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

July 13, 2022 Belinda Reeve Global Health, Healthcare Law Covid-19, patents and intellectual property, TRIPS

Dr Olugbenga Olatunji, Lecturer, The University of Sydney

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

July 4, 2022 Belinda Reeve Food, Health Policy, Public Health Law Food governance, food policy, Indigenous food sovereignty

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 policymaking 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

June 23, 2022 Belinda Reeve Health Policy, Public Health Law ABAC Scheme, advertising self-regulation, alcohol

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

Another step forward for the Pacific Legislative Framework

April 20, 2022 rogermagnusson Uncategorized Global Health, health development, Non-communicable diseases (NCDs), Pacific Community (SPC), Pacific island countries and territories (PICTs), prevention, public health law, World Health Organisation;

Pacific Island Countries and Territories have some of the world’s highest rates of obesity, diabetes, smoking and other risk factors for non-communicable diseases (NCDs).

In response, Public Health Division of the Pacific Community (SPC) has been driving an initiative to develop policies and legislative provisions for tackling the key risk factors, particularly tobacco use, harmful alcohol use, and dietary risks.

The result is the “Pacific Legislative Framework”.

Meeting on 22 March this year, Pacific Health Ministers endorsed the Pacific Legislative Framework, adding to its momentum as a public health tool and agent for change.

This remarkable document, now available in English and French, consists of three parts.

The framework begins by setting out policy for addressing a surprisingly wide range of risk factors, including core areas of tobacco control, core areas of liquor control, health promotion, protection for breastfeeding, regulation of marketing of unhealthy foods and drinks to children, reducing consumption of salt, sugar and trans-fat in the diet, and tax measures for tobacco, alcohol and unhealthy food/sugar-sweetened drinks.

The “policy” element includes overall policy objectives and recommendations for each area, as well as priority areas for reform and a brief legislative plan.

The appendices to the Framework consist of draft legislative provisions covering each of the thematic areas/risk factors.

These provisions can be implemented as off-the-shelf legislation, or adapted by National Parliaments to national circumstances.

The Pacific Legislative Framework is an impressive effort – entirely driven by Pacific Island Countries and Territories themselves, in collaboration with the Pacific Community (SPC) and the WHO Western Pacific Regional Office.

The Framework is a logical extension in a chain of initiatives, driven by Pacific Island Countries and Territories, to address the burden of NCDs.

These include the foundational “healthy islands” vision embodied in the 1995 and 2005 Yanuca Declaration, together with the Pacific NCD Roadmap (2014), the Joint Forum Economic and Pacific Health Ministers’ Meeting (2014), the Pacific NCD Summit (2016), and the “Tobacco Free Pacific 2025” strategy.

In 2017, the Pacific Monitoring Alliance for NCD Action (Pacific MANA) was established. Pacific MANA has developed a dashboard-style accountability tool to report on progress with policies and laws to address NCDs in Pacific Island Countries and Territories.

You can see the baseline report for 2018 here.

The MANA dashboard now functions as an accountability tool for action on NCDs in the Pacific.

There is a long way to go, and gaps to be filled, including political commitment and actions to prevent conflicts of interest that undermine tobacco control policies in the Pacific. There is also an urgent need for Pacific Island Countries and Territories to grow their capacity for enforcing public health laws.

A short(ish) explainer on public health law

March 21, 2022 Belinda Reeve Public Health Law Covid-19, Non-communicable diseases (NCDs)

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.

Closing the Gap and health governance reform: a brief review

February 22, 2022 rogermagnusson Uncategorized Aboriginal and Torres Strait Islanders, Health governance, Health Policy

7566_National_Reconciliation_Week, Cadigal Green, Darlington Campus.

NSW Premier Dominic Perrottet has confirmed that the Aboriginal flag will fly permanently atop the Sydney Harbour Bridge “as soon as possible“.

