Legal Update on End-of-Life Care
+91 99620 16424 maimoonalegal@apollohospitals.com Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai – 600 018 KNOW YOUR LAW Dear Apollo Family. At some point in time each of us has had to face the anguish of losing a loved one. How much harder it becomes when as a family member/guardian you are called upon to make end of life decisions for the patient lying incapacitated in the ICU, on life support or in a situation he/she cannot make decisions. Up until now, in such scenarios, doctors provided patients’ families with the Do Not Resuscitate (DNR) option. The defining moment is recognising futility of care and giving a patient the chance to have a dignified end. It becomes a collaborative process with doctors setting expectations and families making informed decisions on the continuum of care. In 2018, based on a Petition filed by a registered society named Common Cause, the Supreme Court recognised the right to die with dignity as a fundamental right. It also gave effect to Advanced Medical Directives (Living Will) to allow people with declining health or terminal illnesses to execute a document that will give them autonomy to make end of life care decisions. Unfortunately, the guidelines the Supreme Court put in place were virtually impossible to act on and in January 2023 they passed an order simplifying the procedure for execution of Advance Directives and provided the guidelines to give effect to a patient’s wishes in both circumstances, namely, where there are Advance Directives and where there are none. In the light of this judgment Apollo Hospitals, Chennai has taken the initiative to constitute a committee, which shall formulate and implement an effective and rational SOP for end of life care. For an overview of the legal position on this subject, please see the attachment. Sincerely Maimoona Badsha LEGAL UPDATE ON END-OF-LIFE CARE The Supreme Court in its Judgement dated March 9th,2018 in the matter of Common Cause (A Regd. Society) vs. Union of India and anr., discussed the concept of Advance Directives. “Advance Directives for health care go by various names in different countries though the objective, by and large, is the same, that is, to specify an individual’s health care decisions and to identify persons who will take those decisions for the said individual in the event he is unable to communicate his wishes to the doctor.” In an application filed by the Indian Society of Critical Care Medicine seeking clarification of the judgment reported in Common Cause (A Registered Society) v. Union of India and anr, a Constitution bench of the Supreme Court, passed an Order dated January 24th,2023 simplifying the process earlier suggested in the matter of end of life care. The Apex Court laid down principles for the execution of Advance directives and guidelines in both circumstances — where there are Advance Directives and where there are none. Valid Elements for Advanced Directive: 1)The Advance Directive can be executed only by an adult who is of a sound and healthy state of mind and in a position to communicate, relate and comprehend the purpose and consequences of executing the document. 2)It must be voluntarily executed and without any coercion or inducement or compulsion and after having full knowledge or information. 3)It should have characteristics of an informed consent given without any undue influence or constraint. 4)It shall be in writing clearly stating as to when medical treatment may be withdrawn or no specific medical treatment shall be given which will only have the effect of delaying the process of death that may otherwise cause him/her pain, anguish and suffering and further put him/her in a state of indignity. 5)It should clearly indicate the decision relating to the circumstances in which withholding or withdrawal of medical treatment can be resorted to. 6)It should be in specific terms and the instructions must be absolutely clear and unambiguous. 7)It should mention that the executor may revoke the instructions/authority at any time. 8)It should disclose that the executor has understood the consequences of executing such a document. 9)It should specify the name of a guardian or close relative who, in the event of the executor becoming incapable of taking decision at the relevant time, will be authorized to give consent to refuse or withdraw medical treatment in a manner consistent with the Advance Directive. 10)In the event that there is more than one valid Advance Directive, none of which have been revoked, the most recently signed Advance Directive will be considered as the last expression of the patient’s wishes and will be given effect to. 11)An individual may withdraw or alter the Advance Directive at any time when he/she has the capacity to do so and by following the same procedure as provided for recording of Advance Directive. Withdrawal or revocation of an Advance Directive must be in writing. 12)It will be open to the executor to revoke the document at any stage before it is acted upon and implemented. PROCEDURE FOR EXECUTING AN ADVANCE DIRECTIVE 1)The document should be signed by the executor in the presence of two attesting witnesses, preferably independent, and attested before a notary or Gazetted Officer. 2)The witnesses and the notary or Gazetted Officer shall record their satisfaction that the document has been executed voluntarily and without any coercion or inducement or compulsion and with the full understanding of all the relevant information and consequence. 3)The executor shall inform, and hand over a copy of the Advance Directive to the guardian or close relative, as well as to the family physician, if any 4)A copy shall be handed over to the competent officer of the local Government or the Municipal Corporation or Municipality or Panchayat, as the case may be. The aforesaid authorities shall nominate a competent official in that regard who shall be the custodian of the said document. 5)The executor may also choose to incorporate their Advance Directive as a part of the digital
