Global Health

Rule of law in the Covid-19 response

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

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

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

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

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

Covid-19 and the rule of law

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

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

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

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

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

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

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

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

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

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

Law’s mission in public health

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

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

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

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

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

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

International Guidelines on Human Rights, Healthy Diets and Sustainable Food Systems: could they make a difference?

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The BMJ has published an Opinion calling on the Director-General of the World Health Organisation, Dr Tedros Adhanom Ghebreyesus, and the United Nations High Commissioner for Human Rights, Dr Michelle Bachelet, to jointly initiate a process to develop International Guidelines on Human Rights, Healthy Diets, and Sustainable Food Systems.

180 signatories from 38 countries have supported this Open Call – experts in global health and development, human rights, food systems, and HIV.

You can join the Call and add your name in support here, at the Healthy Societies 2030 website.

Healthy Societies is also hosting supporting documents, including a suggested process for strengthening links between human rights and healthy diets at the global level, and moving towards international guidelines.  (You can contribute to the discussion form, follow on twitter, and join the mailing list).

But pausing for a moment.

How would International Guidelines on human rights and healthy diets make a difference?

The Open Call published in BMJ draws on the example of the International Guidelines on HIV/AIDS and Human Rights (1998), which clarified the legal obligation of States, under international law, to respect, protect and fulfill human rights in the context of HIV.

These Guidelines helped to consolidate the framing of global strategy for HIV prevention and treatment in terms of the human rights of those affected by HIV.

And they provided language and conceptual tools for civil society organisations to hold governments to account.

In the BMJ Opinion, we argue that joint WHO/OHCHR guidelines could have a similar effect, by putting people at the centre of food systems, and strengthening the protection of health in global and national policies.

 

Framing global strategy effectively: the example of HIV

Getting global strategies right matters because they affect national strategies, actions and budgets.

These days, human rights are at the centre of the global response to HIV.

A focus on human dignity, preventing discrimination, empowering those with, or at risk of HIV, and ensuring that no one is left behind – these human rights values lie at the core of global strategies to prevent transmission and treat infection.

It wasn’t always that way.

In Australia, in the 1980s and early 1990s, public debate about rising rates of HIV infection was often framed by prejudice and fear.

HIV was the “gay plague”.  As a PhD student, I remember seeing a call by the Queensland Association of Catholic Parents to brand homosexuals in order to “stop AIDS”.

In Australia at that time, otherwise sane people were arguing that everyone in the country should be tested for HIV, and those with HIV should be removed from society or quarantined in the desert somewhere.

Fortunately, a kinder, more rational and humane approach – a human rights approach – prevailed.

By working with and through those affected by HIV – rather than against them – HIV rates have remained low in Australia.

It didn’t happen by accident.  It took a great deal of effort to ensure that national strategy was framed in such a way as to make it effective.

(The Honourable Michael Kirby, a former Justice of the High Court, and tireless advocate for a human rights approach to HIV – especially during the critical decades of the 1980s and 1990s – is one of the signatories to this Open Call).

 

Why a human rights frame for healthy diets and sustainable food systems?

So human rights have played an honourable role in the global response to HIV.

But how could they have a similar positive impact on nutrition, diet, and health around the world?

Some of the most urgent public health problems today revolve around the interlinked crises of obesity, poor nutrition, hunger, and climate change.

The starting point is that in many countries, market forces are failing to deliver healthy diets, adequate nutrition and sustainable food systems.

If framing food purely as a commodity, and if framing food systems purely as business networks supplying commodities in response to market demand – was effective, then countries wouldn’t be buckling under the strain of a massive, preventable burden of diabetes, obesity and chronic, diet-related diseases.

The Lancet Commission on Obesity called for “a radical rethink of business models, food systems, civil society involvement, and national and international governance” to address these problems.

While many actions will need to be taken, the BMJ Opinion argues that human rights concepts and language are powerful, under-used tools.

Interested in supporting breast-feeding, and preventing the predatory corporate practices that undermine it?  Try doing that without the moral support of human rights concepts.

Interested in the quality of food and drinks served in schools?  Or the stealth marketing of unhealthy foods and drinks to children using online platforms?  You could, of course, revert to the well-worn concepts of parental responsibility and consumer choice.  How’s that working out?

