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.
In September 2015, all countries committed themselves to a new set of sustainable development goals (SDGs). One of the targets to achieve the health SDG is Universal Health Coverage (UHC), whereby everybody receives the health services they need without suffering financial hardship[i]. Across the world, countries are recognizing that achieving UHC requires a publicly financed health system to ensure risk pooling where healthy and wealthy members of society subsidize services for the sick and the poor[ii]. Conversely, a privately-financed, free market in health services has proven that it will never achieve UHC – a fact which has now been recognized by experts and agencies who previously promoted private health financing[iii].
Countries such as Thailand, Sri Lanka and Costa Rica have demonstrated that the key to achieving UHC is to replace private voluntary health financing (user fees and private insurance) with compulsory public financing (in particular tax financing). This not only improves people’s access to health services it also reduces the impoverishing burden of out-of-pocket (OOP) health expenditure[iv].
A country which learnt this lesson before many of its peers is Malawi. Despite only having a GDP per capita of around $350, Malawi was one of the few African countries to achieve MDG 4 in reducing child mortality. This achievement was celebrated in a Lancet Global Health paper[v] which highlighted Malawi’s success in increasing the utilization of a number of effective health interventions by children– for example immunizations and treatments for infectious diseases.
However, this analysis didn’t mention a key feature of Malawi’s health system which has made it unique within the continent of Africa: Malawi has been the only country in Sub-Saharan Africa to provide universal free health services throughout its public health system and never charge user fees – with the exception of some recent worrying user fee experiments I have written about here. Having not put in place this demand side barrier, utilization of services has been higher in Malawi which has enabled the country to make faster progress towards the MDGs and UHC[vi].
This is illustrated vividly in the following graph, from WHO Afro Region. The graph illustrates that with a relatively high level of public financing of 5.8% GDP (which includes aid financing) and a no user-fees policy in place in public facilities, Malawi records only a 12% share of total health expenditure in the form of out-of-pocket financing. This is a good proxy measure for the level of financial protection offered by the Malawian health system and it is at a level significantly below the 20% maximum level recommended by WHO.
Conversely in Nigeria, which only spends 0.9% of its GDP in the form of public health financing and where user fees are charged at all levels, private out-of-pocket health financing accounts for 72% of total health expenditure – one of the highest rates in the world. At these levels of OOP payments not only are millions of Nigerians being impoverished by health care costs or prevented from accessing vital healthcare altogether, considerable human rights violations are also resulting where many people are detained in health units because they can’t pay their hospital bills[vii]. This latter phenomenon is unheard of in Malawian public hospitals.
But perhaps the most stark illustration of the difference in performance between these two countries at the opposite ends of this curve, is that whereas Nigeria is 8 times richer than Malawi, Nigeria’s child mortality rate (109 deaths per 1000 live births) is 70% higher than Malawi ’s (64 deaths).
In reviewing these records, the obvious policy recommendation for Nigeria is that it too should increase its public health spending and abolish user fees in its public health system. And for Malawi, the lesson should be to build on this success and use further increases in public financing to improve the availability and quality of free services.
The Government of Malawi’s recent policy announcement to implement service level agreements which will fund selected CHAM facilities to provide free services will be an excellent way to fulfill this objective. Needless to say, if Malawi wants to stay ahead of the pack, it should scrap the hospital bypass fees that have been introduced recently, and certainly ignore the siren calls to introduce user fees more broadly in the public health system. This would simply take the country up the curve to join those where poor people don’t access health services because they can’t afford them, and where more children die before their fifth birthday.
 And a very brief period in 1964, when a misguided expatriate advisor persuaded the government to introduce fees. However, following extensive public demonstrations President Banda soon reversed this policy to restore universal free services
 Christian Health Association of Malawi
[ii] Yates R Universal Health Coverage: progressive taxes are key
The Lancet , Volume 386 , Issue 9990 , 227 – 229 Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60868-6/abstract accessed 28 July 2016
[iii] Lane R 2013 Dean Jamison – Putting economics at the heart of global health The Lancet Vol. 382, No. 9908 Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62613-6/fulltext?rss=yes Accesed 28 July 2016
[iv] Evans TG et al Thailand’s Universal Coverage Scheme: Achievements and Challenges. An independent assessment of the first 10 years (2001-2010). Nonthaburi, Thailand: Health Insurance System
[v] Kanyuka, Mercy et al. Malawi and Millennium Development Goal 4: a Countdown to 2015 country case study The Lancet Global Health , Volume 4 , Issue 3 , e201 – e214 Available at: http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(15)00294-6/abstract Accessed 28 July 2016
[vi] Yates R, Child mortality in Malawi The Lancet Global Health , Volume 4 , Issue 7 , e444 Available at http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(16)30083-3/abstract Accessed 28 July 2016
[vii] Agbonkhese J FG urged to end detention of women in hospitals nationwide Vanguard online 2 February 2015 Available at http://www.vanguardngr.com/2015/02/fg-urged-end-detention-women-hospitals-nationwide/ Accessed 28 July 2016
“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.
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!
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.
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.
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.
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 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.
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. 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.
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.
Organisation for Economic Co-operation and Development
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
The WHO has announced that the election process for the new Director General (DG) is now open. The election comes at a critical time in the organisation’s history. WHO was criticised by many for failing to respond to Ebola sufficiently quickly, while the fact that Member States had de-prioritised WHO’s emergency work and cut WHO funding was not widely acknowledged.
WHO has been facing serious financial difficulties for more than 6 years. The crisis prompted Margaret Chan to launch a reform process in 2010. Implied in the reform plan was a correction of the imbalance in the WHO budget whereby ear-marked project funds outweighed flexible core funding in a ratio of 80/20. Six years later and the financial imbalance has not improved. It is also not clear what different member states require from the reform. WHO is in danger of becoming a ‘pay-as-you-go’ service organisation, far from its constitutional mandate.
The results of underfunding its core budget are not only limited to decreased WHO ability to perform its functions, but it also threatens its independence. Countries rely on WHO’ guidance on the assumption that advice is independent from commercial and political interests and is based on science and evidence.
Previous elections lacked transparency and failed to allow public scrutiny of the process. The global health community did not know the “manifestos” of the candidates or how they would prioritise and deal with global health problems.
The prestigious medical journal The Lancet has attempted to fill the manifesto gap by inviting candidates to share their visions. The journal also did its own ranking of the candidates according to the key competences needed for the job.
In the new recruitment processes, the WHO has announced some changes aimed at enhancing transparency. These include a forum for Member States to interact with the candidates, and allowing the WHA to choose from three candidates – instead of simply approving one.
The new DG will have to face huge challenges in terms of the impact of years of financial stringency on core functions and on moral and mandate as well the difficulties facing the role of the WHO in the complex global health field. Given the critical importance of the DG role and the challenges he/she will face, we recommend that mechanisms be put in place to enable public scrutiny of the candidate’s vision for the WHO. In order to enable this public engagement we propose:
As countries begin to nominate their candidates, the global health community is entitled to know where candidates stand on key health questions as well as on the fundamental challenges and issues facing the WHO.