Developed countries, dwindling national flexibilities, and access to essential medications during public-health emergencies

Dr Olugbenga Olatunji, Lecturer, The University of Sydney

Photo by Diana Polekhina on Unsplash

In a recently published paper, I historicise the gradual but potent attacks of the developed countries on the breadth and effectiveness of flexible obligations in international patent agreements. Flexibilities are usually included in these agreements to strike a balance between the monopolistic nature of patent rights and the right of states to suspend or abridge them in national interests. The paper discusses this flexibility-winding-back phenomenon through the lens of two treaties – the Paris Convention for the Protection of Industrial Property (Paris Convention) and the Agreement for the Trade-Related Aspects of Intellectual Property Rights (TRIPS). This post summarises the highlights of this paper. Given the currency of this topic, especially in view of the COVID-19 pandemic, a cursory comment is also provided on the recently adopted Decision of the World Trade Organisation (WTO) on improved access to COVID-19 vaccines.

Paris Convention – the ‘draining’ of a hitherto broad flexibility reservoir

The Paris Convention (PC) was adopted in 1883 to regulate industrial property (IP) like patents, trademarks, service marks, geographical indications, utility models, etc. It is pivoted on a tripartite principles of national treatment (NT), priority rights (PR), and common rules (CRs). NT (article 2, PC) requires subscribers to the PC to extend to citizens of other subscribers the same level of IP protection enjoyed by their citizens. PR (article 4, PC) is particularly useful for applicants who intend to protect their IP in multiple jurisdictions, as it allows them a grace period within which to submit applications for the same IP in other jurisdictions without losing the filing date of their first application – the duration of PR depends on the type of IP involved. Lastly, CRs outline principles of general application in respect of each of the IP categories covered in the agreement (e.g., see articles 4, 4bis, 4ter, 4quater and 5).

Two broad heads of patent-related flexibilities in the PC are discussed in the paper. The first and the most comprehensive one is the ‘non-binding’ nature of the PC tripartite principles. This is because these principles (NT, PR, and CRs) are only activated for members who offer protection for any of the IP categories under the PC. This approach is particularly advantageous in that a member may invoke not offering patent protection as a policy tool for expanding national technological base and promoting access to needed medications. Even where patent protection exists, this fluid approach means members could suspend or abridge patent rights to cater to access demands during public health emergencies. The second (equally broad) flexibility is forfeiture/revocation (article 5, PC). PC subscribers are empowered to revoke granted patents for abuses of patent rights like non- or insufficient working of the patents or other anti-competitive practices. This makes sense given one of the oft-cited justifications for rewarding creativities with monopoly rights is to foster industrial development through technical education and technology transfer.

Next, the paper traces the barrage of attacks directed at the broader forfeiture/revocation flexibility incorporated into the original PC (see 3.2). The first stop is the 1900 Brussels Revision which imposed two conditions for using the exception: first, members must wait 3 years post-patent-filing before invoking the flexibility even after non- or insufficient working of the invention had been established; and second, affected patentee must have no justification for not working or for insufficiently working their inventions (see article 2). The 1925 Hague Revision heralded a further tightening of this flexibility by requiring, in addition to the Brussels conditions, that forfeiture/revocation would only be available if the remedy of compulsory licensing (CL) could not resolve an alleged patent abuse (see article 5). In 1934, the London Revision added another condition, to wit, flexibility not to be available unless an alleged patent abuse remains unredressed two years after the grant of CL (see article 5(4)). The 1958 Lisbon Revision completes this process by refining the period within which CL could issue in addition to providing that CL must only be non-exclusive (see article 5(4)).

Cumulatively, all of these revisions decimated the revocation/forfeiture exception as patentees are now allowed to ‘justify’ alleged abuse of patent rights. Interestingly, the developed countries still yearned for more pro-patentee revisions and were only stopped by the increased membership of low-and-middle-income-countries (LMICs) who not only opposed further pro-patentee revisions, but also unsuccessfully pushed pro-access revisions of their own (e.g., see Loughran at 424-31). This stalemate led to a US-championed forum-change to the General Agreement on Tariffs and Trade (GATT) – now the WTO.                          

Transition to GATT, TRIPS, and access concerns

Sections 4, 5, and 6 of the paper examine the behind-the-scenes political intrigues that produced TRIPS as well as potential effects of the new treaty on access. In a nutshell, TRIPS’s structure mirrors that of the PC to the extent that it provides for NT, PR, CRs, and flexibilities. However, one distinction between TRIPS and the PC is that TRIPS exterminates the most consequential flexibility under the PC, namely, deference to members on if and how to incorporate the three pillars of the PC at national level. Hence, TRIPS now requires that all WTO members must entrench in their national laws TRIPS minimum standards, including provisions on enforcements and dispute resolutions. This universalisation of minimum standards is an incredible win for developed countries and their multinational corporations (MNCs) for two reasons: one, it makes it easier for their MNCs to obtain and enforce IP protection in LMICs; and two, with no obligation to exploit patents in countries of grant, it arguably legitimises ‘rent-seeking’ behaviour also in LMICs. It is for these reasons, among others, that TRIPS has been criticised as an impediment to access (e.g., see FM Abbott article).

The above notwithstanding, the paper acknowledges the simultaneous inclusion of flexibilities like parallel importation and compulsory licence in TRIPS. Theoretically, these could be used by members to temperate potential threats that TRIPS may constitute for access. The problem here though is that the freewill of LMICs to utilise flexibilities is tremendously constrained by developed countries, using different political-cum-economic stratagems to thwart their attempts. Apart from political/economic might, developed countries have also deployed Free Trade Agreements (FTAs) to diminish the scope and effectiveness of flexibilities post-TRIPS. FTA IP chapters are notorious for enacting TRIPS-plus obligations – obligations far higher than TRIPS minimum (see section 6). Countries like India, Brazil, Argentina, Thailand, and South Africa (just to mention a few) have been strategically targeted by the US, for example, either for using or attempting to use TRIPS flexibilities (e.g., see Drahos and Braithwaite).

In section 7, the paper identifies four ways through which this continuing attack on national flexibilities could exacerbate the access situation in LMICs, namely by:

  • legitimising external influence in national IP rule-setting (US & EU use trade access to control IP rule-settings in several LMICs);
  • imposing additional constraints on the use of certain flexibilities (e.g., compulsory licence for export and parallel importation);
  • unjustifiably adopting higher IP regime in the mistaken belief that this would foster technology transfer and FDI (e.g., Tanzania and Kenya); and
  • threatening the continued existence of India as the ‘pharmacy of the developing world’ (US has repeatedly placed India on a priority watchlist for using flexibilities, MNCs have developed strategies for challenging legitimate use of flexibilities in India, and a section of the Indian generic industry is becoming exceedingly pro-patent owing to influence from MNC collaborators).         

Postscript: the WTO Decision on improved access to COVID-19 vaccines   

Since early 2020, the world has witnessed a once-in-a-lifetime pandemic which originated in China in December 2019. The resulting shortage of PPEs, ventilators, diagnostics, vaccines, and therapeutics, later complemented by a wave of vaccine nationalism among developed countries, led South Africa and India to submit a proposal in October 2020 to the WTO offering ways out of this access quagmire. This proposal called for a blanket waiver of section 1 (copyright and related rights), section 4 (industrial design), section 5 (patents), and section 7 (protection of undisclosed information) of Part II of TRIPS for 3 years to enable a fast-tracked containment and treatment of COVID-19 infections.

