TWN Info Service on Intellectual Property Issues (Mar10/11)
31 March 2010
Third World Network

Dear All,

Please find below a paper by Chan Chee Khoon on the issue of Influenza Virus and Benefit Sharing presented at the Conference on Strengthening Health and Non-Health Response Systems in Asia: A Sustained Approach for Responding to Global Infectious Disease Crises (co-organized by Nanyang Technological University and the World Health Organization, 18-19 March 2010, Singapore

Regards
Sangeeta Shashikant
Third World Network
email: sangeeta@thirdworldnetwork.net 

Equitable Access to Pandemic Flu Vaccines
Chan Chee Khoon
Center for Policy Research & International Studies Universiti Sains Malaysia
Paper presented at the Conference on Strengthening Health and Non-Health Response Systems in Asia: A Sustained Approach for Responding to Global Infectious Disease Crises (co-organized by Nanyang Technological University and the World Health Organization, 18-19 March 2010, Singapore ckchan50@yahoo.com

Donor Leverage for Access to Avian Flu Vaccines

In late 2006, the Indonesian government made a controversial decision to withhold its H5N1 avian flu virus samples from WHO’s collaborating centers as leverage for a new global mechanism for virus sharing that had better terms for developing countries.    In breaking with the existing practice of freely sending flu virus samples to these laboratories, Indonesia expressed dissatisfaction with a system which obliged WHO member states to share virus samples with WHO’s collaborating centers, but which lacked mechanisms for equitable sharing of benefits, most importantly, affordable vaccines developed from these viral source materials.   The Indonesian decision, invoking provisions in the Convention on Biological Diversity (1992) for sovereign rights over biological resources, aroused indignation and accusations of irresponsibility which endangered global health.  There were however also expressions of support and sympathy, including an editorial from The Lancet:   To protect the global population, 6.2 billion doses of pandemic vaccine will be needed, but current manufacturing capacity can only produce 500 million doses.  Indonesia fears that vaccines produced from their viruses via the WHO system will not be affordable to them… In November 2004, a WHO consultation reached the depressing conclusion that most developing countries would have no access to vaccine during the first wave of a pandemic and possibly throughout its duration… The fairest way forward would be for WHO to seek an international agreement that would ensure that developing countries have equal access to a pandemic vaccine, at an affordable price.  Such a move would demonstrate global solidarity in preparing for the next pandemic (Lancet editorial, February 17, 2007).  

On March 29, 2007, immediately following an interim agreement for Indonesia to resume sending flu virus samples to WHO, health ministers of eighteen Asia-Pacific countries issued a Jakarta Declaration which called upon WHO “to convene the necessary meetings, initiate the critical processes and obtain the essential commitment of all stakeholders to establish the mechanisms for more open virus and information sharing and accessibility to avian influenza and other potential pandemic influenza vaccines for developing countries”.  These concerns were tabled at the 60th World Health Assembly in Geneva (May 14–23, 2007) as part of a resolution calling for new mechanisms for virus sharing and for more equitable access to vaccines developed from these viral source materials.    In the course of the deliberations, it emerged that WHO had not abided by the terms of the 2005 WHO guidelines on sharing of viruses which required the consent of donor countries before WHO’s collaborating centers could pass on the viruses (other than the vaccine strains) to third parties such as vaccine manufacturers.  While discouraging the use of material transfer agreements (MTAs) at the point when donor countries transferred their virus samples to WHO, WHO’s collaborating centers nonetheless resorted to MTAs when they transferred to third parties vaccine strains containing parts of the viruses supplied by developing countries such as Indonesia, Vietnam and China.  Indeed WHO’s collaborating centers themselves, as well as third parties, had sought patents covering parts of the source viruses used in developing vaccines and diagnostics.  Possibly the most contentious item on the health assembly’s agenda in 2007, the issue of virus sharing and access to avian flu vaccines remained unresolved until the final hours of the assembly when a resolution was adopted mandating WHO to establish an international stockpile of vaccines for H5N1 or other influenza viruses of pandemic potential, and also to draft new terms of reference for the sharing of influenza viruses.   The Indonesian government’s stance was notable on four counts:  

