|Year : | Volume
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Ethical and legal issues concerning COVID 19 vaccinations in persons with mental illness in India
Sharad Philip, Satish Suhas, P Lakshmi Nirisha, Praveen Pandey, Narayana Manjunatha, Channaveerachari Naveen Kumar, Suresh Bada Math
Department of Psychiatry, National Institute of Mental Health and Neurosciences [NIMHANS], Bengaluru, Karnataka, India
|Date of Submission||02-Nov-2021|
|Date of Acceptance||11-May-2022|
|Date of Web Publication||18-Aug-2022|
Department of Psychiatry, National Institute of Mental Health and Neurosciences [NIMHANS], Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Mental healthcare in India faces severe challenges amid the ongoing pandemic. India runs the largest vaccination drive globally, including booster doses to rapidly vaccinate its population of over a billion. As persons with mental illness are at greater risk of adverse outcomes from COVID 19, they need prioritized access and administration of these vaccines. This manuscript examines the current legislation and identifies how the legal and ethical frameworks can prioritize COVID 19 vaccinations for persons with mental illness in India through a review of the various legislations of India concerning persons with mental illness and judicial judgments concerning the pandemic and vaccination. Subsequently, we discuss ethical and legal challenges associated with vaccination in this vulnerable population and possible solutions. Based on the current review, the authors recommend the guidelines for capacity assessment for vaccination decisions and discuss existing legal frameworks relevant to the vaccination of persons with mental illness.
Keywords: Capacity to consent for vaccination, COVID 19 vaccination, India, legislation, mental health capacity, mental illness
|How to cite this URL:|
Philip S, Suhas S, Nirisha P L, Pandey P, Manjunatha N, Kumar CN, Math SB. Ethical and legal issues concerning COVID 19 vaccinations in persons with mental illness in India. Ind Psychiatry J [Epub ahead of print] [cited 2022 Sep 26]. Available from: https://www.industrialpsychiatry.org/preprintarticle.asp?id=353879
The COVID 19 pandemic has disrupted healthcare delivery worldwide.[1–4] After age, severe mental illness is the next most important risk factor associated with poorer outcomes related to COVID 19.,
Mental health capacity is a dynamic construct. Persons with mental illness [PWMI] may lack the capacity to make decisions regarding their vaccination. Alternatively, they may have preserved capacity as per the capacity assessment guidelines and still refuse vaccination, especially in the presence of psychopathology related to COVID 19 and vaccination themes. It is challenging for psychiatrists to ensure that patients' autonomy is respected while simultaneously ensuring that they are not denied a potentially lifesaving vaccine secondary to psychopathology.
Although priority vaccination of PWMI is recommended given the increased risk of morbidity and mortality in PWMIs who contract COVID 19, institutionalized and wandering persons with mental health conditions are at higher risk of being marginalized in the largest known global vaccination drive.
In addition to persons with severe mental illnesses, intellectual disability, institutionalized PWMI, and neurocognitive disorders are at an increased risk for adverse outcomes due to COVID-19.,,
Triad of ethical principles governs COVID-19 vaccination, namely benefits outweighing risks, equal concerns for all marginalized groups, and mitigation of access inequities. In keeping with these principles, the prioritization should extend beyond persons with severe mental illness to those with neurodevelopmental disorders such as intellectual development disorder, autism spectrum disorder, wandering persons with mental illness, institutionalized persons with mental illness, and their caregivers.
Vaccine ethics demand equity in access for every person. These priorities are congruent with the ethical principles of the COVID-19 vaccination detailed by the World Health Organization. We discuss the ethical and legal challenges in vaccinating PWMI in India.
| Methods|| |
We searched Indian legal database registries and provisions in Indian legislation, international guidelines, and policy documents, including the United Nations convention on rights of persons with a disability concerning the healthcare of PWMI:
- Listing of legislation pertinent to mental healthcare, including the rights of PWMIs
- Exploration of these legislative provisions to identify clauses that directly or indirectly impact COVID-19 vaccination.
