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Time for cancer patients to come before corporate profits by Manon Ress, co founder and acting director of UNACT

On 26th Of May, the World Health Assembly adopted the long debated Resolution on Cancer Prevention and Control. This is an important step towards supporting countries to address this disease in order to achieve Universal Health Coverage (UHC).

Cancers are a leading cause of morbidity and mortality worldwide, with approximately 14 million new cases and 8.2 million cancer-related deaths in 2012, 70% of which occurred in low and middle income countries. These numbers are expected to increase as society ages and lifestyles change, particularly in developing countries. The societal cost, as measured by human potential loss and economic cost, is high.

In addition to prevention efforts, addressing cancer requires access to prevention and treatment but this goal cannot be achieved under the existing policies that shape the price of medicines.

Breast cancer is the most common cancer in women both in developed and developing countries. Women with positive gene “human epidermal growth factor receptor 2” (HER2) face serious challenges related to the high prices of two effective medicines.

Trastuzumab is marketed by Roche under the brand name Herceptin. 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 where more than 80 percent of the country’s population seek care. Moreover, high co-payments required by medical insurers to access treatment are simply unaffordable for many who use the private sector”.

When the patient is able to get Herceptin, the cancer can go into remission and treatment can be stopped. But if treatment is delayed and the cancer spreads, the medicines have to be used for much longer, which can eventually lead to resistance to trastuzumab.

The second medicine is a new trastuzumab combination called T-DM1 has saved the lives of many women, including myself. T-DM1 is also marketed by Roche as ‘Kadcyla’. Since its first registration, Kadcyla has generated more than $2.7 billion in sales for Roche.

T-DM1 is extremely expensive; I have received bills that range from $ 3,000 to $ 5,000 per week. The price in the UK was initially around £90,000. The high price meant that NICE did not recommend it to be prescribed by the NHS in England. According to the European Society for Medical Oncology, access to T-DM1 is limited in 30 of 48 European and Central Asian countries. It is expected that access to these medicines is even more limited in developing countries. In fact none of the 56 new medicines registered with the US Food and Drug Administration to treat cancer between 2010 and 2016 are on the WHO Model List of Essential Medicines-partly because of the high price.

The ever-increasing prices of cancer medicines are “justified” by the need for incentives to reward and induce private sector investments in R&D. However, funding R&D via high medicine prices results in rationing medicines and thus in unnecessary suffering and even death. This is neither morally acceptable nor economically sound. Achieving the targets of universal health coverage and of equitable access to safe and quality treatments for all requires reforming the R&D system in radical ways.

Firstly, governments need to implement new policies that put patients’ health before companies’ profit. Governments must move toward different ways of funding R&D that do not lead to high prices such as direct public funding and prizes for inventions. This was one of the recommendations of the UN High Level panel on access to medicines.

The Union for Affordable Cancer Treatment (UACT) proposes that a coalition of countries place a percentage of treatment budgets or GDP into an innovation fund. Funding can then be allocated to a combination of direct funding, subsidies, interim prizes, end product prizes, and rewards for openly sharing knowledge, data, materials and technology.

This proposed Cancer Innovation Fund would promote innovation that results in affordable prices of medicines without making trade-offs between access and innovation.

 

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Tobeka Daki: Denied a chance to live by Catherine Tomlinson (Cancer Alliance), Marcus Low and Lotti Rutter (Treatment Action Campaign) South Africa

 

Tobeka Daki 1-formatted

Photographer: Laura Lopez-Gonzalves

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

Notes

[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.

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Cancer care : how inequality kills by Mohga Kamal-Yanni, Senior Health policy Advisor, Oxfam

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[1]. 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.

[1] See next blog

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Why Brazil should not take a U-turn on its health system, by Pallavi Gupta, Health Programme Coordinator, Oxfam India

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 [1]. A long political struggle and the Brazilian Health Reform Movement led to the establishment of the Unified Health System (SUS) [2]. The SUS decentralized and universalised access to health care, with municipalities providing comprehensive and free health care, financed by the states and federal government [1]. 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 [2]. 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 [2]. Since 2000, the government has been investing 3 to 4 % of GDP in health [3]. 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 [2].

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 [4]. Today, 70 to 80% of the country’s more than 190 million people rely on SUS for their healthcare needs [2[4].

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 [4].

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 [5]. 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 [5]. 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 [6]. 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 [7]. 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.

References

[1] 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)

[2] Jairnilson Paim, Claudia Travassos, Celia Almeida, Ligia Bahia, James Macinko. The Brazilian health system: history, advances, and challenges. Lancet 2011; 377: 1778–97

[3] http://apps.who.int/nha/database/ViewData/Indicators/en (accessed 30 November 2016)

[4] Katarzyna Doniec, Rafael Dall’Alba, Lawrence King. Austerity threatens universal health coverage in Brazil. Lancet 2016; 388:687

[5] 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)

[6] 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)

[7] Voices of Conscience from the Medical Profession. Support for Advocacy and Training to Health Initiatives, Oxfam India 2015.