• it called into question a system that had worked satisfactorily in routinely transferring viruses to manufacturers which produced seasonal flu vaccines for markets in affluent countries, but whose (pre-)pandemic flu vaccines were beyond the reach of poorer communities 
• it was explicitly a critique of WHO’s balance of pragmatism which it felt was overly accommodative of corporate priorities and structural inequities, to the detriment of the health and wellbeing of underserved communities among its member states 
• it was an exercise of leverage by a source country of biological materials seeking to redress the inequities of access to what may be vitally important health inputs (avian flu vaccines) developed from these source materials 
• it was seeking equitable benefits from commercial developers not just for its nationals but for other communities as well who were likely to be sidelined by commercially-driven product development and distribution.

Global Health Security, or Global Public Health?

In April 2003, as the SARS pandemic was unfolding, Ilona Kickbusch, Professor of Global Health at Yale University’s School of Public Health lamented the weak enforcement mandate of international agencies such as the WHO for securing the cooperation of member states in safeguarding global health.  In parallel with “an incentive system for countries who act as responsible global citizens”, she issued an accompanying call “to explore sanctions by the UN Security Council, the WTO and the IMF for countries that do not adhere to global health transparency and their obligations under the IHR”.    Similar sentiments, couched in terms of health security and health policing, had been expressed about Indonesia’s refusal to dispatch H5N1 virus samples to the WHO’s collaborating centers.  In a strongly-worded op-ed in the Washington Post (August 10, 2008), Richard Holbrooke and Laurie Garrett castigated Indonesia’s “dangerous folly” as “morally reprehensible” actions of a recalcitrant state which jeopardized global health security (perhaps calling for humanitarian intervention?):  Here's a concept you’ve probably never heard of: “viral sovereignty.” This extremely dangerous idea comes to us courtesy of Indonesia's minister of health, Siti Fadilah Supari, who asserts that deadly viruses are the sovereign property of individual nations - even though they cross borders and could pose a pandemic threat to all the peoples of the world… Disturbingly, the notion has morphed into a global movement, fueled by self-destructive, anti-Western sentiments. In May, Indian Health Minister A. Ramadoss endorsed the concept in a dispute with Bangladesh. The Non-Aligned Movement - a 112-nation organization that is a survivor of the Cold War era - has agreed to consider formally endorsing the concept of “viral sovereignty” at its November meeting… Political leaders around the world should take note - and take very strong action.  

A year later in July 2009, as the H1N1 pandemic was unfolding amidst efforts to boost vaccine production, along with widespread concerns over supply limitations and distribution, Garrett belatedly acknowledged the essential point about “viral sovereignty”, that it was above all an exercise of sovereign leverage for more equitable access to lifesaving vaccines in a pandemic situation:   The Minister of Health of Indonesia, Dr. Siti Supari, has insisted for several years that it is not the duty of her country to share samples of H5N1 bird flu viruses.  Supari’s position all along has been that the drug companies will turn these viruses into vaccines, and then charge so much for their products that the poor countries will never be able to afford the life-saving products. What we now see unfolding with the H1N1 vaccine scenario would seem to validate her argument… when a pandemic comes, the rich world takes everything and saves itself (ScienceInsider, July 28, 2009).   Despite appeals to humanitarian solidarity   and to enlightened self interest, almost all of the first billion doses of H1N1 vaccine produced in 2009 were allotted to 12 wealthy nations which had made advance orders.  Sanofi Pasteur and GlaxoSmithKline pledged 120 million doses to the WHO for distribution to poor countries, but even those pledges could only be fulfilled months after the pandemic had waned.     In Mexico, the epicenter of the H1N1 pandemic where health authorities had promptly shared its viruses with WHO’s Global Influenza Surveillance Network (GISN), Health Secretary Jose Angel Cordova revealed that “we had to wait in the second line to buy the vaccine, because obviously the first shipments were for the countries that make the vaccine”.  With no domestic production capacity at the time, Mexican officials had ordered 30 million doses of the vaccine from Sanofi Pasteur and GlaxoSmithKline, most of which could be delivered only in February or March 2010.  Under the circumstances, they made an arrangement to borrow 5 million doses from Canada, as the pandemic waned in the northern hemisphere.  