After over 18 months of negotiations, a Decision finally emerged at the Ministerial Conference held in June 2022. Unsurprisingly, this Decision has no scintilla of resemblance to the original proposal from India and South Africa. Instead, it considerably reflects an alternative proposal sponsored by the EU, which identifies the overhauling of TRIPS’s CL framework as the holy grail to improved access for COVID-19 vaccines and therapeutics. It is worth noting however, that though based on the EU proposal, the Decision is narrower in scope. For instance, unlike the EU proposal, the approved Decision will only apply to vaccines, while negotiations regarding diagnostics and therapeutics will follow 6 months from the date of adoption (see paras 1 and 8).

The Decision’s substantive provisions may be grouped into three: the first refines TRIPS provisions on article 31 CL by removing the need for prior authorisation under article 31(b) and re-defining adequate remuneration under article 31(h) (paras 3a and 3d). In the second group are provisions focused on addressing some of the criticisms raised against article 31bis (CL for exports). These provisions clarify the circumstances for waiving TRIPS article 31(f) (para 3b); the re-exportation of imported vaccines (para 3c); and the timing of communication of actions under the Decision to Council for TRIPS (para 5). The last group of provisions addresses the issue of duration (5 years, though extendable) (para 6), and the problem associated with access to test data where CL has been granted under articles 31 and 31bis (para 4).       

In retrospect, the process that produced this Direction confirms how emboldened the developed countries have become, not only in attacking national flexibilities pre-TRIPS, but also in manipulating LMICs to ‘voluntarily’ surrender flexibilities. As explained in the paper, this domination is heightened by the successful linkage of trade and IP under the WTO, such that developed countries can now use trade access as a carrot-and-stick instrument to reward cooperating LMICs (increased trade access) or punish recalcitrant ones (withdrawal of trade access). This seems to explain why the India-South Africa proposal did not see the light of the day (in whole or in part) despite the tremendous supports it garnered within and outside the WTO. It also seems to explain why LMICs with capacity to manufacture COVID-19 vaccines would agree to undertake not to use the Decision, even though the Decision is intended to benefit all LMICs (see footnote 1 of the Ministerial Decision).                      

Moving forward despite dwindling flexibilities

It is indisputable that there is no quick fix to the ubiquitous conundrum of inadequate access, especially during a deadly pandemic like COVID-19. However, a few potential solutions may be explored. The lead recommendation in the paper is a political one, which makes sense given the political nature of this problem. Thus, since the laws of many LMICs provide for TRIPS flexibilities, they are advised to muster political will to use these flexibilities not minding any threat of economic sanctions from their developed country counterparts. India is a leading example here as it has defied repeated US harassments aimed at preventing it from using flexibilities. Second, while the June Decision falls short of the widely supported proposal, LMICs could still take advantage of the clarified provisions of TRIPS articles 31 and 31bis CLs. This recommendation, however, circles back to the need for LMICs to show unabashed political will to use the Decision. Third, LMICs may also consider the possibility of using the WTO platform to secure an undertaking from developed countries not to interfere in attempts by LMICs to use flexibilities. Lastly, not all countries can or should venture into pharmaceutical production; as such, a specialised agency could be instituted (perhaps, within the WHO) to coordinate the donation of urgently needed pharmaceutical products to these vulnerable countries where patent is not the issue.

Indigenous Peoples’ Inclusion in Food Governance

For NAIDOC Week, Dr Mark Lock speaks to Dr Belinda Reeve about championing health equity for First Nations Australians and their meaningful inclusion in all dimensions of food governance. 

Reposted with permission from the Sydney Environment Institute website: https://sei.sydney.edu.au/qa/indigenous-peoples-inclusion-in-food-governance/

Red native fruit plant.
Santalum acuminatum, desert bush tucker peach quandong, Australian native fruit via Shutterstock, ID: 734790040.

Industrialised, corporatised food systems contribute to some of the most urgent challenges facing the planet. These include climate change, the depletion of environmental resources, rising food insecurity, high rates of non-communicable diseases, and poor working conditions in the food and agricultural sectors. The dominant food system – and the policies, laws, and practices that govern it – has also marginalised, oppressed, and ignored the voices, perspectives, and participation of Indigenous Peoples, Black People and People of Colour. This occurs even at the highest levels: the recent United Nations Food Systems Summit has been criticised as privileging corporate, agro-industrial, and Global North interests at the expense of human rights, the Global South and Indigenous food systems.  

In light of growing interest in Indigenous food sovereignty, anti-racism and decolonising the food system, The Charles Perkins Centre’s Food Governance Node will be hosting an event on Wednesday 27 July on the ‘Inclusion of Indigenous Peoples in Food Governance in Australia and Aotearoa/New Zealand’. Here, we speak to Dr Mark Lock, Senior Lecturer at the University of Technology Sydney, Research Fellow at Deakin University, and one of the event’s panellists.   

Dr Belinda Reeve: Could you please tell us a bit about your background?  

Dr Mark Lock: I’m from the Ngiyampaa mob and with ancestry from the First Fleet (on the maternal side) and from Latvia and England (on the paternal side) but grew up with ridgy-didge Koori experience in rural NSW, before moving to Newcastle 30 years ago. I study committees and governance because it was invisible people on secret committees who made decisions about Aboriginal people, without Aboriginal people. That’s from the experience of my Nan, a Stolen Generations survivor. She is also why I continue to do research on the participation of Aboriginal people in policy​making processes, such as food and nutrition policy. It’s also why I research cultural safety because Indigenous people are diminished, demeaned and disempowered through poor governance. I currently work as a Research Fellow with the Murnong Health Research Mob (at Deakin University, School of Health & Social Development, Faculty of Health), and I’m also Senior Lecturer at the School of Public Health, University of Technology Sydney. 

Your current research focuses on the Commercial Determinants of Indigenous Health. Could you please explain this research lens to us? 

​Commercial activities influence our society in many ways. It can be advertisements on social media platforms, sponsorship of sporting teams, funding research activities, lobbying politicians, to bringing jobs and products to local communities. So, if business activities are a normal part of our society in many positive ways, then it also holds true that there are negative influences on health and wellbeing. However, it is only recently that Indigenous health policy makes specific mention of commercial determinants of health. In other words, governments have focused on behaviour change programs, health promotion activities, and legislation that influences public services to be health promoting, and ‘businesses and the market’ operate outside of healthy public policy. This means concepts such as health equity are not included in the governance of commercial activities. 

It is inequitable that Indigenous peoples have the highest food prices in communities with lowest incomes and less access to education and employment opportunities – combined with low quality housing and health hardware. But put a mine in the ground and everything changes – fuel subsidies, extraordinary wages, low taxes, and incredible infrastructure to generate wealth for the nation, and massive profits and revenue for a few people. It’s in these very different comparisons (nutrition inequity and mining equity – pun intended) that shows the potential for commercial determinants of health.

“It is inequitable that Indigenous peoples have the highest food prices in communities with lowest incomes and less access to education and employment opportunities – combined with low quality housing and health hardware.”

You’ve also explored the themes arising in submissions to the Australian Government’s 2020 Inquiry into Food Pricing and Food Security in Remote Indigenous Communities. What were some of your findings? 

