On World Cancer Day in 2016 (4 February) the Fix the Patent Laws coalition in South Africa launched the Campaign for Access to Trastuzumab to advocate for broad access to the WHO-recommended essential treatment for early stage and metastatic HER2+ breast cancer[i]. One year later we are renaming the campaign the Tobeka Daki Campaign in memory of the woman who led our advocacy for trastuzumab during 2016 – whilst herself unable to access the potentially life-saving treatment.
Tobeka Daki was a single mother from Mdantsane Township in South Africa who was diagnosed with HER2+ breast cancer in 2013. Following her diagnosis, Tobeka was informed that she needed trastuzumab, in addition to a mastectomy and chemotherapy, to improve her chances of survival. A chance of survival that Tobeka was denied – not for medical reasons – but because she could not afford to buy the medicine .Tobeka’s cancer spread to her spine and on 14 November 2016 she died in her home.
In South Africa, a 12-month course of trastuzumab costs approximately ZAR 516,700 ($38,000) – or around 5 times the country’s average household income. Given its unaffordability, trastuzumab is not available in South Africa’s public health sector[ii] where more than 80% of the country’s population seek care. Additionally, high co-payments required by medical insurers to access the treatment are simply unaffordable for many who use the private sector.
Despite very limited access, Roche is able to generate significant income from the sale of trastuzumab in the South Africa. In 2015, trastuzumab was the second highest driver of expenditure on a medicine in South Africa’s private sector. During the same year, Roche earned more than US$ 8.9 billion in profits globally.
The excessive income and profits generated by the sale of trastuzumab reflect pharmaceutical companies’ common practice of price hikes in order to maximize their profits – at the expense of patients’ access to the medicines they need.
Recently academics in the UK estimated that a full 12-month course of trastuzumab can be produced and sold for as little as R3,300 (US$245) – a mere fraction of prices charged by Roche in South Africa and elsewhere. This low figure includes a 50% mark-up on the cost of production for profit and is similar to estimates for producing trastuzumab provided confidentially from a competitor company in 2013. Multiple patents granted on trastuzumab combined with the slow market entry and registration of biosimilar[iii] products globally allowed Roche to charge exorbitant prices for the life-saving treatment for far too long.
Recognising the injustice faced by herself and others who are unable to access trastuzumab while Roche reaps massive profits, Tobeka threw herself into advocating for equitable medicine access for all during 2016. In February, she was featured in a short video in which she noted: “if I can get [trastuzumab] treatment, it will give me a chance to see my two sons and my grandson growing”. Even as the likelihood of her being able to access trastuzumab diminished, Tobeka’s determination to ensure other women could access the medicine only grew stronger.
Tobeka went on to lead several demonstrations calling on Roche to drop the price of trastuzumab and gave testimony regarding her inability to access trastuzumab treatment in front of the United Nation’s High Level Panel on Access to Medicines .
Finally, less than 2 months before her death, Tobeka led a march calling on the South African government to end delays in reforming South Africa’s patent laws to improve medicine access.
On World Cancer Day 2017, the Fix the Patent Laws coalition will rename its campaign the Tobeka Daki Campaign for Access to Trastuzumab – to remember Tobeka, to recognise her inspirational leadership and to pledge ourselves to continue her struggle for access to affordable medicines.
Starting in February, activists across the world will highlight the excessive price of trastuzumab and Roche’s unconscionable profits as women continue to die as a direct result of their prices. We will demand access for every woman who needs it.
The campaign will call on Roche to drop the price of trastuzumab so that all women living with HER2+ breast cancer who need it can access it; to immediately cease all litigation against biosimilar versions of trastuzumab; to stop abusive patenting practices that needlessly extend their patent monopoly on trastuzumab; and to immediately cease litigation against the Brazilian and Argentinian governments for their use of TRIPS flexibilities in order to decrease the price of the medicine. .
To follow the campaign in South Africa, visit @FixPatentLaw or www.fixthepatentlaws.org, and follow the hashtags: #ForTobeka
[i]Approximately 1 in 5 women diagnosed with breast cancer are HER2 positive – meaning that the human epidermal growth factor receptor (HER2) is over expressed in the breast cancer tumor. HER2 over expression is associated with more aggressive disease, higher rates of recurrence and higher mortality rates than HER2 negative tumors.
