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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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My duck is not the only one

Ducks“The neighbours called us the duck and her ducklings” . Pearl Van-Dyck shares the story of her mother’s struggle to stay alive.

Today would have been her birthday. I remember the afternoon when my mother told me that the hospital result showed that the lump on her arm was cancer. My life changed that afternoon. I couldn’t imagine our lives without her. We were so close that the neighbours called us “the duck and its ducklings”. .

She was desperate to stay alive “I just need 3 more years to allow Jo finish school” she often said. (Jo is my younger sister) .Then my mother began the very expensive treatment at the Korle Bu Teaching Hospital in Accra.

Hospital Accra

The Korle Bu Teaching Hospital

Watching her enduring the treatment but worrying about the exorbitant cost of the treatment was very difficult indeed. Both my parents were professionals with regular earnings. Yet, the treatment became unaffordable on their incomes alone. There were times when she missed treatment due to shortage of money. I often ask myself: what if she could have had all the treatment sessions? What if cancer treatment were not so expensive? Would she still be here to see my children?

My mum is one of many- according to the WHO, cancer is one of the leading causes of death in developing countries. Most affected people are simply unable to afford the cost of treatment.

The outrageous cost of cancer treatment is not limited to developing countries. Last year, NICE decided that Kadycla, a medicine to treat breast cancer, is not to be prescribed by the NHS due to its high cost. The outrageous cost of Kadcyla -£90,000 annually per patient- led a coalition of public health advocates to send a letter to Jeremy Hunt requesting that he issues a compulsory licensing to break the patent and enable generic production of affordable versions. Needless to say, that the UK will not do so.

Yet if the British government can’t afford the price of medicines, what chances have the governments of poor countries got to provide such drugs for their citizens? And how rich should a person be in order to be able to afford cancer medicines?

But pharmaceutical companies hide behind the lack of health care in developing countries as a justification of ignoring the plight of people living with cancer there. Recently the CEO of Astra ZDuckeneca claimed that free cancer medicines are not beneficial for Africans. If he looked back he might have remembered similar claims about HIV medicines when it was said that Africans cannot handle ARVs. Yet thanks to civil society campaigns and generic medicines, now 15 million people are on treatment.

Clearly African governments need to invest in health systems in order to achieve their commitment to Universal Health Coverage and provide the much needed services to their citizens. This has to go hand in hand with global efforts to decrease the prices of medicines.

Sadly my mum didn’t get the three years she wished for and I miss her dearly. But I really hope for the time when people won’t lose their loved ones just because they couldn’t afford the medicines they need. I am awaiting the report of the High Level Panel, set up by the UN Secretary General to address the imbalance between human rights, trade and Intellectual Property and access to medicines. It is critical that the HLP makes clear recommendations to the UN leaders on how to ensure that the global system for R&D results in health technologies being affordable to all patients.

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When wealth buys health, Niramaya may be the answer by Pallavi Gupta, Health Programme Coordinator, Oxfam India

I grew up learning that “Health is Wealth”. But today it seems that it is the other way round: one needs a substantial amount of Wealth to buy Health.

Article 14 of the Indian Constitution grants all Indians the Right to Life. Yet that right cannot become a reality when a quarter of the country’s population does not seek medical treatment because they cannot afford it and 65% do not have access to the medicines they need. India has one of the highest private out-of-pocket expenditures on healthcare at almost 70%[1]. Two-thirds of the out-of-pocket expenditure is on medicines alone[2]. Therefore, providing free medicines in public facilities can have a great impact on people’s healthcare costs and health outcomes.

Historically government hospitals were supposed to provide free medicines along with free consultation. Yet over the years buying medicines from private pharmacies has become almost a norm. Availability of medicines in public hospitals has been very limited over the last couple of decades[3]. To fix this problem, many state governments have announced their own free medicines scheme and set up state owned corporations to operationalise it. Tamil Nadu set up its corporation in 1995 to ensure availability of all essential medicines in the government medical institutions throughout the State.

Other states like Kerala, Andhra Pradesh, Bihar, Madhya Pradesh, Chhattisgarh followed suit. Rajasthan was the first of the Empowered Action Group of states[4] to roll it out successfully, thus inspiring other states in similar fiscal health. Evidence from Rajasthan illustrates that the availability of free medicines at public health facilities increases their utilization and is an important step towards strengthening the public health system.