I’ve analysed 83 submissions from different organisations. I’m thinking about how commercial activities influence food security. There’s some interesting themes coming out as cultural norms, such as the absence of a framework for commercial determinants of Indigenous health; that health equity is excluded from corporate governance; that Indigenous people (and cultural knowledge) are mostly excluded from participating at decision-making tables; and that there is an enduring norm of hardship expected for Indigenous people in rural and remote communities. However, the great things to see and build on are themes such as cultural resilience where Indigenous peoples use commercial activities in an innovative way, that many commercial activities benefit from the inclusion of cultural knowledge, and of course the theme of ‘collaboration nation’ where Indigenous communities proactively form partnerships – between communities and businesses – to leverage reforms at the local level. 

“Commercial activities influence food security. There’s some interesting themes coming out as cultural norms, such as the absence of a framework for commercial determinants of Indigenous health; that health equity is excluded from corporate governance.”

The most illuminating aspect of the research is to make visible what is currently invisible. That’s the culture of commercial determinants, by which I mean to uncover the hidden pattern of values, norms and behaviours underlying the link between commercial activities and nutrition equity. Why is it normal for rural and remote Indigenous communities to suffer enduring nutrition hardship? How can the value system of Western monetary wealth be reconciled with Indigenous sovereignty? How can business behaviours towards equity be supported and rewarded? One thing is a clear theme, with this being the third inquiry on this topic, it’s time get on with actions that are aligned with a dedicated commercial determinants of health framework. 

“Inclusive governance is more than a principal and deserves to be empirically investigated. I know that’s not a simple ‘one-page’ answer, but food policy and governance are complex and nuanced with many stakeholders vying for a profitable wedge into the system. Simple policy​ on the run will not work.”

The focus of this event is on the inclusion of Indigenous peoples in food policy and governance. What do you think truly inclusive food governance looks like? 

I think about how Indigenous peoples can influence every ‘point and pathway’ of governance. So, I a) yarn with relevant Indigenous people from the beginning, b) map the governance system, c) identity every point and pathway where Indigenous people should influence the system, d) ethically research and gather knowledge, e) develop a system design where the process includes all stakeholders, f) build in evaluation, measurement, and monitoring, and g) close the loop by ensuring good ongoing governance with Indigenous communities.

Therefore, inclusive governance is more than a principal and deserves to be empirically investigated. I know that’s not a simple ‘one-page’ answer, but food policy and governance are complex and nuanced with many stakeholders vying for a profitable wedge into the system. Simple policy​ on the run will not work. Finally, thinking about my Nan and Stolen Generations as we come into NAIDOC Week 2022, I’d like to see the food and nutrition industry “Get Up! Stand Up! Show Up!” for nutrition equity with First Nations Australians. 

To hear more from Dr Mark Lock, register for the panel discussion, ‘Inclusion of Indigenous Peoples in Food Governance in Australia and Aotearoa/New Zealand’. 


Dr Mark J Lock is a Ngiyampaa First Nations Australian. He combines both cultural rigour and scientific rigour through a culturally safe research methodology. He has published on Aboriginal holistic health, participation in health policy, nutrition and food policy, and cultural safety in paediatric emergency departments, and cultural safety in research and policy. He is an ARC Discovery Indigenous Research Fellow (2013); Co-chair of the NSW Agency for Clinical Innovations Aboriginal Health Working Group on Patient Reported Outcome Measures; and Vice President of the Hunter Writers Centre. His advocacy – through Freedom of Information – resulted in the release of the Evaluation of the National Aboriginal and Torres Strait Islander Nutrition Plan, and in the release of the Scoping Study for an Australian National Nutrition Policy. 

Dr Belinda Reeve is a Senior Lecturer at the University of Sydney Law School and one of the co-founders of the Charles Perkins Centre’s Food Governance Node, a platform for interdisciplinary research on the role of law, regulation, and policy in creating a healthy and sustainable food system. She is also the lead researcher on an ARC Discovery Project investigating the role of Australian local governments and communities in strengthening food system governance at the local level.  

Alcohol companies continue to play by their own rules, putting our children’s health at risk

A mother and her young son playing together in a park

Reposted from the Foundation for Alcohol Research and Education (FARE). FARE is the leading not-for-profit organisation working towards an Australia free from alcohol harms. They approach this through developing evidence-informed policy, enabling people-powered advocacy and delivering health promotion programs. https://fare.org.au/alcohol-companies-continue-to-play-by-their-own-rules-putting-our-childrens-health-at-risk

Last year, a Dan Murphy’s mobile billboard rolled into Byron Bay, parking itself 185 metres from Byron Bay High School. Emblazoned across it read, “Go for a skate while you wait for your Dan Murphy’s order to arrive.”  

Our community expects advertising of harmful and addictive products like alcohol to follow government-led rules that protect our children, families, and communities from harm. But alcohol companies are largely left to write and administer their own rules through the Alcohol Beverages Advertising Code (ABAC) Scheme. 

The result — our children are increasingly exposed to alcohol marketing, increasing their risk of using alcohol at an earlier age and in higher volumes.i 

So, when community members complained that the Dan Murphy’s billboard was targeting their children, their complaint was dismissed by ABAC.ii  

This is a typical response by ABAC, which is funded and managed by the three major alcohol industry peak bodies (Brewers Association, Spirits & Cocktails Australia, and Australian Grape & Wine).  

Fundamentally, the ABAC Scheme is flawed. This is most clear through the voluntary nature of their advertising code, meaning that alcohol companies are not required to abide by the code and don’t face the consequences for breaching it. 

The voluntary code is also limited in scope and ambiguous, which often leads to interpretations favourable to alcohol company interests, allowing our children to be exposed to harmful marketing practices. 

There are clear contradictions in recent ABAC adjudication decisions that dismiss community complaints about alcohol marketing targeting children and adolescents.  

For example, in the Dan Murphy’s billboard case, the ABAC panel determined that the advertisement was not appealing to children because the advertisement used dark rather than bright and contrasting colours. However, in June 2021, the panel also dismissed a community complaint about marketing by alcohol giant Diageo that used bright and contrasting colours and childlike phrasing ‘New can, who dis?’. The panel stated that the ‘retro’ design made the advertisement primarily targeted to adults.iii  

In December 2021, the ABAC panel dismissed community complaints about a bright cartoon-styled mural advertising the rapid alcohol delivery company Boozebud on the same street as a primary school. Not only did the panel dismiss this community complaint, but ABAC also ‘worked collaboratively’ with Boozebud to develop this lively mural. Although hundreds of children passed by this mural every day, the panel dismissed the complaint because it appealed to adults as well.iv  

Despite the Code stating that the use of designs that create confusion with soft drinks constitute an appeal to children and adolescents, in March 2022, ABAC dismissed a community complaint about an advertisement for Bundaberg Rum that closely resembles non-alcoholic ginger beer. The advertisement featured a cross-promotion between the alcoholic and non-alcoholic products, with both products depicted, but it was still deemed not to breach the Code.v  

In further contradiction, the use of Bundy Bear in this cross-promotion was not deemed to breach the code, despite the ABAC panel having previously stated that Bundy Bear has the potential to appeal to children.vi This builds on the history of Diageo’s Bundaberg Rum advertising to children, including during the popular show for toddlers, Dora the Explorer.vii 

These are just a few examples of ABAC’s recent failure to protect children and adolescents from alcohol marketing, but the systemic failures of the ABAC Scheme are well documented.viii  

Our community deserves better advertising standards for alcohol products. These should be developed and administered by a governing body that represents the community’s interests, not the interests of alcohol companies. Only then can we see alcohol companies being held accountable for harmful targeting of children.  


