8 December 2020

A vaccine is here! How can the law promote the effective deployment and use of a COVID-19 vaccine to alleviate the current public health crisis?

By Rhiannon Frowde

On 2nd December 2020, the UK Government announced that it would be the first country in the world to approve the use of the Pfizer/BioNTech COVID-19 vaccine, following regulatory approval by the Medicines and Healthcare products Regulatory Agency. By contrast, the European Medicines Agency has urged caution in moving forward too quickly with the approval process, and will only decide by December 29th whether to provisionally authorise the vaccine.

This blog considers some of the challenges and barriers to effective deployment and use of these vaccines, such as the historically long regulatory approval process, rates of voluntary uptake, the availability of workforce, and potential liability issues should regulatory approval prove premature and precipitous. The focus is on the role of the law in the UK to mitigate these issues.

Background

At the start of December 2020, there were 13 vaccines in the final stages of testing worldwide, with early trials indicating their effectiveness in reducing morbidity and mortality, and growing evidence that they may also reduce transmission, with the potential to create herd immunity, leading to a resumption of “normalcy” [1]. Promising such results, vaccines may be key to alleviating the COVID-19 crisis, and as such, it is pertinent to consider how the law may support their effective deployment and use.

Dr Raine, Chief Executive of the MHRA, stated that the UK’s quicker decision has stemmed from the MHRA teams working in parallel, operating under a ‘rolling review’, analysing data as it comes in. Despite this, she held that “the same stringent standards” had been met and “no corners had been cut”.

What can the law do?

The following are some of the key measures which may be taken, although these are not exhaustive.

Expedite the market approval process

In the UK, medical products, must typically be licensed before they can be marketed, however this is normally a long process which can take many months. Such a delay is intolerable during a pandemic where thousands are dying daily worldwide. Two key measures are available and have been employed in expediting the approval process: licensing directly in the UK, without waiting for EU approval, and granting temporary approval prior to licensing.

Prior to reforms of the Human Medicines Regulations 2012 (the 2012 Regulations) in October 2020, the only body with the power to grant a license was the European Medicines Agency (EMA) which could take up to a year. The Medicines and Healthcare products Regulatory Agency (MHRA) now has the power to grant licenses without waiting for the EMA. It is through these powers that the Pfizer vaccine was approved in the UK.

Contrary to claims made by the Health Secretary, Matt Hancock, that this is “because of Brexit”, the MHRA and EMA currently remain bound together, and the UK is subject to decisions made by the EMA until the end of the transition period from the EU.

The approval process for the vaccine was further expedited under Section 174 of the 2012 Regulations which permits the temporary authorisation of ‘unlicensed’ medicinal products to tackle public health threats, such as the spread of a pathogen.

These powers do not mean steps to ensure safety may be skipped; all vaccines, licensed or not, must meet clinical trial requirements. Rather, they afford temporary authorisation pending the granting of a licence. It is the review of the trial data by the regulatory bodies that has been expedited, confirming that the product meets the necessary efficacy and safety requirements, and that, for most people, the benefits significantly outweigh the disadvantages. For the Pfizer vaccine, this is occurring on a rolling basis as new data becomes available.

Moreover, the reforms introduced safeguards for the use of these powers, including the requirement to review the impact of any authorisation within a year from use, and that temporary authorisations may be subject to conditions (e.g. specifying who the product is suitable for, setting batch testing and quality assurance standards, ensuring appropriate storage is in place). As the basis of the MHRA’s decision remain unknown, it is not yet clear what safeguards are in place for the Pfizer vaccine and whether these are satisfactory.

Should any unforeseen consequences arise, liability will be limited. As the decision to distribute unlicensed products will be made at a nationwide level, Section 345 holds that key actors in the medical supply chain will be immune from civil liability. As such, unless products are defective or do not meet safety standards (as defined by Section 2 of the Consumer Protection Act 1987), only the Government itself will be liable. This encourages vaccines to be made available as early as is safely possible, while still offering some routes of recourse.

It will be important that, in the interests of public confidence, if the government chooses to exercise either of these options, the reasons for regulatory divergence are fully disclosed, especially in its interpretation of safety and efficacy if this differs from the EMA’s. At present, this has not been done.

Promote public confidence

Public confidence in vaccines is a major factor in promoting voluntary uptake. At present there is no legal basis for a compulsory vaccination programme in the UK, and with vaccination rates at a current low, measures to reassure the public and encourage vaccination will be important. A number of regulatory methods may be employed to promote this, including requirements for governmental and manufacturer transparency, promotion of reliable information, and the regulation of disinformation.

Transparency, such as the publishing of clinical trial protocols and governmental trade deals, is important as it allows external scrutiny, building confidence in a process which has experienced waning trust following cases of research fraud and weak methodologies in COVID research spaces. There should be transparency across all aspects, including pricing and agreements of the whole COVID vaccine developments process, which may be enforced through the introduction of novel regulations.

