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Liability Immunity & Compensation Programmes During Public Health Emergencies

Ashwin Sathyanath
6 July 2020 2:14 PM GMT
Liability Immunity & Compensation Programmes During Public Health Emergencies
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Introduction:

Over the past few months, we saw this nation collectively coming forward with various gestures and events to appreciate the efforts of our health care workers amidst the Covid-19 outbreak. Simultaneously, we also witnessed an increasing violence against these frontline warriors which led to the promulgation of an ordinance[1] to curb the same. This puzzling contrast itself is a definite indication for the state to ensure further policy safeguards to protect the interest of those who fight our battle against this omnipresent threat. This is a new fight for humanity and undoubtedly the world is treading an unlit walkway of life. However, when the rays of hope find us to make the future more visible, there will always be a tendency to point fingers against those errors or mistakes which arguably could have been avoided to save more lives and limit injuries. 'Liability immunity' from such possible future claims except in cases of willful misconduct is a minimum safeguard which the state should guarantee to those in the health sector in order to augment their relentless efforts in these testing times. Equally important is to redress the grievance of those who are aggrieved during this process by establishing pragmatic 'compensation programmes'.

The Bolam's Test:

In the case of 'Bolam v. Friern Hospital Management Committee'[2], McNair. J, formulated a test to determine the standard of care expected out of a medical practitioner. According to him, the standard is that of an ordinary skilled man exercising and professing to have a special skill. Thus in the case of a medical man, negligence can only be attributed to him, if he fails to act in accordance with the standards of reasonably competent medical men at the time. Furthermore, a doctor will not be guilty of negligence, if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even if there are other body of opinions that take a contrary view.[3] In India, though the courts always reserved its right to be the final word in assessing negligence irrespective of professional opinions[4], the above test was widely accepted as decisive of the standard of care required both of professional men generally and medical practitioners in particular.[5] Thus, there has always been a certain standard based on which the courts evaluated an act to decipher the elements of negligence in the medical field. However, when we encounter novel threats like the corona virus against which there is neither a definitely accepted treatment protocol nor a body of medical men who can presently be considered as an authority, there exist a certain difficulty in defining the standard of care expected in these situations. Moreover, in a scenario where the private hospitals are gradually joining hands with the government towards their fight against this pandemic, there is an impending possibility of medical professionals and hospitals (both private[6] and government[7]) being dragged to departmental or court proceedings with varying claims of negligence under the Consumer Protection Act[8] in cases of charged services and under Tort and Criminal Law in general.

Liability Immunity:

'Liability' is defined as an accountability and responsibility to another enforceable by legal actions and 'Immunity' is a personal favour granted by law contrary to the above general rule.[9] In the United States, 'The Public Readiness and Emergency Preparedness Act of 2005' (PREP Act)[10] authorizes the Secretary of the 'Health and Human Services' in cases of public health emergencies to issue a 'Declaration' to provide liability immunity to 'covered persons' (health care professionals, drug manufacturers, distributors etc.) against any claims of loss caused by, arising out of, relating to, or resulting from the administration or use of a 'covered countermeasure' (drugs, vaccines, pandemic products etc.) except for claims involving 'willful misconduct'.[11] Thus, prior to the declaration, the secretary determines as to whether there exists a public health emergency. If yes, he will further identify the countermeasures (covered countermeasures) which may include a drug, biologic, vaccine or other devices which are used to treat, prevent, or mitigate this emergency. The declaration then delineates a class of individuals and institutions (covered persons) who are given liability immunity from claims of loss arising out of the administration or use of the covered countermeasure. The underlying purpose of the declaration is threefold. Firstly, it ensures absolute contribution of those providing services during a public health emergency by eliminating the risk of liability claims against them. Secondly, it permits the special use of drugs and other medical products off-label and sans FDA review[12] during an emergency without any risk of liability. Finally, it acts as a catalyst for experiments and innovations in the medical field which would pave way for combating a health emergency at the earliest. Similar declarations served its purposes in the United States during prior threats like Zika, Ebola, Pandemic Influenza (2009 H1N1), Small pox etc. Now in the wake of the existing Covid-19 situation, voices are raised around the world by health care workers seeking immunity protections of similar nature in order to cope up with the tremendous pressure and challenging conditions faced by them.[13] In India, providing liability immunity to our health care workers will qualify as a measure that come within the purview of the Disaster Management Act,2005.[14]Under the same, the central[15] and state governments[16] are vested with extensive powers notwithstanding any law in force[17], to take all such measures that are necessary for the management of disasters including public health emergencies. Thus, the time is ideal for the nation to stand behind its health care workers by ensuring them a liability free environment with larger public interest in the foresight.