i Anderson et al. (2009) Impact of Alcohol Advertising and Media Exposure on Adolescent Alcohol Use: A Systematic Review of Longitudinal Studies. Alcohol & Alcoholism 43(3):229–43; Smith L.A. and Foxcroft D.R. (2009) The effect of alcohol advertising, marketing and portrayal on drinking behaviour in young people: systematic review of prospective cohort studies. BMC Public Health 9(51) doi:10.1186/1471-2458-9-51; Jernigan et al. (2016) Alcohol marketing and youth alcohol consumption: a systematic review of longitudinal studies published since 2008. Addiction 112: 7–20 doi:10.1111/add.13591; Sargent and Babor (2020) The Relationship Between Exposure to Alcohol Marketing and Underage Drinking Is Causal. Journal of Studies on Alcohol and Drugs. 

ii ABAC (2021) ABAC Adjudication Panel Determination 129/21.

iii ABAC (2021) ABAC Adjudication Panel Determination 145/21.

iv ABAC (2021) ABAC Adjudication Panel Determination No 273/21.

v ABAC (2022) ABAC Adjudication Panel Determination No 11/22.

vi http://www.abac.org.au/wp-content/uploads/2013/04/Final-Determination-Bundaberg-23-April-2006.pdf

vii Amy Corderoy, Sydney Morning Herald, ‘Bundaberg Rum advertisements on Dora the Explorer videos spark outrage’ (2015) <https://www.smh.com.au/healthcare/bundaberg-rum-advertisements-on-dora-the-explorer-videos-spark-outrage-20150923-gjte3x.html>.

viii For academic reviews see: Reeve B. ‘Regulation of Alcohol Advertising in Australia: Does the Abac Scheme Adequately Protect Young People from Marketing of Alcoholic Beverages?’, QUT Law Review (2018) 18(1) 96–123; Pierce H et al. ‘Regulation of alcohol marketing in Australia: A critical review of the Alcohol Beverages Advertising Code Scheme’s new Placement Rules.’ Drug Alcohol Review (2019) 38(1) 16–24. For government reviews see: Northern Territory Government, ‘Alcohol Policies and Legislation Review Final Report’ (2017) Available from https://alcoholreform.nt.gov.au/milestones/about-the-review/final-report; Education and Health Standing Committee. Alcohol: Reducing the harm and curbing the culture of excess. Legislative Assembly, Parliament of Western Australia; 2011. Available from: https://www.parliament.wa.gov.au/parliament/commit.nsf/(Report+Lookup+by+Com+ID)/1511331A52931060482578B80007F0D5/$file/97909904.pdf

A short(ish) explainer on public health law

Image by Pam Menegakis via Unsplash

Stay-at-home orders, curfews, and mandatory quarantine have brought public health law to the public’s attention during the Covid-19 pandemic.

While public health law might be new to some, there is an entire academic discipline devoted to it, with a host of researchers and practitioners based in law schools (including dedicated health law and public health law centres), research institutes, non-profits, and health departments around the world. Public health law experts also work for global organisations such as the World Health Organisation. This is a short explainer on the discipline of public health law for anyone coming to it for the first time.

Public health law is distinct from health law, which is concerned with the law’s role in areas such as the provision of healthcare, the regulation of healthcare professionals and new medical technologies, medical negligence, and health information privacy.

The scope of public health law is much broader. Based on Lawrence Gostin’s widely cited definition, it is:

…the study of the legal powers and duties of the state to ensure the conditions for people to be healthy… and the limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals for protection or promotion of community health.

A key focus is dedicated public health laws and their provisions on infectious disease control. These laws create the infrastructure for public health services and disease surveillance and reporting, but they also grant officials extensive powers to order the testing, treatment, vaccination, isolation, and quarantine of individuals with an infectious disease. These powers were rarely used in many countries (and may even have seemed archaic), until the Covid-19 global pandemic broke out. This is perhaps the first time that many people understood the coercive nature of public health law and saw these laws operating in practice.

There is now an extensive body of public health law research on national legal responses to Covid-19, as well on the international dimensions of the pandemic response, such as the WHO’s use of the International Health Regulations to declare Covid-19 a public health emergency of international concern (PHEIC).

Official powers on infectious disease control illustrate some of the fundamental tensions at the heart of public health law. These include the tension between protecting individual rights and freedoms and promoting collective goods. Another is between achieving public health goals and achieving other social and economic objectives. Management of Covid-19 demonstrates this, with measures such as quarantine (which limits freedom of movement and other individual rights) being used extensively in the name of public health. Stay-at-home orders also limited the spread of Covid-19 but came at the expense of people’s ability to work, and at the expense of national economic functioning.

Some might think that public health lawyers would be unquestionably in favour of such measures. But a key part of the discipline is testing when the use of government powers is justified, legitimate, and proportionate to the objectives governments are trying to achieve, and holding governments accountable for the misuse (or failure to use), their public health powers. It is crucial to critique the use of extraordinary government powers, particularly if accompanied by the suspension of usual human rights protection measures, and media freedoms.

These kinds of tensions between individual rights and collective goods also play out in relation to legal measures to prevent non-communicable diseases (NCDs) such as cardiovascular disease, diabetes, and cancer, which are now the leading cause of preventable death and illness globally. Governments have introduced a range of legal measures that address the risk factors for these diseases: some examples include restrictions on tobacco marketing, taxes on sugary drinks, and minimum floor prices for alcoholic drinks. Laws on NCD risk factors – particularly diet – are sometimes presented as the new, ‘fringe’ dimension of public health law, but measures such as sugary drinks taxes have been used (effectively) by governments around in the world.

There is a perception that the law shouldn’t be used to address these kinds of issues because they lack the fundamental justification found in infectious disease control measures: NCDs are by their nature non-infectious, and the development of a chronic illness is one person doesn’t pose a risk of transmission to others. Yet we accept a degree of government paternalism in many areas of public risk and safety (think of laws requiring seatbelt use, for example). This argument also ignores the huge costs these diseases impose on societies, economies, and healthcare systems, and would remove one of the most effective tools for preventing NCDs from governments’ toolboxes.

The discipline of public health law also acknowledges the critical health impact of laws outside the field of public health. Modern public health understands the determinants of health and illness as a set of interacting causes that operate at the individual level (genes, biology, and health behaviours), and encompass the conditions in which people live and work, their access to resources such as housing, education, and income, and the broader structural, economic, and cultural dimensions of our societies. Law itself can be seen as one of these broad, ‘social determinants‘ of health.

Addressing the social determinants of health requires changes to a wide range of laws and policies, including those on employment, housing, and social welfare. So, for example, organisations such as ChangeLab Solutions (a US public health law non-profit) have developed guidance on how urban planning laws can be designed to promote healthy and equitable communities. Social welfare laws in Australia have been analysed for their impact on the diets of people in lower income groups.  As almost anything can be framed as a public health issue, so this brings to into question the legitimate scope of public health law, which can become the study of life, the universe, and everything.

As well as being interested in how law can address different illnesses and their causes, public health lawyers are concerned with the nature of ‘law’ and categorising the different powers available to governments to improve public health. In a foundational model, Lawrence Gostin describes these as the power to: tax and spend; alter the information environment; design and alter the physical environment; intervene in the economic system by addressing socio-economic disparities; directly regulate businesses, people, and professionals; and to deregulate when law and regulation is an impediment to public health. Clearly law is not just a prohibition on a particular form of activity or behaviour but is a mechanism to shape social norms, economic markets, and physical and informational environments.

