Memorandum by Professor Fidler, Indiana
University School of Law
This document contains responses to the Committee's
Call for Evidence on "Acting through Intergovernmental Organisations
to Control the Spread of Communicable Diseases." The Committee
should be aware that I am an international lawyer and not a scientist,
epidemiologist, or public health practitioner. My responses reflect
my area of expertise as an international lawyer with experience
working on global health issues, especially communicable disease
threats, and working with intergovernmental organizations, particularly
the World Health Organization. I have coded my responses to the
questions set by the Committee (eg, responses 1.1 and 1.2 address
Question #1), but, for space reasons, I have not included the
questions. I have limited my responses to the questions relevant
to my expertise and to the 6-page (A4) limit set by the Committee,
but I would be willing to provide further responses in writing
or travel to London to answer questions from the Committee.
1.1 The UK Department of Health was correct to
identify the unfounded nature of the post-war sense that industrialized
societies had conquered communicable diseases. The reasons for
this complacency are complex, but all countries, including developing
countries, are now paying a heavy price for it. Despite the progress
made since the mid-1990s in global health, the international system
has not yet achieved change that is sustainable. To paraphrase
Churchill, we have only reached the end of the beginning of mounting
adequate national and international responses to the threat posed
by communicable diseases.
1.2 Opining on whether the "global
situation" is deteriorating is difficult because we have
multiple "global situations" that reflect different
levels of progress, inertia, and deterioration. For example, HIV/AIDS
is a different kind of threat from avian influenza, so any progress
on HIV/AIDS does not necessarily translate into progress against
containing avian influenza and preparing for its possible genetic
shift into a killing microbial menace. The Committee needs to
disaggregate the global situation, examine the various types of
communicable disease threats, the capabilities of intergovernmental
organizations (IGOs) across these threats, and then reassemble
the pieces to get the composite picture. Talking in terms of a
crisis is not an exaggeration, and the scale and intensity of
efforts over the past decade underscore that a sense of crisis
has, and continues, to exist.
2.1 As an international lawyer, I am not trained
in epidemiology, so I cannot comment on the reliability of data
generated by national governments and IGOs. I can share some thoughts
on the political and legal aspects of data generation and use
concerning communicable diseases. From a public health perspective,
data collection and analysis (eg, as done in surveillance) forms
the basis for formulating and implementing interventions (eg,
vaccination, quarantine). Public health strives for evidence-based
measures, so reliable data gathered as frequently and comprehensively
as possible are critical. The acceleration of globalization has
made the need to accomplish this task domestically and internationally
ever more important. Achieving this objective politically and
legally in an international system of nearly 200 sovereign States
has proved, however, a very difficult task.
2.2 Globalization has helped revolutionize
the environment affecting communicable disease emergence and spread
by facilitating convergences of disease "vectors," such
as trade and travel, migration, antimicrobial resistance, and
social determinants of health (eg, poverty). Globalization has
not, however, had an equivalent impact on the structure and dynamics
of international politics and international law. We are chasing
the whirlwind of 21st century globalization with an international
system still tethered to 19th century patterns of State behavior
and cooperation. Caught in the middle are IGOs, such as WHO, which
appreciate the disease trends but remain accountable to sovereign
States and their interests.
3.1 The intergovernmental surveillance with
which I am most familiar is the WHO's Global Outbreak Alert and
Response Network (GOARN). GOARN's capabilities have grown impressively
since its establishment in the early 21st century, and the progress
made connects to WHO's strategy of making GOARN a "network
of networks," including information sources beyond governments.
Despite GOARN's development, this intergovernmental surveillance
capability remains inadequate because (1) WHO member States do
not fund it properly, and (2) underlying national and sub-national
surveillance systems on which GOARN ultimately relies, especially
in developing countries, still remain in poor condition.
