What is behind the sudden Global Marketplace call for Universal Health Care: Co-opting in the making

After setting up the public health infrastructure to fail, the World Bank and their allies are proposing a new solution: to create a publicly funded insurance package using the now expanded network of private providers, who will participate in the program, as long as they are guaranteed payment. While reinforcing the notion that healthcare is a commodity and not a basic human right, this approach has several problems and side effects: fragmentation of care, higher cost, precedence of procedures over preventive medicine and further dismantling of the public healthcare system. At the same time, insurance packages divert attention and funds from a more comprehensive approach directed at modifying the root causes of disease, through socioeconomic interventions aimed at increasing equity

What is Behind the Sudden Global Marketplace Call for Universal Health Care: Co-opting in the Making

      by David Chiriboga*, MD, MPH

Former President of the Health Council for the Union of South American Nations (UNASUR) and former Minister of Health of Ecuador

       

Universal health care (UHC), meaning equal access to healthcare services for all, has been a longstanding demand from progressive movements around the world, for whom health is considered a basic human right and not a commodity to be privatized for economic gain. The neoliberal policies of “€œfiscal responsibility”€ promoted by the World Bank focus on decreasing public spending on social programs, with public healthcare services among the main targets. This has caused massive privatization of healthcare services worldwide and severely limited access for the poor. Why is there an apparent change of heart of the World Bank and the global corporate interests? Why do these organizations now seem to be rallying in support for UHC?

The answer to this change in heart stems from the understanding of the economic impact of “€œinvesting in health,”€ since the healthcare industry can be a significant component of economic growth, and when people have access to healthcare people live longer, and they produce and consume more. Global corporate interests have one goal: increased returns, and the best way to achieve this, aside from maximizing profit margins, is by increasing market share. As many other industries, including the tobacco and fast food industry, the healthcare industry, currently around a USD $7 trillion industry worldwide, with its related corporations (pharmaceutical industry, medical devices and equipment, and private insurance) are targeting previously untapped populations: the large pool of poor people in “€œthird-world”€ countries, where over 3/4ths of the world’€™s population reside. A strategy to access that market share is to implement insurance packages, ideally publicly funded, since the poor have minimal out-of-pocket resources. These insurance packages tend to cover few specific conditions that affect certain high-risk population groups, like women of childbearing age and young children. However, many of these resource-poor countries have precarious public healthcare systems that have been severely undermined by the very same austerity policies put forward by the World Bank over two decades ago. After setting up the public health infrastructure to fail, the World Bank and their corporate and academic allies are proposing a new solution: to create a publicly funded insurance package using the now expanded network of private providers, who will participate in the program, as long as they are guaranteed payment. This will not only strengthen the private network, but will increase the market share of healthcare corporations, while reinforcing the notion that healthcare is a commodity and not a basic human right.

Although this approach may in fact save lives, albeit selectively, publicly funded insurance packages, delivered by private providers, have several problems and side effects: fragmentation of care, higher cost, precedence of procedures over preventive medicine and further dismantling of the public healthcare system. At the same time, insurance packages divert attention and funds from a more comprehensive approach directed at modifying the root causes of disease, through socioeconomic interventions aimed at increasing equity, since socioeconomic injustice is directly responsible for over one third of deaths in the world, about 20 million avoidable deaths each year, for the past 20 years. Investing on improving socioeconomic inequality could have an enormous impact on overall health and wellbeing that providing partial health insurance does not address.

Insurance packages provoke fragmentation of healthcare services and its associated health disparities under the banner of progressive (a little at a time) universalization, since they cover only specific services in restricted population subgroups. This causes huge gaps in care even within families, if a family member who is not a young woman or a child of a specific age group, the family will have to struggle to access the now dismantled public healthcare sector, or pay out-of-pocket for the private services. Similarly if the woman or child who is insured suffers an illness that is not covered, they are left to fend for themselves. Since eighty percent of the world population live on less than US $10 per day, when a serious illness strikes in this already vulnerable population, oftentimes, not even selling all their possessions and going into debt will cover the full cost.

As part of the neoliberal mandate, reimbursing private providers’€™ services takes priority in the government’€™s budget, therefore private doctors and hospitals, as well as the pharmaceutical industry, and the medical device and equipment companies, get reimbursed for their services first. In the meantime, public services continue on their downward spiral of quality due to chronic underfunding, decaying physical and technological infrastructure and brain drain. As a result, the private sector starts booming, since through the insurance packet the government picks up the tab, effectively subsidizing private practice, further distorting the notion of a rational, equitable healthcare system.

The packages cover for the most part procedures, and procedures will be done even if medically not indicated, as the mounting evidence shows, among a “€œcadre”€ of overbilling abuses, even in countries with strong regulatory agencies. An analogy could be drawn to having fire departments and firemen paid on the basis of the number of fires: it would become a system with perverse incentives. Therefore there is a need for a strong oversight, but, given that there are no appropriate governmental agencies to supervise the system, again as direct a result of the fiscal austerity policies and corruption, the usual prescription from the neoliberal cookbook will be to find a private third-party hired to do the job. Even with regulatory agencies in place there is growing evidence that in general they are seldom effective and tend to not be able to keep up with their mandate.

The end result is that by using publicly-funded health insurance packages, there is an effective co-opting of the term universal health care, shifting from a human rights’€™ approach, towards the private sector, for profit-€“healthcare becomes a product that can be bought or sold. Therefore the World Bank and associates’€™ new proposal is yet another attempt at privatization of healthcare services, this time using government subsidies. Since the public sector has been set up to fail and deemed ‘inefficient’, the private sector appears to save the day.

The private sector and its proponents claim that individual freedoms of both providers and patients are essential. Initially individual physicians may have the power to make decisions about practice patterns as well as pricing of services and procedures. As the private health market progresses, physicians groups take over that role and subsequently, the decision-€“making power shifts to insurance companies and healthcare corporations. Most physicians and other healthcare providers become salaried employees and have progressively less of a say on how business is run. Providers increasingly clash with the demands of meeting their daily quota of patients, while finding that sometimes even clinical decisions on individual patients are taken remotely by administrators, who respond to institutional financial needs and not always patient needs. As for the freedom of the population to choose providers in the private sector, the freedom is related to the purchasing power of the individual and to the type of insurance. As a general rule, the wealthier the person, the better the choices, otherwise, type of insurance, co-payments and caps progressively limit choice, and in the case of severe illnesses or catastrophic events, bankruptcy ensues. Individuals with public insurance tend to have little freedom of choice.

As the public insurance package only covers certain needs that selected high-risk individuals may have, the rest of the population fall prey to the supplemental private insurance market. Before the era of medical insurance the price of private services and procedures was limited by the out-of-pocket capacity of the population, however, with insurance this market safeguard has disappeared and allowed the price of procedures and services across the board to skyrocket, since now it is not just the cost of the procedure or the service, but the added compensation for an intermediary. Supplemental insurance is yet another way in which insurance package progressive UHC works for the private sector. Ultimately, people may end up having to pay several times for their healthcare services: first, in the form of taxes to finance the public services and limited insurance packages (a progressive tax); second, as workplace health insurance (social security and private insurance, which tend to be regressive -€“USD $300 a month per person is not the same percentage of the salary for a factory worker than it is for a corporate CEO); a third time as private supplemental insurance, also regressive, to cover the gaps in basic public and private insurance; and, finally, a fourth time, as out-of-pocket costs, for everything that is not covered by any of the preceding programs.

Health insurance packages are a method to induce progressive dependence on insurance companies. Once they are able to introduce the basic package, the rest will follow. They create a “€œneed”€ by inducing fear of having to confront the high costs of private healthcare-€“made higher through their participation. They also market their services to providers as physicians and hospitals welcome the security of reimbursement, even if it means splitting the earnings to a point dictated by the size of the group practice. If the government subsidizes the initial package, this is welcome news, and the private insurance market is there to feed on fear, promising progressive coverage for the right asking price. Insurance companies thrive with low risk coverage (young and healthy individuals) and tend to use unethical “€œcherry picking”€ practices to avoid insuring those at higher risk, like pre-existing conditions, complications of deliveries, neonatal care, cancer, etc., either by refusing coverage or by applying event, yearly or life ‘€˜caps’€™ on reimbursement and progressively increasing the price tag. As happens with the rest of the corporate world, these companies usually have little governmental oversight and regulation, even in high-income countries.

