Regulations and COVID-19 Response: Concerns in the Indian context

Introduction

“Everybody knows that pestilences have a way of recurring in the world; yet somehow we find it hard to believe in ones that crash down or our heads from a blue sky.”

– Albert Camus (The Plague, 1948)

The world today is grappling with global COVID-19 public health emergency and its social, economic and political ramifications.  There have been 33.86 lakh confirmed cases and 2.4 lakh fatalities in 187 countries/regions till today.¹ The world has never before seen a pandemic sparked by the coronavirus.² These are hard times that necessitate ‘urgent and aggressive action’ on part of individuals, communities, organizations and governments to prevent and limit the spread of infection and control the epidemic. Several countries including India have implemented stringent measures like travel restrictions, self-quarantines, closing schools/colleges, lockdowns to prevent the transmission at the community level. Essentially, they have adopted what is called the “Social Distancing measures” as a way to reduce the spread of the virus. Social Distancing- physical distancing- measures, as argued by experts, are essentially to ‘flatten the curve’– a term used to describe the strategy aimed at spreading the damages caused by the virus over time so that health systems do not get overwhelmed.³ However, social distancing measures have other second order effects such as income loss, shortage of goods/services, malnourishment, social anxiety, violence against women and human rights abuses, amongst other effects, which impact the well-being of the population at large. Hence, there is a need to strike a fine balance in COVID-19 response and relief strategy between protecting lives and safeguarding livelihoods while minimizing social disruption and respecting human rights.

The global pandemic response has exposed the under-preparedness in spite of warnings and previous local epidemic outbreaks like Ebola, SARS. This article locates the COVID-19 measures in India in its two central legislations and analyzes the lacunae or gaps in regulations that renders COVID-19 response strategy non-democratic, inadequate and not in sync with constitutional values. This article, going forward, proposes to drive a shift in the notion and understanding of security from macro to micro perspective, that’s rooted in the security of individuals and communities. The lessons from Ebola outbreak and recently successful Kerala model in COVID-19 response highlight an approach rooted in local community leadership and oversight coupled with strong and effective public systems.

Figure 1: Total confirmed cases worldwide and social distancing measures to flatten the curve

Government Intervention- Rationale and Toolkit

The foremost question is – does the pandemic fall into a class of problems that legitimises the role of the State? What is the market failure that the state intervention seeks to address here? The state’s coercive power- the capacity to coerce to change or modify individual actions/behaviors and the capacity to inflict violence upon individuals- has legitimate grounding only when the ‘freedom doesn’t work well’.⁴  Externalities are such situations where ‘persons impact upon each other in ways that are not intermediated through voluntary agreements’.⁵

Epidemics have large externalities because it may impact multiple sectors and spill across borders.  The spread of infection through local or community transmission is a negative externality because it imposes cost on others who have no control over this spread. Hence, individual behaviors may be regulated to contain the spread because high social cost outweighs low private cost.  This regulation or modification of behaviors may be achieved through stringent penalties and/or better risk awareness. Pandemic also results into shortage of food supplies due to supply-side disruption or collectively irrational consumer behaviors such as panic buying. The government’s coercive action, therefore, will be necessary to curb market power in order to ensure regular supply of essential goods and services through producing or financing. Additionally, the outbreak may aggravate living conditions of those living in the margins such as migrant labor, urban poor, self-employed etc because the social distancing and lockdown measures may force them to give up their livelihoods.  Thus the government intervention in pandemic scenario emanates from the urgency due to a combination of factors like ‘low risk awareness, diffuse accountability, multisectorality, externalities’.6

Laws and Regulations: Existing Framework

‘When two alternative tools yield the same outcome, we should prefer the one which uses the least coercion.’                                                             -Occam’s razor of public policy

Policy interventions like epidemic mitigation are always imperfect and have unintended consequences.⁷ The right way to minimize unintended consequences is by ensuring all coercions by the state are codified into laws and regulations that again are grounded in the principles of Rule of Law, Separation of Powers.

