Legal Preparedness Research Articles

Respond to Public Health Emergencies and The Law Preparedness Challenges and Solutions

Laws are a very powerful tool for defending human rights. These could be parliamentary enactments, local panchayat regulations, international conventions, or constitutions. Every facet of the emergency and public health response is based on law and policy. Laws made it possible to establish lockdowns, declare states of emergency, and, more recently, speed the clearance process for vaccines. The removal of antiquated laws, regulations, and backup plans frequently revealed them to be insufficient or out-of-date, necessitating the quick creation of new legislation. Never before have so many laws concerning one incident been passed in so many nations in such a short period of time. Communities are kept safe and lives are saved by domestic legal preparedness for catastrophes, which includes public health emergencies. The cornerstones of disaster risk management are law and policy, which establish guidelines for the who, what, and when of emergency response operations. When preparedness and response efforts lack a solid legal foundation, they may be disorganised and ineffectual, which frequently causes the most vulnerable individuals to wait longer for critical assistance. This essay suggests that there is a general deficiency of robust public health emergency legislation as well as a lack of legal readiness for such situations.

Strengthening legal preparedness and response within the global health emergency framework: the role of the GHSA Legal Preparedness Action Package*

The COVID-19 pandemic exposed failings in preparedness and response across the world and a shortfall in global health security. The crisis also highlighted shortcomings in global and regional legal frameworks, including the International Health Regulations (2005) and relevant European Union law, as well as in national public health legislation and emergency plans. Lessons learned from the pandemic converge around strengthening preparedness and response capacities at all levels, with special attention to be paid to legal preparedness, a critical component of public health emergency preparedness. Improving legal capacities at country level is one of the strategic priorities set by the Global Health Security Agenda (GHSA), which established a new Legal Preparedness Action Package (LP AP) in order to elevate attention to and the importance of legal preparedness worldwide. Since 2021 the LP AP has been front and centre in international efforts to bridge the legal preparedness gap at national level. In bringing together technical experts in global health law and government health policy officials from a broad range of countries and partners, the LP AP seeks to set a foundation for legal preparedness by developing technical and capacity-building tools, legal guidelines, policy briefs, information and training. This article aims to illustrate and contextualize the work of the GHSA LP AP and raise awareness about the importance of its contribution to enhanced global health security. It also intends to highlight how its work promotes and develops synergies with parallel initiatives, processes and tools, facilitates regime interaction and harmonization of technical assistance and ultimately ensures consistency of action, methodology and approaches.

Programmatic and Legal Preparedness of India on Early Childhood Development

Abstract Early childhood development (ECD) is the period of rapid and critical development that occurs from conception upto 6 to 8 years of age. During this time, children experience significant growth and changes in all areas of development, including physical, cognitive, linguistic and socio - emotional. A variety of factors can influence ECD, including genetics, environment and health. This presents a unique opportunity to invest in ECD and build a foundation for a prosperous and equitable future for the country. This review looked at the programmatic and legal preparedness of India in taking forward the agenda of ECD. A review of the laws and programs was undertaken to discern this objective. Besides desk review, interviews were conducted with programme officers handling child health at the central and state levels. Based on the direction for action given by the national health and other policies and several statutes, the central government has launched various programmes and schemes under various ministries within the overarching framework provided by the Constitution of India. There are 5 policies, 15 statutes/acts/laws and nearly 40 government schemes and programmes relating to children in India. The activities are majorly coordinated through Ministries of Woman and Child Development, Health and Family Welfare, Ministry of Education, Drinking Water and Sanitation and Tribal Affairs. Despite these efforts, there is still a significant gap between the demand and supply for ECD services.

Healthcare workers’ freedom of movement in times of pandemics: an emerging norm of customary international law

