regulation on pharmaceuticals and medical devices · > gdp 2014: us$ 2.240 bi > gdp per...
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2 n d B R A Z I L - J A P A N S E M I N A R
R E G U L A T I O N O N P H A R M A C E U T I C A L SA N D M E D I C A L D E V I C E S
V I E W O F M D A S S O C I A T I O N S
S e p t e m b e r 1 0 t h , 2 0 1 5
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A G E N D A
Healthcare environment
Medical Devices Market in Brazil
Brazilian Industrial policies
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H E A L T H C A R EE N V I R O N M E N T
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Economy
> GDP 2014: US$ 2.240 bi
> GDP per capita 2014: US$ 11,141
> Inflation rate 2014: 6.41 %
> SELIC - Basic interest rate Jul/15: 14.25 %
> GDP growth 2014: 0.1 %
> GDP growth exp. 2015: -1,5 %
Labor
> Urban unemployment: 7,1% (2014)
M A C R O D A T A
Source: IBGE, BC, Copom, PNAD
Population
> 201.3 mil. Inhabitants (Aug. 2013)
> Growth rate: 1,7% per year
> Life expectancy: 71.3 m / 78.6 w
> Illiteracy: 8.7% (> 15y) 2012
Geography
> 8.514 million km2
> ~ 5,560 cities
> 7,500 km coastline
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15.
7
62.
6
5.2
3.8
12.
6
14.
8
42.
5
6.6
28.9
7.245.
3 18.
2
18.
9
10.
9
6.8
A C O U N T R Y O F C O N T R A S T S
Source: IBGE, BC, Copom, PNAD
% of land
% of population
% of total GDP
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> 60 % covered by public services
> 40 % covered by private services
H E A L T H C A R E E X P E N D I T U R E S 2 0 1 0
> 47 % covered by public services
> 53 % covered by private services
Worldwide
10.2 % of global GNP: US$ 7.6 tri.Brazil
9,4 % of GDP: US$ 212 bi. (7th largest in the world)
Source: WHO
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H E A L T H C A R E E X P E N S E S
Billions of USD in 2010
Source: WHO
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TOTAL EXPENDITUREON HEALTH (9,1% GDP)
PUBLIC HEALTH (43%)R$ 216.2 bi 2.9% GNP
PRIVATE HEALTH (57%)R$ 286.2 bi 5.2% GNP
SUPPLEMENTARY HEALTHCARE
(INCOME) R$ 127.2 bi2.3% GNP
Federal (43.4%)
R$ 93.8bi 1.7% GNP
State(23.2%)
R$ 50.2 bi0.9% GNP
Municipal (33.4%)
R$ 72.2bi1.3 % GNP
OUT-OF-POCKET EXPENDITURES
WITH HEALTHCAREAND DRUGSR$ 159.1 bi
2.9% GNP
Source: WHO/ans 2014
R$ 502.4 bi
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6,300 hospitals (70 % private)
494,740 hospital beds
95,990 supplementary
healthcare services
Source: CNES, CFM Jan 2015
B R A Z I L I A N H E A L T H C A R E F I G U R E S
432,523 physicians
2,58 million other healthcare
professionals
143,998 dentists
70,000 drugstores
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Micro Up to R$ 240 thousand
Small From R$ 241 to R$ 2.4 millions
Medium from R$ 2.4
to R$ 6 millions
Medium/LargeFrom R$ 6 to R$ 50 millions
LargeAbove R$ 50 millions
Source: MDIC, PIA/IBGE
C O M P A N I E S B Y S I Z E ( % )
58,6 %10,7 %
3,3 %
14,7 %
14,7 %
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Total ofcompanies4.032
D I S T R I B U T I O N O F C O M P A N I E S
Source: FGV
8
22
211
24
22
43
47
130
76
22
30
29
87
31
112
542
292
190
101
2201447
345
35
41
114
9
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P O P U L A T I O N P Y R A M I D
Source: ANAHP / IBGE
11,3 % of elderly population (60 years old or +)
23 million 41,5 million
18,6 % of elderly population (60 years old or +) Brazil2014 to 2030
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N o n c o m m u n i c a b l e d i s e a s e s - N C D
Source: ANAHP / IBGE
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M E D I C A L D E V I C E S M A R K E T
I N B R A Z I L
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> US$ 670 bi - Pharma
> US$ 9 bi - Vaccines
> US$ 25 bi - IVD - Invitro Diagnosis
> US$ 300 bi - MD - Medical Devices (Brazil: U$ 11 bi)
Total market: US$ 1 tri
Source: WHO
M E D I C A L M A R K E T
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Source: Websetorial
M E D I C A L D E V I C E S M A R K E T
14,000 companies
140,000 employees
0.6 % - GNP
Taxes: US$ 2.4 bi
Import: US$ 4.5 bi
Export: US$ 700 mi
Local production: US$ 3.1 bi
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Source: FGV; 2015: estimative
R E V E N U E S B Y I N D U S T R I A L S E G M E N T I N R $ B I
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Source: ALICEWEB e FGV 2015 -Estimative
B R A Z I L : T R A D E B A L A N C E I N U S $ B I
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B R A Z I L I A NI N D U S T R I A L
P O L I C I E S
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H O W B R A Z I L I A N I N D U S T R I A L P O L I C I E S C O N T R I B U T E T O R & D
M I N I S T R Y O F H E A L T H P O L I C I E S
> PDP – Partnership for Productive Development (Ord. 2888/2014) Technology transfer x governmental procurement
> Offset model – e.g.: Linear accelerators for radiotherapy
M D I C A N D M C T I P O L I C Y
> PPB – Basic Productive Process e.g.: Imaging products
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P R O J E C T B R A Z I L I A N H E A L T H D E V I C E S
Started in 2002 with 82 participating companies
165 companies are active members
These companies represent 32% of total Brazilian exports of health products
Brazilian health products exports have grown by over 260% since 2002
Aim to increase Brazilian exports of health products
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P R O J E C T B R A Z I L I A N H E A L T H D E V I C E S
Business intelligence department that provides information and elaboration of international market analyses
Participation in major international fairs around the world in Brazilian pavilions
Organization and promotion of trade missions for business rounds with distributors
Business rounds in major national fairs
Training courses for export and international certification
Program incentive FDA and CE certifications
International Project, which consists in allocating a sales representative abroad
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T R A D E S H O W S
CDSFIME
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M E D I C A L D E V I C E S E X P O R T M A I N P R O D U C T S
Odonthology: chairs, dental implants, consummables
Catheters, suture needles
Radiology
Orthopaedic implants and articles
Neonatal incubators
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Source: ALICEWEB
E X P O R T S B R A Z I L – M A I N C O U N T R I E S
US$ FOB million
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Source: ALICEWEB
I M P O R T S B R A Z I L - M A I N C O U N T R I E S
US$ FOB million
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T R E N D S
H I G H L I G H T S
> Focus on post-market activities
> Rationalization of regulation (with safety)
> Rational use of surveillance system (3 government levels)
> Good Regulatory Practices