Reforming and restoring WHO to good health
In this trenchant critique of its failings, German Velasquez says that the basic starting point of any reform of WHO should focus on how to regain its public and multilateral character.
THE World Health Organisation (WHO), the United Nations specialised agency for health, is slowly dying in the eyes of the international community which is divided among promoters, accomplices and observers of the disaster. The recent World Health Assembly in May did not manage to treat the disease afflicting the organisation.
In the management of the H5N1 avian flu in 2005, at least two flaws, among many others, can be identified. The first flaw was that, in August 2005, the Executive Director of the WHO Director-General's office announced in a press release that 150 million people could die of this global epidemic. Five years later, WHO reported the total deaths due to H5N1 to be 331 people, concentrated mainly in Indonesia and Vietnam.1 Between 150 million and 331 deaths, the least we can point out is the lack of rigour in epidemiological forecasts.
The second flaw in relation to management of the avian flu was the enormous waste of security stocks of the drug oseltamivir (known under the brandname Tamiflu). Never in the history of medicine were there stocks of a drug whose effectiveness was not known, for a disease that had not yet come and that never came. Some years later, the scientific community proved that, in addition to the resistance created by the drug's overuse, it had no efficacy. The quantities stored were gigantic, for 25% of the population in Canada, 25% in the US, 25% in the UK, 50% in France and other European countries, and 23% in Japan.2
In 2009-11 with the H1N1 flu outbreak, WHO sounded a new alarm; it declared the highest global pandemic phase, contrary to the view of internationally recognised experts. Although this disease was characterised by very rapid transmission, mortality rates were very low. While about 500,000 people die each year from the normal seasonal flu, WHO reported only 18,449 deaths over a period of two years for H1N1. The declaration of the highest pandemic phase enabled the vast majority of industrialised countries, with WHO's recommendation, to buy several million vaccines, of which 90% eventually had to be incinerated because they were not used. France, for example, with a population of 66 million, bought 94 million doses, out of which only 6 million were used. The waste in France was of the same proportion as in the US, Germany, Belgium, Spain, Italy, the Netherlands and Switzerland, with regard to the purchase of vaccines and, again, with regard to the stocks of oseltamivir.
It seems that little has been learnt from past mistakes. The Ebola outbreak was announced in March 2014 by Medecins Sans Frontieres and WHO began to act only in July/August of the same year - a delay of four months which was probably one of the reasons the outbreak reached the dimensions of a global threat.
Ebola is a type of haemorrhagic fever that first appeared in Zaire (now the Democratic Republic of Congo) in 1976, almost 40 years ago. In previous periodic outbreaks, an average of 300 deaths per year had been reported. On 25 January 2015, WHO reported 20,689 cases and about 8,626 deaths, mainly in Sierra Leone, Liberia and Guinea. Why this significant jump in the number of cases? The delay in commencing action against this outbreak could have been one cause, but surely not the only one.
In all the documents produced by WHO in the past eight months, no one asked about the causes of the disease and especially the drastic increase in the number of cases. WHO's priority was to raise funds and conduct clinical trials for a vaccine that has been in the hands of the US and Canadian armies for the last 10 years. Some ongoing studies3 seem to suggest that one of the main causes could be massive deforestation for agriculture and mining, which has changed the balance between the forest animals and man.
This outbreak, which is now dying out, may come back stronger if the possible causes are not studied and if efforts are limited to raising funds to build health infrastructure and to store vaccines. The WHO plan also foresees the training of health personnel. However, the issue of 'brain drain', or what public health expert David Sanders prefers to call 'brain robbery', is unfortunately not mentioned in the WHO resolution approved by the World Health Assembly in May. There are more doctors from Sierra Leone working in the rich OECD countries than in their own country.4
In January 2015, WHO announced 'reforms' to better prepare for future epidemics. However, the causes and the roots of the problem have not been addressed - causes that are probably associated with environmental damage due to massive mining activities by foreign companies.
