Indonesia fights to change WHO rules on flu vaccines

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Author: Edward Hammond
Date: 18 April 2009
Translations: Español and Français
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Edward Hammond | 18 April 2009 | Seedling - April 2009

The WHO’s global surveillance system acts as a free virus collection and R&D department for the world’s largest vaccine companies, yet gives very little benefit back to the developing countries in terms of available vaccines. Angered by the inequity, Indonesia decided in 2007 to suspend its sharing of viruses with the WHO. This action sent shock waves around the world. It alerted many developing nations to the need for reform, while provoking companies and the developed nations to fight to maintain the status quo. The outcome is still to be determined, while the world awaits the next pandemic.

Edward Hammond

In mid-2005, Indonesia began to suspect that something was badly wrong with the World Health Organisation’s influenza virus research system. In July of that year, a virulent new strain of the H5N1 “bird flu” cropped up in Indonesia, infecting poultry and, worse, people. [1] The world watched Indonesia, fearful that the virus might start spreading from human to human (and not just from poultry to humans), potentially triggering a pandemic.

In late 2005, as the new virus type (called a “clade”) infected poultry, and several more human victims died in Indonesian hospitals, officials scrambled to respond to the unprecedented crisis. Previous outbreaks had occurred in other parts of south-east Asia, where officials had similarly struggled (and continue to struggle) to contain them.

Indonesian health officials encountered disturbing problems. The antiviral drug Tamiflu, made by Switzerland’s Roche, was not available to them in large quantities at any price. [2] Although it has since lessened in importance, at the time Tamiflu was considered critical for treating and containing human infections. But rich countries had already locked up the supply, even though they were not the ones suffering H5N1 outbreaks.

In addition to difficulty in acquiring drugs, Indonesia’s health and agriculture officials often faced criticism from abroad, as they worked to stamp out infections. [3] Many foreign commentators were unreasonable, and had little or no specific knowledge of circumstances in Indonesia. Often they based their criticisms on sources of questionable reliability, for example, nearly unintelligible and error-prone computer translations into English of Indonesian news articles written in Bahasa. [4]

Another source was Andrew Jeremijenko, a disaffected Australian general medical practitioner working in Indonesia. Jeremijenko held jobs with the international petroleum industry in Indonesia and, simultaneously, at a US military laboratory in Jakarta called NAMRU-2, which was closed by Indonesian authorities in late 2008 (see Box 1).

Jeremijenko’s tenure at the US military lab had ended in early 2006, and included friction with Indonesia’s health ministry over handling of H5N1 samples. Now a telemedicine entrepreneur (and local political candidate in a Brisbane suburb in 2006–7), Jeremijenko’s criticisms of the Indonesian government were frequently accepted at face value by news media and public health commentators in the North. [5]

Despite the criticisms, and as has been customary for more than four decades, Indonesia shared the H5N1 viruses isolated from its victims with the WHO Global Influenza Surveillance Network (GISN). As is also customary, the viruses were shared without any material transfer agreement (MTA) or other document articulating rights over them.

Not long thereafter, an Indonesian virus from the 2005 outbreak was selected by WHO GISN for use in vaccines. Indonesia was displeased to learn that, although the virus was sent by WHO labs to companies and other researchers, vaccine made from it would not be available to Indonesians. [6] Later, when patent claims on this and other H5N1 viruses emerged, Indonesia’s discontent grew further.

How did it come to pass that WHO’s global surveillance system acts as a free virus collection and R&D department for the world’s largest vaccine companies, with familiar names such as Sanofi-Pasteur, Novartis, and Astra-Zeneca, yet gives very little benefit to developing countries?

Global virus vacuum

The GISN is WHO’s influenza laboratory network. [7] It exists to identify and characterise influenza viruses and to create and distribute virus seed strains that can be used to produce vaccines. The key labs in the system, called WHO Collaborating Centres, are all located in wealthy countries – Japan, the US, the UK, and Australia. Of these, the dominant facility is the US Centers for Disease Control in Atlanta, part of the US Department of Health and Human Services, whose technical capabilities significantly outstrip the others.

