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caused the harm regardless of whether the vaccine producers or adminis-
trators were at fault. According to a recent study, fourteen vaccine injury
compensation programs exist worldwide, exclusively in highly developed
154 BIOVIOLENCE: PREVENTING BIOLOGICAL TERROR AND CRIME

countries.61 The United States National Vaccine Injury Compensation Pro-
gram (VICP), discussed below, takes this approach.
Third, the government can indemnify vaccine producers who might
be held liable for harm. An objection to this approach is that it does not
provide the vaccine industry with enough liability protection because the
government may not cover the costs of litigation, and in some instances
indemni¬cation is limited to only “reasonable” liability costs.62
Fourth, the government can alter the normal liability rules. For exam-
ple, the Support Antiterrorism by Fostering Effective Technologies Act
(SAFETY) of 200263 prohibits punitive damages and limits liability to the
amount of insurance that is “reasonably available.”
The United States has combined approaches in the National Child-
hood Vaccine Injury Act that establishes the Vaccine Injury Compensa-
tion Program (VCIP), a no-fault compensation scheme that provides lia-
bility protections to producers of vaccines against childhood diseases.64
The Vaccine Injury Table lists injuries presumed to be caused by vac-
cines and the time period in which they generally occur; listed injuries
are compensable.65 Victims who accept compensation are paid through
the program trust fund raised from taxes on each vaccine delivered in the
United States. Victims who suffer an injury that is unlisted or does not
occur during the designated timeframe may recover but only if they pro-
vide additional proof of harm.66 Victims who are denied compensation or
are dissatis¬ed with their compensation may appeal the decision or may
sue the manufacturers directly.67 Although manufacturers seem content
with the program, some victims™ advocates claim that proving causation
complicates getting compensation.68
Notably, only vaccines that are recommended for routine administra-
tion are included. Biodefense vaccines are left out, most likely because
the harms associated with such vaccines are largely unknown. An impor-
tant question, therefore, is whether these policies should similarly limit
liability of companies that produce vaccines or medications as counter-
measures for use in bioviolence emergencies. The United States has
recently enacted the Public Readiness and Emergency Preparedness
(PREP) Act that establishes the “Covered Countermeasure Process Fund”
to compensate persons who suffer serious injuries or death due to a coun-
termeasure™s use. Producers and distributors are protected from liability if
there is an of¬cially declared public health emergency or a credible threat,
except if the harm results from their “willful misconduct.”69
During the 2003 smallpox vaccination campaign, three cardiac deaths
occurred; all victims (two civilians and one person in the military) were
155
IMPROVING RESISTANCE THROUGH SCIENCE

in their mid-¬fties.70 Thereupon, the Smallpox Emergency Personnel Pro-
tection Act of 200371 was passed to encourage medical and public health
workers to get vaccinated. The Act establishes the Smallpox Vaccine Injury
Compensation Program which provides compensation for listed injuries to
speci¬c personnel (health care workers, law enforcement of¬cers, ¬re¬ght-
ers, security personnel, emergency medical personnel, and other small-
pox emergency response personnel) who receive the vaccine. As under the
VCIP, victims of unlisted injuries may receive bene¬ts but must provide
additional proof that the vaccine caused their injuries. For Department
of Defense (DoD) civilian employees and contractor personnel, however,
adverse events that occur under the U.S. Department of Defense Anthrax
Vaccine Immunization Program are covered under either federal or state
worker™s compensation programs.72
This brief account of recently enacted law in only one nation “ the
United States “ is confusing. Consider the multiple levels of confusion
and disconnect for a pharmaceutical producer who seeks to market drugs
worldwide. These matters are indeed complex, but there is no valid reason
why legal solutions are not identi¬ed globally. Harmonization of liability
rules and protections worldwide should be an immediate priority.


Patent Barriers
A huge legal issue vexing global distribution of vaccines concerns the
intellectual property rights associated with vaccine production. From the
perspective of vaccine producers and government of¬cials in developed
nations, the high risks of making safe and effective vaccines would make
no economic sense if, having con¬gured a critical drug, someone could
readily copy and sell it for a price that need not re¬‚ect the sizeable research
investment plus a reasonable pro¬t. From developing nations™ perspective,
paying a price that re¬‚ects research costs plus pro¬t is virtually impossible.
They could produce the drug at a fraction of the cost, and their popula-
tions desperately need these medications; they argue that the pharmaceu-
tical sector™s pursuit of exorbitant pro¬ts should not be a death sentence
for millions of innocent people. Indisputably, any restriction on access
to medicines necessarily advantages developed nations™ producers that
account for over 90 percent of new pharmaceutical patents.73
This con¬‚ict of perspectives is being played out in the rari¬ed con-
text of the World Trade Organization™s (WTO) Trade-Related Aspects of
Intellectual Property Rights (TRIPS).74 States must extend patent pro-
tection to micro-organisms and microbiological processes, albeit not to
156 BIOVIOLENCE: PREVENTING BIOLOGICAL TERROR AND CRIME

