Transportation and Global Health, an Underestimated Challenge

If the present trend continues, road traffic injuries (RTIs) are expected to kill approximately 1.9 million people per year by 2020, which would raise them to rank three of the leading causes of death. RTIs are the most important cause of death among young people between 15 and 29 years of age.  And the burden is hardly shared equitably around the world: over ninety percent of the fatalities occur in low- or middle income countries
 Promoting non-motorized forms of transport, notably walking and cycling, comes with the double benefit of both mitigating the triple health burdens of RTIs, climate change and air pollution and of providing the positive health benefits of increased physical activity. This double advantage appears true both for cities in high-income industrialized and in middle-income industrializing countries

 Transportation and Global Health, an Underestimated Challenge

by Iris Borowy

Institute for the History, Theory and Ethics of Medicine, RWTH Aachen UniversityGermany

Mobility is a crucial part to people’€™s lives everywhere. People need to get around to go to work, to schools or to university, to reach stores or markets and to get to doctors and hospitals to receive medical care. People also need to be able to transport goods, either on a private basis to buy and transport home what they need and to see what they produce, or commercially, to sell and buy the products that sustain the economy. Of these functions, access to medical care has the most direct connection to health, but, in reality, all factors affect central determinants of health: education, employment, income and access to the necessities of life. Generally, a functioning economy is vital to population health, and in many ways, increasing transportation possibilities increases the health potential of a society. However, increasing transportation also increases its health risks, and, depending on its form and circumstances, at some point, the health burden of mobility risks overwhelming its health benefits.

 Nothing epitomizes this risk as poignantly as the meteoric rise of the car. A mere 150 years ago, cars were unheard of. In a matter of a few generations, this new invention revolutionized the way people in industrialized countries traveled, worked, shopped and lived in spaces that were increasingly designed to accommodate car traffic. The number of cars and trucks in the world exploded from roughly one million in 1910 to 50 million in 1930, 100 million in 1955, 500 million in 1985 and one billion in 2010. It has kept rising since. In high- and increasingly in middle-income countries, car traffic has determined how people move around, how and where they live, work, buy what they need and how they spend their free time.  In addition, average driving distances expanded, further increasing overall traffic exposure.  In many places, cars represent the dominant or even the only prevalent means of transportation beyond walking distances. For many people, having a car represents freedom and a sense of options in life.

In global health terms, the price for this development is stiff. One area of health risk, which has been attracting substantial attention in recent years, involve road traffic injuries (RTIs). Every year, approximately 1.24 million people die of RTIs as a result of crashes involving a motorized vehicle. Between 20 and 50 million people suffer non-fatal injuries. Economic costs are estimated to range between one and three percent of national GNPs.   RTIs rank ninth among the ten leading causes of death, and seventh in upper middle income countries. And the numbers are rising. If the present trend continues, RTIs are expected to kill approximately 1.9 million people per year by 2020, which would raise them to rank three of the leading causes of death. RTIs are the most important cause of death among young people between 15 and 29 years of age.  And the burden is hardly shared equitably around the world. Over ninety percent of the fatalities occur in  low- or middle income countries.

 Those particularly at risk are the “€žvulnerable road users”€œ, i.e. pedestrians, cyclists and motorcyclists. They are also the heaviest users of roads in low-income countries and are, themselves, often poor, demonstrating the social gradient involved in RTI risks. The distribution of different groups of RTI victims varies dramatically between countries of different income levels. Approximately 45% of road traffic fatalities in low-income countries are among pedestrians, but only 29% in middle-income and 18% in high-income countries. These changes reflect similarly different absolute numbers.  227,835 pedestrians are estimated to die in low-income countries each year, compared to 161,501 in middle-income and 22,500 in high-income countries. In addition, there is a distinct gender gap. Worldwide, men are almost three times as likely to be killed in a road accident as women. Given the age and gender specificities, the victims of RTI form the economically most active group. Often, families depend on their income, and if they die or are incapacitated, many people are affected. In a larger sense, the societies at large suffer from the disproportionate risk carried by their potentially most productive members.  Thus, the present and future health burden of RTIs is disproportionately borne by people, who cannot afford to own cars, and by  countries that can least afford to meet the health service, economic and societal challenges.

 RTIs prevalence is not fate. It is the result of a complex combination of circumstances and policies and, thus, amenable to changes. Industrialized countries have seen a drastic decline in RTI mortality since its peak in the 1970s. For instance, in Australia, RTI fell from 30.4/100,000 in 1970 to 5.7/100,000 in 2012. Declines were similarly steep in Austria (34.5 to 6.3), France (32.6 to 5.8), Germany (27.3 to 4.9) and Italy (20.5 to 6.0). In 2012, RTI mortality in industrialized countries ranged from 2.8/100,000 in the United Kingdom and Iceland to 10.7/100,000 in the USA. This development reflected changes in a broad range of relevant factors, falling under the responsibility of various actors. A key factors involve the behavior of individual traffic participants, notably the prevention of speeding, drunk driving and the use of protective gear, especially helmets and seat-belts. A focus on the role of vehicles points to the responsibility of manufacturers and the role of car designs and equipment, such as air bags. Several factors highlight the responsibility of administrations, which decide on the set-up of roads, notably their size, surface, markings, signs and maintenance, but also its structure which may or may not allow the separation of different traffic participants with different lanes for cars, bicycles and pedestrians. The establishment of pedestrian zones also falls into this category. Administrations are also responsible for the extent to which traffic regulations exist and are enforced. Meanwhile, medical services have an important role to play. Generally, the quantity and quality of ambulances and hospitals and, more specifically, the degree to which staff is trained to treat RTIs all help determine in how far traffic crashes translate into long-term injury and disability. Most of these factors improve with the economic development of a country. High-income countries simply tend to have better cars, better roads, better regulations, better law enforcement and better medical services. This point is borne out by a comparison with RTI mortality data with low- and middle-income countries, which are comparable to those experienced in industrialized countries some decades ago, such as the Dominican  Republic (41.7), Iran (34.1), Malaysia (25.0), Nigeria (33.7) or Thailand (38.1).