The discipline of public health law understands that often there is not just one law operating in isolation, but that attention needs to be paid to supporting regulations and codes of practice (or in the case of international treaties, documents such as interpretive comments), as well as any case law interpreting statutory provisions. In some areas, the main source of law may be case law (or statute law), depending on jurisdiction. Understanding the interactions different legislative and regulatory instruments, and between legislation and case law, is a key skill that lawyers bring to the field of public health.

Lawyers also bring to the study of public health an understanding of the fundamental principles of the legal system (which obviously differ according to jurisdiction), including the division of powers between federal, state, and local governments, and how the powers and functions of each level of government are determined by legislative and constitutional frameworks. For example, the issue of pre-emption is critical in the US, where there is growing concern about state governments enacting new laws to limit the ability of public health officials and local government to introduce Covid-19 control measures.

Forms of regulation or governance developed by non-government actors are also increasingly important to public health, particularly in addressing obesity and diet-related health, which has seen the rise of industry self-regulation and collaborative partnerships with ‘Big Food’ in areas such as regulating junk food marketing to children. Public health law draws attention to the wide range of ‘soft’, collaborative, or voluntary forms of regulation developed by, or involving, businesses, trade industry bodies and NGOs. Some of these forms of ‘private regulation’ are just as complex and detailed as laws developed by governments. Public health law researchers pay close attention to the terms and conditions, implementation, and enforcement of these initiatives, as these are key factors which ultimately determine their impact on public health outcomes.

Lawyers have other specialised skills that we apply in public health law research. These include an understanding of the conventions and rules that should be followed in interpreting a legal document, and the ability to systematically identify, synthesize and analyse case law and legislation. This forms one important component of public health law research: ‘policy surveillance’, which can be used to create large databases of legal instruments that are a powerful tool for analysing law’s effect on health. Lawyers can also draft legislation and other legal documents relevant to public health.

But public health law research goes far beyond doctrinal analysis. As with other areas of legal research, it draws on a wide range of qualitative and quantitative methodologies, including health impact assessments, surveys, interviews and focus groups. It also uses theories from a variety of disciplines including epidemiology, law, sociology, political science, and psychology.

Public health law research is not simply the study of ‘law in books,’ though. Researchers analyse the implementation of laws, their enforcement, their impact on features of the physical environment relevant to health (think smoke-free laws), on people’s health-related behaviours, and on broader population health and equity outcomes. Researchers are interested in, for example, how laws on wearing seat belts or bicycle helmets are disproportionately enforced against homeless people or People of Colour. Consider too the argument that Covid-19 stay-at-home orders were used disproportionately against lower-income, diverse suburbs in Western Sydney, as compared to higher-income, majority white populations in Sydney’s Eastern suburbs. Finally, public health law research is concerned with the unintended health impacts of laws that are not targeting health, as with the effect of laws criminalizing drug use on illicit drug users’ risk of contracting HIV.

Since the outbreak of Covid-19, there has been commentary, discussion, and analysis of public health law from people with a range of different professional backgrounds. That’s great: these laws should be poked and prodded from different angles. But don’t forget: there’s an entire discipline of legal researchers who have spent their careers investigating the role of law in creating the conditions for people to live healthy, fulfilling lives.

The courts’ role in treatment for childhood gender dysphoria: recent updates

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In 2020 and 2021, there were significant developments in the courts’ role in treatment for childhood gender dysphoria.  The UK case of Bell v Tavistock is well known, but Re Imogen is of more practical importance here in Australia. Both cases illustrate the changing role of the courts in treatment for childhood gender dysphoria, following developments in our understanding of gender dysphoria and its treatment. They also engage key principles coming out of Gillick v West Norfolk and Wisbech Area Health Authority, where, in a legal turning point, the House of Lords held that a minor can consent to their own treatment when they achieve “a sufficient understanding and intelligence to enable him or her to understand fully what is proposed.”

When a child is not “Gillick competent”, generally speaking, their parents can consent to treatment on their behalf. The Australian courts have created an exception, however, for forms of “special medical treatment” that must be authorised by the courts.

The Family Court has previously held that both “stage one” (puberty blockers) and “stage two” (cross-sex hormones) of (medical) treatment for childhood gender dysphoria were forms of special treatment that required court authorisation. But it has gradually relaxed this stance, deciding in 2013 (in Re Jamie) that stage one could be consented to parents, and in 2017 (in Re Kelvin) that court authorisation was no longer required for stage two. However, court authorisation was still required where there was a dispute or genuine controversy about whether the treatment should be administered.

Re Imogen concerned this last point coming out of Re Kelvin. Key to the case was that Imogen’s parents disagreed on whether she should receive treatment, with her mother disputing Imogen’s diagnosis of gender dysphoria, as well as her competency. Justice Watts in the Family Court held that if a parent or medical practitioner dispute (i) the competence of an adolescent; (ii) a diagnosis of gender dysphoria or (iii) the proposed treatment, an application to the Family Court is mandatory.

A controversial point is that Justice Watts held that even if the child was competent to consent to treatment themselves, if there is a dispute about diagnosis or treatment, the court must still decide the diagnosis and whether treatment is in the young person’s best interests.

Justice Watts also held that under existing Australian law, a medical practitioner treating a minor was unable to commence any stage of treatment without first obtaining the consent of both parents to treatment, and if there was any dispute, court authorisation was required. To the extent that guidelines on the Australian Standard for treatment stated that parental consent was not required in relation to a competent minor (although it was desirable), they were incorrect.

Academics Stephanie Jowett and Fiona Kelly criticise Re Imogen both for its practical implications for healthcare professionals and transgender young people and their families, and on the basis of legal principle.

Assuming an adult is competent, they are free to make whatever healthcare decision they choose (within the scope of healthcare options that are available to them – clinicians are not obliged to provide futile treatment), even if it is harmful to their health or could lead to their death. But Jowett and Kelly point out that the courts are reluctant to leave Gillick competent minors to make healthcare decisions for themselves, where that decision could have significant implications for their health.

Re Imogen illustrates this point in relation to treatment for childhood gender dysphoria: if a young person is Gillick competent, why does the court then have to decide on their diagnosis or treatment if there is a dispute between their parents on these issues? If the young person has achieved competency, why can’t they make the decision themselves?

There may be good reasons to accept some degree of court oversight and paternalism in relation to competent minors, but the circumstances in which court intervention is required (and whether alternative dispute resolution processes could be made available) should be considered carefully.  

Re Imogen requires healthcare professionals to seek consent from both parents prior to treatment, and Jowett and Kelly point out that this means an unsupportive parent could trigger court intervention by challenging the diagnosis, the proposed treatment, or both. This is the case even if a parent is absent from their child’s life or has a problematic relationship with the child. The judgment also places a significant administrative burden on healthcare professionals to obtain the consent of both parents prior to treatment, or (where consent cannot be obtained) to support transgender young people to obtain court authorization through lengthy and expensive court proceedings. This could result in significant (perhaps prohibitive) costs to families, as well as delays in treatment during a critical window for intervention.

The UK High Court’s 2020 decision in Bell v Tavistock represented an increase in court intervention in treatment for childhood gender dysphoria, but the decision has since been overturned by the UK Court of Appeal.

Two claimants sought a declaration that the UK Gender Identity Development Service had acted unlawfully in prescribing puberty blockers to children under the age of 18. The UK High Court did not find the practice unlawful but made a declaration that a child would have to understand the implications of both stage one and stage two treatment to achieve Gillick competence.