Another issue with the insurance package UHC, delivered by private providers is the creation of double standards. As the private sector gets stronger with the cash infusion from the government, it becomes more selective and tends to favor patients who have private insurance, since public insurance packages reimburse a lesser amount. In response to the progressive discrimination of the “€œpoor”€ in the healthcare setting, the government has to setup economic stimulus, in the form of grants, for non-governmental organizations (NGOs) to compete over federal funding every year to provide healthcare services to the poor. This situation occurs in the United States (US) with the Medicaid program, a public insurance program in the US, which reimburses private providers for healthcare services. Many private providers stop taking care of patients with Medicaid insurance because the reimbursement is less. Therefore the system does not provide equal access. Not only double standards in terms of access, but there are many reports of public insurance holders receiving substandard healthcare services as compared to the private insurance holders.

Cost containment is an increasing concern, however, in a government-funded progressive UHC system delivered through private providers, there is limited opportunity to use the purchasing power in price negotiations for medications, medical supplies, devices and equipment. It is definitely not the same to buy, pain medication, anti-retroviral or chemotherapeutic agents for one hospital or even a group of hospitals, than it is to buy for the entire healthcare network of a country or even a continental region. The same applies to medical supplies, devices, and equipment, from blood pressure monitors to magnetic resonance imaging scanners. Given current levels of health expenditure we cannot afford not to use the leverage of a government or a continental region to control expenditures. Along the same lines of cost containment for the long run, and under the premise of health as a basic human right from a global perspective, novel and ethical ways of thinking about the outdated international patent system are required. International laws to defend the public domain, pool patents, and facilitate the strategic development of national or regional not-for-profit production of pharmaceuticals, as well as medical devices and health technology and equipment.

The end result of using this progressive UHC based on insurance packages and delivered through private providers is a highly complex, extremely expensive, procedure-based, publicly-subsidized private healthcare system, with a plethora of primary and supplemental private insurance companies, healthcare corporations, managed care organizations, private and public control agencies; with a struggling, disjointed yet massive administrative maze, in a frantic quest for quality assurance and cost containment. In the US, the richest country on the planet, and probably the most important exponent of healthcare as a commodity, the end product is not a system but an intricate patchwork scheme, with a price tag of around USD $3 trillion, or 18% of its GDP in healthcare.

That is with about 47 million non-elderly adults (15% of the population) devoid of any form of health insurance, either public or private. After the enactment of President’s Obama Affordable Care Act, which makes it compulsory to purchase health insurance or face tax penalties – a regressive measure, the number of uninsured dropped to 40 million. These uninsured people in the US are not poor enough to qualify for public insurance but neither have enough income to afford private insurance. In 2013, according to the US Institute of Medicine, in spite of this massive expenditure people in the US have shorter lives and poorer health than people in other high-income nations, making it not only an inefficient but also an economically unsustainable model.       

 On the other hand, in Europe, where there has been a longer tradition of health as a human right and of comprehensive UHC systems, with a mixture of public and private providers, there is a real danger of insurance companies gaining market share and causing and deepening fissures in the public system by selling supplemental health insurance, to either “€œjump the queue or other forms of preferential treatment, preying on the limitations of public systems. As long as health is treated as a commodity, there will be double standards based on one’s ability to pay. Unlike most merchandise which we choose to purchase or not, all of us will need to use the healthcare system at some point, and when we do it needs to be accessible to all, effective and compassionate.

There is much to learn from successes and failures of universal healthcare systems across the globe. Those that succeed honor the right to health and recognize that economic injustice accounts for a significant proportion of morbidity and mortality, and by investing in the social determinants of health: sanitation, housing, education, job security, access to quality food, alternative urban planning, pollution control, among others, countries can improve health and overall wellbeing to a much greater extent than through healthcare services in and of themselves.

There are enormous challenges ahead for a mature, ethical world, which acts on universal societal principles, abiding by all basic human rights, so that we can provide the best possible level of physical, psychological and social wellbeing for all, while preserving our world for generations to come. To negate the catastrophic effect on our planet of having unregulated sustained economic growth and GDP as the sole goals is tantamount to insanity. We need an urgent change of course. We need to reclaim our say in the political realm and not let self-serving, economic, corporate and partisan interests dictate our fate and that of our planet. We will be responsible either way.

Citizens of countries with universal health care have a historical duty to defend true UHC from private co-opting, as an expression of their right to health, by participating in the search for creative solutions to the limitations of the current system, and by not giving in to the private market equivocation, a responsibility shared by governments of those countries, and international democratic organizations like the World Health Organization. Publicly funded insurance packages are NOT equal to universal health care and rather pursue the consolidation of the private healthcare sector and the health-associated corporations. So yes, we need universal health care (meaning for all people), through appropriate funding mechanisms, like fair regressive taxation, and developing a sensible, straightforward, ordered healthcare system based on the ethics of equity. A system that promotes, facilitates and rewards excellence in service; that is centered in health promotion and disease prevention, and which includes the active participation of the population in its design and implementation. Health is a basic human right, not an article of trade.

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*Dr. Chiriboga obtained his doctorate degree in medicine at Escuela de Medicina de la Universidad Central del Ecuador, and his postgraduate training in Preventive Medicine and in Public Health at the University of Massachusetts Medical School and School of Public Health. He held academic appointments at the University of Massachusetts Medical School. He designed and implemented a comprehensive healthcare system for the indigenous people in central Ecuador 1988-2001.  He served as Minister of Health in Ecuador (2010-11) where he undertook a major re-structure of the healthcare system of the country. He also served as President of the Health Council for the Union of South American Nations (UNASUR) 2010, bringing key draft resolutions regarding generic medicines and research and development of medicines for neglected diseases approved by the World Health Assembly.  Dr. Chiriboga was the keynote speaker at the European Union Conference in Global Health held in Brussels in 2010. His interests include global health equity, the development of affordable universal health care systems, as well as multi-sectorial prevention strategies. 

 

 

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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries

 

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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries

 

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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries

 

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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries

 

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Whither the Endgame of the Anti-Vaccination Movement?

Effective immunization programs protect our communities and our way of life from innumerable communicable diseases, while encouraging development efforts abroad. Eradication is a laudable goal that can only mean better health for all. Thus, it matters not if anti-vaccinators are radical militants or Hollywood celebrities; they stand with each other, and with these preventable diseases

Whither the Endgame of the Anti-Vaccination Movement?

 

By Lawrence C. Loh, MD, MPH, CCFP, FRCPC*

Adjunct lecturer at the University of Toronto’s School of Public Health, co-founder and Director of Operations at The 53rd Week

 

 

A roadside bomb detonates in northwest Pakistan, and militants open fire on a convoy in an hour-long attack that kills 12 and wounds dozens more.  This attack successfully disrupts the delivery of polio vaccine to a remote area of the subcontinent, delaying and hampering ongoing efforts to eradicate poliovirus from the face of the earth. Meanwhile, across the world, in a boardroom meeting in Canada, a group of public health professionals fall silent at news that containment of a measles outbreak has failed. Despite their best efforts, what started as a few cases in a school with poor vaccination coverage has now exposed people in retail settings, transport terminals, universities, and healthcare facilities. These widespread community exposures are compounded with declining rates of vaccine coverage, which all but assure ongoing spread. Measles remains as infectious at it has ever been.

These professionals are fighting the same war that humanity has waged against disease and contagion for millennia.  These scenes are battles, repeated all over the world, to that cause; battles of recent times that have not gone well. Increasingly, public health encounters opposition from the very people who they are trying to protect from these diseases. Be it allegations that vaccination is a Western plot to sterilise Muslims, or misguided beliefs based on spurious or fully retracted research, a small but vocal minority in populations cling to their beliefs, spread misinformation, and make it easier for the diseases to spread and win battles. A decision to not vaccinate threatens overall community immunity, allows the re-establishment of disease transmission in the public, and threatens to undo the work of decades of battles won against vaccine-preventable diseases.

