the admission of persons from economically weaker sections to private hospitals and who argued for the petitioner in the High Court, further stated: "At present, the AIIMS is providing treatment to 16 people suffering from the same disorder. Of them, 11 patients are government servants or related to government servants and five are being funded by international NGOs [non-governmental organisations]."</p><p> </p><div style="text-align: justify">On April 17, in a landmark judgment in the Delhi High Court, Justice Manmohan ruled that the State government had a constitutional obligation to provide free treatment to the child in this instance at the AIIMS and stated that the government was bound to ensure that poor and vulnerable sections of society had access to treatment for rare and chronic diseases, such as Gaucher's disease. The court upheld the right to health and access to health care as part of the right to life guaranteed under Article 21. Accordingly, every person has a fundamental right to quality and affordable health care.</div><p> </p><p style="text-align: justify">What makes the problem very complicated is the lack of affordable medicines manufactured by generic pharmaceutical companies. A rare disease, usually a genetic disorder, is one that affects less than 0.1 per cent of the population and is usually present throughout the lifetime of the affected person. According to an estimate of the Organisation for Rare Diseases India, a group of eminent leaders in health care, NGOs, doctors and government bodies, about 70 million people in India suffer from such diseases, which include haemophilia, primary immunodeficiency in children and lysosomal storage disorders, such as Gaucher's disease and Pompe disease, genetic conditions in which the metabolic system is unable to digest fats and proteins.</p><p style="text-align: justify">In the absence of affordable medicines, state funding is the only avenue for poor patients suffering from such diseases. Mohammed Ahmed's case highlights the lack of a viable policy on a recurring financial assistance to such people. Ashok Aggarwal pointed out that the issue was linked to a lack of adequate funding for public health programmes: "Though health is a State subject, there is no legislation explicitly recognising a right to public health at the State level. In 2009, Assam enacted a Right to Public Health Act, but it only mandated the State government to pay in case of an emergency." In recent times, some States have made feeble attempts to set aside funds for the treatment of rare diseases. The recent budget of Karnataka proposed to set up a special treatment unit at the Indira Gandhi Institute of Child Health in Bangalore.</p><p style="text-align: justify"><em>Lack of policy</em></p><p style="text-align: justify">This case has highlighted the lack of a viable policy at the national and State levels to address the concerns of patients suffering from lifelong genetic disorders. On February 28, the Ministry of Health and Family Welfare submitted to the Delhi High Court that it had not been possible to devise a viable policy for financial assistance on a recurring mode on a long-term basis for the entire lifetime of patients suffering from lysosomal storage disorder. In the present case, the court steered clear of formulating any policy for the treatment of such diseases. It observed: "Keeping in view the concept of separation of powers as incorporated in the Constitution, this court cannot direct Parliament to enact a Central legislation on Right to Public Health or with regard to rare diseases or orphan drugs, even though the same may be eminently desirable."</p><p> </p><div style="text-align: justify">Further, the recently revised rules of corporate social responsibility also make it difficult for pharma companies to donate money for the treatment of such diseases under their CSR schemes. During the hearing of the case, Shyel Trehan, amicus curiae for the case, submitted notifications issued by the Ministry of Corporate Affairs on February 27 that stipulated that CSR activities could not include activities undertaken by a company in pursuance of its normal course of business. Trehan stated that as a result of the present rules a pharmaceutical or medical device-manufacturing company would not be able to donate its drugs, devices, implants, etc., to the needy.</div><p> </p><p style="text-align: justify">The courts have largely been sympathetic to the question of the obligations of the state towards the health concerns of the poor. In Parmanand Katara vs Union of India (1989), the Supreme Court, while ruling on the right of every injured citizen to be brought for treatment, observed that the preservation of human life was of paramount importance. In Paschim Banga Khet Mazdoor Samity vs State of West Bengal (1996), the Supreme Court held that the state had a constitutional obligation to provide adequate medical services to the people. It observed that the state could not ignore its constitutional obligations on account of its financial constraints.</p><p style="text-align: justify">In the present case, the High Court was sympathetic to the plight of the child and his family. In an order on February 12, the court observed: "In the present case the right to life of a small child must be given utmost priority irrespective of the rarity of the disease, especially when a known treatment is available for the same. Cost of the treatment should not be an impediment as far as the life of a child is concerned. Being a welfare state, it is the constitutional obligation of the state machinery to do whatever it is necessary to preserve human life in a time bound manner." The court also directed the Ministries of Health of the Union of India and the State government to hold a meeting to look into the issue of a possible policy to treat such patients. Affordable treatment is not available for these diseases because generic pharma companies do not have incentives to invest in research and development in the area of rare diseases.