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Critical issues in the prevention and control of non communicable diseases

There is now worldwide recognition of the global health and economic impact of non- communicable diseases (NCDs). The health goal of the Sustainable Development Goals (SDGs) has a specific target to “reduce by one third the level of premature mortality from NCDs”. However, progress towards achieving the target has been poor.

The WHO set up a special Commission to make actionable recommendations for governments to act on in order to respond to the crisis of NCDs. The commission outlined six recommendations, including the critical importance of strong political will to ensure that NCDs prevention and treatment are top national and international priorities.

These recommendations will contribute to the third UN High Level Meeting on NCDs to be held in September. If NCDs are to be prevented and controlled, governments and international institutions need to address the following issues to curb the resulting health and economic impact:

  1. Women

Women bear the brunt of chronic diseases as the most likely unpaid carers of sick family members. Women’s unpaid health care work has been valued at 3.09% of the global gross domestic product – a hidden subsidy to countries’ health budgets. Lack of access to treatment for any member of the family adds to women’s unpaid care work. Moreover, some of the NCDs carry stigma for women. For example, a young women may never get married if it is known that she is diabetic, and the cost of treatment is a factor in her rejection. The costs of treating cancer and the stigma attached to the disease, especially breast cancer, may lead to women being rejected by husbands without financial or other support.

Just two weeks ago, the WHO called for the elimination of cervical cancer given that vaccination and screening programmes are feasible. It is critical that governments expand awareness and delivery programs for early detection, diagnosis and treatment of breast and cervical cancer, as well as other NCDs. These programmes are critical not only for health but also for removing stigma against affected women.

  1. Access to medicines

High prices are a major barrier for patients’ use of medicines that save lives, significantly improve the quality of life and decrease suffering. Globally there is stark inequality in access to medicines for NCDs, which is reflected in the higher morbidity and mortality rates in poorer populations and poorer countries.

Cancer is the second cause of mortality worldwide. Early detection of cancer without affordable treatment could feel as a death sentence for patients. Anecdotal data shows the serious impact of high prices of medicines on patients’ lives.

The UN and its member states must find sustainable solutions to the crisis in medicines if they are to tackle NCDs in a meaningful way. Prevention alone is not the answer for the millions who already suffer NCDs, nor for their families who suffer the economic and emotional impact of ill health and of lack of treatment. The UN High-Level Panel on Access to Medicines proposed actionable recommendations for governments and relevant international agencies that pave the way to improving access to medicines and innovation. These must be urgently implemented. By doing so, governments would adopt strategies that make medicines affordable to payers.

It is also time that the WHO lead in developing an R&D convention that ‘de-links’ financing R&D from the price of medicines so that research is driven by public health needs, not financial incentives, and thus produce medicines at low prices.

  1. Health in trade

Free Trade Agreements (FTAs) usually include conditions that have negative implications on the health of the population in the signatory countries, especially in relation to NCDs. Firstly, FTAs usually include further protection of intellectual property rules beyond the TRIPS[1] agreement, and therefore increase the potential of high prices for new medicines.

Secondly, Investor-state dispute settlement clauses (ISDS) prevent governments from implementing policies that aim to protect public health. There are recent examples of this impact in the case of a Lily pharmaceutical company using ISDS to stop the Canadian government from adopting policies to cut the price of a medicine for treating Attention Deficit Hyperactivity Disorder. Another example is Philip Morris tobacco company taking legal action against the governments of Uruguay and Australia for including warnings against smoking on cigarette packets. In three cases the companies used ISDS clauses in an FTAs that considered governments’ actions not as protection of population’s health, but as cutting companies’ profit. Although the companies lost their cases, threat of arbitration can be a deterrent to developing countries preventing the adoption of policies to respond to NCDs.

Therefore, before signing an FTA, governments must conduct impact assessments of the potential impact of the agreement on health policies and access to medicines with meaningful engagement of civil society, parliament and media. WTO needs to monitor and condemn pressure from countries and companies on those governments who intend to use the flexibilities enshrined in the TRIPS agreement to decrease the price of medicines.

  1. Universal Health Coverage

Sustainable investment in healthcare is critical to creating resilient public health systems that can prevent and treat NCDs.  Strategies that tier services according to ability to pay, result in increased societal inequality and ill health in addition to being inefficient. No country has achieved or made progress towards achieving UHC without the majority of financing coming from the public purse. Lack of government spending and delivery of health care results in more unpaid caring work for women and high impoverishing out of pocket spending. Most countries face a health work force crisis, which requires long term investment in training and remunerating workers.

Governments need to increase investment in public healthcare systems in order to reach a minimum of 15% of public expenditure or 5% of GDP. Public investment has to prioritise financing of healthcare through progressive taxation, and avoid regressive and unaffordable insurance schemes, which tend to exclude the poorest and most vulnerable people at scale in countries with large informal sectors. Health services should be free at the point of use to ensure equity of access to healthcare. Public investment in comprehensive primary health care should be prioritised including the training and remuneration of Community Health Workers, especially women workers to enhance reaching women in rural and remote areas.

Donor countries must support developing countries to invest in building resilient public healthcare systems; including training and remuneration of health workers, through aid.

  1. Private sector’s engagement

Clearly the private sector has a role to play in responding to NCDs. However, commercial determinants of health present huge risks given that profit motives of tobacco, processed food and beverage companies, are directly at odds with public health goals. It is highly unlikely that “voluntary” actions by companies would result in cutting the negative impact of those products, given that cuts in sales act directly against companies’ commercial interest.

State-led initiatives and strong regulation are critical to tackling the NCDs crisis. “Sin taxes” on sugar products, tobacco and alcohol have been heavily opposed by those industries, despite the clear evidence of the positive impact of tax on lowering consumption of those harmful products and generating revenue for public spending on health.