As with any conflict, there are sides, each with their own resources and special weapons. In the fog of war it is often difficult to determine which side will be victorious, and sometimes difficult to see which side is the “€œright side”€. To make this analogy easy, let us define the “€œright side”€ as the side you’€™re meant to cheer for when you’€™re watching the hindsight Hollywood depiction years later. In this sense, public health professionals and advocates will argue that they make a compelling case for being that side. Their weapons and tools are immunisation, surveillance, and isolation, all backed by research and evidence that prove their effectiveness in turning the tide.

Deploying these resources has brought about measured successes, including the eradication of smallpox and the bringing of polio to the brink. Immunisation and related efforts have prevented innumerable cases of diseases worldwide, directly alleviating human suffering and protecting healthcare resources while indirectly driving the educational, social, and economic development of nations.

So who is on the other side? For centuries, the diseases that plagued society stood alone on the other end. As outbreak after outbreak crippled children, scientists raced to discover an effective way to treat or prevent disease while societies stood together to support these efforts. The discovery of vaccination meant that slowly, one by one, former scourges fell to the ingenuity of science and innovation.  Diseases like diphtheria, measles, and mumps, all became far less commonplace. As communicable disease rates plummeted, civilisations flourished. Quality of life improved, economies thrived, and non-communicable diseases began to replace vaccine-preventable diseases as contemporary concerns.

In their near defeat, the vaccine preventable diseases found an unlikely ally. Their virtual disappearance made them less of a threat to human society. Through success, though, vaccination turned out to be its own worst enemy perhaps; by removing these diseases from public consciousness, vaccines themselves have come under scrutiny. The spectre of crippling polio was replaced by pointed questions about vaccines. A spectrum of reasons -€””€œconscientious”€ objection, anti-establishment views, religious re-interpretation -€”brought together with junk science and double-agents – €”has succeeded in giving vaccine preventable diseases a breakthrough in areas which have not seen battle for many years.

Celebrities make spurious claims about long-disproved, barely rational linkages between immunisations and any number of diseases. Healthcare workers taking care of vulnerable populations still continue to resist policies that make immunisation with flu vaccine mandatory. And as they do, the diseases return with a vengeance. Measles, once nearly eliminated in North America, now leaves communities all over the continent stricken. Public health departments struggle with limited resources to control outbreaks of pertussis.

Thus, to return to the analogy: the war yet rages on, but today, the sides and their resources are far more complex. Public health and their allies continue with their tools of immunisation, surveillance, isolation, prophylaxis, and prevention, while anti-vaccination folks have aligned with these preventable diseases, spreading their opinion and sharing misinformation that leads people to opt-out of vaccination. That much is clear.

As with any war, there is also strategy involved. And for at least one of these sides, the endgame is absolutely clear. Those that stand on the side of immunisation are looking to defeat these diseases. After the success of smallpox, with polio on the brink, these groups would imagine a world where the threat of many of these communicable diseases is eliminated or minimised as much as possible. Their endgame is the safeguarding of health through prevention, and through the eradication, of vaccine preventable diseases.

 

The polio endgame

The polio campaign is one of the most demonstrable examples of the strategic goal of those who support immunization. Polio, once an endemic virus spread by fecal-oral transmission, once darkened many families’€™ hopes with paralysis and iron lungs. Today, it is endemic in three final countries in the world: Pakistan, Afghanistan, and Nigeria. The formerly perceived impossibility of interrupting poliovirus transmission in India came to pass in January 2014, with endemic transmission of polio not seen in this populous nation for 3 full years.

Driven by the World Health Organization (WHO), Rotary International, the United States Centers for Disease Control (CDC) and the United Nations International Children’s Emergency Fund (UNICEF), the Global Polio Eradication Initiative oversees ongoing programs in polio endemic areas, research, and fundraising worldwide. An ambitious goal of no wild-type transmission of polio by 2014 has been set. There are detailed, outlined plans to strengthen surveillance systems and secure polio vaccine stocks and certify regions as polio-free while synchronising an eventual change from oral polio vaccine to inactivated polio vaccine.

Efforts to eradicate polio drew their inspiration from smallpox eradication efforts. To date, smallpox remains the only such disease eradicated. It had the benefit of a very effective, heat-stable vaccine that could be transported to myriad far-flung locations and administered with a bifurcated needle that was readily available in remote outposts and could be readily re-sterilised. Trained local staff, together with international experts, would quickly identify outbreaks of smallpox and deploy the vaccine to prevent its spread. In the last days of smallpox, efforts intensified; cases were actively sought out and their close contacts vaccinated. Hard work paid off when the last case of smallpox was reported in 1977 in Somalia.

Polio eradication efforts stand on the cusp of a similar victory. It has been a far more challenging road, but the endgame and strategy remains the same -€”use vaccination to wipe an otherwise incurable disease off the face of the earth. Provided diseases meet certain criteria, they could all theoretically be a candidate for eradication. And the optimists in the public health field often highlight that a world without vaccine-preventable diseases would be a wonderful world indeed.

As Poonam Singh, the South-East Asian Regional Director for the World Health Organization, stated on India’€™s being certified polio-free: “Such an achievement can also be reached for diseases such as measles and rubella […] eradication helps to reduce poverty and give children and families a greater chance of leading healthy and productive lives.”€

In the ongoing struggle against communicable disease, those who would vaccinate espouse a clearly defined strategy with unequivocal goals.

 

The rise of the anti-vaccinators

One wonders what vision those who are against vaccines hold. Much vaccine refusal is rooted in fear: fears that certain vaccines are linked to autism (a research finding since retracted and heavily discredited); fears of the contents of vaccines; fears of societal medicalisation; moral fears of promiscuity in adolescents. Despite the disease-free modern world we live in today as a tribute to earlier immunisation programs, vaccines have become the enemy, and are feared.

Many famous anti-vaccine activists are successful because they appeal to base human fears of the unknown. In a world where measles or mumps no longer causes encephalitis (brain inflammation), they become an unknown. “€œWhat is this vaccine really doing to our kids? How can we know it is preventing what it claims to be preventing? How do we know it isn’€™t necessarily causing something worse? “€œ

Anti-vaccinators trot out stories of their children. Their stories tug at heartstrings, and they support their views with whatever “€œevidence”€ they can find, rather than let evidence dictate their views. And in doing so, they influence a too-often persuadable public to not vaccinate. Other members of the public find other reasons to not vaccinate: “€œbig pharma is screwing us”€, “€œit’€™s not the natural solution I ascribe to”€, or “€œI’€™m simply just scared of needles”€.

The end result is still the same. The collective immunity that protected our communities from these diseases and drove the prosperity of the 1960s-2000s is now dropping across continents. Measles outbreaks from the Netherlands get imported into our backyard here in North America. Pertussis has returned with a big whoop and cry. Public health departments, struggling to cope with rising obesity, cardiovascular disease, cancer and diabetes (the other by-products of affluence: chronic disease) now contend with re-established transmission of diseases once thought eliminated.

And through it all, anti-vaccinators get what they wanted; they did not need to take a vaccine. In many ways, this reflects the “€œme-first”€ nature of today’€™s society. They get what they wanted. Never mind that with the return of these diseases, the weak and infirm are more vulnerable to being exposed, infected, and dying. Never mind the economic impact that new measles outbreaks will cause as tourists flee and business close to prevent spread. And of course, as diseases re-establish transmission in communities, at least their kid didn’t have to get vaccinated, never mind that someone else’s kid manages to contract meningitis.

 

A story of two endgames

Thus, returning to the initial premise that there are two sides, we can see that each side’€™s strategies and resources drive towards very different ends.

Those who would vaccinate propose an endgame where collective health is a target to be aimed towards. They recognize the importance of collective immunity in interrupting disease transmission, and are acutely aware that public health departments need to be able to focus on the challenges of our time. Health needs to be able to turn back obesity, chronic disease, and mental health issues without also worrying about preventable communicable diseases.

Those who would vaccinate believe the world would be a better place without polio, mumps, measles, meningitis, whooping cough, Hepatitis B, cervical cancer, and any other number of diseases. These are the people who are putting themselves out there every day; working tirelessly to deliver immunisations, educate the public, and in some cases, putting themselves in harm’s way for the cause of polio eradication.