Although the GISN in theory exists as a WHO-led international public health collaboration, in many respects it can be more accurately described as a global virus vacuum, acquiring and processing thousands of influenza samples every year, determining which are most appropriate for use in vaccines, and then handing over those strains and vaccine selections – for free – to industry, which is 90 per cent concentrated in the North.

Although industry is the primary beneficiary of the WHO GISN, it views countries like Indonesia not with gratitude for providing viruses, but as markets. And since demand for influenza vaccine in the event of a pandemic will far outstrip production capacity, industry is uninterested in contracting to provide vaccine at affordable prices for developing countries, even if the wealthy countries where the vast majority of vaccine antigen is produced were to allow exports in the event of a global influenza crisis (which many observers find very doubtful).

Best of all for industry, the international movement of influenza (and other) viruses in the WHO system has historically ignored the concept of sovereignty over genetic resources, and the equitable sharing of benefits derived from them. Thus, no protections against patent claims by companies and others are built into the WHO GISN system, nor do the Terms of Reference and other agreements that govern its operation reflect a significant commitment to equity and benefit sharing. [8]

As a result, even though Indonesia and other countries cooperated with GISN labs that had been approved by and signed Terms of Reference with the World Health Organisation, they lost all legal rights over viruses sent to the WHO system. When attention later focused on a wave of patent claims being filed on GISN H5N1 viruses (see below), tensions grew. The fact that some of these patent claims were made by WHO GISN labs [9] themselves made matters worse, and showed WHO’s lack of interest in preventing predation of GISN’s public health goods by private interests.

Indonesia in the dock

Until 2007, WHO’s virus vacuum had operated for four decades with few objections being raised. However, fears of a new pandemic focused attention on influenza and, as a result, the GISN’s overt inequity became apparent. Stung by critics, a senior WHO official recently privately lamented that “nobody used to care about influenza”, suggesting – with some reason – that WHO Member States’ historic inattention to the GISN was in part responsible for its problems. [10]

In 2007, with developing countries largely still unable to access H5N1 treatments, and the WHO Secretariat still embarrassed at the GISN’s inequity having been revealed, Indonesia suspended its sharing of viruses with WHO and came to the World Health Assembly (WHA) in Geneva determined make big changes to the WHO’s system. [11]

Indonesia’s suspension of virus sharing sent a shock through the international scientific community and vaccine makers. Without access to Indonesia’s virus, H5N1 vaccine research and development in the North would be seriously impaired. Indonesia also objected to the patenting of GISN materials, raising concern from industry and other labs that viewed the GISN’s resources as free for appropriation.

The suspension brought on another wave of international criticism, including from the WHO, which harshly accused Indonesia of “threaten[ing] global public health”. [12] This and other criticisms were picked up by news media and on the internet. Few of Indonesia’s critics, however, knew what the GISN was, let alone understood how it operates.

Ignorance of the GISN and intellectual property issues among public health commentators and health writers commingled in a distorted feedback loop between press and bloggers, resulting in several articles erroneously asserting that Indonesia was claiming intellectual property rights over viruses and that this was interfering with the GISN’s public health work. [13] The reality was the complete opposite. Indonesia had not claimed intellectual property over any virus, had disavowed profiting from the virus and, in fact, one of its key objections was that WHO was allowing patenting of GISN materials.

Many developed countries seemed caught off-guard by Indonesia’s determination to change the GISN. A series of WHO meetings have ensued since the 2007 World Health Assembly but have yet to agree on a solution. As it became clear that Jakarta was not content to merely register a protest and then resume the business of sharing viruses as usual, developed countries placed a series of obstacles, many still unresolved, in the path of reforming or replacing the GISN to make it fairer to developing countries.

For instance, the US at first refused to accept that virus transfers should be conducted using an MTA. US negotiators said that this would be too burdensome, despite the fact that influenza viruses are routinely transferred inside the US using highly detailed MTAs, including when they are shared by US government agencies.

The US and others also scrambled benefit-sharing language when it crept into the draft resolution, for example turning “access to genetic resources [viruses] and sharing of benefits arising therefrom” into “mandatory sharing of viruses in return for access to vaccines through regular market mechanisms”. [14] In other words, it fought for the status quo, resisting any suggestion of inequity in the GISN system.

