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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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World AIDS Day: Lessons for reversing inequality by Mark Goldring, Oxfam UK Executive Director

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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.

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The High Level Panel Report: to gather dust or create real change on access to live saving medicines?

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There is hardly a day that goes by without some headline about a highly priced medicine that is beyond the means of those who need it. For decades, access to medicines was automatically associated with problems in poor countries. However, it has now become clear that the high price of medicines is crippling healthcare systems everywhere in the world. Patients’ stories from South Africa to Sweden and from Colombia to the UK tell the difficult reality of people’s struggle to get access to life-saving medicines.

For example, the price of effective medicines to treat Hepatitis C can be over $100,000 per patient. The Dutch government’s submission to the High Level Panel states that “We have an estimated 20,000 patients with this disease. Such costs make our healthcare unaffordable. If we continue in this way, it will become nearly impossible to reimburse patients for these medications”.

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The prices of cancer medicines are beyond the reach of many patients who need them especially in developing countries.

 

“I was diagnosed with breast cancer in 2013. My insurance refused to cover my Herceptin treatment because of the high price. Now the cancer has spread all over my body. I need Herceptin so that I can live and bring up my two boys”.
“Tobeka Daki from South Africa”

 

While the high medicine prices is one side of the access problem, the Ebola crisis highlighted the other side: lack of innovation for public health needs. The current global system relies on intellectual property (IP) rules that create monopolies in order for pharmaceutical companies to generate profits and thus to finance research and development (R&D). Where companies see they can make money, they even invent new disease’ names for medical conditions to market their medicines – as in the latest case of opioid-induced constipation. In that case, clinicians who found a way to ease the suffering of the dying got investors to bring a drug to market only when a broader market was identified – the opioid dependence that has reached crisis levels in the United States. But where there is no profit, such as in the case of Ebola, there is no investment from companies.

In December 2015, the UN Secretary General established a High Level Panel (HLP) to “recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” The HLP is a unique opportunity to advance access to health technologies for several reasons. The HLP acknowledges the potential conflict of interest between the human right to health and IP rules. Moreover, unlike other initiatives that have tended to focus on neglected diseases, the HLP tackles all health technologies for all diseases in all countries.

The HLP published its report in September 2016, which includes recommendations that represent positive steps to advance access to medicines[1]. On the innovation side, the report recommends that the UN Secretary General start a process for UN member states to negotiate a binding R&D convention that delinks the cost – and hence financing – of R&D from the price of the final product. This is a critically important initiative. The pharmaceutical industry justifies the ever increasing prices of medicines by citing the high cost of their R&D even though all information related to those costs is shrouded in secrecy. The industry also fails to recognize the important role of public financing for R&D. The HLP report calls for increased public financing through domestic resources as well as innovative sources like the financial transaction tax. However, increasing public financing for R&D is not enough unless there are binding agreements for affordable prices of the resulting products.

Nearly all issues related to medicines are shrouded in secrecy. Therefore, it is important that the HLP report recommends transparency of information involving R&D costs, medicine pricing, patent status and clinical trials, as well as negotiation of Free Trade Agreements (FTAs).

On the access side, the report recognises the political and commercial pressures that countries face when they try to use the flexibilities enshrined in the World Trade Organization’s (WTO) Trade Related Aspects on Intellectual Property Rights (TRIPS) Agreement, which allows governments to adopt specific policies to protect public health. Free Trade Agreements (FTAs) include measures that actually restrict governments’ ability to adopt pro-health policies. While the report recommended that countries register any pressure they face at the WTO, and countries to conduct impact assessment on potential effect of FTA measures on access to medicines, it fell short of proposing an immediate ban on excessive IP protections in FTAs.

Unfortunately, the US government and pharmaceutical companies started attacking the report even before it was published. The unholy alliance between rich country governments and the pharmaceutical industry employs extensive resources and pressures to stop the development or promotion of alternatives to the current IP system to finance R&D, which is based on conferring monopoly power to extract the highest profit from the end product. But this system is failing patients around the world. Now is the time for change, for a system that places the human right to health as the determinant of the R&D agenda and enables affordable pricing of products.

Good recommendations require active engagement that leads to action if they are to bring about beneficial change. Concerted efforts are now needed for the UN system and member states to adopt and implement the HLP recommendations. Otherwise the report will simply end up gathering dust on some shelves in a UN office. It is now in the hands of the UN Secretary General to move this process forward. His action would be a valuable parting gift to the world as he leaves office at the end of this year, a critical step toward ensuring access to medicines for all so no one is left behind.

[1]These recommendations have limitations, which are explained in the Commentary included in the report’ Annex, by three panel members, including Winnie Byanyima, Executive Director of Oxfam International.

 

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