Re: "Developing Countries, Donor Leverage, and Access to Bird Flu Vaccines"
[for the unbroken links see the bottom of this post]
Economic
&
DESA Working Paper No. 41
ST/ESA/2007/DWP/
41
June 2007
Developing Countries, Donor Leverage,
and
Access to Bird Flu Vaccines
CHAN Chee Khoon and Gilles de
Wildt
Social Affairs
Abstract
In early 2007, the
Indonesian government decided to withhold its bird flu virus samples
from
WHO’s collaborating centres pending a new global mechanism
for virus sharing that had better
terms for developing countries.
The 60th World Health Assembly subsequently resolved to establish
an international stockpile of avian flu vaccines, and mandated
WHO to formulate mechanisms
and guidelines for equitable access
to these vaccines. Are there analogous opportunities for study
volunteers or donors of biological materials in clinical trials
or other research settings to exercise
corresponding leverage
to advance health equity?
JEL Classification: I18-Government
Policy; Regulation; Public Health
Keywords: avian flu vaccines,
global health equity, international health security, essential
medicines,
public patents
CHAN Chee Khoon, Sc.D., is with
the Health & Social Policy Research Cluster, Women’s
Development
Research Centre, Universiti Sains Malaysia, 11800 Penang, Malaysia.
He can be
reached at:
ckchan50@yahoo.com.
Gilles de Wildt,
M.D., is with the Jiggins Lane Medical Centre, Bartley Green,
Birmingham
B32 3LE, and: Medact (
www.medact.org), The Graystone
Centre, 28 Charles Square, London
N1 6HT, United Kingdom. He
can be reached at:
gillesdewildt@yahoo.com.
Comments should
be addressed by email to the authors.
Contents
Shifting
Alignments in International Health? ..........................
........................................................ 1
Commodification
and the Gift Relationship ....................................
............................................... 4
Reasserting
the Public Domain: Between Commons and Commodifi cation ......
.............................. 5
Donor Leverage and Trusteeship
Arrangements? ................................................
.............................. 7
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Developing Countries, Donor
Leverage, and Access to Bird Flu Vaccines
CHAN Chee Khoon
and Gilles de Wildt
Shifting Alignments in International Health?
On February 16, 2007, the Minister of Health of Indonesia
Siti Fadilah Supari informed senior World
Health Organization
(WHO) officials David Heyman (Assistant Director General for Communicable
Diseases) and Keiji Fukuda (Director for the Global Influenza
Program) that Indonesia would continue withholding its bird flu
virus samples from WHO’s collaborating centres pending 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, the health minister
expressed dissatisfaction with a system
which obliged WHO member
states to share virus samples with WHO’s collaborating centres,
but which
lacked mechanisms for equitable sharing of benefits,
most importantly affordable vaccines developed from
these viral
source materials by patent-seeking commercial entities:
Indonesia
will insist on a material transfer agreement before sending the
Indonesian strain
of bird flu virus to foreign laboratories
to prevent them from being used for commercial
purposes…We agree
to send the virus to the WHO with new conditions or mechanisms
approved by both parties as well as by other developing countries.
Until then, we won’t share
the samples…The organization [WHO]
sometimes forgets the good of the people in general
and we want
to change that…
Siti Fadilah Supari, Minister of Health, Indonesia
www.thejakartapost.com, February 17, 2007
(accessed on February
23, 2007)
A month later, the Indonesian government reiterated
its stance, reported thus by Th e Nation
(Bangkok) on March
15, 2007:
Indonesia will not share bird flu samples with the
World Health Organisation without a
legally binding agreement
promising the virus will not be used to develop an unaff ordable
commercial vaccine, the health minister said yesterday. Health
Minister Siti Fadilah Supari
said last month’s letter of guarantee
from WHO Director-General Margaret Chan was not
good enough.
“That’s just an agreement in principle” Supari said, [further
adding that] the
system, which enables influenza [virus] samples
to be freely passed throughout the global
community for public
health purposes, needs to be revised so it is “fair for developing
countries, poor countries, affected countries. We will not share
our virus sample without a change
in [WHO’s virus sharing] rules”.
Indonesia is worried that large drug companies will use its
H5N1 strain to make vaccines that will ultimately be unaffordable
for developing nations.
