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.
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.
The ongoing Ebola story has highlighted the importance of the World Health Organization (WHO) in coordinating international action to combat emerging infectious disease threats. But it has also revealed the deficiencies in its performance which have now allowed a disease outbreak in West Africa to turn into a major international emergency. But in the current crisis in West Africa blame for its performance has been more prevalent than praise. As even its senior officials now admit WHO was too slow to recognize the potential seriousness of the outbreak – while also blaming the cutbacks in its emergency response capability agreed by its member states, as well as the unusual nature of the outbreak which it says caught the international community as a whole on the hop. The officials also point out that WHO is a technical assistance agency: there to help and advise governments on how to respond and supply needed expertise rather than run emergency healthcare operations on its own account.
On the other hand, some NGOs such as MSF, working to combat Ebola on the frontline, have criticized WHO’s slow response. They say that it should have recognized much earlier than it did the need to take the lead in mobilizing funding and personnel from other international actors to strengthen the weak healthcare infrastructures in the affected countries, as well as intensifying its own efforts to support governments with technical assistance and expertise.
Others blame WHO’s slowness and lack of leadership on its fundamental structural problems, which the reform programme launched by Margaret Chan in 2010 was intended to address. These structural problems include both its funding and its unique structure of regional offices which elect their own leaders. Much adverse comment has been directed at the role of WHO’s Africa regional office in Brazzaville which Peter Piot recently described as being staffed with political appointees rather than the most capable people, and the alleged lack of good cooperation between Brazzaville and Geneva. While there is undoubtedly financial stringency in WHO, and a severe shortage of experienced staff in HQ, the case is different with country staffing. The three most affected countries have country office staff exceeding 100 in total, there are nearly 750 in the country offices in the West African region as a whole, and there is nearly 600 staff in the regional headquarters in the Congo. In addition the African region has nearly 2500 contracted staff involved in polio eradication. It is hard to believe that more could not have been done with all these staff on the ground if properly mobilized and managed.
A report on WHO reform published in May this year, based on the deliberations of a working group convened by Chatham House, noted that WHO’s core functions as defined by WHO excluded explicit reference to promoting and maintaining global health security, specifically including its response to disease outbreaks and public health emergencies.
But the report focused mainly on the WHO’s structural problems that the ongoing internal reform process in WHO was not dealing with. The Ebola story illustrates many of these. The report asked: whether WHO really needed six semi-autonomous regional offices? Was this not a recipe for conflict and slow and poor decision-making? And did it need 150 country offices? How did politicization and the politics of patronage adversely affect WHO’s performance, credibility and effectiveness at all three levels of the organization? Was its complex governance structure not the main reason that it spends one third of its budget on administration and management at the expense of its technical programmes? Were there not more efficient ways to do what WHO needed to do? Why was WHO often reluctant to lead rather than to follow its member states? Why did the member states countenance this state of affairs?
The report has evoked practically no response at all – from governments, the academic community, NGOs or anyone else for that matter. Why is this?
A plausible explanation, which was suggested often by one of the members of the Chatham House working group, is that no one cares sufficiently about WHO reform to do anything about it. The status quo is too comfortable, or not sufficiently uncomfortable, for any member state to want to change things.
The weird financing arrangements, whereby 75% or more of WHO’s income is in the form of voluntary contributions, suits member states for different reasons. A few rich countries (and charities such as the Bill and Melinda Gates Foundation), by directing their voluntary contributions in ways of their own choosing, get to control what WHO does in spite of being a small minority in the World Health Assembly, or not in it at all. Yet because of this effective subsidy, poorer countries pay contributions which are a quarter of what they would be if WHO was wholly financed by member state subscriptions. Thus for the great majority of member states WHO membership is a bargain. They get a WHO country office whose budget (paid for by WHO) will normally exceed by a large margin their WHO contribution.
Because WHO regional offices are run as semi-autonomous replicas of WHO in Geneva, ministries of health also get the opportunity to influence appointments to regional and country offices where those chosen can access UN-related salary and benefit packages. Thus it is not just a financial bargain but often carries actual or personal benefits for senior country officials. So there is little mystery about why change should be resisted. Even where it is recognized that a WHO country office may have outlived its utility (in a country like Thailand for instance) it would be a brave politician or official who suggested closing what is essentially a free gift from the international community.
So no mystery there. The non-response of the ‘public interest’ NGO movement is more puzzling on the face of it. But perhaps the answer is not totally dissimilar. These NGOs have no financial stake in WHO and therefore no direct influence on its governance. Many regard the WHO as a forum where they may express their views and the annual World Health Assembly as a perfect gathering of notables in the global health community to pursue advocacy and influence member state delegates. While NGOs may be critical of the WHO, as in the case of Ebola, they also hold it in great esteem as the one international organization with the responsibility of striving for “the attainment by all peoples of the highest possible level of health”. The NGO mindset is therefore to seek to defend this noble objective and, in particular, protect it from political and commercial pressures which are seen as a threat to this mission.
