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V
494 P H R / S–O 2006 / V 121
The Fourth Pillar of the Framework
Convention on Tobacco Control:
Harm Reduction and the International
Human Right to Health
B M M, JD,
LLM
a
D S, MD, MPH
a
a
Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY
Address correspondence to: Benjamin Mason Meier, JD, LLM, Center for Health Policy, Columbia Univ., 617 W. 168th St., New York, NY
10032; tel. 212-305-0047; fax 212-305-3659; e-mail <bmm2102@columbia.edu>.
©2006 Association of Schools of Public Health
The Framework Convention on Tobacco Control (FCTC), while successful in
its execution, fails to acknowledge the harm reduction strategies necessary to
help those incapable of breaking their dependence on tobacco. Based on the
human right to health embodied in Article 12 of the International Covenant on
Economic, Social and Cultural Rights, this article contends that international
law supports a harm reduction approach to tobacco control. Analyzing the right
to health as an autonomy-enhancing right, countries must prioritize health
interventions to promote those treatments most likely to increase autonomy
among those least able to control their own health behaviors. Harm reduction
can involve the use of novel, purportedly less hazardous tobacco products. By dis-
sociating nicotine from the ancillary carbon monoxide and myriad carcinogens
of smoking, these tobacco harm-reduction products may allow the individual
smoker to retain addictive behaviors while limiting their concomitant harms.
These less hazardous products, while not offering the preferred benets of
abstaining from tobacco entirely, might nevertheless become a viable strategy
for buttressing individual autonomy in controlling health outcomes. Working
through the FCTC framework, countries can create the international regula-
tory and research capacity necessary to assess harm-reduction products and
programs.
The harms of smoking are truly global in scope. More than 1.1 billion people
smoke worldwide, resulting in cardiovascular diseases, various cancers, and
obstructive lung diseases.
1
Approximately one-quarter of all lifelong smokers will
die in middle age (between 35 and 69) as a result of smoking, losing between
20 and 25 years of life. Another quarter of these smokers will die in their latter
years as a result of smoking.
2,3
Globally, this “quiet pandemic” claims the lives of
approximately 5 million persons per year, a gure that will rise to 10 million by
2030, with the burden of death increasingly being felt by developing countries.
4
With globalization’s dismantling of trade barriers permitting the burgeoning
initiation of smoking in unsated developing countries—particularly among the
children and adolescents of these countries—tobacco is projected to become
the world’s leading cause of avoidable death.
5
H R I H R H 495
P H R / S–O 2006 / V 121
In May 2003, the member states of the World Health
Organization (WHO) challenged the global spread of
tobacco by adopting an international tobacco control
treaty, the Framework Convention on Tobacco Control
(FCTC). The FCTC represents the rst time in its 55-
year history that WHO has used its authority to draft
a binding international treaty.
While successful in its execution, this international
legislation focuses primarily on non-health related
approaches to tobacco control—including price and
tax measures to reduce demand, strategies to reduce
smuggling, indoor air laws, and limits on tobacco adver-
tising—but fails to directly address smoking cessation
and harm reduction strategies.
6
This article argues that
the international human right to health supports a
harm-reduction approach to tobacco control and that,
working under the FCTC framework, countries should
create international mechanisms to research and regu-
late harm-reduction products and programs.
Harm reduction can be dened as a strategy that
lowers total tobacco-related mortality and morbidity
despite continued exposure to tobacco-related toxi-
cants.
7
Harm reduction strategies include using behav-
ioral methods, nicotine replacement therapies, or so-
called “safer” cigarettes manufactured by the tobacco
industry to reduce daily cigarette consumption.
8
This
article addresses these industry-sponsored substitute
tobacco products—including, but not limited to, low-
carcinogen cigarettes, devices that heat tobacco to
release nicotine, smokeless tobacco, and novel nicotine
products—all of which have yet unproven benets.
9
Many smokers who want to quit are unable to over-
come their nicotine dependence. Despite advances in
the treatment of nicotine dependence,
10
less than half
of smokers achieve success with counseling and phar-
macotherapy and only about one-fth remain abstinent
in the long term.
11
Moreover, traditional cessation
treatments tend to aid the less dependent smokers,
targeting only 5% to 20% of smokers interested in
quitting immediately.
12
Harm reduction “recognizes
a broader range of tobacco and nicotine goals, and
accepts a longer or even indeterminate time frame to
achieve the goals.”
13
For those addicted to nicotine and
unwilling or unable to quit smoking, harm-reduction
strategies have the potential to minimize the net dam-
age to their health and the economic ramications of
tobacco use.