The question becomes: What are those laws that give governments authority to draft regulations during pandemics? Are there sufficient checks and balances to limit arbitrariness and concentration of power? Does the law comprehensively control executive discretion?

Figure 2: Daily number of confirmed cases and series of government interventions to contain the spread

Indian government’s efforts to tackle COVID-19 pandemic is centered in following legislations-

• The Epidemic Diseases Act (EDA), 1897:

This colonial era legislation, enacted to control Bombay bubonic plague in late 19^th century, empowers central and state governments to take special measures and prescribe regulations.

• It empowers central government to inspect ships or vessels leaving or arriving at any port in India and detain people if necessary (Section-2A).
• It empowers state governments to take any necessary measures and prescribe regulations to prevent the spread of infections (Section 2).
• It enforces by making any non-compliance as criminal offence (Section 3) and provides protection to officials/persons acting under this law (Section 4).

As evident, the powers granted under EDA to the centre is very limited and it’s ultimately left to the individual states to frame appropriate regulations and enforce its advisories. Various states, therefore, invoked this law to pass orders and guidelines on social distancing measures, closure of establishments and limitation on group activity for example – Maharashtra COVID-19 Regulations 2020 listed down the notifications. Though used to control epidemics like cholera recently in Gujarat, EDA lacks teeth because it doesn’t authorize the government to enforce a lockdown or even screening of passengers at the airports.

• Disaster Management Act (DMA), 2005.
  DMA covers all natural or man-made disasters which ‘results in substantial loss of life or human suffering’ and are ‘beyond the coping capacity of the community’.  National Executive Committee, under DMA, delegated power to Union Health Secretary to enhance the preparedness and containment of COVID-19, retrospectively from Jan 17.
• Section-2(d) empowers National Disaster Management Authority (NDMA) to classify as notified disaster under DMA. It empowers the central government ‘to declare the entire country or part of it as affected by a disaster and to make plans for mitigation to reduce risks, impacts and effects of the disaster’.
• Section-6(2),-38,-72 enshrines a duty on states to follow the directions of NDMA so as to ensure consistent implementation of measures across the country.
• It empowers the centre and state officials to quickly mobilize financial resources under National Disaster Response Fund (NDRF) or State Disaster Response Fund (SDRF) and to provide cash relief and compensation.

Prime Minister’s three-week nationwide central lockdown measure starting March 25 derived its power from DMA. This Act also empowers district level committees to take coordinated measures.

• International Health Regulations (IHR, 2005)

India is signatory to World Health Organization (WHO) International Health Regulations 2005 (IHR) and therefore, obligated to strengthen prevention, detection, protection and control of public health events of international significance (PHEIC). WHO  declared COVID-19 outbreak as ’Public Health Emergency of International Concern (PHEIC)’ on Jan 30, 2020 and this declaration allowed signatory countries to respond through a series of trade and travel restrictions such as travel ban, cancellation of almost all visas, sealed border.

Besides the regulations involved in containing the spread of the disease, there are several others laws and regulations like Essential Services Act, Indian Medical Council Act that are at the forefront to inform COVID19 response in ensuring healthcare preparedness and supply of essential services.

Figure 3: Timeline of Indian government interventions in response to COVID19

Analysis of regulatory frameworks and some examples-

The question worth asking is: Do public healthcare laws fall short of meeting the needs of pandemic situation?

The present legislative framework and its provisions lack in the following aspects: –

Enforcement and Coordination: EDA, 1897 lacks in consideration of national level policy, strategy and public messaging in order to facilitate a whole-of-nation approach. A consistent application and implementation of measures across the country is considered necessary to ensure maintenance of essential services and supplies in the times of outbreaks. The invocation of DMA, 2005 provisions have empowered a unified approach, however it impinges on federal structure as public health in the state subject as per Schedule 7. EDA, 1897 doesn’t provide administrative and governance arrangements to facilitate consultation process involving exchange of public health surveillance, healthcare system preparedness or coordinated public health messaging. An example is- Australian Health Protection Committee (AHPC), constituted as per National Health Security Act 2007, is the highest level emergency forum ‘tasked with high level cross jurisdictional collaboration in public health preparedness’.⁸  The federal aspects of public health emergency challenge has been addressed in Draft Public Health (Prevention, Control and Management of epidemics, bio-terrorism and disaster) bill 2017 (PHPCM) that empowers state governments ‘to amend the rules prescribed as appropriate to the circumstances of each state.’