[ii]Except in very limited circumstances. See more at: http://www.fixthepatentlaws.org/wp-content/uploads/2016/11/Cancer-Alliance-motivation-for-the-provision-of-trastuzumab-in-the-public-sector-November-2016-2.pdf
[iii]Follow-on versions of biologic medicines- usually produced by companies other than the originator producing company. As biological medicines are produced from living organisms, biosimilar medicines are not exactly identical to biologic medicines but are comparable in terms of safety and efficacy.
I shall never forget our neighbour Zahia (meaning bright) when I was growing up in Egypt. She was a really bright lady, clever, always smiling and radiating beauty and happiness. Her kids would go to school looking immaculately dressed despite being poor. One day she just disappeared and I later saw her kids in rags wandering around. As a child, I could not comprehend the neighbours’ whisper of a “bad disease” that killed her, but I clearly saw it was so bad that the family had to leave their house and the kids were destitute. Years later I learnt that Zahia had breast cancer that was diagnosed at a late stage and that her family had to sell everything so she could have treatment that was too late to save her life.
Zahia’s tragic death is a result of injustice in an unequal world, where cancer survival rates in much lower in poor countries than in rich countries. Within countries, inequality also means that access to early diagnosis and treatment is beyond the means of low income people like Zahia. She adds to the case fatality rate which is 74.5% in low income countries but 46.3% in high-income countries where access to diagnosis and treatment is much more secure.
Simply put, lack of access to diagnostics leads to late recognition of cancer, after the disease spreads all over the body and become prohibitively expensive or clinically impossible to treat, leading to unnecessary death.
Access to cancer care in developing countries is hindered by a complex web of several factors: lack of awareness and information about cancer prevention and diagnosis; underfunded and challenged health systems that are struggling to cope with communicable diseases; out of pocket payment for services that are unaffordable even for the middle class, much less people in poverty, and dreadfully expensive prices of cancer treatment.
Yet cancer incidence is rising in developing countries. The latest WHO figures show that cancer kills 8.8 million every year, the majority of which are in developing countries. Addressing the rising incidence of cancer cases requires a comprehensive approach that encompasses prevention, diagnosis and treatment, including surgery, radiation and medicines. Prevention requires public health policies that restrict carcinogenics like tobacco and encourage actions for good health such as physical exercise. However, focusing only on prevention makes cancer appear as a personal responsibility and leaves patients to bear the cost of their own treatment according to their means.
Diagnosis and treatment of cancer depend on availability of health services with trained staff that can provide quality services, including surgery and radiation, as well as affordable chemotherapy and medicines. Many governments and donors do not prioritise cancer care as part of financing health care. The International Atomic Energy Agency (IAEA) implements a programme of support to countries that are committed to investment in cancer care. More donor actions are needed to support countries in building their capacity to deal with cancer before it becomes an even more serious crisis.
Since Zahia’s death there has been great progress in chemotherapy and medicines that treat breast and other cancers. However, the price of these medicines is escalating to a degree that is beyond the means of the majority of cancer patients worldwide, and even beyond payers (whether through tax or insurance) in rich countries. Such unaffordable high medicine prices have a devastating impact on patients. The tragedy is that these prices need not be so high. A recent study investigated the potential cost of production of a number of key cancer medicines and found that they can be produced and sold at a fraction of the current market price. The cases of docetaxel and letrozole medicines are illustrative of how generic competition is an effective means to make prices more affordable.
Generic production of new medicines is delayed by monopolies due to patent protection. Pharmaceutical companies often succeed in extending their monopoly via multiple follow-on patents (evergreening), thus enabling companies to maintain high prices for longer time.
While pharmaceutical companies can issue voluntary licensing for generic production when they feel it suits them, governments have the right to issue compulsory licenses to override patent monopolies, which enables generic competition and reduces prices. Despite the rhetoric that governments can use this and other tools, rich countries severely object to and punish governments that try to use it. This was the case when India rejected a patent on imatinib for treating chronic myeloid leukaemia. Novartis, the patent holder, took the government of India to court. The US government has been exerting pressure on India to change its intellectual property law, which enabled the country to reject the patent as invalid because it failed to meet India’s standards for innovation.
In recognition of the fact that high prices of new medicines are a global problem, the UN Secretary General’s High Level Panel on access to medicines made strong recommendations to enhance access to health technologies. We are yet to see the UN system and member states implementing these recommendations.
Inequality in access to cancer treatment is a death sentence for low income people. It is time that world leaders prioritise investment in public health systems and in new models of research that lead to affordable medicines that are accessible to all, in order to fulfil their commitment that no one be left behind.
 See next blog
Brazil has been the envy of the world in terms of its successes in reducing health inequality. Yet recent developments threaten its health achievements. This blog looks at the potential impact of recently announced policies on the public health system in Brazil by exploring how similar policies have played out in the Indian health system.
