Advancing the Right to Health: the Vital Role of Law

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.

WHO Commission on Ending Childhood Obesity presents final report and recommendations

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The World Health Organisation’s Commission on Ending Childhood Obesity, appointed by WHO Director-General Dr Margaret Chan in 2014, has now formally presented its final report.

The Commission was co-chaired by Sir Peter Gluckman, the Chief Science Advisor to the Prime Minister of New Zealand, and Dr Sania Nishtar, the founder and President of Heartfile, a health policy think tank based in Pakistan.

The Commission held hearings in all 6 WHO regions, and was supported by two technical working groups: the Ad Hoc WG on Science and Evidence, and the Ad Hoc WG on Implementation, Monitoring and Accountability.

In 2014, an estimated 41 million children under 5 years of age were either overweight or obese (this is defined as the proportion of children whose weight for height scores are more than 2 standard deviations, or more than 3 standard deviations, respectively, from the WHO growth standard median).

The Commission’s strategic approach rests on three categories of interventions:

  • interventions to tackle the obesogenic environment in order to improve the healthy eating and physical activity behaviours of children;
  • interventions targeting critical stages of the lifecourse; ie (i) preconception and pregnancy; (ii) infancy and early childhood; and (iii) older childhood and adolescence;
  • interventions to treat obese children in order to improve their current and future health.

A number of the Commission’s recommendations addressing the obesogenic environment, and critical stages of the lifecourse, in particular, confirm the role for law and regulation in improving the food and physical activity environment for children.

In a move sure to thrill the fizzy drinks industry, the Commission has called on countries to implement an effective tax on sugar-sweetened beverages, and noted that some countries may also consider a tax on foods high in fats or sugar.

Noting “unequivocal evidence that the marketing of unhealthy foods and sugar-sweetened beverages is related to childhood obesity”, the Commission has called on countries to implement the WHO’s Set of Recommendations on the Marketing of Foods and Non-alcoholic Beverages to Children.   It has also called for cooperation between Member States of the World Health Assembly to reduce the impact of cross-border marketing of unhealthy foods and beverages.

The Commission has called for a standardised global nutrient labelling system, as well as the implementation of interpretive front-of-pack nutritional labelling supported by public education to improve nutritional literacy.  Interpretive food labelling has consistently been a highly contested area of food law and policy.  For example, the European Food Industry reportedly spent 1 billion euro to ensure that front-of-pack traffic light labeling did not become a Europe-wide standard.  Traffic light labels interpret the quality of the nutrition of food by means of highly visible red, amber and green symbols that correspond to the amount of saturated fat, salt and added sugar in the product.

The Commission’s recommendation that schools, child-care settings and children’s sports facilities should be required to create healthy food environments may also require legislation or regulations for successful implementation in some countries.  The Commission has also specifically recommended that countries eliminate the sale or provision of unhealthy foods, such as sugar-sweetened beverages and energy-dense, nutrient-poor foods, in schools.

In the United States, the federal government subsidises the provision of breakfasts and lunches served at school to children from low-income families.  This has enabled the US Department of Agriculture to issue regulations  requiring schools that participate in the national school lunch and breakfast program to improve the nutritional quality of the foods that are served.   However, these standards have faced relentless opposition from the junk food industry and from Congress.  Mandatory standards to improve the nutritional quality of school food have been introduced in a number of jurisdictions, including England and Scotland.

Other recommendations that may require legislative or executive action include the enforcement of the International Code of Marketing of Breast-milk Substitutes and subsequent resolutions of the World Health Assembly (WHA).

The Commission’s report will be presented to the members of the WHA in May 2016, where further actions may be taken to support the implementation of the Commission’s recommendations.

Those with an interest in obesity should also keep an eye out for the report of the Lancet Commission on Obesity, co-chaired by Professor Boyd Swinburn (University of Auckland), and Professor Bill Dietz (George Washington University).  In this paper, Professors Swinburn and Dietz outline the work of their Commission.