 This observation has given rise to the theory that the development of RTIs generally follows a Kuznets-curve like trend, i.e. RTIs first increase with rising national income along with growing but largely unregulated motorization, but then decrease after a peak, as regulations and improved material quality and services take over. Consequently, it has been suggested that low- and middle-income countries would have to undergo a developmental process.  This view was taken by, among others, a World Bank report of 2003, which predicted that “€žthe fatality rate will rise to approximately 2 per 10,000 persons in developing countries by 2020, while it will fall to less than 1 per 10,000 in high-income countries.”€œ This prediction has largely become true, and these data appear to support an underlying assumption that low-income countries would repeat the past experience of industrialized countries, that things will have to get worse before they get better and that the best policy to reduce the burden of RTIs would be to foster economic growth. A similar claim is still being made, albeit with a focus on wealth, reduced corruption and improvements in medical care and technology. Not surprisingly, this approach has been popular in the industrial sector. Thus, a 2007 study that was financially supported by the automobile industry found that lives could be saved by lowering either vehicles per capita or the fatalities by vehicle but ruled out the first strategy since it was “€œinextricably linked to economic growth. Consequently, the focus should be on reducing fatalities per vehicle.”€ Clearly, this approach would limit anti-RTI strategies to those not harmful to the interests of the car industry. It also portrayed RTIs as a regrettable but temporary side effect of modernisation.

However, this perspective is questionable for several reasons: from an ethical and even a medical point of view it seems difficult to accept that this dramatic number of lost lives should be the price to be paid for increasing economic well-being and for -€“ eventually -€“ a reduced health risk of traffic. Besides, the logic is flawed. According to a 2003 report by the UN Secretary General, WHO and the World Bank, estimated global costs of the RTI burden amounted to $ 518 billion per annum and $ 100 billion in developing countries “€˜twice the annual amount of development assistance to developing countries.”€™ Thus, instead of price that must be paid for a generally beneficial economic development RTIs must primarily be understood as a powerful impediment to development.

Besides, one must question the theory that it will be possible for low-income countries to repeat the development of industrialized countries, with a traffic system largely based on individual motorized vehicles. For many years, this assumption determined many development aid and investment decisions, which focused on the construction of streets and motorways. Thus, 73 percent of the -€“ substantial -€“ World Bank commitments to the transport sector in supported countries between 1996 and 2006 were dedicated to road construction. The rationale provided referred to the impact of road transportation on poverty reduction but also to the importance of roads to free market trade and to the immense growth potential of the automobile sector in emerging economies like India and China. In other words, the export interests of industries in Northern countries influenced development decisions in and for Southern countries in support of modes of transportation that mimicked infrastructures of industrialized countries and favored motorized traffic participants at the expense (and the risk) of the others, privileging the needs of a minority of affluent citizens, who could afford cars, over those of a majority, who could not. But even if such self-interested motives are discounted, a repetition of the industrialized transportation model all over the world is neither desirable nor realistic. The long-term availability of fuel is obviously in doubt. But even assuming that the discovery of new oil wells and of new alternative techniques of oil exploitation such as fracking, will postpone fuel shortages for many decades to come, a very optimistic assumption, it is difficult to imagine that the planet should be able to provide the material resources for the production, the operation and the disposal of a cars on a scale of motorization in industrialized countries today. In the USA, the most motorized country of the world, there were 808 motorized vehicles for every 1,000 people in 2012. The corresponding numbers in other parts of the world are 187 in Brazil, 81.5 in China, 33.6 in Africa and 24.4 in India. A ten-fold increase in China alone would roughly double the number of cars in the world today.

But even if this was materially possible, the health burden resulting from the environmental effects would be unacceptable. According to a WHO study, published in 2000, motor vehicles are a major source of a series of air pollutants, emitted very close to people and often near nose height, estimated to cause between 36,000 and 129,000 adult deaths in European cities or approximately twice the number of deaths resulting from RTIs (!). Road traffic related air pollution is also believed to cause substantial increase of chronic bronchitis and asthma. An addition, motorized traffic accounted for approximately one quarter of all CO2 emissions in EU countries, establishing a direct link between road traffic and climate change. The potential health impact of climate is truly frightening.  A study by the Potsdam Institute for Climate Effects, published by the World Bank in 2013 describe a scenario of an increase of world temperature by four degrees centigrade, foreseeing, among other effects, a substantial increase in infant mortality, of respiratory, cardiovascular, gastrointestinal and vector-borne diseases, of loss of lives and livelihoods resulting from increasingly frequent extreme weather events and a decrease of global food production. Given the uneven distribution of these effects, climate change would also increase global inequalities, increasing the likelihood of violent conflict.

 Theoretically, it is conceivable that one day we may have a means of individualized transportation that does not require fossil fuels, does not emit harmful exhaust fumes, and uses recyclable material.  But in the foreseeable future, no such solution is in sight on a mass and affordable scale. Clearly, an evaluation of the health effect of transportation must take these considerations into account.

 To some degree, comprehensive approaches to the health repercussions of transportation have emerged in high-income countries. Between the 1970s and the 1990s, most industrialized countries sought to decrease the health risk of transportation related air pollution by prohibiting leaded fuel, by making catalytic converters mandatory and by generally tightening emission standards. However, these policies have largely been considered in a context of air pollution, disconnected from considerations of overall concepts of transport and mobility. Most efforts in that regard have focused on reducing RTI mortality, a more direct and immediately visible link between road traffic and public health. In recent years, these efforts have given rise to various, sometimes contradictory approaches. They included Vision Zero in Sweden, which shifts the responsibility for traffic safety from the participants to a system, designed to allow increased traffic flow while reducing crashes (ideally to zero) through a strict separation of traffic participants. On the other hand, there has been a long list of initiatives to restore urban space as shared  living space for all citizens and to reduce traffic accidents by forcing all participants to assume the full responsibility for their own and each other’€™s safety.

Meanwhile, until recently, the health burden of transportation in the rest of the world has long been a somewhat neglected topic compared to other burdens of diseases of comparable magnitude. The picture changed in the early twenty-first century when a host of international activities have addressed the issue, of which the following are only a few pivotal examples. By 2002, RTIs were coined a global public health problem. In  2003, a UN study on the Global road safety crisis called attention to the importance of the issue in low- and middle-income countries. Taking inspiration from developments in urban areas in high-income regions, it advocated integrating RTI consideration into a broader vision of urban development and transportation planning, which avoided a one-sided concentration on car-based system of traffic but also included alternative modes of transport. Its call for a “systems approach” was echoed in a large-scale study published jointly by the WHO and the World Bank a year later. After an extensive analysis of the issue, this document recommended, among other measures, indirect but highly relevant strategies of designing the material and organizational infrastructure that would satisfy human needs for food, household items, work and leisure activities while reducing transportation needs. This goal would require a reorientation of city planning, aiming at clustered, mixed-use community services and making ample use of electronic long-distance communication. Remaining unavoidable transportation should de-emphasize individual motorized forms of mobility. However, though offering a wide visions and far-sighted considerations, these recommendations only took a relatively small part of the very comprehensive report, a lot of which focused on more conventional measures such as speed control and the use of seat-belts. It appears that follow-up activities have largely focused on these tangible measures, which promised to make road traffic safer without requiring fundamental systemic change.

