Incentives for global public health: Patent law and access to essential medicines

This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza, and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key international fora, such as the World Trade Organization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass policy solutions which encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pools, open-source drug development and forms of 'creative capitalism'.

Pacific Rim treaty threatens public health: Patent law and medical procedures

Doctors, surgeons, and physicians around the Pacific Rim should be concerned by the proposals revealed by WikiLeaks in the Trans-Pacific Partnership (TPP). One of the most controversial features of the TPP is the proposal to provide for patent protection in respect of medical procedures. As Public Citizen observed, ‘Health providers, including surgeons, could be liable for the methods they use to treat patients.’ The civil society group noted: ‘Essentially, except for when a surgeon uses her bare hands, surgical methods would be patentable under the U.S. proposal.’ The TPP takes a broad approach to patents and medicine; lacks appropriate safeguards; and fails to address larger questions about equity, development, and human rights. Such a measure could result in greater litigation against medical professionals; barriers to access to medical procedures for patients; and skyrocketing health costs.

TPP draft reveals surgical strike on public health

On 13 November, WikiLeaks released a secret draft text of the Intellectual Property Chapter of the Trans-Pacific Partnership (TPP). The text reveals substantive proposals for expanded protection in respect of copyright, patent, trade mark and trade secrets law, and intellectual property enforcement.

Access to essential medicines: Public health and international law

Historically, there have been intense conflicts over the ownership and exploitation of pharmaceutical drugs and diagnostic tests dealing with infectious diseases. Throughout the 1980’s, there was much scientific, legal, and ethical debate about which scientific group should be credited with the discovery of the human immunodeficiency virus, and the invention of the blood test devised to detect antibodies to the virus. In May 1983, Luc Montagnier, Françoise Barré-Sinoussi, and other French scientists from the Pasteur Institute in Paris, published a paper in Science, detailing the discovery of a virus called lymphadenopathy (LAV). A scientific rival, Robert Gallo of the National Cancer Institute, identified the AIDS virus and published his findings in the May 1984 issue of Science. In May 1985, the United States Patent and Trademark Office awarded the American patent for the AIDS blood test to Gallo and the Department of Health and Human Services. In December 1985, the Institut Pasteur sued the Department of Health and Human Services, contending that the French were the first to identify the AIDS virus and to invent the antibody test, and that the American test was dependent upon the French research. In March 1987, an agreement was brokered by President Ronald Reagan and French Prime Minister Jacques Chirac, which resulted in the Department of Health and Human Services and the Institut Pasteur sharing the patent rights to the blood test for AIDS. In 1992, the Federal Office of Research Integrity found that Gallo had committed scientific misconduct, by falsely reporting facts in his 1984 scientific paper. A subsequent investigation by the National Institutes of Health, the United States Congress, and the US attorney-general cleared Gallo of any wrongdoing. In 1994, the United States government and French government renegotiated their agreement regarding the AIDS blood test patent, in order to make the distribution of royalties more equitable... The dispute between Luc Montagnier and Robert Gallo was not an isolated case of scientific rivalry and patent races. It foreshadowed further patent conflicts over research in respect of HIV/AIDS. Michael Kirby, former Justice of the High Court of Australia diagnosed a clash between two distinct schools of philosophy - ‘scientists of the old school... working by serendipity with free sharing of knowledge and research’, and ‘those of the new school who saw the hope of progress as lying in huge investments in scientific experimentation.’ Indeed, the patent race between Robert Gallo and Luc Montagnier has been a precursor to broader trade disputes over access to essential medicines in the 1990s and 2000s. The dispute between Robert Gallo and Luc Montagnier captures in microcosm a number of themes of this book: the fierce competition for intellectual property rights; the clash between sovereign states over access to medicines; the pressing need to defend human rights, particularly the right to health; and the need for new incentives for research and development to combat infectious diseases as both an international and domestic issue.

Tobacco's mad men threaten public health

Non-communicable diseases – Matthew Rimmer examines plain packaging as a way to curb tobacco use. Smoking is one of the biggest causes of non-communicable diseases.