- Iterative deliberations amongst the authors regarding these provisions, barriers, and facilitators as well as tenable solutions
| Discussion|| |
Legislations and policy documents
We identified legislative provisions pertinent to mental healthcare, COVID-19 vaccination, and human rights in India. The following relevant legislation, global conventions, and international policy documents that represent guidelines or soft laws that are detailed below:
- Fundamental Rights in part III of the Constitution of India
- The Epidemic Diseases Act, 1897 (TEDA, 1897) and the Epidemic Diseases (Amendment Act), 2020
- Disaster Management Act (DMA, 2005)
- National Human Rights Advisory, 2021
- The Mental Health Care Act, 2017 (MHCA, 2017)
- The Rights of Persons with Disabilities Act, 2016 (RPWD,2016)
- The National Trust Act, 1999 (NTA, 1999)
- Indian Penal Code, 1860 (IPC, 1860)
- Universal Declaration of Human Rights and
- United Nations Convention on the Rights of Persons with Disabilities, 2007 (UNCRPD)
We highlight legal and ethical considerations of vaccinating these PWMIs. Decisions regarding vaccinations for PMI after informed consent are rarely straightforward. Ethical and legal concerns include the capacity to consent, extents of disclosure, and logistic challenges such as registration as beneficiaries. We discuss the possible solutions regarding capacity to consent and approaches to PWMI who lack capacity or refuse vaccination.
The constitutional position
The right to health can be read within the Right to Life and Liberty in Article 21, part III of the Indian Constitution, which details fundamental rights. In multiple judgments,[23–25] the Supreme Court of India has established the right to health within this article. Juxtaposed within this article is the right to liberty that would protect from coerced interventions. The right to equality before law ensconced in article 14 also protects PWMIs refusing vaccinations along with readings of the right to freedom of speech and expression in article 19. Notably, none of these rights of PWMI reads to condone or endanger equal rights for others in their environment. A collective duty to preserve life by getting vaccinated against COVID- 19 from article 21.
The Epidemic Diseases Act of 1897, invoked by the union and some state governments towards controlling the spread of COVID 19, has granted sweeping powers to public officials and health administrations. Violations of public health measures are punishable under section 188 of the IPC and must be brought under section 195 of the Criminal Procedure Code (CrPC) to the courts. Punishments may range from simple imprisonment of 1-6 months to fines of INR 200 to 1000. Section 269 criminalizes negligent acts that are likely to spread diseases dangerous to life; Section 270 criminalizes malignant acts that spread diseases dangerous to life with imprisonments up to 2 years; Section 271 provides punishments for disobediences quarantine rules.
In the larger interests of society, governments have been able to initiate measures such as contact tracing and enforcement of hygiene and distancing regulations even though these measures may impinge on inalienable fundamental rights. Exemplarily, a homeopathic doctor, was ordered to comply with vaccination against cholera in 1973 under TEDA, 1897; this disobedience was read to have the intent required to initiate criminal procedures.
Taken together, these provisions heavily slant towards public health interests over individual autonomy and fundamental rights of persons. PWMIs not complying with health directives and taking adequate precautions, including vaccinations against Covid 19, may find themselves on the wrong side of the law. Readings of the Disaster Management Act of 2005 also provide a similar leaning towards public health interests over individual autonomy and rights. This act provided the legal disposition for instituting 'lockdowns' and imposing restrictions on gatherings as well as regulated commercial undertakings. Greater relevance of these provisions and health directives ought to be accorded to PWMIs living in congregate settings such as MHEs.
Can mandatory vaccinations be an answer?
Legislative mandates supporting compulsory vaccination may appear suitable on paper. Many healthcare measures can be legally enforced in India, with the TEDA, 1897, and DMA, 2005 currently invoked. At the beginning of the pandemic, states across India promulgated stringent regulations under TEDA, 1897. These legal mandates empower public health officials to enact health and safety measures. Examples include guidelines issued by the states of Uttar Pradesh, Bihar and Delhi during the COVID 19 pandemic. If wearing masks and not gathering as groups can be legally enforced, [which in themselves impinge on individual autonomy] can vaccinations in PWMI can also be enforced as a public health measure?. Hypothetically even if such enforcement was possible, such a mandatory vaccination initiative, if limited to PWMI, would be tantamount to discrimination. A possible alternative would be compulsory vaccination of the entire population irrespective of their mental health status. PWMIs, too, should benefit from protection under Articles 14 and 19. Although psychopathology can adversely influence vaccination-related decisions, mandatory vaccinations for PWMI may be highly paternalistic and protectionist. Nevertheless, the duty of PWMIs to adhere to health safety measures both in self and public interests cannot be compromised. Health officials may suspect adherence to such safety measures and advocate mandatory vaccinations - they would be acting well within their legal powers in such cases.
Individual autonomy is an essential inseparable component of personhood. Once accorded the freedom to make decisions, the empowering agency cannot suspend it, citing a public good. The distance between individual autonomy and public health security must remain unabridged. A compelling reason for mandatory vaccinations of PWMIs in congregate living can be the persistently increased risk of transmission, more morbidity, and higher mortality associated with SARS-CoV-2 infection in such settings.[37–39] However, these concerns cannot justify 'forced' or 'coerced' vaccination. Also, Section 6 of the RPWD Act, 2016 prohibits the participation of PWDs in any research endeavor without their free, informed consent. Such consent must be obtained through accessible means, modes, and communication formats.
