1. Lessons From the Experience of the Framework Convention on Tobacco Control Professor Allyn Taylor Time Magazine

2. Recent Developments in Global Health Law l 2003 WHO Framework Convention on Tobacco Control l 2005 International Health Regulations l 2006 United Nations Convention on Disabilities l United Nations (failed) negotiations on a proposed convention on reproductive cloning l 2010 WHO Global Code of Practice on the International Recruitment of Health Personnel l 2011 WHO Pandemic Influenza Preparedness Framework l 2012 Protocol on Illicit Trade in Tobacco Products

3. Recent Developments in Global Health Law l Over 30 proposals for new global health treaties in last few years, including: l F ramework convention on infectious diseases l Framework convention on alcohol control l Framework convention on obesity l Framework convention on biomedical technology l Framework convention on global health l Framework convention on nanotechnology l Framework convention on R & D l Framework convention on occupational safety and health l Framework convention on health worker migration for the Caribbean l Binding instrument on marketing unhealthy foods and beverages to children l Treaty on global health l Protocol on polio l Treaty to reduce child deaths by 2025 l Essential health and biomedical R & D treaty l Treaty on health technology cost-effectiveness evaluation and competitive tender l Treaty on R & D for neglected diseases l 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.

4. Questions For Consideration for Future Global Health Law Negotiations l 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? l When is a global health issue ‘ripe’ for the negotiation of an international legal instrument? l How can we design international legal instruments to make them potent tools of health policy? l What are the critical legal, political and other factors that can contribute to the success or failure of global health lawmaking efforts?.

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

6. Context: Legal Authority for Global Health Lawmaking and Historical Neglect l WHO’s Constitution vests the Organization with broad legal authority to serve as a platform for treaty negotiations among Member States: l The Health Assembly shall have authority to adopt conventions or agreements with respect to any matter within the competence of the Organization. (Art. 19). l The objective of the World Health Organization shall be the attainment by all peoples of the highest possible level of health. (Art. 1). l Health has been historically neglected as a field of international legal concern.

7. WHA Resolution 49.17 (1996): A Critical First Step in Formal FCTC Process l 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: l deal with aspects of tobacco control that transcend national boundaries l include a strategy to encourage member nations to move progressively towards adoption of comprehensive tobacco control policies. l Resolution 49.17 was a critical first step in formal FCTC negotiation process: l Defined parameters of legal scope of FCTC. l Established negotiation of FCTC as a legal mandate of the Health Assembly.

8. Global Tobacco Control: Factors Contributing to “Ripeness” for International Lawmaking l The problem: globalization of the tobacco epidemic l Increasing recognition of need for innovative strategies, including mechanisms to enhance multilateral cooperation, to protect population health. l The politics: Evolution of WHO’s traditional organizational culture l Election of Dr. Gro Harlem Brundtland as WHO DG and creation of TFI to advance the FCTC. l The politics: Evolution of global political environment l Tobacco litigation in the United States, release of internal industry documents and transformation of public image of industry. l Damage awards. l The politics: tobacco industry “failing to take the FCTC seriously” l 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.

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

10. Global Perspective: Tobacco Pandemic

11. Industrialized Nations Tobacco-Related Death is a Major “Epidemic” in Developed Nations 5 0 Year Estimates, Death From Smoking 1950-2000 Developed Countries Only Age at DeathMaleFemale 35-6933 million4.8 million 70+19 million5.7 million Total52 million10.5 million Peto and Lopez

12. Legislation for Tobacco Control l Fiscal measures (taxes and subsidies) l Discouraging consumption by young people (including access and appeal of tobacco) l Environmental tobacco smoke measures l Packaging and labeling of tobacco products l Measures to control advertising, promotion and sponsorship l Mandatory health education l Measures to control smuggling l Treatment of tobacco dependence l Regulation of the tobacco product Ruth Roemer, JD 1918-2005

13. 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

14. 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

15. 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)

16. Transnational Dimensions of Tobacco Control l Taxes and prices l Smuggling l Advertising and sponsorship l Tobacco package design and labeling l International trade l Tobacco and agricultural policy l Testing, reporting and regulation of toxic and other constituents l International cooperation and information sharing l Duty free tobacco products

17. Transnational Dimensions of Advertising and Promotion: Spillover l Cable and satellite television l Movies and films l Foreign newspapers and magazines l Internet l Product promotion

18. Global Dimensions of Illicit Trade in Tobacco Products l Illicit trade in tobacco – smuggling, counterfeiting and other illegal manufacture as well as bootlegging - is a major international problem. l In 2006 it was estimated that illicit trade accounts for 10.7% of global cigarette sales or almost 600 billion cigarettes. l Illicit trade deprives governments of US$ billions in taxation, fuels organized crime and undermines tobacco control efforts.

19. Global Tobacco Control: Factors Contributing to “Ripeness” for International Lawmaking l The problem: globalization of the tobacco epidemic l Increasing recognition of need for innovative strategies, including mechanisms to enhance multilateral cooperation, to protect population health. l The politics: Evolution of WHO’s traditional organizational culture l Election of Dr. Gro Harlem Brundtland as WHO DG and creation of TFI to advance the FCTC. l The politics: Evolution of global political environment l Tobacco litigation in the United States, release of internal industry documents and transformation of public image of industry. l Damage awards. l The politics: tobacco industry “failing to take the FCTC seriously” l 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.

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

21. éTreatment of tobacco dependence Possible Protocols to the FCTC éAgricultural policies éEnvironmental Tobacco Smoke éHealth Education & Research éTesting and reporting of ingredients éProduct regulation éAdvertising and sponsorship éProtecting children and adolescents éIllicit Trade éDuty-free sales éTobacco taxes/price

22. 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)

23. Content: The Final Text of the FCTC l “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). l “I tried to kill the FCTC. I succeeded in giving it cerebral palsy.” ( US FCTC Negotiator).

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

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

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

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

28. Limitations of the Final FCTC Text: Strategic Miscalculations l 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). l 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. l 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.

29. Has The FCTC Been Effective? l Meanings of ‘Effective’: l Legal Effectiveness: do outcomes conform with rule requirements? l Behavioral Effectiveness: Has the FCTC encouraged states to modify their behavior in the ‘right’ direction? l Problem Solving Effectiveness: Has the FCTC solved the global tobacco problem it addresses? l Difficulties in Measuring Effectiveness of FCTC: l Most of the substantive obligations are broad and general. l FCTC implementation procedures remain underdeveloped. l If the FCTC has been effective, is this due to endogenous factors related to treaty elements or exogenous political factors?

30. The impact of the FCTC and FCTC negotiation process for global tobacco control: the ‘power of the process’ l The sheer process of negotiating an international instrument can stimulate national action and international cooperation long before instrument is adopted: l Negotiation process can bring an issue to the global stage. l Negotiation process can bring together different ministries within national governments to forge national solutions. l Negotiation process can encourage the development of national coalitions and international partnerships. l Negotiation process can promote the development and coordination of civil society, nationally and internationally.

31. Lessons From The FCTC for Future Negotiations l Lesson 1: Context matters.:policymakers should assess whether or not there is political will for global health lawmaking. l 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. l 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.

32. Lessons From The FCTC for Future Negotiations l 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. l Lesson 5: Above all, global health lawmaking is not a panacea.