Julia Gillard, Big Pharma, patent law and public health

It takes a lot of bravery for governments to stand up to big business. But the Gillard government has shown a lot of guts during its tenure. It stood up to Big Tobacco in the battle over plain packaging of tobacco products and has defended individuals and families affected by asbestos. It took on Big Oil in its Clean Energy Future reforms and stood up to the resource barons with the mining tax. The government is now considering Big Pharma - the pharmaceutical industry and their patents – and has launched several inquiries into patent law and pharmaceutical drugs...

Doctors for divestment: Climate change and public health

On the Global Divestment Day on the 13–14 February 2015, doctors and health professionals were at the forefront of the campaign for fossil fuel divestment. In Australia, medical professionals have pushed for fossil fuel divestment, climate action, and re-investment in renewable energy. Professor Fiona Stanley has been a key leader in the debate over public health and climate change, delivering a Monster Climate Petition to the Australian Parliament. In the United Kingdom, the British Medical Association has led the way, with its decision to divest itself of investments in coal, oil, and gas. The landmark report Unhealthy Investments has provided further impetus for the United Kingdom health and medical community to engage in fossil fuel divestment. In the United States and Canada, there is a burgeoning fossil fuel divestment movement. At an international level, there has been a growing impetus for climate action in order to address public health risks associated with global warming.

Using political science to progress public health nutrition: a systematic review

Objective Poor dietary intake is the most important behavioural risk factor affecting health globally. Despite this, there has been little investment in public health nutrition policy actions. Policy process theories from the field of political science can aid understanding why policy decisions have occurred and identify how to influence ongoing or future initiatives. This review aims to examine public health nutrition policy literature and identify whether a policy process theory has been used to analyse the process. Design Electronic databases were searched systematically for studies examining policymaking in public health nutrition in high-income, democratic countries. Setting International, national, state and local government jurisdictions within high-income, democratic countries. Subjects Individuals and organisations involved in the nutrition policymaking process. Results Sixty-three studies met the eligibility criteria, most were conducted in the USA and a majority focused on obesity. The analysis demonstrates an accelerating trend in the number of nutrition policy papers published annually and an increase in the diversity of nutrition topics examined. The use of policy process theory was observed from 2003, however, it was utilised by only 14% of the reviewed papers. Conclusions There is limited research into the nutrition policy process in high-income countries. While there has been a small increase in the use of policy process theory from 2003, an opportunity to expand their use is evident. We suggest that nutrition policymaking would benefit from a pragmatic approach that ensures those trying to influence or understand the policymaking process are equipped with basic knowledge around these theories.

Public Health Psychology: A Conceptual and Practical Framework

Introduction For many years concern for public health has transcended the boundaries of the medical sciences and epidemiology. For the last 50 years or so psychologists have been increasingly active in this field. Recently, psychologists have not only begun to see the need to take action to mould health promoting behaviours in individuals, but have also pointed out the need to join in an effort to develop appropriate social, political, economic and institutional conditions which would help to improve the state of public health. Psychologists have postulated the need to distinguish a new subdiscipline of psychology called public health psychology which, together with other disciplines, would further the realization of this goal. In the following article the historical and international context of health psychology and the changing nature of public health are put forward as having important implications for the establishment of a ‘public health psychology’. These implications are addressed in later sections of the article through the description of conceptual and practical framework of public health psychology in which theory, methods and practice are considered. Many aspects of the conceptual and practical framework of public health psychology have relevance to the health social sciences more generally and forming a basis for interdisciplinary work. The framework of public health psychology, together with the obstacles that need to be overcome, are critically examined within an overall approach that contends it is necessary to increase and improve the contribution of health psychology to public health.

Evaluation of hospital preparedness for public health emergencies in Sichuan (China)

The aim of this research was to develop a set of reliable, valid preparedness metrics, built around a comprehensive framework for assessing hospital preparedness. This research used a combination of qualitative and quantitative methods which included interview and a Delphi study as well as a survey of hospitals in the Sichuan Province of China. The resultant framework is constructed around the stages of disaster management and includes nine key elements. Factor Analysis identified four contributing factors. The comparison of hospitals' preparedness using these four factors, revealed that tertiary-grade, teaching and general hospitals performed better than secondary-grade, non-teaching and non-general hospitals.

