On October 5, 2004, the United States lost
half of its anticipated influenza vaccine supply when the
United Kingdom suspended the manufacturing license of the
Liverpool, England facility of California-based Chiron Corporation.
Chiron was to produce between 46-48 million doses of influenza
vaccine for the United States.
The U.K. government stopped production
because it identified bacterial contamination in vaccine
This development triggered a crisis for
U.S. federal and state public health officials, who are
trying to direct the remaining supply of influenza vaccine
to people most in need.
Events like this, involving influenza vaccine
supplies, raise potential issues under international law.
Fears Concerning Influenza and the Importance of Vaccines
Influenza poses a public health problem
for developed and developing countries. Influenza annually
kills approximately 36,000 people in the United States and
between 250,000 and 500,000 worldwide.
In addition to the seasonal threat, health
officials have warned about the emergence of a pandemic
of virulent influenza that could kill millions worldwide.
The 2004 epidemic of avian influenza
A (H5N1) in Asia again rang alarms about the dangers influenza
poses to global public health.
As the Director of the U.S. Centers for
Disease Control and Prevention put it, "A time bomb is ticking."
Vaccines are one of the most effective
and cost-efficient interventions against influenza.
As a result, public health experts advocate
greater vaccine use in all regions of the world. In the
absence of adequate supplies, governments would have to
ration vaccine, bear the increased costs and burdens of
treating influenza patients in health care facilities, and
perhaps utilize non-medical interventions (e.g., isolation
of patients and increasing "social distance" by suspending
public gatherings and schools).
According to the World Health Organization
(WHO), current global manufacturing capacity for influenza
vaccines "is finite and inadequate."
Over 90% of world production of influenza
vaccines is located in North American and Europe, home to
less than 10% of the world's population.
This situation creates problems for maintaining
or increasing vaccine use to address seasonal epidemics
and represents a dangerous context in the event of pandemic
influenza. The crisis in the United States caused by the
suspension of Chiron's license demonstrates the fragility
of global vaccine production capabilities even for developed
and International Law
Historically, international law norms and
processes created directly for control of infectious diseases
did not apply to influenza. The main international legal
framework for infectious disease control, the International
Health Regulations (IHR), originally promulgated by WHO
in 1951, has never included influenza as a disease subject
to its rules. Instead, WHO established in 1952 a WHO Influenza
Surveillance Network to identify influenza strains that
would most likely spread in the next influenza season. The
identified strains then become the basis for the production
of influenza vaccines by pharmaceutical companies.
Concerns about the inadequacy of global
vaccine production capacities for seasonal epidemics or
a pandemic have stimulated proposals for building a global
regime to ensure increased vaccine supplies, more stable
vaccine production, and more equitable distribution of vaccines
in time of need.As
a result, issues are raised that implicate international
law. These issues divide into measures to increase global
vaccine supplies and responses to influenza epidemics or
pandemics when vaccine supplies are inadequate.
Increasing global vaccine supplies
Public health experts have warned for years
that efforts to increase the scale and stability of influenza
vaccine production are needed. Presently, global "manufacturing
capacity is sufficient to cover less than 5% of the world's
Increasing vaccine supplies involves
action at the national level to increase demand for influenza
vaccines (e.g., by educating people of the importance of
vaccination) and incentives for more pharmaceutical companies
to produce vaccines (e.g., reducing the costs companies
have to bear from regulatory approvals and vaccine-related
experts believe, however, that ad hoc, uncoordinated national
efforts will not adequately address the problem. Thus, a
global strategy is required.
Through binding and non-binding international
instruments, the tasks of increasing and stabilizing global
vaccine supplies have to address a number of challenges,
. Greater incentives for pharmaceutical
companies to manufacture more influenza vaccine are needed,
which could involve commitments to increase national demand
through vaccine awareness campaigns and to contribute to
influenza vaccine purchasing funds. Boosting
demand and providing credible, stable purchasing commitments
would increase the financial attractiveness of influenza
vaccine manufacturing to existing pharmaceutical companies
and perhaps attract new manufacturers to the market.
. According to WHO, increasing the number
of vaccine manufacturers, particularly in the developing
world, will require "[a] global approach to the sharing
of intellectual property rights."
