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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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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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Durban 2016: A call to world leaders to enhance research and development (R&D) and access to medicine

“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”.

These were Tobeka Daki’s words to the audience during a session at the International AIDS Conference in Durban last week. The session, titled ‘A call to world leaders to enhance research and development (R&D) and access to medicine, and an appeal to the UN High Level Panel (HLP) on human rights and access to medicine’, was co-sponsored by Treatment Action Campaign, Stop AIDS, Open Society Foundation and Oxfam.

Tobeka is deprived of the medicine that can save her life because Herceptin costs half a million Rand ($35,049) per patient per year in South Africa. Meanwhile, Roche is celebrating its successful financial results of June 2016:

“The net income increased 4% to 5.5 billion Swiss francs ($5.57 billion) in the six months to June 30, beating analyst estimates of 5.3 billion. Revenue rose 6% to 25 billion francs, in line with estimates”. ’

The global R&D system for health technologies results in such high prices of new medicines because it is based on maximisation of profits to incentivise investment in R&D. The system has generally failed to deliver affordable health technologies to prevent and treat diseases. While governments (except Least Developed Countries ) are obliged to implement intellectual property protection as part of the agreement on Trade Related Aspects on Intellectual Property Rights (TRIPS), they are also obligated under international human rights law to fulfill their citizens’ rights to health and access to treatment.

The mandate of the HLP, established by the UN Secretary General, is to make recommendations to remedy “the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”

Sixteen years ago at the International AIDS Conference held in Durban in 2000, civil society sent a strong message to world leaders that people living with HIV must have access to life-saving antiretroviral medicines (ARVs). At that time, ARVs were available only in the “North”, while the majority of people living with HIV lived in Southern countries. At this year’s conference, people celebrated the fact that 17 million women, men and children are now accessing treatment. Thanks to generic competition that dramatically reduced the price of ARVs, it was possible to mobilise global public funding to pay for treatment programmes. However, will it take another 16 years before the 19 million people living with HIV – but without access to treatment – can receive the medicines they urgently need?

Generic competition for new medicines is almost completely limited because India, commonly known as the pharmacy of the developing world, has adopted TRIPS and is now under great pressure to increase its intellectual property protection even beyond TRIPS.

Meanwhile the world is waking to the reality that cancer is not a disease of rich countries but is affecting increasing numbers of people everywhere. According to the World Health Organisation, 70% of cancer mortality (5.5 million people) now occurs in the developing world. Other diseases such as multiple sclerosis – which used to be considered “Northern” conditions – are increasingly being diagnosed in developing countries. The prices of medicines for these diseases are beyond the means of patients, governments and insurers.

Activists show solidarity with women unable to access vital medecines used to treat breast cancer

Activists show solidarity with women unable to access vital medecines used to treat breast cancer

It is in this context that the scope of the HLP covers all diseases and is not limited to neglected diseases in developing countries. The HLP recognises that new cancer medicines are priced beyond the capacity to pay even of governments in the North. Both the public and the private sectors are struggling to provide these medicines to patients in Europe and in the US.

And it is not only cancer medicines that are unaffordable. At the conference I met two people from Sweden working to support women living with HIV. We talked about medicine prices and they assured me several times that they did not face any problem in Sweden because medicines are free in the public sector. One of them compared her “good luck” to people in Africa who face high prices for hepatitis C treatment. She then said that she herself suffered from hepatitis C but could not get the medicine because according to national guidelines her liver “is not bad enough” to qualify for treatment. It was eye-opening to see how Europeans are unaware of the relationship between high prices and the rationing of treatment. Today England was criticised for rationing hepatitis c treatment by limiting the number of people who get the medicines every year.

As civil society we see the need to revitalise the access to treatment movement in order to promote much needed global reforms in the R&D system for health technologies. The HLP provides an important opportunity for UN member states to address the conflict between securing the human right to health and medicine, and countries’ obligations under the TRIPS agreement, taking account of access problems in all countries, for all diseases. These reforms could be a vital first implementation of world leaders’ commitment to “leaving no one behind”.

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No health security without health systems by Mohga Kamal-Yanni, Senior Health Advisor, Oxfam GB

The Ebola outbreak has shocked the entire world of global health. Even while Ebola lingers in West Africa the future of health security and the organisation of health systems are being debated.