An interactive method for engaging the public health workforce with evidence

Introduction Systematic review authors are increasingly directing their attention to not only ensuring the robust processes and methods of their syntheses, but also to facilitating the use of their reviews by public health decision-makers and practitioners. This latter activity is known by several terms including knowledge translation, for which one definition is a ‘dynamic and iterative process that includes synthesis, exchange and ethically sound application of knowledge’.1 Unfortunately—and despite good intentions—the successful translation of knowledge has at times been inhibited by the failure of reviews to meet the needs of decision-makers, and the limitations of the traditional avenues by which reviews are disseminated.2 Encouraging the utilization of reviews by the public health workforce is a complex challenge. An unsupportive culture within the workforce, a lack of experience in assessing evidence, the use of traditional academic language in communication and the lack of actionable messages can all act as barriers to successful knowledge translation.3 Improving communication through developing strategies that include summaries, podcasts, webinars and translational tools which target key decision-makers such as HealthEvidence.org should be considered by authors as promising actions to support the uptake of reviews into practice.4,5 Earlier work has also suggested that to better meet the research evidence needs of public health professionals, authors should aim to produce syntheses that are actionable, relevant and timely.2 Further, review authors must interact more with those who will, or could use their reviews; particularly when determining the scope and questions to which a review will be directed.2 Unfortunately, individual engagement, ideal for examining complex issues and addressing particular concerns, is often difficult, particularly when attempting to reach large groups where for efficiency purposes, the strategy tends to be didactic, ‘lecturing’ and therefore less likely to change attitudes or encourage higher order thinking.6 …

Family-based programmes for preventing smoking by children and adolescents: Evidence and implications for public health

- P -General population, nonsmoking children (aged 5 to 12) and adolescents (aged 13 to 18) with their parents - I -Interventions with children and family members intended to deter tobacco use. Any components to change parenting behaviour, parental or sibling smoking behaviour, or family communication and interaction. - C -Usual practice, or a program of no family intervention - O -Smoking status of children who reported no use of tobacco at baseline.

Turing and the Trans-Pacific Partnership: Intellectual Property, Public Health, and Access to Essential Medicines