 As a case in point, the WHO Global status report on road safety 2009 presented recorded or estimated RTI data of 178 countries, while its analysis and recommendations focused on five key items: speed, drinking and driving, use of motorcycle helmets, seatbelts and child restraints, as well as related legislation.  They are still identified as the major risk factors and the WHO criticizes than only 28 countries, representing a mere 7 percent of the world population, have adequate laws that address all five factors. There is no doubt that these factors are crucial and improving them would go far in reducing the immediate health burden of RTIs. But they have little to do with a comprehensive vision of local, national and global transportation and mobility that would best serve long-term health considerations.

It is difficult to quantify yet impossible to overlook that many initiatives in recent years have carried the sign of involvement of the automobile industry, which strove to improve its reputation and maintain the acceptance of car traffic by supporting measures that would improve its safety without challenging its principle. Notably, the FIA Foundation, an association of automobile clubs and motorsport associations, became involved in high-level international initiatives to promote road safety, thus narrowing the question from how to provide healthful forms of communication and mobility to that of safe roads. Thus, it was one of many partners, including international organizations, governments, NGOs and the private sector, when the UN declared a Decade of Action for Road Safety 2011-2020, meant to energize participating countries into taking active measures in the field. Its agenda focuses on five “€œpillars”€: Road safety management, safer roads and mobility, safer vehicles, safer road users, and post-crash response. These recommendations, while mentioning the need to promote alternatives to private motorized transportation, tended to bury them in a majority of technical recommendation on ways to make car and motorcycle traffic safer.

 The latest examples in this series of high-level international publications upgrade non-motorized traffic to some extent. The 2013 update  Global status report on road safety 2013 designed as a baseline report for the Decade of Action Road Safety Campaign, published by the WHO and the Bloomberg Foundation, included a chapter on existing programs to promote non-motorized transportation and on the importance of making public transportation safe. Recently, even the Make Roads Safe Campaign, an initiative jointly carried by NGOs, public health advocates, automobile associations and the car industry, have included walking and the safety of pedestrians in their call for “€œsafe roads”, otherwise more interested in maintaining the acceptance of car traffic on those roads. Similarly, a road safety manual on Pedestrian Safety, jointly published by the WHO and FIA Foundation addressed various measures to make pedestrians traffic safer, including the separation of pedestrian from motorized traffic and the encouragement of public transportation.

These signs are encouraging and should be welcomed. But at a time of continuing increases in the number of cars on roads worldwide, they also appear painfully inadequate. They show that the international attention to RTIs in low- and middle-income countries, though crucially important and badly overdue, have also been a mixed blessing. By restricting the focus on technical approaches within a narrow focus on RTIs as the supposedly central factor of health relevance, it has effectively prevented a larger view on the relation of transportation and health, including important aspects of air pollution, climate change and physical exercise.  This is unfortunate, since the health costs of continuing a transportation system based on individual motorized traffic are far higher than measurable in RTIs and, by the same token, the health benefits of a changed system are far higher and multi-faceted.

 Promoting non-motorized forms of transport, notably walking and cycling, comes with the double benefit of both mitigating the triple health burdens of RTIs, climate change and air pollution and of providing the positive health benefits of increased physical activity. This double advantage appears true both for cities in high-income industrialized and in middle-income industrializing countries. A comparison of different scenarios of possible future traffic developments in London and Delhi, supported and published by Lancet in 2009, found that major public health benefits could be achieved by a combination of reduced motor vehicle use, more walking and cycling, and the use of low-carbon-emission motor vehicles. In Delhi, this scenario entailed a 10-€“25% cut in heart disease and stroke, a 6-€“17% reduction in diabetes and a 33 percent reduction in RTIs while cutting CO2 emissions by three fifth. Consequently, the authors, scholars of various institutes in Britain and in India, conclude that “€œreplacing motor vehicle trips with walking or cycling is a win-win in both developed & developing countries”,€ that “€œpedestrians and cyclists have the right to direct, pleasant and safe routes”€ and that motor vehicles should be restricted in terms of “€œspeed, road space and convenience.”€

 Indeed, in the long run, the crucial challenge for safeguarding population health in the future appears to be not so much how to coordinate private motorized traffic, public transportation and non-motorized traffic in a way that maximizes the safety of all participants, but how to replace private motorized traffic while safeguarding the health benefits of a modern economy in general and of efficient transportation in particular. Making transportation compatible with population health will require a fundamental transformation of how people and societies interact. Concepts of what such a transformation could or should like vary. Sociologist John Urry sees the demise of the dominance of the car on mobility and life in general during the twenty-first century. He envisages a “…€žpost-car system”€œ, a  high-tech system whereby the digital world is integrated for coordination and payment of a variety of individual and collective transportation means  and also an improvement of virtual forms of communication leading to a reduction of face to face meetings. If and to what extent such a transformation will be applicable on global scale remains to be seen. Presumably, different places will require different approaches, adapted to local needs and traditions. But to be truly conducive to health in high- as well as low-income countries, any concept will have to take into account a combination of social determinants, including the risk of accidents, air quality, climate stability and the access to rural and urban space for a variety of activities. This will require a changes in industry (including but not limited to the car industry), of employment, of local and global trade and, by extension, of production and consumption. It will require creativity, courage and optimism. Above all, it will require acknowledging the significance of transportation and mobility as a public health issue for today and far into the future.

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In Ebola’s Wake, How Should the World be Financing Global Health?

While individual donations cannot operate in lieu of government or multilateral funding, engaging the general public in global health issues and providing them with easy ways to donate could be extremely effective

In Ebola’€™s Wake, How Should the World be Financing Global Health?

by Sara Gorman*, PhD 

 Department of Health Policy & Management, Columbia University Mailman School of Public Health 

Why did the Ebola epidemic get so out of control? This is the question on the minds of world leaders, members of the global health community, and members of the general public as we reflect on the continuing tragedy of Ebola in West Africa.

Global health funding has typically come mainly from governments and multilateral institutions such as the World Health Organization (WHO). But as we continue to see disappointing progress toward some of the Millennium Development Goals (MDGs), especially reducing maternal mortality, the global health community has been increasingly calling for a restructuring of the funding landscape. Of course, the global health financing landscape has already changed dramatically since 1990, with new figures such as the Gates Foundation and the GAVI Alliance emerging and contributing to a dramatic increase in development assistance for health, a figure that reached $28 billion in 2010. Yet in a world where 800 women still die each day due to preventable causes related to pregnancy and childbirth , it becomes more and more important to examine what we are currently doing and how it can be done better.