International human rights law provides a powerful way to frame these, and other challenges.

States owe an obligation to respect, protect and fulfil the right to health, as recognised in Article 12 of the International Covenant on Economic, Social and Cultural Rights.

Amongst other things, this requires States to protect the right to health from interference by others, including corporations pursuing economic interests without reference to the impact on health or the environment.

Joint WHO/OHCHR guidelines could help to push human rights concepts and language beyond the “UN human rights silo”.

The subtle form of forum sharing and coalition building that we advocate, through joint WHO/OHCHR guidelines, is increasingly recognised in other areas of the global health response, such as the Global Strategy to Accelerate Tobacco Control (2019), adopted by the Conference of the Parties to the WHO Framework Convention on Tobacco Control.

Many new ideas appear surprising at first glance.  And action at the global level may appear indirect, and abstracted from reality.

However, International Guidelines on human rights and healthy diets could help to mobilize multisectoral action, strengthen the accountability of States and the private sector, and deepen community engagement in the urgent task of developing healthier, fairer and sustainable food systems.

Let’s leave no one behind.

You can join the Open Call on Dr Tedros and Dr Bachelet here.

 

 

Infrastructure…non-communicable diseases: Australia’s pivot to the Pacific islands an opportunity to take Pacific health priorities seriously

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Barely 100 metres from Australia’s High Commission in Nukoalofa, Tonga, lies this plaque – erected by the People’s Republic of China.

In 2012, China upgraded a small section of road in the Tongan capital, installing drains beside the sidewalk in a town prone to flooding.

Close by, in other parts of the town, rain collects in deep pools and has nowhere to run, even though the sea lies only metres away.  There are no drains.

And two blocks from the Australian High Commission, a dead dog lies in the water outside someone’s submerged front yard.  It takes days, people say, for the rainwater to subside.

Welcome to the Pacific.

Australia’s pivot to the Pacific is welcome news.

Although significantly driven by Australia’s national security interests, higher levels of investment and development assistance provide at least the possibility of alignment with the public health needs of the region, and an opportunity to take Pacific health priorities seriously.

Health security begins with adequate sanitation, drainage, and safe water supplies.  But increasingly, mitigation will be needed against tidal surges and seawater level rises, and the impacts global warming will have on agriculture and food security, water supplies, housing and livelihoods.

Non-communicable diseases (NCDs) including diabetes and cardiovascular disease are out of control in the Pacific, thanks to high rates of smoking, obesity, and the displacement of traditional diets with cheap, imported junk foods.  A culture of feasting may also play a role.  (For further comment, see here, and here).

Significant progress has been made.  Around Nukualofa, for example, you’ll find fresh fruit and vegetable markets, and curbside stalls selling locally-grown produce.

Tonga has also innovated in ways that Australia has not, establishing a statutory Health Promotion Foundation (2007), and training new cohorts of NCD-specialising nurses.

In 2013, Tonga introduced an excise tax on sugar-sweetened beverages, and a T$1 per kilogram tax on a range of animal fats, in order to discourage consumption of fatty meat, including mutton flaps and turkey tails.  Taxes on fatty meats and sugary drinks were increased further in 2017.

But geography and the absence of economies of scale work against these dispersed island groups.  Tonga has beaches and coral waters to die for, yet it is not well known as a tourist destination.

On the island of Foa, in the Ha’apai island group, there are two low-key resorts owned by expats, where you’ll be charged NZ$60 for the 5km drive, across the causeway, to the airport.

A few Tongan nationals work at the resort, but how much money filters down to the impoverished communities that live on the island?

In any event, Pacific island economies need far more than tourism.  They need more economic activity across the board, and the infrastructure to enable it.

Throughout the Pacific, public health legislation needs updating.  Enduring sources of funding are needed to build regulatory capacity, including for enforcement.  Episodic funding, with heavy emphasis on epidemic preparedness, is of course welcome but leaves other core challenges under-funded.  The Pacific Commission’s Public Health Division has done magnificent work; this work, and the funding that supports it, needs to continue.