As important as this symbolism is, arguably more important is the Premier’s announcement that he will be taking an all-of-government approach to the national “Closing the Gap” targets, by committing his entire cabinet to “close the gap in their respective portfolios under a new section of their ministerial charter“.

The National Agreement on Closing the Gap is an ambitious all-of-government framework for improving the health and welfare of Australia’s first nations peoples.

This post briefly reviews the Agreement and considers its significance as an example of health governance reform.

Health and “governance reform”

A great deal of public health law is outward looking: it regulates the “world out there”, whether it be harmful products, the businesses that sell them, occupiers, premises, professionals, or the population generally. Equally important, however, are the actions taken by governments to structure their own functions and activities effectively.

Sometimes this takes statutory form, such as legislation to establish a National Children’s Commissioner, or the legislation that established Australia’s “zombie” health agency, the National Preventive Health Agency (the legislation remains in force, but in 2014 the agency was abolished and its functions absorbed back into the Commonwealth Health Department).

At other times, health governance initiatives may consist of new organisational structures, “frameworks”, and agreements – including inter-governmental agreements.

One of the most important inter-governmental agreements in Australia today, on any measure, is the National Agreement on Closing the Gap.

This is an agreement between the Council of Australian Governments or COAG (comprising the Commonwealth, States, Territories and the Australian Local Government Association) and the Coalition of Aboriginal and Torres Strait Islander Peak Organisations (“Coalition of Peaks”).

The “Coalition of Peaks” convenes over 50 community-controlled Aboriginal and Torres Strait Islander peak and member organisations in every state and territory.

While not intended to be legally enforceable, the Closing the Gap Agreement is our best hope yet of addressing the appalling disparities that persist between the health and socio-economic circumstances of indigenous and non-indigenous Australians.

COAG no more

The National Agreement on Closing the Gap was made between the Council of Australian Governments (COAG) and the Coalition of Peaks.

However, on 29 May 2020, COAG was replaced by the National Cabinet, a new inter-governmental forum that now excludes local government: see here, here and here.

[National Cabinet has also established National Cabinet Reform Committees in five areas, although at the time of writing there is little publicly available information. These committees include the Health Ministers’ Meeting Forum (formerly the Health Council), which is supported by the Health Chief Executives Forum, formerly the Australian Health Ministers Advisory Council (AHMAC).]

In addition to the National Cabinet, another inter-governmental structure is the National Federation Reform Council. Meeting annually, the Council convenes the Prime Minister, Premiers and Chief Ministers, Treasures and the Australian Local Government Association: see here and here. See these links for summaries of 2020 and 2021 meetings.

The National Federation Reform Council has established several NFRC Taskforces to address inter-governmental priority areas falling outside the job creation focus of National Cabinet, including the Women’s Safety Taskforce, and the Indigenous Affairs Taskforce.

Closing the Gap

Back to the Closing the GAP Agreement. The Agreement took effect on 27 July 2020. It built on an earlier Partnership Agreement on Closing the Gap, which recognised that the key to accelerating improvements in health and livelihoods of Aboriginal and Torres Strait Islanders lies in “shared decision making with Aboriginal and Torres Strait Islander community controlled representatives in the design, implementation and monitoring” [of the National Agreement].

As expressed in the Preamble to the National Agreement on Closing the Gap:

6 This Agreement also stems from the belief that when Aboriginal and Torres Strait Islander people have a genuine say in the design and delivery of services that affect them, better life outcomes are achieved. It recognises that structural change in the way Governments work with Aboriginal and Torres Strait Islander people is needed to close the gap.
7 In response, all Australian Governments are now sharing decision-making with Aboriginal and Torres Strait Islander people represented by their community-controlled peak organisations on Closing the Gap, the Coalition of Aboriginal and Torres Strait Islander Peak Organisations (Coalition of Peaks). This is an unprecedented shift in the way governments work, by encompassing shared decision-making on the design, implementation, monitoring and evaluation of policies and programs to improve life outcomes for Aboriginal and Torres Strait Islander people.