With EU support, the US has also promoted the idea that the revised International Health Regulations (IHR) require Indonesia to send viruses to the WHO. This would mean that Indonesia was violating an international agreement by not sending viruses to the GISN. But advancing this dubious argument was difficult, not least because the revised IHR doesn’t actually require the sharing of disease agents. In fact, a draft provision that would have done so was discarded because of US objections!

The WHO Legal Counsel, to its discredit, refuses to put to rest the uncertainty about the IHR that has been created by the US and EU. Only reluctantly does WHO concede that there is no virus sharing requirement in the IHR per se. But when it does so, it invariably also insists on suggesting various ways in which the IHR might be reinterpreted to require virus sharing, thereby perpetuating confusion about actual requirements. The impression left is that the WHO is inappropriately politicking for itself, encouraging Member States to grant the WHO power to compel countries to send it viruses, bacteria, and other disease agents.

A pandemic of patents

Since 2007, NGO research has documented a recent and dramatic increase in patenting of influenza vaccines, especially H5N1 vaccines. This includes patent claims over WHO GISN materials shared by countries such as Indonesia, Thailand, and Vietnam. Not only have claims been made by private industry, they even extend to two WHO Collaborating Centres for influenza – the Centers for Disease Control and St Jude’s Children’s Research Hospital, both in the US.

A hastily organised WHO consultation in Singapore began on 31 July 2007, only weeks after the WHA. Although the Singapore meeting was privately described by one WHO official as an attempt to “ambush” Indonesian negotiators, the ambush backfired when Indonesia tabled a detailed proposal to restructure the WHO system, including material transfer agreements, improved access to vaccines, and new terms of reference to govern the relationships between the WHO, GISN labs, industry, and developing countries.

The WHO Secretariat watered down Indonesia’s proposal and put forward a “Chair’s Text” of largely unexplained provenance.[15] It mostly reflected US and EU positions, but was not introduced by those countries; rather, it simply appeared without explanation. Unsurprisingly, advances at Singapore proved difficult because developed countries were unprepared to negotiate in detail, having arrived instead apparently hoping simply to press Indonesia to drop its initiative. Subsequent negotiating sessions, led by the Australian health minister, have rehashed and reformulated this draft agreement.

H5N1 patents graphs

Before 2006, only one international patent application for an influenza vaccine had ever been filed with the term H5N1 in the claim. In 2006 there were five claims, followed by eleven in 2007, and seven by September 2008. US and EU companies account for nearly all applications. Source: WIPO/PatentScope

It was not until the end of 2007 that signs of progress appeared. The US relented on the matter of an MTA (calling it “standard terms and conditions”), and the WHO began to wake up to modern genetic resource realities. At the end of a tough IGM negotiating session in Geneva, WHO Director-General Margaret Chan confessed to delegates that she hadn’t previously understood the positions of Indonesia and its allies, but that after listening to the negotiations she had “come to understand what is meant by equitable sharing of benefits”.

The details, however, matter greatly. Having agreed to a material transfer agreement for WHO GISN biological materials, the IGM’s definition of those biological materials becomes highly significant.

The influenza virus is very small. Its genome is about 12,500 genetic bases long, which is roughly one fiftieth the size of the smallest bacterium, and a much smaller fraction of that of higher organisms. The HA (hemagglutinin) and NA (neuraminidase) genes, which are of greatest interest for vaccines, are only about 1,750 and 1,350 bases long, respectively. [16]

Small size coupled with a virus-engineering technology called reverse genetics makes lab synthesis of influenza genes and recreation of viruses by machines increasingly easy to accomplish. New technology also makes the virus relatively easy to manipulate genetically. Further, there are technical aspects of H5N1 vaccine development that encourage genetic manipulation of vaccine strains. As a result, even though they remain utterly dependent on WHO for sequence information, acquiring actual virus from the GISN is becoming less necessary for companies and other labs, who are increasingly able to synthesise influenza genes and viruses from published sequence data.

