REGULATION ON PHARMACEUTICALS AND MEDICAL DEVICES · > GDP 2014: US$ 2.240 bi > GDP per capita 2014: US$ 11,141 > Inflation rate 2014: 6.41 % > SELIC -Basic interest rate Jul/15:

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

A G E N D A

Healthcare environment

Medical Devices Market in Brazil

Brazilian Industrial policies

H E A L T H C A R EE N V I R O N M E N T

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

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

> 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

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

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

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

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 %

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

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

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

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

> 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

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

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

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

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

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

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

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

T R A D E S H O W S

CDSFIME 

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

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

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

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