Brazil: success and threats
In response to its commitment to the 1978 Alma-Ata declaration of “health for all”, the constitution of Brazil enshrined health as a right of all citizens in 1988, thereby mandating the state to provide universal and equal access to health services to its population . A long political struggle and the Brazilian Health Reform Movement led to the establishment of the Unified Health System (SUS) . The SUS decentralized and universalised access to health care, with municipalities providing comprehensive and free health care, financed by the states and federal government . Primary health care (PHC) has been key to Brazil’s health reform strategy. PHC integrates medical care with health promotion and public health actions. Family health-care teams, comprising one doctor, one nurse, one auxiliary nurse, and four to six community health workers are assigned per 600–1000 families . Despite opposition from the private health sector as well as underfunding, the SUS has managed to vastly improve access to primary and emergency care, reach universal coverage of vaccination and prenatal care, and invest in the expansion of human resources and technology, including the production of essential medicines . Since 2000, the government has been investing 3 to 4 % of GDP in health . Consequently, fertility rates in Brazil decreased from 5·8 per woman in 1970 to 1·9 in 2008, and infant mortality reduced from 114 per 1000 live births in 1970 to 19·3 per 1000 live births in 2007 .
Furthermore, in response to protests by Brazilians demanding better access to physicians, Brazil sourced doctors from the country and from Cuba as part of its “More Physicians” (Mais Médicos) programme introduced in 2013 by Dilma Rousseff’s government. This additional workforce benefited 63 million Brazilians living in remote and vulnerable areas, which previously had shortages of health professionals . Today, 70 to 80% of the country’s more than 190 million people rely on SUS for their healthcare needs [2, .
However, the austerity measures proposed by the new government after the impeachment on August 31st 2016 and approved by the senate in December 2016 include the control of public spending for 20 years, which will have an impact on public education and public health services. Another measure that has been controversial since the interim government (from May to August 2016) is the creation of a plan to encourage people to seek healthcare from private providers instead of the country’s public health system, while the government is ending the monitoring of the private health-care sector. There are also attempts to diminish the role of public health care as evident by the staff cuts in the National Unified Health System. There is also a possibility of reduction in the number of foreign professionals in the country’s “More Physicians” programme .
Learning from India
Will looking at the fate of people in India make the new President and Minister of Health of Brazil think again about their plan? What the Brazilian government is planning to dismantle is exactly what civil society organisations and health rights groups have been calling to be established in India for decades. 70% of the out-patient care in India is sought from the private sector and nearly 60% of healthcare expenditure in the country is paid out-of-pocket by people at time of use . One of the reasons for this is the abysmal state of the public health system in the country which has forever been underfunded, at a meagre 1.28% of GDP5. Shortages of health staff is a huge challenge that India faces, especially in the rural and tribal areas. The private healthcare industry, that has been growing by leaps and bounds, is largely unregulated and enjoys tax sops in more ways than one . The central government passed the Clinical Establishment (Registration and Regulation) Act 2010 to regulate private medical services across the country, so that the patients can get good quality services with some control over their cost . However, the whole private health care industry, including the Indian Medical Association (a private voluntary association of doctors) has been protesting the implementation of the Act and the sector continues to operate more or less on its own terms, leaving patients at their mercy.
Oxfam India supported the collection of testimonies of 78 rationally practicing doctors who shared the inside stories of how private healthcare operates in an “industry mode” and how patients are frequently fleeced of their money and right to care . For example, a pathologist in a leading Indian city hospital gave a fake report declaring a patient diabetic (when his blood sugar was normal) on the suggestion of the doctor who had referred the patient. By doing so, the doctor ensured having a long term patient under his care who would be a continuous source of income. And this is not a one-off case.
The results of the proposed measures in the Brazilian public health system can be seen in Indian healthcare.
As the saying goes, “to make, it takes one lifetime, and to break, it takes one day”. India’s one life time for progressive changes is still to come but Brazil’s “one day to break” is right here. Given the impact that we witness everyday of a weak health system on people, we can only hope that the Brazilian public health system does not take a U-turn and tread the India Path.
