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Ministério da Saúde Secretaria de Vigilância em Saúde - SVS

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

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Ministério da Saúde Secretaria de Vigilância em Saúde - SVS

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

  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; Source: ANVISA The red and blue line highlights the influence of the Ministry purchases in 2004 and 2005.

  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 1st 2006) • Specific Regulation established the “CFC absence criteriafor the purchases of MDIs by the Ministry of Health from January, 1st 2008”. (Normative Act/ Portaria GM/MS nº 2.799, October, 30th 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 1st 2011; • defines an adjustment of the current registers for MDIs with CFCs before December 31th 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. Brazilian Transition Strategy Technical Actions • 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; • 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; • In analyses by the Brazilian Congress a new law project prohibiting MDIs containing CFCs.

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

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