Access to Pandemic H1N1 Vaccines:  A Worrisome Preview

As it turned out, the H1N1 pandemic peaked in October-November 2009 in the northern hemisphere, and it furthermore remained mild, more comparable in severity to the 1957 and 1968 pandemics than to the feared 1918 pandemic.    Many nations cut back on their vaccine orders, others attempted to sell off excess stock or pending deliveries as the threat perception receded and skepticism about the vaccines’ safety resurfaced among the general public.  France, for example, had ordered 94 million doses for its 65 million people and eventually tried to sell off 50 million doses of excess inventory.  In Britain, the government negotiated to reduce prior contracts for 90 million doses.  The United States had contracts to buy 251 million doses from five companies.  It reduced by 22 million doses an order of 36 million from CSL Ltd. http://www.csl.com.au/ an Australian manufacturer that fell behind on deliveries, while retaining the other orders.  As of early February 2010, only about 62 million doses had been administered to US residents.  There had been earlier controversies over the reluctance of US health authorities to deploy adjuvanted vaccines, i.e. vaccines with booster additives which could have doubled the available doses at a time when vaccine demand greatly exceeded vaccine supply.   In September 2009, President Obama’s administration had brokered an agreement with eight other wealthy nations (Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, and the United Kingdom) to donate ten percent of their vaccine supplies to WHO for use in poor countries, on top of the pledges by Sanofi Pasteur and GlaxoSmithKline. (Eventually, two additional countries and four more manufacturers came on board, raising the total pledges to 180 million doses of vaccine).  

As of early February 2010 however, only two of the 95 countries listed by WHO http://www.who.int/en/  as having no independent means of obtaining flu vaccines - Azerbaijan and Mongolia - had received any.  WHO had earlier planned to deliver vaccines to 14 of these countries by then, and even then shipments were adequate to protect only 2 percent of the countries’ populations.  Pledges and exhortations aside, few were really surprised that when faced with perceived national emergencies, countries that could afford vaccines prioritized their own nationals first, and only when the worst had passed, transferred their leftovers to the poor using the WHO as a clearinghouse.  

In the wake of the mild pandemic, WHO’s alert system for influenza pandemics also came under scrutiny.  Under WHO’s six-stage approach, the highest (pandemic) stage is declared when a new flu strain that spreads easily among humans and causes serious illness, shows evidence of sustained community level spread in at least two regions of the world.  The system however focuses more on transmissibility, while lacking an index of virulence or lethality.  This causes confusion among people who equate “pandemic” with a high death rate, usually measured by the “case-fatality ratio” (CFR, the ratio of deaths to infections).  In truth, the CFR is an unstable parameter in the early stages of a novel outbreak, since it is usually the fatalities and severe cases that come to early attention, thus inflating the CFR as an artifact of underreported mild or asymptomatic infections.   There were also allegations of scaremongering by parties with vested interests in vaccine manufacture and sales, squandering of scarce health resources and diversion of attention from more urgent priorities in global health.  Prior to the H1N1 pandemic, some researchers had already begun to question the efficacy of seasonal flu vaccines (Jackson 2005, Jefferson 2006).  

In any case, whether one felt cheated by or relieved at the mild course of the pandemic, it provided a valuable preview of likely scenarios for vaccine supply and timely access, in the event of a more virulent pandemic.  For developing countries, this dress rehearsal was uncomfortably close to the scenarios anticipated by Dr Siti Fadhilah Supari, the Third World Network, and others.    Resolution WHA60.28 in 2007 (“Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits”) was notable in declaring for the first time, at the highest levels of representative global health diplomacy, that affordable access to the benefits of virus sharing in such forms as vaccines, medicines, and diagnostics was the equitable quid pro quo of global virus sharing arrangements for pandemic alert and response.    Indeed the WHO Intergovernmental Meeting (IGM) on Pandemic Influenza Preparedness, a process mandated by WHA60.28, included by consensus the following paragraph in its draft framework for reforming the GISN :    Recognise that member states have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits considering these as equally important parts of the collective action for global public health.   In the absence of reciprocal benefits, the International Health Regulations (2005) in particular, which impose mandatory disease reporting obligations on signatory member states, could reduce poorer front-line states to the role of pandemic “canaries” in an early warning system for emergent flu pandemics.