|Year : 2010 | Volume
| Issue : 1 | Page : 11-17
Influenza pandemic preparedness and response: A review of legal frameworks in India
Manish Kakkar1, Sukanya Hazarika2, Sanjay Zodpey3, K Srinath Reddy4
1 Public Health Specialist, Public Health Foundation of India
2 Legal Officer, Public Health Foundation of India
3 Director (Public Health Education), Public Health Foundation of India
4 President, Public Health Foundation of India
|Date of Web Publication||29-Sep-2010|
Legal Officer, PHFI, New Delhi, India
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: The potential of pandemics to cause global destabilization calls for robust pandemic preparedness plans with supportive health legislation. Few international studies have investigated their national legal preparedness in case of a pandemic. This study reviews India's legal preparedness in the face of an epidemic. Materials and Methods: This study reviewed and analyzed seminal publications pertinent to pandemic preparedness and relevant legal frameworks in India. The analyses are presented in matrix formats and reviewed by national experts. Results: Current legal frameworks are largely 'policing' in nature. These provisions seem to be adequate to deal with small scale emergencies but do not appear to be sufficient for large scale health crises during pandemics. Conclusion: India needs a critical mass of public health legislations to make impact and not police acts to control epidemics. This study aims to assist policy makers to create comprehensive pandemic preparedness plans, translating preparedness 'on paper' to 'in practice'.
Keywords: Public health law, pandemic preparedness, influenza, legal framework, review
|How to cite this article:|
Kakkar M, Hazarika S, Zodpey S, Reddy K S. Influenza pandemic preparedness and response: A review of legal frameworks in India. Indian J Public Health 2010;54:11-7
|How to cite this URL:|
Kakkar M, Hazarika S, Zodpey S, Reddy K S. Influenza pandemic preparedness and response: A review of legal frameworks in India. Indian J Public Health [serial online] 2010 [cited 2017 Dec 11];54:11-7. Available from: http://www.ijph.in/text.asp?2010/54/1/11/70539
| Introduction|| |
Influenza pandemics are known and expected to result in major national and international consequences including global economic and political destabilization, health resources crises and panic.  Emergency planning is a prerequisite for effective health disaster preparation and includes preparedness, mitigation, response and recovery.  These processes necessarily involve development of plans, policies and procedures and it is inevitable that comprehensive legal frameworks are required to strengthen such planning.
A sound public health law infrastructure establishes the powers and duties of government to prevent disease and injury, and to promote the population's health.  Legal frameworks play a critical role during emergency situations since it can prescribe not only rights and duties of individuals but also the scope of government's responses to public health emergencies at local, national and international levels. 
However, legal frameworks are not the solely effective response to a pandemic. While law plays a crucial role in shaping the role of state action, state action is also shaped by a range of factors such as culture, relationship between the community and the state and the economic standing of its populations  . Along with law as an important tool for containment of communicable and non-communicable disease, social measures authorized by law are as important as medical interventions. 
The Haddon Matrix and Pandemic Avian Influenza highlighted the following areas as requiring legal intervention  :
- Pre-event: Ethical/legal standards for distribution of antivirals and vaccine and for physical restraint (isolation, quarantine, banning of gatherings).
- Event: Legal and ethical framework for implementation of response measures, including contingencies for health-care delivery, maintenance of essential services and the public health measures to be implemented.
The WHO Influenza Pandemic Preparedness checklist has also identified several areas that require legal frameworks to ensure transparent assessment and justification of implementing public health measures. These areas include:
- Isolation or quarantine of infected person or persons suspected of being infected or persons from areas where pandemic strain influenza infection is established
- travel or movement restrictions
- closure of educational institutions
- prohibition of mass gatherings
- influenza vaccination of health-care workers (HCWs), workers in essential services or persons at high risk
- use of privately owned buildings for hospitals
- off-license use of drugs
- compulsory vaccination or implementation of emergency shifts in essential services
The spectre of influenza pandemic has prompted the need for a well coordinated preparedness strategy in India. These are required for a robust response and mitigation of impact of the pandemic, including social and economic disruption that may be caused. 
| Materials and Methods|| |
This study has been done as a narrative review, wherein legal frameworks pertinent to pandemic preparedness in India, have been grouped together, based on the authors' holistic comprehension as well as contemporary public health opinions on this subject. The strength of such a synthesis is that it enables flexible usage of reflective practice, for a topic such as the above, that tends to be too broad and exploratory for a conventional systematic review.