Thus, if the definition WHO GISN materials excludes items such as synthesised copies and viruses that are slightly genetically altered, then companies can avoid proposed MTA requirements such as restrictions on patents as well as benefit sharing, including making vaccine technology freely available or mandatory contributions to a pandemic preparation fund for developing countries.

Box 1: The US Military and Influenza Samples

Naval Medical Research Unit No. 2 (NAMRU-2), the US military lab in Jakarta, is part of a large, little-known network of US military labs that conduct biomedical research and collect disease samples outside the United States. For influenza, the US military system parallels the World Health Organisation’s GISN but does not entirely share its public health purposes.
The US military collects influenza viruses in at least 56 countries (as of 2007). These samples are shipped to the US, but only some are sent to the WHO GISN. In 2006, this number was 120 viruses (about 1.5 per cent of those collected), meaning that more than 98 per cent do not enter the WHO system. All are kept by the US military for its own purposes.
The Pentagon claims credit, however, for being the source of several important influenza viruses that have been selected by WHO for use in seasonal and H5N1 vaccines from 2000 to the present. These include viruses from Panama, Peru, Nepal, Malaysia, and Indonesia.

Developed countries including the US have insisted that developing countries may only share influenza viruses with the WHO GISN and not bilaterally. Yet the massive US military virus collection programme contradictorily provides only a very small percentage of what it collects to the WHO.

The size of the programme has more than doubled in recent years. In 2005, it was active in 30 countries and included three high containment (BSL-3) labs with a total processing capacity of 9,000 influenza specimens per year. By 2007, the network was active in 65 countries and included eight BSL-3 labs and the capacity to process 18,000 samples annually.
It is unclear if and how viruses collected by the US military in other countries would be covered by a WHO GISN material transfer agreement because they are obtained and transferred outside what is now understood to be the WHO system.

A US Air Force lab in San Antonio, Texas coordinates the collections. In 2006 and 2007, the systemwide budget was over US$40 million per year. Collected viruses (especially H5N1 viruses) are provided to the US Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick in Frederick, Maryland. USAMRIID is the historical home of the US offensive biological weapons programme (terminated in 1969), and is now the headquarters of the US military’s biological defence effort.
According to the San Antonio lab, “The principal objective is to enable the rapid discovery of novel strain mutations that could trigger a pandemic and to monitor these strains for their ability to transmit and to cause disease … the priority of the DoD is to maintain readiness and protect the health of service-members and beneficiaries, the contributions from surveillance program also benefit the greater global health community.”

Five overseas labs operated by the US Department of Defense act as regional coordination centres. They are:
•   Naval Medical Research Unit No. 2 (NAMRU-2) in Jakarta.
•   Naval Medical Research Unit No. 3 (NAMRU-3) in Cairo.
•   Naval Medical Research Centre Detachment (NMRCD) in Lima.
•   Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok.
•   US Army Medical Research Unit-Kenya (USAMRU-K) in Nairobi.

Excepting NAMRU-2, which was recently closed by Indonesia, each of the above labs works not only in the country in which it is located but also in nearby countries, where laboratory and personnel detachments are sometimes placed.

Although the Pentagon’s viruses have frequently contributed to WHO vaccine strain selections, none of the negotiating texts or background documents made available by WHO in the course of GISN negotiations have discussed the military virus collection system, much less explained the unusual relationship between it and the GISN.

Now, WHO optimistically hopes that an agreement to reform or replace the GISN, presently called a “WHO Framework”, can be finalised and adopted at the World Health Assembly in May 2009. But the current draft text, despite several meetings and iterations, leaves many key issues unresolved, including restrictions on intellectual property, definitions of WHO materials, exact types and requirements for benefit sharing.

The scope of the agreement also remains in question. WHO and developed countries have fought to restrict it to viruses isolated in humans. Yet WHO-selected human vaccines are also made from H5N1 viruses that come from animals, making any agreement that solely pertains to human-isolated viruses of limited utility. In addition, WHO has asked its Member States to send animal viruses to the GISN for a number of years (a fact that WHO officials embarrassingly forgot at an important negotiating juncture). In fact, one of the WHO’s collaborating centres, St Jude’s Research Hospital in Memphis, Tennessee (US), specifically focuses on collecting and evaluating influenza in animals.