3.2 Intergovernmental surveillance systems
exist at regional levels as well, such as in the EU, ASEAN, APEC,
and the Americas. Efforts to strengthen these regional systems
themselves, and how they integrate into GOARN, should be pursued
by individual governments, these regional organizations, and WHO.
4.1 Without more funding and sustained political
commitment from governments and IGOs, the development of global
surveillance and intervention capabilities could easily stagnate
and regress in the next 10 years. I already detect a growing sense
in non-health foreign policy circles that enough, for the moment,
has been done for global cooperation on communicable diseases,
and that other pressing issues (eg, global warming) deserve priority
attention. So much progress has been made that people unfamiliar
with global health's precarious evolution sometimes assume that
the challenge has been adequately met, not realizing that the
progress made does not get the international community where it
needs to be with respect to the communicable disease threat.
4.2 One pattern already conspicuous is the
growing gap between developed and developing countries in terms
of public health capabilities to address communicable diseases.
The likely continuation of this pattern will not only create epidemiological
holes in global capacities but also stimulate tensions between
rich and poor countries. We have seen these tensions arise in
the controversy over Indonesia's stance on withholding avian influenza
samples.
5.1 HIV/AIDS. Although some trends are positive
(eg, increasing numbers of persons infected with HIV in developing
countries receiving antiretrovirals), the scale of the pandemic
still beggars the imagination. The decrease in the rate of new
infections (if the data is reliable), still means the international
community has a massive, long-term problem on its hands. Looking
ahead, I see a number of potential problems: (1) funding levels
that plateau and begin declining; (2) continued lack of a breakthrough
on an HIV vaccine; (3) continued or accelerated "brain drain"
of health care personnel from developing to developed countries;
and (4) the emergence and rapid spread of resistant strains of
HIV.
5.2 Tuberculosis. I am most worried by the
prospects of the increased and accelerated spread of MDR-TB and
XDR-TB (still linked to the HIV/AIDS crisis) without development
of new TB antibiotics that are affordable and accessible in developing
countries.
5.3 Malaria. Potential obstacles to better
malaria control and prevention include (1) continued development
and spread of resistant forms of malaria; (2) lack of development
of affordable and accessible anti-malarial drugs; (3) lack of
sustained commitment to current effective initiatives, such as
the increases in distribution and use of bed nets in Africa; and
(4) multiplying challenges from other vector-borne diseases, such
as dengue fever, that may divert resources from anti-malarial
campaigns.
5.4 Avian influenza. Future challenges include
(1) resolving the standoff on sharing virus strains for surveillance
and vaccine development purposes; (2) continued weaknesses in
cooperation between animal and human health agencies nationally
and internationally; (3) tapering off of political interest in
pandemic influenza preparedness; and (4) signs of genetic drift
or shift causing countries to revert to narrow approaches to their
self-interests, which would undermine global cooperation.
5.5 Better intergovernmental cooperation.
"Better," "smarter," or "improved"
intergovernmental cooperation and action is often prescribed for
the challenges these four and other communicable diseases present.
Strengthened intergovernmental cooperation is not, however, a
panacea for these challenges. I doubt whether better or smarter
intergovernmental cooperation will remove the obstacles mentioned
above. The scale of these problems overwhelms intergovernmental
capabilities, the priorities of member States are too diverse,
and the rise of non-state actors (eg, Gates Foundation) may exacerbate
the on-going fragmentation of global health diplomacy.
7.1 I have been an advocate for giving global
health higher priority in States' foreign policies because communicable
and other disease problems require political commitment from more
than the public health sector. Without heightened political priority,
strategies against the four diseases will tend to drift back towards
technical, ad hoc, and reactive responses that will not address
underlying causes of the emergence and spread of communicable
diseases.
7.2 Intergovernmental action in non-health
areas is important, but, to the surprise of many in public health
not familiar with the history of intergovernmental efforts on
poverty reduction, population control, or climate change, the
track record of efforts on non-health issues is not typically
impressive. Framing non-health problems as health crises, as happens
more frequently today, only goes so far in generating greater
political interest in tackling the issues. In addition, to address
some underlying problems in an effective and sustainable fashion
would require regime change for public health in many countries,
a task that understandably makes foreign policy makers interested
in global health select less ambitious objectives.
