MANOJ M v. STATE OF KERALA AND OTHERS

## **IN THE HIGH COURT OF KERALA AT ERNAKULAM** ## **PRESENT:** **THE HONOURABLE MR. JUSTICE P.B.SURESH KUMAR** **THURSDAY, THE 22ND DAY OF SEPTEMBER 2016/31ST BHADRA, 1938H** **WP(C).No. 21897 of 2016 (J) ----------------------------** **PETITIONER:** **-----------** **MANOJ M, MANGAT HOUSE, MEZHATHUR P.O., TRITHALA (VIA), PALAKKAD DISTRICT.** **BY ADVS.SRI.V.G.ARUN SRI.T.R.HARIKUMAR SRI.JAIBY PAUL SRI.ARJUN RAGHAVAN SRI.ADITHYA RAJEEV** **RESPONDENT(S):** **--------------** **1. STATE OF KERALA, REPRESENTED BY ITS CHIEF SECRETARY, GOVERNMENT SECRETARY, THIRUVANANTHAPURAM-695 001.** **2. THE PRINCIPAL SECRETARY, HEALTH AND FAMILY WELFARE DEPARTMENT, GOVERNMENT SECRETARIAT, THIRUVANANTHAPURAM-695 001.** **3. THE KERALA SOCIAL SECURITY MISSION, REPRESENTED BY ITS EXECUTIVE DIRECTOR, POOJAPPURA, THIRUVANANTHAPURAM-695 001.** **4. THE KERALA MEDICAL SERVICES CORPORATION LTD., REPRESENTED BY ITS MANAGING DIRECTOR, THYCAUD. P.O., THIRUVANANTHAPURAM-695 014.** **5. UNION OF INDIA, REPRESENTED BY ITS SECRETARY, HEALTH AND FAMILY WELFARE DEPARTMENT, CABINET SECRETARIAT, RAISINA HILL, NEW DELHI-110 011.** **R1 & R2 BY GOVT. PLEADER SRI.ARUNKUMAR.M.K. R4 BY ADV. SRI.M.AJAY, SC** **R5 BY SRI.N.NAGARESH, ASSISTANT SOLICITOR GENERAL ADV.SMT.SINDHUMOL.T.P., CGC** **THIS WRIT PETITION (CIVIL) HAVING COME UP FOR ADMISSION ON 28-07-2016, THE COURT ON 22-09-2016 DELIVERED THE FOLLOWING:** **mbr/** **WP(C).No. 21897 of 2016 (J)** ## **----------------------------** ## **APPENDIX** ## **PETITIONER(S)' EXHIBITS:** ## **-----------------------** |**P1**|**:**|**A TRUE COPY OF THE BROCHURE ON POMPE DISEASE.**| |---|---|---| |**P2**|**:**|**A TRUE COPY OF THE ANALYSIS REPORT DATED 10.08.2010**| |||**ISSUE FROM THE SANDOR PROTEOMICS PVT. LTD, HYDERABAD.**| |**P3**|**:**|**A TRUE COPY OF THE NEWS ITEM PUBLISHED IN THE INDIAN**| |||**EXPRESSED DATED 25.6.2011.**| |**P4**|**:**|**A TRUE COPY OF THE LETTER DATED 9.12.2010 RECEIVED**| |||**FROM OFFICE OF THE HON'BLE SPEAKER.**| |**P5**|**:**|**A TRUE COPY OF THE CERTIFICATE ISSUED BY THE**| |||**ASSOCIATE PROFESSOR, DEPARTMENT OF MEDICAL GENETICS,**| |||**SAT MEDICAL COLLEGE & HOSPITAL, TRIVANDRUM.**| |**P6**|**:**|**A TRUE COPY OF THE COMMUNICATION FORWARDED BY THE**| |||**NATIONAL HUMAN RIGHTS COMMISSION TO THE CHIEF TO**| |||**THE CHIEF SECRETARY, GOVERNMENT OF KERALA**| |||**DATED 29.05.2012.**| - **P7 : A TRUE COPY OF THE LETTER DATED 16.8.2012 ISSUED BY THE 2ND RESPONDENT.** - **P8 : A TRUE COPY OF THE REPRESENTATION SUBMITTED BEFORE THE HON'BLE CHIEF MINISTER DATED 09.11.2012.** - **P9 : A TRUE COPY OF THE CHEQUE DATED 23.12.2013, DISBURSED FROM THE CHIEF MINISTER'S RELIEF FUND.** - **P10 : A TRUE COPY OF THE LETTER ISSUED BY THE KERALA SOCIAL SECURITY MISSION TO THE PETITIONER DATED 06.02.2013.** - **P11 : A TRUE COPY OF THE DETAILS REGARDING THALOLAM PROJECT PUBLISHED IN THE WEBSITE OF THE KERALA SOCIAL SECURITY MISSION.** - **P12 : PERSONAL DATE OF SOME OF THE PATIENTS SUFFERING FROM LSD. AND UNDERGOING TREATMENT AT AMRITHA INSTITUTE OF MEDICAL SCIENCES, KOCHI.** - **P13 : A TRUE COPY OF THE REPRESENTATION SUBMITTED BY THE PETITIONER BEFORE THE HON'BLE CHIEF MINISTER ALONG WITH RECEIPTS.** **RESPONDENT(S)' EXHIBITS: NIL ----------------------//TRUE COPY//** **mbr/** **P.S. TO JUDGE** ## **C.R.** ## **P.B.SURESH KUMAR, J.** ## **= = = = = = = = = = = = = = WP(C).No.21897 of 2016-J.** ## **= = = = = = = = = = = = = =** Dated this the 22[nd] day of September, 2016. ## **J U D G M E N T** A serious issue as to the scope of right to life guaranteed under Article 21 of the Constitution arises for consideration in this matter. 2. The undisputed facts are the following:- The petitioner belongs to an economically weaker section of the society. The meager income from the small time business carried on by the petitioner is the only means of livelihood of his family. The son of the petitioner Govind is suffering from a rare disease called Pompe. Pompe is a Lysosomal Storage Disorder. Lysosomal Storage Disorder is a genetic defect in one or more specific Lysosomal enzymes, resulting in deficient enzymatic activity. If a Lysosomal enzyme is deficient, the substrate it targets accumulates in a progressive manner interfering with normal cellular activity resulting in cellular death. The most **WP(C).No.21897/2016-J.