Transcript here - Erasmus Observatory on Health Law

Lessons From the Experience of the
Framework Convention on Tobacco Control
Professor Allyn Taylor
Time Magazine
Recent Developments in Global Health Law
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2003 WHO Framework Convention on Tobacco Control
2005 International Health Regulations
2006 United Nations Convention on Disabilities
United Nations (failed) negotiations on a proposed convention on
reproductive cloning
2010 WHO Global Code of Practice on the International Recruitment of
Health Personnel
2011 WHO Pandemic Influenza Preparedness Framework
2012 Protocol on Illicit Trade in Tobacco Products
Recent Developments in Global Health Law
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Over 30 proposals for new global health treaties in last few years, including:
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Framework convention on infectious diseases
Framework convention on alcohol control
Framework convention on obesity
Framework convention on biomedical technology
Framework convention on global health
Framework convention on nanotechnology
Framework convention on R & D
Framework convention on occupational safety and health
Framework convention on health worker migration for the Caribbean
Binding instrument on marketing unhealthy foods and beverages to children
Treaty on global health
Protocol on polio
Treaty to reduce child deaths by 2025
Essential health and biomedical R & D treaty
Treaty on health technology cost-effectiveness evaluation and competitive tender
Treaty on R & D for neglected diseases
The proliferation of global health treaty proposals in the last few years reflects
the pervasive influence of the perceived success of the FCTC. However,
widespread enthusiasm for new lawmaking has not always been accompanied by
sound legal and political analysis of the context and circumstances.
Questions For Consideration for Future Global
Health Law Negotiations
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Under what circumstances is international law an effective tool for global
health policymaking? What are the trade-offs involved in pursuing
alternative legal and non-legal strategies?
When is a global health issue ‘ripe’ for the negotiation of an international
legal instrument?
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How can we design international legal instruments to make them potent
tools of health policy?
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What are the critical legal, political and other factors that can contribute to
the success or failure of global health lawmaking efforts?
Lessons from the FCTC for Future Global
Health Lawmaking Efforts:
Process and Power in Global Health Law
Negotiations
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[A]nalysis of power and process can add value to those attempting to
influence policy change (Buse. et. al., “How Can Analysis of Power and Process in PolicyMaking Improve Health Outcomes?”).
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A close and systematic analysis of the factors (context, process,
content and actors) that affected the negotiations of the FCTC can
provide important guidance for future global health lawmaking
endeavors.
Context:
Legal Authority for Global Health Lawmaking and
Historical Neglect
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WHO’s Constitution vests the Organization with broad legal authority to
serve as a platform for treaty negotiations among Member States:
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The Health Assembly shall have authority to adopt conventions or
agreements with respect to any matter within the competence of the
Organization. (Art. 19).
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The objective of the World Health Organization shall be the attainment
by all peoples of the highest possible level of health. (Art. 1).
Health has been historically neglected as a field of international legal
concern.
WHA Resolution 49.17 (1996):
A Critical First Step in Formal FCTC Process
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The Health Assembly Resolution 49.17 called upon the Director General of
WHO to initiate development of a framework convention in accordance with
Article 19 of the WHO Constitution to:
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deal with aspects of tobacco control that transcend national boundaries
include a strategy to encourage member nations to move progressively
towards adoption of comprehensive tobacco control policies.
Resolution 49.17 was a critical first step in formal FCTC negotiation
process:
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Defined parameters of legal scope of FCTC.
Established negotiation of FCTC as a legal mandate of the Health
Assembly.
Global Tobacco Control: Factors Contributing to
“Ripeness” for International Lawmaking
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The problem: globalization of the tobacco epidemic
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Increasing recognition of need for innovative strategies, including
mechanisms to enhance multilateral cooperation, to protect
population health.
The politics: Evolution of WHO’s traditional organizational culture
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Election of Dr. Gro Harlem Brundtland as WHO DG and creation
of TFI to advance the FCTC.
The politics: Evolution of global political environment
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Tobacco litigation in the United States, release of internal industry
documents and transformation of public image of industry.
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Damage awards.
The politics: tobacco industry “failing to take the FCTC seriously”
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State and industry interests opposed to regulation didn’t take
international legislative efforts seriously until legal process was
too late to reverse without legal action from the Health Assembly.
The Problem:
Global Burden of Disease and Globalization of Epidemic
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Tobacco use kills 5.4 million
people a year.