Measures to promote reliable information regarding the vaccine to the public will also be welcome. For example, following the reforms to the 2012 Regulations, a COVID-19 vaccine may be promoted as part of national vaccination or treatment campaigns.

Following from this, the circulation of disinformation has contributed to diminished public confidence. Social media, in particular, has been highlighted for spreading conspiracy theories, such as a belief that the vaccination injects a microchip into the patient. Measures which may be taken include imposing legal requirements upon social media companies to flag unsubstantiated claims as misleading or disputed.

While criminal sanctions and penalties are available in some countries for the spreading of disinformation, imposing these would be a significant threat to principles of free speech and administration of the rule of law.

Increase Workforce Capacity

With 40 million doses of the Pfizer vaccine available, it is important that there is sufficient capacity to support a mass vaccination campaign across the UK. Methods of maximising opportunities for persons to receive each vaccine may include regulatory reform, expanding the range of trained personnel who may administer vaccines. Under these measures it is not yet clear, and will be important to clarify, the scope of protection from civil liability for this additional workforce.

Concluding thoughts

The importance of alleviating the current public health crisis cannot be understated. With the Pfizer vaccine rolling out as early as the 7th December 2020, and a number of other vaccines on the horizon, it is important that the law supports their effective deployment and use. From measures to expedite deployment and to increase opportunities for access through a greater workforce, it will be important to maintain transparency throughout to promote public confidence and consequently voluntary adoption.

[1] M Perkis, G Leung, ‘What can we expect from first-generation COVID-19 vaccines?’ (2020) 396(10261) The Lancet 1467 <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31976-0/fulltext> accessed 30 November 2020.


Rhiannon Frowde recently graduated with an LLM in Medical Law and Ethics from the University of Edinburgh.

18 November 2020

COVID-19: UK Government inaction raises serious human rights concerns

By Graeme Laurie


While draconian government action such as this week’s lockdown raises important concerns, the bigger question must be: what are the human rights implications of the UK government’s serial inaction in the face of the COVID-19 crisis?

 


As deaths related to COVID-19 surpass 50,000 in the UK, it has become depressingly clear that the country has been behind the curve from the very early days of the pandemic. As infections tore through Europe, our government was given a grace period where important lessons could have been learned from our neighbours. Its arrogance meant that it neither learned those lessons, nor acted on them. 

 

Despite early warnings, the UK declined to join a European scheme to source personal protective equipment (PPE). In February and March, the government’s focus on leaving the European Union led it to missing eight meetings with EU heads of state and health ministers. This, in turn, led to a missed deadline to participate in a common purchase scheme for critical health supplies. This would prove to be a serious error, creating shortages of critical resources for frontline health workers.

 

In early-to-mid March, Italy, France, and Spain went into lockdown while our government sat on its hands in an extraordinary act of national harm. 

 

Two days after Greece shut its schools, Boris Johnson attended a Six Nations Rugby match with 82,000 closely-packed spectators. As Ireland cancelled its St Patrick’s day parade on the 9th of March, the UK government allowed the Cheltenham Festival to go ahead, with crowds of over 250,000 people. When the WHO declared a pandemic on the 11th of March, and Madrid closed its schools as it became the epicentre of Spain crisis, the UK welcomed 3,000 Atl├ętico Madrid in Liverpool.

 

Its inertia and inaction also extended to its wilful neglect of older people in residential care, who were discharged from hospitals to care homes without access to tests. This proved catastrophic, as infected elderly patients spread the virus into care homes, leading to further mass casualties across the country. 

 

Serial inactions such as these have contributed to the UK having one of the highest per capita death rates in the world. Minutes from the Scientific Advisory Group for Emergencies (SAGE) from the 21st of September recommended immediate action – “a circuit-breaker (short period of lockdown) to return incidence to low levels”. After an interval of almost seven weeks, England eventually entered a lockdown that will last at least one month. Delay is heaped upon delay. All of this has serious consequences for human rights, as I and my colleagues recently discussed in the journal Asian Bioethics Review.

 

Human rights are the basic rights and freedoms that belong to everyone. They operate at international, European, and domestic levels. Additionally, in times of emergency, the UN Siracusa Principles provide an important benchmark for assessing states’ actions and to guard against violations of human rights in the name of addressing a crisis. Against all of these measures, there are numerous ways in which UK Government inaction raises profound human rights concerns. 

 

Article 2 of the European Convention on Human Rights (ECHR) provides that “Everyone’s right to life shall be protected by law”. This extends to a positive obligation to protect lives. In the context of COVID-19, inaction led to a failure to provide the PPE to healthcare staff, discharging potentially infected older people into care homes, avoiding lockdown until weeks after positive action had been taken by our neighbours, and allowing the number of cases to reach such high levels by abandoning widespread test-and-trace. All of these inactions have strong implications for UK citizens’ right to life. 