Formal or informal international instruments
would be needed to create global access to patented technologies
that are important to new ways to develop vaccines, such
as reverse genetics.
. Internationally coordinated research
and development efforts are needed to advance vaccine-production
methods from current egg-based techniques to more modern
approaches, such as cell-culture technology, that may shorten
production times, increase doses produced, and reduce manufacturing
. Global harmonization of biosafety requirements
for vaccine development and manufacture will facilitate
safer and more rapid vaccine production, particularly when
influenza creates public health crises, as would occur with
The construction of a global regime to
increase and stabilize influenza vaccine production would
be an unprecedented public health undertaking. Non-binding
instruments, such as WHO recommendations, may suffice for
encouraging countries to increase national demand for influenza
But creating purchase funds, establishing a
global approach to intellectual property issues, and harmonizing
biosafety regulations involve tasks that might require the
negotiation of treaties at regional and/or international
Increasing global vaccine supplies would
also face political and economic obstacles, including competition
for attention and resources created by other infectious
disease problems, such as fighting HIV/AIDS and defending
Responding to influenza when vaccine
supplies are inadequate
Public health officials stress the importance
of countries preparing for influenza epidemics and pandemics
when vaccine supplies are insufficient. Responding to influenza
epidemics or pandemics in the context of vaccine shortages
implicates international law in various ways.
Influenza vaccine shortages and the revision of the IHR
In November 2004, intergovernmental negotiations
will begin on WHO's proposed revision of the IHR.
WHO has proposed changes to the international
legal framework on infectious disease control that would
bring serious influenza epidemics or pandemics within the
scope of the new rules. WHO's proposal includes authority
for WHO to issue recommendations with respect to public
health emergencies of international concern.
Disruption or shortages of influenza
vaccine during seasonal epidemics or pandemics could contribute
to, or itself constitute, a public health emergency of international
concern, triggering WHO's recommendatory authority on what
measures WHO member states should take to address the consequences
of restricted vaccine supplies.
Further, the IHR revision would obligate
WHO member states to develop and maintain adequate public
health capabilities to identify and address public health
emergencies of international concern;
these obligations would cover epidemic
and pandemic influenza preparedness and response capacities.
Failure to engage in influenza planning, particularly for
scenarios when vaccine supplies might be scarce, could constitute
a breach of obligations under the revised IHR.
Exchange of information concerning
influenza vaccine production problems
According to the U.S. Food and Drug Administration,
the U.K. government's suspension of Chiron's manufacturing
license came as a surprise.
The U.K. government acted to locate other
sources of vaccine supplies before it suspended Chiron's
Advance notice of the seriousness of the problems
at Chiron's facilities may have provided the U.S. government
more time to craft a strategy for addressing influenza with
reduced vaccine supplies. Establishing procedures to facilitate
improved information flows between vaccine-exporting and
vaccine-importing countries through non-binding memoranda
of understanding or binding agreements could enhance importing
countries' efforts to address vaccine shortages caused by
Vaccine rationing among countries when shortages occur
International public health experts are
worried that influenza vaccine shortages may trigger a process
of rationing supplies among countries that is inequitable,
particularly for developing countries that have no vaccine
production facilities. In the context of pandemic influenza,
WHO has warned that "[c]ountries without manufacturing capability
will face the most acute vaccine shortages, as countries
with manufacturing capacity can be expected to reserve scarce
supplies for their own populations."
Agreements or arrangements between vaccine-exporting
countries and vaccine-importing countries may be needed
to ensure that, in contexts of vaccine shortages, rationing
of available stocks takes into account the needs of all
affected nations, not just those states in whose territory
production facilities are located.
Shortages, or the threat of pandemic influenza,
may force governments to nationalize foreign-owned manufacturing
facilities in their territories,
perhaps triggering consequences under
expropriation provisions of regional or bilateral investment
Vaccine shortages may cause other transnational
effects that potentially implicate international law. Some
U.S. citizens have attempted to obtain influenza vaccine
in Canada; many have been turned away because they are not
Canadian residents, without regard to whether they may be
more in need of the vaccine than many Canadians.