14
Addressing the needs of those addicted to nicotine,
however, requires a new paradigm for international
tobacco control: the human right to health. By apply-
ing the right to health to tobacco control, this article
advocates for research in and evaluation of these
purportedly less hazardous tobacco products through
the FCTC framework. Only by acknowledging these
tobacco harm-reduction products and appraising them
as part of national comprehensive tobacco control
strategies can governments realize their obligations
under the right to health. Casting success as the
reduction in exposure to toxins, these less hazard-
ous nicotine-delivery products, while not offering the
preferred health and economic benets of abstaining
from tobacco entirely, might nevertheless become a
viable component of a nation’s comprehensive tobacco
policy.
NICOTINE ADDICTION AND
THE ROLE OF HARM REDUCTION
Nicotine addiction does not result from a failure of
will, but rather a neurological and psychiatric disorder
brought on by psychosocial, cultural, environmental,
and genetic factors. While generally understood as a dis-
order of altered brain function brought on by the use of
a psychoactive stimulant, the neurobiology of nicotine
use and the pharmacological mechanisms leading to
nicotine addiction remain largely unknown.
15
At pres-
ent, neuroimaging techniques have allowed researchers
to theorize that nicotine activates acetylcholinergic
receptors, specically nicotinic cholinergic receptors,
increasing the synthesis and release of dopamine to
produce rewarding, pleasurable, stimulating, and
anxiety-ameliorating effects on the brain.
16
These bio-
logical variables interact with psychological effects to
create and maintain nicotine dependence.
17
Although nicotine is not the direct agent of harm,
it is nevertheless the behavioral and biological basis
of tobacco smoking, causing deadly consequences for
users and nonusers alike. It is now axiomatic that nico-
tine is a drug of addiction, inducing pharmacological
and behavioral processes similar to those of heroin and
cocaine.
18
Cigarettes and other tobacco products can
therefore be viewed as highly engineered drug delivery
vehicles, which, if used as directed, cause death.
An individual’s initial decision to begin smoking is
made frequently when he or she is too young to be
truly informed about the risks of smoking and give
meaningful consent to those risks. Because tobacco
use then results in a powerful addiction that impairs
autonomous decision-making and impedes voluntary
choice, an individual’s decision to continue nicotine
self-administration cannot be said to be the result of a
free, informed choice.
3,19
As a result, tobacco control—
once considered a private good, stemming from only
lifestyle choices—must now be reevaluated as a public
good, requiring a systemic health-based approach to
treat involuntarily recalcitrant smokers.
496 V
P H R / S–O 2006 / V 121
Tobacco control efforts have frequently been articu-
lated by three principal pillars: (1) prevention of initia-
tion, (2) cessation for smokers, and (3) protection from
environmental tobacco smoke. To this longstanding
tobacco control triad, the introduction of harm reduc-
tion—a separate, fourth pillar—“seeks to minimize
the net damage to health associated with the use of
tobacco products.”
20
Harm reduction acknowledges the
pharmacologic and psychological effects of nicotine
in preventing complete abstinence from tobacco and
assumes that, even with effective cessation treatments,
many smokers will be resistant to quitting altogether.
21
For these “hard-core” smokers—often vulnerable as a
result of poverty, poor education, or a co-morbidity
such as mental illness—harm reduction offers the
promise of increasing individual autonomy while saving
lives.
22
Similar to analogous harm-reduction approaches
in other health-related elds—for example, providing
clean needles or methadone to heroin addicts (which
was also controversial upon inception but soon gained
widespread acceptance)—tobacco harm reduction
allows health practitioners to achieve modied health
goals based upon individual needs.
FRAMEWORK CONVENTION ON TOBACCO
CONTROL: ABSENCE OF HARM REDUCTION
The FCTC has created broad principles of norma-
tive consensus for international tobacco control,
challenging the globalization of smoking through
the globalization of tobacco control. WHO member
states intend the broad obligations of the FCTC to
be supplemented by several individualized protocols,
which will develop specic governmental obligations
for the respective aspects of tobacco control addressed
by the FCTC. Despite this successful, albeit incremen-
tal, transnational approach to tobacco control, nei-
ther the FCTC nor any currently proposed protocols
adequately addresses the subject of harm reduction
with any specicity. Although the core text of the treaty
recognizes the importance of cessation and product
regulation, the FCTC fails to place afrmative obliga-
tions on countries vis-à-vis harm reduction, focusing
instead on the globalized aspects of the tobacco pan-
demic—regulation of tobacco advertising, taxation,
trade, and smuggling. In effect, the FCTC proposes to
change the social environment for smoking through
an emphasis on policy and legislative approaches but
offers little direct help to smokers in overcoming their
addiction through cessation or harm reduction. As a
result, the FCTC—the rst treaty drafted explicitly to
protect public health—has been criticized for lacking
a rm basis in public health.