7.3 More trans-intergovernmental cooperation
on communicable diseases occurs today than in the past, and this
"joined-up" thinking and action has produced benefits.
The elasticity of joined-up thinking within national governments
and between IGOs is not, however, as high as anticipated. Breaking
national ministries and IGOs out of their traditional policy "silos"
remains fraught with difficulties that limit what "joined-up"
governance can achieve. This low elasticity contributes to the
proliferation of more initiatives rather than consolidation of
activities into more centralized policy synergies within and between
governments.
9.1 The growing global TB problem has multiple
facets--the connection to the worldwide HIV/AIDS epidemic, the
breakdown of public health and health care systems in many countries,
the declining effectiveness of anti-TB drugs, and the failure
of strategies pushed by WHO (eg, DOTS) to be sustainable in many
countries. These facets, viewed collectively, should call into
question the assertion that TB is, in fact, a treatable disease.
This assertion assumes that conditions prevalent in industrialized
countries (eg, available drugs, functioning public health and
health care systems, social conditions that make sustained therapy
regimens work) exist or can easily be created in countries struggling
against TB.
9.2 Again, intergovernmental action is important,
but intergovernmental approaches against TB should be more intense
at the regional level, and not just at WHO. Diffusion of anti-TB
activities across regional organizations will become even more
important as regional spread of MDR-TB and XDR-TB occurs.
10.1 The impact of restrictions on the use
of DDT on malaria's spread started before 2004 because donor countries
and governments in malarial regions decreased funding and use
of DDT for anti-malarial control before adoption of the Stockholm
Convention. In addition, care must be taken in assigning causal
effect to the non-use of DDT in malaria's spread because other
factors have played significant roles as well (eg, misuse of anti-malarials,
failure to make effective use of bed nets, lack of funding for
anti-malarial programs, climatic changes encouraging spread of
mosquitoes to new areas). I am not aware of a risk assessment
that specifically compares the dangers to human health from DDT
use versus exposure to malaria.
11.1 WHO, in collaboration with FAO and
OIE, has worked to improve early detection of the transmission
of avian influenza from birds to humans. WHO has also worked with
WHO member States to improve surveillance on any potential human-to-human
transmission cases. Although not perfect, the extent of the surveillance
that does exist is, historically speaking, impressive, and these
IGOs should continue to deepen and broaden their collaborative
efforts on avian influenza surveillance.
11.2 This emerging early warning system
for avian influenza is not sufficient to prevent an influenza
pandemic. In fact, most public health experts would agree that
the chances of identifying and containing a pandemic virus with
the current system are very poor, which makes the developing global
surveillance system a resource for alerting national capabilities
for the potential spread of a dangerous flu virus. This dynamic
is what irks many developing countries—they share data that
only help developed countries use their superior resources to
protect themselves. The controversy over Indonesia's refusal to
share samples of avian influenza strains reflects these underlying
North-South tensions. More efforts need to address the lack of
response capabilities in developing countries.
12.1 Antimicrobial resistance has been a
major factor in the re-emergence of TB and malaria, but such resistance
has not yet been as significant with respect to HIV/AIDS and avian
influenza. Enough resistant strains of HIV and H5N1 have emerged,
however, to make the antimicrobial resistance nightmare a real
possibility with HIV/AIDS and avian influenza.
12.2 The problem of antimicrobial resistance
has risen in importance on intergovernmental agendas in the past
decade, and WHO supports a global effort against the threats posed
by antimicrobial resistance. Data suggest, unfortunately, that
intergovernmental efforts made to date have not had material impact
on reducing the threat of antimicrobial resistance in these four
diseases, and, worryingly, other diseases as well.