Vermont asked the Province of Quebec
whether it could supply Vermont with some vaccine because
of the shortage in the United States, and Quebec responded
that such an arrangement would have to be negotiated between
the two federal governments.
This situation raises the question whether
countries should negotiate arrangements under which vaccine
supplies are shared in situations of unexpected shortages
to ensure that people most in need get vaccinated.
Vaccine rationing among individuals within states
The suspension of Chiron's manufacturing
license forced the United States to devise a strategy under
which the available vaccine is directed toward those most
at risk from influenza. In countries that recognize the
international human right to health (e.g., states parties
to the International Covenant on Economic, Social, and Cultural
Rights), rationing could implicate this right because it
might impede the prevention of epidemic disease by restricting
access to vaccine.
Moreover, distribution of scarce vaccine supplies
would need to comply with internationally-recognized disciplines
applicable to the right to health.
Depending on the shortage's severity, governments
may need to seize vaccine supplies owned by private entities
(e.g., pharmaceutical companies, vaccine distributors, or
health care facilities) in order to distribute vaccine effectively
to those most in need. Government takings of privately owned
vaccine supplies would implicate the international human
right to property in jurisdictions recognizing the right
because the takings would deprive owners
of their property. The right to property does not preclude
government seizures of vaccine supplies, but it would require
public-interest seizures to follow legally prescribed procedures
and could trigger a government's duty to compensate affected
Tension between rationing and human rights
could also appear in connection with limited supplies of
anti-virals used to treat sick patients.
Vaccine shortages may also force governments
to utilize non-medical interventions that have human rights
implications, including measures to increase "social distance"
(e.g., closing schools and suspending public events), restrict
travel, or prevent infected persons from transmitting the
virus (e.g., confinement or isolation).
Some experts have described the disruption
of the supply of influenza vaccine to the United States
in October 2004 as a "wake up call"
concerning the fragility of influenza
vaccine supplies, the vulnerability of strong and weak countries
to the inadequate nature of global influenza vaccine production,
and the dangerous lack of preparedness in many countries
concerning the prospect of pandemic influenza. Whether governments
take this "wake up call" seriously remains to be seen.
David P. Fidler is Professor of Law and
Harry T. Ice Faculty Fellow at Indiana University School
of Law, Bloomington and Senior Scholar at the Center for
Law and the Public's Health at Georgetown and Johns Hopkins
David Brown, Half of U.S. Flu Vaccine Withheld; Supply Due from British Firm Tainted, Washington Post, Oct. 6, 2004, at A01.
See U.S. Centers for Disease Control and Prevention, 2004-05 Flu Vaccine Shortage, at www.cdc.gov/flu/protect/vaccineshortage.htm; and U.S. Centers for Disease Control and Prevention, Fact Sheet: 2004-05 Flu Vaccine Shortage: Who Should Get Vaccinated, Oct. 7, 2004.
Jeanne Whalen, Betsy McKay, and Sarah Lueck, U.S. Flu Vaccines Face Rationing as Plant is Shut, Wall Street Journal, Oct. 6, 2004, at A1.
World Health Organization, Pandemic Preparedness, at www.who.int/csr/disease/influenza/pandemic/en/ (“In the past, new [influenza] strains have generated pandemics causing high death rates and great social disruption. In the 20th century, the greatest influenza pandemic occurred in 1918-1919 and caused an estimated 40-50 million deaths world wide. Although health care has improved in the last decades, epidemiological models from the Centers for Disease Control and Prevention, Atlanta, USA project that today a pandemic is likely to result in 2 to 7.4 million deaths globally.”)
World Health Organization, WHO Consultation on Priority Public Health Interventions Before and During an Influenza Pandemic, 16-18 March 2004 (WHO: Geneva, 2004), at 1 (noting that one of the most important dangers arising from the avian influenza outbreak in Asia “is the risk that conditions present in Asia could give rise to an influenza pandemic.”) For a previous Insight on avian influenza, see David P. Fidler, Global Outbreak of Avian Influenza A (H5N1) and International Law, January 2004, at www.asil.org/insights/insigh125.htm.
Bernard Wysocki, Jr. and Betsy McKay, Flu-Vaccine Shortage Signals U.S. Vulnerability to Pandemic, Wall Street Journal, Oct. 8, 2004, at B1.