They recognize that the modern societies we live in today have enjoyed economic prosperity and development owing to the immensely effective control of communicable disease through hygiene and vaccination. They want to address communicable disease because today’€™s challenges are increasingly non-communicable: over a quarter of most adults in the industrialised world are obese, while depression and injuries take their toll on the younger, more productive members of our society. Tobacco and unsafe alcohol use continue to take lives every year and years off of lives.

They also recognise that in the developing world, immunisation remains one tool in an arsenal against poverty; it guarantees a modicum of health for those who live in indigent settings; it allows healthy children and youth to make use of education and social services to become productive members of a growing nation and economy.

On the other side, what precisely is the anti-vaccination endgame?

In a world where vaccinations are shunned, we have the return of outbreaks that bring fear and hamper efforts on other critical public health issues of our time. Massive recurring measles outbreaks become de rigueur; when one pops up, isolation protocols disrupt daily life, bankrupting small businesses while turning schools and community centres into ghost towns. Public health efforts to address other issues (chronic disease, or mental health) go by the wayside as outbreak after outbreak calls for containment.

People remember the halcyon days where adequate population coverage meant that they could travel without having to regularly check their immunity at their physician’€™s office. Influenza strikes more people harder due to more frequent transmission and mutation. Eventually, driven by a massive swing in popular opinion, governments de-list immunizations from public insurance plans. Some individuals pay for immunizations privately and benefit, but society as a whole does not reap the benefits of collective immunity because there simply aren’t enough people vaccinated.

This dystopian future serves to illustrate a simple point: ask an anti-vaccinator what their endgame is. We need to challenge their assertions beyond the surface answer. Dig deeper, and genuinely explore how they see the future. No matter how much one believes in celebrity star power, natural solutions, or even the non sequitur “€œbecause I believe in being healthy”€, the fallacy of an anti-vaccine argument unravels very quickly when taken to its logical question of “€œBut what if we as a society chose not to vaccinate? What then?”

Effective immunization programs protect our communities and our way of life from innumerable communicable diseases, while encouraging development efforts abroad. Eradication of polio and other vaccine preventable diseases is a laudable goal that can only mean better health for all.

Thus, it matters not if anti-vaccinators are radical militants or Hollywood celebrities. By refusing to vaccinate, they stand with each other, and with these ancient, preventable diseases.

Seen in the stark light of the endgame and goals, “€œthe right side”€ in the vaccination debate becomes quickly obvious.

 

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*Dr. Lawrence Loh is a global public health and family physician based in Vancouver. He serves as a Medical Health Officer at Fraser Health Authority and as an adjunct lecturer at the School of Public Health at the University of Toronto. A proud alumni of the Schulich School of Medicine at the University of Western Ontario, he completed his residency at the University of Toronto and obtained his Master of Public Health from the Johns Hopkins Bloomberg School of Public Health. He serves as co-founder and Director of Operations for The 53rd Week and is committed to reducing the harms and maximising the outcomes of short-term global health experiences through awareness advocacy, innovation, and research.

To learn more about what The 53rd Week is doing to improve short-term volunteerism abroad, visit www.the53rdweek.org

The High Price of Drug Patents: Australia, Patent Law, Pharmaceutical Drugs and the Trans-Pacific Partnership

 Published by the Australian Government on the 20th March 2014, the independent "Pharmaceutical Patents Review Report" recommends to shorten and reduce patent term extensions, to address the problems of evergreening and data protection, and to reverse Australia's passive approach to the negotiation of intellectual property and international trade. The report emphasizes the need for Australia to protect its public health interests in the negotiation of the "Trans-Pacific Partnership"

The High Price of Drug Patents: Australia, Patent Law, Pharmaceutical Drugs and the Trans-Pacific Partnership

by Matthew Rimmer*

Associate professor, Australian National University College of Law, Canberra

This week, the secrecy surrounding an independent Australian report on patent law and pharmaceutical drugs has been lifted, and the work has been published to great acclaim.

On the 20th March 2014, the Australian Government published the final version of an independent policy report, the Pharmaceutical Patents Review Report, after much public pressure.1 The report has significant implications in respect of patent law, pharmaceutical drugs, the Pharmaceutical Benefits Scheme, and trade policy -€“ particularly in respect of the Trans-Pacific Partnership. The independent report has also highlighted the opportunity of great savings for the Australian health-care system through shortening patent term extensions. The economist Peter Martin has warned: ‘€˜Australia’s enthusiastic approach to extending the life of pharmaceutical patents has cost the economy “€œbillions of dollars”€ an independent review has found.’€™2

This paper provides a short review of the Pharmaceutical Patents Review Report, and highlights key recommendations. In particular, it looks at the call by the review for a frugal, parsimonious approach to the granting of patent rights in respect of pharmaceutical drugs in Australia. The paper considers the recommendations of the Pharmaceutical Patents Review Report to shorten and reduce patent term extensions. It examines the proposed recommendations to address the problem of evergreening. This paper also considers the debate over data protection. Finally, the Pharmaceutical Patents Review Report is critical of Australia’€™s passive approach to the negotiation of intellectual property and international trade. The findings of the report emphasize the need for Australia to protect its public health interests in the negotiation of the Trans-Pacific Partnership.

The Pharmaceutical Patents Review Report

Under the leadership of Julia Gillard, the Australian Labor Party took a keen interest in the impact of patent law upon research, patient care, and the provision of health-care.3 Indeed, Gillard had taken a particular interest in patent owners engaging in the nefarious practice of ‘€˜evergreening’€™ -€“ extending the life of patents beyond their natural term by making minor changes.

The report had been commissioned by Mark Dreyfus QC MP, a Parliamentary Secretary for Innovation in the former Australian Labor Party Government. The review was designed to examine whether Australia’€™s patent system was ‘€˜effective in securing timely access to competitively priced pharmaceuticals and in supporting innovation and employment in the industry.’€™ The report was undertaken by three well-respected experts -€“ Tony Harris; intellectual property academic Professor Dianne Nicol, and economist Dr Nicholas Gruen.

Initially, the Minister for Industry Ian McFarlane for the new Coalition Government was reluctant to release the final report. Melissa Parke MP -€“ the member for Fremantle -€“ asked in the Australian Parliament: ‘€˜By what date will he release the final report of the 2012 Pharmaceutical Patents Review, and is he considering the draft recommendations released in April 2013?.’€™4 Ian McFarlane responded that ‘€˜the Government has no plans to release the final report at this stage’€™ and ‘€˜the Government is not considering the recommendations made by the panel in the draft report.’€™ Ian McFarlane maintained: ‘€˜As the Pharmaceutical Patents Review was commissioned by the previous government and conducted by an independent panel, the government is not obliged to release the report.’

Dr Deborah Gleeson from LaTrobe University highlighted the failure of the Coalition Government to publish the report.5 She noted: ‘€˜While Treasurer Joe Hockey is complaining that Australia is running out of money to fund the health system, the Coalition Government has buried a report with recommendations for large-scale savings on drug costs.’€™ But the burial of the final report, the submissions made to the review and the economic estimates of the costs of patent term extension is particularly concerning in the light of the current Government’s search for cost-cutting measures.’€™ Gleeson lamented: ‘€˜It will be a shame if we end up with knee-jerk policies like $6 GP co-payments in an attempt to cut health system costs when sensible reforms to patent law could generate hundreds of millions of dollars of savings through the Pharmaceutical Benefits Scheme’€™. She warned that ‘€˜an even worse prospect would be the further extension of patent monopolies through our international trade agreements, adding hundreds more millions to the health budget.’ 

Information activist Brendan Molloy -€“ a member of Pirate Party Australia, and Electronic Frontiers Australia – sought to reveal the report through freedom of information requests.6 

In the end, the Australian Government relented, and published the Pharmaceutical Patents Review Report. The Australian Government was non-committal about the recommendations of the report:

Government statement on the Pharmaceutical Patent Review final report. The Pharmaceutical Patent Review was commissioned by the previous government and conducted by an independent panel. The review panel provided its final report to the previous government in May 2013, which did not release the report. The government notes that the report is one of a number of reviews of the pharmaceutical system conducted during the term of the previous government. The government has no plans to respond to the report at this stage but may take information in the report into account when considering future policy. The views expressed and recommendations made in the report are those of the review panel and do not necessarily reflect government policy.