 Flawed but fair: Brazil’s health system reaches out to the poor, Bulletin of the World Health Organization, Volume 86, Number 4, April 2008, 241-320. http://www.who.int/bulletin/volumes/86/4/08-030408/en/ (accessed 7 December 2016)
 Jairnilson Paim, Claudia Travassos, Celia Almeida, Ligia Bahia, James Macinko. The Brazilian health system: history, advances, and challenges. Lancet 2011; 377: 1778–97
 http://apps.who.int/nha/database/ViewData/Indicators/en (accessed 30 November 2016)
 Katarzyna Doniec, Rafael Dall’Alba, Lawrence King. Austerity threatens universal health coverage in Brazil. Lancet 2016; 388:687
 Vikram Patel, Rachana Parikh, Sunil Nandraj, et al. Assuring health coverage for all in India. Lancet 2015; 386: 2422–35. http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)00955-1.pdf (accessed 30 November 2016)
 The Clinical Establishments (Registration and Regulation) Act, 2010, Ministry of Health and Family Welfare, Government of India. http://clinicalestablishments.nic.in/cms/Home.aspx (accessed 30 November 2016)
 Voices of Conscience from the Medical Profession. Support for Advocacy and Training to Health Initiatives, Oxfam India 2015.
Today is World AIDS Day, a day to celebrate the many lives saved and to remember the many lost to the HIV virus. Importantly it is a day to reflect on what we have learnt from working to address the inequality challenges of the HIV epidemic. This is particularly critical for civil society, and others, working to reverse inequality. I will focus here on 4 lessons:
Lesson one: Inequality kills. Millions have died because they were too poor to pay the exorbitant prices of medicines & hospital fees. Investing in public health systems to offer free service as the point of use and in affordable medicines are essential to save lives and tackle inequality – both health inequalities and crucially, economic inequality.
We must remember that it was civil society movements that put pressure on pharmaceutical companies and created the environment for Indian companies to compete and thus slash the price of HIV medicines from $10,000 to around $ 100/ person /year leading to the over 18 million people on treatment now. Inequality in access to medicines affects millions all over the world. A big cause of this inequality is the global system of biomedical research and pricing, which leaves critical decisions on medicines- basically the decision on who lives and who dies – in the hands of pharmaceutical companies. This system needs re-thinking to ensure availability of the medicines we need at affordable prices.
Therefore, the recommendations of the UN Secretary General high level panel on medicines published just a couple of months ago are a great step in the right direction to ensure that the research and development (R&D) system produces affordable medicines for people who need them. We hope for the UK leadership in implementing these recommendations. We see interdependence between progress on the issue of anti-microbial resistance (on which we have seen magnificent leadership from the UK government) and delivery on the UN panel recommendations to transform the R&D system for accessing medicines.
The second lesson is related to a critical dimension of inequality, which is accessing health services. A big lesson from HIV is that its services are fundamentally free and thus saving the lives of the 18 million people who are on treatment. This must extend to all health services. Paying for health care pushes 100 million people into poverty each year. One billion people are denied health care because they can’t afford to pay. Health services free at the point of use are critical to prevent this situation and to enable people to stay healthy and productive – thus improving livelihoods and economic growth. Women bear the brunt of paying for health care as they have to care for sick family members and they are the last to access paying services. Recently the UN statistical group mandated to frame the indicators to measure the Sustainable Development Goals, agreed on the indicator that measures the financial protection arm of Universal Health Coverage. The indicator 3.8.2 will measure what really matters: the out of pocket expenditure on healthcare. Again, civil society has been instrumental in establishing this indicator.
ِِِِAccess to HIV treatment could not happen without securing adequate financing. This is the third lesson. Thanks to domestic and donors funding like the Global Fund, poor and marginalised people can access the services.
Building resilient health systems that provide services needed for HIV, other diseases including non communicable diseases and emerging infections, requires adequate and sustainable financing. Public financing is critical – there is now consensus across the global health community that all governments must push forward urgently on achieving universal health coverage. At the core of the consensus is an understanding that an increase in public financing for health is a non negotiable ingredient for success.
Oxfam campaigns on tax reforms as a fundamental solution to raising additional needed revenue and at the same time redressing extreme economic inequality. However, few low and lower middle income countries have sufficient resources, even with significant tax reform, to pay for health care for all. Aid should be provided in the right way – supporting the expansion and improvement of public health systems, the removal of fees and the scale up of the health work force
It’s a worrying trend that the marginalised and vulnerable in middle income countries are being left behind as a direct result of the trend of withdrawing development assistance from these countries. This is clearly illustrated in the negative impact on HIV programmes that is supporting marginalised groups and civil society advocacy. Donors have a responsibility to transform their support in a way that addresses the needs of marginalised groups.