 

Other human rights are also affected. Article 5 ECHR protects liberty, Article 8 requires respect for private and family life, and Article 11 protects the right to freedom of assembly and association with others. While none of these rights is without exceptions – that is, a state can act to restrict rights in times of public health emergencies – the ineptitude of management of COVID-19 in the UK is likely to mean that liberty, assembly, and private lives will continue to be encroached upon in a protracted and prolonged cycle of lockdown and misery. This sustained governmental interference becomes an unwarranted intrusion on citizens’ lives, and is something that people across many parts of the UK will be living with during the next few weeks and months.

 

As a reply to these charges, the UK Government might point to the legislative measures that have been introduced, stemming from the Coronavirus Act 2020. But these have suffered from a woeful lack of time for robust parliamentary scrutiny and must also be judged by the Siracusa Principles, which set standards that any restrictions to human rights must meet. These require, among other things, that any measures should be the least intrusive and restrictive to achieve the public health objective, be of limited duration, based on scientific evidence, and neither arbitrary nor discriminatory. On this last point, it has become all too apparent that lockdown measures have disproportionately adverse impacts on poorer communities and Black, Asian and minority ethnic citizens. The UK legal framework simply enables ongoing intrusion.  

 

People in the UK have been harmed by government inertia. This harm could have been avoided through a number of different, positive strategies – as seen in other countries. Instead, our government has rolled over and let the virus take charge. The human rights consequences of its inactions are severe. To show due respect for these rights in the future, the UK Government has some hard lessons to learn. First amongst these is that, when dealing with COVID-19, inaction has to take the backseat it deserves.


Graeme Laurie is Professorial Fellow in the School of Law, University of Edinburgh

“Kung Flu”: It’s Not Me, It’s You

Emma Nance, postgraduate student on the LLM programme in Medical Law and Ethics at the School of Law, University of Edinburgh, shares her thoughts and personal experience of racism in the context of Covid-19.


Type “kung flu” or “Chinese virus” into your search engine—how many results do you get? By my last count, both search terms combined return over 1 billion results. Though the WHO officially termed the novel coronavirus“COVID-19” in February 2020, this measure did not deter people from continuing to use these slurs and to justify attacks against Asian people. Since news of the coronavirus first began making headlines, there has been a documented rise in acts of anti-Asian discrimination, with people reporting being yelled at, spit at, bullied, verbally assaulted, threatened, and attacked.

This discrimination has been especially apparent in the US,where racial tensions are already high given the context of Black Lives Matter and police brutality protests. President Trump has consistently reminded his followers that the virus originated in China, continuing to use terms such as the “Wuhan virus” to discuss the pandemic. Leaders in countries such as Italy and Brazil have also spread misinformation and fear about Asian people, culture, and dietary practices. While journalists have heavily criticised the use of xenophobic terms and other world leaders have condemned the ongoing stigmatisation of China and people of presumed Asian heritage, it is extremely difficult to reverse the tide of racism.

As Cecilia Wang, deputy legal director of the American Civil Liberties Union wrote in an op-ed, immigrants and minority ethnic groups have historically been scapegoated for bringing and spreading infectious diseases. She concludes her piece with explicit directions: “any response to COVID-19 should be grounded in science and public health, not xenophobia.” However, it is clear that many institutional responses to the pandemic have exacerbated xenophobic and racist sentiments rather than promoted global solidarity and scientific validity.

For me, it has been interesting to have the opportunity to study global solidarity and public health through my course in Medical Law and Ethics, discussing terms such as quarantine, isolation, and choice elimination in abstraction in class just weeks before putting them into practice. Now in my 16th week of quarantine in Scotland, I have experienced liberty-limiting principles designed to protect and promote public health, something which I had previously only researched and written on. And, as an Asian-American person, while I have experienced racial discrimination before, this is the first time that I have experienced people abruptly turning away from me in supermarket aisles when they see my face, pointedly applying Purell when I am nearby, and yelling at me on the street for spreading coronavirus.

As an adopted Chinese girl, I am used to people making incorrect assumptions about my heritage, ranging from the “no, where are you really from?” questions to the “wow, you speak such good English” comments, to the “you’re not really adopted, right?” incredulity. I have never wanted to entertain these pointed questions and enjoy the look of confusion on an insistent stranger’s face when I reveal that my mother’s family is originally Irish and that my father’s family can trace their ancestry back to the Celts. While I am by no means ashamed of my heritage, an explanation of my identity is not something which I owe to a belligerent observer. This discrepancy between my race and my cultural upbringing is certainly not a nuance that I can, or want, to summarise quickly to the casual racist in the store or on the street.

Growing up in a predominantly white environment, it has often felt akin to appropriation to acknowledge my Chinese heritage or refer to myself as a woman of colour. I find myself downplaying incidents of racism that I have experienced as “not that bad”. While rationally I know that recognising all instances of prejudice and inequality are key components of social justice and global solidarity, it is sometimes difficult to internalise this fact emotionally.