</p><p style="text-align: justify">Some countries have provided drug companies with special incentives to promote research in the area. In the United States, the Orphan Drug Act passed in 1983 provides various incentives, including seven-year market exclusivity and tax credits for up to 50 per cent of the costs for clinical trials, for the research and development of drugs to treat orphan diseases (that is, rare genetic disorders). The European Union also provides similar incentives. But in the Indian context, it is not yet clear whether such incentives will necessarily ensure greater involvement of pharma companies in the area.</p><p> </p><div style="text-align: justify">Swaraj Paul Barooah, a researcher at the University of California, Berkeley, who specialises in intellectual property rights issues, highlighted the reasons for the lack of affordable treatment for genetic diseases: "On account of the small clientele, pharma companies do not have enough incentive to carry out research and development of rare diseases. Even if the patients are rich, the sale of drugs by itself does not yield substantial returns. The Orphan Drug Act in the United States has promoted innovation in treatment for rare diseases. In some countries the treatment of rare diseases is sponsored by the government. In the Indian context, given the limited resources of the government, it is a difficult choice between providing funds for expensive treatment for rare genetic diseases and making available quality heath care for other diseases. It is difficult to quantify suffering and then create hierarchies between diseases."</div><p> </p><p style="text-align: justify">The difficult question facing both the state and the courts at present is whether to approach the issue of medical aid to people suffering from a rare disease merely on the logic of numbers or to take a more holistic view of the constitutional obligations of the state towards the health and overall well-being of people.</p>
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<br><a href="http://www.frontline.in/social-issues/general-issues/onus-on-the-state/article5950781.ece" class="re" target="_blank">Frontline, 16 May, 2014, http://www.frontline.in/social-issues/general-issues/onus-on-the-state/article5950781.ece</a><div class="clear"></div>
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A Delhi High Court verdict says the State government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases.
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<h1 class="cat-box-title">Onus on the state-Sagnik Dutta</h1>
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<div style="text-align: justify">-Frontline</div><div style="text-align: justify"> </div><p style="text-align: justify"><em>A Delhi High Court verdict says the State government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases. </em></p><p style="text-align: justify">SEVEN-YEAR-OLD Mohammed Ahmed Khan looked on helplessly as his father, Sirajuddin, narrated the sordid tale of the loss of four of his children to Gaucher's disease, a rare genetic disease that requires lifelong, exorbitantly expensive enzyme replacement therapy. Sirajuddin, a rickshaw puller, earns Rs.250-300 a day. His children were turned away by government hospitals between 2005 and 2012 as he could not pay for their treatment. Mohammed Ahmed is his last hope.</p><p style="text-align: justify"><em>Delhi High Court case</em></p><p style="text-align: justify">A petition filed before the Delhi High Court in November last year alleged that the denial of treatment to the petitioner (Mohammed Ahmed Khan) on account of the failure of his parents to pay the exorbitant costs of the treatment violated the right to life guaranteed under Article 21 of the Constitution. The petition made the Union of India, the Government of Delhi and the All India Institute of Medical Sciences (AIIMS) respondents in the case. Mohammed Ahmed was admitted to the Department of Paediatrics at the AIIMS in a critical state with Gaucher's disease type 1. In this disease, the body does not produce an enzyme called glucocerebrosidase, which leads to a build-up of harmful substances in the liver, spleen, bones and bone marrow and prevents the normal functioning of cells and organs. Mohammed Ahmed required enzyme replacement therapy at a cost of Rs.4.8 lakh a month, according to a certificate issued by the Genetic Unit of the Department of Paediatrics. The hospital refused him treatment as his father could not afford it. Following some assistance from the Directorate of Health Services, Government of Delhi, in July 2013, the AIIMS began the treatment the next month. However, on November 15, the hospital asked the family to bring in money for further treatment as the funds received from the government had already been utilised. The petition asked for uninterrupted treatment free of cost for the patient. It stated that the government hospitals where Sirajuddin's four other children had been admitted were mute spectators to their unfortunate deaths, which happened mainly because he was not able to afford the treatment.</p><p style="text-align: justify">Ashok Aggarwal, who heads a Delhi High Court-appointed committee monitoring the admission of persons from economically weaker sections to private hospitals and who argued for the petitioner in the High Court, further stated: "At present, the AIIMS is providing treatment to 16 people suffering from the same disorder. Of them, 11 patients are government servants or related to government servants and five are being funded by international NGOs [non-governmental organisations]."