Last but not least, active citizenship – people’ involvement in decision making has been a great driving force to overcome discrimination and the marginalisation of women, sexual minorities and other marginalised groups. This is at the heart of the success in the response to HIV and is at the heart of our inequality campaign
These four factors require the world to make long term commitments to investment in R&D, in free public services and in enabling community and civil society participation in decision making and in monitoring the commitments of governments, donors and international agencies. This is critical if the world leaders are serious about leaving no one behind.
We are delighted to announce a victory for the drive for universal health coverage. We will now be able to count the cost of paying for healthcare for households around the world. It is truly exciting that in a couple of years we could have sound global data on what kinds of health financing mechanisms are most effective for leaving no one behind in healthcare. Armed with this, we can call for policy changes to achieve more equity in health and prevent the 100 million people currently being pushed into poverty each year paying for health care.
Today, the group of experts tasked with developing the indicator framework to measure progress towards the Sustainable Development Goals (SDGs), have agreed to measure financial risk protection of universal health coverage by ‘’proportion of the population with large household expenditures on health as a share of total household expenditure or income”. This signals a great shift in from the previous dangerous indicator that would just measure population with access to health insurance or a public health system.
The previous indicator was flawed because it did not measure whether or not people were actually financially protected against potentially catastrophic costs for health care. It would have also failed to measure progress across different income groups or by gender. It was also dangerous as it sent a signal to governments around the world that health insurance was the route to achieving Universal Health Coverage despite robust and scientific evidence that many voluntary health insurance schemes have exacerbated inequality.
A global campaign was mobilized to replace the dangerous indicator with one which ‘measures what matters’.
In a campaign largely coordinated by Oxfam, civil society organisations, academics, development agencies and statistical authorities expressed their deep concerns with letters, lobbying and public statements. Now we can celebrate a step closer to universal health coverage that leads to everyone accessing the quality health services they need without being pushed, or pushed further, into poverty.
In March this year we posted a blog on global health check about a dangerous and surprising last minute change to the indicator measuring financial risk protection for Universal Health Coverage (UHC), being developed by the Inter-Agency Expert Group on the Sustainable Development Goals (IAEG-SDGs). The IAEG is meeting in Geneva this week and aims to conclude discussions on this indicator (3.8.2), along with some of the other contentious indicators they have identified within the SDGs global indicator framework.
Since we reported on the danger of the nonsensical indicator undermining the highly valued SDG target on achieving UHC (that gives everyone access to quality health services, without causing impoverishment), the global health community has mobilized in large numbers to call for the reinstatement of the original indicator or a revised version of it, as proposed by the World Health Organisation (WHO) and World Bank (WB). Here are a few highlights of the actions from a range of constituent communities with a stake in this issue over the past few months:
The motivation for all this is to warn against keeping the current indicator whether on its own or in combination with the WHO/WB refined indicator. The current – flawed – indicator to measure financial risk protection for UHC reads:
‘coverage by health insurance or a public health system per 1,000 population‘.
The reasons this is not fit for purpose are manifold:
As an illustration of these flaws see the stories of Ranu and Esther.
Thankfully the IAEG is considering the alternative WHO/WB proposed indicator – one that is based on a global consensus following extensive consultation over a 3 year period. This alternative reads:
“Proportion of the population with large household expenditures on health, as a total share of household expenditure or consumption.”
This is relevant to the UHC target, as it directly measures the financial impact on households of the costs of health services. It is methodologically sound and grounded in an internationally agreed standard definition which is scientifically robust and policy neutral. Information and data is readily available from routine household surveys conducted by national statistical offices (e.g. Budget Surveys, Income and Expenditure Surveys, Living Standards Measurement Surveys) to support calculations. Furthermore, it is amenable to disaggregation on income, gender and geographical location.
A risk remains that in an attempt to reach agreement the IAEG members will include the WHO/WB proposed indicator as an addition rather than replacement to the flawed indicator. This is unacceptable for all the reasons above but also because countries are already straining with the weight of the SDG measurement framework and it would be a waste of their precious resources. Any data issued by governments using this indicator as a measure will be useless and thus easily ignored by health and statistical experts such as the 351 signatories who signed the health academics letter, the 100s of NGOs who’ve signed letters on this, and the 22 statistical authorities who submitted to the online submission. It would work to counter the hard won global consensus and huge momentum on UHC. And the losers would be all those currently left behind by their own national health systems – those like Raju and Esther who face the stark consequences of paying out of pocket for their health care.
To avoid this danger, the current indicator must be taken off the table completely. Instead of keeping this wasteful indicator, let’s measure what really matters: the impact of health spending on households.