While it has been claimed that extending the WHO agreement into animal viruses conflicts with the domain of other intergovernmental organisations (FAO and OIE), in fact, this does not appear to be a major concern. That is because a distinction can be drawn between use of samples for human vaccine development and pandemic risk assessment, versus similar uses directed toward animal health.

Box 2: Bird flu in Indonesia and Vietnam

Indonesia and Vietnam are two of the countries in south-east Asia most affected by the continuing bird flu crisis. In July 2008, GRAIN met some small-scale poultry farmers and people involved in the development of policies to deal with the disease. The situation in both countries is deeply troubling. The authorities are using bird flu as a pretext to destroy a highly efficient food system built up over generations. This system provides livelihoods for millions of people, from small farmers to wet market butchers; it is completely sustainable, and reliably provides urban and rural populations with affordable, nutritious food. Now, on the ashes of Asia’s richly diverse poultry culture, giant poultry corporations are erecting their modern factories.

Indonesia has suffered more than any other country from bird flu. Across the archipelago, many local and international programmes and policies have been set up to deal with the disease. But practically nothing has been done to deal with the big poultry companies, which are responsible for the initial introduction and spread of the disease. Dr Muladno, the Planning and Development Coordinator of Indonesia’s National Committee on Avian Influenza Control and Pandemic Influenza Preparedness (Komnas FBPI), told GRAIN that the government is aware of outbreaks at large farms, even though these are not reported: he mentioned a specific outbreak at a large farm in Subang that was happening at the time but was not being talked about. There is still no legal obligation for companies to report bird flu outbreaks on their farms, and health inspectors cannot legally enter an industrial farm without the owner’s permission.
Government policies have, however, had a devastating impact on small-scale poultry operations. Muladno says that roughly 90 per cent of the local chickens in Jakarta were culled and never replaced because of a ban on poultry production within the city. All this for what? The measures did not have the desired effect of reducing human cases of H5N1 in Jakarta. The city remains a hotspot for human bird flu infections: about 70 per cent of the country’s human cases occur in the Jakarta region. It is obvious, therefore, that the disease is being trucked in by poultry operations elsewhere in the country. To deal with this, the government is now in the midst of implementing a second round of policies that will ban the transport of live birds into the city, while not lifting the ban on poultry production within the city. The transportation ban will put an immediate end to more than 1,300 traditional poultry slaughterhouses in the city, which supply 80 per cent of the poultry meat consumed in Jakarta and provide for the livelihoods of thousands of small-scale butchers. All of the poultry meat will be shipped into the city by a few large operations that can afford the cold-chain infrastructure that will soon be required.

The same fate awaits Indonesia’s many medium-scale poultry farmers. These farms typically have a couple of thousand birds, and often operate under contract to a bigger company. Muladno says that they will either have to grow, with the necessary “biosafety” requirements, or “die”. This means that the farmers will either have to go into debt to set up large contract operations with the big companies, or get out. Muladno agreed that about 90 per cent of these medium-scale farmers would go out of business.

The only voice for small-scale poultry farmers on Komnas FPBI is Ade M. Zulkarnain, a small-scale poultry farmer from Sukabumi, West Java. Ade is the Chairman of the Indonesian Native Chicken Community (Keprak), which was formed in 2003 and now brings together 1,800 farmers in 22 (out of 33) provinces. He is also a “founding father” and active member of the Indonesian Local Poultry Farmers Association (HIMPULI), formed in 2007 to help poultry farmers to improve their farming and livelihoods.

Ade’s poultry farm sits in the middle of a densely packed village, and it was here, in July 2005, that the first reported outbreak of H5N1 bird flu occurred in local (kampung) chicken. He says that one person and 2,200 local chickens died during that outbreak – 850 of them in the government’s cull. He suspects that the bird flu came into the community by way of industrial feed or people working in the industrial operations. Since then, there has not been a single outbreak, even though the area is considered a hotspot for bird flu. In conversation with GRAIN, Ade pointed to a nearby area of big poultry farms, where 500,000 chickens had recently died in an outbreak of bird flu that was not reported by government or media. He said that the company did not even allow government inspectors into the premises.