In the case of Sierra Leone, interest in untapped mineral resources has sparked a flood of investment. The country's economic growth rate - 20% last year, according to International Monetary Fund (IMF) data - is among the highest in the world. This exceptional growth appears not to be benefiting the national economy, however. Tax evasion is one of the main causes of revenue losses, especially in the mining sector. In 2010, the country's mining industry contributed nearly 60% of exports but only 8% of government revenues. Of the five major mining companies in Sierra Leone, only one is currently paying taxes.5
If the country had benefited from this 'economic boom', some health infrastructure could at least have been built to address the Ebola epidemic. While WHO usually speaks of the social and economic determinants of health, it has failed to do so in relation to the Ebola epidemic in Sierra Leone. It is a pity that the World Health Assembly resolution in May has 'forgotten' to mention this aspect.
In managing Ebola, in addition to the delay in reaction, there are scandalous dimensions from an ethical point of view. For a disease that has been known for nearly 40 years, it is strange that WHO and the media announced that the American army and the Canadian army have had for 10 years a vaccine to protect themselves in case of a biological attack - but not to save the lives of the poor in Africa. This proves once again the failure of the current model of research and development of pharmaceutical products where innovation is dictated more by purchasing power than by the frequency of a disease.
As on other occasions, WHO argues that the problem is due to a lack of funds to address the Ebola epidemic. This may be true to an extent, but the problem is less of a financial than structural nature. What is at stake is the ability of the agency to respond to such problems. The answers are slow, the recommendations are not always clear and enforcement mechanisms for the implementation of strategies and action plans are almost non-existent.
In national health contexts, deficiencies in managing such problems often lead to the resignation of the health ministers. In the case of WHO's mismanagement of the Ebola epidemic, the World Health Assembly diplomacy preferred to keep in place the WHO high-level staff in Geneva.
Parallel to the repeated failure in handling health problems worldwide, a progressive privatisation of the agency has occurred, led by some industrialised countries with the complicity of the WHO secretariat. At the turn of the century, some 50% of WHO's budget was financed by mandatory contributions from member countries, but now this source constitutes less than 20% of funding. The agency is currently in the hands (more than 80% of its budget) of philanthropic foundations like the Bill and Melinda Gates Foundation, 19 industrialised countries that offer some voluntary contributions, and the pharmaceutical industry. At the WHO Executive Board meeting in May, the US delegation expressed its satisfaction over the 'change in the budget process', i.e., from regular public contributions to voluntary funding. The UK 'welcomed and strongly supported' the US statement.
At the beginning of the reform launched by the present WHO Director-General three years ago, the financial situation of the organisation and the role of 'non-state actors' were discussed together as the two issues are highly interrelated. Definition of the role of non-state actors should precede any change in the way the organisation is funded (whether public or private financing or mixed financing, and if mixed, in what proportion). Strangely, however, the WHO secretariat then decided to delink the two items and proceed with what in the end was called a 'financing dialogue' and, as the US delegate at the WHO Executive Board put it, 'change the budget process' from public to private funding.
The vertiginous loss of control of the budget leads to an inability to set priorities. While the member states may try to outline priority issues, the funds come from the private sector and are allocated towards areas specified by the private (and public) donors, who may be seen as in effect the new owners of the organisation.
At the WHO Executive Board meetings in January and May, the normative role of the organisation was attacked during discussions on the agenda item dealing with 'WHO guidelines: development and governance'. In March 2014, WHO had issued a draft guideline suggesting reduction of the recommended free sugar intake from a maximum of 10% of total energy intake to 5%. This suggestion remained in the final version of the guidelines which was formally published in March 2015.
At the January 2015 Executive Board meeting, a motion from Italy was announced proposing a supplementary item on the agenda aiming to open up WHO's guidelines development processes to interventions by member states. The issue was postponed to the May meeting. The essence of the Italian proposal was that WHO's guidelines protocols 'should be reviewed and updated in order to take into account a different international commitment by stakeholders, in particular Member States, to make them more reliable by increasing the accountability and transparency of the Organisation .'.