To consolidate regional support for
this initiative, a meeting of Asia Pacific developing countries
was
convened in late March 2007 to explore mechanisms for more
equitable access to vaccines produced from
virus sharing arrangements.
The Indonesian decision elicited unease, but also sympathy from
a cross-section
of the global community, including an editorial
from the Lancet:
2
DESA Working Paper No. 41
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. 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…Indonesia’s move to secure
an affordable vaccine supply for its population
is understandable…
the country has made a controversial decision not to share its
H5N1
virus samples with WHO. Indonesia is instead planning to
provide a US pharmaceutical
company [Baxter] with the strains
in exchange for technology to manufacture a pandemic
vaccine.
This strategy is a marked departure from the existing WHO virus-
sharing system,
in which influenza viruses are donated by countries
and flow freely to the global community
for vaccine development.
Indonesia fears that vaccines produced from their viruses via
the
WHO system will not be affordable to them. 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”1. These
proposals 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 violated the terms
of the 2005 WHO
guidelines2 on sharing of viruses which required
the consent of donor countries before WHO’s collaborating
centres
could pass on the viruses 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 centres 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
centres themselves, as well as third parties, had sought patents
covering parts of the source viruses used in developing vaccines
and diagnostics3. Possibly the most contentious item on the health
assembly’s agenda in 2007, the issue of virus sharing and access
to avian fl u vaccines
remained unresolved until the final hours
of the gathering when a resolution was adopted mandating WHO
to establish an international stockpile of vaccines for H5N1
or other influenza viruses of pandemic potential,
and to formulate
mechanisms and guidelines for equitable access to affordable pandemic
fl u vaccines4. Th e
1
Full text of the Jakarta Declaration
on Responsible Practices for Sharing Avian Influenza Viruses and
Resulting Benefi ts,
available at
http://www.indonesia-ottawa.
org/information/details.php?type=press_releases&id=122 (accessed
on 11
May 2007).
2
Avian and pandemic influenza: developments,
response and follow-up, and application of the International
Health
Regulations (2005) - Best practice for sharing influenza
viruses and sequence data. EB120/INF.DOC./3 (WHO
Executive Board,
120th session), 11 January 2007. Geneva: World Health Organisation.
3
TWN Information Service on Health Issues, 22 May 2007.
http://www.twnside.org.sg/title2/health.info/
twninfohealth090.
htm (accessed on May 23, 2007).
4
Pandemic influenza preparedness:
sharing of influenza viruses and access to vaccines and other
benefi ts. Resolution
WHA60.28, adopted at the 60th World Health
Assembly (Geneva, 23 May 2007)
http://www.who.int/gb/ebwha/
pdf_files/WHA60/A60_R28-en.pdf (accessed on May 29, 2007).
Developing Countries, Donor Leverage, and Access to Bird Flu
Vaccines
resolution also requested a WHO working group to
draft new Terms of Reference (TORs) for WHO collaborating centres
and its H5 reference laboratories for the sharing of influenza
viruses, to be submitted to a
special intergovernmental meeting
of WHO member states.
The Indonesian standoff with WHO came
on the heels of Director-General Margaret Chan’s
admonishment
to the Thai Ministry of Public Health in February 2007 over the
issuance of compulsory
licenses for HIV/AIDS and heart medications5.
In the course of a visit to the National Health Security Office
in Bangkok, she had publicly urged the Thai health authorities
to seek instead a negotiated compromise
with pharmaceutical
companies over high drug prices. This perceived tilt drew strong
criticism from health
advocates in Thailand and elsewhere who
pointed out that the Thai Ministry of Public Health “has been
in
regular contact with the industry over high prices of its
drugs in Thailand, but these negotiations have led
nowhere.
The best price for originator’s efavirenz is still twice the price
available from Indian generic sources
(US$500 per patient a
year vs $224). The best offer for originator’s lopinavir/ritonavir
is $2000 per patient
a year, five times more than WHO’s estimate
of manufacturing costs. Th e Thai Ministry of Health estimates
that the price of clopidogrel would fall by over 90% if made
generically. These are substantial price diff erences in a country
where the average annual wage is $1400 a year” 6.
It is unclear
whether these episodes amount to tactical shifts, let alone a
more fundamental re-alignment between WHO, member states, corporate
actors, and health activists on the issue of access to essential
medicines. Th e ramifications are clear however for the interlinked
concerns of global health equity and
international health security.
