Globalisation of the Tobacco Epidemic - Allyn Taylor Presented on Monday 9th June 2014.

1. The Contribution of International Law
to Global Health Governance
Lessons from the Experience of the WHO
Framework Convention on Tobacco Control
Allyn Taylor
Georgetown University Law Center
O’Neill Institute for National and Global Health Law

2. Potential Role of International Law in Global
Health Governance
Historically, health has been neglected as a matter of international
legal concern.
WHO adopted its first convention, the FCTC, in 2003. Since the
adoption of the FCTC, interest in international health law making has
grown significantly.
International law can be understood, in part, as one policy tool that
can be used by the international community to promote global action,
cooperation and coordination on public health matters.
The tool of international law may become increasingly important as a
consequence of the globalization of public health as more issues
transcend national boundaries and demand global cooperation.

3. 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

4. Over 30 proposals for new global health treaties in last few years, including:
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.
Recent Developments in Global Health Law

5. 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?
How can we design international legal instruments to make them
potent tools of health policy?
What are the critical legal, political and other factors that can
contribute to the success or failure of global health lawmaking
efforts?
.
Questions for Consideration for Future Global
Health Law Negotiations

6. [A]analysis 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 Policy-Making Improve Health Outcomes?”).
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.
Lessons from the FCTC for Future Global Health
Lawmaking Efforts: Process and Power in Global Health
Law Negotiations

7. WHO’s Constitution vests the Organization with broad legal authority
to serve as a platform for treaty negotiations among Member States:
The Health Assembly shall have authority to adopt conventions or
agreements with respect to any matter within the competence of
the Organization. (Art. 19).
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.
Context: WHO Legal Authority for Global
Health Lawmaking and Historical Neglect

8. 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:
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:
defined parameters of legal scope of FCTC.
established negotiation of FCTC as a legal mandate of the Health
Assembly.
WHA Resolution 49.17 (1996): A Critical First
Step in the Formal FCTC Process

9. The problem: globalization of the tobacco epidemic
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
Tobacco litigation in the United States, release of internal industry
documents and transformation of public image of industry.
World Bank report on the economics of tobacco.
Damage awards.
The politics: tobacco industry “failing to take the FCTC seriously”
State and industry interests opposed to regulation didn't’t take
international legislative efforts seriously until legal process was too
late to reverse without legal action from the Health Assembly.
Global Tobacco Control: Factors Contributing
to “Ripeness” for International Lawmaking

10. Tobacco use kills 5.4 million people
a year.
Based on current trends, tobacco
will cause 8 million annual deaths
by 2030, with 80% of those deaths
occurring in low-income countries.
By 2020, it is estimated that only
15% of the world’s smokers will live
in high-income countries.
WHO
The Problem: Global Burden of Disease and
Globalization of Epidemic

11. 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.
Google Images & John’s Hopkins SPH
Globalization of the Tobacco Epidemic: The Contribution
of International Lawmaking to Global Tobacco Control

12. Taxes and prices
Smuggling
Advertising and
sponsorship
Tobacco package
design and labeling
International trade
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 Tobacco
Control

13. Cable and satellite
television
Movies and films
Foreign newspapers and
magazines
Internet
Product promotion
(SWAG)
Transnational Dimensions of Tobacco
Advertising and Promotion: Spillover

14. The problem: globalization of the tobacco epidemic
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
Tobacco litigation in the United States, release of internal industry
documents and transformation of public image of industry.
Damage awards.
World Bank report and economics of tobacco control.
The politics: tobacco industry “failing to take the FCTC seriously”
State and industry interests opposed to regulation didn't’t take
international legislative efforts seriously until legal process was too
late to reverse without legal action from the Health Assembly.
Global Tobacco Control: Factors Contributing
to Ripeness for International Lawmaking

15. No technical legal meaning
Step 1: Framework Convention
International cooperation in achieving broadly stated
goals and institutions for global governance.
Future Steps: Protocols
Specific measures designed to implement goals of the
parent framework convention or add further institutional
commitments.
Framework Convention-Protocol Approach: A
Dynamic Model of Global Lawmaking