The following protocol was followed for the review:
1. Identification of root legal frameworks in India: Legal frameworks that were pertinent to pandemic preparedness and emergency heath action were identified based on in-house expertise and consultations with other national experts. This involved a manual search of the key legislations such as the Indian Penal Code, Epidemic Diseases Act, 1897, Indian Ports Act (Act 15 of 1908), Livestock Importation Act 1898, Aircraft (Public Health) Rules, 1954, Drugs and Cosmetics Act, 1940, draft National Health Bill, 2009, draft Gujarat Public Health Bill, 2009 and Municipal Acts of states; Manupatra (an online legal database) and recent relevant publications.
2. Extending the scope of the review: Using the key documents, the scope of the review was extended using the following strategies:
- Some search terms were defined based on the seminal publications and these were used for further exploration of the topic.
- Relevant national legislations were accessed
- Experts in relevant fields were contacted.
- The official websites of central and state governments and World Health Organization were accessed for relevant legal frameworks/ provisions.
3. Content review and appraisal of documents: The above legislations were reviewed based on their content, and clustered together in matrix formats. The exclusion and inclusion criteria for the papers were deliberately kept flexible, but a broad guideline for reviewing and for clustering the papers together was derived from the WHO Influenza Pandemic Preparedness checklist.
4. Synthesis of the review: The matrix that developed from the content analysis step went through a series of iterations and finally developed into the condensed tabulations that are presented in this paper.
| Results|| |
India's existing legislations relating to relating to communicable diseases are highlighted in [Table 1].
India's draft influenza pandemic preparedness plan (IPPP) of MoHFW (GoI) was reviewed to identify public health measures that would require legal provisions for implementation in the face of a pandemic. Salient public health measures that would require legal backing include [Table 2]:
- Ensuring availability and distribution of vaccine and anti-viral drugs
- Implementation of response measures
- Isolation cases or quarantine of suspected cases/ material
- Measures that may undertaken by central or state governments to restrict fundamental rights of citizens to prevent the spread of pandemic
Legal provisions, existing as well as new, were then mapped and reviewed for their appropriateness and effectiveness as public health legislations. Some of the existing legal frameworks from which the states could draw support include:
- Indian Penal Code (45 of 1860)
- Epidemic Act 1897,
- Livestock Importation Act 1898
- Indian Ports Act (Act 15 of 1908)
- Aircraft (Public Health) Rules, 1954
- Indian Port Health Rules, 1955
- The Drugs and Cosmetics Acts, 1940 (Act No. 23 of 1940)
- Draft National Health Bill (2009)
- Draft Gujarat Public Health Bill (2009) (in the state of Gujarat)
- Municipal acts (of 5 states)
Several efforts were made to obtain a copy of the Model Public Health Act, 1987 from the Central Bureau of Health Intelligence (CBHI). But CBHI could not provide a copy of the publication. The Act was also not available online. Nevertheless, our review of the draft National Health Bill (2009) presents a more recent perspective of the central and state governments, in the light of the latest infectious disease outbreaks.
Of the ten frameworks identified as relevant to provide legal support to public health measures in an epidemic/ pandemic situation, eight were identified as 'public health legislations' - Epidemic Act 1897, Livestock Importation Act 1898, Indian Ports Act (Act 15 of 1908), Indian Port Health Rules 1955, Aircraft (Public Health) Rules 1954, Indian Port Health Rules, 1955, The Drugs and Cosmetics Acts, 1940 (Act No. 23 of 1940), Draft National Health Bill (2009), Draft Gujarat Public Health Bill (2009) and Municipal Acts.
The true existing public health legislation i.e. Epidemic Act 1897 is an archaic framework and 112 years old. The latest revision Public Health Act, by National Institute of Communicable Diseases, was undertaken in 2003 and is still pending for approval by central authorities. All other public health legislations are over 50 years old.
All the above mentioned 8 'public health legislations' were found to be suitable for only two of the five public health measures that are likely to be implemented in a pandemic situation, namely, 'Isolation or quarantine' and 'Availability of and distribution of vaccine and drugs'. 'Implementation of response measures' and 'measures that may undertaken by central or state governments during an outbreak of dangerous or infectious disease' have not been provisioned in public health legislations as a result, these measures lack a public health focus.