Increasingly budget-strapped governments are shying away from global health funding, ramping up their budgets only when disasters such as Ebola come into view. This is clearly not an ideal state of affairs. Some have suggested that governments view investment in global health as an inevitable loss. As a result, some have suggested a different approach: impact investing and socially-responsible investments. Impact investments are investments made into companies or organizations with the expectation of a measurable, beneficial social or environmental impact as a solid return on the investment. Other models focus on financing techniques to spur more innovation for neglected diseases in the pharmaceutical industry, such as advance market commitments and transferable market exclusivity, in which a company can gain an extension on a patent for a drug of its choice in exchange for investing in and successfully creating a drug for a neglected or unprofitable disease area.

Yet there is another tremendous opportunity that remains largely untapped: individual donations. While individual donations cannot operate in lieu of government or multilateral funding, engaging the general public in global health issues and providing them with easy ways to donate could be extremely effective. Studies show that 95.4% of U.S. households gave to charity in 2013, and that individual donations constituted the largest source of charitable donations at $241.32 billion (or 72% of all U.S. charitable giving), compared with foundations ($50.28 billion) and corporations ($16.76 billion). There is reason to believe that the public is interested in global health issues but is not quite sure where to start. In a Kaiser Family Foundation survey from 2012, 52% of people said that the media pays too little attention to health issues in developing countries. When given a list of health issues in developing countries and asked to rank priorities, the public had a difficult time choosing, and about 1/3 of people claimed that all 12 named issues should be “€œone of the top”€ priorities. What this suggests is that the general public, at least in the U.S., is interested in engaging more with global health and believes that more funding is the “€œright thing to do”€, but many feel overwhelmed by the number of dire health issues in developing countries and simply does not know where to start, what exactly to donate to, and how to find worthy sources of donation. Finding ways to better engage this portion of the population, including through more extensive coverage of everyday health problems in developing countriesrather than just crises such as Ebola and perhaps through more extensive online resources to nudge the public in the right direction is sorely needed.

The Ebola crisis is a terrible tragedy. But it also represents an important opportunity not only to re-evaluate “€œbusiness as usual”€ but also to engage an interested and concerned public in the more extensive needs of developing country health systems. We should not let this extremely important opportunity pass us by.

————————————————————————————————-

*Sara Gorman, PhD is an MPH candidate in Health Policy and Management at Columbia University Mailman School of Public Health. She has written extensively about global health, HIV/AIDS policy, and women’€™s health, among other topics, for a variety of health and medical journals, including PLoS Medicine and International Journal of Women’€™s Health. She is currently working as a consultant for Janssen (the pharmaceutical companies of Johnson & Johnson) in Global Public Health division. She has worked in the policy division at the HIV Law Project and as a researcher at the Epidemiology Department at Harvard School of Public Health. She has also analyzed mental health policy under the ACA for the Vera Institute of Justice and researched the effectiveness of semi-mobile HIV clinics in rural Kenya for HealthRight International. 

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Fighting for Hepatitis C Treatment Access: We Cannot Repeat the Mistakes of the HIV Epidemic

Hepatitis C virus (HCV) infection can be cured now thanks to highly effective oral direct-acting antivirals (DAAs). But it remains only a distant dream for most who need it worldwide. We must fight HCV DAA bank-busting price tags, and the intellectual property regime and the industry behind it, that collude to undermine public health

Fighting for Hepatitis C Treatment Access: We Cannot Repeat the Mistakes of the HIV Epidemic

Karyn Kaplan_photo

by Karyn Kaplan*

                          International Hepatitis/HIV Policy and Advocacy Director, Treatment Action Group (TAG)

Over the past year, news headlines across the globe heralded the arrival of a cure for hepatitis C virus (HCV), which kills 500,000 people each year (more than 185 million are estimated to be infected). The advent of oral direct-acting antivirals (DAAs) that are more effective, simpler to administer, easier to tolerate, and are taken for a shorter duration than previous standard of care has led experts to predict the potential of global HCV eradication. But as new DAAs pour onto the market, questions about access, particularly in low- and middle-income countries (LMICs), loom large.

 Gilead’€™s Sovaldi (sofosbuvir), one of the first DAAs to receive regulatory approval in the US and Europe, is considered the backbone of the new HCV standard of care. Sovaldi is priced at US$84,000 for a three-month course. Harvoni, Gilead’€™s combination therapy, a once-a-day pill approved for HCV genotype 1, costs US$94,500 for the same duration. For people in LMICs, home to 85% of people with HCV and the majority of the world’€™s poor -€“ more than a billion living on less than US$1.25/day, according to the World Bank – €“this extortionate pricing is tantamount to a death sentence.

Even high-income countries in Europe, and the US, and Australia, have balked at DAA high pricing. In the US, Medicaid (a federal program that pays for medical services for low-income citizens) has rationed and outright denied these new medications to patients due to their high price tag. States such as New York, California, and Illinois are basing treatment eligibility on cost considerations, not medical criteria.

 In November 2014, hepatitis C activists in New York State traveled to Albany, the state capitol, to protest restrictions to HCV DAAs that include:

 -Requiring patients to wait until they demonstrate late-stage disease progression before they can have treatment

-Denying HIV/HCV-coinfected patients treatment if, in the past 6 months, they have had detectable HIV RNA viral load

-Requiring that patients demonstrate “€œno high-risk behavior (recurring alcohol use, intravenous drug use, etc.).”

 Approaches that limit rather than expand access are increasingly common, in the US, Europe and Australia where DAAs are on the market but too expensive for national and local healthcare programs. The result is disastrous for people living with chronic HCV, which, untreated, causes serious liver disease including cirrhosis and liver cancer, and death. “€œWe don’€™t make HIV-positive people in New York wait for treatment until they have AIDS, we don’€™t tell people who eat meat that they can’€™t be treated for heart disease, and so we shouldn’€™t withhold HCV treatment from people who need it. New York should not backslide into unethical cost-cutting,”€ pointed out Tracy Swan, Treatment Action Group (TAG) Hepatitis/HIV Project Director and participant in the protests.

 For people in LMICs, prospects for accessing new DAAs are even more dismal. DAA producers like Gilead and Bristol-Myers Squibb (BMS) have not registered their drugs in most of these countries. Their recently announced global access plans reflect a greater interest in emerging market profit-seeking than expanding access to treatment in developing countries, which is their stated goal.