“Vaccines are the single most important intervention for preventing influenza-associated morbidity and mortality during both seasonal epidemics and pandemics.” WHO, supra note 6, at 41.
David Brown, Fixing Vaccine Supply System; Task Will Not Be Easy, Say Health and Drug Industry Officials, Washington Post, Oct. 9, 2004, at A05 (quoting Julie Gerberding, Director of the U.S. Centers for Disease Control and Prevention: “We continue to have a completely fragile vaccine production system in this country—and it is getting more fragile daily.”).
“One example of a regional purchasing scheme is a revolving fund maintained by PAHO [Pan American Health Organization] for bulk purchasing of influenza vaccines, with local filling, for some Latin American countries.” Id. at 40.
Influenza expert David S. Fedson raised the possibility of creating a “Global Influenza Vaccine Fund . . . to facilitate multinational vaccine purchases and distribution, especially for countries with limited resources.” David S. Fedson, Pandemic Influenza and the Global Vaccine Supply, 36 Clinical Infectious Diseases 1552, 1561 (2003).
See, e.g., World Health Assembly, Prevention and Control of Influenza Pandemics and Annual Epidemics, WHA56.19, May 2003, at ¶1 (urging WHO member states to increase vaccination coverage of all people at high risk).
Fedson also raised the potential need for the negotiation of a WHO Framework Convention for Influenza Pandemic Preparedness and Vaccine Supply. Fedson, supra note 14, at 1561.
World Health Organization, Review and Approval of Proposed Amendments to the International Health Regulations: Draft Revision, A/IHR/IGWG/3, Sept. 30, 2004, Article 13.
Id. at Article 4.1 (“Each State Party shall develop, as soon as possible but no later than five years from the date of entry into force of these Regulations for that State Party, the capacity to detect, assess, notify and report events in accordance with these Regulations, as specified in Annex 1.”) and Article 11.1 (“Each State Party shall develop, as soon as possible but no later than five years from the date of entry into force of these Regulations for that State Party, the capacity to respond promptly and effectively to public health threats and public health emergencies of international concern as set out in Annex 1.”).
Whalen, McKay, and Lueck, supra note 4, at A1; Jeanne Whalen, Sarah Lueck, and Besty McKay, Closing of Flu-Vaccine Plant by British Regulators Took Chiron, U.S. by Surprise, Wall Street Journal, Oct. 7, 2004, at B1; Glenn Frankel and Glenda Cooper, Britain: U.S. Told of Vaccine Shortage; Flu Shot Records Contradict FDA, Washington Post, Oct. 9, 2004, at A01; Sarah Lueck and Pui-Wing Tam, U.S. Uncovered Problems at Chiron Plant in 2003, Wall Street Journal, Oct. 11, 2004, at A3; Rob Stein, FDA Denies It Had Alert on Flu Vaccine, Washington Post, Oct. 12, 2004, at A03; Betsy McKay and Sarah Lueck, Florida Sues Flu-Vaccine Supplier, Wall Street Journal, Oct. 14, 2004, at A3.
Stein, supra note 21, at A03 (quoting FDA acting commissioner Lester M. Crawford: “We do not have a data-sharing agreement [with the British] . . . that would tend to force them to inform us of this kind of thing.”).
WHO, supra note 6, at 41. See also Wysocki and McKay, supra note 7, at B1 (quoting Chiron executive warning a U.S. Senate subcommittee that the United Kingdom could require Chiron to fulfill U.K. vaccine needs first followed by vaccine needs in Europe before vaccine would be made available to the rest of the world).
WHO has stated that “while governments are not urged to nationalize manufacturing capacity during a pandemic, governments are likely to face great pressure to do so.” WHO, supra note 6, at 40.
Graeme Smith and David Ebner, Canada Shuts Out Vaccine Seekers: Demand from U.S. Prompts Provinces to Implement Restrictions for Flu Shots, Toronto Globe and Mail, Oct. 16, at A1.
The Associate Medical Officer of Health for the Niagara Region observed that “[t]he lessons of SARS and other recent outbreaks have been that viruses can pass quickly across political boundaries . . . so the best way to protect Ontarians would be to share vaccines with the most needy people on the other side of the Niagara River.” Id.
