1. Ministério da Saúde Secretaria de Vigilância em Saúde - SVS Coordenação Geral de Vigilância em Saúde Ambiental - CGVAM Bangkok - July 6 th, 2008 CONSULTATIVE MEETING ON ESSENTIAL USE NOMINATIONS FOR CFCs FOR MDI MANUFACTURING IN ARTICLE 5 COUNTRIES BEYOND 2009 Brazilian Transition Strategy

2. Brazilian Context Ministry of Health has the responsibility, established by law and normative acts, to distribute MDIs as a way to execute Health Attention Programs for Asthma and Chronic Obstructive Pulmonary Diseases and Disasters; Government is responsible for the highest MDIs consumption rates; The red and blue line highlights the influence of the Ministry purchases in 2004 and 2005. Source: ANVISA

3. Brazilian Context Government controls the medicine prices; The CFCs importation is just for the manufacturing of MDIs; In our country there are only Multinational manufacture companies acting in this field; Currently, most of the medicine alternatives are available in the market (some approved, some in review, some waiting for register), specially for beclometasone and salbutamol purchased by Ministry of Health; Some Municipalities and States are distributing MDIs CFCs free and no kind of adverse reaction have been noticed.

4. Brazilian Transition Strategy Regulatory Actions Ministry of Health is part of the Brazilian Interministerial Committee for Ozone Layer Protection. Specific regulation was established in order to create an official Working Group inside the Ministry of Health for planning, managing, monitoring and evaluating the implementation of the Montreal Protocol. The WG is composed by the National Sanitary Surveillance Agency and four main ministry sectors responsible for the government health policies implementation. (Normative Act/ Portaria GM/MS nº 1.788, August 1 st 2006) Specific Regulation established the “CFC absence criteria for the purchases of MDIs by the Ministry of Health from January, 1 st 2008”. (Normative Act/ Portaria GM/MS nº 2.799, October, 30 th 2007 )

5. Brazilian Transition Strategy Regulatory Actions Regulation of the National Agency of Sanitary Surveillance: forbids the production and importation of MDIs with CFC after January 1 st 2011; defines an adjustment of the current registers for MDIs with CFCs before December 31 th 2010; establishes that new registers for MDIs without CFCs will be priorized; Defines as an obligation the labeling of MDIs containing CFCs with key messages such as: “This medicine contains ODS and will be substitute. Consult your physician for more orientation”. (Consulta Pública nº 104/2007)

6. Surveys and evaluation data of the MDIs manufacturers, importers, exporters, registers, identification of potential conversion projects and alternative therapeutics; Surveys and evaluation data of the MDIs manufacturers, importers, exporters, registers, identification of potential conversion projects and alternative therapeutics; Behavior changing actions and advertisement with concise information and divulgation material; Behavior changing actions and advertisement with concise information and divulgation material; Stimulates local governments to follow federal example; Stimulates local governments to follow federal example; Establishes the Cooperation between Brazilian Pneumology Society and the Ministry of Heath for education, divulgation and touching of the medical class; Establishes the Cooperation between Brazilian Pneumology Society and the Ministry of Heath for education, divulgation and touching of the medical class; In analyses by the Brazilian Congress a new law project prohibiting MDIs containing CFCs. In analyses by the Brazilian Congress a new law project prohibiting MDIs containing CFCs. Brazilian Transition Strategy Technical Actions

7. Thank You! marie.kalyva@saude.gov.br+55.61.3213.8432