** 2 common Lysosomal Storage Disorders are Gaucher, Fabin and Pompe. If this disease is left untreated, the patient is unlikely to survive. The elder daughter of the petitioner Sarika was also suffering from Pompe and she had succumbed to her illness during 2010. A treatment by name Enzyme Replacement Therapy with the help of an imported drug by name Myozyme is available for Pompe disease. Enzyme Replacement Therapy has to be administered in the form of fortnightly infusions life long. Govind requires eight vials of Myozyme every fortnight. One vial of Myozyme costs approximately Rs.45,000/-. In other words, the cost of the yearly treatment of Govind comes approximately to Rs.43,00,000/-. The manufacturer of Myozyme namely, Genzyne has introduced a charitable programme by name India Charitable Access Programme and the drug is being supplied by the manufacturer free of cost to a few children suffering from Pompe disorder under the said programme. The son of the petitioner is presently being extended treatment by the Amritha Institute of Medical Sciences, Kochi under the said programme. According to the petitioner, the said charitable programme is likely to be withdrawn by the manufacturer at any time and if the said **WP(C).No.21897/2016-J.** 3 programme is withdrawn, the son of the petitioner will have no option but to die as he is unable to afford the cost of the treatment of his son. The materials placed on record indicate that when the petitioner had brought his pitiable condition to the notice of the State Government, it provided six vials of the drug to his son under a charitable programme. As indicated above, the drug provided by the State Government was not even sufficient for a fortnightly treatment. The petitioner then approached the National Human Rights Commission, which in turn, forwarded the complaint of the petitioner for appropriate action to the State Government. In response to the said directive of the National Human Rights Commission, the State Government requested the Ministry of Family Welfare, Government of India to provide necessary financial assistance for the treatment of the son of the petitioner as a special case. Since there was no action in response to the directive of the National Human Rights Commission, the petitioner approached the Chief Minister of the State. The Chief Minister then provided a sum of Rs.1,00,000/from the Chief Minister's Relief Fund for the treatment of the son of the petitioner. Later, at the instance of the Chief Minister, the **WP(C).No.21897/2016-J.** 4 petitioner was also informed that the treatment expenses of his son excluding the cost of the drug, will be met by the State Government. According to the petitioner, the cost of the drug is the most expensive part of the treatment and therefore, the said offer from the Government is of no solace to the grievance of the petitioner. This writ petition is filed, in the said circumstances, seeking directions to the respondents to provide Enzyme Replacement Therapy to the son of the petitioner, free of cost. The case of the petitioner is that the State Government is constitutionally obliged to provide the said treatment to the son of the petitioner free of cost. 3. A statement has been filed in this matter on behalf of the State Government by its Principal Secretary to the Health and Family Welfare Department. It is brought on record by the State Government that out of 5,50,000 children born on an average in an year in the State, fifteen cases of Lysosomal Storage Disorder including Pompe are reported on an average; that the cost of their yearly treatment comes to approximately Rs.50,00,000/- per person; that the annual budgetary allocation for purchase of the essential drugs in the Government Hospitals is 5 ## **WP(C).No.21897/2016-J.** only Rs.300 crores; that if all the patients suffering from Lysosomal Storage Disorder are given treatment free of cost, in about eighteen years, half of the said allocation has to be earmarked for the treatment of such patients; that the Government is not in a position to increase the allocation of funds towards the purchase of the essential drugs in Government Hospitals and that therefore free treatment to patients suffering from Lysosomal Storage Disorder would affect the treatment of persons who are availing the services of the Government hospitals for their requirements. The stand of the Government as discernible from the statement is that the Government is not in a position, with the available resources, to provide free treatment to patients suffering from Lysosomal Storage Disorder. It is, however, recited in the statement that since the State does not have the resources to meet the treatment expenses of Lysosomal Storage Disorder patients, the State will certainly take efforts to cater to their needs by taking up the issue with non-Government and charitable organizations. 