Australia’s “pivot” is an opportunity to re-set relations and to invest meaningfully in Pacific health priorities.

At least in this area, perhaps a bit of strategic competition isn’t a bad thing.

Are you interested in health law?  Sydney Law School offers a Master of Health Law, and Graduate Diploma in Health Law that is open to lawyers, health professionals and other approved applicants.  Click here, here and here for more information.

The World Health Organisation, the International Health Regulations, ebola and other pandemics: seminar announcement

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The International Health Regulations (IHR) (2005) are the primary global instrument for responding to, and seeking to prevent and limit the impact of public health emergencies of international concern, including communicable diseases with pandemic potential. The International Health Regulations are legally binding on all World Health Organization (WHO) Member States, including Australia.  The IHR were revised following the SARS outbreak in 2003.

Over the past decade, the world has faced a number of significant health events, including H1N1 pandemic influenza in 2009, the 2014–2016 Ebola outbreak in West Africa, and the 2018 Ebola outbreaks in the Democratic Republic of Congo. Each of these events has tested the utility and function of the revised IHR.

In this seminar, a panel of leading experts in public health law and global health security will examine whether the International Health Regulations are meeting their goal of protecting public health, international trade, and human rights, and whether the obligations in the IHR are sufficiently robust to respond to ever more complex public health emergencies.

The speakers are:

Dr Mark Eccleston-Turner, Lecturer in Law, Keele University

Title: The WHO response to Ebola in the DRC: a critical analysis of the legal application of the International Health Regulations

Dr. Alexandra Phelan, Centre for Global Health Science and Security, Georgetown University; Adjunct Professor, Georgetown University Law Center

Title: Human Rights under the International Health Regulations in an era of nationalism: laws in Australia and the United States

Dr. Sara Davies, A/Professor in International Relations, School of Government and International Relations, Griffith University

Title: The Politics of Implementing the International Health Regulations

Venue: Sydney Law School, Monday 17 June, 6.00-7.30pm.

This free event is a side-event to the first Global Health Security Conference in Sydney, Australia held from 18 – 21 June 2019.

You can register to attend this event here.

For more background on the speakers, click here.

Update and summary guide to the WHO report: Advancing the right to health: the vital role of law

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In September 2018 the World Health Organisation published an Update and Summary Guide to the report Advancing the Right to Health: the Vital Role of Law.

[See here for a previous post on the full report].

The summary Guide, like the full report, was a collaboration between the World Health Organisation, International Development Law Organisation, Sydney Law School, and the O’Neill Institute for National and Global Health Law at Georgetown University, Washington DC.

The aim of the original report, published in January 2017, was to raise awareness about the role that the reform of public health law can play in advancing the right to health and creating the conditions in which people can live healthy lives.

The Update and Summary Guide keeps the same focus: providing an introduction to the role of law in health development, with links to the full report, while also drawing attention to topics that were beyond the scope of the original report, and to links between law and the health-related Sustainable Development Goals.

The Update and Summary Guide integrates new health data and refers to new developments, including a list of highly cost–effective legal measures for reducing risk factors for non-communicable diseases (“NCDs”), drawn from the updated Appendix 3 of the WHO Global Action Plan for Prevention and Control of NCDs. It also references selected new decisions, such as the unsuccessful claim by a tobacco company against Uruguay’s tobacco control laws, and the decision of the Constitutional Court of Colombia confirming the right to receive information about the health effects of sugary drinks.

Cracking the Codex: the new frontier for nutrition labelling

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Alexandra Jones, Global health lawyer and PhD Candidate at The George Institute for Global Health and the University of Sydney
Dr Anne Marie Thow, Senior Lecturer in Health Policy at the University of Sydney
Dr Carmen Huckel Schneider, Senior Lecturer, Health Policy at the University of Sydney and co-lead of the Health Governance and Financing Group and the Menzies Centre for Health Policy

Food labels hit the New York Times recently when leaks from North American Free Trade Agreement negotiations suggested the US was being urged by big American food and soft-drink companies to limit the ability of the pact’s three members – Mexico, Canada and the US – to implement warning labels on unhealthy foods.