The Court also provided guidance that it was “highly unlikely” that a child aged under 13 could be competent to their own treatment, and “very doubtful” that children aged 14 or 15 could be competent. It may be appropriate for court authorisation to be sought for children aged 16-17, although a statutory presumption of competency takes effect at 16 in the UK. This guidance was understood by clinicians as requiring court authorisation for treatment of any child for gender dysphoria.

The Court made findings about the nature of treatment for childhood gender dysphoria that were fundamental to its guidance on whether minors could be competent to consent. The court characterised treatment as perhaps “unique” and “experimental” due to uncertainty over its short- and long-term impacts. It also has life-long and life changing consequences, going to the heart of individual identity.

The Court rejected the idea of stage 1 treatment as a neutral “pause” that gave children time to mature and consider their options (some Australian commentators have expressed a similar opinion), and that stage 1 and 2 of treatment were entirely separate. Instead, it conceptualised the two stages as one clinical pathway, and so to achieve competence, a child would need to understand not just the implications of taking puberty blockers, but also those of progressing to cross-sex hormones, including that: the majority of patients taking puberty blockers go on to take cross-sex hormones; cross-sex hormones may lead to a loss of fertility; and may negatively impact on sexual function. There would be obvious difficulties for younger children in understanding these kinds of ideas, and therefore no age-appropriate way of explaining them.

Following the judgment, the Court’s characterisation of treatment was disputed by professional bodies involved in treating transgender young people in the UK. Bell v Tavistock was not binding on Australian healthcare professionals, but it appears that some Australian service providers reconsidered their approach to obtaining consent to treatment for childhood gender dysphoria following this decision, in conjunction with Re Imogen. The idea of stage 1 and 2 of treatment as inexorably linked also appears contrary to the approach of the Australian Family Court, which has tended to treat the two stages as distinct since Re Jamie.

Bell v Tavistock was appealed in 2021, and the UK Court of Appeal held that (among other things) the factual findings made on the nature of treatment were not open to the High Court to make (based on the nature of the Court’s jurisdiction when undertaking judicial review), and that the declaration made by the Court was contrary to Gillick.

This was because the High Court’s declaration provided a list of factual circumstances that had to be evaluated in determining whether a child was competent to consent to medical treatment (related to whether the child could understand the implications of stage two treatment). This would essentially mean that healthcare professionals would be substituting the judgment of the court for their own clinical judgment when determining a child’s competency. Yet, said the Court of Appeal, the ratio of Gillick was “that it was for doctors and not judges to decide on the capacity of a person under 16 to consent to medical treatment.” [76]

The UK Court of Appeal also held that the High Court should not have issued guidance on the age at which children could consent to treatment, as it was not able to generalize about children’s competency to consent at different ages. Further, the guidance required court applications in circumstances where the High Court itself recognised there was no legal requirement to do so. The Court of Appeal recognised that this would have the effect of denying treatment for young people who lacked the resources to make such an application, and that the requirement for court authorisation where the child, parents, and clinicians all agreed on treatment would be inconsistent with previous UK authority.

The most recent decision in Bell v Tavistock will come as a relief for transgender young people, their families, and clinicians, as it removes the requirement for (expensive and time consuming) court intervention when all parties involved agree on treatment. Some role for the courts in disputes over the treatment of competent minors may be justified. However, continuing changes in the law on treatment for childhood gender dysphoria can only create stress and uncertainty for transgender young people, their families, and the clinicians treating them.

The Covidsafe app: speed at the expense of transparency and accountability

Photo: Markus Winkler via Unsplash

Australia’s COVIDSafe app was launched by the Australian Government in April 2020. The app uses Bluetooth technology to record “contact events” or “digital handshakes” between app users, which are stored on users’ phones for 21 days. Contact events include the encrypted ID of the other contact user, the Bluetooth signal strength during the event, and its duration and time (but not location data). If a user tests positive, this information is uploaded to the National COVIDSafe Data Store (a cloud-based data repository supported by Amazon Web Services and administered by the Digital Transformation Agency), where it can be decrypted for use by state contact tracers.

The app has been hampered by concerns about its security, privacy, and effectiveness. Amendments to the federal Privacy Act (1987) created a legislative framework for protecting the privacy of app data and preventing ‘function creep’, i.e., the risk of data being used for purposes other than contact tracing, such as law enforcement. This framework follows the same format as other privacy laws in Australia (such as legislation that applies to the MyHealth Record System), setting out a series of permitted uses, collections, and disclosures of app data related to contact tracing and maintaining the data store and the app. All other collections, uses, or discloses are prohibited, as is uploading app data from a user’s device to the data store without their consent, retaining or disclosing data to someone outside Australia (unless for contact tracing purposes), and decrypting app data on a user’s device.

Crucially, the legislation protects voluntary use, for example, by making it an offence to require someone to download or use the app, or to refuse to provide them with goods or services because they’re not using it. The legislation also creates a mechanism for dismantling the system when it is no longer needed, and for deleting the information contained in the data store.

The basic legislative privacy protections on the app are sound, although commentators have identified some ways in which they could be strengthened, for example, by providing for the periodic removal of contact event data from the data store.

Where the system really falls down is in the design and operation of the app itself. This invokes the concept of privacy by design, i.e., building privacy protections into the physical design, architecture, and computer code of the device or system concerned. Privacy in the digital realm can be protected through multiple channels, including contractual mechanisms, legislation, and design-based solutions. The physical design of the system or device is at least as important – if not more so – than any legal frameworks that apply. This is often referred to as “code” or “architecture”-based regulation, and it’s interesting to consider whether or how the privacy and transparency concerns raised below could also be addressed through legislation.

Privacy advocates and tech experts have extensively canvassed the security and privacy flaws in the app, as well as technical problems that prevent it from operating effectively. This report, by a group of software developer and cybersecurity experts, provides a comprehensive and readable summary. Some of the early bugs included “phone model and name being constantly exposed and unique identifiers being available to track over time… undetectable, permanent long-term tracking of iOS and Android devices and attackers being able to control devices remotely” (p.7). The authors point out that many of the app’s technical challenges stem from the use of Bluetooth for a function it wasn’t originally intended for, i.e., continually and indefinitely scanning the environment for other devices, and then making connections with them.  

They also say that some of the technical issues with the app resulted from a lack of consultation with tech experts (and the wider community) during its development, as well as a lack of testing and verification.

Also concerning has been the DTA’s slow response to concerns raised by the tech community once the app was launched, as well as limited transparency in the scheme’s operation. This includes the DTA’s failure to release the number of active users, and the Government’s reluctance to release the full version of an independent report on the app’s operation, which found that the app imposed significant time costs on contact tracers for no little additional benefit. Some of this information was omitted in a shorter version of the report originally made publicly available.

The Government has taken steps to address some of the bugs in the app, including through the adoption of the “Herald” protocol in December 2020, although the authors of the report mentioned above say this protocol still has problems, and in fact reintroduced some issues that had been fixed previously. They call for the Government to adopt the Exposure Notification Framework developed by Apple and Google, which doesn’t create the same privacy and security challenges as the Covidsafe app.

There have also been developments in the responsiveness and transparency of the scheme. For example, the DTA has identified a contact point for security concerns, and in April 2020, it made publicly available the full source code for the app, which is hosted on a Github repository. But, according to researcher Emma Blomkamp, the early lack of community engagement was a missed opportunity to build public acceptability of the app or a ‘social licence to operate’ (particularly among Australia’s diverse communities) and to inform the public about the app’s operation and the privacy protections that would apply.