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Based on current trends,
tobacco will cause 8 million
annual deaths by 2030, with
80% of those deaths occurring
in developing countries.
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By 2020, it is estimated that
only 15% of the world’s
smokers will live in developed
countries.
WHO
Global Perspective: Tobacco Pandemic
Industrialized Nations
Tobacco-Related Death is a Major “Epidemic” in Developed
Nations
50 Year Estimates, Death From Smoking 1950-2000
Developed Countries Only
Age at Death
Male
Female
35-69
33 million
4.8 million
70+
19 million
5.7 million
Total
52 million
10.5 million
Peto and
Legislation for Tobacco Control
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Fiscal measures (taxes and subsidies)
Discouraging consumption by young
people (including access and appeal of
tobacco)
Environmental tobacco smoke measures
Packaging and labeling of tobacco
products
Measures to control advertising,
promotion and sponsorship
Mandatory health education
Measures to control smuggling
Treatment of tobacco dependence
Regulation of the tobacco product
Ruth Roemer, JD
1918-2005
Why is Domestic Legislation Important?
“Legislation can express government policy on the
production, promotion and use of tobacco;
emphasize government’s commitment to
combating smoking by allocating resources to
effective anti-tobacco programmes; launch
governmental and voluntary anti-smoking
activities; encourage smokers to stop smoking and
dissuade potential smokers from starting to
smoke; protect the rights of non-smokers from
passive smoking; and contribute to a climate of
opinion and social pressure in which smoking is
unacceptable.”
Source: Ruth Roemer
Globalization of the Tobacco Epidemic:
The Contribution of International
Lawmaking to Global Tobacco Control
The tobacco epidemic is being
spread and reinforced through
complex mix of factors that
transcend national borders
Globalization of the epidemic
restricts the capacity of countries to
regulate tobacco through domestic
legislation alone
Impact of International Trade Liberalization
on Tobacco Consumption
The recent trend towards the
increased liberalization of trade
in most good and services has
significantly reduced high-tariff
and non-tariff barriers to trade in
tobacco and tobacco products
and contributed to the sharp
increase in tobacco use in many
low-income and middle income
countries.
(Taylor, Chaloupka, Guindon & Corbett,
2000)
Transnational Dimensions of Tobacco Control
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Taxes and prices
Smuggling
Advertising and
sponsorship
Tobacco package design
and labeling
International trade
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Tobacco and agricultural
policy
Testing, reporting and
regulation of toxic and
other constituents
International cooperation
and information sharing
Duty free tobacco
products
Transnational Dimensions of Advertising and
Promotion: Spillover
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Cable and satellite
television
Movies and films
Foreign newspapers
and magazines
Internet
Product promotion
Global Dimensions of Illicit Trade in
Tobacco Products
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Illicit trade in tobacco – smuggling,
counterfeiting and other illegal manufacture
as well as bootlegging - is a major
international problem.
In 2006 it was estimated that illicit trade
accounts for 10.7% of global cigarette sales
or almost 600 billion cigarettes.
Illicit trade deprives governments of US$
billions in taxation, fuels organized crime
and undermines tobacco control efforts.
Global Tobacco Control: Factors Contributing to
“Ripeness” for International Lawmaking
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The problem: globalization of the tobacco epidemic
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Increasing recognition of need for innovative strategies, including
mechanisms to enhance multilateral cooperation, to protect
population health.
The politics: Evolution of WHO’s traditional organizational culture

Election of Dr. Gro Harlem Brundtland as WHO DG and creation
of TFI to advance the FCTC.
The politics: Evolution of global political environment
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Tobacco litigation in the United States, release of internal industry
documents and transformation of public image of industry.
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Damage awards.
The politics: tobacco industry “failing to take the FCTC seriously”
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State and industry interests opposed to regulation didn’t take
international legislative efforts seriously until legal process was
too late to reverse without legal action from the Health Assembly.
Framework Convention-Protocol Approach
A Dynamic Model of Global Lawmaking
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No technical legal meaning
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Step 1: Framework Convention
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International cooperation in achieving broadly stated goals and institutions
for global governance.
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Future Steps: Protocols
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Specific measures designed to implement goals of the parent framework
convention or add further institutional commitments.