Restrictions & Guidelines: Medical Practitioners/Institutions Advertisement of Services/Credentials
Restrictions & Guidelines: Medical Practitioners/Institutions Advertisement of Services/Credentials Uniform Code for Pharmaceutical Marketing Practices, 2024 On 12th of March, 2024, the Department of Pharmaceuticals released the “Uniform Code for Pharmaceutical Marketing Practices (“Code”). All Indian Pharmaceutical Associations are to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of this Code. The Code essentially focuses on promotional activities relating to drugs, which include “all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs.” The section that applies to medical professionals is similar to the principles in the Medical Council of India, 2002 Regulations and Telemedicine Guidelines with an addition of “ Brand Reminders”, which permits distribution to medical professionals the following: Informational and education items books, calendars, diaries, journals (including e journals), dummy device models and clinical treatment guidelines for professionals used in healthcare settings value of which does not exceed Rs. 1000 per item. Such items should not have an independent commercial value for the healthcare professionals; and Free samples of drugs, which shall not be supplied to any person who is not qualified to prescribe such a product. and the monetary value of samples so distributed should not exceed two percent of the domestic sales of the company per year. There is also an exception that allows Pharmaceutical Companies to sponsor travel and hospitality to doctors if they are speakers of a CME or CPD Program. These CMEs are required to be mandatorily conducted in India. This exception did not exist in the 2002 Regulations. Medical Council of India, 2002 Regulations and TMP Guidelines MCI (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Clause 6.1.1 banned the “self-aggrandisement” of doctors and has summarised what a doctor can show of themselves in public. In clause 6.8, they have detailed a code of conduct for doctors in their relationship with the pharmaceutical and allied healthcare industry. The Telemedicine Practice Guidelines in Guideline 5 have placed a ban on doctors participating in platforms that provide ratings including reviews, advertisements and promotion of the doctors by “any means”. Any means includes the manipulation of algorithms and search engines. Consumer Protection Act, 2019 The Consumer Protection Act, 2019 (“COPRA”) which weighs heavily in the favor of consumers deals with misleading advertisements which i) falsely describes a product or service, ii) gives a false guarantee or is likely to mislead the consumers as to the nature, substance, quantity or quality of a service, iii) conveys an express or implied representation which if made by the service provider would constitute and unfair trade practice and iv.) deliberately conceals important information. It has also been recommended by the Department of Consumer Affairs that the Indian Standard (IS) 19000:2022’ should be complied with. Essentially these standards prescribe guidelines for online consumer reviews. In November 2023, news reports indicated that the same will be made mandatory and actionable under the Consumer Protection Act, 2019. Key highlights of the framework relevant to the medical industry include that the reviews on online e-commerce platforms should be published accurately, that the review information should be handled in a secure and confidential manner and the manner of collection of such a review. For example, while soliciting the review, the invitation should mention who is the person soliciting the review, the details of the product or service for which the review is sought, how the review will be used and what is the exact material that will be published. Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022 The 2022 Misleading Advertisements Guidelines require advertisements to a) contain truthful and honest representation, b) not mislead consumers by exaggerating the benefits, c) not suggest the claims as universally accepted when there is significant informed view to the contrary, d) to ensure that unsubstantiated claims do not mislead consumers; and e) comply with sector specific rules and regulations. The guidelines further set regulations for bait advertisements, free claim advertisements and children targeted advertisements. They contain a complete ban on surrogate advertisements. Guidelines on Dark Patterns A dark pattern is a User Interface that is craftily designed in order to trick user in order to perform such actions. Guidelines relating to deceptive practices used by e-commerce companies were released by the Central Consumer Protection Authority on the 30th of November, 2023. The Guidelines identify 10 dark patterns which are considered as unfair trade practices under the Consumer Protection Act 2019. The dark patterns identified are false urgency, basket sneaking, confirm shaming, forced action, subscription trap, interface interference, bait and switch, drip pricing, disguised advertisement, nagging, trick question, SAAS Billing and Rogue Malware. An example provided as per the guidelines is as follows: “While giving a choice to opt, “Do you wish to opt out of receiving updates on our collection and discounts forever?” using phrases like, “Yes. I would like to receive updates” and “Not Now”, instead of the option, “Yes”. The Drugs and Magic Remedies (Objectionable Advertisements Act, 1954) One of the older legislations in this list, an amendment was proposed to this particular law in 2020. The Act places a blanket ban on the advertisement of drugs for diseases and disorders such as miscarriage, menstrual disorder, miscarriage or conception and a list of about 54 other diseases and ailments. Further, section 4, prevents false and misleading claims related to drugs and prevents doctors from taking part in the publication of such advertisements. Penalties include imprisonment with a fine and are divided on the basis of the number of convictions. The Advertising Standards Council of India Code and Guidelines Products of the Advertising Standards Council of India (ASCI), these codes and guidelines are non-binding and no legal action can be taken on this basis. However, adherence to them are considered to be good industry practice in the advertising industry and it is advisable to follow them. The ASCI Code contains four
Greenwashing Guidelines
Greenwashing Guidelines Note on Greenwashing Guidelines The Central Consumer Protection Authority, on the 20th of February 2024 released “Draft Guidelines on the Prevention and Regulation of Greenwashing” for public consultation. These guidelines, in a nutshell, are to prevent false or misleading environmental claims by service providers, product sellers, advertising agencies or “endorsers”. This is colloquially known as Greenwashing. Though they are not yet law, they are likely to become enforceable soon and hence, companies engaging in making environmental claims with respect to goods/services should take note. Definition of Greenwashing The draft guidelines define Greenwashing as “i.) any deceptive or misleading practice, which includes concealing, omitting, or hiding relevant information, by exaggerating, making vague, false, or unsubstantiated environmental claims and ii.) use of misleading words, symbols, or imagery, placing emphasis on positive environmental aspects while downplaying or concealing harmful attributes”. Further, the definition of “environmental claims” is broad enough to include any sort of advertising with respect to a good or a service. There are certain broad exceptions, of course, and the same have been covered in the final section. Greenwashing in the Healthcare Industry Instances of greenwashing in the healthcare industry have been particularly noted in the pharmaceutical and medical devices sectors. For example, with respect to certain allopathic and ayurvedic products, companies often use terms like “clean”, “pure”, “natural”, “hypoallergenic”, “green formula”, “safety-tested”, or “organic”. Further, with respect to medical devices, claims such as “CO2 neutral,” “environmentally friendly,” or “recyclable” are often made. In general, the guidelines apply to all advertisements and products/services that make environmental claims. It is not only the service provider or product seller but an advertising agency or “endorser” who will be subject to these guidelines. To be specific, the applicability is as follows: (a) all advertisements regardless of form, format or medium. (b) a manufacturer, service provider or trader whose goods, product or service is the subject of an advertisement, or to an advertising agency or endorser whose service is availed for the advertisement of such goods, product, or service. Ban on Greenwashing There is a specific ban on greenwashing as per the guidelines and action will be taken under the Consumer Protection Act, 2019 for any violations. There are no additional penalties provided as of now in the Guidelines. Environmental Claims, generally need to be substantiated by adequate scientific evidence. Where using technical terms such as “environmental impact assessment”, they need to be explained in a “consumer friendly” manner. Generic terms such as “clean”, “green”, “eco-friendly” need to be backed by verifiable evidence. With respect to the level of clarity and unambiguity, the illustrations below provide some useful clarifications: Illustration 1: “Go green with our product!” The claim is unclear and ambiguous, as it doesn’t specify what does the word ‘green’ convey or how the product is environmentally friendly. Hence case adequate qualifiers and substantiation should be provided. Illustration 2: “Harnessing the power of sustainable technology!” In relation to such a claim, specific details about how the technology is sustainable should be disclosed. Disclosures Required Truthfulness: At the outset, it is important to note that any disclosures made should not contradict the claim made. They need to be truthful and specific. Material information with respect to a claim needs to be disclosed by inserting a QR Code or URL which will contain the relevant information. Such information cannot be “cherry-picked” and be one-sided. Specificity: It should be specified if the claim is related to the good, manufacturing process, packaging, manner of use of the good or disposal or service. Futuristic environmental claims can be made only when such claims are explained as to how those objectives will be achieved. Illustrations for truthful and specific claims as per the guidelines are provided below: Illustration 1: “Our packaging is made from 100% recycled materials.” Without verifiable evidence or certification, this claim might be misleading. Illustration 2: “Energy-efficient technology for a greener tomorrow!” Without providing specific data or comparisons, this claim may lack substance. Comparisons: If products or services are being compared, they must disclose the exact aspects being compared and must be based on verifiable data. Illustrations from the guidance note regarding the same are produced below: Illustration 1: “Our energy-efficient