It is a credit to the Minister Ian MacFarlane to release the report, so that there could be a full and frank public discussion in respect of patent law and pharmaceutical drugs.

A Frugal Approach to Patent Rights

The final 233-page report – Pharmaceutical Patents Review Report – is essential reading for those interested in intellectual property and public health. The combination of Tony Harris, Dianne Nicol, and Nicholas Gruen has ensured that the work is a multi-disciplinary investigation into patent law and pharmaceutical drugs. The report is a thorough, systematic, and balanced piece of work. The report is informed wide-ranging consultations and interactions with industry, government, academia, and consumers.

The Pharmaceutical Patents Review Report emphasizes that ‘€˜the question of how much patent protection to offer is crucial.’€™ The study noted:

Pharmaceutical patent rights that run for too long or that are defined too expansively will deprive people of drugs because purchasers, including Governments, cannot afford them. They can also constrain follow on innovation: too weak a patent system means patients will suffer because the industry has inadequate incentives to develop new drugs. 

The Pharmaceutical Patents Review proposed a frugal approach to the grant of patent rights. The Review recommended that ‘the Government should expeditiously seek a situation where Australia has strong yet parsimonious IP rights – that is, rights that are strongly enforced and that provide the incentive necessary to underpin an appropriate level of investment in innovation – but that are not defined so broadly as to impose costs on innovation or other activity without commensurate benefits.‘  The report suggested: Australia should take a leadership role in seeking consensus with jurisdictions with similar interests to identify and pursue a range of changes in international patent law and practice along these lines.‘  The report observed: ‘€˜While the patent system must be strong to be effective, it should also be parsimonious, avoiding restrictions on trade and innovation that are not necessary for it to deliver incentives to innovate.’€™

Patent Term Extensions

The Pharmaceutical Patents Review Report makes a number of important recommendations relating to patent term extensions. Under Australia law, the patent term lasts for twenty years. Since 1998, pharmaceutical drug patents can obtain additional term extensions for up to a further years. The inquiry noted:

An important part of the terms of reference of this inquiry is to evaluate the extension of term (EOT) that the Australian patent system allows. It applies to some pharmaceuticals for which patentees have taken at least five years from the effective patent filing date to obtain regulatory approval for the pharmaceutical’s use. The current scheme dates from 1998. It aims to attract investment in pharmaceutical R&D in Australia, as well as providing an effective patent term for pharmaceuticals more in line with that available to other technologies. The scheme currently provides an effective patent term of up to 15 years. 

The report noted that patent term extensions were expensive for the Australian Government: ‘€˜The estimate for 2012-13 is around $240 million in the medium term and, in today’€™s dollars, around $480 million in the longer term’€™. The report stressed: ‘€˜The total cost of the EOT to Australia is actually about 20 per cent more than this, because the PBS** is only one source of revenue for the industry.’€™ The report emphasized: ‘€˜Using the patent scheme to preferentially support one industry is inconsistent with the TRIPS rationale that patent schemes be technologically neutral.’€™

**acronym for Pharmaceutical Benefits Scheme

The inquiry canvassed a number of policy options to address patent term extensions:

Australia is required by AUSFTA to provide some form of pharmaceutical EOT but its scope and length are not specified. Actual savings obtained from reducing the term of the extension would be affected by many factors, including price changes caused by increasing sales volumes, the 16 per cent mandated price reduction following the entry of a second drug, the influence of competing generic manufacturers and reductions from price disclosure mechanisms. But there are timing issues in reducing the EOT provisions immediately without compensation. Savings from the options considered in this report, including the recommendation to reduce the effective life of extended Australian pharmaceutical patents, would take several years to reach full effect.

The inquiry recommended: ‘€˜The Government should change the current EOT to reduce the maximum effective patent life provided from 15 years.’€™ There was a difference of opinion between the members of the review: ‘€˜Harris and Gruen support reducing the effective life to 10 years, whereas Nicol supports reducing the effective life to 12 years.’€™ The report advised: ‘€˜The length of the extension should be calculated as being equal the number of days between the patent date and the date of first inclusion on the Australian Register of Therapeutic Goods minus 20 years less the maximum effect patent life.’€™ The report noted: ‘€˜The current 5 year cap on extensions should remain, providing a maximum of 25 years patent term for extended patents.’

The Pharmaceutical Patents Review Report emphasized that there could be significant savings to Australian tax-payers from the reform of Australian patent term extensions. The recommendation by Harris and Gruen was predicted to provide for massive savings:

Mr Harris and Dr Gruen recommend reducing the effective patent life from 15 to 10 years. Over time this would save the PBS approximately $200 million a year. in today’€™s dollars, based on current pricing arrangements (that the entry of generics will lead to price falls of 35 per cent) which the Government has agreed with Medicines Australia. The savings would grow in line with PBS costs which are growing at 4.5% per annum, substantially faster than real GDP. If the Government secured all of the pricing benefits allowed by the entry of generics, annual savings in today’€™s dollars could amount to around $400 million which would similarly be expected to grow with PBS costs. This is calculated on data that generics have led to a 70% price reduction in the United States. This is consistent with recent findings by the Grattan Institute that the price of generics paid by the PBS is several times the price secured by relevant Australasian Governments.

It is calculated that Professor Nicol’€™s recommendation to shorten the effective patent life would result in significant savings: ‘€˜The estimated savings resulting from this reduction would be approximately $130 million a year.’€™ Moreover, it was noted: ‘€˜If a 70% price reduction from generic entry was achieved as discussed above, the savings would be approximately $260 million a year.’€™

Patent Standards and the Problem of Evergreening

The former High Court of Australia Justice Michael Kirby observed in a case that patent law ‘€˜should avoid creating fail-safe opportunities for unwarranted extensions of monopoly protection that are not clearly  sustained by law.’€™

The Pharmaceutical Patents Review Report also addressed the pernicious problem of evergreeening -€“ where patent owners seek to indirectly extend the life of patent protection, beyond its natural monopoly. The report noted:

In most developed countries, including the United States and Europe, there are concerns about pharmaceutical manufacturers using patents and other management approaches to obtain advantages that impose large costs on the general community. The cost arises because these actions impede the entry of generic drugs to the market. Although some find the term to be a pejorative, relevant literature has dubbed such actions ‘€˜evergreening’: steps taken to maintain the market place of a drug whose patent is about to expire.

The report noted: ‘€˜It is probable that less than rigorous patent standards have in the past helped evergreening through the grant of follow-on patents that are not sufficiently inventive.’€™ The report called for improvements in the oversight of patent quality standards: ‘€˜The Panel sees a need for an external body, the Patent Oversight Committee, to audit the patent grant processes to help ensure these new standards are achieved, and to monitor whether they inhibit the patenting of follow-on pharmaceuticals which promote evergreening with no material therapeutic benefit.’

Data Protection

The inquiry also considered the vexed question of data protection for pharmaceutical drugs. The report noted: 

When an originator seeks regulatory approval for a drug, it must provide data to the TGA*** demonstrating the drug’€™s safety and efficacy. Although these data remain confidential to the TGA, it may use them after a five year period to approve a generic or equivalent drug. This saves the pointless replication of tests to show safety and efficacy.

***acronym for Therapeutic Goods Administration 

The pharmaceutical drugs industry argued that the five-year period of data exclusivity in Australia was too short. The Pharmaceutical Patents Review Report found that there was no need to extend data protection in respect of pharmaceutical drugs: 

It is conceivable that drugs might not be brought to Australia, for example, because regulatory and marketing costs cannot be recouped within five years. Medicines Australia submits that some of its members chose not to supply a total of 13 drugs to the Australian market because of the inadequacy of the data exclusivity period. However, they are only able to identify three of these, and the Panel’€™s analysis – shown in chapter 8 – suggests they are not convincing. AbbVie offers a more compelling example, but even there the Panel believes that expanding data exclusivity for all or for a wide class of drugs is a poorly targeted response to issues affecting a small number of pharmaceuticals. A policy of subsidising drug development discussed above seems more appropriate.

The report noted: ‘€˜The Government should actively contribute to the development of an internationally coordinated and harmonised system where data protection is provided in exchange for the publication of clinical trial data.’

Such a finding has a broader significance, given the push by the United States for stronger data protection in the Trans-Pacific Partnership.