It is important to identify and combat racist slurs, microaggressions, physical attacks, and other instances of racism whenever they occur. For me, that starts with adding my experience to other narratives of injustice such as Joey S. Kim’sKenya Evelyn’s, Ibram X. Kendi’s, and Bruce Y. Lee’s, to name a few voices. To answer a question posed by Dr Agomoni Mitra Ganguli in a previous blog post, I want to build the kind of society that does not glorify hate speech nor pretend it is colourblind but instead one which is actively anti-racist and seeks to learn from the past. I want to build a society that, when I search the term “kung flu”, returns one billion search results which promote the voices of those who have been affected by racism, not the views of those who seek to weaponise it. 

16 April 2020

DNACPRs and advance care planning in the COVID19 pandemic: key lessons

By Catriona McMillan and Victoria Sobolewska
Patient-doctor discussions surrounding do not attempt cardio-pulmonary resuscitation (DNACPR) orders amidst the COVID-19 pandemic have caused widespread, understandable panic in the UK, set against a backdrop of proportionately higher elderly deaths, discussions surrounding resource allocation (particularly with reference to ventilators), and emerging stories of rising care home deaths. Here, we highlight how current debates surrounding DNACPRs – and advanced care planning more generally – raise important lessons for the future surrounding how we might improve when clinicians and patients have these discussions in the process of care.
There is an understandable fear amidst the public at the moment that having a DNACPR order in place means that doctors will not try to save your life. This is not the case. The GMC guidance is clear that DNACPR orders do not imply that other treatments, for example oxygen, fluids, or antibiotics will be withheld or withdrawn. Moreover, DNACPR orders are not legally binding. Where DNACPR order has been made, CPR is still advised in certain situations, for example in cases of respiratory arrest from a reversible cause. However, it is important to be clear with patients that CPR is an undignified process, used to try to restart the heart. If successful, almost all patients require admission to ITU for ventilation, and this might not always be appropriate in patients with certain underlying co-morbidities, as full recovery would be very unlikely. The BMA ethical guidance on COVID-19 notes:
The pandemic, and the restricted availability of intensive care, will influence other clinical decision making within the hospital. For example, it will be important for clinicians to review and document the appropriateness of cardiopulmonary resuscitation for all inpatients (with or without COVID-19 associated illness) where there is a possibility of acute deterioration. If patients have sufficient background illness, co-morbidity and/or frailty that they would not be admitted to intensive care (because of the necessary restrictions on admissions), it is important that cardio-pulmonary resuscitation is not commenced in the event of a collapse. Performing advanced resuscitation for a patient for whom post-resuscitation intensive care cannot be provided would potentially cause harm to the patient, consume limited resources at a time of considerable strain, and potentially put the resuscitation team at unnecessary personal risk.
Ultimately the decision to put an order in place lies with the clinician, not the patient. However, clinicians considering making a recommendation for a DNACPR order, there is a legal requirement for them to discuss the matter with the patient (see Tracey v Cambridge University Hospital NHS Foundation). Exceptions to this are where a patient does not wish to discuss it, or if the clinician believes the discussion would cause the patient psychological harm (more than ‘distress’). Where patient lacks capacity to participate in discussion, clinicians must involve those appropriately interested in their welfare, for example a family member (see Winspear v City Hospitals Sundeerland NHS Foundation Trust).
We should carefully consider the ways in which we can learn from the understandable widespread concern surrounding DNACPRs in the context of COVID-19. As Ruth May (Chief Nursing Officer) and Stephen Powis (National Medical Director) have made clear, it is important that blanket polices with reference to age, disability, or medical condition should  not be adopted amidst this crisis. It is crucial that this continues to be the case. Reflection on the effects of the above concerns raised during this pandemic enables us to be more thorough with respect to when this decision process takes place between patient and clinician. Early discussions surrounding advance care decisions also enables patients to have more detailed, clear discussions surrounding why a DNACPR order has been suggested by their clinician. In urgent situations, for example at the time of an acute presentation to hospital, patients may be unable to communicate their wishes, or rationalise information about the likely effects of CPR (although this is certainly not always the case). Having these discussions while acutely unwell can cause distress, and have a detrimental effect to patient wellbeing. Facilitating advance care discussions when patients are well enables effective, sensitive communication, and avoids impersonal – and for some, alarming – methods such as letters. Making these decisions before triage thus enables clear doctor-patient communication as to a) why the patient may, or may not want a DNACPR order, and b) why the clinician does or does not believe a DNACPR order is appropriate. Dignity is a key factor in any discussion surrounding the end of life, and having these discussions earlier in the care process allows patients to consider what dying with dignity means for them, and while the decision ultimately lies with their clinician, it can also empower the patient to, for example, decide to stay at home for their last hours or days if they so wish.
Initiatives to reflect these suggestions are already underway. The ReSPECT form is a process to develop, and keep under review, choices about clinical care in emergency. Advance processes such as these enable patients to clearly distil and reflect their priorities in writing. However, this initiative is only being used in a few places at the moment. Public concerns raised about DNACPRs during the COVID-19 pandemic gives us opportunity to reflect on how we can improve normative clinical practice surrounding advance care planning in the long-term, for example by using ReSPECT forms, or advance statements. By improving the facilitation of patient-doctor and family discussions surrounding the end of life as common practice where appropriate, we can enable many more patients to record and update their wishes (in a legally valid manner), so that they are in place before any emergency care is required.
(Originally published on the Journal of Medical Ethics blog, here)
Authors and Affiliations:
Dr Catriona McMillan, Senior Research Fellow in Medical Law and Ethics, University of Edinburgh. Twitter: katy_mcmillan.
Dr Victoria Sobolewska, Internal Medicine Trainee, NHS Lothian.