The Indonesian government’s stance in particular was notable
on three counts:
•
it was explicitly a critique of WHO’s
balance of pragmatism which it felt was overly accommodative of
corporate priorities7, to the detriment of the health and wellbeing
of a key constituency
that WHO was mandated to defend, the 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 fl u vaccines)8 developed
from these source
materials
5
WHO raps compulsory licensing plan: Govt urged
to seek talks with drug fi rms. (The Bangkok Post, 2 February
2007)
available at
http://lists.essential.org/pipermail/ip-health/
2007-February/010493.html (accessed on April 2, 2007);
compulsory
licenses issued in January 2007 by the Thai Ministry of Public
Health for a heat-stable formulation of
Kaletra (anti-retroviral)
and Plavix (clopidogrel, anti-platelet drug) are posted at http:/
/www.cptech.org/ip/health/c/
thailand/ (accessed on April 2,
2007).
6
P Cawthorne, N Ford, J Limpananont, N Tienudom
& W Purahong. 2007. WHO must defend patients’ interests,
not
industry. Lancet 369: 974-975.
http://www.thelancet.com/journals/
lancet/article/PIIS0140673607604735/fulltext
(accessed on April
4, 2007).
7
Th e Third World Network (TWN) has also criticised
WHO’s “best practice” guidelines for sharing of virus samples,
pointing out that a well-meaning non-profi t modus operandi
expected of national influenza centre laboratories, WHO
collaborating
centres and H5 reference laboratories, along with an expectation
that candidate infl uenza vaccine
strains be provided gratis
to any vaccine producer requesting for such materials, would undercut
the leverage of source
countries in negotiating for fair benefit-
sharing in line with the Convention on Biological Diversity’s
principles of
access, prior informed consent and benefit-sharing.
(“Winners and losers in the sharing of avian fl u viruses”. TWN
Information Service on Health Issues, May 11, 2007)
http://www.
twnside.org.sg/title2/health.info/twninfohealth089.
htm (accessed
on May 12, 2007).
8
In April 2007, the US Food & Drug
Administration approved the first human vaccine against H5N1 avian
infl uenza.
This pre-pandemic vaccine, approved for people aged
18 to 64 years, is administered in two doses separated by a
month’s interval. Th e efficacy of 45 per cent (protective levels
of antibody response among half the trial subjects) is
quite
modest but would still have an impact on population health if
the protective effect extends as well to the actual
pandemic
viral strain.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01611.
html (accessed on May 24, 2007).
4
DESA Working Paper
No. 41
•
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 systems
Commodification
and the Gift Relationship
These developments call to mind
The Gift Relationship, a study of blood donation systems in the
US and UK
published by Richard Titmuss, a pre-eminent figure
of UK social policy at the London School of Economics
and Political
Science. In this 1970 classic9, Titmuss demonstrated that a blood
donation system relying on
unpaid donors and operated on a non-
commercial basis by the public sector (UK) outperformed a system
relying largely on paid donors (in cash or in kind) and on profit-
driven processing and distribution (US), by
the criteria of
availability and affordability, quality and safety, and economic
effi ciency and equity.
That of course was pre-Thatcherite
Britain. With the prevailing (and still tenacious) ethos of neoliberalism,
donors of biological materials which might eventually yield commercially
profitable products not
surprisingly come to expect a share
of the financial gains made possible by their donated materials.
John Moore v. The Regents of the University of California
(1990) for instance was a celebrated case of a
leukemia patient
who underwent surgery in 1976 at the University of California
for removal of his cancerous
spleen. The University of California
was later granted a patent for a cell line called “Mo” established
from
his spleen, which produced valuable proteins [cytokines,
including ones which mediate antibacterial and
cancer-fi ghting
activity] with a long-term commercial value estimated at over
one billion dollars. Moore fi led
suit and demanded the return
of the cells and control over his body parts, but the California
Supreme Court
ruled that he was not entitled to any rights to
his own cells after they had been removed from his body10.
This principle was re-affirmed in the New Jersey state legislature
in 1996 when it enacted legal protections against genetic discrimination
in employment and in health insurance. This same legislature however
also rejected a draft clause which would have declared individual
genomic information to be individual,
private property, which
prompted George Annas, professor of law and public health at Boston
University to
remark that it was “bizarre that other people
can own your genetic information [and body parts], but you
can’t”11.