13.1 Intergovernmental efforts to address
antimicrobial resistance globally include the problem of hospital-acquired
infections. As illustrated by the problems with such infections
in Britain and the United States, most attention generated on
this issue has come from developed countries. Serious antimicrobial
resistance problems in developing countries concerning HIV, TB,
malaria, and avian influenza are not significantly related to
the spread of resistant microbes through hospital treatment. IGOs
have to set priorities on what antimicrobial resistance problems
they should address.
13.2 Although WHO might need to prioritize
antimicrobial resistance not related to hospital treatment, regional
IGOs (eg, EU, APEC, ASEAN) can improve their cooperation and information
flows about hospital-acquired resistant infections. One stumbling
block to this suggestion is the reluctance of countries to share
such data because countries are trying to attract "health
tourists" by offering cheaper, faster health and medical
services to a growing global market of health consumers.
14.1 I do a significant amount of work with
WHO on the relationship between health and trade. In this work,
many controversies in this relationship (eg, trade in health services,
application of sanitary and phytosanitary measures) have settled
down and given way to more constructive efforts at producing coherency
between trade and health policies. The one area that remains contentious
and unproductive involves intellectual property rights. Developments
in international trade law, particularly the proliferation of
regional and bilateral trade agreements containing TRIPS-plus
provisions, ensure that the controversies over the impact of patents
on access to medicines will continue unabated.
14.2 Despite the on-going controversies
involving intellectual property rights, care should be taken in
addressing just how much patents cause problems for global communicable
disease threats. For example, of the four diseases of most interest
to the Committee, patent concerns have arisen in HIV/AIDS (with
respect to antiretrovirals) and avian influenza (with respect
to patents and potential vaccine development), but not seriously
with TB or malaria. Patent controversies have not, however, prevented
massive increases in the availability of antiretrovirals in the
developing world, nor have patents, to date, materially undermined
treatment strategies for those infected with avian influenza.
Development of the next generation of drugs for TB and malaria
through public-private partnerships will probably not be hampered
by the kinds of intellectual property controversies that arose
with antiretrovirals.
14.3 Whether more intergovernmental action
on the patent issues is necessary depends on whether such future
action can break stalemated patterns in IGOs already established
over many years, in particular within WHO and WTO. More of the
same is, well, more of the same. As indicated above, the proliferation
of TRIPS-plus provisions in regional and bilateral trade agreements
has reduced the policy traction WHO and WTO previously had in
this area.
15.1 IGOs, especially the WHO, and national
public health agencies, such as the U.S. CDC, engage in programs
designed to improve the ability of transition and developing countries
to identify disease events, diagnose specific diseases, and undertake
effective interventions. I understand that more of these kinds
of programs are envisioned as part of the implementation of the
International Health Regulations 2005, thus ensuring robust intergovernmental
activity in this area for the foreseeable future.
15.2 The biggest problem is the mismatch
between the scale of the need for such improvements and the paucity
of resources made available to undertake these capacity-building
programs. WHO does not have sufficient resources to engage in
these activities on a sustainable basis, and many developed countries
have to expend serious resources to improve their own surveillance
and response systems after decades of neglect. For example, the
United States has spent much more on strengthening its own surveillance
and response systems than it has allocated to international assistance
for strengthening communicable disease surveillance and response.
Seeking more intergovernmental activity does not usually equate
to more resources for such activity, and IGOs, especially WHO,
typically are tasked to do more without increased access to resources.
15.3 Some big influxes of money into global
health have come from non-governmental sources, such as private
foundations, and the activities funded by these non-state actors
have not typically focused on building sustainable public health
infrastructure. In fact, many experts are concerned that the non-governmental
programs are cannibalizing public health systems in developing
countries (eg, through employing highly skilled medical and health
personnel) and producing even weaker public health infrastructures
in the very countries where stronger infrastructures are needed.