</p><p> </p><div style="text-align: justify">On April 17, in a landmark judgment in the Delhi High Court, Justice Manmohan ruled that the State government had a constitutional obligation to provide free treatment to the child in this instance at the AIIMS and stated that the government was bound to ensure that poor and vulnerable sections of society had access to treatment for rare and chronic diseases, such as Gaucher's disease. The court upheld the right to health and access to health care as part of the right to life guaranteed under Article 21. Accordingly, every person has a fundamental right to quality and affordable health care.</div><p> </p><p style="text-align: justify">What makes the problem very complicated is the lack of affordable medicines manufactured by generic pharmaceutical companies. A rare disease, usually a genetic disorder, is one that affects less than 0.1 per cent of the population and is usually present throughout the lifetime of the affected person. According to an estimate of the Organisation for Rare Diseases India, a group of eminent leaders in health care, NGOs, doctors and government bodies, about 70 million people in India suffer from such diseases, which include haemophilia, primary immunodeficiency in children and lysosomal storage disorders, such as Gaucher's disease and Pompe disease, genetic conditions in which the metabolic system is unable to digest fats and proteins.</p><p style="text-align: justify">In the absence of affordable medicines, state funding is the only avenue for poor patients suffering from such diseases. Mohammed Ahmed's case highlights the lack of a viable policy on a recurring financial assistance to such people. Ashok Aggarwal pointed out that the issue was linked to a lack of adequate funding for public health programmes: "Though health is a State subject, there is no legislation explicitly recognising a right to public health at the State level. In 2009, Assam enacted a Right to Public Health Act, but it only mandated the State government to pay in case of an emergency." In recent times, some States have made feeble attempts to set aside funds for the treatment of rare diseases. The recent budget of Karnataka proposed to set up a special treatment unit at the Indira Gandhi Institute of Child Health in Bangalore.</p><p style="text-align: justify"><em>Lack of policy</em></p><p style="text-align: justify">This case has highlighted the lack of a viable policy at the national and State levels to address the concerns of patients suffering from lifelong genetic disorders. On February 28, the Ministry of Health and Family Welfare submitted to the Delhi High Court that it had not been possible to devise a viable policy for financial assistance on a recurring mode on a long-term basis for the entire lifetime of patients suffering from lysosomal storage disorder. In the present case, the court steered clear of formulating any policy for the treatment of such diseases. It observed: "Keeping in view the concept of separation of powers as incorporated in the Constitution, this court cannot direct Parliament to enact a Central legislation on Right to Public Health or with regard to rare diseases or orphan drugs, even though the same may be eminently desirable."</p><p> </p><div style="text-align: justify">Further, the recently revised rules of corporate social responsibility also make it difficult for pharma companies to donate money for the treatment of such diseases under their CSR schemes. During the hearing of the case, Shyel Trehan, amicus curiae for the case, submitted notifications issued by the Ministry of Corporate Affairs on February 27 that stipulated that CSR activities could not include activities undertaken by a company in pursuance of its normal course of business. Trehan stated that as a result of the present rules a pharmaceutical or medical device-manufacturing company would not be able to donate its drugs, devices, implants, etc., to the needy.</div><p> </p><p style="text-align: justify">The courts have largely been sympathetic to the question of the obligations of the state towards the health concerns of the poor. In Parmanand Katara vs Union of India (1989), the Supreme Court, while ruling on the right of every injured citizen to be brought for treatment, observed that the preservation of human life was of paramount importance. In Paschim Banga Khet Mazdoor Samity vs State of West Bengal (1996), the Supreme Court held that the state had a constitutional obligation to provide adequate medical services to the people. It observed that the state could not ignore its constitutional obligations on account of its financial constraints.</p><p style="text-align: justify">In the present case, the High Court was sympathetic to the plight of the child and his family. In an order on February 12, the court observed: "In the present case the right to life of a small child must be given utmost priority irrespective of the rarity of the disease, especially when a known treatment is available for the same. Cost of the treatment should not be an impediment as far as the life of a child is concerned. Being a welfare state, it is the constitutional obligation of the state machinery to do whatever it is necessary to preserve human life in a time bound manner." The court also directed the Ministries of Health of the Union of India and the State government to hold a meeting to look into the issue of a possible policy to treat such patients. Affordable treatment is not available for these diseases because generic pharma companies do not have incentives to invest in research and development in the area of rare diseases.</p><p style="text-align: justify">Some countries have provided drug companies with special incentives to promote research in the area. In the United States, the Orphan Drug Act passed in 1983 provides various incentives, including seven-year market exclusivity and tax credits for up to 50 per cent of the costs for clinical trials, for the research and development of drugs to treat orphan diseases (that is, rare genetic disorders). The European Union also provides similar incentives. But in the Indian context, it is not yet clear whether such incentives will necessarily ensure greater involvement of pharma companies in the area.