Ministrio da Sade

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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
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• 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.
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• 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.

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• 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
  criteria for the purchases of MDIs by the
  Ministry of Health from January, 1st 2008.
  (Normative Act/ Portaria GM/MS nº 2.799, October,
  30th 2007 )

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• 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)
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• 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.

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Thank You!
marie.kalyva_at_saude.gov.br 55.61.3213.8432
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