While it is true that the protocols do not require the participation of 'member states and other stakeholders' in guidelines development, the sugar guideline in question had been exposed for public consultation for a year before the finalised guideline was published.
It is not clear what the Italian proposal meant by 'a different international commitment', nor what additional involvement of 'stakeholders' in guidelines development is envisaged. It could entail a requirement for formal approval by one of the governing bodies before the draft can be promulgated as a formal finalised guideline. To suggest that the involvement of 'other stakeholders' in the process needs to be strengthened, above and beyond a year of public exposure/consultation, implies a more direct involvement of industry stakeholders in the deliberations leading to the draft and in evaluating consultation feedback.
The Under-Secretary for Health of Italy, Vito De Filippo, described the Italian proposal as a 'generic request', but in fact the aim was very specific: to reopen the guidelines, claiming that 'sugar is an essential nutrient' and arguing that reducing sugar intake as a proportion of total calorie intake to 5% was 'overly restrictive'. (De Filippo did not mention that one of the members of the Italian delegation to the January Executive Board meeting, Luca del Balzo, was senior adviser of Ferrero - the world's largest chocolate producer.)
In response to the Italian intervention, the WHO secretariat prepared a document which provides a useful summary of the core principles of the WHO Handbook for Guideline Development, published in 2012. The secretariat's response was a smart political move, but several questions remained open:
* What is the status of the WHO handbook? Is it binding for all WHO programmes?
* Have WHO guidelines published before 2012 been reviewed in line with the criteria and principles of the handbook?
* There was no answer from the chair of the Executive Board or the WHO secretariat concerning the intention of Italy to come back to the item.
* There is no clear information from the secretariat on how it will proceed in the future in relation to the issue of conflicts of interest.
* This issue, like the 'financing dialogue', is necessarily linked to the question of non-state actors, on which consensus among member states still proved elusive during the last World Health Assembly in May.
Concerns over improvisation, delays, lack of independence and conflicts of interest have led, unsurprisingly, to WHO's loss of credibility. The funds for health available in the international community are beginning to be used for other bodies such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNITAID, UNAIDS, UNDP and PEPFAR. And now, in the debate regarding delays in WHO intervention, some have suggested the need for a new agency that can respond to global health emergencies.
Suddenly, we find ourselves today with a public multilateral agency that has become a cumbersome bureaucracy, with excess staff of about 3,000 in Geneva (when the World Trade Organisation has fewer than 600 staff). This fact is not being highlighted to support the argument of countries like the Netherlands that are opposed to any increase in WHO's budget on the grounds of 'efficiency gains'; rather, the point being made here is that there is a need for a reorganisation of WHO's bureaucratic structure.
WHO has serious financial problems and this is compounded by the fact that there is an overall disconnect in the hierarchical structure of power between the headquarters in Geneva and the six fully independent WHO regional offices, which do not report to the Director-General but to the ministers of health of each region, who elect the Regional Directors. Over 150 country offices do not report to the regional offices or headquarters but, for some reason, to the health minister of each country. Under this structure, the organisation is like an army without a central command, unable to respond in a timely and effective manner to problems such as the H5N1, H1N1 and Ebola outbreaks.
Gro Harlem Brundtland, the Director-General of WHO from 1998 to 2003, used the term now in fashion, 'health diplomacy'. Diplomacy has been very useful for finding solutions to border conflicts, military problems or any kind of dispute amenable to negotiated agreements where different parties only make small concessions. However, in public health and medical care, where there is scientific evidence for something, 'prescription' is not negotiable. A drug dose that is less than what is needed will be useless while an excess dosage can become toxic and kill the patient.
In WHO, there are currently several issues being handled through health diplomacy, negotiated by the diplomats from the member states' missions in Geneva, such as: the quality of medicines, how to fund research and development of pharmaceuticals, nutrition, the issue of non-state actors, and Ebola.