</p><p> </p><div style="text-align: justify">Swaraj Paul Barooah, a researcher at the University of California, Berkeley, who specialises in intellectual property rights issues, highlighted the reasons for the lack of affordable treatment for genetic diseases: "On account of the small clientele, pharma companies do not have enough incentive to carry out research and development of rare diseases. Even if the patients are rich, the sale of drugs by itself does not yield substantial returns. The Orphan Drug Act in the United States has promoted innovation in treatment for rare diseases. In some countries the treatment of rare diseases is sponsored by the government. In the Indian context, given the limited resources of the government, it is a difficult choice between providing funds for expensive treatment for rare genetic diseases and making available quality heath care for other diseases. It is difficult to quantify suffering and then create hierarchies between diseases."</div><p> </p><p style="text-align: justify">The difficult question facing both the state and the courts at present is whether to approach the issue of medical aid to people suffering from a rare disease merely on the logic of numbers or to take a more holistic view of the constitutional obligations of the state towards the health and overall well-being of people.</p>
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<br><a href="http://www.frontline.in/social-issues/general-issues/onus-on-the-state/article5950781.ece" class="re" target="_blank">Frontline, 16 May, 2014, http://www.frontline.in/social-issues/general-issues/onus-on-the-state/article5950781.ece</a><div class="clear"></div>
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LATEST NEWS UPDATES | Onus on the state-Sagnik Dutta
A Delhi High Court verdict says the State government is bound to ensure that poor and vulnerable sections of society have access to treatment for rare and chronic diseases.
SEVEN-YEAR-OLD Mohammed Ahmed Khan looked on helplessly as his father, Sirajuddin, narrated the sordid tale of the loss of four of his children to Gaucher's disease, a rare genetic disease that requires lifelong, exorbitantly expensive enzyme replacement therapy. Sirajuddin, a rickshaw puller, earns Rs.250-300 a day. His children were turned away by government hospitals between 2005 and 2012 as he could not pay for their treatment. Mohammed Ahmed is his last hope.
Delhi High Court case
A petition filed before the Delhi High Court in November last year alleged that the denial of treatment to the petitioner (Mohammed Ahmed Khan) on account of the failure of his parents to pay the exorbitant costs of the treatment violated the right to life guaranteed under Article 21 of the Constitution. The petition made the Union of India, the Government of Delhi and the All India Institute of Medical Sciences (AIIMS) respondents in the case. Mohammed Ahmed was admitted to the Department of Paediatrics at the AIIMS in a critical state with Gaucher's disease type 1. In this disease, the body does not produce an enzyme called glucocerebrosidase, which leads to a build-up of harmful substances in the liver, spleen, bones and bone marrow and prevents the normal functioning of cells and organs. Mohammed Ahmed required enzyme replacement therapy at a cost of Rs.4.8 lakh a month, according to a certificate issued by the Genetic Unit of the Department of Paediatrics. The hospital refused him treatment as his father could not afford it. Following some assistance from the Directorate of Health Services, Government of Delhi, in July 2013, the AIIMS began the treatment the next month. However, on November 15, the hospital asked the family to bring in money for further treatment as the funds received from the government had already been utilised. The petition asked for uninterrupted treatment free of cost for the patient. It stated that the government hospitals where Sirajuddin's four other children had been admitted were mute spectators to their unfortunate deaths, which happened mainly because he was not able to afford the treatment.
Ashok Aggarwal, who heads a Delhi High Court-appointed committee monitoring the admission of persons from economically weaker sections to private hospitals and who argued for the petitioner in the High Court, further stated: "At present, the AIIMS is providing treatment to 16 people suffering from the same disorder. Of them, 11 patients are government servants or related to government servants and five are being funded by international NGOs [non-governmental organisations]."
On April 17, in a landmark judgment in the Delhi High Court, Justice Manmohan ruled that the State government had a constitutional obligation to provide free treatment to the child in this instance at the AIIMS and stated that the government was bound to ensure that poor and vulnerable sections of society had access to treatment for rare and chronic diseases, such as Gaucher's disease. The court upheld the right to health and access to health care as part of the right to life guaranteed under Article 21. Accordingly, every person has a fundamental right to quality and affordable health care.
What makes the problem very complicated is the lack of affordable medicines manufactured by generic pharmaceutical companies. A rare disease, usually a genetic disorder, is one that affects less than 0.1 per cent of the population and is usually present throughout the lifetime of the affected person. According to an estimate of the Organisation for Rare Diseases India, a group of eminent leaders in health care, NGOs, doctors and government bodies, about 70 million people in India suffer from such diseases, which include haemophilia, primary immunodeficiency in children and lysosomal storage disorders, such as Gaucher's disease and Pompe disease, genetic conditions in which the metabolic system is unable to digest fats and proteins.