diagnostic, therapeutic, or surgical methods. States that allow infringe-
ment of a patented vaccine risk losing their coveted WTO privileges.
There are exceptions. States may grant compulsory patent licenses that
permit domestic producers to manufacture a patented item without the
patent holder™s consent so long as licenses are nonexclusive and granted
only on an individual basis, and the producer must have sought the original
patent holder™s approval on reasonable terms. These restrictions need not
apply in cases of national emergency. Compulsory licenses must be limited
to meeting domestic needs, not for export, and the original patent holder
is to be paid adequate compensation.75 See Box 6-4 for the steps required
for compulsory licensing of pharmaceuticals.
The issue here is whether a State may grant a compulsory license to a
domestic producer of a vaccine against a bioviolence threat, say anthrax.
The answer is very much unresolved.
Two recent events shape this issue. In 2001, the WTO Ministerial Con-
ference adopted the Declaration on the TRIPS Agreement and Public Health
(“Doha Declaration”), which states that TRIPS “can and should be inter-
preted and implemented in a manner supportive of WTO Members™ right
to protect public health and, in particular, to promote access to medicines
for all. . . . WTO Members with insuf¬cient or no manufacturing capacities
in the pharmaceutical sector could face dif¬culties in making effective
use of compulsory licensing under the TRIPS Agreement.” The Council
pledged to ¬nd “an expeditious solution to the problem.”76
Two years later, the WTO Council announced that a country may pro-
duce generics of patented drugs for export if another country is in need.
The exporter must include unique characteristics on the product that
distinguish it from the patented version, and the products must not be
diverted for an alternative use. The importing country must inform the
Council about the types and quantities of the products it seeks, but there
are complaints that the time-consuming procedure to inform the TRIPS
Council could be a signi¬cant obstacle during an unforeseen public health
emergency when patented products are immediately needed.77 Patented
vaccines for rarely occurring diseases might not be available in needed
quantities when a bioviolence emergency arises.
The issue of compulsory licensing has been contentious. In the 1990s,
South Africa and Brazil each allowed generic manufacturing and parallel
importation of needed drugs, especially to combat AIDS. Brazil grounded
its argument for a TRIPS emergency exception on its need for cheap
drugs to combat HIV/AIDS; South Africa simply ignored the TRIPS provi-
sions on compulsory licensing. The United States initially disputed both
157
IMPROVING RESISTANCE THROUGH SCIENCE


BOX 6-4. TEN REQU I RED STEPS FOR COM PU LSORY LICEN S I NG OF
PHARMACEUTICALS

Developing countries must go through ten steps before patented drugs would be
available to them. Each step must be followed every time a drug is exported even if
the same drug is being exported to another country. Some experts argue that this
procedural nightmare is not in the spirit of the Doha Declaration because it impedes
countries trying to provide relief for their citizens who are in desperate need of life-
saving pharmaceuticals. The ten steps are as follows:
1. A country that is seeking to import a drug through a compulsory license must seek
a voluntary license on commercially reasonable terms for a reasonable period of
time.
2. If the importing country is unsuccessful in obtaining a voluntary license, it must
apply to the WTO for a compulsory license.
3. If the compulsory license is for import, the importing country must assess its
industry™s capacity to produce the medicine locally.
4. If its capacity is insuf¬cient, it must notify and explain to the WTO the reason for
its decision.
5. The importing country must notify a potential exporter.
6. The exporter must, in turn, seek a voluntary license on commercially reasonable
terms for a reasonable period of time.
7. The exporter must seek a compulsory license from its own government on a
single-country basis.
8. Royalty compensation must be set based on standards of reasonableness in the
importing country.
9. If a license is granted to a generic producer, the exporter must investigate pill
size, shape, color, labeling, and packaging of the patent holder™s product in the
importing country and differentiate its new product in all respects, regardless of
cost.
10. The generic producer would need to seek product registration and prove bio-
equivalence based on a pill of different size and shape.



