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.
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.
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.
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).
His more recent comments to the media illustrate the challenges of attempting to investigate the origins of SARS-CoV-2 as part of a WHO-convened expert team (more of which below).
This post briefly reviews two current Covid-19 review processes, as well as recent media reports about the WHO-convened Covid origins study.
At the World Health Assembly on 19 May 2020, the Assembly adopted resolution WHA73.1 on the Covid-19 response that, amongst many other things, requested the Director-General to carry out a review on “lessons learned from the WHO-coordinated international health response to COVID-19”, including the functioning of the International Health Regulations and “the actions of WHO and their timelines pertaining to the COVID-19 pandemic” (para 10).
Independent Panel for Pandemic Preparedness and Response
This Panel is co-chaired by the Rt. Hon. Helen Clarke, the former Prime Minister of New Zealand who more recently was Administrator of the UN Development Programme, and Her Excellency Ellen Johnson Sirleaf, the former President of Liberia.
Other key messages from the Independent Panel for Pandemic Preparedness & Response:
Non-pharmaceutical public health response measures (such as social distancing, hand hygiene and wearing masks) will need to continue to be implemented at scale globally, irrespective of whether a vaccine is rolled out.
The global pandemic alert system is not working and needs to come into the digital era, enabling preventive actions to be taken within days, rather than weeks. The process for declaring a public health emergency of international concern is not working.
The IHR lack teeth, and the incentives are too weak to ensure compliance. The Panel put this conclusion in more modest language: “The incentives for cooperation are too weak to ensure the effective engagement of States with the international system in a disciplined, transparent, accountable and timely manner” (p 7).
Review Committee on the Functioning of the International Health Regulation
The Committee pointed to the lack of a robust accountability mechanism to monitor and incentivise compliance with the IHR, beyond the requirement for States Parties’ and the Director-General to report to the World Health Assembly on the implementation of the Regulations (Art. 54). A “robust system of compliance evaluation built into the Regulations” was proposed as one possible approach.
Recommendations to strengthen the IHR have been circulating for years. See here and here for short, helpful, reviews.
The Committee noted that “A peer-review mechanism, based on the Universal Periodic Review used by the Human Rights Council,” could be a useful way of strengthening countries’ levels of preparedness and response, and compliance with their legal obligations (para 18).
The interim report states that WHO requested verification of the initial reports on 1 January, receiving a response from the China Focal Point on 3 January.
Under the IHR, States Parties are supposed to reply to WHO requests for verification or further information within 24 hours (IHR, Art. 10), but the report notes that delay beyond 24 hours is not unusual.
The Committee stated that the timelines for country response are not realistic, given that social media can result in information reaching the public domain before a comprehensive risk assessment is completed. It also noted that “countries may be reluctant to report on events if they perceive consequences, mainly related to travel and trade, deriving from early notification.”
In an ideal world, perhaps borders could remain open and watertight screening, contact tracing and isolation measures could effectively prevent spread. But it’s a brave country that completely trusts its own implementation of these important public health controls: SARS-CoV-2 is devilishly infectious, and aerosol transmission can occur even when normal hotel quarantine and infection controls are in place.
Public health experts regard Australia’s travel bans as an important and necessary part of Australia’s successful response. For example, Duckett and Stobart regard “Australia’s decision to close its borders to all foreigners on 20 March to ‘align international travel restrictions with risks'” as a “turning point” in Australia’s response.
In her evidence to the Senate Select Committee Inquiry into Australia’s Response to Covid-19, Professor Raina MacIntyre, who leads the Biosecurity Program at the Kirby Institute at the University of New South Wales, described travel bans (border closures) as “the single most important measure” (para 2.43), a conclusion supported by this modelling study. Unfortunate – certainly, but necessary to avoid importing new cases.
WHO-convened Global Study of the Origins of SARS-CoV-2
In late January, an international team of virologists travelled to Wuhan on a fact-finding mission as part of a WHO-convened global study into the origins of SARS-CoV-2.
However, when you consider the scale of the death and economic harm caused by Covid-19, it is simply breath-taking that such an outbreak should go unexamined. Not surprisingly several inquiries are now proceeding.
Investigating the origins of SARS-Cov-2 was and is unavoidably sensitive, not only because it involves asking where the virus may have originated, and the conditions that facilitated its spread into the human population, but because the likely time period during which the first-observed cases arose goes to China’s level of compliance with the IHR, and the impact this may have had on the international spread of SARS-CoV-2.
The controversy surrounding the WHO-convened study has escalated since the international team left Wuhan.
Dr Dwyer also told the ABC that the expert team’s request to test stored samples of blood donations made in Wuhan around December 2019 was denied, apparently for legal reasons, although it might have given a picture of SARS-CoV-2 levels in the wider community at that time.
These sources of information might have given a clearer picture of whether and how much virus was circulating in the community prior to December 2019.
“We also know the Chinese were reporting the people who went to hospital were really sick,” Dr Dwyer said. “But we now know there’s a lot of ordinary transmission going on between otherwise healthy people, so there must’ve been many, many more cases in December than were identified.”
The scientists wrote that “We have…reached the conclusion that the joint team did not have the mandate, the independence, or the necessary accesses to carry out a full and unrestricted investigation into all the relevant SARS-CoV-2 origin hypotheses – whether natural spillover or laboratory/research-related incident”.
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.
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?
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.
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.
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 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.
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.
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.
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.
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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.
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.
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.
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.
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?
Background paper: Public health nutrition and front-of-pack nutrition labelling at Codex
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).
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:
In some countries, public health agencies have also used their regulatory powers to implement food fortification programs and to remedy nutrient deficiencies, as Nigeria did by requiring the universal iodization of salt.
Even when new legislative proposals are adopted or accepted, they nevertheless illustrate new ways of addressing health risks, and possible future directions.
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.
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.
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.
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.
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.
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.
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.
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