Gilead’€™s voluntary license to 7 Indian generic companies, publicized in September 2014, allows sales of cheaper generic versions of their DAAs in only 91 countries (at time of announcement). Gilead excludes 73 million people with HCV from the deal, including 30 million in China, and other high-prevalence countries like Brazil, Russia, Thailand, Ukraine and the US, where need is greatest; while “€œbeefing up”€ the scope of their license with many low-prevalence small island nations. BMS’€™ plan (“€œbusiness as usual,”€ according to Médecins Sans Frontières) covers just 90 countries, similarly denying affordable access to nearly half of the world’s people with HCV.

kaplan_gilead_vl_worldmap_simple-9a940

Source: Gilead’€™s License on Hepatitis C drugs, Sofosbuvir and Ledipasvir: a Fool’s Bargain. Available at: www.hepcoalition.org

The global HIV/AIDS treatment access movement demonstrated the critical role of competition among generic drug makers to help drive down the price of treatment. The price of standard HIV medications dropped by 99 percent as a result. Also, communities of people living with HIV/AIDS and allies advocated to their governments to utilize legal safeguards in international trade agreements and domestic law, including compulsory licensing and patent opposition, so locally produced or imported generic versions of antiretroviral therapy (ART) could be made available. Without widespread access to generic ART, millions of lives would have been lost.

Andrew Hill and colleagues have shown the minimum cost to produce HCV DAAs generically is only a fraction of their market price. Combination treatment, including genotype testing and treatment monitoring (and providing for a 4% profit margin) could cost just US$177-444.

Governments have an obligation to promote the highest attainable standard of physical and mental health for its people. According to the World Health Organization (WHO), every United Nations Member State has ratified at least one international human rights treaty recognizing the right to health. Therefore, governments –regardless of resources –must make progress toward fulfilling this right. The UN and multilateral funding agencies such as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), have an instrumental role to play in helping to increase the capacity of governments to successfully address HCV.

 In May 2014, the World Health Assembly, the policymaking body of the World Health Organization (WHO), unanimously passed a resolution calling for stepped-up action on viral hepatitis from the WHO Director-General and Member States. The WHO issued their first-ever HCV treatment guidelines, to encourage countries develop plans and programs. These are significant advances, pushed for by activists on the ground who are engaged in raising awareness, building treatment demand, and advocating for political will in the countries where they live. Yet, the potential impact of WHA and WHO action is greatly diminished if the medications remain priced too high and generic versions of oral DAAs blocked for decades by patents granted to originator companies. UN agencies need to do more – in particular, to address the devastating price and patent barriers erected by the pharmaceutical industry.

In July 2012, a global coalition of HCV community advocates **– people with HCV, people with HIV/HCV, and people who inject drugs– and their allies -€“ issued the Washington Call, a platform of principles and demands including to the pharmaceutical industry to drop the price of HCV diagnostics and medications; donors to support community mobilization and treatment literacy; and political leaders to mobilize resources. Since then, the coalition has launched global advocacy campaigns, held community capacity-building workshops, organized meetings with Pharma and high-level policymakers, and used direct action demonstrations and other strategies to increase access to HCV treatment and care. Yet the cure remains out of reach for most people who need it now, and all stakeholders need to do more.

It would be unethical and unforgivable to allow the lessons of the HIV epidemic, such as promoting urgent access to affordable generic medications to meet the scale of the treatment need, to go unheeded. HCV can be cured, now. But it remains only a distant dream for most who need it. We must fight HCV DAA bank-busting price tags, and the intellectual property regime and the industry behind it, that collude to undermine public health.

——————————————————————————–

*Karyn Kaplan is the Director of International Hepatitis/HIV Policy and Advocacy at Treatment Action Group (TAG) in New York. She is the co-founder of Thai AIDS Treatment Action Group (TTAG), and worked on HIV and human rights with grassroots communities in Thailand for 20 years. She is the recent recipient of a Health GAP Global Health Justice award. 

**For further information on the global coalition and its campaigns and publications, as well as how to get involved, please visit www.hepcoalition.org, or contact the author at karyn.kaplan@treatmentactiongroup.org

 

 

 

 

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Post-Trial Access to Communities: The Case of Haematological Malignancies

The issue of post-trial equitable access to essential medicines for treating non-communicable diseases (NCDs) in low and middle-income countries is raising increasing concerns. This article suggests some short-term measures to fill in the relevant gaps

 Post-Trial Access to Communities : The Case of Haematological Malignancies

 by Raffaella Ravinetto*

Head of Clinical Trials Unit, Antwerp Institute of Tropical Medicine

 

The issue of access to medicines in Middle and Low Income Countries (LMICs) has often been investigated from the perspective of transmissible diseases, such as HIV/AIDS, malaria, tuberculosis, and of transmissible tropical diseases. However, non-communicable diseases (NCDs) are more and more prevalent in LMICs: according to the WHO, 80% of deaths from NCDs now occur in LMICs. Inevitably, the issue of access to essential medicines for treating them is raising increasing concerns. A few countries like India and Indonesia have issued compulsory licenses to improve access to some life-saving cancer drugs. According to Bollyky (2013) the controversy over patented medicines for NCDs and their affordability in developing countries is comparable to the one prompted, more than one decade ago, by antiretroviral drugs, and addressing this new access-crisis will require a transformation in global health (1).

As a first step of a broader investigation, and as an attempt to contribute to the ongoing debate, we explored the model of hematological malignancies, and we illustrated our findings in a Comment which has been recently published in the Lancet Hematology (2). We chose this therapeutic field for different reasons. First, new and innovative medicines today allow to cure hematological malignancies in an important group of patients. Second, the high price of these medicines makes them hardly accessible in LMICs, including Middle Income Countries (MICs) like South Africa (3). Third, clinical trials for marketing authorization purposes are often carried out in MICs: our preliminary analysis concerning twelve haematological drugs recommended by international guidelines and/or under development shows that thirty % of phase 3, interventional, commercial trials registered in ClinicalTrials.gov, involved sites in MICs, where the  likelihood that the medicine will be accessible to all is poor, due to pricing issues.

This raises, in addition to the general access issues, the specific issue of post-trial access to the general population in the countries where the trials took place. According to the main international ethical guidelines (4-6), the obtainement of scientific results in a vulnerable group should be linked to health benefits for that population, so that conducting a clinical research in a MIC where all or a part of the population cannot benefit from the study finding is unethical, and even exploitative.

In practice, looking at the clinical development plan adds a layer of complexity -and of ethical challenges- to the problem of access to medicines. In our paper, we suggest some short-term measures for achieving an  equitable distribution of the burdens and benefits of clinical research. First, regulatory agencies should require an “€œethical clause”€ binding the marketing authorization holders to offer innovative, patented drugs at tiered prices in all MICs where trials are conducted. Second, physicians and patients in MICs, hopefully joined in this effort by peers in high income countries, should lobby for a “juxtum pretium” for patented, life-saving drugs tested in trials in their countries.

The mobilization of patients, physicians and civil society has played a major role in the effort to fill the gaps in access to life-saving therapies for HIV/AIDS, and this lesson should now be retaken to correct the unequal distribution of  burdens and benefits in globalized  clinical research, and more generally to fill in the unacceptable gap in access to life-saving therapies for non-communicable diseases.