countries™ actions but later retracted its objection in recognition of the
extent of the AIDS crisis.78 In 2005, Brazil announced that it planned to
produce a generic version of the antiretroviral drug Kaletra. The patent
holder, Abbott, agreed to supply the drug to Brazil at a discounted price.79
The threat of bioviolence has impacted the perspective of developed
countries, especially the United States, toward compulsory licensing. After
the anthrax attack in 2001, both Canada and the United States considered
circumventing the patent protection of the drug Cipro “ the “drug of the
hour” for combating anthrax. Canada overrode the patent.80 The Bush
158 BIOVIOLENCE: PREVENTING BIOLOGICAL TERROR AND CRIME

administration™s threat to circumvent Cipro™s patent protection evoked a
promise from Bayer, the patent holder, to supply the drug at a deeply dis-
counted price. More broadly, the U.S. pharmaceutical industry protested
against such threats to circumvent patent protections yet promised to help
the United States build a stockpile of drugs.81 Developing nations criticized
the United States in view of its past “hard-line” position on compulsory
licenses for developing countries. This policy shift was a primary reason
for the Doha Declaration and its subsequent interpretation: if the United
States and other developed nations claim that a public health emergency
forces them to choose between their welfare and honoring patents, simi-
lar claims of developing nations must be respected as much if not more.82
However, the WTO has not of¬cially ruled on the matter.
What conditions should enable claims of compulsory licensing? Under
the latest TRIPS rulings, States are freer to pursue compulsory licensing to
address their public health emergencies. In 2002, the United States argued
that the compulsory licenses for public health emergencies should be
limited to only a few infectious diseases such as tuberculosis, malaria,
and AIDS.83 The European Union offered a much more expansive list.84
Other countries, such as India and Singapore, have argued against narrowly
de¬ning which infectious diseases amount to a public health emergency “
any limitation on the list of diseases may limit a country™s capacity to
respond to a threat through the use of compulsory licensing.
Through 2006, there had been no legal challenge concerning use
of compulsory licensing to stockpile drugs or vaccines for responding
to bioviolence. Apparently, drug manufactures would prefer to supply
cheaper drugs than to risk having their patent overridden by a compulsory
license or resort to costly litigation against a county that violates the patent
protection. The “threat” of a compulsory license has become a bargaining
tool for countries to press patent holders to meet their needs. The situ-
ation is too new to accurately assess whether the specter of compulsory
licensing under the TRIPS agreement to negotiate for cheaper medicines
will prove to be balanced or will adversely impact the manufacturing of
drugs and vaccines for responding to bioviolence. The untested issue is
whether a country can claim an emergency exception to issue a compul-
sory license if an attack has not yet occurred. The threat of HIV/AIDS is a
clear reality in Brazil and South Africa. Can the same be said for anthrax
in the United States? Presumably, as to threats that appear more remote,
countries™ claims to an emergency exception are unlikely to qualify for
exemption under the Doha Declaration.
159
IMPROVING RESISTANCE THROUGH SCIENCE

In sum, too little attention has been devoted to how global efforts for
promoting biotechnology can have positive implications for enhancing
resistance against bioviolence and how much bioviolence should be a
driver for those programs. As this book goes to press, a group of wealthy
nations has announced a new initiative to prepare vaccines for develop-
ing regions. This is an important step forward in global efforts to com-
bat disease generally, and it suggests ways that developed nations can
reduce risks of vaccine production, at least for vaccines that are likely to
have widespread use. It is far too early to even wonder if this proposed
initiative will grapple with bioviolence threats.85 Until the issue of how
to promote bioviolence resistance measures is addressed globally and in
connection with broader efforts to combat pandemic disease, real hope
for progressive measures is stalled.
7 Public Health Preparedness




Public health preparedness can reduce vulnerability to some types of biovi-
olence. It would be the height of folly to not be as prepared as possible.
Of course, better that an attack not happen at all, but it would be reckless
to rely exclusively on complication and resistance measures. Mitigating
harm to potential victims is mandatory. If all else fails, we should be able
to contain bioviolence™s consequences.
Preparedness measures include pre-attack efforts to reduce vulner-
ability by distributing vaccines and hardening potential attack sites. A
perpetrator is unlikely to in¬‚ict a disease against an effectively immu-
nized population or try to spread it in a guarded site. Also, preparedness
measures include rapid detection and post-attack commitment of pub-
lic health resources to treat victims. An intentionally perpetrated disease
will less catastrophically ruf¬‚e a community whose medical profession-
als can promptly apply counter-measures. Finally, preparedness measures
include establishing quarantines to limit the spread of contagion.
Preparedness measures have indisputable virtues, yet serious ques-
tions abound. Can they be suf¬ciently effective to reduce the need for the
complication measures (discussed in Chapter 5)? How should vaccines
be fairly stockpiled and distributed worldwide? Which targets should be
hardened? Which persons should be vaccinated, perhaps without their
consent? How can quarantines operate without trampling civil liberties?
This chapter propounds a note of skepticism. Reliance on prepared-
ness measures raises unhappy choices, and to ignore their implications by
offering a false palliative for security is disingenuous. Preparedness mea-
sures can be modestly effective for preventing bioviolence, but there is
no magic pill that will inoculate us against threats or promptly cure us if
threats materialize. Moreover, preparedness refers to a bottomless grab
bag of things to do that government of¬cials often brag about doing, but

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