There is no escaping the health imperative here. Obesity has nearly tripled since 1975 worldwide: 41 million children under 5 are now overweight, while 1.9 billion adults are overweight or obese. Spiralling health and economic costs mean governments are turning to evidence-based policies to prevent and control diet-related diseases like obesity, heart disease, stroke, diabetes and dental caries.

Better nutrition labelling – including front-of-pack labels that interpret nutrition information through symbols, colours or words – are part of the comprehensive package recommended by the World Health Organization. Over 20 countries already have policies in place – they include the UK’s traffic lights, France’s Nutriscore, Chile’s ‘stop sign’ warnings (which Peru appears set to follow), and Australasia’s Health Star Rating.

This proliferation and diversity poses trade and commercial challenges, and calls for some degree of consistency in global approach have been made.

Cracking the Codex (Alimentarius Commission)

This is where the international food standards body – the Codex Alimentarius Commission – comes in.

A UN body created by the WHO and UN Food and Agriculture Organization, Codex has a dual mandate: to protect consumer health, and promote fair trade practices.

Codex standards and guidance are voluntary, but in practice frequently act as a touchstone for countries looking to develop national policies. As Codex enjoys recognition as an international standards setting body by the WTO, guidance it develops also has potential to show up in trade discussions around food.

In short: what happens at Codex matters for public health nutrition.

Done well, Codex could bolster countries to take action. Left unchecked, there’s a risk outcomes could deter countries’ from implementing policies desperately needed to stem the rising global tide of non-communicable diseases.

As Codex is also notoriously slow – there’ll be a general meeting 2-6 July in Rome, and a further discussion paper for feedback later this year – it’s critical that the process itself not be used as a ‘brake’ on growing global momentum to implement strong front-of-pack labels.

Time for public health to assume a seat at the Codex table

Industry Observers have been quick to jump on opportunities to provide input into new Codex work on front-of-pack labelling. The first working group included representation from 13 international organizations representing the food industry, particularly the sugar and beverages sectors. Only two consumer groups were there.

It’s now critical we ensure public health bring their perspective to the table.

What you can do:

Read our briefing note for more information, and

  • Get involved – contact your national Codex Contact Point or join an Observer organization
  • Speak up about the public health priorities, like:
    • the importance of a definition of ‘front-of-pack nutrition labelling’ that supports schemes most likely to be effective in achieving public health objectives – and not, for example, industry preferred options such as the Guideline Daily Amount that aren’t backed by evidence
    • preserving policy space for strong and innovative measures – evidence is rapidly evolving but currently suggests for informing consumers and improving diets, this may include mandatory labels that use interpretive elements like colours, symbols or words, underpinned by robust and transparent criteria for scoring foods
  • Encourage continued action at a national level – remember, nothing in the current process prevents interested countries from pursuing front-of-pack labelling

Want to read more?

 

This piece was originally posted on the PLOS Global Health Blog on 25/06/2018, and has been re-posted with author consent.

 

Advancing the Right to Health: the Vital Role of Law

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N0032287 Group portrait of seven boys, Ethiopia

More than 20 years ago, Chris Reynolds, an Australian pioneer in our understanding of public health law, wrote that: “law is a powerful tool, as potent as any of the medical technologies available to treat disease”, and yet “our understanding of the potential of [public health law]…to help…citizens to lead longer and healthier lives, is not well developed”. (Reynolds, “The Promise of Public Health Law” (1994) 1 JLM 212).

A new report entitled Advancing the Right to Health: the Vital Role of Law, published last week by the World Health Organisation, illustrates just how central law is to our health and wellbeing.

The full report, and each of its chapters, can be downloaded (free of charge) here.

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Law a powerful tool for improving public health…everywhere

Countries around the world are using law and legislation across a broad range of areas to protect the health of their populations.

These areas include communicable and contagious diseases, and public health emergencies, maternal and child health, sanitation, water and vector control, the prevention of non-communicable diseases and their risk factors (such as tobacco, alcohol and obesity), prevention of violence and injuries, not to mention essential medicines and universal health coverage, and the regulatory challenges of strengthening health systems.

In each of these areas countries have a great deal to learn from each other.