 

REFERENCES

1) Bollyky TJ. Access to Drugs for Treatment of Non-Communicable Diseases. PloS Med 10 (7): e1001485. doi: 10.1371/journal.pmed.1001485.

2) Ravinetto R, Guenzi PD, Massat P, Gaidano G. Globalisation of clinical trials and ethics of benefit sharing. Lancet Haematology (2014); 1: e54-e56. Accessible upon registration at http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(14)00004-0/fulltext?version=printerFriendly

3) Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 2013; 121:4439-42

4) World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA 2013;310: 2191–4

5) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, 1979.

6) International Ethical Guidelines for Biomedical Research Involving Human Subjects, Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the WHO. CIOMS 2002, Geneva.

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*Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine.   

After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011).   

Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health. 

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Latest News Links is 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 real-time news and the best options for use of trade and government rules related to public health by resource-limited countries

 

 

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People’s Health Before Corporate Profits: U-Turn for Governance in a Changing World

Unbiased solutions for global health depend on political will to improve equity, coherence, coordination, collaboration, transparency and accountability both at domestic and international level. Unfortunately, governments’€™ directions in the most affluent countries run contrary to these principles while turning intellectual property agendas into policies which protect monopolistic interests at the expense of equitable access to care and lifesaving treatments in resource-limited settings. As such, prospects for equity in health only hinge on non-stop, multi-sector engagement worldwide to pressure governments into doing U-Turn changes by common measures on shared agenda

People’s Health Before Corporate Profits: U-Turn for Governance in a Changing World

by  Daniele Dionisio*

Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

 

Worsening Health Inequity 

At a time when the low- and middle-income countries (LMICs) have been cut off from access to medicines for years, the most affluent countries wobble under the burden of new medicines huge costs that are beyond the grasp of their public health systems. Meanwhile, the worldwide rise of non-communicable diseases (NCDs) is  of special concern for the resource-limited countries still tackling the ongoing business of communicable diseases.  

The US$ 2 billion gap between the resources needed to adequately respond to the global TB epidemic and the funding currently provided by countries and donors still persists. This occurs even as 75 percent of the estimated 150-€“180 million people infected with hepatitis C live in LMICs where about 7 million people still do not have access to anti-retroviral medicines.

From bad to worse, since the incentives of current patent system are driven by profits, where short-term maximization of returns to shareholders is prioritized, the lower-income countries lacking profitable pharmaceutical markets are all the more discriminated.

Overall, this represents the failure of the current policies for global health as revealed at least by the scandalous  absence of a treatment for the deadly Ebola virus. 

In today’€™s world landscape, which is torn by dis-alignment, litigations and frictions among the involved parties, the root causes of health inequities are to be found in weaknesses in political domains at the supranational level. As reported, these include: democratic deficit, weak accountability, institutional stickiness, missing institutions and restricted policy space for health.  

This context entails that unbiased solutions for global health only hinge on political will to improve equity, coherence, coordination, collaboration, transparency and accountability both at domestic and international level. 

Unfortunately, the current governments’€™ directions and trade agreements, largely by the European Union (EU) and the United States (US), run contrary to these principles while turning intellectual property (IP) agendas into policies which protect monopolistic interests at the expense of equitable access to care and lifesaving treatments in resource-limited settings. 

Concern refers to still underway international negotiations, such as the Trans-Pacific Partnership (or TPP), the EU-India and EU-Thailand deals, and the Transatlantic Trade and Investment Partnership (or TTIP), at a time when an already signed Canada-EU Trade Agreement  and a recent EU custom regulation have incurred relevant criticism.

Not to mention that the government of Canada recently killed a bill on access to medicines for developing countries.

These cases just represent the tip of the iceberg for the underhanded tactics to ensure that developing countries adopt clauses that go beyond the full extension they had a right to under the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS). TRIPS-plus measures would include: making it easier to patent new forms of old medicines that offer no added therapeutic efficacy for patients (“€œevergreening”€ rules); restricting “€œpre-grant opposition,”€ which allows a patent to be challenged before it is being granted; allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including “€œin transit”€ products that are legal in origin and destination countries; expanding data exclusivity beyond WTO’€™s request for data protection against unfair commercial use only; extending patent lengths beyond 20-year TRIPS requirements; and restricting countries’€™ ability to use to the full the public health flexibilities recognized in the TRIPS agreement, including compulsory licenses and patent exceptions.

This comes as no surprise now that, coupling with the lack of transparency of a closed-doors TPP round in October, a leaked document – a revised copy of IP chapter from the secret TPP negotiations dated May 2014 – also disclosed US-Japan TRIPS-plus positions, with Australia backing “€œevergreening”€ rules.

These circumstances add concern that, like the Canada-EU deal, terms encompassing an investor state dispute settlement (ISDS) provision could end up in the final TPP text (as feared for other, including TTIP, in progress deals). ISDS would enable foreign investors from TPP states to sue the governments who sign up to it if those governments act in a way that harms their interests. 

As such, ISDS provision links in with a WTO non-violation nullification of benefits (or NV) clause that could be used if a WTO member deems that another member’€™s actions caused an unexpected loss of benefits, even if there is no violation of a WTO agreement. Developing countries are wary of NV provision while the moratorium on its use  under TRIPS continues to be renewed at WTO Ministerial Conferences. 

The non-transparent dynamics bound up with ISDS and NV terms compound fear that its allowance would be something that ultimately backs the developed economies rather than making headway on the right to health in resource-limited countries. Hence, it was not by chance that at June 2014 TRIPS Council Meeting  the US put forward a text arguing in favour of NV complaints under TRIPS.

Should NV and ISDS provisions be allowed, WTO and TPP member states might face pressures to reverse already enacted policies or measures under the threat of legal complaints on the grounds of a loss of expected benefit to the patent holders or foreign investors. These complaints could be used to threaten members’€™ use of flexibilities laid down in the TRIPS agreement also as regards access to medicines. 

Governments’€™ moves to obtain lower cost generic versions and cut extortionate prices of new medicines (such as antiviral, anticancer innovative combination treatments) could be argued indeed to make pointless or erode the expectations of the patent owners. Relevant risk sectors also include tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidise home manufacturing of the same medicine. A complaint against this country would be allowed to re-establish the conditions of competition in the original transaction.

Additionally, the sectors relevant to packaging and labelling requirements, and to IP protection enforcement measures, may also result as risk target areas, since they might affect the patent holders’€™ access to the market of medicines.

Under these circumstances, a claim could easily be lodged against a government for nullifying or eroding benefits by applying IP protection rules or packaging and labelling models that, despite full alignment with TRIPS requirements, are deemed to be insufficiently stringent or fraudulent.

These strategies add to the current breakthrough of multinational drug corporations in the middle-income country markets including through takeovers and buyouts of local companies.