Oversight: Regulations must be grounded in evidence to demonstrate expertise and reason.  It’s quite likely to exercise wide-ranging executive powers to tackle public health emergency. A good regulatory design shall ensure the measures are evidence-based, duration of lockdown measures is appropriate and the privacy infringement is proportional.   The present legislative framework guiding COVID-19 response doesn’t provide oversight over decision making that authorizes regulations and therefore, fails to limit the footprint of executive discretion. The coercive measures of the officials are implemented without ‘reasoned orders’ and neither are the orders are subjected to appeal. There is no Ombudsman. Draft PHPCM Bill 2017 provides for appeal against the orders before authority notified under the act.

Healthcare system capacity: Equipments and Personnel: As the number of COVID-19 cases rise in India, there is going to be a rapid and huge increase in demand for testing and treatment equipments/facilities. The capacity augmentation during such times is constrained by regulatory hurdles such as import tariffs that have limited expansion of in-house capacity in order to strengthen the supply chain of medical resources such as masks, gloves, ventilators.⁹ In absence of a comprehensive public health care law, these regulatory hurdles persist. Public health emergency situation also requires some flexibility or relaxations in government regulations to timely respond to crisis such as addressing shortage of healthcare staffs or protective equipment.¹⁰ The urgency of COVID19 has facilitated deregulations or regulatory certainty. Medical Council of India (MCI) regulations have been revised to engage nearly 100,000 doctors in COVID19 response In order to address the shortage of health professionals. Telemedicine Practice Guidelines 2020 have enabled e-adoption of healthcare services through platforms like DocsApp, mfine, Practo to allow patients to connect with doctors and schedule virtual consultations.¹¹

Healthcare data privacy and security: There is a trade-off between the disclosure of patient’s medical information and public health. The aggressive surveillance measures to track individuals, a crucial pillar of track-test-treat strategy, require a balance with the data privacy and protection laws (Hao 2020).¹² Aarogya Setu app sets up a mechanism to trace and track those who came in contact with an infected person in order to isolate and test quickly before it spreads. This App operates in regulatory vaccum and hence there are genuine concerns of disclosure, transfer or access of digital health data. Draft Personal Data Protection (PDP) Bill, 2019 and Draft Digital Information Security in Healthcare Bill (DISHA) 2018 categorizes health data as sensitive personal data and legitimizes its sharing even during public health emergency conditional on being demonstrated as ‘strictly necessary’. Several privacy designs principles like use limitation, data minimization and retention have been applied.¹³

Finances- Amidst looming uncertainty and growing apprehension that the COVID-19 threat may last longer, several countries have allocated substantial fiscal resources as credit guarantee plans, wage subsidies etc to safeguard livelihoods and provide income support. India, with substantial portion of small and medium enterprises and informal labors, lacks the legislative framework guiding COVID-19 response delineate methods and mechanisms to mobilize finances. The inter-governmental transfers become necessary during the emergency situations like COVID-19 because state governments alone cannot handle such situations on its own. The State Disaster Risk Fund (SDRF) have been mobilized now but a dedicated financial mechanism is required.

Rights based framework: A good regulatory design influences individual and institutional actors through a structure of information and incentive.¹⁴ The present legislative framework guiding COVID-19 response puts too much focus on the ‘duties of the government in preventing and controlling epidemic and little on the rights of citizens.’¹⁵ Even the health and administrative risks of infection spread among healthcare personnel have not received adequate attention. The provision of high-quality PPE in sufficient quantity is likely to save approximately 4 Doctor Duty days per PPE.¹⁶

Conclusion: A new framework of regulations to fight pandemic

The management of public health emergency like COVID19 crisis requires a strong partnership of the government, the scientific community, the healthcare providers, the law enforcing bodies and others. There is need of a rights based comprehensive public healthcare framework rooted in following design principles-

• A balance between a whole-of-nation approach and decentralized response.
• Informed by evidence and Oversight over executive discretion.
• Systems capacity augmentation through systemic collaboration across private players, governments and multilateral institutions.
•  Dedicated mechanism to mobilize fiscal resources.
• A balance between data privacy and public health concerns.