One benefit of taking a global perspective on public health law is that you get a better sense how the field is buzzing with innovation.

For every jurisdiction where political will is lacking, there’s another that is trying out the new, whether at national, state, or local/city level.

Take legal responses to dietary risks as an example:

Even when new legislative proposals are adopted or accepted, they nevertheless illustrate new ways of addressing health risks, and possible future directions.

One example is the Sugar-Sweetened Beverages Safety Warning Bill introduced for three consecutive years into California’s legislature, which would have required sugar-sweetened beverages and vending machines to carry the warning: STATE OF CALIFORNIA SAFETY WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay.”

This proposal has not yet been successful in California.  However, San Francisco has passed a local ordinance requiring the same warning, although it is now subject to litigation.

N0032285 Group portrait of seven boys, Ethiopia

Sydney Health Law…partnering with WHO, IDLO and the O’Neill Institute

Advancing the right to health is the result of a collaboration between Sydney Law School’s health law program, the O’Neill Institute for National and Global Health Law at Georgetown University, the International Development Law Organisation (IDLO) and the World Health Organisation.

The key message from this report is that there is enormous, untapped potential for governments to use law more effectively to reduce health risks and to make communities healthier and more resilient.

The report provides guidance about issues and requirements to be addressed during the process of developing public health laws, with case studies drawn from countries around the world to illustrate effective law reform practices and critical features of effective public health legislation.

Advancing the Right to Health: The Vital Role of Law was launched at the Graduate Institute in Geneva by Dr Marie-Paule Kieny, Assistant Director-General, Health Systems and Innovation, WHO.  WHO’s feature on the report is available here.

For comments made by Mr David Patterson, Senior Legal Expert – Health, International Development Law Organisation, see here.

For comments made at the launch by Professor Roger Magnusson, principal author of the report, on the connections between public health law and universal health coverage, see the following link: roger-magnusson-comments-at-launch-of-report-advancing-the-right-to-health-16-jan-2017

Are you interested in studying health law?  Sydney Law School’s Graduate Diploma in Health Law, and Master of Health Law are open to both lawyers and non-lawyers.  For further information, click here.  For information on Sydney Health Law, the Centre for Health Law at Sydney Law School, click here.

N0032286 Group portrait of seven boys, Ethiopia
N0032286 Group portrait of seven boys, Ethiopia

UN Secretary-General’s High-level Panel: a bold vision for improving access to essential medicines, or a “deep disappointment”?

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The UN Secretary General’s High-level Panel on Access to Medicines published its final report on 14 September 2016.

It took just two days for the US State Department to dismiss the report in a strongly-worded rebuke.

The Panel’s recommendations cover a wide area, including countries’ use of the flexibilities contained in TRIPS [the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement] and TRIPS-plus  provisions, incentives for research and development of health technologies, and global governance arrangements for R&D, production, pricing and distribution of medicines and health technologies.

The UN report took place against the background of efforts by US pharmaceutical companies to strengthen IP protection for medicines, including through the (now apparently very dead) Trans Pacific Partnership Agreement.

The Panel, which included Sydney Law School alumnus and former High Court Justice Michael Kirby, was an eminent but mixed group ranging from grassroots HIV treatment activists, former politicians, academics and senior executives of pharmaceutical firms.

Glancing over the biographies of members, you get the feeling that finding a consensus was always going to be a challenge.

Half the Panel members wrote additional commentaries to the Panel’s report, criticising the report for making dubious and unrealistic assumptions, or alternatively, for failing to adopt bolder and more visionary proposals on financing, IP and access (pp 54-63).

Regrettably, the Panel’s report, like the appointment of the Panel itself, has been ignored by Australia’s media.

Australians live in a bubble, protected by the Pharmaceutical Benefits Scheme (PBS) from experiencing the reality of real-world prices for essential medicines.

Under the PBS, patients pay a maximum of $38.30 for medicines listed on the PBS.  “Concessional patients” ie those who hold a pensioner concession, seniors health care or other concession card, pay only $6.20.

Unfortunately, Australia’s much-loved safety net for pharmaceuticals leads to lack of interest in this most pressing of global health issues: how to increase access to medicines at prices that are affordable to those who need them, while ensuring incentives exist for future R&D in health technologies.