Reportedly, this links in with US relentless pressure on India to open to more direct foreign investment and to further liberalize the Indian economy to make it easier for multinational corporations to operate there under TRIPS-plus IP measures.  As such, the newly  launched “€œIPR Think Tank to Draft National IPR Policy“€ in India could disappointingly converge on this.

These concerns add to criticism incurred by seven Indian manufacturers as regards pacts recently inked with Gilead for reverse engineering hepatitis C innovative regimens. With a limited territory covered, these pacts raise doubts about the coherence of Indian counterparts at a time when there are no relevant patents in India, several pre-grant oppositions have been filed and unrestrained competition by compulsory licences could have been pursued.  

Feeding  the conflicting issues above is a strategy by some pharmaceutical companies to undermine efforts of the South African government to amend its IP laws, increase affordability of medicines and brighten the future of healthcare in South Africa. Revealed through a leaked document bluntly titled, “€œCampaign to Prevent Damage to Innovation from the Proposed Draft National IP Policy in South Africa”€, this campaign fully backs the business interests while trying to sell the idea that stronger IP protections are essential to foreign investment, innovation, and achievement of public health goals. As such, the campaign refrain papers over evidence that heightened IP rights, instead of leading to greater innovation and affordable prices, make consumers captive to Big Pharma’€™s extortionate pricing.

Taken together, all insights above are an indication that, under EU and US governments’€™ complicity, corporate profits now outweigh any commitment to the global human rights.  

Worse, the current supranational policies have critically impaired access to food in the resource-limited settings, with a deeply negative impact on health. Over the last 20-30 years, the World Bank and the International Monetary Fund (IMF), and more recently the WTO, have forced countries to decrease investment in food production and to reduce support for peasant and small farmers. Under neo-liberal policies, state-managed food reserves have been considered too expensive and governments have failed to protect farmers and consumers against sudden price fluctuations, while being forced to “€œliberalise”€ their agricultural markets through reducing import duties and accepting imports for at least 5% of their internal consumption even if they did not need it. As such, the critics argue that the neo-liberal policies have destroyed the capacities of countries to feed themselves.  

This occurs even as land grabbing and evictions as part of neo-colonialism policies, including for biofuel agribusiness, are on the rise in Africa and elsewhere under national governments complacency and a widespread corruption.

Meanwhile, more coherence with Lisbon Treaty commitment to “€œhigh level of human health protection in all policies”€ should have been displayed by the EU as regards the Economic Partnership Agreements (EPAs*) negotiated with the African, Caribbean and Pacific (ACP) countries, that were flaunted to promote sustainable development and growth, poverty reduction, better governance and the gradual integration of ACP countries into the world economy. 

These insights add to criticism that the EU is becoming more protectionist in agriculture, trade and aid areas, at a time when substantial reform of EU’€™s agricultural subsidies has been  called for.

*EPAs are reciprocal, but asymmetric trade agreements, where the EU, as one regional block, provides full duty free and quota free market access to EPA countries and/or regions and where ACP countries/regions, commit to open at least 75% of their markets to the EU. As of 1 October 2014, EPAs have been concluded by 28 countries of the EU with 49 ACP countries, covering over 900 million people, on 4 continents. 

And there is more.

The World Health Organization (WHO) performances, including its Medicines Pre-qualification Programme, are suffering  from funding shortages and inadequate collaboration by member governments, at a time when an alarm bell is ringing over the fact that the majority of medicines granted marketing authorisation has no added therapeutic value compared to medicines already on the market. In some cases the new medicine even did more harm than good. 

Not to mention that dis-alignment by member governments accounts for the exceedingly slow pace of the WHO Member State Mechanism on SSFFCs (Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit medical products) since it was established in May 2012. This is disappointing now that the poor legislative and regulatory framework monitoring the quality, sale and transit of medicines in the developing countries, coupled with the scarcity of human and financial resources and a lack of political will, still allows the trade in counterfeit and substandard medicines to boom.

These circumstances add to the critical shortage of health care professionals that limits the access to care to billions of individuals in resource-limited settings. One third of the world’€™s population -€“ over 2 billion people -€“ do not have regular access to the essential medicines that they need.  

Meanwhile, the real impact on global health and development is pending as regards the BRICS (Brazil, Russia, India, China, South Africa) countries and other fast-growth Next Eleven or N-11 (Bangladesh, Egypt, Indonesia, Iran, Mexico, Nigeria, Pakistan, the Philippines, Turkey, South Korea, Vietnam) economies.

The BRICS emphasize “€œSouth-South”€ cooperation through commitment to collaborate with each other on health, and have already contributed to global health through financing, capacity building, dramatically improved access to affordable medicines, and development of new tools and strategies.

Although the BRICS have their own motives, including economics and politics, for engaging in international assistance, the increased investments in health innovation and the production of low-cost medicines, diagnostics and vaccines by the BRICS will expectedly continue to provide benefits to developing countries. 

Relevantly, it is big news that at the BRICS summit in Brazil last July the BRICS established their New Development Bank, which has long-term implications for global order and development.    

Common Health Agenda, Nothing Less

What expectations on the whole background above? Hopes that a comprehensive global health goal could be reached soon are hardly credible with the load of unresolved issues still on the table. As reported  “€œ…Achieving health equity is not just a matter of coming up with technical solutions and providing the means to finance them. We have to consider the political landscape and rectify the dysfunctions in global governance that undermine health”… 

Admittedly, governments in the most advanced countries look like they wouldn’€™t be ready to embark on the gaps highlighted here as an opportunity for national security and profitable return on their disbursements instead of just a heavy burden in times of economic slump. Rather, they seem to be captive to their eagerly profit-hungry corporate holdings in a vicious circle of mutually reinforcing political and commercial interests over public health concerns.

As such, prospects for equity in health only hinge on non-stop, multi-sector engagement worldwide to pressure governments into doing U-Turn changes by common measures on shared agenda that include:

Rejecting pressures towards adopting heightened IPRs and strengthened enforcement mechanisms as the keys to foreign investments and innovation 

As reported, “…inclusive evidence typically shows that most low- and middle-income countries do not benefit economically from IP maximization since they are net importers of IP goods and since the path to technological development is ordinarily through copying and incremental innovation-development tools that are severely undermined by IP monopoly rights and their related restrictive licensing agreements”…

Rejecting World Bank income classification to measure a country’s capacity to afford high-priced medicines

As argued, …..the World Bank classification dates back to the 1980s and only measures a country’s per-capita average of total income. However, the map of poverty has changed since the 1980s. Today, the majority of the world’s poor no longer live in poor countries, but rather in places where there is greater wealth along with higher inequality.