Trade and the Trans-Pacific Partnership

The Pharmaceutical Patents Review Report observed that ‘€˜Larger developed countries that are major net IP exporters have tended to seek longer and stronger patents, not always to the global good.’€™ The report warned: ‘€˜The acquiescence of Australia and other countries to that agenda means that some features of Australia’s patent law are of little or no benefit to patentees but impose significant costs on users of patented technologies.’

The Pharmaceutical Patents Review Report was highly critical of Australia’€™s passivity in international negotiations over intellectual property and trade. The report found:

In their negotiation of international agreements, Australian Governments have lacked strategic intent, been too passive in their IP negotiations, and given insufficient attention to domestic IP interests. For example, preventing MFE**** appears to have deprived the Australian economy of billions of dollars of export revenue from Australian based generic manufactures. Yet allowing this to occur would have generated negligible costs for Australian patentees. The Government does not appear to have a positive agenda regarding the IP chapters of the TPP Agreement.

****acronym for Manufacturing for Export

The report noted: ‘€˜The Government has rightly agreed to only include IP provisions in bilateral and regional trade agreements where economic analysis has demonstrated net benefits, however this policy does not appear to be being followed.’€™

The Pharmaceutical Patents Review Report recommended that ‘€˜the Government should ensure that future trade negotiations are based on a sound and strategic economic understanding of the costs and benefits to Australia and the world and of the impacts of current and proposed IP provisions, both for Australia and other parties to the negotiations.’€™  The Pharmaceutical Patents Review Report stressed that ‘€˜the Government should strongly resist changes -€“ such as retrospective extensions of IP rights -€“ which are likely to reduce world economic and social welfare and it should lead other countries in opposing such measures as a matter of principle.’€™

Furthermore, the Pharmaceutical Patents Review Report recommended: ‘€˜Given the current constraints placed on Australia by its international obligations, as an interim measure the Government should actively seek the cooperation of the owners of Australian pharmaceutical patents to voluntarily agree to enter into non-assertion covenants with manufacturers of generic pharmaceuticals seeking to manufacture patented drugs for export’€™. In its view, ‘€˜This would help them avoid the embarrassment of Australia’€™s trade and investment performance being penalised by its previous agreement to strengthen IP rights.’

The Pharmaceutical Patents Review Report warned: ‘€˜There are signs that these past failures are being replicated in the current Trans-Pacific Partnership (TPP) negotiations because small, net importers of intellectual property, including Australia, have not developed a reform agenda for the patent system that reflects their own economic interests – and those of the world.’ 

WikiLeaks has published a draft text of the Intellectual Property Chapter of the Trans-Pacific Partnership.7  The Intellectual Property Chapter contains a number of measures, which support the position of pharmaceutical drug companies and the biotechnology industry.8 Notably, the United States has pushed for extensions of the patent term in respect of pharmaceutical drugs, including where there have been regulatory delays. There has been a concern that the Trans-Pacific Partnership will impose lower thresholds for patent standards, and result in a proliferation of evergreening. There has also been a concern about patent-registration linking to marketing regimes. The United States has also pushed for the protection of undisclosed data for regulatory purposes. There has been wide concern that the Trans-Pacific Partnership will result in skyrocketing costs for health-care systems in the Pacific Rim.

Disturbingly, Australia has been quite passive in the debate over intellectual property and public health in the Trans-Pacific Partnership negotiations. Other countries -€“ such as Canada, New Zealand, and Malaysia -€“ have argued, more passionately, that there is a need for the patent system to protect public health.

Moreover, the Trans-Pacific Partnership also contains an investment chapter, with investor-state dispute settlement. The brand name pharmaceutical drug company Eli Lilly have deployed an investor clause under the North American Free Trade Agreement to challenge Canada’€™s drug patent laws. There is a concern that the investor-state dispute settlement regime in the Trans-Pacific Partnership could be deployed to challenge public health measures, and reforms to the patent system designed to combat problems such as evergreening.

Professor Joseph Stiglitz has been concerned about the impact of the Trans-Pacific Partnership upon equality and human rights.9 He observed that ‘€˜Agreements like the TPP have contributed in important ways to this inequality’€™. Stiglitz warned: ‘€˜Corporations may profit, and it is even possible, though far from assured, that gross domestic product as conventionally measured will increase’€™. He feared that ‘€˜the well-being of ordinary citizens is likely to take a hit.’€™ The Nobel Laureate warned that ‘€˜Trickle-down economics is a myth’€™. Stiglitz concluded that ‘€˜enriching corporations -€” as the TPP would -€” will not necessarily help those in the middle, let alone those at the bottom.’

Conclusion

The Pharmaceutical Patents Review Report is a landmark report, which should receive serious consideration by policy-makers in Australia, and throughout the Pacific Rim. The study deserves a wide readership amongst intellectual property academics, economists, and health experts. The Pharmaceutical Patents Review Report provides a cautionary warning of the need to design a patent regime, which is appropriate and well-adapted to Australia’s economy, research and development system, and public health-care regime:

The Report shows that the Australian patent system has worked against Australia’€™s best interests. Patents are clearly necessary and important for the development of and access to needed drugs. But Australia’€™s patent system has allowed and will continue for some time to allow patents to be granted which would not be granted elsewhere; it has awarded a longer effective patent life than is provided in the United States or than seems necessary to underpin drug development in Australia; it has allowed patents to expire later in Australia than in its major trading partners. All of this has limited the generic manufacturing base, employment and exports and it has increased Australia’€™s pharmaceutical costs. The Raising the Bar Act which recently came into force may moderate this, but its efficacy will not be evident for some years, and there is the prospect that, even with the changes introduced by Raising the Bar, patent standards are still insufficient to moderate evergreening in the pharmaceutical industry. The Panel’€™s recommendations, if adopted, would only start the next phase of the repair work.

The report also highlights the problem of patent owners seeking corporate welfare in domestic patent law reform and international negotiations. There is a need to guard the integrity of the patent system against being co-opted by brand-name pharmaceutical companies and biotechnology companies. Patent term extensions and evergreening undermine the public bargain of patent law to promote the progress of science and the useful arts. There is a need to ensure that the public domain is not captured by private companies. The report should be a guide in Australia’€™s future approach to domestic patent law reform, and international negotiations over intellectual property and trade. The study highlights the need for greater consideration of the economic impact of legal revisions -€“ particularly in the area of patent law and pharmaceutical drugs. Australia’€™s patent regime should protect the public health of its citizens.

References

1          Tony Harris, Dianne Nicol, and Nicholas Gruen, Pharmaceutical Patents Review Report, Canberra, 2013, http://www.ipaustralia.gov.au/pdfs/2013-05-27_PPR_Final_Report.pdf

2          Peter Martin, ‘€˜Drug Patents Costing Billions’€™, The Sydney Morning Herald, 2 April 2013, http://www.smh.com.au/national/health/drug-patents-costing-us-billions-20130402-2h52i.html

3          Matthew Rimmer, ‘Julia Gillard, Big Pharma, Patent Law, and Public Health’, The Conversation, 27 November 2012, https://theconversation.edu.au/julia-gillard-big-pharma-patent-law-and-public-health-10226 

4          Melissa Parke MP, ‘€˜Pharmaceutical Patents Review’€™, House of Representatives, Australian Parliament, 11 February 2014, http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22chamber%2Fhansardr%2F55d46158-f865-4a9f-9015-36543a3b6b7b%2F0183%22

5          Deborah Gleeson, ‘€˜Cost-Cutting Crusade Ignores Health Savings’€™, ABC, The Drum, 6 March 2014,  http://www.abc.net.au/news/2014-02-28/gleeson-cost-cutting-crusade-ignores-vital-health-report/5289726 

6          Brendan Molloy, ‘€˜Pharmaceutical Patents Review’€™, Right to Know, 28 February 2014, https://www.righttoknow.org.au/request/pharmaceutical_patents_review_fi 

7          WikiLeaks, ‘€˜Advanced Intellectual Property Chapter for All 12 Nations with Negotiating Positions (30 August 2013 consolidated bracketed negotiating text)’€™ https://wikileaks.org/tpp/ 