Social justice should be key to pandemic planning and response

By Agomoni Ganguli Mitra
Covid-19 Supermarket
At the start of every public health ethics course I teach, I give my students a list of questions to explore, but leave the most important one until last: 'What kind of society do we want to be?'
I want them to circle back to this thought, no matter the topic, to instil in them the understanding that public health practice and policy are always based on value judgments. Our job, as ethicists, is not always to provide the right answer, but to clarify the values and interests embedded in our decision making.
The Covid-19 crisis illustrates why questions of social justice should be at the core of medical and public health responses. During a crisis, health care professionals are forced to make tragic choices. Should ventilators be prioritised for those with no underlying health conditions to help ensure better survival rates? Or should people in greatest need take precedence? The moral dilemmas facing health workers can be excruciating, but ethicists can help to illuminate the values that inform such decisions.
In our response to the current crisis, we can also provide direction on wider questions of social justice, which go far beyond how we determine medical priorities. Indeed, we face ethical dilemmas at a broader policy level. By adopting, for instance, a model that favours acquiring herd immunity – and opting to sacrifice some lives to save many more – we might fail to weigh up which lives, and vulnerable groups, we would be sacrificing.
Similarly, curbs on individual freedom – so highly prized in liberal societies – can become a focus of ethical tension. We might justify restrictive measures by invoking the collective good, or by showing that a relatively small burden on the general population will protect the most vulnerable. These varying approaches reflect different ethical values and attitudes towards justice, and the solutions are not straightforward.
Pandemics are as much about moral questions as medical ones. Issues of social justice, human vulnerabilityand structural inequality come into play at home and abroad. Pandemics, as we know, do not respect borders. Our global response should be one of partnership, rather than protectionism, and one based on solidarity and even a minimal sense of global justice.
A fresh approach is needed in our collective ethic. Reports of racism prompted by the pandemic are hugely concerning – a situation that is exacerbated by the protectionist political measures adopted by several countries, fuelling further nationalist sentiments. At an individual level, we see this ethos of looking after our own interests, at the expense of others, reflected in our empty supermarket shelves.
As politicians hasten to address economic concerns, we must stop to consider how our decisions are exacerbating inequalities associated with race, age, class, gender and disability. Are we only hearing the voices of the powerful, and silencing those of the most disadvantaged? It is a question we need to grapple with, individually and collectively.
There is growing evidence that the long-lasting effects of the pandemic will deepen structural and social inequalities. The imposition of strict social distancing will see many women and children forced to remain with their abusers while, in even the most privileged circumstances, women will bear the brunt of care work and provision of emotional support.
Similarly, people with disabilities not only face greater health risks, but will also suffer most from a lack of support services. In our rush to save lives, there is a growing risk that people with disabilities are seen as expendable. Among the worst affected will be those who have little or no claim on our governments; think of migrants stranded on the margins of society. There is no possibility of self-isolation in a refugee camp, or when you have a forced mass migration.
In the coming months, as our health systems focus on how to save lives – and, eventually, rebuild – an ethic based on social justice might prompt us to consider those socio-economically vulnerable members of society who have helped to prop up our economy and political structures during this crisis. Indeed, although we speak of a crisis, a pandemic of this nature has severe long-term repercussions. Will those of us who enjoy much privilege be willing to endure further sacrifice so that those who have lost the most in this pandemic are able to recuperate?
When I teach my class this autumn, the pandemic will loom large in my thinking. As I sit just now in my makeshift home-study and imagine training the next intake of doctors, lawyers and policy makers, I am increasingly convinced that ethics and justice should underpin all of public and global health. My key question to my new students will be: What kind of society do you want to build in the decades ahead? It may just make its way to the top of my list.
(Originally published on the Justice in Global Health Emergencies & Humanitarian Crises website, here)

17 March 2020

The COVID-19 pandemic: are law and human rights also prey to the virus?