16. Treatment of
tobacco
dependence
Agricultural
policies
Environmental Tobacco Smoke
Health Education & Research
Testing and reporting of
ingredients
Product regulation
Advertising and sponsorship
Protecting children and
adolescents
Illicit Trade
Duty-free sales
Tobacco
taxes/price
Possible Protocols to the FCTC

17. FCTC Timeline
•First Session of the INB (October 2000)
Chair’s Text: January 2001
•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)
• 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)
•Adoption (May 2003)
•Entry into Force (February 2005)

18. “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.” ( FCTC
Negotiator).
Content: The Final Text of the FCTC

19. National measures to combat the
problem
Education, training, public awareness
Cooperation in scientific research
Financial and technical assistance
Framework Conventions: General
Obligations

20. General Obligations (Art. 5).
Measures Relating to Reduction of Demand (Arts. 6-14).
Price and tax measures; environmental tobacco smoke; regulation
of tobacco product contents; tobacco product disclosures;
packaging; advertising, and; cessation.
Measures Relating to Reduction of Supply (Arts.15-17).
Protection of Environment (Article 18).
Scientific and Technical Cooperation and Communication of Information
(Articles 20-22).
The FCTC Final Text: A Catalog of
Substantive Obligations

21. Science
advisory
body
Implementation
body
Financial
mechanism
Meeting of
the contracting parties
Secretariat
The FCTC: A Limited Institutional Framework

22. Powerful industry opposition to
FCTC.
Inexperienced NGO community.
Inexperienced secretariat.
Failure of Member States to
“take FCTC process seriously.”
Challenges to Lawmaking During FCTC
Negotiations

23. 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).
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.
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.
Limitations of the Final FCTC Text: Strategic
Miscalculations

24. Meanings of ‘Effective’:
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?
Difficulties in Measuring Effectiveness of FCTC:
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?
Has the FCTC Been Effective?

25. The sheer process of negotiating an international instrument can
stimulate national action and international cooperation long before
instrument is adopted.
Negotiation process can bring an issue to the global stage.
Negotiation process can bring together different ministries within
national governments to forge national solutions.
Negotiation process can encourage the development of national
coalitions and international partnerships.
Negotiation process can promote the development and
coordination of civil society, nationally and internationally.
The Impact of the FCTC and FCTC Negotiation Process
on Global Tobacco Control: the ‘power of process’

26. Protocol is designed to prevent and counteract the illicit trade of tobacco products
through national measures and international cooperation.
Illicit trade in cigarettes to evade tobacco taxes is the biggest area of concern.
National Measures include:
licenses for the manufacture, import, and export of tobacco products and
equipment;
establishment of national or regional tracking and tracing systems for tobacco
products manufactured in, or imported into, the state;
and the creation of sanctions for the illicit manufacture or smuggling of tobacco
products and the destruction of confiscated materials.
International Cooperation
Global tracking and tracing regime.
International cooperation between parties for investigations, legal assistance,
and extradition.
2013 FCTC Protocol to Eliminate Illicit Trade
in Tobacco Products

27. States are primarily regulating e-cigarettes under two different product
categories:
E-Cigarette Regulation
Regulated as a Tobacco
Product
Regulated as a Product with
Health/Therapeutic Claims
Belgium
Bhutan
Brazil
Republic of Korea
Norway
The Seychelles
Singapore
Uruguay
Australia
Belgium
Canada
Germany
Hungary
Japan*
New Zealand
Norway
Turkey
United Kingdom*
Uruguay*
(WHO 2012)*Regulated as a product with health/therapeutic claims w/ or w/o nicotine

28. Lesson 1: Context matters - policymakers
should assess whether or not there is political
will for global health lawmaking.
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.
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

29. 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.
Lesson 5: Above all, global health
lawmaking is not a panacea.
Lessons from the FCTC for Future
Negotiations