A neo-liberal environment thus tends to undermine altruistic
(gifting) inclinations, encouraging
instead pecuniary if not
mercenary tendencies among donors who might otherwise be disposed
towards voluntarism, communitarian practices and the common good.
Bluntly put, “if researchers and their commercial
sponsors
are going to enrich themselves using my biological samples and
personal data, why shouldn’t I get
my share of it?” Publicly
supported charities however such as Cancer Research UK notably
continue to allow
free use of its research output (such as the
patented breast cancer gene BRCA2) by publicly-owned laboratories
and hospitals12.
9
Richard M. Titmuss. 1970. The Gift
Relationship: From Human Blood to Social Policy. London: LSE Books
(republished
in 1997, with additional chapters, edited by
Ann Oakley and John Ashton).
10
John Moore v. The Regents
of the University of California, Supreme Court of California:
51 Cal. 3d 120, 793 P.2d 479,
271 Cal. Reporter. 146 (July
9, 1990).
11
Nature, November 21, 1996.
12
Susan Major.
2004. Charity makes cancer gene freely available across Europe.
BMJ 328: 423 (21 February, 2004).
Developing Countries,
Donor Leverage, and Access to Bird Flu Vaccines
Reasserting
the Public Domain: Between Commons and Commodification
Edward
R. Murrow (reporter): Who owns the patent on this [polio] vaccine?
Jonas Salk: Well, the people, I would say. There is no patent.
Could you patent the sun?
12 April 1955, Ann Arbor, Michigan13
In the 1990s, Rural Advancement Foundation International
(RAFI, now the Action Group on Erosion,
Technology and Concentration,
ETC) together with a network of indigenous peoples support groups
proposed an international campaign aiming at a formal Declaration
of a Global Genetics Commons. Sir
John Sulston (2002 Nobel laureate
in medicine or physiology) endorsed a very similar idea, which
sought a
declaration of the human genome as the common heritage
of humanity and for its DNA sequences to be off
limits to patents
and intellectual property claims.
In the event, the idea was
shelved, in part due to the realisation that even if genomic DNA
sequences were not patentable, downstream technologies arising
for example from transcriptomics and proteomics
could still
be subject to intellectual property claims14.
Was the patenting
of body parts and genetic information part and parcel of an unavoidable
trend
towards the commodification of life forms then?
A
middle path which accepts intellectual property claims on these
biological entities but which ensures that these are retained
within the (international) public domain (vested for example in
trustee institutions which are mandated to serve the public good
on an equitable needs basis) is one option which may be
worth
exploring. Indeed the Convention on Biological Diversity (1993)
, in recognizing the sovereign rights
of countries over their
biological and genetic resources, enshrines one form of this principle.
In the US, it would be appropriate to reappraise the Bayh-
Dole Act (1980) and the Stevenson-
Wydler Act (1980) which markedly
altered the balance between public versus private claims on intellectual
property arising from publicly-funded research. Prior to 1980,
patentable findings arising from federally
funded research
became the intellectual property of the US federal government
which was vested in public
agencies such as the National Institutes
of Health.
13
Jane S. Smith, in her book Patenting the Sun:
Polio and the Salk Vaccine (New York: William Morrow & Company,
Inc. 1990, p. 305-312) records that Jonas Salk made these oft
quoted remarks during a televised interview to announce
the
results of successful population trials of the killed-virus polio
vaccine. Cynics, and Salk’s detractors have pointed
out that
lawyers for the March of Dimes foundation (his research funders)
had earlier determined that no part of his
vaccine procedure
was new and could be patented. But that misses a point - would
Salk (or the March of Dimes)
have gone for a patent under the
present more relaxed patent regimes, most importantly, the landmark
US Supreme
Court decision in Diamond v. Chakrabarty (1980) to
allow the patenting of life forms, the Bayh-Dole (1980) and
Stevenson-Wydler (1980) Acts, John Moore v. The Regents of the
University of California (1990), all contributing towards
the
enabling legal environment for the rapid expansion of profit-driven
biotechnology. Rather than just focus and
speculate on Salk’s
moral core, perhaps one should also ask what alternative enabling
environments would help tilt the
balance between public vs.
private claims on publicly-funded intellectual property, to advance
health equity and the
public good? We are left pondering, for
instance, what John Moore might have done if he were presented
with various
hypothetical scenarios for disposition of benefits
arising from his cells.