Relevantly, MSF contends  that….the US Medicaid-defined poverty line ($21.50/person per day) would be a far more reliable tool to estimate how many millions will live below it once countries cross the high-income threshold. As regards TPP countries, MSF highlights that “…In eight of the 12 TPP countries for which there is data, more than a quarter of a billion people will live below the U.S. Medicaid line when their country is classified as high income. By the time Malaysia and Mexico reach high income designation, more than 80 percent of their populations will still fall below this poverty line. Among current high-income TPP countries, the percentage of the population under this poverty line ranges widely, going as high as 69 percent in Chile”€.

Rejecting  privatization policies, including by publicly funded insurance packages using networks of private providers 

As reported, ….while reinforcing the notion that healthcare is a commodity and not a basic human right, this approach, proposed by the World Bank and their allies, 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.  

Inherently, as per a report from the Philippines, “…the current privatization policies of the Philippine government do not provide an answer to the enormous health needs. Despite the name of the Philippine “€œUniversal Health Care”€ program that claims to “€œbring equity and access to critical health services to poor Philippinos”€,  commercialisation of health services will do exactly the opposite. Unfortunately, the European Commission is supportive of these policies and formerly approved a contribution of euros 33 million in support of the Health Sector Reform Agenda of the Philippine government”….  

Rejecting closed doors negotiations since they blur transparency

Banning the non-violation nullification of benefits ( NV) clause under TRIPS 

Banning TRIPS-plus clauses, including investor state dispute settlement (ISDS) provisions, that could negatively affect health and worsen inequalities in access to care and treatments 

Withdrawing pressures on LMICs to jeopardize the use of TRIPS safeguards and flexibilities relevant to the price of medicines

Pushing for open knowledge and new approaches to  pharmaceutical innovation that do not rely on the patent system and de-link  the costs of R&D from the price of medicines

Promoting technology transfer with least-developed countries without exporting excessive IP standards through assistance programs

Backing generic competition as the most effective way to lower medicine prices in a sustainable way

Backing governments that make use of  TRIPS safeguards and flexibilities to protect and promote public health

Linking  together patent offices and legislators worldwide to develop evidence-based reforms of the patent regime of medicines

 As reported, “…[I]f countries set higher standards for incremental innovation patenting, and permit citizen or third-party review of patents before and after examination, then we will likely see increased generic competition in the …..market, new combination therapies, and lower … prices. In the longer term, higher inventiveness standards will help clear the patent thicket to allow new products to develop, and push industry towards genuine innovations”….

Calling on companies to join the Medicines Patent Pool  

Actively supporting partnership agendas (as per DNDI and GAVI examples among others) that are devoted to the development of new medicines and vaccines for neglected diseases that disproportionately affect poor population settings

Ensuring that the Global Fund to Fight AIDS, Tuberculosis and Malaria continues to use generic medicines and support UNITAID work to make quality medicines and diagnostics available and affordable   

Ensuring that revenues from a Financial Transaction Tax (FTT), whose approval is in progress in Europe, will substantially be committed to development and for the fight against health scourges, diseases of the poor and pandemics

FTT revenues would be a resource for the EU to channel towards the WHO and Global Fund needs. An FTT would be instrumental to the spirit and resolutions of latest WHO Assemblies. Hence, it should be up to the EU to push that non-discriminatory access to health and lifesaving medicines becomes a substantial objective for FTT revenues.

Ensuring that leading institutions and organisations enhance working with health ministries to strengthen national systems, invest in infrastructures, improve transparency and accountability, and boost needs-driven rather than market-driven rules

 This would mean giving up “€œclosed doors”€ negotiations and adopting multi-sector participatory models for decisions affecting national health, growth, employment and budgets.

Ensuring that international agreements include clauses whereby donors must strengthen WHO-aligned quality clauses in tender transactions with non-governmental organisations, while purchasers must insist that manufacturers and distributors supply medicines that meet WHO requirements, and governments must authorise export only of products meeting WHO quality, efficacy and safety standards

Ensuring that research and innovation for health is linked to improving economic prosperity and is critical to eradicating poverty (since poor health and disability contribute substantially to poverty) 

Ensuring that indicators for R&D for health tools that primarily affect LMICs address a comprehensive set of outcomes including financing needs, infrastructure and human resources needs, enabling policies, necessary partnerships, capacity strengthening, and access requirements 

Ensuring that any research and innovation indicators measuring progress against the goals and targets outlined in the post-2015 agenda* also increase accountability of researchers, governments, and funders, and inform research processes 

Ultimately, the success or failure of the post-2015 agenda relies just as much on how the goals and targets are implemented as it does on how progress will be measured 

*In support of the inclusion of research and innovation for health in the post-2015 agenda, over 150 organizations and individuals recently signed a petition to United Nations (UN) Secretary General Ban Ki-moon and Member States urging the UN to keep the research, development, and delivery of new and improved health tools for diseases and conditions impacting LMICs at the heart of the post-2015 development agenda  

Seeking  synergies among global level institutions to address global health challenges, support stronger leadership by the WHO to improve global health, enhance dialogue and joint action with key players, including UN agencies involved in global health, international financing institutions, regional organisations, regional health networks, and countries, in order to coordinate actions, advance in the achievement of commitments, and avoid overlapping and fragmentation 

Seeking synergies for equitable health access with fast growing, including BRICS and N-11, middle-income country economies 

Pushing for a complementary relationship, rather than a conflicting one, between World Bank, IMF and the New BRICS Development Bank as regards the development and health needs of marginalized population settings in LMICs

Pushing for full exemption of out-of-pocket expenses for the poor; poor-friendly pathways towards universal health coverage; heavy taxation on tobacco and other harmful substances; and reduction or elimination of agricultural export subsidies and energy subsidies on air-polluting fuels 

Opposing land grabbing, deforestation  and state-managed food reserve dismantling policies 

Reversing “€œBrain Drain”€, health worker shortage by a transformation of the present training approach, as to adapt curricula to local needs, promote strategies to retain expert faculty staff, expose trainees to community needs during training, promote multi-sector approach to education reforms, and strengthen links between the educational and health care delivery system. Western academic institutions’ role is to facilitate the process 

Asking for the European Medicines Agency (EMA) to be financed only through EU budget as per application fees channeled to the European Commission 

This would improve transparency and accountability.

Asking for anti-counterfeit laws and law enforcement policies not to substitute for effective national regulatory frameworks

Asking for organizations with potential conflicts of interests and IP perspectives to issue statements eschewing the use of IP law to counter generic medicines

Asking for investment in technologies to detect “€œbad medicines”€ to be followed up with provisions to increase public awareness and incident reporting, along with regulations on medicine quality that include definitions as per shared WHO terms  

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*Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “€œMedicines for the Developing Countries”€ for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). He may be reached at d.dionisio@tiscali.it  https://twitter.com/DanieleDionisio