A recent controversy in the United States over drug pricing by Turing Pharmaceuticals AG has raised larger issues in respect of intellectual property, access to medicines, and the Trans-Pacific Partnership (TPP). In August 2015, Turing Pharmaceuticals AG – a private biopharmaceutical company with offices in New York, the United States, and Zug, Switzerland - acquired the exclusive marketing rights to Daraprim in the United States from Impax Laboratories Incorporated. Martin Shkreli, Turing’s Founder and Chief Executive Officer, maintained: “The acquisition of Daraprim and our toxoplasmosis research program are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated.” He emphasised: “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.” In September 2015, there was much public controversy over the decision of Martin Shkreli to raise the price of a 62 year old drug, Daraprim, from $US13.50 to $US750 a pill. The drug is particularly useful in respect to the treatment and prevention of malaria, and in the treatment of infections in individuals with HIV/AIDS. Daraprim is listed on the World Health Organization’s (WHO) List of Essential Medicines. In the face of much criticism, Martin Shkreli has said that he will reduce the price of Daraprim. He observed: “We've agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit.” He maintained: “We think these changes will be welcomed.” However, he has been vague and ambiguous about the nature of the commitment. Notably, the lobby group, Pharmaceutical Research and Manufacturers of America (PhARMA), disassociated itself from the claims of Turing Pharmaceuticals. The group said: “PhRMA members have a long history of drug discovery and innovation that has led to increased longevity and improved lives for millions of patients.” The group noted: “Turing Pharmaceutical is not a member of PhRMA and we do not embrace either their recent actions or the conduct of their CEO.” The biotechnology peak body Biotechnology Industry Organization also sought to distance itself from Turing Pharmaceuticals. A hot topic: United States political debate about access to affordable medicines This controversy over Daraprim is unusual – given the age of drug concerned. Daraprim is not subject to patent protection. Nonetheless, there remains a monopoly in respect of the marketplace. Drug pricing is not an isolated problem. There have been many concerns about drug pricing – particularly in respect of essential medicines for HIV/AIDS, tuberculosis, and malaria. This recent controversy is part of a larger debate about access to affordable medicines. The dispute raises larger issues about healthcare, consumer rights, competition policy, and trade. The Daraprim controversy has provided impetus for law reform in the US. US Presidential Candidate Hillary Clinton commented: “Price gouging like this in this specialty drug market is outrageous.” In response to her comments, the Nasdaq Biotechnology Index fell sharply. Hillary Clinton has announced a prescription drug reform plan to protect consumers and promote innovation – while putting an end to profiteering. On her campaign site, she has emphasised that “affordable healthcare is a basic human right.” Her rival progressive candidate, Bernie Sanders, was also concerned about the price hike. He wrote a letter to Martin Shkreli, complaining about the price increase for the drug Daraprim. Sanders said: “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.” He has pushed for reforms to intellectual property to make medicines affordable. The TPP and intellectual property The Daraprim controversy and political debate raises further issues about the design of the TPP. The dispute highlights the dangers of extending the rights of pharmaceutical drug companies under intellectual property, investor-state dispute settlement, and drug administration. Recently, the civil society group Knowledge Ecology International published a leaked draft of the Intellectual Property Chapter of the TPP. Knowledge Ecology International Director, James Love, was concerned the text revealed that the US “continues to be the most aggressive supporter of expanded intellectual property rights for drug companies.” He was concerned that “the proposals contained in the TPP will harm consumers and in some cases block innovation.” James Love feared: “In countless ways, the Obama Administration has sought to expand and extend drug monopolies and raise drug prices.” He maintained: “The astonishing collection of proposals pandering to big drug companies make more difficult the task of ensuring access to drugs for the treatment of cancer and other diseases and conditions.” Love called for a different approach to intellectual property and trade: “Rather than focusing on more intellectual property rights for drug companies, and a death-inducing spiral of higher prices and access barriers, the trade agreement could seek new norms to expand the funding of medical research and development (R&D) as a public good, an area where the US has an admirable track record, such as the public funding of research at the National Institutes of Health (NIH) and other federal agencies.” In addition, there has been much concern about the Investment Chapter of the TPP. The investor-state dispute settlement regime would enable foreign investors to challenge government policy making, which affected their investments. In the context of healthcare, there is a worry that pharmaceutical drug companies will deploy their investor rights to challenge public health measures – such as, for instance, initiatives to curb drug pricing and profiteering. Such concerns are not merely theoretical. Eli Lilly has brought an investor action against the Canadian Government over the rejection of its drug patents under the investor-state dispute settlement regime of the North American Free Trade Agreement (NAFTA). The Health Annex to the TPP also raises worries that pharmaceutical drug companies will able to object to regulatory procedures in respect of healthcare. It is disappointing that the TPP – in the leaks that we have seen – has only limited recognition of the importance of access to essential medicines. There is a need to ensure that there are proper safeguards to provide access to essential medicines – particularly in respect of HIV/AIDs, malaria, and tuberculosis. Moreover, there must be protection against drug profiteering and price gouging in any trade agreement. There should be strong measures against the abuse of intellectual property rights. The dispute over Turing Pharmaceuticals AG and Daraprim is an important cautionary warning in respect of some of the dangers present in the secret negotiations in respect of the TPP. There is a need to preserve consumer rights, competition policy, and public health in trade negotiations over an agreement covering the Pacific Rim.

Review of the Deakin University Master of Public Health Program

This work is one in a series of reports that forms a national review of Indigenous Public Health Core Competencies Integration into Master of Public Health programs. The review is a component of the Indigenous Public Health Capacity Building (IPHCB) Project funded by the Australian Government Department of Health.The Indigenous public health competencies are a core component of the Foundational Competencies for MPH Graduates in Australia (ANAPHI 2009), a curriculum framework that integrates the six core competencies in Indigenous public health expected of every Australian MPH graduate. The aim of this review is to investigate the integration of the core Indigenous public health competencies into the curriculum of MPH programs nationally in order to document and disseminate examples of best practice and to find ways of strengthening the delivery of this content. This report, one in a series, relates to the curriculum review conducted at Deakin University’s Burwood campus, Melbourne in April 2013.