 

 

World Health Organisation publishes new report on overweight, obesity, diabetes and the law

Posted by Jenny Kaldor and Roger Magnusson

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This is the view when you look out the front gates of the World Health Organisation’s regional headquarters in Manila.

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A few blocks away, in the processed food aisles of the supermarket, parents are encouraged to purchase “nutrition power for kids”.

The Western Pacific Region, which includes Australia, is home to 138 million adults with diabetes, and includes a number of Pacific Island countries where more than one third of the population have diabetes, and around one half of the population are obese.  [See separate blog post]

In response to these issues in our region, Manila was the venue for a consultation on 9-11 April 2014, on overweight, obesity, diabetes and the law, co-hosted by the University of Sydney (Sydney Law School and the Boden Institute), and by the International Development Law Organisation (IDLO).  The consultation brought together public health practitioners, community leaders and academics from around the region, including Fiji, Singapore, New Zealand, Indonesia, Cambodia, South Korea, Mongolia, PNG, the Philippines and more.

The consultation was co-chaired by Professor Stephen Colagiuri (Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders), Professor Roger Magnusson (Sydney Law School), and Mr David Patterson (IDLO).  The background paper and meeting report were written by the rapporteur for the consultation, Ms Jenny Kaldor, who is a PhD candidate at Sydney Law School.

The Western Pacific Regional Office of the World Health Organisation (WHO – WPRO) was the co-sponsor and convenor of the consultation, and has just published the meeting report, which is available below:

WPRO CONSULTATION ON OVERWEIGHT OBESITY DIABETES AND THE LAW – 9-11A APRIL 2014 – FINAL REPORT – RS_2014_GE_66_PHL_eng.

The report illustrates the variety of legal issues that overweight, obesity and diabetes are causing for countries within the Western Pacific WHO region, as well as how law might be used to improve health outcomes.  These include the problems of diabetes-related disability discrimination, discrimination in access to diabetes medications, and good practices in legislation to improve food environments and opportunities for physical activity, from across the region.  The report discusses the opportunities for, and obstacles to, using law effectively, as well as the challenge of ensuring that trade agreements and trade laws do not work at cross-purposes to health policies on obesity and diabetes.

The meeting report highlights several important conclusions:

  • There is a strong need to build the evidence-base on legal interventions relating to obesity, diabetes and population diets.  Case studies, feasibility studies, guidelines, summaries and other tools can assist countries to share their knowledge and experience with legal and regulatory interventions.  Researchers and academics have an important role to play.  Networks need to be built across the region to better facilitate information sharing.
  • Developing local expertise in public health law and in particular, law related to obesity, overweight and diabetes, is a priority.
  • In-depth technical advice is needed on promising interventions.  These include a tax on sugar-sweetened beverages; restrictions on unhealthy marketing of food and beverages to children; requirements for interpretive, front-of-pack labelling; and legislation to create environments that facilitate and encourage physical activity.
  • Civil society has a vital role to play in the development, implementation and enforcement of innovative legal approaches to overweight, obesity and diabetes.
  • Addressing the interference of the food and drinks industries in policy development and implementation in countries across the region is a priority.  Clear guidelines are needed to avoid conflicts of interest and to ensure that government interactions with the food industry are transparent and constructive, and do not jeopardise public health goals.
  • Law needs to be better integrated into the agenda of the World Health Organisation.  Law is central to advancing the goals of WHO, and can enable countries to protect, respect and fulfil the right to health.

Does Coca Cola have a role in delivering Pacific aid?

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Posted by Roger Magnusson and Alexandra Jones

The Foreign Minister, The Hon. Julie Bishop MP has announced that Australia will partner with companies like Coca-Cola to distribute essential medicines to Pacific Island recipients of Australian aid.

The Minister is right about one thing: tobacco and fizzy drink companies have strong distribution networks that reach into the remotest parts of low income countries around the world.  And they would welcome the legitimacy that comes from “being part of the solution” – from “helping to save lives”.