In addition to embedding formal partnerships and shared decision-making, the National Agreement on Closing the Gap set out a number of additional priority reforms (see para 6):

to strengthen the Aboriginal and Torres Strait Islander community-controlled sector to deliver services to support closing the gap;
to transform mainstream government organisations “to improve accountability and respond to the needs of Aboriginal and Torres Strait Islander people”; and
to improve access to data for the purposes of monitoring progress in closing the gap.

The Agreement sets out targets for the priority reforms mentioned above, as well as socio-economic outcomes and targets; the latter are discussed further below.

Parties to the Closing the Gap Agreement committed to agreeing to “partnership actions” throughout the life of the Agreement, which would be implemented by all Parties in order to ensure “joined up national action on the Priority Reforms“.

The Agreement provided for the development of implementation plans by the Commonwealth, States and Territories, Australian Local Government Association, and Coalition of Peaks. Jurisdictional Implementation Plans must be “whole-of-government plans, covering government agencies and statutory bodies“, developed and implemented in partnership with other governments, the Coalition of Peaks, and other Aboriginal and Torres Strait Islander partners.

See here for the current NSW Implementation Plan.

The Commonwealth Implementation Plan can be found on the website of the National Indigenous Australians Agency, a Commonwealth agency established in 2019 to lead the development and implementation of Commonwealth government policies and programs on indigenous affairs.

Public accountability: The National Agreement on Closing the Gap called for annual, public reports by each Party, with progress monitored by the Joint Council (see below), a comprehensive review of progress every three years by the Productivity Commission (and a further Independent Aboriginal and Torres Strait Islander led review within 12 months of the Productivity Commission’s review).

Joint Council on Closing the Gap

The Partnership Agreement on Closing the Gap 2019-2029 announced the creation of a Joint Council on Closing the Gap.

Co-chaired by the Commonwealth Minister for Indigenous Australians (the Hon. Ken Wyatt AM MP), and the Lead Convenor of the Coalition of Peaks (Ms Pat Turner AM), the Joint Council embodies the promise of shared decision-making and accountability.

The Joint Council convenes one Minister with responsibility for Closing the Gap from the Commonwealth, States, Territories and one representative from the Local Government Association, together with twelve representatives from the Coalition of Peaks.

The Joint Council is responsible for “monitoring the implementation of the National Agreement on Closing the Gap, including progress by the Parties against their Implementation Agreements” (see also here).

National Federation Reform Council – Indigenous Affairs Taskforce

The Indigenous Affairs Taskforce formed under the new National Federation Reform Council (referred to above) does not displace the governance arrangements to which governments have committed under the Closing the Gap Agreement. The Taskforce convenes the Commonwealth, State and Territory ministers with responsibility for indigenous affairs. Meeting twice a year, and involving government members of the Joint Council on Closing the Gap, the Taskforce will consider issues referred to it by the Joint Council, and other policy issues requiring “in-depth focus, collaboration and agreement from the Federation“.

7618_Rural_Health_Orange_Dubbo. School of Rural Health, students, Medicine.

Closing the Gap Targets

The National Agreement on Closing the Gap is supported by outcome measures, and targets.

The targets provide an important accountability mechanism for measuring performance and if realised, will transform the lives and opportunities available to Aboriginal and Torres Strait Islander people. For example:

Target 1: Close the gap in life expectancy within a generation, by 2031.

The Australian Institute of Health and Welfare reports that for Aboriginal and Torres Strait Islander people born in 2015-17, life expectancy is 71.6 years for males and 75.6 years for females: that’s 8.6 years lower than for non-Indigenous Australian males (80.2 years), and 7.8 years lower than for non-Indigenous Australian females (83.4 years).

Other health-related and socio-economic targets relate to healthy birthweight (Target 2), early-childhood development (Target 4), completion of tertiary education (Target 6), and appropriately sized (not overcrowded) housing (Target 9).