By Graeme Laurie

COVID-19 was declared a global pandemic by the World Health Organization (WHO) on 11 March 2020. In the United Kingdom, after extensive criticism across different sectors of society regarding government inaction and ineffective policies  as well as piecemeal communication about possible measures relating to citizens over age 70 to maintain social distancing for a period of months   HM Government announced on 15 March that daily press conferences will be held “…to keep the public informed on how to protect themselves”. As for first responders and other professionals who find themselves at the front line of the battle to delay the spread of the virus, guidance is available, but its accessibility and absence of detail is worrying, as a cursory look at the official website will reveal. Importantly for this blog, the Department of Health and Social Care’s Coronavirus Action Plan makes no mention whatsoever of the legal position underpinning any of its initiatives. So, in this blog I ask:

Are law and human rights also prey to the impact of the COVID-19 virus?

In attempting to answer this question, I make the case for constant vigilance with respect to the role of the law and human rights in a public health emergency, as well as giving a brief account of the complex legal provisions that can be deployed as public health measures. I offer a checklist of considerations for delivering legal preparedness in emergency contexts, including the value of civil liberties impact assessments that can help to monitor compliance with law and human rights throughout these difficult times. 

On the importance of law in a public health emergency  

Law is a social tool of considerable importance. This is never truer than in the middle of a global health crisis when the situation changes rapidly and dramatically on an hourly basis. Law and legal institutions become crucial in maintaining the delicate balance between order and chaos, between public and private interests, and between promotion of the common good and protection of civil liberties. Global health emergencies require rapid, complex, multi-agency and multiple agent actions, as well as multi-layered-readiness at four stages, being: (1) preparation, (2) response (3) protection and (4) recovery. Lack of clarity about the role of law, or continued uncertainty about legal rights and responsibilities, can seriously hinder or impede effective responses. It is now clear that we are deep in the third phase (protection) of the COVID-19 pandemic, and any national and international governmental failures to prepare in advance for this latest pandemic will rapidly become apparent. This makes it all the more crucial that attention is paid to legal preparedness to respond responsibly to an rapidly-changing – and undoubtedly in the short-term  worsening situation, as plans and contingencies fail. 

At the time of the N1H1 flu pandemic, just over a decade ago, a speaker at a US summit on preparedness made the following astute comment:

 …when it comes to pandemics, any community that fails to prepare – expecting that federal government can or will offer a lifeline – will be tragically wrong. Leadership must come from governors, mayors, county commissioners, pastors, school principals, corporate planners, the entire medical community, individuals and families [1].

This suggests that there is a risk in over-centralisation of response mechanisms to global health emergencies. The threats are manifold, potentially affecting communication, coordination and contingency planning. From a legal perspective, it highlights that first responders and others, such as healthcare professionals, hospital and school administrators, and local officials must be properly supported and folded into rapid decision-making when responsibilities for hands-on management of the crisis falls to them. As a minimum, there must be clarity of legal responsibilities and obligations, including domestic laws and international human rights. 

What is the legal position on public health emergencies?

The legal position on responding to a public health emergency of international concern (PHEIC), as it is officially termed in legal parlance, begins with the International Health Regulations (IHRs, 2005). These establish ‘an agreed framework of commitments and responsibilities for States and for WHO to invest in limiting the international spread of epidemics and other public health emergencies while minimizing disruption to travel, trade and economies’. However, while acknowledging that the WHO and the IHRs may play an important role in surveillance and reporting of pandemics, and in providing a framework for tackling them, effective action must begin and end at the state level, as it remains the sole entity – in principle – with the sanctioned power to enact policies that can lawfully curtail civil liberties. This is also because of an obvious and serious limitation within the international regime: the absence of sanction mechanisms within the international framework to require compliance by countries. And, while WHO can assist a country in its surveillance and response if requested (Article 44), the real problem of dealing with an aberrant state remains.

Domestically in the UK, the legal position is piecemeal (to say the least). While the Coronavirus Action Plan acknowledges the importance of all four nations’ administrations to work together, the legal basis for this is fragmented. For example, in England and Wales, the bulk of legal authority is found in the Health and Social Care Act 2008, amending the Public Health (Control of Disease) Act 1984. The 2008 Act amendments are largely concerned with responses once a threat has already presented itself; it less concerned with contingency planning to coordinate responses prior to any such threat. While there are provisions for monitoring and notifying outbreaks, there is far less consideration for joined-up working beyond the very local response. Sections 45B and 45C of the 2008 Act confer powers on the Secretary of State to make provision by Regulations with respect to health protection measures for international travel and domestic affairs respectively. Provisions can be made both with respect to requiring action from professionals and authorities in the face of a public health threat and with respect to members of the public, their behaviour and their rights. As to the effect on members of the English and Welsh public, Regulations can impose restrictions or requirements in relation to persons, things or premises in the event of or in response to a threat to public health (s.45C(3)(c)). In particular, this can include a requirement that a child be kept away from school, and a prohibition or restriction on the holding of an event or gathering (s.45C(4)). Regulations can also include provision for imposing ‘a special restriction or requirement’ as set out in Sections 45G(2)(e)-(k), 45H(2), and 45I(2). These include, among other things, that a person be disinfected or decontaminated; that a person wear protective clothing; that a person’s health be monitored and the results reported; that a ‘thing’ be seized or retained, or be kept in isolation or quarantine; or that a premises be closed, decontaminated, or destroyed. Pursuant to section 45D(3), however, and unlike the powers in relation to international travel, domestic Regulations may not require that a person (i) submit to a medical examination; (ii) be removed to a hospital or other suitable establishment; (iii) be detained in a hospital or other suitable establishment, or (iv) be kept in isolation or quarantine. Such measures may be imposed only by an Order from a Justice of the Peace on application from a Local Authority. 