Key issues and recommendations

A key argument in the Panel report is that there is an incoherency and imbalance between the right to health and the rules and practice of international trade and intellectual property protection.

For example, while IP rights are enforced by dispute resolution provisions found in WTO agreements, and in bilateral and multilateral free trade and investment agreements, the accountability mechanisms for human rights, including the human right to health, lack precision, legal weight and enforceability (p 8).

The Panel referred to the proliferation of “TRIPS-plus” free trade agreements that require countries to dispense with the flexibilities in TRIPS (see pp 24-25), writing that:

“Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement as reaffirmed by the Doha Declaration” (p 8).

The Panel report encourages countries to continue to make full use of TRIPS flexibilities in the spirit of the Doha Declaration, curtailing the evergreening of patents and ensuring that legislative criteria for the award of patents only reward genuine innovations.

The Panel encourages countries to adopt legislation authorising the issuing of compulsory licences, particularly in order to ensure affordable supply of essential medicines.

The Panel also encourages universities and research organisations that hold patents for inventions developed with public funds to prioritise public health objectives over financial returns, including by issuing non-exclusive licences, and participating in public sector patent pools.

The Panel urged governments to review the access to medicines situation in their own countries in light of human rights principles, ensuring that civil society is given the support it needs to submit shadow reports.  According to the Panel, national policy on R&D should be coordinated by an inter-ministerial body to ensure coherence.

Similarly, the Panel recommended that the UN Secretary-General should establish an inter-agency taskforce on health technology innovation and access for the duration of the Sustainable Development Goals (2015-2030).  The Taskforce would oversee the implementation of the recommendations of the High-level Panel and would report annually to the UN Secretary-General.

The Panel saw transparency as a vital accountability mechanism, urging private sector companies to “have a publicly available policy on their contribution to improving access to health technologies”.  The policy should set out timeframes, reporting procedures and lines of accountability, including board-level responsibilities for improving access to health technologies (p 11).

Two further interesting recommendations were that national governments should require manufacturers and distributors of health technologies to disclose commercial in-confidence information to drug regulatory and procurement authorities.  This should include the costs of R&D, production, marketing and distribution of the health technology, as well as the existence of any public funding received by the company during the process of development.

Secondly, the Panel recommended that the World Health Organisation should maintain an accessible, global database showing the prices of patented and generic medicines (and biosimilars) in the public and private sectors of all countries where the medicines are registered.

State Department’s response

In its rebuff to the Panel’s report, the State Department said:

We believe that we can both increase access to medicines and support innovation for the development of new and improved drugs for the world’s most critical health challenges. Indeed, there can be no access to drugs that have not been developed: support for innovation is essential.

No one disputes that the costs of investment in new health technologies can be substantial.

However, the UN Panel pointed to the complexity of the challenge.  In some cases, the problem is that the market for diseases that affect few patients, or disproportionately affect the citizens of poorer countries, is simply inadequate to incentivise the necessary investment.

In 2014, 1.7 billion people in 185 countries were living with a neglected tropical disease.  These diseases account for around 12% of the global burden of disease, yet over the period 2000-2011 only 4% of therapeutic products registered by the European Medicines Agency and the US Food and Drug Administration were for these diseases.

Similarly, antimicrobial resistance is a slowly mounting crisis, yet “only one novel class of antibiotics has been developed in the past 40 years” (p 14).

This state of affairs suggests that it is an over-simplification to simply assert that the answer lies in countries ratcheting up their IP protections in the hope that market forces will fix the problem.

One doesn’t need to deny the value of patent rights and incentives to nevertheless conclude that the system is broken.

It’s impossible to conclude otherwise when millions of the world’s citizens lack the safety net of a PBS, and where access to the medicine they need at real-world prices overwhelms their productive capability.

A substantial literature illustrates that essential medicines remain unaffordable for many people, in many countries of the world; see, for example here, and here.

Are you interested in studying health law at Sydney Law School?  You do not need a background in law to do so.  Sydney Law School offers a Graduate Diploma and a Masters degree in health law that is open to qualified applicants.  Click here for further details.