In this pursuit, Government of Odisha increased its budget allocation for medicines to more than USD 15 million in 2012-13 and set up its state corporation for the purpose. Going a step further the government announced a specific free medicines scheme in the state called the “Niramaya Yojana” in April 2015 and increased the budget allocation to USD 32 million for the year 2014-15[5]. The increase is comparable to Rajasthan’s spending of around USD 48 million to provide more than 400 medicines.

In November 2015, I visited the Bhubaneswar public hospital, a multi-speciality 547- bed flagship hospital of Government of Odisha as part of Oxfam India’s campaign on free medicines (“#HAQBANTAHAI:Muft Dawa, Haq Hamara”). The hospital caters to over a million people. The hospital has 5 Drug Distribution Centres (DDCs) under the Niramaya Scheme, of which only two were functional at the time of my visit because of shortage of staff. One of the two DDCs operates 24 hours all days of the week while the other is open only during the day time. Out of the 570 medicines in the state’s essential drug list, the DDCs at the Hospital had only 236 medicines as the government is still in the process of procuring and providing more medicines.

According to the Central Medicines Store officer, “free medicines have always been available at government hospitals. It is just that now they are being provided under the name of a scheme”. He felt that the main problem with any scheme is the lack of “follow-up” after it is launched. The Central Medicines Store which manages the supply of medicines within the hospital regularly updates doctors on the availability of medicines to guide their prescriptions.

Staff at the DDC which functions 24×7 said that they serve nearly 1000 patients daily. In order to ensure continuous supply of medicines, they only dispense 3 to 7 days’ supply, even if patients came from far and had a chronic illness like diabetes or hypertension. As a result, the patients either discontinue the medicines or buy them from private pharmacies at higher costs or make additional trips to get the supply which for poor people is an additional financial burden.

Despite these limitations, I was very heartened to see the well-functioning DDC where patients trust the quality of its medicines. The DDC was clean and well-kept with medicines stored in racks in an organized manner. The room was well-equipped and staff were dispensing medicines very efficiently. In fact, the DDC could well pass off as one in any big private hospital.

The example of DDCs in Bhubaneswar clearly demonstrates that people use public facilities when they are available and well equipped. However, for continued success, the scheme must be “followed-up” as the officer mentioned above: the remaining 3 DDCs are opened, the stock of medicines is increased from the current 236 to the 570 on the essential drug list; and the doctors prescribe medicines available at the DDC. The success of the scheme would add to the evidence that public facilities do function!

References

[1]Global Health Observatory data repository, Health expenditure ratios, by country, 1995-2013, WHO

[2]Selvaraj S. and Mehta A., Access to Medicines, Medical Devices and Vaccines in India, India Infrastructure Report 2013-14

[3]Universal Access to Medicines in India: A Baseline Evaluation of the Rajasthan Free Medicines Scheme, WHO 2014

[4]Term used for socio-economically underdeveloped states in India.

[5]http://www.orissadiary.com/CurrentNews.asp?id=59020; Demand for Grants and Budget at a glance, government of Odisha http://www.odisha.gov.in/finance/Budgets/2015-16/Annual_Budget/DEMAND_FOR_GRANTS.pdf

 

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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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Let’s break the vicious circle of inequality in health and access to medicines By Leïla Bodeux Policy Officer, Oxfam-Solidarité

A recent Oxfam report states that by 2016, 1% of the world population will own more wealth than the rest of us combined. This economic injustice is intertwined with gender inequality, and also with inequality in access to education and health. Inequality in access to medicine is a key feature of this global inequality.

Medicine: A hugely profitable business: Medicines, so critical for saving lives and protecting public health, can also deliver eye-watering profits. In 2013 the 10 leading pharmaceutical companies had combined revenue of US $440 billion. The biggest pharmaceutical company in the world, Pfizer, generated US $50 billion of revenue and US $22 billion profit in 2014. Such profits flow from the prices set for some of the newer medicines. In 2014 Gilead Sciences set the US price of its new drug to treat Hepatitis C at US $1000 per pill, or US$ 84,000-110,000 per treatment, a price that generated sales worth US $10 billion in 2014 for this medicine alone. It is worth remembering that approximately 150 million people are infected with hepatitis C, 75% of whom live in Low- and Middle-Income Countries (LMICs), and that about 350,000 of these die each year.

New cancer medicines allow big pharma to charge more than US $100,000 per treatment. These astronomical prices have become unaffordable even in rich countries. The UK has refused to reimburse several cancer medicines due to exorbitant prices. An op-ed co-signed by 100 leading oncologists in the prestigious journal Blood in 2012 called for a reduction of cancer medicine prices, which they deemed economically unsustainable. These unprecedented prices turn life-saving medicines into a highly profitable business.