light bulbs outperform all others!” The claim lacks context and does not specify which bulbs are being compared. For fair and meaningful comparisons, the company should compare its bulbs to others with similar characteristics and intended uses. Illustration 2: “Chemical-free cleaning for a safer environment!” This claim may mislead consumers by implying that other cleaning products are unsafe. Absolute and relevant: If a claim is with respect to a specific feature, part or stage, the same should be disclosed. Illustration 1: “A packaged product is labelled with an unqualified claim, “recyclable.” It is unclear from the type of product and other context whether the claim refers to the product or its package.” Exclusions There are two main exceptions. Firstly, the guidelines will not apply to any advertisements or communication that is not specific to any product or service, unless the advertisement or communication directly or indirectly links to any product or service. Illustration: A Company in its Mission Statement makes a statement that “its growth will be based on sustainability principles”. For the purpose of the guidelines this will not be treated as environmental claim as it does not relate specifically to a product or service. However, if the Company further makes a statement that “and all its products are manufactured in sustainable manner”, then such an environmental claim will be examined for greenwashing. Secondly, there is an exception regarding the usage of “(i) obvious hyperboles, puffery, or (ii) the use of generic colour schemes or pictures; either not amounting to any deceptive or misleading practice”. The standard of “obvious hyperboles/puffery
POSH & COPRA Guidelines
Supreme Court Recommends Re-consideration of the Principle of Law that makes Doctors liable under the Consumer Protection Act. Supreme Court Recommends Re-consideration of the Principle of Law that makes Doctors liable under the Consumer Protection Act. On 14th of May, 2024 the bench of Justices Bela Trivedi and Pankaj Mithal of the Hon’ble Supreme Court pronounced a verdict that advocates cannot be held liable under the Consumer Protection Act. In a major development,Justice Trivedi opined that its 1995 judgment in the case of Indian Medical Association v VP Shantha, which brought medical professionals under the Consumer Protection Act, required reconsideration. “Having said that we have opined that the decision in Indian Medical Association v VP Shantha’s (1995) 6 SCC 651 deserves to be revisited and we have requested the CJI to refer it to the larger bench for re-consideration.,” said Justice Trivedi while readingthe verdict. “We have distinguished profession from business and trade. We have said that a profession would require advance education and training in some branch of learning or science. The nature of work is specialisation and skill, substantial part of which ismental than manual. Having regard to the nature of work of a professional, which requires a high level of education and training and proficiency, and which involves skill and specialised kind of mental work operating in specialised spheres, where actual success depends on various factors beyond one’s control, a professional cannot be treated equally or at par with a businessman or a trader or a service provider of products or goods,” Justice Trivedi stated. Based on the above, the Hon’ble Supreme Court has requested the CJI to consider placing it before a three-judge bench for an overview. Supreme Court’s Recent Directions on the Implementation Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013. (“POSH Act”) The Hon’ble Supreme Court of India has recently issued a landmark judgment in the case of Aureliano Fernandes Vs. State of Goa and Others, highlighting the importance of effective implementation of the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013. (“POSH Act”) The Hon’ble Supreme Court also issued a number of directions to the Union of India, State Governments, and Union Territories to ensure effective implementation of the POSH Act. These directions include: All concerned Ministries, Departments, Government Organizations, Authorities, Public Sector Undertakings, Institutions, Bodies, etc., must constitute Internal Committees (ICs) or Local Committees (LCs), as the case may be, in accordance with the provisions of the POSH Act. The composition of ICs/LCs must be strictly in terms of the provisions of the POSH Act.. Information regarding the constitution and composition of ICs/LCs, details including email IDs and contact numbers of the designated person(s), the procedure prescribed for submitting an online complaint, as also the relevant rules, regulations and internal policies must be made readily available on the website of the concerned authority/ functionary/ organization/ institution/ body, as the case may be. Authorities/managements/employers must take immediate and effective steps to familiarize members of the LCs/ICs with their duties and the manner in which an inquiry ought to be conducted on receiving a complaint of sexual harassment at the workplace, from the point when the complaint is received, till the inquiry is finally concluded and the report is submitted. Authorities/management/employers must regularly conduct orientation programmes, workshops, seminars and awareness programmes to upskill members of LCs/ICs and to educate women employees and women’s groups about the provisions of the POSH Act, the rules and relevant regulations. The recent ruling and directives from the Supreme Court mark a pivotal advancement in the battle against workplace sexual harassment. It’s evident that the Court is committed to enforcing the POSH Act rigorously and safeguarding women’s rights in the workplace.