8          Alexandra Phelan and Matthew Rimmer, ‘Trans-Pacific Partnership #TPP #TPPA Drafts Reveal a Surgical Strike against Public Health’, East Asia Forum, 2 December 2013,http://www.eastasiaforum.org/2013/12/02/tpp-draft-reveals-surgical-strike-on-public-health/ 

9          Joseph Stiglitz, ‘€˜On the Wrong Side of Globalization’€™, The New York Times, 15 March 2014, http://opinionator.blogs.nytimes.com/2014/03/15/on-the-wrong-side-of-globalization/  

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*Dr. Matthew Rimmer is an Australian Research Council Future Fellow working on Intellectual Property and Climate Change. He is an associate professor at the ANU College of Law and an associate director of the Australian Centre for Intellectual Property in Agriculture (ACIPA). He holds a BA (Hons) and a University Medal in literature, and a LLB (Hons) from the Australian National University. Rimmer received a PhD in law from the University of New South Wales for his dissertation on The Pirate Bazaar: The Social Life of Copyright Law. He is a member of the ANU Climate Change Institute. Rimmer is the author of Digital Copyright and the Consumer Revolution: Hands off my iPod, Intellectual Property and Biotechnology: Biological Inventions, and Intellectual Property and Climate Change: Inventing Clean Technologies. He has co-edited Incentives for Global Public Health: Patent Law and Access to Essential Medicines, and Intellectual Property and Emerging Technologies: The New Biology. Rimmer has published widely on copyright law and information technology, patent law and biotechnology, access to medicines, clean technologies, and traditional knowledge. His work is available here. 

News Link n. 87

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries

 

News Link 87

On the Wrong Side of Globalization

Global Health Best Buys  

Interview With Hans Hogerzeil: Recognising Good Practices Of Pharma

EU Parliament To Vote On Compulsory Publishing Of Clinical Trial Data 

Medicines Made in India Set Off Safety Worries

Let’s go the distance: Investing in partnerships for a healthier future

Devex Reporters Discuss Public-Private Partnerships In U.S. Foreign Aid

Does health aid reach the poor? 

Will It Be Famine or Feast for Africa As Big Food Retailers Look to the Continent? 

If China Sneezes, Africa Can Now Catch a Cold

AFRICA’S YOUNGEST BILLIONAIRE JOINS INITIATIVE FOR GLOBAL DEVELOPMENT’S LEADERSHIP COUNCIL 

Addressing Violence Against Women and Children Is Critical to Achieving an AIDS-Free Generation and the Millennium Development Goals  

Moment ‘ripe’ for improving women’s access to finance

MakaPads Helping Disadvantaged Girls And Women In Uganda

African women and girls at the grassroots – Their say on their world post 2015  

Promozione della salute o profitto a ogni costo: una terza via è possibile? 

What nonprofits can learn from Coca-Cola

The Gates Foundation’s Hypocritical Investments

IMF: To solve inequality, tax food, books and funerals

Beginning of the end of the neoliberal approach to development 

Global health philanthropy and institutional relationships: how should conflicts of interest be addressed?

Forests crucial to green growth

Breeders’ Group CIOPORA Redefining Its Position On IP  

WHO and regional malaria experts reiterate warning about drug resistance 

 

 

 

 

The Health Impact Fund: a Mechanism to Improve Access, Innovation and Delivery of Medicines

Problems of innovation, access and delivery in the domain of pharmaceuticals still exclude billions of people from the health benefits that advanced medicines can provide. This article turns the spotlight on the Health Impact Fund as an initiative that could systematically and sustainably address these problems

The Health Impact Fund: a Mechanism to Improve Access, Innovation and Delivery of Medicines 

by  Thomas Pogge* 

Director of the Global Justice Program and the Leitner Professor of Philosophy and International Affairs at Yale University

Introduction

Despite much heralded advances in health and well-being over the past twenty years, there remain significant disparities in access to lifesaving medicines globally. About 30 percent of the world’€™s population still lack access to essential medicines.  In addition, no adequate and effective treatments exist for the numerous neglected diseases that disproportionately affect the poor. Indeed, only 1% of therapies introduced between 1975 and 1999 targeted these diseases, despite the fact that they affect over one billion people globally.

Such gaps are a direct result of the misaligned incentives present in the current pharmaceutical innovation system. Drug development is currently incentivized and rewarded through the exorbitant mark-ups that innovators, protected by patents from market competition, can charge for their products during their early years on the market. Given very high economic inequality globally and increasingly also within countries, innovators find that the profit-maximizing prices for their pharmaceuticals make these products unaffordable to a substantial majority of the world’€™s population. As a result, many poor people, even in the more affluent countries, suffer or die because they cannot afford medicines whose marginal cost of production and distribution is quite low. Moreover, innovators shun research on diseases concentrated among the poor because they will not be able to recover their R&D costs from mark-ups on new products in such an area.

The existing system presents three major problems. First, R&D is focused on drugs that are conceived to be the most profitable, rather than on those that would lead to the most cost-effective improvements in health.  Second, profit-maximizing prices prevent much of the world’€™s poor from purchasing even the medicines medicines we have available so long as they are still under patent. Third, even when a treatment is priced affordably, there remain gaps in access due to the “€œlast mile”€ problem – that is, the challenge of ensuring that available medicines are of good quality as well as accessible to and correctly used by the people who need them. These three problems exclude billions of people from the health benefits that advanced medicines can provide.

Incomplete Solutions to An Access to Medicines Crisis

Two decades ago, lawyers in Geneva included in an international trade treaty an agreement on intellectual property (IP) rights that has had a massive impact on medical treatment for individuals suffering from many of the world’s deadliest diseases. One effect of this Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was to apply standards for patents developed in the world’s most industrialized countries to any country intent on joining the World Trade Organization (WTO). Member countries must grant 20-year product patents on pharmaceuticals, for instance, and must ensure that corporations owning such patents can price their products without fear of competition.

Before TRIPS, IP rights were only enforced domestically. Many industrialized countries were members of international organizations and signatories of agreements that required a specific level of IP protection. Yet, none of these organizations had enforcement mechanisms and the consequences of not respecting these IP norms rarely affected other aspects of international commerce. Further, many least developed countries had only weak IP protections, or none at all. India, for example, had seven-year process patents that generic firms there were typically able to circumvent by finding a different process for manufacturing the drug.

Realizing the impact the TRIPS agreement was having on access to medicines, the World Trade Organization in 2001 issued the Doha Declaration, which provided flexibility for member states to rescind the patent protection guaranteed by TRIPS when needed to protect public health. However, patent owners simultaneously lobbied their governments to increase the legal protection for their proprietary rights in the drugs used to treat these diseases. They did so through agreements now often referred to a TRIPS-plus. Pressure continues to mount on many countries to extend patent terms, agree to data exclusivity, or agree to other measures that indirectly increase the cost of pharmaceuticals. This has had a disastrous impact on access to essential medicines.

A number of initiatives have responded to the global health crisis resulting in part from a lack of access to medicines caused by the TRIPS and TRIPS-plus agreements. Beyond the usual declarations, working papers, conferences, summits, and working groups, these initiatives include inter-governmental initiatives such as UNITAID; governmental programs such as the US President’€™s Emergency Plan for AIDS Relief; and public-€“private partnerships such as the Global Alliance for Vaccines and Immunization and the Global Fund to Fight AIDS, Tuberculosis and Malaria. They also include attempts to foster new drug development such as the Drugs for Neglected Diseases Initiative, the Institute for One World Health, and the Novartis Institute for Tropical Diseases; and various prizes and advance market commitments (AMCs).

While improving the situation relative to what it would otherwise be, these efforts are not sufficient to secure access to medicines for the poor. Few expect that sufficient resources will be devoted to neutralizing the cost imposed on the world’s poor by the globalization of 20-year patents and none anticipate that such billions will reliably and efficiently be spent year after year. As a result we turn to a more systemic solution to address the global health crisis. Involving institutional reform, such a systemic solution is politically more difficult to achieve but also politically much easier to sustain once achieved. It also preempts the huge and collectively inefficient mobilizations required to fund the many stopgap measures listed above, which can at best only mitigate the effects of structural problems they leave untouched.