BackgroundA shortage of healthcare workers can hinder the ability to prepare for and respond to global security threats caused by diseases that are prone to pandemics. During the COVID-19 pandemic, the shortage of healthcare workers became a growing concern worldwide. Recognizing these challenges, countries adopted measures to ensure healthcare workers’ freedom of movement in the face of the COVID-19 pandemic. As the WHO continues the negotiation process to reform the 2005 International Health Regulations and to adopt a new Pandemic Treaty, with one key provision relating to healthcare workers’ mobility, questions remain as to whether States will actually adopt a binding international legal instrument or whether its effectiveness will be watered down by the intrinsic vulnerabilities of an international legal system that has (too) often been unable to tame geopolitical interests. Considering these challenges, we assessed the emergence of a norm of customary international law allowing the free movement of healthcare workers during pandemics.MethodsOur study examined the laws and policies adopted during the COVID-19 pandemic concerning healthcare workers’ mobility in 10 countries, representing all continents. The country selection was based on regional representation and a preliminary analysis indicating their early adoption of measures related to healthcare workers’ mobility. Temporal limits were set. To gather relevant data, we employed various methods including research databases, media sources, and the COVID-19 Law Lab database.ResultsOur research identified and assessed instances of state practice and evidence of opinio juris to determine whether a norm of customary international law mandating states to ensure healthcare workers’ freedom of movement during pandemics exists.The findings indicate a strong consensus towards ensuring the free movement of healthcare workers in times of pandemics as a way to respond to outbreaks of disease. Within months, Argentina, Colombia, Kenya, South Africa, India, Japan, Spain, the United Kingdom, Canada, and the United States, ten nations representing most regions of the world, recognized, as law, the practice of excluding healthcare workers from prohibitions on movement.ConclusionUltimately, this discussion is critical for global health because if a norm does exist in this regard, it will further strengthen pandemic legal preparedness efforts. As such, it becomes clear that the reform of the 2005 International Health Regulations and/or the adoption of a new pandemic treaty will bolster the strength of this emerging norm of customary international law and crystallize it. These legal instruments would propel a norm that is already in the process of formulation into existence. Thus, crystallizing a norm that is otherwise emerging among states.

Preventing pandemics: the vital role of the law. Strengthening countries’ legal preparedness for public health emergencies

Preventing pandemics: the vital role of the law. Strengthening countries’ legal preparedness for public health emergencies

Legal Preparedness for International Disaster Assistance in the SADC Region

Legal Preparedness for International Disaster Assistance in the SADC Region

COVID-19, Religious Freedom and the Law: The United States' Case.

During the emergence of SARS-CoV-2 and the COVID-19 pandemic, public health officials exercised their police powers to combat the spread of the virus. The pandemic-related legal interventions adopted throughout the United States included lockdown orders and mask mandates. However, these policies and interventions meant to promote the general welfare of the public, in defense of common good, were met with legal challenges, especially in opposition to interventions' impact on the exercise of religion. This article provides a legal analysis of the policies meant to curb the COVID-19 pandemic with a focus on legislative and judiciary actions and their implications for religious freedom. Ultimately, we hope this article will help inform future legal analyses on conflicts between public health and religious freedom in the context of pandemic legal preparedness efforts.

Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management.

Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel's legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies.

6.G. Workshop: The European Health Data Space 2: is Europe ready to maximise the re-use of health data?

Abstract The EU's Heads of State called in October 2020 to set up a European Health Data Space (EHDS): “The European Council welcomes the creation of common European data spaces in strategic sectors, and in particular invites the Commission to give priority to the health data space”. As a response, multiple initiatives were set-up to engage the views and expectations from EU member states in the development of the upcoming legislative proposal on the EHDS for primary (EHDS1) and secondary use of health data (EHDS2). One of these was the launch of the Joint Action (JA) Towards the European Health Data Space (TEHDAS) in February 2021. The aim of TEHDAS is to support the European Commission (EC) and Member States (MS), identifying the challenges and providing concepts and options for the EHDS2. It is built on the needs and expectations of national and international stakeholders, citizens’ engagement and existing infrastructure. The major expected outcome of this JA is a sustainable roadmap towards the EHDS2 implementation promoting the cross-border sharing of health data for secondary use. The EHDS2 will benefit population health by facilitating the timely exchange of and access to health data, improving not only the care of patients but also facilitating research, epidemiology, disease prevention and data-based policy decisions. This workshop aims to provide an overview of the preparedness of MS to join the EHDS for secondary use of health data, covering current state-of-play of health data management systems in the EU, barriers on the secondary use of health data, the ongoing work on the development and deployment of the EHDS2 infrastructure and finally, how population health research can benefit from the EHDS2. The workshop will begin with a short introduction on the TEHDAS JA, followed by a presentation on the outcomes of the TEHDAS country visits. In these country visits, the state-of-play of the health data management system and the preparedness to join the EHDS2 were mapped in 12 different EU MS. The next presentation will continue with the results from a study that collected more evidence on the barriers to cross-border sharing of health data for secondary use and options on how to overcome these. It will focus on the legal preparedness and barriers and will discuss how the options proposed by experts in the field align with the legislative proposal for the EHDS2. The audience will be able to give their opinion on the different options through an interactive voting poll during the session. Some of the options on how to overcome technical barriers will be taken further in the development of a pilot infrastructure for the EHDS2. Therefore, the last two presentations will focus on the development and deployment of this pilot infrastructure for the EHDS2 and the role and benefits that population health research will have in it. Throughout the workshop there will be discussion sessions between presentations to allow exchange of knowledge, experiences and opinions with the audience. Key messages • The main outputs will support EU countries to prepare their health data management system for the EHDS2 based on the best practices and actions presented. • The presentations will inform and align participants on the current work on the technical EHDS infrastructure that is being developed for secondary use of health data, the EHDS2.

COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland.

Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks.

Advancing Legal Preparedness through the Global Health Security Agenda.

The Global Health Security Agenda (GHSA) is a multilateral, multisectoral partnership comprised of more than 70 countries, international organizations, foundations, and businesses to strengthen global health security.

A Global Health Law Trilogy: Transformational Reforms to Strengthen Pandemic Prevention, Preparedness, and Response.

This is a pivotal moment in the global governance response to pandemic threats, with crucial global health law reforms being undertaken simultaneously in the coming years: the revision of the International Health Regulations, the implementation of the GHSA Legal Preparedness Action Package, and the negotiation of a new Pandemic Treaty. Rather than looking at these reforms in isolation, it will be necessary to examine how they fit together, considering:how these reforms can complement each other to support pandemic prevention, preparedness, and response;what financing mechanisms are necessary to ensure sustainable health governance; andwhy vital norms of equity, social justice, and human rights must underpin this new global health system.

Canada's legal preparedness against the COVID-19 Pandemic: A scoping review of federal laws and regulations.

As the world continues to grapple with the COVID‐19 pandemic, the preparedness of governments to respond to it will likely undergo review. A key component is the legislative capacity and authority that governments had in place or could rapidly introduce to address the social, economic and health consequences of the emergency. We review Canada’s legal preparedness for public health emergencies and the use of federal legislation to address the pandemic. We provide an overview of the concept of legal preparedness, summarize the federal statutes, regulations and orders enacted, and analyze the coherence of federal activity and its relevance to provinces, territories and international health regulations. We determine that the federal government has relied on spending power rather than constitutional authority over public health or existing legislation on influencing the course of the pandemic.

COVID-19 and the legislative response in India: The need for a comprehensive health care law.

The outbreak of the SARS CoV2 virus, commonly referred to as the COVID‐19 pandemic, has impacted the social, economic, political, and cultural lives of citizens around the world. The sudden outbreak of the pandemic has exposed the legal preparedness, or lack thereof, of governments to reduce and contain its drastic impact. Strong legislative measures play a crucial role in any epidemic or pandemic situation. In this situation, the Indian Government has requested all state governments to invoke the Epidemic Disease Act (EDA) of 1897 to address the COVID‐19 emergency. The Central Government has also used the powers provided in the Disaster Management Act (DMA) of 2005. As the country is facing its first major health emergency since independence, the existing legislative measures to deal with a COVID‐19 like situation are lacking and require certain amendments to address such situations in the future. This paper aims to present the current constitutional and legislative response to health emergencies in India and attempts to identify gray areas in the statutory provisions. Based on the analysis, this paper suggests several recommendations for amending current legislation and suggests the promulgation of comprehensive public health law. This paper is largely based on primary sources such as the EDA and the DMA, regulations, guidelines, rules issued by the public authorities and court cases related to health and health emergencies along with secondary resources such as newspaper articles and published papers.

Perceptions of Indian neurosurgeons about medicolegal issues and malpractice suits.