Similar provisions exist in Northern Ireland and Scotland, but underpinning all of this at the UK national level is the Civil Contingencies Act 2004.  The Civil Contingencies Act 2004 (CCA) is a measure of last resort when it comes to the creation of ‘emergency powers’, leaving existing legislation to govern responses across an incredibly wide range of areas and actors. The ability of this legislation to empower all relevant actors to respond adequately is questionable. The CCA itself lays down a broad framework for preparedness, but it is far from clear how, or indeed when, this would operate when we move from the stage of preparation to action, and whether the complex lines of communication and coordination that are essential to an effective response to a public health emergency are in place. Nor is it clear whether relevant actors are sufficiently apprised of the measures and the legal parameters within which they will be expected to act when an emergency such as COVID-19 is upon us. 

The legal position, albeit complex can be summed up as follows: legislation such as the 2008 Act (and equivalent measures in Scotland and Northern Ireland) should be used in the first instance, while escalation of a crisis to an ‘emergency’ – defined to include “(a) an event or situation which threatens serious damage to human welfare in a place in the United Kingdom”  triggers the centralised provisions of the CCA 2004. But how are officials, professionals and the public to navigate such complexities and to know what is being done legally or when the balance has been tipped too far away from the adequate protection of civil liberties in favour of a putative threat to public health?

Legal preparedness in the face of public health emergencies

In an attempt to begin to answer this question, I offer further core questions that should be at the heart of all plans and planning exercises for global or public health emergencies. These are:

i. Are all public health officials and other actors with responsibilities fully apprised of the relevant legal provisions, their duties and the limits of their roles?

ii. What is the level of informational joined-up-ness between sectors, jurisdictions, disciplines and professionals? That is, are lines of communication and balance of responsibilities clear within the complex web of potential actors? 

iii. Do existing laws impede preparedness, either through unnecessary provisions or lack of clarity or inflexibility?

iv. Are we aware of gaps in existing legal provision and are we clear on how these gaps will be filled (in particular how the CCA will be deployed)?

v. Are we naive in our premises, for example, that voluntary compliance with self-isolation or quarantine will prevail? If so, are we clear enough on what will happen next? 

vi. Do we have adequate mechanisms to test legal preparedness and to benchmark best practices? 

vii. Do we have adequate mechanisms to test the competencies of relevant actors with respect to legal preparedness?

viii. What are provisions for effective communication and coordination of legal materials and information about legal responsibilities?

ix. What provisions exist for decision-making when information is ‘less than complete’? 

x. What is the role of social distancing and who has authority to require or restrict it?

xi. What is the role, if any, of the military?

Wither human rights?

For so long as the UK remains a member of the Council of Europe and signatory to the European Convention on Human Rights, all legal preparedness must also be about ensuring that any measures taken that impact on civil liberties and human rights are necessary and proportionate to the social objective sought. The Civil Contingencies Act 2004 cannot amend the Human Rights Act 1998 (c.42), and any emergency regulations made under the Act are treated as subordinate legislation for the purposes of the 1998 Act. 

Pursuant to Section 22 of the 2004 Act (Part 2), emergency regulations may provide for: 

• The confiscation of property (with or without compensation); 
• The destruction of property, animal life or plant life (with or without compensation); 
• The prohibition or requirement of movement to or from a specific place; 
• The prohibition of assemblies (of specific kinds, at specific places or at specific times); 
• The prohibition of travel. 

Most obviously, these provisions could raise the following human rights/civil liberties issues:

• privacy; (Article 8 of the European Convention on Human Rights) 
• property; (First Protocol to the Convention); 
• mobility/liberty; (Article 5 of the Convention); and  
• freedom of association; (Article 11 of the Convention). 