Trust in government is crucial to an effective response to the COVID-19 pandemic. By now, we all know that governments possess highly coercive powers for responding to public health emergencies. But to a significant extent, governments must rely on people voluntarily doing the right thing, including downloading the Covidsafe app and sharing their personal information with contact tracers. That’s much more likely to happen when people trust the government, and that trust is much more likely when there’s a transparent and accountable system in place, combined with rigorous privacy protections, both “code” and law based.

This is an area where a fast rollout shouldn’t have come at the expense of a responsive, transparent, or accountable one.


Big Alcohol and COVID-19: industry rules fail. Again.

By Hannah Pierce, Kathryn Backholer, Sarah Jackson and Florentine Martino

Reposted from MJA Insights: https://insightplus.mja.com.au/2021/11/big-alcohol-and-covid-19-failing-self-regulation-again/

Image by Vova Drozdey (Unsplash)

WE know some people are more likely to drink – and drink more – during times of uncertainty and stress. Unsurprisingly, the alcohol industry is also aware of this.

The COVID-19 pandemic has illustrated how quickly and creatively the alcohol industry will adapt its marketing practices to appeal to people’s vulnerabilities. And in Australia, there are few rules in place to stop these predatory actions. This is despite the link between risky alcohol use and weakening of the body’s immune response to COVID-19; not to mention the long-established impacts that risky alcohol use has on the physical and mental health of individuals, families and communities.

Two studies released recently show just how deceptive the alcohol industry has been during the COVID-19 pandemic and why current industry marketing codes fall far short of protecting public health.

The extent and nature of COVID-19-washing through social media marketing

In a recent study led by the Global Obesity Centre at Deakin University and VicHealth, all COVID-19-related social media posts made by leading alcohol brands and delivery services on their official public accounts were audited over a 4-month period during the COVID-19 pandemic in Australia (February to May 2020). The study found that COVID-19-related marketing on Facebook, Instagram, YouTube and Twitter was highly prolific. Of the 26 alcohol brands and services audited, more than 400 social media posts were identified with up to a million plus “likes” or “shares” for a single post.

Sentiments of “community support” and “coping with stress” were most commonly used as a lure. For example, one brewery posted: “Connect with your mates online and we’ll get through this together, with a [beer brand] in hand”. One alcohol retailer promoted “wine” down time and another encouraged “knock off” drinks from home and “conference calls with colleagues to give you a sense of Knock Off Normality”.

Isolation activities involving consumption of alcohol were also heavily advertised. For example, one alcohol retailer posted videos with cocktail recipes, calling for #virtualhappyhour; organised online trivia nights using Facebook Events “with $300 in [retailer’s] eGift Cards (to help fund your next trivia night)”; gave away boxes of wine (valued at $100) in a competition where “community heroes” could be nominated; and organised virtual whisky tastings in collaboration with a popular brand of scotch.

Citing corporate social responsibility, donations of money and the production and donation of hand sanitisers were also common. By building goodwill, increasing company reputation, and thus insulating themselves from criticism, the alcohol industry may be creating an environment where further regulation of alcohol can be resisted, or worse, existing regulation may be weakened.

In our opinion it is clear that Big Alcohol is using the pandemic as an opportunity to sell more alcohol. But the question is whether there is a system in place that prevents companies from targeting vulnerable communities with harmful alcohol marketing.

Current controls on alcohol marketing in Australia

There are very few controls on alcohol marketing in Australia. Most alcohol marketing is covered only by the alcohol industry’s own rules in the Alcohol Beverages Advertising Code (ABAC) Scheme. This voluntary scheme is developed, managed and funded by the very same companies that spend millions of dollars every year promoting their alcohol products. A substantial body of research has examined the effectiveness of this system over the past 20 years and consistently concluded that the ABAC Scheme does not effectively protect children and young people from exposure to alcohol marketing.

Having observed the industry tactics during the early months of the COVID-19 pandemic, Cancer Council WA and Cancer Council Victoria saw an opportunity to examine whether the current ABAC Scheme was expansive or comprehensive enough to deter harmful promotion of alcohol during this time. To do this, 18 determination reports considering community complaints and other publicly available documents on the ABAC Scheme website that referred to COVID-19-related alcohol marketing were reviewed against a framework for evaluating the effectiveness of industry-based regulation. The report Giving the ok to “Stay In. Drink Up” outlines the result, highlighting five problems with relying on the ABAC Scheme during the pandemic:

  • the objective of the ABAC Scheme is inadequate and unsuitable, resulting in a system that fails to protect the community, and particularly those who are vulnerable, from harmful alcohol advertising;
  • key terms in the ABAC Code are not clearly defined, leading to the dismissal of complaints about promotions that encouraged drinking in the home during lockdown;
  • the ABAC Code provisions are too narrow to capture all the themes alcohol marketers are using during the COVID-19 pandemic;
  • there is no monitoring system, so it’s not possible to know how often alcohol companies are ignoring the rules — harmful promotions stay in market unless a community member goes out of their way to make a complaint that is then upheld; and
  • there are no meaningful penalties for advertisers who breach the ABAC Scheme, providing very little incentive for alcohol companies to avoid using harmful messages during the pandemic.

When assessing the complaints about alcohol ads that referenced the pandemic, the ABAC Panel appeared to give no consideration to the impact the pandemic was having on the Australian community. For example, one Facebook ad promoted a “14-day isolation pack”, which included nine bottles of wine to “help you through” 14 days of isolation. In the determination report, there was no mention of the significant amounts of stress and anxiety that many individuals and families in the Australian community were experiencing due to the pandemic. Instead, the ABAC Panel decided that promoting alcohol via an “isolation deal” was the same as referencing a “Christmas pack”. They believed that the post would not be understood as encouraging people to drink all nine bottles of wine in 14 days and so the complaint was dismissed. Similarly, alcohol ads including the phrases “Stay In. Drink Up”“survival kits”, and “all day every day” were all deemed acceptable.

In our opinion the ABAC Scheme has been inadequate at preventing harmful alcohol marketing during the pandemic. Previous research has focused on the ABAC Scheme’s ability to prevent the exposure of children and young people to alcohol marketing. This is because we know the more children are exposed to alcohol advertising, the more likely they are to start drinking earlier and more heavily. An effective regulatory system is crucial for protecting children from exposure to alcohol marketing.

In our opinion, the COVID-19 pandemic has left many more Australians vulnerable to influential marketing messages from the alcohol industry. The well recognised deficiencies of the ABAC Scheme have allowed the alcohol industry to bombard the community with harmful alcohol marketing at a time when they are most vulnerable.

The need for government regulation to protect Australians from harmful marketing practices

The management of the COVID-19 pandemic in Australia is an excellent example of the positive health outcomes we can achieve when decision makers listen to public health advice and implement evidence-based policies. These new publications mentioned above highlight once again that alcohol companies cannot be trusted to write the rules on alcohol advertising, and demonstrate the urgent need for the Australian Government to introduce legislation to protect the community from harmful marketing practices. It is time for the government to step up, listen to the public health evidence and advice, and put people before profits.