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An odd one out or part of the same system? By Mohga Kamal-Yanni, Senior health policy advisor, Oxfam

“It was a business decision. It was about money. And screw you.” A journalist said after talking to Martin Shkreh the CEO of Turin, the US-based pharmaceutical company. The company shocked the US when it raised the price of daraprim, a 62 years old medicine by 5000% from $13.5 to $750 per tablet. The US Pharmaceutical companies association (PhRMA) was quick to tweet that “.@TuringPharma does not represent the values of @PhRMA member companies.”So is PhRMA right?

In reality Turin represents a typical symptom of the same disease: putting profit before patients. Otherwise how can we explain the escalating price of new (and sometimes old) medicines not only in Europe and US but also in low and middle income countries? Take Gilead’s medicine that cures hepatitis C as an example. Sofosbuvir (marketed as Sovaldi) was launched at $1000/pill/day. Even at the reduced price offered to some countries, the price is too high. We estimated that treating just half patients suffering with hepatitis C would have cost the Egyptian ministry of health nearly two thirds of its budget.

New cancer medicines are reaching the market at exorbitantly priced and thus unaffordable in most countries even in Europe and the US. NICE, the body that advises the UK’s NHS on medicines rejected Roche’s breast cancer medicine trastuzumab emtansine (Kadcyla) not because of ineffectiveness but because of its high price. Needless to say the price is far beyond the dreams of patients in developing countries.

Patients and advocates for access to medicines have been campaigning on access to medicines in developing countries for years. Their success is clear when the price of the anti-HIV cocktail dropped from US$ 10,000/patient/year to around US $100. Now similar actions have started in rich countries too. One of these groups sent a letter to Jeremy Hunt the UK secretary of health urging him to issue a compulsory license that enables the importation of cheaper versions of the same medicine so that women are not denied a life saving treatment.

Having “temporary” monopoly over pricing seems to be not enough for pharmaceutical companies. Pharma lobbyists carry significant influence in the corridors of power pressurising governments to design and enforce rules that exceed what is already agreed at the WTO through the TRIPS[1] agreement.

Intense lobbying to increase intellectual property rules in free trade agreements has created global public anger. Last September a cancer patient was arrested when she was accused of disrupting the negotiation of the Trans-Pacific Partnership (TPP). The recently concluded TPP negotiations were carried out over more than five years in secret and the text will only be available for elected bodies and the public when it is ready for signing.

Free trade agreements (FTAs) like the TPP are notorious for expanding corporate powers at the expense of public health and the public interest. For example, the FTAs allow corporations to sue governments over measures to promote access to medicines (such as price controls, reimbursement decisions, marketing approvals, and drug safety decisions, or stricter patentability standards). Corporations argue that such measures would damage their investments, which they insist must be protected by the FTAs. This is already happening as Eli Lily has taken the Canadian government to court over government action to make some drugs affordable.

Similar damaging FTAs are currently being negotiated –also behind closed doors- between the EU and Thailand, India and the US.

Moreover, when developing countries try to use legal tools to control or decrease prices, they are put under huge pressure from rich countries under the influence of ‘big pharma’. When Thailand issued compulsory licensing for key medicines to treat HIV and cardiovascular diseases, ‘big pharma’ launched intense pressure on the country to revoke the decision. Under the influence of ‘big pharma’, the US trade representative put Thailand on the Special 301 ‘Priority Watch list’ of countries, which subjects countries to extreme pressure from the US government. Pharma’s influence on the EC resulted in pressure from the European Commission on the Thai govt to change its decision.

Recently some Members of US congress wrote to the US administration urging it to put pressure on India to change its national intellectual property law in order to strengthen monopoly protections on pharmaceuticals. The law had previously been challenged in court by one pharmaceutical company but the court turned the claim down. Changing the Indian law by increasing intellectual property protection will deprive patients from access to needed medicines not only in India but also in the rest of the developing countries. India is considered “the pharmacy” of developing countries.

The root of the companies’ monopoly power and influence is the current model for funding for research and development (R&D) of medicines. Pharmaceutical companies justify the high prices of medicines by the need to recover the R&D costs. Yet the actual cost of R&D is kept as a big secret by the industry. In reality it is becoming increasingly clear that medicine pricing is not determined by production costs and a profit margin, but by what the market can bear.

Clearly the current R&D system is failing patients and health providers all over the world. It is high time that global leaders work for an alternative system that separates the financing of R&D from pricing the resulting medicines. It cannot be left to the pharmaceutical industry to cater only to those who can afford to pay high prices- practically deciding who lives and who dies.

 


[1] Trade Related Aspects on Intellectual Property Rights

 

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Global Health Check was created by Anna Marriott and is currently edited by Mohga Kamal-Yanni