4. Heard the learned counsel for the petitioner as also the learned Government Pleader. 6 ## **WP(C).No.21897/2016-J.** 5. The learned counsel for the petitioner firmly contended that Article 21 of the Constitution casts an obligation upon the State to preserve the life of every citizen and when it is admitted that the life of the citizen is in danger, the obligation being absolute, all other considerations have to give way. He has relied on the decisions of the Apex Court in **Paschim Banga Khet Mazdoor Samity v. State of W.B.** , [(1996) 4 SCC 37] and **Brij Mohan Lal v. Union of India,** [(2012) 6 SCC 502], in support of the said preposition. The learned counsel for the petitioner has also brought to my notice the decision of the Delhi High Court in WP(C).No.7279 of 2013 rendered on an exactly identical case. Per contra, the learned Government Pleader contended that right to life in a developing country like India cannot be so stretched to include free treatment to all beyond the limited resources of the State. According to the learned Government Pleader, the State has equal obligation towards all citizens and it has to use its resources so as to provide the maximum benefit to the maximum number of people. 6. The fact that the minor son of the petitioner is suffering from the rare disease Pompe and the fact that he is 7 ## **WP(C).No.21897/2016-J.** unlikely to survive, if he is not subjected to Enzyme Replacement Therapy, are not in dispute. There is also no dispute to the fact that the petitioner is unable to afford the cost of the said treatment. As indicated in the statement filed on behalf of the Government itself, Pompe is a rare disease caused on an average of five out of 5.5 lakhs children born in the State in an year. Drugs for such diseases, which are popularly known as 'Orphan Drugs', are ridiculously expensive, for, the manufacturers of the same have to recover the costs of their research and development from the limited number of patients. The materials on record indicate that while countries like United States, Japan, Australia, Israel as also members of European Union have evolved policies to provide affordable treatment to patients suffering from such rare diseases, neither the Union Government nor the State Governments in India have evolved any policy to address the grievances of such patients. As such, the right, if any, of the petitioner to claim the reliefs sought in the writ petition has to be examined in the light of the provisions contained in the Constitution. 7. Article 21 of the Constitution casts an obligation on 8 ## **WP(C).No.21897/2016-J.** the State to preserve the life of every citizen. Article 24(2)(b) of the United Nations Convention on the Rights of the Child, to which India is a party, casts an obligation upon the State parties to ensure the provision for necessary medical assistance and health care to all children. Article 25.01 of the Universal Declaration of Human Rights to which India is a party affirms that everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services. Article 12.01 of the International Covenant on Economic, Social and Cultural Rights to which India is a party makes it obligatory for the State parties to recognise the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The scope of Article 21 is, therefore, to be understood in conformity with the terms of the aforesaid International instruments. 8. It is now settled by a long catena of decisions that the right to health and medical care is a facet of Article 21. The State is, therefore, duty bound to extend medical assistance for preserving human life. [(See **Parmanand Katara v. Union of India,** [(1989) 4 SCC 286] and **Paschim Banga Khet Mazdoor** **WP(C).No.21897/2016-J.** 9 **Samity v. State of W.B.