Advisory Regarding Violence
Advisory Regarding Violence/Harassment/Abuse towards Doctors and the Hospital The escalating incidents of violence against healthcare service personnel such as doctors and nurses, and the damage or loss to the property of healthcare service institutions in the country, demand our collective attention and immediate action. There have been recent incidents in Apollo centres where patients or their attenders/relatives have displayed abusive, unruly, or violent behaviour and have refused to leave the hospital despite the patient recovering and fit for discharge. In order to combat such behaviour of such persons, several State governments have enacted laws to protect hospital property and medical personnel from damage/harm. 23 States/Union Territories have enacted specific legislation on the topic as listed out below. The Government of Tamil Nadu has enacted the Tamil Nadu Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage or Loss to Property) Act, 2008 (“The Act”), which provides for specific punishments in the case of “any harm, injury or endangering the life or intimidation, obstruction or hindrance” to any medicare service person or property. Under the Act, violence to hospital personnel are offences which are cognizable, non-bailable, and may lead to punishment with imprisonment for a term which shall not be less than three years, but which may extend to ten years and with a fine. Further, in case of damage to property, the person shall be liable to pay compensation for the damage or loss caused to the property. Thus, whenever there is unnecessary harassment that is being caused by a patient/family/attenders due to any issue, we recommend that in consultation with Group legal Advisor, Corporate Compliance & Management, that (i) an FIR is filed with the Police clearly documenting the abusive/ unruly/ violent/ intimidatory behaviour of the patient/ attenders/ relatives, invoking the provisions of the relevant legislation (ii) steps are taken with the support of the police to discharge the patient or shift the patient to a government hospital or one of their choice. If the Apollo centre is transferring the patient in their ambulance, please ensure adequate medical care is provided enroute. Please note that if the case is an emergency, then the patient must be treated, and discharge cannot happen until stabilisation of the medical issue. Also, please ensure that nowhere is it recorded whether in the complaint before the police or the discharge summary that the patient was being discharged/transferred due to non-payment of hospital bills. Annex 1: List of States S.No. State Act 1. Andhra Pradesh The Andhra Pradesh Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence And Damage To Property) Act, 2008. 2. Delhi The Delhi Medicare Service Personnel and Medicare Service Institutions. (Prevention of Violence and Damage to Property) Act, 2008 3. Punjab Punjab Protection of Medicare Service Persons and Medicare Service Institutions (Prevention of Violence & Damage tocProperty) Act, 2008 4. Tamil Nadu Tamil Nadu Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence & Damage Or Loss to Property) Act, 2008 5. Madhya Pradesh Chikitsak Tatha Chikitsa Sev Se Sambaddha Vyaktiyon KiSuraksha Adhiniyam, 2008 6. Orissa Orissa Medicare Service Persons & Medicare Service Institutions (Prevention of Violence & Damage to Property) Act, 2008 7. Haryana Haryana Medicare Service Personnel & Medicare Service Institutions Act, 2009 8. Karnataka Karnataka Prohibition of Violence against Medicare Service Personnel & Damage to Property in Medicare Service Institutions Act, 2009 9. Maharashtra Maharashtra Medicare Service Persons & Medicare Service Institutions (Prevention of Violence & Damage or Loss to Property) Act, 2010 10. Chhattisgarh Chhattisgarh Medicare Service Persons & Medicare Service Institutions Act, 2010 11. Assam Assam Medicare Service Persons & Medicare Service Institutions Act, 2011 12. Puducherry Puducherry Medicare Service Persons & Medicare Service Institutions (Prevention of Violence and Damage or loss to Property) Act, 2011 13. Bihar Bihar Medical Service Institution & Person Protection Act, 2011 14. Gujarat Gujarat Protection of Medicare Service Persons and Medicare Service Institutions (Prevention of Violence & Damage to Property) Act, 2012 15. Goa Goa Medicare Service Personnel & Medicare Service Institutions Act, 2013 16. Uttarakhand Medicare Service Persons and Institutions (Prevention of Violence and Damage to Property) Act, 2013 17. West Bengal The West Bengal Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence And Damage To Property) Act, 2009. 18. Uttar Pradesh The Uttar Pradesh Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, 2013 19. Kerala The Kerala Healthcare Service Persons and Healthcare Service Institutions (Prevention of Violence and Damage to Property) Act, 2012 20. Himachal Pradesh The Himachal Pradesh Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence And Damage To Property), Act, 2009 21. Rajasthan The Rajasthan Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, 2008 22. Manipur The Manipur Medicare Service Personnel and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, 2015 23. Arunachal Pradesh The Arunachal Pradesh Protection Of Medical Service Personnel And Medical Service Institutions (Prevention Of Violence And Damage Or Loss Of Property) Act, 2019