Disclosures and information sharing
Tailor-made vaccine education programs with an open discussion on the risk of COVID 19 related adverse outcomes and the emphasis on vaccination should be conducted in MHEs. They should have an equal opportunity to clarify doubts about vaccination to facilitate decisions after adequate time and information to dispel misconceptions. Mental health professionals are uniquely positioned to facilitate this decision in a non-prejudiced manner.
The following information should be provided to the PWMI in their language,
- Vaccines offer protection from COVID 19. Even if infected, the course of illness will be milder.
- Vaccines do not cause COVID 19
- Most vaccines are administered twice at least
- There can be adverse effects to getting a COVID 19 vaccination
- Some adverse effects are minor, common, and expected. Very rarely, adverse effects may be severe.
Feedback on the information given should be taken; any apprehension must be allayed with further clarification.
Concerns regarding capacity to consent
Will, preferences, and rights are used interchangeably. However, regarding vaccination decisions all three of these can be aligned in different directions. The benefits of COVID-19 vaccination far outweigh the risks. Capacity for persons with mental health care decisions is described under section 4, chapter 2 of the MHCA, 2017. In compliance with the UNCRPD, it stipulates that capacity is deemed present until proven otherwise. Notably, this description of capacity and tenets for its determination is limited to making mental health care treatment decisions. Per section 81 of the same act, authorities have also issued a capacity assessment guidance document instituted for routine use. Since COVID 19 vaccination is not related to mental healthcare treatments, this capacity assessment guidance may need to be expressly modified. Section 13 of the RPWD Act, 2016 protects people with disabilities (PWD) from infringing their legal capacity and recognition before the law. PWDs enjoy legal capacity equal to any other person in all aspects of life, including healthcare decisions.
However, there are no recommendations on how their capacity to consent for vaccinations may be assessed. There are also no guidelines or advisories on how vaccine refusal or lack of capacity to consent for vaccination may be addressed. There have been no previous systematic examinations of the ethical and legal nuances surrounding vaccination of PWMIs.
The MHCA, 2017, legally protects the decision-making capacity of any person with mental illness. The UNCRPD, in its article 12, mandates equal recognition before the law and mandates decisional support has adequate checks and balances. The MHCA, 2017 requires capacity assessment to decide on the initiation of decisional supports like advance directives and NRs. Such assessments are necessary to initiate involuntary treatments. It is a clinical decision on when a person's capacity to make mental healthcare treatment decisions should be assessed. However, the assessee must not dictate the nonconformity to desirable behaviors. The RPWD Act, 2016 also enshrines equal decision-making capacity for PWDs. Treating professionals may be advised to assess capacity to consent for vaccination for PWMI in the following situations.
- History suggestive of impaired decision-making capacity and judgment in the recent past
- Recent behavior indicating impaired judgment
- Noncompliance with hand and respiratory hygiene measures
- Noncompliance with distancing norms
- Persons refusing the second dose of vaccination after consenting to first dose
We recommend a modified capacity assessment guidance based on accepted legal standards suggested by Applebaum et al. and section 81 of the MHCA, 2017 to consent for vaccination [Figure 1]. This capacity assessment guidance supports an individual's autonomy to make decisions after receiving adequate information about COVID-19 illness and vaccination, provided that orientation, comprehension, and communication ability are intact.
Provisions for substituted decision making
In the presence of impaired capacity to consent for mental healthcare treatment decisions, the MHCA, 2017 provides for Nominated Representatives (NR) who can be regarded as surrogate decision-makers. Here, we suggest that the provision of NRs, especially in sections 15 and 17, be read to include persons in long-stay homes as having no next of kin or caregiver or non-governmental organization to make decisions in their stead. As per sections 14 and 15, treating healthcare professionals have been empowered to appoint an NR for this person's temporary healthcare decision-making purposes. We suggest these provisions can apply to vaccination decisions as well. As detailed in section 17, NRs act in the person's best interests while considering their values and preferences.