 See International Covenant on Economic, Social, and Cultural Rights, (1966), Article 12.2(c) (indicating that states parties’ obligations under the right to health involve the prevention of epidemic disease).
 Under Article 4 of the International Covenant on Economic, Social, and Cultural Rights, states parties to the Covenant may subject those rights only to such limitations as is compatible with the nature of the rights and solely for the purpose of promoting the general welfare in a democratic society.Consequently, a state party that takes measures that restrict access to vaccines against the community’s major infectious diseases “has the burden of justifying such serious measures in relation to each of the elements identified in article 4. Such restrictions must be in accordance with the law, includinginternational human rights standards, compatible with the nature of the rights protected by the Covenant, in the interest of legitimate aims pursued, and strictly necessary for the promotion of the general welfare in a democratic society.” Committee on Economic, Social and Cultural Rights, General Comment 14, The Right to the Highest Attainable Standard of Health, U.N. Doc. E/C.12/2000/4 (2000), ¶ 28.
 See Universal Declaration of Human Rights (1948), Article 17; Protocol No. 1 to the European Convention on Human Rights and Fundamental Freedoms (1952), Article 1; American Convention on Human Rights (1968), Article 21; African Charter on Human and Peoples’ Rights (1981), Article 14; Arab Charter on Human Rights (1994), Article 25; Charter of the Fundamental Rights of the European Union (2000), Article 17.
 American Convention on Human Rights, Article 21.2 (“No one shall be deprived of his property except upon payment of just compensation, for reasons of public utility or social interest, and in the cases and according to the forms established by law.”).
 According to WHO, opportunities to use anti-virals are restricted by “the extremely limited supplies . . . and negligible surge capacity for production.” WHO, supra note 6, at 31.
Addendum: Conclusions from Influenza Vaccine Summit
By David P. Fidler
In response to growing concerns about the inadequacy of global capabilities to produce a vaccine for an influenza pandemic, the World Health Organization (WHO) hosted on November 11-12, 2004, a meeting involving influenza vaccine manufacturers, national licensing agencies, and governmental representatives to discuss influenza pandemic vaccines. The participating experts agreed that “[a]n influenza pandemic, when it arrives, will be an immediate threat to the health of nearly everyone on Earth, but very little is being done to prevent its potential devastation[.]” The main objectives of the meeting were to review the existing capabilities for producing vaccine for pandemic influenza, identify the obstacles to developing a vaccine for an influenza pandemic, and formulate solutions to such problems.
According to WHO, participants agreed that the threat of pandemic influenza was real and growing, but that the existing structure and dynamics of influenza vaccine development and manufacturing are inadequate to respond to the emergence of pandemic influenza. The participants identified as pressing concerns the need for: good scientific data on pandemic vaccine formulation; studies to determine the feasibility of techniques to stretch limited vaccine supplies; funding for clinical trials; addressing vaccine liability concerns; and work on licensing and regulatory issues. On a positive note, industry representatives “announced that intellectual property issues for patented technologies, including reverse genetics, would not affect either the development of a prototype strain or clinical trials of a candidate vaccine.”
The meeting also stressed the importance of scaling up the use of influenza vaccine for seasonal epidemics because such increasing vaccine use contributes to creating incentives for companies to engage in influenza vaccine development and production, building vaccine manufacturing capacity, and priming licensing and regulatory systems for pandemic contexts. Participants called for governments to increase their engagement in pandemic vaccine development and for WHO to play a stronger role in coordinating activities related to pandemic vaccine development, such as testing.
David Brown, WHO Meeting Warns of Flu Pandemic; Experts Say Countries Have Not Done Enough to Prevent the Spread of Virus, Washington Post, Nov. 13, at A04.
WHO, supra note 1.
The purpose of ASIL Insights is to provide concise and
informed background for developments of interest to the
international community. The American Society of International
Law does not take positions on substantive issues, including
the ones discussed in this Insight. Educational copying
is permitted with due acknowledgement.
For more information, resources, and reliable versions of international law documents on the web, consult EISIL, the Electronic Information System for International Law at www.eisil.org.