Of all the legal frameworks, public health or otherwise, provisions are largely 'restrictive' in nature and not true public health legislations. As a result, these provisions seem to be good enough to deal with small scale emergencies/ outbreaks; they do not appear to be adequate to safeguard for social and economic disruptions and large scale health crises expected to caused during pandemics. Also, there is no explicit reference to ethical frameworks or principles to protect human rights during a response to a pandemic influenza.
Though the IPPP aims to create several legal frameworks to bolster its pandemic preparedness, the Ministry of Law has not been highlighted as an involved agency. It is not clear how the states will create requisite legal frameworks for effective implementation. The usual mechanisms for their implementation is through the offices of District Administration which then implies that existing legislations are largely 'policing' in nature, rather than being based on a specific public health focus.
The existing legislations provide for public health responses, but in a scattered nature. All important public health issues have not been addressed in a single legislation. There is an urgent need to assemble these provisions in one over-arching public health legislation, so that the implementation of the responses to an epidemic can be effectively monitored.
The National Health Bill does not provide a list of agencies which will be involved in the development of standards and regulations, before and during an outbreak of infectious disease.
The Gujarat Public Health Bill appears to be the only more coordinated public health legislation at the state level; an in-built consultative mechanism of involving the State Public Health Boards is expected to ensure standardized public health response.
| Discussion|| |
This article maps key national and sub-national legislations in India which relate to public health response in the face of an influenza pandemic. Through this mapping exercise, the article aims at highlighting the key gaps and some recommendations to strengthen the legal framework of the country so that response to public health emergencies can be more effective, consistent and standardized.
The above matrices highlight that there is a need for further strengthened legal provisions to prevent and control the entry, spread and persistence of infections to India.
The regulatory mechanisms in the country are essentially 'policing acts'. A piece-meal approach by the state governments such as Municipal Acts, Clinical Establishment Acts may not be able to adequately address issues emerging out of a public health emergency. The state Municipal Acts do not address all measures to be undertaken during an outbreak of a dangerous disease and are often vague. For instance, while the Delhi Municipal Corporation Act is reasonably detailed, the Manipur Municipalities Act does not provide guidelines on the measures to be taken during an epidemic. In other words, current instruments are only limiting instruments; we need a critical mass of public health legislations to make impact and not police acts to control epidemics.
Often, the implementation agencies at center and state look up to the ministries for implementation of public health measures in hours of emergencies and even otherwise. However, it must be remembered that ministries only minister public health measures and laws. There is a need for a regulatory agency that can administer these laws, somewhat on the lines of the recently found Telecom Regulatory Authority of India.
While we need a regulatory agency for implementation of these laws, we also require a 'public health standards defining agency' which can set standards for these measures and ensure uniformity in implementation of control measures, including legal enforcement. Technical organization like US CDC's National Institute for Occupational Safety and Health (NIOSH) and UK's National Institute of Health and Clinical Excellence (NICE) are some examples.
The revision of the Epidemic Act 1897 in the form of the National Health Bill needs to be expedited. This would still be a central instrument. To make the delivery of these public health measures more effective in the event of pandemic and other emergencies, we need to start building consensus from below. For this we should advocate for inter-state dialogue where the Center can be an honest broker. One such example of existing forums where these dialogues can occur and understandings achieved is National Development Council (centre is observer, states develop their own protocol)
Another perspective to consider for smooth implementation of legal provisions during public health emergencies would be engagement, dialogue and strengthening of Civil Society. This lacks completely in the Indian context. Also, perception of individual liberty has undergone considerable evolution since our public health laws were introduced and today, public have high expectations about preservation of individual liberty and freedom of movement.  Therefore, involving the public in developing policies is crucial for successful implementation of these policies. We can draw upon UK's example - UK's national framework to responding to an influenza pandemic states that "engaging the public in the development of policies, plans and choices, and ensuring that expectations are realistic and that advice and information are readily available prior to and during a pandemic are key elements of planning and should assist in minimizing the risk of civil disorder". 
While creating pandemic preparedness plans, it is imperative that legal frameworks are fully integrated into these plans from the national level to the local levels to ensure health care continuum prior to, during, and after a pandemic.
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[Table 1], [Table 2]