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The 56 th World Health Assembly adopted on May 21, 2003 by Resolution WHA56.1 the WHO Framework Convention on Tobacco Control (FCTC). The FCTC is the first international agreement adopted by the World Health Organization since its establishment in 1948. Even though the Health Assembly is empowered, under Article 19 of the Constitution, to adopt conventions or agreements "with respect to any matter within the competence of the Organization," the WHO has shied away until now from this regulatory function, preferring a technical or policy approach to global public health problems. The adoption of the FCTC is the culmination of a four-year process launched in 1999 by the 52 nd World Health Assembly with Resolution WHA52.18. At the same time, it is a landmark development in the history of the WHO's efforts to address the tobacco epidemic and its health effects. Forty ratifications are required for the entry into force of the FCTC; both the Secretariat and many states which have supported the process are determined to maintain the current positive momentum to achieve an early entry into force. It was in the mid-1990s that the WHO Secretariat, based on a study by Professors Ruth Roemer and Allyn Taylor, proposed the development of a framework convention of a broad nature, supplemented by a number of thematic protocols. The idea of a framework convention, modeled on a number of recent environmental conventions, was presented as a compromise solution between a non-binding declaration and a single agreement, to engage states in an incremental and flexible normative exercise in a novel and diverse area. The precedents of environmental framework conventions, such as those on the protection of the ozone layer, climate change, biodiversity or the transboundary movement of hazardous wastes, have constituted a constant source of reference and guidance throughout the negotiations, both for Member States and the Secretariat. The development and negotiation of the Convention took place in two distinct stages. As a first step, the Health Assembly established a Working Group open to all Member States as well as regional economic integration organizations, to explore possible elements of the FCTC without engaging in negotiations on a draft text. This limited mandate was partly due to the reluctance of some states to immediately begin negotiations without a clearer idea of the possible scope and content of a future convention. The lack of experience of many WHO delegates in treaty negotiations also led to a more prudent and incremental approach. The Working Group held two sessions and submitted to the 53 rd Health Assembly in 2000 a list of possible draft elements. These elements had not been agreed upon by the Working Group and thus only served as a raw material for the subsequent round of negotiations. The actual negotiations were carried out by an Intergovernmental Negotiating Body (INB), which held six sessions between October 2000 and February 2003 and approved without a vote a final draft for submission to the 56 th World Health ...