6,23,24
The harm reduction debate can transcend the nation
under the aegis of the FCTC. Now that the community
of nations has moved to regulate tobacco through
international law, it is incumbent upon tobacco control
advocates to question the absence of harm-reduction
strategies in the FCTC. The FCTC goes far in address-
ing the global tobacco pandemic, but it neglects those
already addicted to nicotine, with this failure treading
heavily upon the right to health. In a previous article,
one of the present authors enumerated mechanisms
for drafting a protocol to the FCTC to address smok-
ing cessation.
6
To address those unwilling or unable
to overcome their nicotine dependence, it is vital that
nations promulgate a similar protocol specic to harm
reduction, afrming their commitment to health and
human rights by analyzing the prospective benets of
harm-reduction products.
ANALYZING HARM REDUCTION
The effectiveness of harm reduction at the popula-
tion level is questioned by some in the tobacco con-
trol community. Some warn that advising smokers to
switch to harm-reduction products will undermine
efforts to help larger populations of smokers through
population-based cessation programs and result in a
net increase in users.
25
There is a concern that the
marketing of harm reduction, “choosing the lesser of
two evils,” will be viewed as a tacit acceptance of smok-
ing, which retains inherent dangers eliminated only
through permanent abstinence.
10
Critics fear that any
legitimation of smoking by the medical establishment
would “send the wrong message” about the best way to
reduce harm—quit smoking. Further, critics caution
that introducing new forms of tobacco will mollify
health concerns among children experimenting with
tobacco, with harm-reduction products acting as a
gateway to conventional cigarettes and countenanc-
ing former smokers who reengage their addiction.
20,26
Thus, although the individual may reduce his or her
individual harm, this approach may unintentionally
lead to an aggregate increase in harm at the popula-
tion level, through which acceptance of smoking for
the individual, albeit limited, would sanction societal
initiation or continuation of smoking.
Moreover, as borne out by the past disingenuous
marketing of “light” cigarettes in the United States
in the 1950s and low tar cigarettes in the early 1970s,
critics fear that sophistic harm reduction claims will be
made that contradict etiological and epidemiological
evidence.
27,28
In the case of past cigarette regulation
in the United States, although tobacco corporations
marketed ltered cigarettes as a safer alternative for
H R I H R H 497
P H R / S–O 2006 / V 121
smokers—an alternative to quitting altogether—these
corporations knew at the time that the cigarettes posed
the same risk for the smoker. Regulating cigarettes
through the use of “smoking machines” to measure
smoke and tar, the measurement machines employed
by the United States Free Trade Commission failed to
account for known smoking practices, through which
smokers made use of “compensatory smoking behavior”
(inhaling more deeply, smoking more cigarettes, cover-
ing the lter) to counterbalance any mitigating effects
of the lter and thereby ingest an even greater amount
of nicotine and its attendant carcinogens.
29
Thus,
tobacco corporations were able to use the government-
approved imprimatur of “light cigarettes” to undermine
prevention and cessation efforts—providing a disincen-
tive for motivated smokers to quit, encouraging non-
smokers to become dependent on tobacco, and making
quitters more likely to relapse. Even after the myth of
light cigarettes has been debunked, smokers continue
to employ these lower-risk messages in justifying their
continued smoking.
30
Once bitten, health ofcials,
who once “attempted to collaborate with the tobacco
industry to nd a safer product only to learn that the
industry had not cooperated in good faith,”
8
now nd
themselves reexively distrustful of any harm-reduction
product created by tobacco corporations.
20
This inveterate hostility has resurfaced anew in the
modern production of the so-called “safer cigarette,”
with scholars and organizations split on the appro-
priateness of harm reduction for smokers despite the
prospect of reduction of harmful exposures to the indi-
vidual smoker.
8
Among other tobacco products, Philip
Morris, R.J. Reynolds, Star Scientic, and the Vector
Group have all developed and marketed cigarettes or
cigarette-like products that these corporations claim
reduce or eliminate exposure to carbon monoxide,
nicotine, and carcinogens.
31
Although the tobacco
industry has attempted to collaborate with tobacco
control researchers in producing such products, such
efforts “have been met with scorn and have been boy-
cotted by many in tobacco control . . . fear[ful] that
collaboration, complicity, or acquiescence of the public
health community in tobacco industry efforts could
result in increased credibility of the tobacco industry,
making it harder to oppose industry efforts that are
genuinely detrimental to the public health.”