In the absence of affordable medicines, state funding is the only avenue for poor patients suffering from such diseases. Mohammed Ahmed's case highlights the lack of a viable policy on a recurring financial assistance to such people. Ashok Aggarwal pointed out that the issue was linked to a lack of adequate funding for public health programmes: "Though health is a State subject, there is no legislation explicitly recognising a right to public health at the State level. In 2009, Assam enacted a Right to Public Health Act, but it only mandated the State government to pay in case of an emergency." In recent times, some States have made feeble attempts to set aside funds for the treatment of rare diseases. The recent budget of Karnataka proposed to set up a special treatment unit at the Indira Gandhi Institute of Child Health in Bangalore.
Lack of policy
This case has highlighted the lack of a viable policy at the national and State levels to address the concerns of patients suffering from lifelong genetic disorders. On February 28, the Ministry of Health and Family Welfare submitted to the Delhi High Court that it had not been possible to devise a viable policy for financial assistance on a recurring mode on a long-term basis for the entire lifetime of patients suffering from lysosomal storage disorder. In the present case, the court steered clear of formulating any policy for the treatment of such diseases. It observed: "Keeping in view the concept of separation of powers as incorporated in the Constitution, this court cannot direct Parliament to enact a Central legislation on Right to Public Health or with regard to rare diseases or orphan drugs, even though the same may be eminently desirable."
Further, the recently revised rules of corporate social responsibility also make it difficult for pharma companies to donate money for the treatment of such diseases under their CSR schemes. During the hearing of the case, Shyel Trehan, amicus curiae for the case, submitted notifications issued by the Ministry of Corporate Affairs on February 27 that stipulated that CSR activities could not include activities undertaken by a company in pursuance of its normal course of business. Trehan stated that as a result of the present rules a pharmaceutical or medical device-manufacturing company would not be able to donate its drugs, devices, implants, etc., to the needy.
The courts have largely been sympathetic to the question of the obligations of the state towards the health concerns of the poor. In Parmanand Katara vs Union of India (1989), the Supreme Court, while ruling on the right of every injured citizen to be brought for treatment, observed that the preservation of human life was of paramount importance. In Paschim Banga Khet Mazdoor Samity vs State of West Bengal (1996), the Supreme Court held that the state had a constitutional obligation to provide adequate medical services to the people. It observed that the state could not ignore its constitutional obligations on account of its financial constraints.
In the present case, the High Court was sympathetic to the plight of the child and his family. In an order on February 12, the court observed: "In the present case the right to life of a small child must be given utmost priority irrespective of the rarity of the disease, especially when a known treatment is available for the same. Cost of the treatment should not be an impediment as far as the life of a child is concerned. Being a welfare state, it is the constitutional obligation of the state machinery to do whatever it is necessary to preserve human life in a time bound manner." The court also directed the Ministries of Health of the Union of India and the State government to hold a meeting to look into the issue of a possible policy to treat such patients. Affordable treatment is not available for these diseases because generic pharma companies do not have incentives to invest in research and development in the area of rare diseases.
Some countries have provided drug companies with special incentives to promote research in the area. In the United States, the Orphan Drug Act passed in 1983 provides various incentives, including seven-year market exclusivity and tax credits for up to 50 per cent of the costs for clinical trials, for the research and development of drugs to treat orphan diseases (that is, rare genetic disorders). The European Union also provides similar incentives. But in the Indian context, it is not yet clear whether such incentives will necessarily ensure greater involvement of pharma companies in the area.
Swaraj Paul Barooah, a researcher at the University of California, Berkeley, who specialises in intellectual property rights issues, highlighted the reasons for the lack of affordable treatment for genetic diseases: "On account of the small clientele, pharma companies do not have enough incentive to carry out research and development of rare diseases. Even if the patients are rich, the sale of drugs by itself does not yield substantial returns. The Orphan Drug Act in the United States has promoted innovation in treatment for rare diseases. In some countries the treatment of rare diseases is sponsored by the government. In the Indian context, given the limited resources of the government, it is a difficult choice between providing funds for expensive treatment for rare genetic diseases and making available quality heath care for other diseases. It is difficult to quantify suffering and then create hierarchies between diseases."
The difficult question facing both the state and the courts at present is whether to approach the issue of medical aid to people suffering from a rare disease merely on the logic of numbers or to take a more holistic view of the constitutional obligations of the state towards the health and overall well-being of people.
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