Globalisation of the Tobacco Epidemic - Allyn Taylor

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

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.

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

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

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?

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Questions for Consideration for Future Global Health Law Negotiations

[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

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

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

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

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

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

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

Cable and satellite television

Movies and films

Foreign newspapers and magazines

Internet

Product promotion (SWAG)

Transnational Dimensions of Tobacco Advertising and Promotion: Spillover

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

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

Treatment of tobacco dependence

Agricultural policies

Environmental Tobacco SmokeHealth Education & Research

Testing and reporting of ingredientsProduct regulation

Advertising and sponsorshipProtecting children and adolescents

Illicit Trade

Duty-free salesTobacco

taxes/price

Possible Protocols to the FCTC

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)

“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

National measures to combat the problem

Education, training, public awareness

Cooperation in scientific research

Financial and technical assistance

Framework Conventions: General Obligations

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

Scienceadvisory

body

Implementationbody

Financial mechanism

Meeting of the contracting parties

Secretariat

The FCTC: A Limited Institutional Framework

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

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

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?

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’

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

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

BelgiumBhutanBrazil

Republic of KoreaNorway

The SeychellesSingaporeUruguay

AustraliaBelgium Canada

Germany HungaryJapan*

New ZealandNorway Turkey

United Kingdom*Uruguay*

(WHO 2012)*Regulated as a product with health/therapeutic claims w/ or w/o nicotine

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

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