22
Tobacco control advocates’ abjuration of the tobacco
industry has served only to marginalize these profes-
sionals in the ongoing harm reduction development
process. With the tobacco industry alone performing
concerted research on these products, public health
scholars and advocates have been left without an
empirical voice in the harm reduction debate. Without
the oversight of the scientic community and regula-
tory bodies, there is a risk of repeating the “lights”
public health disaster.
To move this debate forward, research is needed on
three fronts. First, research should determine exactly
how different cultural and socioeconomic groups
process and internalize messages of risk with regard to
smoking and harm-reduction products. Even 14 years
after nicotine replacement therapies were launched
into the market, misconceptions about the safety of
these products persist.
32
Second, there must be a better
understanding of how harm-reduction products may
alter the trajectory of tobacco use. Finally, and most
importantly, an international regulatory framework is
necessary within which independent research can be
conducted to conrm tobacco industry claims that
novel smoking products are less harmful than conven-
tional cigarettes. The FCTC provides mechanisms to
establish these regulatory norms, but countries must
make the nancial and political commitments neces-
sary to build these international structures.
26
APPLYING HUMAN RIGHTS TO
HARM REDUCTION
The right to health may help guide the development
of these regulatory structures. An individual’s right to
health is recognized as a fundamental international
human right. Founded upon the non-derogable right
to life, the Universal Declaration on Human Rights
(UDHR) afrms that “[e]veryone has the right to a
standard of living adequate for the health and well-
being of himself and his family, including . . . medical
care and necessary social services. . . .”
33
The United
Nations legislatively embodied the economic and social
parameters of this right in the International Covenant
on Economic Social and Cultural Rights (ICESCR),
which elaborates the right to health to include “the
right of everyone to the enjoyment of the highest
attainable standard of physical and mental health.” To
achieve the full realization of this right, Article 12.2
of the ICESCR requires countries to take afrmative
steps necessary for “(b) [t]he improvement of all
aspects of environmental and industrial hygiene; (c)
[t]he prevention, treatment, and control of epidemic,
endemic, occupational and other diseases; [and] (d)
[t]he creation of conditions which would assure to all
medical service and medical attention in the event of sick-
ness.”
34
Thus, under the plain language of the ICESCR,
the right to health includes a right to health care. But
beyond this, the Committee on Economic, Social and
Cultural Rights (CESCR), the legal body charged in
the ICESCR with drafting ofcial interpretations of
498 V
P H R / S–O 2006 / V 121
and monitoring state compliance with the ICESCR,
has found that the right to health encapsulates a “right
to control one’s health and body,” guaranteeing the
enjoyment of “a variety of facilities, goods, services and
conditions necessary for the realization of the highest
attainable standard of health.”
35
Harm reduction is in accordance with the right
to health. Viewing the right to health as a right that
enhances autonomy and human dignity, countries must
prioritize health interventions “most likely to increase
autonomy amongst those least able to exercise it with-
out outside help.”
36
Although harm reduction might
increase the number of users at the population level,
this is not the basis upon which a human rights-based
approach should be judged. The right to health focuses
on the autonomous individual; it is not a right to public
health.
25,37
As an autonomy-enhancing individual right,
the right to health necessitates the public heath tools
required to protect the right of the informed individual
to make healthy choices for him or herself. WHO has
recognized that nicotine addiction is a disease and
that “nicotine dependence is clearly a major barrier
to successful cessation.”
38
Yet the FCTC does not treat
the addiction as a disease, denying tobacco the clinical
diagnosis that would trigger obligations under the right
to health. Through a harm-reduction protocol to the
FCTC, nations have a unique opportunity to reassert
the legal dominion of the human right to health in
tobacco control discourses.
QUESTIONS REMAIN
Although tobacco harm reduction may be necessary
under the right to health to help those unable to quit
smoking, the evidence necessary to determine the
safety, efcacy, and risk reduction of new tobacco and
tobacco-related products is not available. According
to the Institute of Medicine report Clearing the Smoke,
“regulation is a necessary prerequisite for assuring a
scientic basis for judging the effects of using poten-
tially risk reducing products and for assuring that
the health of the public is protected.”
7
However, no
regulatory system currently exists at the national or
international level to judge the effectiveness of harm-
reduction products, with these potentially deleterious
harm-reduction tobacco products are often subject to
far less regulatory scrutiny than pharmaceutical cessa-
tion products.
