COVID-19, medical research governance, and public health orders

Image: Mika Baumeister

Posted by Belinda Reeve on behalf of Cate Stewart

The impact of coronavirus-related biomedical research and public heath laws have been considered in recent articles co-authored by Cameron Stewart, Professor of Health, Law and Ethics at the University of Sydney Law School.

Science at warp speed: COVID-19 medical research governance

In biomedical research focused on developing COVID-19 vaccines and therapies, the need for speed is taken for granted. But “what, if anything, might be lost when biomedical innovation is sped up”? In a timely article in the Journal of Bioethical InquiryProfessor Cameron Stewart and colleagues, consider a study (on the use of anti-malarial drug hydroxychloroquine for treatment of COVID-19) recently retracted from The Lancet to illustrate the potential risks and harms associated with speeding up science.

As Professor Stewart and his co-authors note:

[T]the potential damage caused by not ensuring effective governance of research during epidemics may be immense. Harmful drugs and devices might go on to injure millions of people, useful drugs and devices might be abandoned, the public’s faith in science and medicine might be undermined, and irrational and ineffective healthcare might proliferate.

The article goes on to suggest a range of measures to address weaknesses in technical or methodological rigour, lack of peer oversight, and unmanaged conflict of interest in pandemic research.

“This is a difficult conversation, but one that must be undertaken. After all, this is not the first time that science has been sped up during pandemics with problematic effects, and we will undoubtedly need to speed science up again, many times in the future.”

COVID-19 public health orders and mental health practitioners

Professor Cameron Stewart and colleagues look at restrictive practices in Australian COVID-19 public health orders and their implications for mental health practitioners in the October 2020 issue of the International Journal of Mental Health Nursing.

Their article notes that due to the COVID-19 pandemic, health authorities in all Australian jurisdictions can invoke public health orders that allow for an extremely broad range of coercive orders, including forcible detention, testing, and treatment of any person reasonably suspected of being COVID-19 positive.

The article highlights relevant public health laws for mental health practitioners to be aware of and suggests that mental health units and public health units establish lines of communication to work together.

Professor Stewart and his colleagues conclude with a call for nationally consistent regulation as “the best way to encourage best practice, fair decision-making, the protection of human rights, and the promotion of public safety”.

Cameron Stewart teaches in Sydney Law School’s Master of Health Law program, including subjects on Death Law, Health Care and Professional Liability, and Government Regulation, Health Policy and Ethics.

Related posts on COVID-19 from the Sydney Health Law team:

https://sydneyhealthlaw.com/2020/03/18/whos-in-control-of-australias-response-to-coronavirus-part-1-legal-frameworks/

https://sydneyhealthlaw.com/2020/03/19/whos-in-control-of-australias-response-to-coronavirus-part-2-operational-responses/

https://sydneyhealthlaw.com/2020/08/26/rule-of-law-in-the-covid-19-response

Rule of law in the Covid-19 response

The International Development Law Organisation (IDLO) has released a short publication that highlights the role of law in governments’ response to Covid-19.  See here.

Established by international treaty in 1988, IDLO is an inter-governmental organisation devoted to upholding the rule of law.  Australia, and the United States, are among its 37 member parties, which span both developed and developing countries.

IDLO works in over 30 countries and across a range of legally-relevant areas, including public health, sustainability, access to justice, the rule of law and gender.

Sydney Law School collaborated with IDLO, the World Health Organisation and the O’Neill Institute for National and Global Health Law at Georgetown University in the 2017 publication, Advancing the right to health: the vital role of law.  An update and summary guide to the report was published in 2018, see here.

The vital role of law in the Covid-19 response identifies a number of lessons that both publications have for law’s role in the current coronavirus pandemic.

Covid-19 and the rule of law

A statement by IDLO’s Director-General, Jan Beagle, also draws attention to how the rule of law can contribute to an effective global response to Covid-19.

The rule of law is the principle that law-making processes should be transparent, laws should be enforced fairly, courts and tribunals should be independent, and the administration of law and its substantive content should be consistent with international human rights standards (see here, p 7).

Director-General Beagle draws attention, firstly, to the way that the rule of law and the justice sector can temper raw political responses to epidemics, allowing “carefully tailored” emergency measures that “protect people from infection and disease, while respecting their civil, political, economic and social rights”.

For example, where legal or executive processes are used to create “disproportionately excessive powers”, international human rights law, and legal instruments such as the International Health Regulations, provide standards for restoring balance.

Secondly, Director-General Beagle points out that the rule of law “can be a lifeline for society’s most vulnerable in times of crisis.  She writes:

“When freedom of movement is restricted and resources are scarce, feelings of stress, anxiety and alienation can exacerbate exclusion, discrimination and social fissures and have a disproportionate impact on people living in extreme poverty, women and girls, the elderly, children, people with disabilities, migrants, refugees and displaced persons, prisoners, and those living in situations of conflict and insecurity”.

Evidence of these social fissures is seen, for example, in rising rates of family and domestic violence since Covid-19 began, particularly against women and children.  See here, here and here.  UN Women calls this a “shadow pandemic”.

At times like this, the role of justice institutions and the rule of law is more important than ever to “protect the rights of the least powerful among us”.

Finally, Director-General Beagle refers to the rule of law in providing “concrete pathways for post-emergency recovery”, including by addressing the “socio-economic consequences of the epidemic”.

“This will require greater investments in public institutions and inclusive and participatory policymaking to help communities to come together and maintain social cohesion in the aftermath of this pandemic”.

Law’s mission in public health

Although commenting specifically on the rule of law, Director-General Beagle’s statement helps to identify some key features of the mission that law can have – in my view ought to have – within the arena of public health.

Law is a tool that can be used for deploying, but also constraining, political power.  Wisely used, it can create an effective legal framework for health protection that is led by government, and informed by human rights.

However, in fulfilling its role in health protection, law’s role is not – or should not only be – to improve health “on average”, but to help tackle the factors that drive inequalities in health: the deep pools of disadvantage that persist even when average health improves.  Health law work is certainly about improving average health, but it’s also about effective health protection for those who will be left behind – or trampled underfoot – if all we care about is the law of averages.  A growing literature is beginning to document the social gradient of Covid-19 transmission, in the sense that economic and social disparities can amplify virus transmission, just as they amplify risks and poor health outcomes in other areas.

Finally, in speaking of law’s role in supporting “the resilience of communities against future crises”, Director-General Beagle also draws attention to the future dimensions of public health law.  The purpose of public health law is not only to secure the present, but to create legal frameworks that will help to give future generations the opportunity to enjoy a healthy life.

Law’s mission in public health is ambitious, and the rule of law is a critical part of that mission.  With Covid-19, global warming, and persistent epidemics of non-communicable diseases (and their risk factors) such as cancer, diabetes, and obesity, the need for health law specialists has never been greater.

Are you interested in studying health law?  Click here, here and here for more details.