There are targets for reducing the rate of Aboriginal and Torres Strait Islander young people in detention (Target 11), the rate of Aboriginal and Torres Strait Islander children in out-of-home care (child protection) (Target 12), and the rate of violence against Aboriginal and Torres Straight Islander women and children (Target 13). Target 14 calls for “significant and sustained reduction in suicide of Aboriginal and Torres Strait Islander people towards zero“.

These targets depend on and are supported by targets to strengthen Aboriginal and Torres Strait Islander cultures and languages, relationships with land and waters as well as “equal levels of digital inclusion”.

The Closing the Gap framework, described above, illustrates institutional structures and arrangements for working across all levels of government, across ministries and sectors (all-of-government), and in particular with Aboriginal and Torres Strait Islander peoples and organisations, through the Coalition of Peaks.

State institutional reforms

Understood against the background of the inter-governmental governance arrangements that make up the Closing the Gap framework, the decision by NSW Premier Dominic Perrottet to embed Closing the Gap actions across his entire cabinet makes perfect sense.

But it’s worth keeping an eye out for further institutional changes, such as the appointment of Aboriginal and Torres Strait Islander Children’s Commissioners, to complement the Children’s Commissioners at State and Federal level.

Victoria appointed a Commissioner for Aboriginal Children and Young People in 2013, and South Australian in 2018 – see also here (Part 2A).

Together with the strengthening of community-controlled child protection and family support services, Aboriginal and Torres Strait Islander Children’s Commissioners could play an important role in reducing Target 12 of the Closing the Gap Agreement: to reduce by 45% the rate of over-representation of Aboriginal and Torres Strait Islander children in out-of-home care. See, further, here.

Prospects for the World Health Assembly’s pandemic instrument

January 20, 2022 rogermagnusson Uncategorized Contagious diseases, Covid-19, Global Health, health security, Infectious disease outbreaks, Infectious diseases, International Health Regulations, Public health emergencies, World Health Organisation;

The World Health Assembly (WHA) has established an intergovernmental negotiating body to “draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”.

The Assembly’s decision was made at the special session of the WHA (29 November – 1 December 2021), convened for the specific purpose of considering the benefits of such an instrument.

The proposed pandemic instrument will almost certainly materialise too late to mitigate the impact of the global Covid-19 pandemic.

There is plenty of irony in the fact that while the European Union has led the push for a legally binding pandemic convention (see here and here), the EU continues to resist the proposal for a waiver of intellectual property rights under the World Trade Organisation’s TRIPS convention – in order to accelerate access to Covid vaccines and other technologies.

(See the TRIPS and Covid-19 waiver proposal here, and the EU’s counter-proposal here).

What do we know so far about the proposed pandemic instrument?

The World Health Assembly has opted for a World Health Organisation instrument, rather than a treaty negotiated under the broader, United Nations system, such as the UN Framework Convention on Climate Change.

There has been some drift in the governance of global health issues away from WHO in recent years to the broader UN system. This is illustrated by the High-level meetings of the UN General Assembly on non-communicable diseases (2011, 2014, 2018, 2025), the health agenda embodied within the Sustainable Development Goals, and many other instruments, strategies and processes. Of course, as the specialised health agency of the UN, the WHO remains centrally involved in helping to coordinate the response to many global health challenges.

The point, however, is that a multi-sectoral, all-of-government response is crucial if governments want to effectively tackle many of the world’s leading health challenges, from tobacco control to pandemics.

The envisaged pandemic instrument, however, will be a WHO instrument, overseen by a body that convenes the world’s health ministers, rather than heads of state. Implementation will be everything.

What kind of instrument?

Under the WHO Constitution, the World Health Assembly has authority to adopt conventions (Article 19), adopt Regulations (Article 21), or make recommendations (Article 23).

For the moment, all of these options are on the table.

The negotiating body will meet by 1 March 2022 in order to elect two co-chairs and four vice-chairs, who are required to develop a process to “identify the substantive elements of the instrument” and to begin the development of a working draft.