Ade maintains several rare breeds of kampung chicken on his farm. He says that Indonesia is home to two of the four original ancestors of chicken. These varieties later diversified into 31 strains, with Indonesia thus having the highest poultry diversity in the world. But the industrialisation of poultry production and the response to bird flu, especially the culling, has reduced this diversity until today only about ten are left. Ade feels that the government’s culling policy, defined in a 2007 presidential decree, is a deliberate attempt to wipe out kampung chicken.
Ade says that his group and his community had already taken the initiative to “restructure” local poultry production before the government began calling for it. The community came together to share ideas, invest collectively in simple machines (such as feed mills and home-made incubators), and establish joint management of chicken coops and vaccination. Their collective actions allowed them to share costs, resources and knowledge and to develop markets. Ade feels that such initiatives should continue to come from the people and that the government should recognise their efforts and provide support. Instead, the government thwarts whatever they propose, either refusing to listen or making promises that it never keeps. For example, a decree that safeguards the control that small-scale farmers have over kampung chicken has been with the government for some time. But in 2006, Charoen Pokphand (CP), the largest poultry company in Asia, started getting involved in producing and marketing its own brand of kampung chicken, produced on its large farms. Ade’s group vociferously opposed CP’s actions and petitioned the government three times, but the government merrely tried to offer them a “win-win” situation: offering them shares in CP’s Indonesian subsidiary if they withdrew their opposition.

Ade is clear that small farms are simply the victims of the big farms when it comes to bird flu. He says that there are no serious outbreaks on small farms; they occur mainly with big producers. He mentioned a 2007 study by the Centre for Indonesian Veterinary Analytical Studies that found that 84 per cent of the poultry at wholesalers in Jakarta, practically all of which is transported into the city by the big poultry companies, was infected with bird flu.

Ade and other poultry farmers in his community and elsewhere in the country are doing what they can to manage the disease. But their efforts can only go so far, when so little is being done to deal with the big players. When GRAIN asked Muladno why the government was doing so little to stop bird flu in the big poultry operations, he was blunt. The Indonesian government is “powerless” to deal with these corporations, he said.

In Vietnam also, small farmers and poultry biodiversity are on the chopping block. Here too, small poultry farmers are affected by bird flu coming out of the larger operations. Hoang Hai Hoa, an officer with Agronomes & Vétérinaires sans frontières (AVSF) in Hanoi, says that the main source of outbreaks among smallholders in remote areas is from the import of layer chicks from large operations – one of the reasons why AVSF is supporting local chick production. Overall, however, there is little government support to help small-scale poultry producers to deal with bird flu. In fact, most government interventions obstruct or even prevent small-scale production.

In Ha Tay province, for instance, the government now requires poultry production to take place on land it is setting aside away from residential areas. Any farmer relocating to these areas must raise production to more than 200 birds. Since most small-scale poultry producers cannot afford to move to these locations, they are simply abandoning poultry.

Business is booming, though, for the big poultry companies in the province, which is the main source of poultry meat supplied to Hanoi. As small-scale production disappears, contract production is on the rise. Currently there are 500 households in the province with farms of 4,000–10,000 birds, and 250 of them do contract production for CP. It is sadly ironic that CP should benefit from this situation when the initial bird flu outbreak in the province originated on a CP farm. Mr Binh, Director of the Sub-Department of Animal Health, Ha Tay Province, told GRAIN that 117,000 chicks were infected at this CP farm, which supplies chicks for the whole nation. From there, bird flu spread rapidly throughout the country.

Another unresolved issue is the boundaries of the WHO system. Many developing countries propose that the WHO system retain rights over GISN viral materials after they are transferred to industry and other labs. Industry would therefore assume certain commitments whenever handling materials sourced from GISN. The US and others, such as Japan, prefer that once materials are sent to industry then they pass out of the GISN system and, for instance, cease to be tracked by WHO’s new virus-tracking system (being implemented at the suggestion of Brazil and others).