Hannah Pierce is an Alcohol Policy and Research Coordinator with the Alcohol Programs Team at Cancer Council Western Australia. Twitter: @hannahpierce01

Kathryn Backholer is a National Heart Foundation Future Leader Research Fellow and Associate Director of the Global Obesity Centre at Deakin University. Twitter: @KBackholer

Sarah Jackson is Senior Legal Policy Adviser at Cancer Council Victoria and leads policy for Alcohol Change Vic, a coalition of  organisations that campaigns for policy reform to prevent alcohol harm in Victoria.. Twitter: @SarsJackson

Florentine Martino is a Postdoctoral Research Fellow at The Global Obesity Centre (GLOBE) at Deakin University in Geelong. Twitter: @fp_martino

COVID-19, patients’ mental capacity and prisoners

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The coronavirus pandemic has raised an abundance of issues at the intersection of law and medicine. In recent co-authored articles, Cameron Stewart, Professor of Health, Law and Ethics at the University of Sydney Law School considers some of these issues.

Mental capacity assessments for COVID-19 patients: Emergency admissions and the CARD approach

In this Journal of Bioethical Inquiry articleProfessor Cameron Stewart and colleagues examine the principles of mental capacity and make recommendations on how to assess the capacity of COVID-19 patients to consent to emergency medical treatment.

“The combination of very sick patients, knowledge deficits, and high pressure environments is likely to make capacity assessment very difficult during the COVID-19 pandemic.”

The article provides examples of mental capacity disputes in a number of common law jurisdictions before recommending that in emergency admissions for COVID-19, health practitioners use what Professor Stewart and his co-authors term the “CARD” approach (Comprehend, Appreciate, Reason, and Decide).

“CARD gives clinicians a legally defensible means of rapidly determining the mental capacity of COVID-19 patients, essential to guide urgent treatment and ensure that patients’ best interests are ultimately served in the process.”

COVID-19, Australian prisons: Human rights, risks and responses

Australian prisons have, so far, avoided the levels of COVID-19 infection experienced in the United States and elsewhere, but the potential for high infection rates remains.

In a November 2020 article in the Journal of Bioethical InquiryProfessor Cameron Stewart and colleagues consider what steps the state should take to protect prisoners. The article looks at Australian prisons’ regulatory responses to COVID-19 and considers calls for the release (decarceration) of some prisoners, including the Victorian case of Rowson v Department of Justice and Community Safety [2020] VSC 236. In that case, a prisoner unsuccessfully sought release pending departmental consideration of his application for release into home detention on health grounds — namely, risk of serious injury or death from COVID-19.

Professor Stewart and his co-authors conclude:

“Ultimately, COVID-19 presents an opportunity to reconsider the deeper issues regarding use of incarceration as a punishment and the human rights of prisoners more generally.”

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/2020/11/04/covid-19-medical-research-governance-and-public-health-orders/

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/

https://link.springer.com/article/10.1007/s11673-020-10055-2

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

Four things to think about before starting a PhD

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Everyone’s thoughts are turning towards 2022, and hopefully, how much better it’ll be than the cluster truck that was 2021. For you, thinking about 2022 could mean considering whether or not to start postgraduate studies, and more specifically, a PhD. This is a big call. A life-changing event, in fact. This blogpost covers four things to think about before starting a PhD, divided into when, where, what, and with whom.

  1. When should I start my PhD? Is now a good time? Is it too late for me to start one?

Obviously, there’s no right answer to this question: so much depends on your personal circumstances and what’s right for you. Many people go straight from undergraduate into postgraduate study. Many other people come back to postgraduate study after they’ve had a long career elsewhere and use their PhD essentially as a retraining exercise (so no, it’s not too late to start one now). Some people do a PhD full-time, while others combine it with paid work, childcare, or other commitments.

Before beginning your PhD, think carefully about your rationale for doing one. You’ll need this big-picture goal to sustain you when you’re stuck in the day-to-day tedium of research, and when you’re living off a meagre scholarship rather than a proper wage. It’s almost compulsory to have a PhD for a career in academia, and (as I understand it) for many other research positions in the sciences. Certainly, you could do one just for fun in your backyard shed (like my friend’s Dad) but consider whether you’ve got the staying power to do a 3-4 year research project simply for the joy of it.

2. Where should I do my PhD?

For many people, the answer to this question is driven by convenience: where your family’s located, where your partner’s job is, or where your children are going to school. But if you’re completely free to choose, then you’ll be considering things like where your ideal supervisor’s located (more on this below), or which universities specialise in your field of interest.

Consider, too, what you want to do after you finish your PhD: if you want to work in a law school, it makes sense to do your PhD in a law school. If you want to work in the US, your PhD could be an entrée into the US academic sector. If you want to work at a particular university (or calibre of university), it might be worth doing your PhD at that university. Keep in mind, however, that some universities can be reluctant to hire former students (at least not without a stint elsewhere first).

When considering a particular university, make sure you understand their requirements for undertaking a PhD, and try to find out how they treat their students. What processes are in place for confirmation of your candidature and for annual review? Will you need to do coursework? Are PhD students considered members of faculty (and invited to seminars, for example), or are they treated like ghosts in the machine? Is there financial support available for PhD students and what form does it take? Will you have access to a shared office or a hot desk? What are the likely opportunities for paid research and teaching work during your candidature?

3. …on what?

Before starting a PhD, your topic may look like: “Globalisation… and something.” It’s OK to only have a rough idea of what your topic looks like before you start. Knowing what specialty or topic area you want to work on is helpful, because that’s how you identify potential supervisors. But you may find that your prospective supervisor helps you refine your topic, or has a topic in mind already (or there’s a scholarship available for a project on a particular topic). It’ll change over the course of your PhD anyway: I looked at my thesis proposal the other day and it’s extremely general compared to the more specific topic I ended up doing my PhD on.

You can be pragmatic in how you identify your topic. My PhD focused on regulation of junk food marketing to kids. I chose this topic because it combines my interests in public health, law, and regulation, rather than because of any deep connection with food advertising regulation. Your PhD topic doesn’t need to be your life’s passion, but it does need to be something that can sustain your interest over three or more years.

4. With whom?

Having a good supervisor is one of the most important contributors to successful PhD completion.  I think it’s even more important than topic choice. Obviously, you’ll be looking for the person that’s an expert in your topic area. But apart from that, you also want someone who’s reliable, offers constructive feedback on your research, supports you in advancing your career, and values the relationships they have with their PhD students.

In specialised areas, there may really only be one choice of person. But it’s still worth doing some due diligence on potential supervisors. If you can, talk to their current or former PhD students and ask them about their experiences. Having at least a couple of meetings with a prospective supervisor will also help you to decide whether they’re someone you can have a good working relationship with.

While your primary supervisor will have a significant influence on your candidature, they’re not the B-all and end all. Students can appoint one or more auxiliary or secondary supervisors, offering the opportunity to appoint someone at a different university or with different expertise. You can also reach out to other academics during your candidature for input or advice on particular aspects of your research.

As you begin the journey

Starting a PhD is a bit like having a baby. Everyone’s going to tell you how hard it is, and how you just won’t understand until you’ve done it. It’s great that we discuss the emotional complexity and challenges involved in big life events. But everyone’s experience of their PhD is different. For me, certainly, there were times of immense stress (realising I’d put the page numbers in the wrong place just before printing the final version), as well as periods of tedium and repetition (hello, doing all of my own interview transcription to save money). But there were also many moments of enjoyment and personal satisfaction, and all of those experiences contributed to where I am today.

My best of luck to you as you start out on your PhD journey.

If you’ve done a PhD, feel free to add advice or links in the comments section!