16.1 As my publications on the International
Health Regulations 2005 (IHR 2005) indicate, I believe that the
IHR 2005 are the most radical development in the history of the
use of international law on global health problems. I refer the
Committee to those writings for the details of why the IHR 2005
represent such a dramatic contribution to global health governance,
and I can provide a list of these publications if needed. The
global framework established by the IHR 2005 is impressive, but
its effectiveness has yet to be tested or proven.
16.2 In fact, the first major communicable
disease event implicating the IHR 2005—the Indonesian virus
sharing controversy—revealed confusion about the IHR 2005's
content and its relevance to this global health crisis. Attempts
by WHO and others to argue that the IHR 2005 required Indonesia
to share virus samples without conditions backfired because the
IHR 2005 do not mandate such sharing, as properly interpreted
under principles of treaty interpretation in international law.
16.3 In terms of future implementation of
the IHR 2005, the radical new framework will not function effectively
without significant improvements in national and sub-national
surveillance and response capabilities. The IHR 2005 can easily
end up as a piece of paper without more serious national and international
efforts to build public health capacity to the point most countries
can fulfill their obligations under the IHR 2005. Unfortunately,
the IHR 2005 neither contains a strategy for achieving this capacity
nor any mechanisms to fund capacity building. WHO does not have
access to the kind of resources needed, and non-governmental funding
entities have tended to show little interest in the kind of capacity
building implementation of the IHR 2005 require.
17.1 For my thoughts on the challenges related
to biosecurity, including analysis on how States, IGOs, and non-state
actors can improve global biosecurity, see David P. Fidler and
Lawrence O. Gostin, Biosecurity in the Global Age: Biological
Weapons, Public Health, and the Rule of Law (Stanford University
Press, 2008).
17.2 In brief, existing intergovernmental
and treaty approaches to biological weapons are in serious trouble
and are rapidly trying to adjust to the new threats biological
weapons and biological terrorism pose. The main treaty on biological
weapons, the Biological Weapons Convention (BWC), has been overtaken
by events, and its relevance for future strategies against biological
weapons and biological terrorism is in serious doubt. Part of
the doubt stems from the BWC's lack of provisions that address
the national and international needs to integrate arms control,
law enforcement, and public health capabilities into a coordinated
biosecurity strategy. Constructing this new kind of biosecurity
strategy will require, as we elaborate in Biosecurity in the Global
Age, the construction of a "global biosecurity concert"
that is not entirely dependent on the BWC or any one IGO.
18.1 The IHR 2005 are designed to prepare
WHO member States to be able to identify and address threats from
new or previously unrecognized communicable diseases, which is
another reason why the IHR 2005 are so important to global health
governance today. Attempting to deal with existing disease problems,
such as the four diseases of most immediate interest to the Committee,
and simultaneously remain prepared for unknown but anticipated
threats constitutes a tall order for governments and IGOs, which
causes strain in national and international public health systems
that remain under-funded and under-staffed.
20.1 The Committee needs to examine more
than IGOs because of the way in which global health governance
is evolving. To provide perhaps the most dramatic example, many
people now believe that the Gates Foundation is becoming the de
facto center of gravity for global health policy and funding,
eclipsing the traditional lead role of the WHO and even the historically
influential U.S. CDC. This example constitutes just one feature
of a rapidly changing context for addressing global health problems,
a context that is increasingly posing more and more difficult
challenges for IGOs.
20.2 Traditionally, States created IGOs
to help manage their relations in a condition of anarchy, a condition
in which States recognized no superior, common authority that
regulated their sovereignty. States and cooperative mechanisms
they created, such as IGOs, dominated this condition of anarchy.
Global health now faces a new kind of anarchy, what I have called
"open-source anarchy", in which State, intergovernmental,
and non-governmental actors access and influence global politics
on health in ways never before seen. The governance task now extends
beyond getting IGOs to function more effectively because non-state
actors play significant, and increasingly influential roles, in
global health, and especially with communicable disease issues.
24 February 2008
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