14
A situation might arise for instance,
akin to the following analogy which unfairly privileges those
in possession of
advanced means of exploiting “global commons
resources”: I have a sophisticated technology which can mine this
exotic mineral found within your borders. Insofar as you cannot
extract it yourself, you deserve no part of the benefi ts
from
my successful exploitation of this mineral, which should be considered
a “commons resource” in the “global
public domain”.
6
DESA Working Paper No. 41
The Bayh-Dole Act (1980) in
essence transferred these rights to federally-funded research
grantees and their institutions for commercial development. The
Stevenson-Wydler Act (1980) required federal
agencies to transfer
technology in their possession to state and local governments
and to the private sector
for commercial development, albeit
subject to certain march-in rights (such as compulsory licenses)
which
could be exercised by governmental authorities in times
of urgent public need or national emergencies. Th ese
march-
in rights applied to both Bayh-Dole and Stevenson-Wydler, but
the Acts also provided for royalties
from commercialisation
to be shared with the inventor as an incentive for useful innovations.
In 2003, US Congressman Dennis Kucinich announced that he
intended to introduce legislation
“that would create a new network
of government labs for the research, development and manufacture
of
pharmaceutical products and biologics… When discoveries are
made, the patents would be held by the government and nonexclusive
licenses would be attached to them. This would allow companies
to compete to
manufacture pharmaceutical products, just like
generic drug companies do now. This would radically bring
down
the cost of drugs [and would also] increase the affordability
of cures worldwide… We have watched
the pharmaceutical industry
fail on three counts: submitting fewer and fewer drugs to FDA
for approval,
creating “copycat” drugs instead of truly new
cures, and raising drug prices higher every year. Our current
patent system is what encourages artificial improvements and
keeps prices high. It seems clear that one of the
keys to public
health is establishing public patents” 15.
Kucinich’s initiative,
an admirable but uphill struggle, would entail a rolling back
of some aspects of
the Bayh-Dole and Stevenson-Wydler Acts.
A less ambitious strategy has been proposed by researchers at
Yale
and University of Pennsylvania which urges US research
universities to adopt open licensing practices, what
were referred
to as Equitable Access Licenses16.
Five years ago, one of
us (CCK) participated in European Commission (EC) grant review
panels for
EC-funded collaborative research between EU and Asian
countries. A suggestion was made that the intellectual property
arising from the projects under review could perhaps be vested
in, say WHO, as an example of
an international public agency,
to keep the intellectual property within the international public
domain. In
such a scenario, WHO could for instance license these
patents on a nonexclusive basis for product development so that
useful and affordably-priced generics could be produced in a competitive
environment. (For
that to happen however, WHO would have to
regain its credibility among developing countries, eroded
in
the aftermath of the 60th World Health Assembly in May 200717,
and achieve a better balance between
profit-driven production
of essential medicines, and equitable access to these products.
Absent this, the International Health Regulations 200518, which
came into force in June 2007 and imposes mandatory disease
reporting
obligations on signatory member states, could reduce poorer front-
line states to the role of pandemic “canaries”19 in an early warning
system for emergent fl u pandemics).
15 Dennis J. Kucinich.
The Case for Public Patents. Th e Nation (New York), June 19,
2003.
16 S Chaifetz, DA Chokshi, R Rajkumar, D Scales, Y
Benkler. 2007. Closing the access gap for health
innovations:
an open licensing proposal for universities. Globalization and
Health 3: 1 (posted 1 February 2007).
http://www.globalizationandhealth.
com/content/3/1/1 (accessed on April 2, 2007).
17 WHO shaken
up by delegates’ criticisms on IPR issues.
http://www.twnside.
org.sg/title2/health.info/
twninfohealth091.htm (accessed
on May 24, 2007).
18 International Health Regulations (2005)
http://www.who.int/gb/ebwha/pdf_fi les/WHA58/WHA58_3-en.pdf
(accessed on June 17, 2007).
19 Canaries, which were exquisitely
sensitive to low levels of carbon monoxide, were early warning
systems for coal miners
confronted with risks of underground
methane and mine explosions (or mine fires), and the resultant
carbon monoxide.