21
While harm reduction may prove to
be an integral part of national tobacco control poli-
cies, any legislative efforts to address harm-reduction
strategies must necessarily address the regulation of
harm-reduction products.
7
As noted by Fox and Cohen,
such regulation involves tradeoffs:
On the one hand, too cautious a stance may discour-
age the development of new products that are poten
-
tially effective in reducing at least some of the risks of
smoking. On the other hand, proposed tobacco harm
reduction strategies should result in more good than
harm, and not simply substitute harm.
22
Countries can improve health without falling prey to
corporate malfeasance, so long as governments create
evidence-based mechanisms to study these products
and survey those who use them.
39
Yet these countries
should not have to face such difcult scientic, psycho-
logical, and human rights issues alone, allowing trans-
national tobacco corporations to more easily “divide
and conquer” in manipulating individual national
policies.
5
Through a process termed “leap-frogging,”
scientic research and policy dissemination can allow
“the adoption of measures in a forerunner state to
serve as models elsewhere.”
40
The FCTC framework provides an ideal forum for
culling research on harm reduction and monitoring
the production and marketing of harm-reduction
products. Under Article 9 of the FCTC:
The Conference of the Parties, in consultation with
competent international bodies, shall propose guide
-
lines for testing and measuring the contents and emis
-
sions of tobacco products, and for the regulation of
these contents and emissions. Each Party shall, where
approved by competent national authorities, adopt
and implement effective legislative, executive and
administrative or other measures for such testing and
measuring, and for such regulation.
41
WHO has already taken the initiative through the
FCTC to monitor the production and marketing of
tobacco products, establishing the Scientic Advisory
Committee on Tobacco Products Regulation (recently
renamed the WHO Study Group on Tobacco Product
Regulation) to support countries in obtaining the best
evidence for tobacco regulation.
42
This system should
be expanded—with a new committee created under
the auspices of the FCTC, either administratively or by
way of a protocol to the convention—to research and
evaluate potential harm-reducing tobacco products
by assessing smokers’ physiological and psychologi-
cal responses to harm-reduction products and their
exposure to carbon monoxide and carcinogens. Using
global laboratory networks similar to those employed to
study and combat Severe Acute Respiratory Syndrome
(SARS), WHO has the capacity to coordinate product
testing and research of novel tobacco products, allow-
ing nations to work together to fulll their obligations
under the right to health.
H R I H R H 499
P H R / S–O 2006 / V 121
CONCLUSION
Even though harm reduction is not perceived to
be the most pressing issue facing many countries, it
is—based upon its dignity-enhancing and life-saving
potential—a fundamental component of the right
to health. Bolstered by the authoritative force of the
FCTC, countries have a unique opportunity to realize
their obligations under the right to health to aid those
addicted to nicotine. Researching and evaluating harm
reduction through the FCTC would give countries
direction in fullling their human rights obligations
in tobacco control.
The adoption of the FCTC—enabling countries to
overcome domestic and collective action problems to
achieve a common good—should be seen as a great
leap forward in tobacco control. While critical of the
FCTC’s approach, the authors cannot and will not
minimize the monumental importance of this effort,
which overcame signicant tobacco industry resis-
tance to become a valuable precedent for national
and global solutions to safeguard public health and
eradicate disease.
Harm reduction is not a panacea for the ills of
tobacco, but it could be, at best, a synergistic com-
plement to the other tobacco-control approaches
employed by the FCTC. Preventing initiation of
smoking and promoting cessation remain the primary
approaches of a comprehensive tobacco control pro-
gram. However, nicotine addiction involves complex
biological and psychological processes, and clearly no
single approach to treatment of this addiction will be
effective in addressing the individualized effects of nico-
tine products. In light of many countries’ widespread
failure to prevent initiation and promote cessation,
both before and after the FCTC, these countries have
a responsibility under the right to health not to deprive
smokers of a possibly efcacious means of reducing
harm through acceptable substitutes to conventional
nicotine self-administration.
Unlike cessation efforts, nations need not do any-
thing to introduce a harm-reduction strategy; private
corporations already are developing and marketing
these products without governmental encouragement.
Through a robust regulatory process, national and
international policymakers must be prepared to engage
these harm-reduction strategies and to assess the place-
ment of harm-reduction products within clinical best
practices. This will be a challenge that need not be
overcome on a country-by-country basis. Countries can
work together within WHO to address issues of tobacco
harm reduction, aiding each other in disseminating
the results of basic science and translating these results
into novel behavioral treatments, pharmacological
regimens, and tobacco products.
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