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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 CONSULTATIVE MEETING ON ESSENTIAL USE NOMINATIONS FOR CFCs FOR MDI MANUFACTURING NOMINATIONS FOR CFCs FOR MDI MANUFACTURING
IN ARTICLE 5 COUNTRIES BEYOND 2009IN ARTICLE 5 COUNTRIES BEYOND 2009
Brazilian Transition StrategyBrazilian Transition Strategy
Brazilian ContextBrazilian 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;
bromidrato de fenoterol 4MG/ML SOL AER DOSIF CT
TB AL X 15 ML + BOCAL + AE; 208.806
dipropionato de beclometasona TB C/ 15 ML
250 MG SPRAY; 441.320
dipropionato de beclometasona TB C/ 15 ML 250 MG SPRAY JET; 491.211
0
100.000
200.000
300.000
400.000
500.000
600.000
J AN2004
FEV2004
MAR2004
ABR2004
MAI2004
J UN2004
J UL2004
AGO2004
SET2004
OUT2004
NOV2004
DEZ2004
J AN2005
FEV2005
MAR2005
ABR2005
MAI2005
J UN2005
J UL2005
AGO2005
SET2005
OUT2005
NOV2005
DEZ2005
Mês
Nú
me
ro d
e a
pre
se
nta
çõ
es
bromidrato de fenoterol 4MG/ML SOL AER DOSIF CT
TB AL X 15 ML + BOCAL + AE; 208.806
dipropionato de beclometasona TB C/ 15 ML
250 MG SPRAY; 441.320
dipropionato de beclometasona TB C/ 15 ML 250 MG SPRAY JET; 491.211
0
100.000
200.000
300.000
400.000
500.000
600.000
J AN2004
FEV2004
MAR2004
ABR2004
MAI2004
J UN2004
J UL2004
AGO2004
SET2004
OUT2004
NOV2004
DEZ2004
J AN2005
FEV2005
MAR2005
ABR2005
MAI2005
J UN2005
J UL2005
AGO2005
SET2005
OUT2005
NOV2005
DEZ2005
Mês
Nú
me
ro d
e a
pre
se
nta
çõ
es
The red and blue line highlights the influence of the Ministry purchases in 2004 and 2005.
Source: ANVISA
Brazilian ContextBrazilian 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.
Brazilian Transition Strategy Brazilian Transition Strategy
Regulatory Actions 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 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 )
Brazilian Transition Strategy Brazilian Transition Strategy
Regulatory Actions 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 This medicine contains ODS and will be substitute. Consult your physician for more orientation”.your physician for more orientation”.
(Consulta Pública nº 104/2007)
Surveys and evaluation data of the MDIs manufacturers, Surveys and evaluation data of the MDIs manufacturers, importers, exporters, registers, identification of potential importers, exporters, registers, identification of potential conversion projects and alternative therapeutics;conversion projects and alternative therapeutics;
Behavior changing actions and advertisement with concise Behavior changing actions and advertisement with concise information and divulgation material;information and divulgation material;
Stimulates local governments to follow federal example;Stimulates local governments to follow federal example;
Establishes the Cooperation between Brazilian Pneumology Establishes the Cooperation between Brazilian Pneumology Society and the Ministry of Heath for education, divulgation and Society and the Ministry of Heath for education, divulgation and touching of the medical class;touching of the medical class;
In analyses by the Brazilian Congress a new law project In analyses by the Brazilian Congress a new law project prohibiting MDIs containing CFCs. prohibiting MDIs containing CFCs.
Brazilian Transition Strategy Brazilian Transition Strategy
Technical Actions Technical Actions