A Market Solution for Market Problems

The Health Impact Fund (HIF) is an initiative that could systematically and sustainably address the three problems of innovation, access and delivery in the domain of pharmaceuticals. Using a pay-for-performance mechanism, the HIF would align the incentives of pharmaceutical firms with the needs of public health, while also allowing these firms to fulfil their responsibility to investors to maximize profit.  Pharmaceutical firms would be given the option to register new medicines with the HIF.  By registering, a firm would agree to provide the drug at cost price worldwide. In exchange, the firm would be rewarded, during the first eight or ten years that its new product is on the market, according to the actual measured health impact of the drug. As all registered products would be competing for a fixed pool of annual funding, the greater the health impact created by a firm’€™s product, the greater would be its share of the reward pool that year. Since registration with the HIF would be optional, firms would be able to decide for each product whether the current patent system or the HIF would be more profitable. Firms would be more likely to register products that have relatively low profitability in the current system, but that would potentially have a high health impact (e.g. effective treatments for neglected diseases). As a complement to the current patent regime, the HIF would thus help lower prices, increase access to medicines, and enable pharmaceutical firms to bring significant benefits to patients while earning a profit.

 The Health Impact Fund (HIF) offers pharmaceutical firms an opportunity to register any of their products for a share of fixed annual reward pools for each of the first eight or ten years on the market. Each pool will be divided according to the health impact that the various registered products have achieved during the year. To exemplify, if all registered products saved twenty million “€œQuality-Adjusted Life Years”€ (QALYs) in a given year, then a registered product that had saved two million of these QALYs would receive ten percent of this year’s reward pool. In exchange, firms would have to sell their registered products at the lowest feasible cost of manufacture and distribution and to offer royalty-free open licenses for generic production following the reward period. In its mission to encourage the development of new medicines for the poor, the HIF depends on funding commitments from countries and other partners

  Since firms will be rewarded based on health impact assessment, it is important to discuss how health impact will be measured. The most important characteristic for measurement of health impact is that it must be consistent across countries and diseases in order to accurately compare and reward drugs. Furthermore, there must be some way of calculating the difference in health benefit between the new drug and the status quo. While the merits of several measurement metrics can be debated, it is important to realize that an ideal metric does not exist and that any payment based on measurement and therefore performance is better than the present system in which reward and health impact are barely correlated. It is crucial for the success of the HIF that the measurement system be designed to ensure that firms are incentivized to deliver health improvements and not game the system (i.e. capture rewards without producing outcomes). If there is margin for gaming, firms may be tempted to manipulate the process by exaggerating the benefit of the product. Doing so would stray from the end goal of increasing overall health benefit.

It is important to realize that the HIF will measure real world outcomes. Both the current system and the HIF use health outcome measurement to determine drug revenue. The current system (exemplified by NICE) uses data from clinical trials to estimate the health benefits of a drug. However, health benefits determined in clinical trials often do not reflect real health impact. There are many reasons for this. For example, patients included in a study have to meet certain characteristics that may not represent the entire population. Furthermore, patients in clinical trials are more closely monitored than they would be in the real world. Most importantly, a pharmaceutical innovator has conflicting incentives with regard to patients likely to derive little or no benefit from some product: incentives to exclude such patients from its clinical trials and yet to include them in its marketing efforts. These differences will lead to differences in outcomes. The HIF model addresses this concern by allowing for adjustments based on evidence of how the drug is used in practice and what the outcomes are.

A Solution for Innovation, Access, and Delivery

As mentioned before, there are three major problems with the current system: innovation, access, and delivery. The HIF addresses all three of these problems. Through the HIF model, firms will find it profitable to develop medicines to treat even the poor because reward will be based on health impact and marginalized populations are where the greatest health impact is waiting to be realized. The HIF will thus incentivize development of medicines for previously neglected diseases which, despite their large disease burden, have received little investment due to their unprofitability in the current innovation system.  The HIF will also ensure that, when beneficial drugs are developed, they are made widely accessible to patients.  The HIF would facilitate increased access to drugs by requiring that they be sold globally at cost price. The HIF would also create incentives for manufacturers to engage in facilitating the appropriate distribution of their products, as well as reducing other non-price barriers to access and rational use, since improved (appropriate) use will increase the rewards they earn. Thus, firms would be incentivized to ensure that drugs actually reach patients and are effectively used, thereby tackling the last mile problem. Thus the HIF will address the three biggest challenges of the pharmaceutical industry 1) incentivizing innovation for currently neglected diseases 2) improving access to life saving and life improving medications 3) addressing the last mile problem.

Conclusion

Importantly, the HIF does not act as a charity for the developing world but rather a system that benefits patients, pharmaceutical firms, and citizens on a global scale. In a time when we have seen significantly reduced global health spending due to the Great Recession and other economic setbacks, it is important to look for sustainable solutions that use the current resources more efficiently. The HIF is one such solution. The HIF would direct research towards the medicines that promise the greatest health gains and would offer those products at the same low cost to all patients. This would benefit patients regardless of their location and wealth. Firms would benefit financially from doing social good through a financing scheme that makes developing high-impact medicines profitable. Citizens, who support governments through tax payments, would benefit from the HIF because it supports efficient spending and results in lower costs for registered products. Ultimately the HIF is a market solution for market problems.

References

World Health Organization. 2004. The World Medicines Situation. Geneva: World Health Organization. http://www.who.int/medicines/areas/policy/world_medicines_situation/en/

Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R & Ford N. 2002. Drug development for neglected diseases: a deficient market and a public-health policy failure. The Lancet, 359(9324)

Agreement on Trade-Related Aspects of Intellectual Property Rights (Marrakesh, Morocco, 15 April 1994), Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 321 (1999), 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [TRIPS]

World Trade Organization, Declaration on the TRIPS Agreement and Public Health of 14 November 2001, WT/MIN(01)/DEC/2, 41 I.L.M. 755 (2002) [Doha Declaration], at para 7. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

Frederick M. Abbott, “The Doha Declaration on the TRIPS Agreement and Public Health: Lighting A Dark Corner at the WTO”, Journal of International Economic Law (2002) 469-505, at 470. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1493725

J.F. Morin, “€œMultilateralising Bilateral TRIPS-Plus Agreements: Is the US Strategy a Failure?”€ 2008, unpublished, quoting GRAIN (2001) TRIPS-plus through the back door [online]. GRAIN publications.  Available at: www.grain.org/publications/trips-plus-en.cfm [accessed on September 2008], http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1276464

F. Abbott (2006) Intellectual Property Provisions of Bilateral and Regional Trade Agreements in Light of US Federal Law. ICTSD-UNCTAD, Geneva; Fink, C. and Reichenmiller, P. (2005) Tightening TRIpharmaceuticals: The Intellectual Property Provisions of Recent US Free Trade Agreements. The World Bank, Washington, DC; http://unctad.org/en/Docs/iteipc20064_en.pdf

Krikorian, G. P. and Szymkowiak, D. (2007) ‘€˜Intellectual Property Rights in the Making: The Evolution of Intellectual Property Provisions in US Free Trade Agreements and Access to Medicine’€™, The Journal of World Intellectual Property, 10(5), pp. 388-418, among others. http://onlinelibrary.wiley.com/doi/10.1111/j.1747-1796.2007.00328.x/abstract

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* This piece received substantial research support from Narmeen Haider, Jake Hirsch-Allen and Zain Rizvi.

Thomas Pogge is the Director of the Global Justice Program and the Leitner Professor of Philosophy and International Affairs at Yale University. Having received his Ph.D. in philosophy from Harvard, Thomas Pogge has published widely on Kant and in moral and political philosophy, including various books on Rawls and global justice. In addition to his Yale appointment, he is the Research Director of the Centre for the Study of the Mind in Nature at the University of Oslo and a Professorial Research Fellow at the Centre for Applied Philosophy and Public Ethics. Pogge is also editor for social and political philosophy for the Stanford Encyclopedia of Philosophy and a member of the Norwegian Academy of Science. With support from the Australian Research Council, the UK-based BUPA Foundation and the European Commission (7th Framework) he currently heads a team effort towards developing a complement to the pharmaceutical patent regime that would improve access to advanced medicines for the poor worldwide (http://www.healthimpactfund.org) and toward developing better indices of poverty and gender equity.

News Link n. 86

 

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries

 

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