The mode of operation of the governing bodies of WHO - an Executive Board composed of representatives of 34 countries (now representatives of governments and not independent experts as in the past) and the World Health Assembly composed of health ministers and delegations from 193 member countries - is totally obsolete. Delegates attend three annual meetings in Geneva (two Executive Board meetings and the Assembly) to discuss the details and language of resolutions that in the end are agreed upon in complicated diplomatic arrangements.
WHO does not have, or rather does not use,6 mechanisms for implementation of decisions that could be made based on technical evidence. Article 19 of the WHO Constitution, which gives the WHO the authority to negotiate binding treaties and measures, has been used only once in 65 years. The US and the EU reject any kind of decisions that are binding on the member states. How, for example, do we prevent the world from running out of antibiotics because of growing antibiotic resistance in all parts of the world? Resistance which is caused largely by the widespread prophylactic use of antibiotics in animals which are then consumed as human food. To recommend or legislate, this is the dilemma.
Until 1998, WHO was relatively unaffected by the influence of the private sector and the public regular contributions of the member countries represented more than 50% of the budget. In 1998, in her first speech to the World Health Assembly, Gro Harlem Brundtland said, 'We have to go find the private sector ... The private sector has an important role to play both in technology development and the provision of service.'7
During the five years of the Brundtland administration, public-private partnerships (PPPs) and, later, product development partnerships (PDPs) grew and developed. This was seen as a 'win-win situation' and any risks or possible negative effects were not considered, because there was little oversight and the rules in this area were not always clear. Today, the pharmaceutical industry and philanthropic foundations participate in meetings of experts on various topics and sit on the board of most PPPs and PDPs.
The PPPs were so heavily promoted that WHO itself is now effectively a large PPP. The owners of 80% of the budget demand more power and participation in decision-making. This debate, which has been going on for three years, was discussed again by the 68th World Health Assembly in May under the rubric of 'framework of engagement with non-state actors'. After long hours of debate which still failed to yield consensus, the Assembly adopted a resolution requesting the WHO Director-General: (1) to convene as soon as possible, and no later than October 2015, an open-ended intergovernmental meeting to finalise the draft framework of engagement with non-state actors on the basis of progress made during the 68th World Health Assembly; (2) to submit the finalised draft framework of engagement with non-state actors for adoption to the 69th World Health Assembly (which will take place in 2016), through the Executive Board at its 138th session; and (3) to develop the register of non-state actors in time for the 69th World Health Assembly, taking into account progress made on the draft framework of engagement with non-state actors. This issue continues, after three years of debate, to be an unresolved fundamental question that has implications for the future of the organisation.
The basic starting point for any reform of WHO should be to focus on how to regain the public and multilateral character of the institution. The choice before the WHO member countries is clear: opt for a PPP to manage projects funded by philanthropic foundations and the private sector, or rebuild a public international agency that can independently steer the health sector.
German Velasquez is Special Adviser on Health and Development at the South Centre in Geneva. He was previously a senior WHO official known for his groundbreaking work on intellectual property and access to medicines. The above is a revised and updated version of an article that was first published in Le Monde Diplomatique (May 2015).
1. German Velasquez, 'The management of A (H1N1) pandemic: an alternative view'. Journal of Health Law, Vol. 13, No. 2, Oct. 2012, pp. 108-122.
3. David Sanders and Amit Sengupta, 'Ebola Virus Disease: What's the primary pathology?' Presentation at the Prince Mahidol Award Conference, Bangkok, January 2015.
5. Sanders and Sengupta, op. cit.
6. In 65 years, Article 19 of the WHO Constitution, which gives WHO the power to negotiate treaties or agreements of a binding nature, has been used only once, in the Tobacco Convention, with an efficiency that we already know.
7. Gro Harlem Brundtland's speech to the 51st World Health Assembly, 13 May 1998.
*Third World Resurgence No. 298/299, June/July 2015, pp 38-41