Compensation Programmes:

'Countermeasures Injury Compensation Programme' (CCIP) formulated through the PREP Act provides benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a 'covered countermeasure'. Apart from the above general programme, there exist a more specific one that cater to the needs of those who suffer injuries or death due to vaccination. 'Vaccine Injury Compensation Programme' compensate individuals who are injured by covered vaccines. The United states, Germany, France, Japan, Taiwan etc., are few countries that already have a mechanism in place to provide compensation to those who suffer adverse effects through vaccination.[18] In India, reportedly over 4.9 lakh individuals developed paralysis solely from the 'Oral Polio Vaccine' between 2000 to 2017.[19] Thus, the absence of a vaccination injury compensation in the country demand a serious intervention especially in a situation when the Universal Immunisation Programme (UIP) is touted as the sole panacea for Covid-19. For us, a permanent fund[20] is already available at the national, state and district levels which can be utilised for compensating the losses arising out of countermeasures and vaccinations. At present, though the central and state governments have handed over and declared compensations for those affected by the pandemic in some cases, it is imperative to have a uniform programme in place to deal with threats both present and future.

Conclusion:

While undoing the past is a mere hope, mastering the future is a definite possibility. The world is transitioning to a 'new normal' and our health care workers are risking their lives on a daily basis to make it a safe reality. At the same time, there are those who succumb midway despite the best efforts and suffer irreparable losses. It is high time for us to address needs of both by evaluating global policies like the above mentioned that can be tailored to the nations interest.

The author is an advocate practising at the High Court of Kerala and may be reached at [email protected]. Views are personal only. 

[1] The Epidemic Diseases (Amendment) Ordinance, 2020 was promulgated on April 22, 2020 amending The Epidemic Diseases Act, 1897.

[2] (1957) 2 All ER 118.

[3] Samira Kohli v. Dr. Prabha Manchanda and another, (2008) 2 SCC 1.

[4] Vinitha Ashok v. Laxmi Hospital and others, (2001) 8 SCC 731, AIR 2001 SC 3914;

Malay Kumar Ganguly & Dr. Kunal Saha v. Dr. Sukumar Mukherjee, (2009) 9 SCC 221.

[5] V. Kishan Rao v. Nikhil Super Speciality Hospital, (2010) 5 SCC 513; Jacob Mathew v. State of Punjab and another, (2005) 6 SCC 1.

[6] Spring Meadows Hospital (M/s.) and Anr. v. Harjol Ahulwalia, (1998) 4 SCC 39; Aparna Datta v. Apollo Hospitals Enterprises Ltd, AIR (2000) Mad 340.

[7] Achutrao Haribhau Khodwa v. State of Maharashtra and Others, (1996) 2 SCC 634.

[8] Indian Medical Association v. V.P. Shanta and another, (2005) 6 SCC 1.

[9] P. Ramanatha Aiyar, Concise Law Dictionary, 3rd edition (reprint), 2010.

[10] Public Readiness and Emergency Preparedness Act of 2005. Pub. L. No. 109-148. Codified in the Public Health Service Act at 42 U.S.C. §§ 247d-6d, 247d-6e.

[11] Declaration under the PREP Act for Medical Countermeasures Against Covid-19, Office of the Secretary, The United States Department of Health and Human Affairs, dated March 10,2020.

[12] FDA Statement Coronavirus (Covid-19) Update: Serological Tests, Press Announcements dated April 07,2020, U.S. Food & Drug Administration.

[13] Covid-19: 'Grant doctors immunity from clin neg claims', by John Hyde, News, The Law Society Gazette, 20 April 2020.

[14] S.2 (e) of the Disaster Management Act, 2005.

[15] S. 35 of the Disaster Management Act, 2005.

[16] S. 38 of The Disaster Management Act, 2005

[17] S. 62 & 72 of The Disaster Management Act, 2005.

[18] An idea whose time has come: Compensation for vaccine-related injuries and death in India, Sarojini Nadimpally, Deepa Banerjee, Deepa Venkatachalam, Divya Bhagianadh, Indian Journal of Medical Ethics.

[19] Vaccine-induced paralysis calls for actions, says study, by Bindu Shajan Perappadan, The Hindu, 21 August 2018.

[20] S. 46 & 48 of The Disaster Management Act, 2005.

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