This draft must then be presented to the intergovernmental negotiating body at its second meeting in August 2022 – by which time it is intended that the negotiating body will identify the constitutional basis for the new instrument: whether a convention, or regulations, or recommendations.

Timeline

The intergovernmental negotiating body has been given a three-and-a-half-year timeline. It must present the outcomes of its deliberations to the World Health Assembly in May 2024 (WHA77), with a progress report to the WHA in 2023 (WHA76).

Relationship with the International Health Regulations

Legally-binding international instruments are rare in global health. Non-binding normative instruments (so-called “soft law”), are far more common: see discussion here.

Two of the best known legally-binding agreements are the WHO Framework Convention on Tobacco Control, and the Protocol to Eliminate Illicit Trade in Tobacco Products.

Another binding instrument is the International Health Regulations (IHR) which (amongst many other things) impose obligations on WHO Member States to report and respond to events that constitute “public health emergencies of international concern”.

The IHR were revised and updated in 2003 following the SARS outbreak.

The limitations of the IHR, compliance problems, and lack of progress in implementation, have been investigated by many committees and expert bodies (see eg here, and here).

It’s safe to say that the failure of the IHR to effectively prevent and manage the Covid-19 pandemic, which has so far claimed nearly 5.6 million deaths, remains a driving force behind the WHA decision. What better illustration of the need for effective global governance of pandemics than Covid-19?

That doesn’t mean that any new pandemic instrument will replace or supplant the IHR. Far from it. The WHA decision calls for “coherence and complementarity” between the process of developing a new pandemic instrument and the work of the “Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies” (a group established at the World Health Assembly in May 2021) “particularly with regard to implementation and strengthening of the IHR” (see para 1(4) here).

Content of an international pandemic instrument

The Report of the Member States Working Group to the WHA special session in November 2021 includes a list of matters that might be included in a global instrument. They include:

global equity issues; for example, the problem of grossly inequitable access to vaccines
strengthened accountability for compliance with IHR obligations
“potential targeted amendments” to the IHR to enhance prevention, rapid risk assessment, detection and response
enhancing surge capacity in countries through strengthening health systems
sharing of pathogens, genetic information, biological samples and information
responding to misinformation and disinformation in national responses
elevating the political response to pandemic preparedness and response through an all-of-government approach

There is a growing literature that discusses the opportunities provided by this new instrument. See, eg here, here, and here.

Are you interested in studying health law? For more information on Sydney Law School’s Master of Health Law degree, including units of study addressing the legal response to pandemics, see here and here.

Vaccine mandates webinar

December 12, 2021 rogermagnusson Uncategorized Contagious diseases, Covid-19, Public health emergencies, Public health legislation

On 9 December, the Parsons Centre for Law & Business, together with Corrs Chambers Westgarth, convened a seminar entitled Vaccine mandates and public health orders: legal and ethical issues for business.

The seminar reviews the emergence of vaccine mandates in public health orders in NSW, and vaccine mandates imposed by businesses and other organisations from a public health law, employment law, tort law, and corporate governance perspective.

The webinar features academics from Sydney Law School and Corrs. The video can be accessed here.

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

November 11, 2021 Belinda Reeve Healthcare ethics, Healthcare Law children, gender dysphoria

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.

Religious discrimination in Australian health law: hype or reality?

Image September 20, 2021 rogermagnusson Uncategorized assisted dying, assisted suicide, Contagious diseases, Covid-19, euthanasia, health professionals, Human rights, Infectious disease outbreaks, medical ethics, medical law, Public health emergencies, religion

Queensland has passed the Voluntary Assisted Dying Act 2021.

I’m disappointed in Queensland’s Parliament, not for passing assisted dying legislation, but for consciously trampling over the religious beliefs of Catholic and other religious healthcare organisations.

Catholic hospitals are right to be aggrieved. It’s entirely predictable that church institutions are now considering civil disobedience. (See “Catholic Hospitals’ Revolt on Euthanasia” Weekend Australian 21-22 August 2021, p 4. See also here).