But conflict of interest looms large.  In some islands of the Pacific, more than a third of the population have diabetes (See the table at the bottom of this post, drawn from a recent paper on non-communicable diseases (NCDs) in the Pacific.  The table is worth reproducing in full, since it illustrates just how bad everything is). Combined rates of overweight and obesity among men and women in some Pacific island recipients of Australian aid reach or exceed 80%.  In some countries obesity rates alone exceed 45% (in Tonga, the rate of obesity in men and women > 20 years is 59.5%).  Do these countries really need Coca Cola?

There might well be novel ways of partnering with the private sector to improve aid performance.  Results matter: the Minister is absolutely correct on this point.  But this applies at home as well.  For example, under-performing public health initiatives such as the stalled Food and Health Dialogue – which was supposed to deliver a healthier food supply with less salt and saturated fat – also need to be overhauled.  (A recent paper by Roger Magnusson and Belinda Reeve illustrates how “regulatory scaffolding” could be used by government to strengthen the performance of this vital initiative while minimising the need for direct, statutory regulation).

In Pacific Island Countries and Territories, partnering with the multinationals that are driving risk factors for obesity and diabetes makes no sense.  Australian Aid wouldn’t partner with a tobacco company like Philip Morris, so why partner with a fizzy drink company selling empty calories to some of the most obese and diabetic countries in the world?

Unlike, say, Unilever, which can diversify into healthier products and create healthier brands, Coca Cola and Pepsico have a real problem: their leading brands are soft drinks.  It would be economic suicide to sacrifice the full-sugar variants, and yet this colours every positive contribution they might otherwise seek to make to development or public health.  People who want to move towards a healthier weight – not to mention better dental health – need less soda, not more, and yet reducing consumption is bad for profits.  Suffice it to say that Coca Cola would surely be delighted at the prospect of becoming integrated into the public health infrastructure in these fragile island states.

It’s worth asking: just how did Coca Cola get inside the Minister’s head?  Why is its name bobbing up now?

At the Joint Forum Economic and Pacific Health Ministers Meeting in Honiara in July 2014, Economic and Health Ministers from Pacific Island Forum countries agreed that non-communicable diseases (NCDs) are ‘financially unsustainable’.  They committed to develop country-specific roadmaps covering the following five priorities (Joint Economic Forum and Pacific Health Ministers Meeting 2014). These priorities are:

    • Strengthening tobacco control;
    • Considering an increase in taxation of alcohol products;
    • Reducing consumption of unhealthy food and drink;
    • Improving efficiency of existing health expenditure; and
    • Strengthening the evidence base to ensure optimal use of resources.

These commitments take place against the background of the World Health Organisation’s Western Pacific Regional Action Plan on NCDs  and the World Bank’s NCD Roadmap Report.  Both documents identify “best buys” and other policy priorities that countries should adopt in order to reduce death and disease from NCDs.

Let’s be honest here: the commitments of Joint Economic Forum and Pacific Health Ministers are not only a business risk to Coca Cola, but to tobacco multinationals and other junk food and beverage companies that operate in the region.  Other risks loom on the horizon.  For example, the World Health Organisation has established a Commission on Ending Childhood Obesity, which has already released an interim report which identifies a number of policy options for reducing intake of unhealthy foods and non-alcoholic beverages by children.  The Commission is holding a hearing in Auckland for the Western Pacific Region within the next few weeks.

Is Coca Cola really part of the solution?  If you have any lingering doubts, just ask a dentist.

Readers may also be interested in a recent paper by Jenny Kaldor and Roger Magnusson (from Sydney Law School) and from Stephen Colagiuri (from the University’s Boden Institute of Obesity, Nutrition Exercise, a WHO Collaborating Centre) on how law and regulation could contribute to efforts to wind back Australia’s epidemic of diabetes.