Despite the rising trend of medicolegal challenges in India, there is an absolute dearth of literature from India on this issue. The authors conducted a survey, to their knowledge a first of its kind, to assess the perceptions of Indian neurosurgeons about the medicolegal challenges faced in everyday practice. An anonymous online survey performed using Google Forms was widely circulated among neurosurgeons practicing in India via email and social media platforms. The questionnaire consisted of 38 questions covering the various aspects of medicolegal issues involved in neurosurgery practice. A total of 221 survey responses were received, out of which 214 responses were included in the final analysis, barring 7 responders who had no work experience in India. The respondents were categorized according to their working arrangements and work experience. Out of all of the respondents, 20 (9.3%) had ≥ 1 malpractice suits filed against them. More than 90% of the respondents believed that malpractice suits are on the rise in India. Almost half of the respondents believed the advent of teleconsultation is further compounding the risk of malpractice suits, and 66.4% of respondents felt that they were inadequately trained during residency to deal with medicolegal issues. Most respondents (88.8%) felt that neurosurgeons working in the government sector had lesser chances of facing litigations in comparison to those working in the private sector. The practice of obtaining video proof of consent was more commonly reported by respondents working in freelancing and private settings (45.1%) and those with multiple affiliations (61.3%) compared to respondents practicing in government settings (22.8%) (p < 0.001). Neurosurgeons working in the private sector were more likely to alter management and refer sick patients to higher-volume treatment centers to avoid malpractice suits than their government counterparts (p = 0.043 and 0.006, respectively). The practices pertaining to legal preparedness were also found to be significantly higher among the respondents from the private sector (p < 0.001). This survey highlights the apprehensions of neurosurgeons in India with regard to rising malpractice suits and the subsequent increase of defensive neurosurgical practices, especially in the private sector. A stronger legal framework for providing for quick redress of patient complaints, while deterring frivolous malpractice suits, can go a long way to allay these fears. There is a dire need for systematic training of neurosurgeons regarding legal preparedness, which should begin during residency.

Coronavirus, Civil Liberties, and the Courts: The Case Against 'Suspending' Judicial Review

Not surprisingly, local and state government orders aimed at mitigating the spread of novel coronavirus have already provoked a series of objections grounded in civil liberties. Just as quickly, courts entertaining challenges to these orders have stumbled into the central (and long-running) normative debate over emergency powers: Should constitutional constraints on government action be suspended in times of emergency (because emergencies are “extraconstitutional”), or do constitutional doctrines forged in calmer times adequately accommodate exigent circumstances? In this essay, we argue that the mitigation strategies adopted in response to the coronavirus pandemic highlight three central problems with the “suspension” approach to judicial review of crisis powers. First, the suspension principle adopted by judges in some crisis powers cases is inextricably linked to the idea that the crisis is of finite — and limited — duration. In Smith v. Avino, for example, the underlying crisis (Hurricane Andrew) was over by the time the challenged county-wide curfew was put into effect; the restriction on civil liberties was meant as a stopgap measure while the government restored order. The Fifth Circuit’s decisions upholding Texas's coronavirus abortion ban likewise characterizes Texas’s order as effectuating a “temporary loss of constitutional rights.” But in a public health crisis like the coronavirus pandemic, when the restrictions are designed to slow the progress of the epidemic (and there might therefore be a relationship between the efficacy of the restrictions and the duration for which they will be needed), the stopgaps are potentially indefinite. Allowing for the suspension of more rigorous judicial review in such circumstances therefore risks allowing the exception to swallow the rule. Second, and relatedly, the suspension model presupposes that “ordinary” judicial review will judge government actions in a crisis too harshly — and, in the process, risks handicapping the government’s response. Here, too, the coronavirus pandemic provides a useful (if still-unfolding) counterexample: Even if curtailments of liberty — from business closures to shelter-in-place orders to quarantine orders for travelers — are subjected to the normal scrutiny arising from comparable government incursions into civil liberties, they are likely to be upheld. Every level of government has an unquestionably compelling interest in preventing the spread of a highly contagious (and often lethal) disease. To similar effect, if that compelling interest can be reasonably vindicated through less restrictive measures that are equally available to the government at the same time, it hardly undermines the government’s response to require it to pursue them. Finally, and perhaps most importantly, the suspension model wholly discounts the independent checking function of courts in a crisis — as perhaps the only institution that is in any structural position to push back against potential overreaching by the local, state, or federal political branches. By subjecting government incursions on civil liberties to meaningful judicial review, courts force the government to do its homework — to communicate not only the purposes of its actions, but also how the imposed restrictions actually relate to and further those purposes. In the process, a robust judicial role may be indispensable not only in minimizing the loss of our liberties, but also in facilitating the development of a sustainable, long-term response to this crisis — and a body of law to guide public health legal preparedness for the next one.

The Role of the Legal System in the Flint Water Crisis.