I mean, if you genuinely believe that intentional killing is wrong, you don’t just help it along because a bunch of politicians told you to, do you?

Catholic moral beliefs preclude intentional killing, yet Queensland’s law will force Catholic hospitals to open their doors and to facilitate actions to end the lives of patients in their care, on their premises, by non-credentialed doctors who do not share their moral values.

The passage of assisted dying laws in Victoria (2017), Western Australia (2019), Tasmania (2021), South Australia (2021), and now Queensland illustrates the growing heft of personal autonomy as a secular value in Australian life.

(I call this the “Dombrink thesis”, after American scholar Professor John Dombrink, who demonstrated the resilience of libertarianism, through – and despite – America’s culture wars. See here, here, and here.)

Recent assisted dying laws follow on the heels of two decades of reform that have greatly liberalised abortion laws in every State and Territory; see eg here, here, and here.

But if personal autonomy means anything, it ought to extend to those who, despite these changes, have a sincere, morally-grounded opposition to killing and assisted suicide.

In my view, co-opting religious health care organisations to facilitate euthanasia is a step too far.

For further detail on what Queensland’s new law will force religious health care facilities to do, see below.

Sharing the love? The importance of singing in church in the middle of a pandemic

Let’s be clear: not all complaints of discrimination or oppression, by churches, in Australia’s largely tolerant democracy, are worthy.

For example, in a Facebook post on 2 July, Pastor Brian Houston of Hillsong fame dismissed Covid delta outbreak restrictions that prohibited singing in church as “religious discrimination…so archaic it’s hard to believe”.

He urged his followers: “Let’s make a stand”.

Judging by their responses, some of Houston’s followers are primed for persecution and reluctant to see themselves as beholden to earthly laws (that is, emergency public health orders).

On 16 June 2021, an outbreak of the insanely infectious delta variant of the Covid virus began in New South Wales. Daily cases are currently averaging over 1200; see here.

On 20 June, masks became mandatory in “places of public worship, being used for public worship or religious services”, in 7 local government areas.

On 23 June, singing in non-residential premises – including places of worship – was banned. However, a number of exceptions applied, including singing in a performance or rehearsal, singing in educational institutions, singing for the purposes of instruction in singing, or if “the premises are a place of public worship, and the persons singing are members of a choir”.

On 26 June, the exception for choirs was eliminated.

In response to questions raised at a Religious Communities Forum held on 28 June, NSW Health advised forum members by email that the delta outbreak restrictions operating at that time (the Public Health (Covid-19 Temporary Movement and Gathering Restrictions) Order 2021, dated 26 June 2021) did, indeed, prevent singing in places of worship, even if a religious leader was singing to a largely empty church or place of worship as part of a livestream. Masks must also be worn.

The intent of the restrictions, NSW Health advised, was to prevent transmission between, for example, a singing pastor, and people providing technical assistance during the livestream, given previous evidence of tansmission via singing in a place of worship.

NSW Liberal MP Tanya Davies raised Houston’s concern with Premier Gladys Berejiklian and Health Minister Brad Hazzard. Hazzard granted an exemption on 3 July, with specified safeguards: see here.

I suspect that quiet diplomacy by Houston would have been equally effective, if the need for religious leaders to sing directly to camera outweighed the importance of protecting others present in the venue from the risk of acquiring the highly infectious delta variant.

I notice one comment on Pastor Houston’s post:

“It’s time people stopped seeing everything as an attack or discrimination. Seriously we are in a pandemic. Christian leaders should be setting a good example”.

Amen to that. As to which, see here, and here.

Moral arm-twisting in Queensland’s voluntary assisted dying legislation

While some complaints of discrimination by religious leaders are over-blown, I would put Part 6 of Queensland’s Voluntary Assisted Dying Act in a different category.

The new Act respects the right of a health practitioner not to provide information about voluntary assisted dying, nor to participate in the assessment process for lawful access to assisted dying that the legislation makes available (s 84).

