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.
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”.
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. 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.
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.
“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.
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”.
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.
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.
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%. Two-thirds of the out-of-pocket expenditure is on medicines alone. 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. 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 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. 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!
Global Health Observatory data repository, Health expenditure ratios, by country, 1995-2013, WHO
Selvaraj S. and Mehta A., Access to Medicines, Medical Devices and Vaccines in India, India Infrastructure Report 2013-14
Universal Access to Medicines in India: A Baseline Evaluation of the Rajasthan Free Medicines Scheme, WHO 2014
Term used for socio-economically underdeveloped states in India.
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