Policy Points A major factor explaining government actors' failure to mitigate or avert the Flint, Michigan, water crisis is the sheer complexity of the laws regulating how governmental agencies maintain and monitor safe drinking water. Coordination across agencies is essential in dealing with multiple legal arrangements. Public health legal authority and intervention mechanisms are not self-executing. Legal preparedness is essential to efficiently navigating complex legal frameworks to address public health threats. The Flint water crisis demonstrates the importance of democracy for protecting the public's health. Laws responding to municipal fiscal distress must be consistent with expected norms of democracy and require consideration of public health in decision making. Context The Flint, Michigan, water crisis resulted from a state-appointed emergency financial manager's cost-driven decision to switch Flint's water source to the Flint River. Ostensibly designed to address Flint's long-standing financial crisis, the switch instead created a public health emergency. A major factor explaining why the crisis unfolded as it did is the complex array of laws regulating how governmental agencies maintain and monitor safe drinking water. Methods We analyzed these legal arrangements to identify what legal authority state, local, and federal public health and environmental agencies could have used to avert or mitigate the crisis and recommend changes to relevant laws and their implementation. First, we mapped the legal authority and roles of federal, state, and local agencies responsible for safe drinking water and the public's health-that is, the existing legal environment. Then we examined how Michigan's emergency manager law altered the existing legal arrangements, leading to decisions that ignored the community's long-term health. Juxtaposed on those factors, we considered how federalism and the relationship between state and local governments influenced public officials during the crisis. Findings The complex legal arrangements governing public health and safe drinking water, combined with a lack of legal preparedness (the capacity to use law effectively) among governmental officials, impeded timely and effective actions to mitigate or avert the crisis. The emergency manager's virtually unfettered legal authority in Flint exacerbated the existing complexity and deprived residents of a democratically accountable local government. Conclusions Our analysis reveals flaws in both the legal structure and how the laws were implemented that simultaneously failed to stop and substantially exacerbated the crisis. Policymakers need to examine the legal framework in their jurisdictions and take appropriate steps to avoid similar disasters. Addressing the implementation failures, including legal preparedness, should likewise be a priority for preventing future similar crises.

Ethical practice during the COVID-19 pandemic

Ethical practice during the COVID-19 pandemic

Evacuation from Healthcare Facilities in Poland: Legal Preparedness and Preparation.

Medical facilities, while providing both essential and demanding health care to society’s most vulnerable populations, also belong to the most demanding category of risk to human life if and when a crisis event occurs within its walls. The development of a safe evacuation plan for these facilities is extremely complicated, as the evacuation of medical facilities is much more complex than for other critical infrastructure. In this category, the evacuated patients constitute a specific risk group requiring specialized medical care. Hospitalized persons may be dependent on life-saving measures, are unconscious or immobile, are significantly restricted in movement or mentally unbalanced, being dependent on the continued assistance of trained third parties. Additionally, the medical transport of evacuated patients becomes more difficult due to the limited capacity of ambulances and available health care facilities to transport them to, which are increasingly limited due to their overcrowded census. The study aimed to analyze the requirements which are placed on hospitals in Poland to ensure the safety of patients in case of an evacuation. The research method used in the paper was retrospective analysis and evaluation of the media and literature. We have found, that Polish law imposes an obligation on the administrator of a medical facility to ensure the safety of both patients and employees. The regulations cover issues of technical conditions to be met by buildings and their location, prevention, and fire protection requirements, and the determination of which staff is responsible for the evacuation. However, available documents fail to describe what the hospital evacuation process itself should entail under emergency evacuation. Taking into account the complexity of the hospital evacuation process, health care facilities should have a well-developed plan of action that must be implemented at least once a year in the form of facility-wide training. Evacuation drills should not be avoided. Only trained procedures offer the possibility of later analysis to identify and eliminate errors and provide the opportunity to acquire skill sets and habits which promote the behaviors expected in real-life emergencies.

Educational Leaders’ Perceptions of Legal Preparedness

Educational leaders’ experiences with legal issues remain relatively unknown. Using an electronic survey, this study explored educational leaders’ ( N = 441) experiences with legal issues and with perceived levels of legal preparedness. Results revealed that years of experience and ethics training courses variables were statistically significant with perceived levels of legal preparedness. The legal issues with the highest frequency reported by educational leaders included suspected child abuse, reports of bullying/harassment, and whether a student poses a danger to other students. Implications for educational leaders and educational training programs are provided.