REFERENCES

[1] “COVID-19 Map,” Johns Hopkins Coronavirus Resource Center, accessed May 8, 2020, https://coronavirus.jhu.edu/map.html.

[2] WHO DG, 2020a. ‘Opening Remarks at the media briefing on COVID-19’, World Health Organization. https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19—11-march-2020

[3] “Social-Distancing Measures May Be Flattening the Curve,” Harvard Gazette (blog), April 9, 2020, https://news.harvard.edu/gazette/story/2020/04/social-distancing-measures-may-be-flattening-the-curve/.

[4] Kelkar, Vijay and Shah, Ajay. 2019. In Service of the Republic: The Art and Science of Economic Policy. Penguin Random House. New Delhi

[5] Ibid – 3

[6] Jonas, Olga. 2014. ‘Pandemic Risk’, Background paper, World Development Report 2014 ‘Risk and Opportunity: Managing Risks for Development’ https://www.worldbank.org/content/dam/Worldbank/document/HDN/Health/WDR14_bp_Pandemic_Risk_Jonas.pdf

[7] “India’s Lockdown Has Brought Unexpected Benefits,” The Economist, accessed May 8, 2020, https://www.economist.com/asia/2020/04/23/indias-lockdown-has-brought-unexpected-benefits.

[8] NatHealth, 2011. ‘National Health Emergency Response Arrangements’, Government of Australia. https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-response-arrangement-nov11-l

[9] Rajagopalan, S. and Tabarrok, A. 2020. ‘Pandemic Policy in Developing Countries: Recommendations for India’, COVID-19 Policy Brief Series, Mercatus Centre George Mason University. https://www.mercatus.org/publications/covid-19-policy-brief-series/pandemic-policy-developing-countries-recommendations-india

[10] Thaler, Richard and Mullainathan, Sendhil. 2020. ‘To Fight the Coronavirus, Cut the Red Tape’, Newyork Times. https://www.nytimes.com/2020/03/24/business/coronavirus-medical-supplies-regulations.html

[11] Sreenidhi Srinivasan, “Coronavirus Has Become the Booster Shot That Telemedicine Was Waiting for in India,” Quartz India, accessed May 8, 2020, https://qz.com/india/1833374/coronavirus-to-boost-telemedicine-apps-mfine-and-practo-in-india/.

[12] Hao, Karen. 2020. ‘Coronavirus is forcing a trade-off between privacy and public health’, MIT Technology Review. https://www.technologyreview.com/s/615396/coronavirus-is-forcing-a-trade-off-between-privacy-and-public-health/

[13] Matthan, Rahul. 2020. ‘The privacy features that are built into Aarogya Setu’, LiveMint.

[14] Roy, Shubho, Shah, Ajay, Srikrishna, BN and Sundaresan, Somasekhar, 2019.’Building State Capacity for Regulation’, In ed Regulation in India: Design, Capacity, Performance (Oxford: Hart Publishing, 2019)

[15] Yadavar, Swagata and Mandhani, Apoorva. 2020. ‘Modi govt is using two laws to tackle coronavirus spread. But one of them needs change.’ The Print. https://theprint.in/theprint-essential/modi-govt-is-using-two-laws-to-tackle-coronavirus-spread-but-one-of-them-needs-changes/386052/

[16] Behl, Rhytm. 2020. ‘Tackling COVID19: The need for effective capacity utilization of health professionals’, ISPP Policy Review. https://policyreview.in/tackling-covid-19-need-for-effective-capacity-utilisation-of-health-professionals/