Developing Countries, Donor Leverage,
and Access to Bird Flu Vaccines
The modest fees that WHO could
earn from this nonexclusive licensing could perhaps further yield
a small bonus by lessening the dependence of the institution
on donor governments (and corporate donors),
and hence expand
the latitude for its independent role in international health
policy advising and technical
support. The recent episodes between
ASEAN governments and WHO, over access to essential medicines,
arguably underscore the importance of independent sources of
revenue for WHO.
Donor Leverage and Trusteeship Arrangements?
Set in this context, the Indonesian initiative on new virus
sharing arrangements is therefore noteworthy and
its exercise
of donor leverage20 may presage a consideration of trusteeships
which could serve as public (international or regional) repositories
of genetic resources, genomic information, and other biological
materials.
The Asian financial crisis in 1997 gave impetus
to a regional effort at managing fi nancial instability
caused
by volatile capital flows and speculative currency attacks. Recognizing
the increasing integration of
East and Southeast Asian economies,
a Chiang Mai Initiative21 emerged in May 2000, initially as a
network
of bilateral swap agreements among ASEAN+3 member states22,
which might yet evolve into a de facto Asian
Monetary Fund
following a May 2007 decision to multi-lateralize an $80 billion
pool of foreign exchange
reserves of ASEAN+3 member states23.
Beyond the risk of financial contagion in globalized capital
markets,
the SARS epidemic of 2002-2003 forcefully demonstrated
the regional economic consequences of a lifethreatening infectious
epidemic24, effects which would pale in comparison with the devastating
human and
economic impact of an outbreak of highly transmissible
and lethal human flu on the scale of the 1918-1919
pandemic25.
Notwithstanding the resolution adopted at the 60th World
Health Assembly requesting WHO to
establish an international
stockpile of vaccines for H5N1 or other influenza viruses of pandemic
potential,
the limited vaccine production capacity globally,
not to mention the financial needs for establishing and
maintaining
a stockpile of adequate size, are key issues that remain to be
addressed. A persuasive case could
therefore still be made that
ASEAN+3 might provide a potential institutional framework for
mobilizing the
financial and technological resources in the
region to enhance regional preparedness and response capabili
20
Donor leverage could be thought of as a conditional form
of the gift relationship. We are familiar with donor leverage
in another context, viz. the conditional gifting of the Gates,
Soros, Rockefeller, Ford and other foundations, not to
mention
the conditionalities of bilateral and multilateral aid. On the
other hand, a commons perspective on biological
or genetic resources
is often expected of donors, be they countries, communities, or
individuals (i.e. an unconditional
gift relationship). In truth,
the difference is more a matter of degree - even the gifting
in the Titmuss sense carries with
it an implicit understanding
or expectation or condition that the donated blood is not to be
processed and distributed
for commercial gain. Th e difference
therefore relates more to “hard” (formal, codified) as opposed
to “soft” (informal,
ethical and moral pressure) enforcement
of conditionalities.
21
Wang Seok-Dong. 2002. Regional Financial
Cooperation in East Asia: the Chiang Mai Initiative and Beyond.
Bulletin on Asia-Pacifi c Perspectives 2002/03. Asia-Pacifi
c Economies: Sustaining Growth Amidst Uncertainties. Bangkok:
UNESCAP.
22 ASEAN (Brunei, Cambodia, Indonesia, Laos, Malaysia,
Myanmar, Philippines, Singapore, Thailand, and Viet Nam)
plus
3 (China, Japan, South Korea).
23 ASEAN+3 agree to cash swap
scheme / Countries to pool reserves for stability. (The Yomiuri
Shimbun online, May 6,
2007)
http://www.yomiuri.co.jp/dy/business/
20070506TDY01003.htm (accessed on May 7, 2007).
24 E. X. Fan.
2003. SARS: economic impacts and implications. ERD Policy Brief
No. 15, Asian Development Bank,
Manila.
25 G. Kolata. 1999.
Flu: The Story of the Great Influenza Pandemic of 1918 and the
Search for the Virus That Caused It.
New York: Farrar Straus
& Giroux.
8
DESA Working Paper No. 41
ties in a
likely epicentre of an emergent flu pandemic. This would go beyond
the existing co-ordination of
surveillance networks to include
the development and acquisition of vaccine manufacturing capabilities,
to
augment regional stockpiles of avian flu vaccines which
can be made available as public goods on a priority
needs basis.