Possible Protocols to the FCTC
Testing and reporting of
ingredients
Product regulation
Duty-free sales
Tobacco
taxes/price
Agricultural
policies
Illicit Trade
Treatment of
tobacco
dependence
Environmental Tobacco Smoke
Health Education & Research
Advertising and sponsorship
Protecting children and
adolescents
FCTC Timeline
•First Session of the INB (October 2000)
Chair’s Text: January 2001
Second Session (April 2001)
•Third Session (November 2001)
•Fourth Session (March 2002)
•Fifth Session (October 2002) (New Chair’s Text)
•Sixth Session (February 2003)
•Adoption (May 2003)
•Entry into Force (February 2005)
Content:
The Final Text of the FCTC
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“It was in fact developing countries
which saved the FCTC from being
gutted by a handful of developed
countries which have no intention of
ever implementing most of its
provisions.” (Hammond and Assunta).
“I tried to kill the FCTC. I succeeded
in giving it cerebral palsy.” (US FCTC
Negotiator).
Framework Conventions:
General Obligations
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National measures to combat the
problem
Education, training, public
awareness
Cooperation in scientific research
Financial and technical assistance
The FCTC Final Text:
A Catalog of Substantive Obligations
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General Obligations (Art. 5).
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Measures Relating to Reduction of Demand (Arts. 6-14).
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Price and tax measures; environmental tobacco smoke; regulation of
tobacco product contents; tobacco product disclosures; packaging;
advertising, and; cessation.
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Measures Relating to Reduction of Supply (Arts.15-17).
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Protection of Environment (Article 18).
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Scientific and Technical Cooperation and Communication of Information
(Articles 20-22).
The FCTC: A Limited Institutional
Framework
Meeting of
the contracting parties
Science
advisory
body
Implementation
body
Secretariat
Financial
mechanism
Challenges to Lawmaking During FCTC
Negotiations
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Powerful industry opposition to
FCTC.
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Inexperienced NGO community.
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Inexperienced secretariat.
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Failure of Member States to “take
FCTC process seriously.”
Limitations of the Final FCTC Text:
Strategic Miscalculations
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As a general rule, there is a trade-off in treaty design
between scope of participation and depth of coverage.
The more concrete and detailed a treaty is, the few
countries that are likely to join. (Barrett).
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A lack of realistic assessment about the potential scope
of participation and depth of coverage haunted the
FCTC negotiations as developing countries sought to
incorporate highly detailed substantive obligations in
text.
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While attention was focused on FCTC substantive
obligations, decisions on strategic legal and institutional
mechanisms were held in negotiation sessions open to
all Member States in which no developing countries
participated.
Has The FCTC Been Effective?
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Meanings of ‘Effective’:
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Difficulties in Measuring Effectiveness of FCTC:
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Legal Effectiveness: do outcomes conform with rule
requirements?
Behavioral Effectiveness: Has the FCTC encouraged states to
modify their behavior in the ‘right’ direction?
Problem Solving Effectiveness: Has the FCTC solved the
global tobacco problem it addresses?
Most of the substantive obligations are broad and general.
FCTC implementation procedures remain underdeveloped.
If the FCTC has been effective, is this due to endogenous
factors related to treaty elements or exogenous political
factors?
The impact of the FCTC and FCTC negotiation
process for global tobacco control:
the ‘power of the process’
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The sheer process of negotiating an international instrument can stimulate
national action and international cooperation long before instrument is
adopted:
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Negotiation process can bring an issue to the global stage.
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Negotiation process can bring together different ministries within
national governments to forge national solutions.
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Negotiation process can encourage the development of national
coalitions and international partnerships.
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Negotiation process can promote the development and coordination of
civil society, nationally and internationally.
Lessons From The FCTC for Future
Negotiations
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Lesson 1: Context matters.:policymakers should assess
whether or not there is political will for global health
lawmaking.
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Lesson 2: Legal design matters: instruments can be
structured to encourage participation and compliance. To
the extent we can improve effectiveness of legal
instruments ‘endogenously’ through better legal design,
then this could help us negotiate more effective treaties.
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Lesson 3: In order to achieve an optimal outcome,
participants need to start negotiations with a realistic
assessment of likely outcome and consider what legal
incentives should be included in an instrument to
promote commitment and compliance.
Lessons From The FCTC for Future
Negotiations
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Lesson 4: Policymakers should consider alternative legal
designs. The value of a legal instrument does not lie
exclusively in its legal structure, but also in the political
process that it generates.
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Lesson 5: Above all, global health lawmaking is not a
panacea.