Yet governments’ engagement with the private sector has been heavily promoted without emphasis on these crucial safeguards. Engagement with commercial actors should be driven by public health concerns not by economic interest.

  1. Promoting mental health

According to WHO, depression is a leading cause of disability in the world. Yet there is a lack of political support for the promotion of mental health and for investing in the diagnosis and treatment of mental health problems. Governments need to invest in evidence based training, to develop appropriate and adequate services for those suffering from mental health problems. Furthermore, integration of mental health awareness, diagnosis and treatment is needed in primary health care. National awareness campaigns in collaboration with civil society and the media are also critical to remove stigma associated with mental health, especially for adolescents who usually suffer in silence.

Conclusion

The forthcoming UN HLM on NCDs is an opportunity for world leaders to commit to protecting their citizens, by turning rhetoric into reality through serious political will and adequate financial commitments. Actions at national and international levels are necessary and feasible to prevent and control the pandemic of NCDs.

[1]Trade Related Aspects on Intellectual Property Rights, which countries automatically sign when they join the WTO

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World Cancer Day 2018: It’s time to bring down the price of medicines. Authors: Tabitha Ha, Advocacy and Campaign Officer, Oxfam International and Mohga Kamal-Yanni, Senior Health policy Advisor, Oxfam GB

Sunday 4th February is #WorldCancerDay and the theme is #WeCanICan – a message uniting the world in the fight against cancer. Indeed, the world must unite to stop high prices being charged for medicines, which prevent patients from getting the treatment that can save their lives. People across the globe need to unite to push for tough actions by governments and UN bodies to change the system that leads to high medicine prices.

The high price of medicines can be a death sentence to those who cannot afford it. Tobeka, a mother from South Africa, spoke in 2016 about her experience with breast cancer. She said that she wanted to live so that ‘I can bring up my two boys’. However, neither herself nor her insurance company were able to cover the high price of the medicine that could have saved her life. Tobeka passed away in 2017, spurring on action amongst people who stood in solidarity with her. They came together to demand that Roche (the pharmaceutical company that markets the breast cancer medicine) drop the medicine’s price so that other breast cancer patients could dramatically increase their chance of survival.

Cancer incidence is increasing all over the world including in low and middle-income countries. Women bear the brunt of lack of access to health services and to medicines. They are often the last in the family to seek healthcare if cost is an issue and they carry the lion’s share of the burden of care for sick family members, especially those who cannot access treatment. Breast and cervical cancer are the main cancer killers amongst women in developing countries. More than 95% of cervical cancer deaths occur in low and middle income countries. Breast cancer cases are increasing at a greater speed in these same countries.

This is the case even though prevention for cervical cancer and treatments for breast cancer already exist. The problem lies in the fact that prices of cancer medicines are soaring and are a major access barrier for patients. In South Africa, a 12-month course of Herceptin, a breast cancer medicine produced by Roche, costs approximately $38,000 or around five times the country’s average household income. Yet at least one possible supplier of the medicine suggests it could be produced and sold for as little as $245. The HPV vaccine that helps prevent cervical cancer, marketed by Merck and GSK, is one of the most expensive vaccines in developing countries. Merck’s vaccine is sold by Gavi, The Vaccine Alliance, at $ 4.5/dose (total of $13.5 for the recommended three doses).

High prices of medicines are not only a developing country issue. In the past 15 years, the average cost of new anti-cancer treatments in Europe has more than quadrupled and some women in the UK have had no choice but to seek charitable donations  to pay for their medicines.

Pharmaceutical companies can charge high prices because new medicines are patented. This gives companies a monopoly on a newly created medicine. Without competition, companies can sell medicines at whatever price they want. The pharmaceutical industry often justifies high prices by claiming that they are necessary to recoup high research and development (R&D) expenditures. However, little is known about the true costs of R&D due to the secrecy of the industry. The ever-escalating figure quoted by the industry and its supporters is based on studies by one university, which has been funded by the pharmaceutical industry. The figure is contested by experts, some of whom estimate that in fact as much as two-thirds of upfront R&D costs are paid by the public sector and not pharmaceutical companies. The lack of evidence to justify high prices of patented medicines, and the devastating consequences of these prices, demonstrates the urgent need for transparency around the costs of R&D.

The fight for access to cancer medicines is inextricably linked to a wider access to medicines fight: the fight to ensure public health has supremacy over profit. Oxfam advocates for governments to adopt the recommendations of the UN High Level Panel on Access to Medicines (HLP) , which tackle the issues caused by the current R&D model that prioritises profit over public health.

Last week at the WHO Executive Board (EB), Oxfam spoke[1] of Tobeka’s story and the reality of the impact of high prices of medicines on patients. The WHO EB debate on medicines represented a fierce battle between protecting the public health of patients all over the world and protecting the commercial interest of pharmaceutical companies. There was wide support from developing countries to urge the WHO to take action on the recommendations of the independent review of the ‘Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property’ without delay. Many of the strategy’s recommendations echo those from the HLP. A number of European countries also raised the issue of high prices in their own domestic markets and called for fair pricing.  But the US and Japan objected to implementation of the recommendations of the review of the Global Strategy – and to specific language on transparency on the cost of R&D. Eventually a draft decision was agreed and will be put forward at the upcoming World Health Assembly in May. If passed, the final decision text would allow member states to implement the majority of recommendations except for a few that require further discussion, including on the transparency of R&D costs,.

High prices affect everyone but they affect the poorest most and especially women. The fight for affordable and accessible medicines is a fight for women’s health. Governments have a set of promising solutions in the form of the HLP recommendations. These recommendations must be implemented without further delay. World Cancer Day is a strong reminder why action must be taken to implement them.

 

 

[1] Under agenda item 3.7

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