Moreover the WHO secretariat is generally regarded as providing objective technical leadership and support to member states in a world dominated by governments and corporations whose motivations and interests may run counter to health objectives. For that reason NGOs are generally only likely to be critical of the WHO secretariat if it appears to be supine in its dealings with commercial stakeholders, or with governments deemed to be unduly influenced by commercial rather than public health interests.
At the same time NGOs, notably Oxfam, have campaigned actively for member states to increase their secure funding of WHO to protect its core functions, such as those which support enhanced access to essential medicines. But member states have to date paid little heed.
So it seems that the political preconditions for fundamental reforms of WHO funding and governance are absent. Nevertheless the world badly needs a global body that can take on a leadership role in global health policies and help control disease outbreaks before they turn into international crises. The panic engendered by the Ebola crisis should result in a reality check for all concerned. The WHO reform process, begun 4 years ago, does not seem to be on course to deliver a WHO that can be relied upon as fit for purpose.
Question: What do the following have in common?
One answer might be that these projects are not designed to deliver health services for the poorest sections of the population. The Lagos insurance scheme excludes all informal sector workers, while one IVF cycle at The Bridge Clinic costs $4,600.
A second might be that both projects make a deeply questionable contribution towards a country’s attainment of Universal Health Coverage (UHC), given their provision of services to small, predominantly urban, and comparatively wealthy elite.
A third is that they have both benefited from investments made as part of the International Finance Corporation’s (IFC) Health In Africa Initiative.
Health In Africa is a $1 billion investment project launched by the IFC in 2008, which aimed to ‘catalyze sustained improvements in access to quality health-related goods and services in Africa [and] financial protection against the impoverishing effects of illness’, through harnessing the potential of the private health sector. Specifically, it sought to improve access to capital for private health companies, and to help governments incorporate the private sector into their overall health care system. Health In Africa would do this through three mechanisms: an equity vehicle, a debt facility, and technical assistance. Perhaps of most importance, the initiative would make extra efforts to ‘improve the availability of health care to Africa’s poor and rural population’.
Emanating from the World Bank Group, Health In Africa’s focus on delivering health care for people living in poverty makes sense. Anything contrary would be at odds with the Bank’s mandate and overarching goal to end extreme poverty by 2030. Oxfam welcomes World Bank President Jim Kim’s emphasis on the centrality of achieving Universal Health Coverage (UHC) to see this goal attained, and the Bank’s target to deliver health care for the poorest 40% by 2020.
However, it seems that with the Health In Africa initiative, the IFC may be working deeply at odds to these stated World Bank aims. Today, Oxfam launched Investing for the Few, analysing the investments made as part of Health In Africa to date. Oxfam’s assessment of the sporadic investment information available finds that far from delivering health care for the poorest, Health In Africa has favoured high-end urban hospitals, many of which explicitly target a country’s wealthy and expatriate populations. The initiative’s biggest investment to date has been in South Africa’s second largest private hospital group Life Healthcare. This $93 million endowment no doubt supported the company in its subsequent expansion (Life Healthcare acquired a 26% stake in one of India’s largest hospital groups in 2011), but there is no evidence it has used this investment to expand access to health care for the 85% of South Africans without health insurance.
Oxfam’s findings show that Health In Africa has also failed to deliver expansion of health care at any sufficient scale or pace to meaningfully contribute towards UHC. Instead the initiative has supported high-cost, low-impact investments. The Lagos health insurance scheme mentioned above cost triple the annual Nigerian government per capita health expenditure for example, and took over five years to secure fewer than 9,000 enrolees. In Nigeria, scaling up to reach UHC at this rate would take over 100,000 years.
Another major concern is the absence of sufficient attempts by Health In Africa to measure its performance. The initiative’s own mid-term evaluation found Health In Africa had failed to define and assess its anticipated results, and that the performance indicators it has used are inadequate to measure any development impact. Whilst an equity fund employed by Health In Africa boasts of its success at reaching patients at the so-called ‘base of the pyramid’, one of the annual income targets used to define this group include all but the top five per cent of earners in sub-Saharan Africa. It is likely Health in Africa’s use of financial intermediaries contributes to this failure to effectively measure impact on poor women and men. Such an arms-length approach to investment brings inherent problems around oversight and transparency.
Oxfam is clear that the IFC must improve the transparency and accountability of the Health In Africa initiative. Our report calls on the IFC to cease all Health In Africa investments until a robust, transparent and accountable framework is put in place to ensure that the initiative is pro-poor, and geared towards meeting unmet need. In addition, it calls on the World Bank Group to conduct a full review of the IFC’s operations and impact to date in the health sector in low- and middle-income countries, to investigate how they are aligned with, and are accountable to, the overarching goals of the World Bank Group: to end extreme poverty and promote shared prosperity.
The IFC needs to fundamentally rethink its activities in health, and ensure any potential projects are aligned with the Bank’s goals. The World Bank Group should focus on supporting African governments to expand publicly provided health care – a proven way to save millions of lives worldwide.