PHM-Exch> Equitable Access to Pandemic Flu Vaccines

[Claudio Schuftan]

From: Chee-khoon Chan ckchan50 at yahoo.com

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*Equitable Access to Pandemic Flu
Vaccines**[1]*<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn1>
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*Chan* Chee Khoon

Center for Policy Research & International Studies

Universiti Sains Malaysia

*ckchan50 at yahoo.com<http://aa.mc335.mail.yahoo.com/mc/compose?to=ckchan50@yahoo.com>
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*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[2]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn2>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[3]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn3>
.  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[4]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn4>.




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”* [5]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn5>
*.  *



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 *(Science*Insider*, July 28,
2009).

* *

Despite appeals to humanitarian
solidarity[6]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn6>and
to enlightened self interest
[7]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn7>,
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”*[8]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn8>
.  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[9]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftn9>
:



*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.

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[1]<http://aa.mc335.mail.yahoo.com/mc/welcome?.gx=0&.tm=1269474215&.rand=b7kftp3e7u3cf#_ftnref1>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 )***



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