Beyond the immediate concerns of timely and affordable access
to pandemic flu vaccines, the Indonesian initiative has also raised
the intriguing possibility of other analogous instances where
individuals or
groups of donors of biological materials and
personal data could utilize the leverage of their gift relationship
in clinical trials or other research settings in furtherance
of the common good (rather than succumb to mercenary tendencies
encouraged by a neo-liberal ethos).
Anecdotal evidence suggests
that individuals or groups volunteering in drug trials or human
genome
research are usually unaware of the potential commercial
trajectories of downstream product development
involving patenting
of products or processes derived from the donated materials and
personal information.
These commodities could be prohibitively
expensive for many end-users, as well as disruptive for follow-
on
research. Even health professionals involved in the recruitment
of volunteers and the execution of the study
may not be adequately
aware of these eventualities. The rules of the US Food and Drug
Administration
(FDA) for instance provide for minimum standards
for pharmaceutical research conducted locally or abroad,
with
an informed consent protocol which refers in very general terms
to “benefits to the subject or to others
which may reasonably
be expected from the research”26. The Declaration of Helsinki
on biomedical research
ethics (World Medical Association general
assembly, 1964; amended 2000)27, sensitive to the vulnerability
of
patients seeking or undergoing treatment, reiterates “the
right [of patients] to abstain from participation in
the [proposed]
study or to withdraw consent to participate at any time without
reprisal”.
We look forward to a time when research volunteers
will be able to specify (elect for) prior conditionalities for
their participation in studies. These might range from good faith
efforts to deploy the research
output in a manner which serves
the public good, to more explicit mechanisms aimed at equitable
benefi ts
on a needs basis.
To that end, we are planning
to undertake a survey of clinical trial volunteers (and potential
volunteers) to canvass their attitudes towards donation of biological
materials and personal information under
various hypothetical
scenarios for benefit apportionment or disposition. Related to
this, we are also keen to
explore trusteeship arrangements28
as repositories for retaining intellectual property (IP) in the
public domain, IP arising from publicly-funded biomedical and
health research and involving biological materials and
personal
information freely donated by individual study subjects or communities.
26 US Food and Drug Administration. Good Clinical Practice;
protection of human subjects. Section 50.25: Elements of
informed
consent.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?fr=50.25 (accessed on May
24, 2007).
27
World Medical Association. Declaration of Helsinki.
http://www.
wma.net/e/meetings/fulltext.htm#helsinki (accessed
on May
24, 2007).
28 We are grateful to Cristina Blohm and Jurgen
Simon of Universität Lüneburg for sharing with us their pre-publication
manuscript ‘Group Consent in Population-based Research’ which
included an exploration of various scenarios for
trusteeship
arrangements.
Developing Countries, Donor Leverage, and
Access to Bird Flu Vaccines
In summary, we intend to, and
we seek potential collaborators to:
•
examine the possibilities
for conditional participation by volunteers in clinical trials
•
conduct a survey of attitudes among clinical trial volunteers
and potential volunteers, in regard
to donation of biological
samples and personal information, under various specified scenarios
of
participation in clinical trials
•
explore possible mechanisms
for operationalizing conditionalities in the recruitment, enrolment,
consent, participation, and donation of information and samples
by volunteers in clinical trials
•
explore possible trusteeship
arrangements to serve as repositories for retaining in the public
domain intellectual property arising from publicly-funded biomedical
and health research which
may involve biological materials and
personal information freely donated by individual study
subjects
or communities.
links:
http://lists.essential.org/pipermail/ip-health/2007-February/010493.html
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.25
http://www.cptech.org/ip/health/c/thailand/
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01611.html
http://www.globalizationandhealth.com/content/3/1/1
http://www.indonesia-ottawa.org/information/details.php?type=press_releases&id=122
http://www.twnside.org.sg/title2/health.info/twninfohealth090.htm
http://www.twnside.org.sg/title2/health.info/twninfohealth091.htm
http://www.twnside.org.sg/title2/health.info/twninfohealth089.htm
http://www.un.org/esa/desa/papers
http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_R28-en.pdf
http://www.who.int/gb/ebwha/pdf_files/WHA58/WHA58_3-en.pdf
http://www.wma.net/e/meetings/fulltext.htm#helsinki
subscription required:
http://www.thelancet.com/journals/lancet/article/PIIS0140673607604735/fulltext
japanese:
http://www.yomiuri.co.jp/dy/business/20070506TDY01003.htm