All PWMI experience disability and are empowered under the provisions of RPWD, 2016. Section 14 provides guardians' appointments to aid the PWD to a limited degree, including asset management, legal representation, and healthcare decisions. However, this requires disabled persons or caregivers to obtain permission from district courts or district collectors. Many states are yet to lay down the guidelines for availing of such guardianship. Another related legislation providing guardianship is the NTA, 1999 specifics for intellectual disability, autism spectrum disorder, cerebral palsy, and multiple disabilities. Guardians so appointed may proceed to provide consent for their wards. Unfortunately, due to limited awareness and access challenges, these provisions remain underutilized for many PWMIs, especially those homeless and in custodial settings.
Proceeding when capacity is impaired
In line with the legislation applicable, NR should be appointed to make decisions on the PWMI. For example, in the MHCA 2017, chapter IV, clause 14, points 4(a)-4(d) explicitly directs the sequential approach to appointing NR. In addition to these four steps, we recommend that the NR have access to detailed vaccine information to make better-informed decisions on behalf of the PWMI.
In impaired capacity, the wishes expressed via advanced directive should be given the first preference. Persons with severe mental illness and disabilities may lack the capacity to consent and make decisions. It is becoming increasingly relevant to revise advanced directives to reflect a person's wishes in a post-pandemic world. In case the advanced directive is silent on issues related to vaccination or other health care decisions, capacity may be reassessed after a period, the timing of which could be just before the next vaccination drive in the local community. If still found to be absent, one may check for any NR or legal guardian of the person. Such representatives may communicate a decision concerning the vaccination. Every effort must have been made to educate the PWMI and caregivers about the vaccination and its benefits/needs. Persistent vaccine refusal needs to be contextualized with their reasons, and these should be documented in their medical records coupled with an assessment of their capacity. The psychiatrist may face challenges in deciding if mental health conditions influence these reasons or judgments. Subsyndromal symptoms of anxiety and depression may also interfere with rational decisions making. Some persons may overestimate the side effects, which may be more immediate, and discount the long-term benefits of vaccination.
However, even persons without mental health conditions may refuse vaccinations that do not warrant inferences of impaired judgments or necessitate capacity assessments. Subsequently, if an advanced directive is absent, a substituted judgment model using the patient-appointed NR can decide. In cases where a patient-appointed NR is not available, efforts must be made to ensure the appointment of an NR who will cater to the patient's best interests as provided in the law. Alternatively, for imminent decisions, a Vaccinating PWMI Committee may be instituted. The Mental Health Review Board (MHRB) established under chapter 6 of the MHCA, 2017 may have been best suited to deliberate and advise in vaccination of PWMI. However, these are not operational yet.
An ideal committee to review vaccination decisions should include multiple stakeholders – PWMI; physician; psychiatrists; nursing personnel; legal, judicial and NGO representatives. However, for pragmatic reasons a small committee involving mental health review board, independent & treating psychiatrists, and designated physician representatives needs to be empowered to review vaccination decisions.
[Figure 2] provides a recommended algorithmic approach towards the facilitation of vaccination in PWMI. The vaccinator may determine consent and cooperation at the time of vaccination and decide on administration using the same.
Insert [Figure 2] about here [Algorithm to proceed with vaccinations against COVID 19 for PMI]
Mental healthcare institutions can utilize the legal routes provided under the MHCA, 2017 by instituting revision of advanced directives to reflect vaccine preferences, fast-tracking the appointment of NRs, and facilitating the appointment of guardians under the RWPD Act, 2016. Additionally, they can incorporate details regarding vaccination in regular COVID-19 vaccination programs. Other measures include creating avenues for positive social reinforcement within the community and congregate settings, positive role-modeling by healthcare staff, and education regarding vaccines with ample opportunities for clarification. Active liaison with healthcare administration is also required to ensure an adequate fast-tracked supply of vaccines for PWMI.
We have proposed modified assessment guidelines for establishing the capacity to consent for vaccination for PWMI. We have arrived at these recommendations based on a detailed review and exposition of the current legislative provisions that concern PWMI. Expediting the rollout of pending provisions of the MHCA, such as appointment and notification of the MHRB, would be a suitable alternative to the setting up of Vaccinating Committees.
The authors have not tested these recommendations for modifying capacity assessment for COVID 19 vaccinations. However, the original capacity assessment guidelines issued per section 81 of the MHCA, 2017, did not have field testing before execution.
| Conclusions|| |
Decisions surrounding the vaccinations against COVID 19 for institutionalized persons with mental illness are highly nuanced and fraught. Indian legislations provide a path for recognizing the medical prioritization of COVID 19 vaccinations for PWMI. They may also be read to provide a framework for ethical administration respecting their dignity and autonomy. Adhering to the existing legislation with minor modifications can protect the vaccination priorities and facilitate vaccine administration for persons with mental illness and other disabilities.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]