Selected risk factors for non-communicable diseases in Pacific Island Countries and Territories, compared to Australia 

Obesity rates % (2013)a
Country Men>20 years Women >20 years Men & women >20 years
Kiribati 39 56 47.5
Samoa 46 69 57.5
Tonga 52 67 59.5
Australia 28 30 29
Smoking prevalence % (2011)b,c
Country Men >15 years Women >15 years Men & women> 20 years
Kiribati 67 37 52
Papua New Guinea 55 27 41
Solomon Islands 45 18 32
Tonga 43 12 28
Australiad   18 14 16
Diabetes prevalence % (2013)e,f
Country Total adult population
Cook Islands 26
Federated State of Micronesia 35
French Polynesia 22
Kiribati 29
Marshall Islands 35
Nauru 23
Tokelau 38
Vanuatu 24
Australiag 4

a Statistics sourced from Ng M, Fleming T, Robinson M, et al (2014) Global, Regional and National Prevalence of Overweight and Obesity in Children and Adults During 1980-2013: A Systematic Analysis for the Global Burden of Disease Study 2013. Lancet 384, 766-781.

b Statistics sourced from World Bank (n.d.) World Development Indicators: Health Risk Factors, viewed December 2014 <http://datatopics.worldbank.org/hnp/HNPDash.aspx&gt;.

c Statistics for Australia sourced from Australian Bureau of Statistics (ABS) (2012) Australia’s Health Survey: First Results, 2011-2012, Tobacco Smoking. 4364.0.55.001, 29 October 2012, viewed December 2014  <http://www.abs.gov.au/ausstats/abs@.nsf/Lookup/73963BA1EA6D6221CA257AA30014BE3E?opendocument&gt;.

d Australian data are for daily smoking rates among adults aged >18 years, for 2011-2012.

e Statistics sourced from Chan J, Cho N, Tajima N, Shaw J (2014) Diabetes in the Western Pacific Region – Past, Present and Future. Diabetes Research and Clinical Practice 103, 244-255.

f Statistics for Australia sourced from ABS (2012) Australia’s Health Survey: First Results, 2011-2012, Diabetes Mellitus. 4364. 0.55. 001, 29 October 2012, viewed December 2014 <http://www.abs.gov.au/ausstats/abs@.nsf/Lookup/D4F2A67B76B06C12CA257AA30014BC65?opendocument&gt;.

g Australian data are for the period 2011-2012.

As part of its Master of Health Law program, Sydney Law School offers several units of study that consider global health, law and development.  These include Critical issues in Public Health Law; Law, Business and Healthy Lifestyles; Global Health Law; and Trade Regulation, Health and the Environment.

[Thanks to Alexandra Jones for references and for information about Australia’ health aid program]

How can pacific island countries reduce the crippling burden of non-communicable diseases?

Pacific island countries and territories (PICTs) are some of the most geographically isolated in the world.  Non-communicable diseases (NCDs), including cardiovascular disease, cancers, tobacco-related diseases and diabetes are rampant in PICTs.  These diseases are partly driven by loss of traditional diets, global trade in harmful products, and by a cluster of inter-related risk factors including tobacco use, harmful use of alcohol, poor diet (excess intake of  saturated fat, salt and sugar), obesity and lack of physical activity.

Building on the World Bank’s NCD Roadmap Report, Pacific Economic and Health Ministers have agreed that non-communicable diseases are financially unsustainable and committed to implementing cost-effective policies.  Global and regional architecture to support these changes is coming into place.  But the challenges of implementation remain.

In a recent paper published in Asia & the Pacific Policy Studies, Roger Magnusson and David Patterson (Department of Strategy and Innovation, International Development Law Organisation) suggest some promising strategies for strengthening the governance and law reform processes that will be needed if PICTs are to reduce the crippling burden of NCDs on their health systems and economies.  In a previous paper, the authors reviewed the role of law and governance reform in the global response to NCDs and identified some priorities for development assistance for NCD-related law and governance reform.