There have been many conferences held and reports published to provide “lessons learned from the Ebola crisis. A thread running through all of these events has been an agreement on the need to build resilient health systems. Yet building such a system requires planning, investment and serious long term commitment. Short term investment does not produce the necessary workforce needed for a functioning health system. Dhillon and Yates identified 5 key areas that require immediate attention in order to rebuild health systems: community based systems; access to generic medicines; restoring preventive measures; integrating surveillance into health systems and strengthening management.

An Oxfam paper identifies six critical foundations for resilient health systems. I can visualise these foundations as a chair with 4 legs. If you keep one leg short and invest in another leg, the balance is tipped and the chair falls. Meantime if you ignore the base or the back of the chair, it moves from the seating area to the recycling bin!chair-01

  1.  An adequate number of trained health workers, including non-clinical staff and Community Health Workers (CHWs)

The urgency of allocating resources over a ten year period cannot be better expressed than by Bernadette Samura, a health worker from Pamaronkoh, Sierra Leone:

“Because many nurses have died, it is time for the government now to train more nurses’.

Based on the WHO’s minimum standards of 2.3 doctors, nurses and midwives /10,000 people, Oxfam calculated the gap in these workers and the cost of training and paying them. Liberia, Sierra Leone, Guinea and Guinea-Bissau require $420m to train 9,020 medical doctors and 37,059 nurses and midwives. Once they were trained, a total of $297m annually would be needed to pay their salaries for 10 years. It is worth remembering that at the height of the outbreak, all humanitarian agencies were desperately seeking program managers, logisticians, financial officers, epidemiologists, community mobilizers, and others in addition to clinical staff. Yet these cadres hardly feature in global talks or statistics about the necessary composition of an adequate health workforce.

2. Available medical supplies, including medicines, diagnostics and vaccines

The lack of vaccines and medicines for Ebola shone a spotlight on the failure of the global research and development (R&D) system. The current system relies on monopoly created by intellectual property rules which leads to pharmaceutical companies conducting R&D in diseases that are expected to produce high profits. In order to get the balance in favour of public health, the public sector has to have a hold over sitting the health priorities and financing of R&D.

3. Robust health information systems (HIS), including surveillance

The Ebola outbreak highlighted the critical role of HIS in disease control. However, surveillance, which is now being highlighted as critical to disease control, needs to be an integral (not parallel) part of HIS and the overall health system. Epidemiologists alone will not be able to produce useful and reliable data. Effective surveillance requires doctors and nurses to diagnose the diseases, and community workers who gain community trust to report cases. All these workers are needed to act appropriately in their respective roles to prevent the spread of and treat those affected by these diseases.

4. An adequate number of well-equipped health facilities (infrastructure), including access to clean water and sanitation

There are 0.8 hospital beds per 10,000 people in Liberia and 0.3 in Guinea compared to an average of 50 beds in OECD[1] Countries. Scaling up the number of well-equipped health posts and district hospitals, especially in underserved areas, is critical not only to address health needs but also to build community trust in health systems.

5. Adequate financing

Countries’ experience clearly indicates that long term sustainable, reliable and equitable financing has to be based on public financing. The annual funding gap that must be covered in order to achieve universal primary health care is approximately $419m for Sierra Leone, $279m for Liberia, $882m for Guinea and $132m for Guinea-Bissau[2]. Although the sums specified are large it is possible to raise the necessary resources by relying on various forms of tax funding, innovative financing and donors’ support. For example, in 2012, tax incentives awarded to six foreign companies in Sierra Leone were estimated to be worth eight times the national health budget.

6. A strong public sector to deliver equitable, quality service

Evidence shows that countries that achieved or made progress to achieve UHC relied on a strong public sector. Relying on private provision risks creating a two tier system, whereby poor people pay for a dubious quality of service from drug peddlers and others, while wealthy people enjoy the services of 5-star hospitals.

Building resilient systems that protect people’s health and deal with outbreaks has to address all the six elements of the system simultaneously and systematically. Achieving better health outcomes for all and protecting the world from emerging diseases requires a long term global commitment for building health systems. This must start now.

Footnotes

[1]Organisation for Economic Co-operation and Development

[2]Calculated from the estimated figure to reach UHC (the agreed $86/person per year multiplied by the population number) and the current public spending on health

 

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