** , [(1996) 4 SCC 37]. Further, our Constitution envisages establishment of a welfare State at the Federal level as also at the State level. All that is done in a welfare State by its Government is for the well being of its citizens. The life of citizens is a matter of paramount importance in a welfare State, for, if the State cannot secure the life of its citizens, the very concept of welfare State would become meaningless. The Government in a welfare State is obliged therefore, to provide adequate medical facilities for securing the life of its citizens. True, if a class or category of persons can afford to pay or partially pay for their medical treatment because of their economic background, free medical treatment to such class of persons may not be part of the Constitutional obligation of the State. [See **Confederation of Ex-Servicemen Assns.** v. **Union of India,** [(2006) 8 SCC 399]. But, in so far as persons who cannot afford to pay for their medical treatment, the State is certainly obliged constitutionally to make adequate provision for their treatment, for, no Government can say that it will not treat patients with rare diseases due to financial constrains. That does not mean that the State has to make use of 10 ## **WP(C).No.21897/2016-J.** its resources for the said purpose, for, the resources of the State are to be utilised for various other purposes as well. In other words, the Constitutional obligation of the State is to make provisions for the same. [See **Brij Mohan Lal** v. **Union of India,** (2012) 6 SCC 502]. For this purpose, the Government can utilise the Chief Minister's Relief Fund which is created out of donations. The Government can also tap the resources of the civil society and non Government and charitable organizations to take care of the situation. In other words, the initiative to tackle situations of this nature has to come from the Government and it cannot shirk its responsibility by contending that it has no resources. 9. As far as the present case is concerned, the plea that the State has no resources to provide medical treatment to persons suffering from rare diseases in the nature of Pompe to preserve their life is raised with reference to the budget allocation for purchase of drugs in Government Hospitals. As noted above, Pompe is a rare disease caused on an average of five out of 5.5 lakhs children born in the State in an year. There is absolutely no justification to connect the grievances in the nature of one voiced **WP(C).No.21897/2016-J.** 11 in the writ petition with the allocation of funds made by the Government for purchase of medicine in the Government hospitals. Since patients afflicted with such ailments do not survive without treatment, there has to be a public health strategy to address their treatment needs. If the case of persons afflicted with such ailments are viewed separately, the expenses required for the treatment is very negligible when compared to the resources of the State. According to me, Article 21 of the Constitution imposes a duty on the Government to take whatever steps that are necessary to ensure that the drugs are made available to such persons, for, a welfare State cannot permit anybody to die for the reason that he/she has no means to afford his treatment expenses. As indicated above, the son of the petitioner is being extended treatment by the manufacturer of the drug themselves under their charity programme as the petitioner cannot afford the treatment expenses. A welfare State is not expected to say that they are unable even to extend the charity that is being extended by a foreign pharmaceutical company to one of its citizens. Just because one is poor, the State cannot let him die. I am fortified in the aforesaid view by the decision of the **WP(C).No.21897/2016-J.** 12 Delhi High Court relied on by the learned counsel for the petitioner. In the result, the writ petition is allowed and the first respondent is directed to extend Enzyme Replacement Therapy to the son of the petitioner in one of the Government Hospitals, if there are facilities for the same, as and when required, free of cost. Needless to say that if there is no facility to extend the said treatment in Government hospitals, the same shall be extended in one of the hospitals providing such services. _**Sd/-**_ **P.B.SURESH KUMAR, JUDGE.** _**Kvs/-**_ _**// true copy //**_