There are a number of points to note about the nature and operation of human rights laws as they relate to global/public health emergencies. It is trite that while human rights are fundamental rights, in most instances they are not absolute. That is, while human rights instruments identify protections that are considered to be of core value to our society, these do not deserve protection at any cost. Exceptions are possible. The starting point is, however, that fundamental rights should be protected and the onus is on those who would interfere with such rights to justify any interference. Thus, Article 5 (protection of liberty) allows for detention of persons ‘for the prevention of the spreading of infectious diseases’, while Articles 8 and 11 (privacy and association respectively) permit interferences ‘…for the protection of health…or the rights and freedoms of others’. By the same token, interference with some rights is more readily justified than in other cases. For example, Article 5 only permits exceptions from a restricted and limited list, while Articles 8 and 11 permit a range of exceptions which are subject to the watchwords of necessity and proportionality. In such cases, interferences with human rights are only justifiable when they are in accordance with the law, necessary to address a pressing social need, and employ proportionate means towards specified ends. This can only be judged on a case-by-case basis, but permits a degree of latitude in determining what is necessary and proportionate, albeit with the proviso that interferences should be minimal to achieve the social objectives. The practical consequence of Article 5 is, however, that a potentially higher level of protection is accorded, in that it is more difficult to depart from its provisions. This gives effect to a form of hierarchy of rights, such that the ease with which interferences can be justified ranges from most difficult (Article 5) through moderate (Articles 8 and 11) to more easily justified (Article 1; Protocol 1 on property). 

Thus, central to the protection phase of legal preparedness is the need for the courts to be maintained, or at least for judicial oversight to be made possible at all times. There is a lack of clarity in the possible meanings of the threshold terms used in law, such as ‘necessary’, ‘proportionate’ and ‘public interest’. Notwithstanding, there is a wealth of case law and literature which has attempted to flesh-out meaning over time and on which to draw. 

Moreover, from the perspective of the ethical content of the value-based decisions, we can consider the intervention ladder developed by the Nuffield Council on Bioethics which offers a way of thinking about possible government action and appreciating the associated consequences for civil liberties. This ranges across options from ‘doing nothing’ and monitoring a situation, through measures oriented towards ‘enabling choice’, ‘guiding choice’, ‘restricting choice’ and, ultimately to ‘eliminating choice’. As the intervention becomes more intrusive, so the need for justification becomes more compelling. While acknowledging that there is an ethics element built into UK planning, governments and other responsible parties would do well to consider a Civil Liberties Impact Assessment to accompany all contingency plans with particularly close attention paid the points at which escalation of action will take place. Such an impact assessment might be modelled, for example, on existing privacy/data protection impact assessments which have operated in many countries world-wide for many years and that in some instances are now required under the EU’s General Data Protection Regulation (GDPR). A Civil Liberties Impact Assessment is also akin to human rights impact assessments, save that its scope will be wider than only looking at rights – our civil liberties encompass both rights and civic freedoms and protect us from state action even when any given human rights instrument might not apply. This is particularly important to bear in mind in the current UK post-Brexit era where there is open hostility in many quarters towards the European Convention on Human Rights. 

Legal Preparedness for Pandemic: a 10-point Plan

Drawing on all of the above, I suggest that there are 10 key areas where the UK could pay close attention to improving legal preparedness for dealing with the current COVID-19 pandemic (and all future global/public health emergencies). 

1. Assessing and meeting the (legal) training needs of all relevant actors, and not merely responders identified in legislation; 

2. Drafting legal instruments to govern practices in emergencies and testing legal validity beforehand; 

3. Establishing an open access central repository of legal instruments and measures; 

4. Identify more clearly tolerances for escalation of efforts and carrying out civil liberties impact assessments on all stages of contingency planning; 

5. Assessing and providing support for courts and associated personnel as crucial mechanism for dispute resolution and protection of civil liberties during outbreaks; 

6. Articulating and exploring the legal situation in the event of full escalation, and in particular, considering worst case scenario planning and the arrangements for policing such scenarios; 

7. Establishing and clarifying legal authority for deployment of military, limits and controls, if contemplated; 

8. Learning (legal) lessons from other public health emergencies, for example, SARS in Canada & Asia, Anthrax in Scotland, or even emergencies in other government departments such as the experiences of the Department for Environment, Food and Rural Affairs with foot-and-mouth disease.

9. Clarifying and assessing balance of powers and competencies across jurisdictions; 

10. Conducting further research on evaluating legal preparedness, for example, how best to protect civil liberties as threats increase and/or plans fail.

Acknowledgement

*This blog is based on research conducted to assessed legal preparedness in the wake of the H1N1 pandemic in 2008, and draws on the text published as Laurie, G & Hunter, KG (2009), 'Mapping, Assessing and Improving Legal Preparedness for Pandemic Flu in the United Kingdom', Medical Law International, vol. 10, no. 2, pp. 101-138. https://doi.org/10.1177/096853320901000202




[1] Special Supplement, The National Action Agenda for Public Health Legal Preparedness, (2008) 36:1 Journal of Law, Medicine and Ethics at 11.