An important factor restraining an agreement is a lack of desire in the North to change the status quo. A cynical refrain among EU delegates in late 2008 was “We need their virus, they need our vaccine, and nobody needs this framework.” This feeling is certainly influenced by industry, which is strongest in Europe and has vastly outnumbered NGOs at the negotiating sessions. Industry has little desire to see the GISN changed either. Also intruding on the negotiations are industry concerns, seldom articulated, that agreement to benefit sharing for influenza virus could lead to pressure for concessions in other infectious diseases.

In the meantime, the WHO GISN continues to operate, but Indonesia and several other countries have limited their sharing of H5N1 viruses with it. Nevertheless, a distinct danger exists that, if developing countries are not sufficiently united and do not insist upon benefit-sharing specifics, the new WHO Framework could mandate virus sharing without a commensurate mandate for companies to share benefits.

Countries reporting major H5N1 bird flu outbreaks in poultry to the OIE (+Indonesia)*

Year

Countries

2008

Bangladesh, Benin, Burma, Cambodia, China, Egypt, Hong Kong, India, Indonesia, Iran, Laos, Nigeria, Pakistan, Poland, Russia, Saudi Arabia, South Korea, Thailand, Togo, Turkey, Ukraine, UK, Vietnam

2009
(1st two months)

Bangladesh, China, India, Indonesia, Nepal, Vietnam

Human cases of H5N1 reported to WHO (up to 24 February 2009)*

Total cases: 488
Total deaths: 255
Total cases 2008: 44
Total deaths 2008: 33

Nearly all cases (42 out of 44) and all deaths in 2008 occurred in 4 countries: China (4 cases), Egypt (8), Indonesia (24), Vietnam (6). In 2009, these four countries account for all the cases and deaths confirmed by the WHO and national authorities.*

*Indonesia stopped reporting confirmed cases to the WHO on 5 June 2008 and the government started following a policy of not reporting cases as they occur but only periodically. Indonesia has not reported outbreaks in poultry to the OIE since September 2006, although it is well-established that H5N1 remains prevalent in much of the country. The Indonesian government publicly confirmed four human deaths from H5N1 in the first 2 months of 2009.

Turning the GISN into a more equitable system will require limiting patent claims. Developing countries, including the Africa Group, Thailand, Brazil, Indonesia, and others, have proposed that there should be no intellectual property over GISN materials and products that incorporate them. [17] The degree to which they are successful remains to be seen.

Stopping patents, however, solves only one part of the problem. Flu vaccine production capacity is presently inadequate to supply the North, much less the South, in the event of a pandemic. And because production capacity is centred in the North, the South is at the end of queue to receive vaccine, meaning that it is likely to suffer disproportionate damage in a pandemic. To put it bluntly: Southerners will die, while Northerners will be vaccinated.

To solve this problem, some developing countries are seeking to link use of GISN virus with technology transfer. Under this proposed system, when industry commercialises a vaccine made from GISN materials in the North, it would incur obligations to make its vaccine technology available in the South, by granting licenses, providing know-how, and making mandatory contributions to a fund designed to ensure that such transfers actually happen.

Uncertainty currently abounds. Nobody can be sure of the timing and severity of a future pandemic, or even whether the H5N1 type of flu will prove to be the culprit. Preventing monopolisation of vaccine technologies and public health resources, however, will reduce the impact of future outbreaks. Indonesia’s stand has alerted many governments to inequities and the need to reform WHO’s virus collection system. But corporate and developed-country pressure for the status quo (or something closely resembling it) is strong. The outcome of the conflict is yet to be determined; but it can be hoped that the resulting system will improve public health by limiting corporate control and placing greater public health resources in the hands of developing countries.