The collective wealth of billionaires with interests in the pharmaceutical and health sectors increased from US $170bn in 2013 to US $250bn in 2014, a 47% increase and the largest percentage increase in wealth of the different sectors on the Forbes list. The World Bank estimated that the economic costs of the Ebola outbreak to Guinea, Liberia and Sierra Leone was US $356m in lost output in 2014, and that this will increase to US $815m in 2015 if the epidemic cannot be quickly contained. The greatest increase in wealth by a single pharma-related billionaire between 2013 and 2014 could pay the entire US $1.17bn cost for 2014–15 three times over. With such huge amounts of money at stake, the pharma sector does everything in its power to ensure that rules and policies are in place to maintain the status quo.

When company lobbyists hijack the decision-making process: Large sums are spent by the pharmaceutical industry in lobbying health-related decision-makers. In 2013, the pharmaceutical and healthcare sector spent more than US $487 million on lobbying in the US alone, more than was spent by any other sector in the US. The same sector spent US $260 million on campaign contributions during the election cycle of 2012. In Europe, the pharmaceutical industry employs around 220 lobbyists and an army of lobbyists covers Capitol Hill. They aim to maintain monopoly controls that allow high prices for as long as possible.

The pharmaceutical sector also lobbies the governments of the US and the EU to expand companies’ intellectual property (IP) monopoly power through the negotiation of Free Trade Agreements (FTA)[1]. These FTAs seek to restrict governments’ ability to use policy tools that promote access to affordable medicines, which has been condemned by the World Health Organization’s (WHO) Director Margaret Chan.

Countries are also put under pressure to strengthen their IP rules outside trade negotiations.

This is the case with the US pressure to reform India’s balanced IP law, threatening to shut down the “pharmacy of the developing world”[2]. The “Pharma Gate” scandal in South Africa in 2014 revealed leaked emails showing that Pharmaceutical Associations based in South Africa and the US (PhRMA) hired a powerful US lobby firm to derail South African IP law reform that facilitated access to generic medicines.

Big pharma should focus on what it’s supposed to do: create useful new medicines to support public health at affordable prices: Pharmaceutical companies play a critical role in public health through creating medicines that save and improve the quality of life. But increasingly the industry has lost its way, concentrating on ‘blockbuster’ products, and spending money on marketing and lobbying for ever stronger monopoly rights. The current system, which is supposed to incentivize R&D by granting 20-year patents on innovative medicines, fails to meet the public health need for affordable medicines. R&D is invested where large profits can be made – often products are priced so that only a small proportion of the needs are met – while diseases that affect primarily poor countries are sidelined. Only 10% of the world R&D is spent on diseases that affect 90% of the world population. It is estimated that more than one billion people affected by neglected tropical diseases fail to get the treatment they need.

Three pharmaceutical companies (GSK, Johnson and Johnson, Novartis) made the greatest financial contribution to the Ebola relief effort, donating more than $3 million in cash and medical products. Although laudable, these same three companies together spent more than US $18 million on lobbying activities in the US in 2013. The non-existence of a treatment or vaccine for Ebola resulted from lack of R&D investment and the absence of a financially profitable market. The industry employs great scientists and researchers whose creativity is channeled to products for highly profitable markets instead of services for the vast numbers of people worldwide who are still denied the benefits of new technologies. Their plight should be the number 1 priority of all actors who have a part to play, including the pharmaceutical companies.

Winnie Byanyima, the head of Oxfam International, rightly put it in Davos: “Let the companies stop lobbying, and put the money into medicine!“. The Oxfam Even It Up campaign seeks to consign to the history books the statistic that 1 person out of 3 does not have access to needed medicines.

[1]The following trade negotiations are currently undergoing: EU-Thailand FTA, EU-India FTA, the Transatlantic Trade and Investment Partnership (TTIP), the Trans-Pacific Partnership (TPP).

[2]India’s balanced IP law allowed its generic industry to lower the price of Antiretroviral treatments by 99 % since 2000, bringing the cost of treatment to below $100 per person per year

 

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Global Health Check is edited by Anna Marriott, Health Policy Advisor for Oxfam GB, and welcomes contributions from different authors. If you would like to write an article for this site or if you have any queries please contact: amarriott@oxfam.org.uk.