However, Part 6 co-opts health practitioners and forces them to facilitate that assessment process, irrespective of their personal beliefs about the ethics of killing.

Let’s count the ways.

Firstly, a health practitioner with a conscientious objection must either refer a patient requesting information on assisted dying to an officially approved “navigator service” for assisted dying, or to a health practitioner who is known not to have moral scruples about assisted dying and may be willing to assist (s 84(2)).

Secondly, a “relevant entity” (meaning a health care establishment such as a hospital, hospice or nursing home) must not hinder a person’s access to information about assisted dying.

In order not to do so, the health facility must provide entry to a registered health practitioner, or member or employee of an approved navigator service in order to “provide the requested information to the person about voluntary assisted dying” (ss 90, 156).

Thirdly, the new Act requires a health care facility operated by a church or religious organisation to provide access to an (external) medical practitioner who is willing to act as the patient’s “coordinating medical practitioner” for the purposes of facilitating assessment and taking the various actions required by the legislation in response to the patient’s first, second and final requests for assistance to die (ss 9, 92-93).

If the medical practitioner requested by the patient is unable to attend, the religious health care organisation must facilitate the transfer of the patient to and from a place where the patient can formally request assistance from a medical practitioner who is willing to act as the coordinating medical practitioner (ss 9, 92(3); 93(3)).

Fourthly, the religious health care facility must facilitate the coordinating medical practitioner (or their delegate) to carry out a “first assessment” of the patient’s eligibility for dying assistance under the Act, either by permitting this to occur within the facility, or by facilitating transfer of the person to and from a place where the assessment can take place (ss 9, 19, 94).

The same obligations apply to the second, independent “consulting assessment” that occurs if the coordinating medical practitioner concludes from the first assessment that the patient is eligible for voluntary assisted dying (ss 9-10, 30, 95).

After making a third and final request, and undergoing a final review, an eligible patient may decide to self-administer a voluntary assisted dying drug or, if advised that this is inappropriate, may choose to have the drug administered by the coordinating practitioner (ss 50, 56).

This step triggers a number of authorisations, including the right to prescribe, supply, possess and self-administer, or administer the drug overdose to the patient (ss 52-53).

Again, the legislation requires a religious health care facility to provide access to the coordinating practitioner so that the patient can choose how the drug will be delivered – whether within the facility, or by assisting transfer and travel to a place outside the facility where these decisions can be made (s 96).

The facility must then provide access to the administering practitioner and witnesses to enable assisted dying to take place on the premises, and must not hinder self-administration if the patient has made a self-administration decision (s 97).

These statutory requirements honour the voluntary assisted dying principle that “a person should be supported in making informed decisions about end of life choices” (s 5(f)), and that “access to voluntary assisted dying…should be available regardless of where a person lives in Queensland” (s 5(e)).

Another principle recognised in the legislation is that “a person’s freedom of thought, conscience, religion and belief and enjoyment of their culture should be respected” (s 5(h)).

However, by forcing religious health care facilities to cooperate in processes whose central aim is intentional killing, (I am not here debating the rigour of safeguards) the legislation tramples over well-known and defended moral values that lie at the heart of professional, competent, yet religiously-informed health care.

The bottom line

Like abortion, assisted dying is one of the enduring ethical fault lines in medicine.

Politicians can’t legislate it away.

Part 6 of Queensland’s Act seems hell-bent on making victims of doctors and religious organisations that have long-standing, deeply felt moral objections to intentional killing.

There ought to be room in Australia’s liberal democracy for religious hospitals and hospices to offer their services, including high-quality palliative care, in accordance with long-standing ethical values, without putting euthanasia on the menu.

Patients who request assessment for assisted dying should be transferred to a facility where such actions do not offend long-standing institutional values, as provided in South Australia’s legislation, which recognises a right of conscientious objection for hospitals and other health care establishments (see s 11, although this does not extend to nursing homes).

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Sydney Health Law

A blog on health governance, law, and ethics, by health law experts at Sydney Law School