Going further

Edward Hammond, Some Intellectual Property Issues Related to H5N1 Viruses, Research, and Vaccines, September 2008, available online, http://www.twnside.org.sg/title2/avian.flu/papers/patent.paper.pdf

Third World Network’s collection of South–North Development Monitor (SUNS) articles on WHO pandemic influenza negotiations, http://www.twnside.org.sg/avian.flu_news.htm

World Health Organisation home page for the Pandemic Influenza Preparedness Intergovernmental Meeting, http://www.who.int/gb/pip/

Immunocompetent. Blog providing occasional news and comment on WHO negotiations, http://immunocompetent.com

GRAIN, “Germ warfare - Livestock disease, public health and the military–industrial complex”, Seedling, January 2008, http://www.grain.org/seedling/?id=533

GRAIN, “Viral times - The politics of emerging global animal diseases”, Seedling, January 2008, http://www.grain.org/seedling/?id=532

GRAIN, web page providing details of GRAIN publications, external documents and other resources on bird flu and its impact on small-scale farmers, http://www.grain.org/birdflu


1 - International Society for Infectious Diseases, “Avian Influenza, Human – East Asia (125): Indonesia, Confirmed”, ProMED-Mail, Archive No. 20050916.2736, 16 September 2005.
http://tinyurl.com/b9v9e8

2 - Personal communication with Indonesian Health Ministry Officials, 2006–7. See also US Embassy, Jakarta, “Questions and Answers on Avian Influenza (Adapted from the U.S. Centers for Disease Control and Prevention and the World Health Organization websites)”, updated 9 December 2005, http://tinyurl.com/czplu8
Andrew Pollack, “Governments Pressing Roche For More of Its Flu Medicine”, New York Times, 20 October 2005, http://tinyurl.com/chkr6x

3 - See, for example, Peter Cave, “Failed Indonesia bird flu response concerns experts”, Australian Broadcasting Corporation, 25 February 2006, http://tinyurl.com/l7z2m

4 - See, for example, the active website Flutrackers.com, particularly its news forum, http://tinyurl.com/dfykxj

5 - See Peter Cave, “Failed Indonesia bird flu response concerns experts”, Australian Broadcasting Corporation, 25 February 2006, http://tinyurl.com/l7z2m

6 - Reuters, “Indonesia defends move to block virus sample sharing”, 16 July 2008, http://tinyurl.com/cl4paa

7 - The Global Influenza Surveillance Network’s web pages can be found on the WHO website, http://tinyurl.com/cf76xa

8 - See Core Terms of Reference for WHO Collaborating Centres for Reference and Research on Influenza, 12 October 2006 version, http://tinyurl.com/c6tnue

9 - See, for example, PCT Patent Application WO2007/100584, Antiviral Agents and Vaccines Against Influenza, published 7 September 2007, and lodged by the US Centers for Disease Control and National Institutes of Health.

10 - Personal communication.

11 - Fitri Wulandari, “Indonesia says WHO must set rules on H5N1 sharing”, Reuters, 12 February 2007, http://tinyurl.com/dgmtq8

12 - Fitri Wulandari and Ahmad Pathoni, “Indonesia to resume sharing bird flu virus samples”, Reuters AlertNet, 27 March 2007, http://tinyurl.com/bqofzk

13 - Geoff Thompson, “Indonesia claims ownership over strain of avian flu”, Australia Broadcasting Corporation AM programme, 1 February 2007, http://tinyurl.com/alx3d3
Michael Perry, “Indonesia ban risks WHO flu protection system”, Reuters, 8 February 2007, http://tinyurl.com/bwqkaf
Maryn McKenna, “Virus ownership claims could disrupt flu vaccine system”, CIDRAP News, 19 June 2007, http://tinyurl.com/bjtq9k

14 - These are not verbatim quotations, but an eye-witness’s paraphrase conveying the flavour of the discussion.

15 - This first Indonesian proposal was never published as an official WHO document. A proposal subsequently put forward by the African Group, however, reflected many of Indonesia’s ideas. The African proposal has been published as an “annex” to WHO document A/PIP/IGM/7, http://tinyurl.com/d62lfp

16 - Edward Hammond, Influenza strains and genes can be copied from sequence data, undermining the WHO flu benefit sharing system, paper prepared for Third World Network, July 2008, http://tinyurl.com/dmh6xo

17 - See, for example, the Africa Region proposal published as an “annex” to WHO document A/PIP/IGM/7, http://tinyurl.com/d62lfp

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