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10 YEARS OF GENERIC MEDICINES
IN BRASIL.
Growth – Earnings – Challenges
PróGenéricos - Generic Medicines Industries Association
Odnir Finotti - CEO
Brasil Population profile x Income x medicines access restriction
Fonte: IBGE (POF), SM = Salário Mínimo
More than US$5800
5%
US$2325 to US$5800
14%
US$930 to US$2325
31%
Bellow US$930
50%
Access Restriction
• No
• 30 – 40%
• 50 – 65%
• Above 65%
Private HealthPlan
• 78%
• 53%
• 29%
• 8%
A
B
C
D
• Generic medicines was created by Law Decree 9.787,
in 1999.
• It introduced the concept of interchangeble medicines
with bioequivalence proof regarding reference
products.
• First product launched in market: Feb/2000
Laws help to create new markets should entrepereneurs
see opportunities.
Objective and challenge: Increase access to reliable
medicines by improving offer and fostering
competitiveness to reduce price.
source: Companies – Pró Genéricos
Investments and Destination
From 1999 to 2004 = US$ 170 million
More US$ 354 million forecasted until 2010.
63%
24%
9%4%
Pharmaceutical and
Bioequivalence Tests
GMP Adjustments
Developing of New
Generic Drug
Increase Productive
Capacity
Employment Growth rate.
1999 = 100%
source: Companies – Pró Genéricos
11,0%
13,9%
21,2%
22,9%
26,8%
44,5%
2000 2001 2002 2003 2004 2005
GENERIC MEDICINES IN
BRAZIL
ACTUAL DATA
Generic Medicines = Market Authorization
source: Anvisa –Jun/2009
90% of the most known diseases
can be treated with generic
medicines.
89 pharmaceutical companies hold registers for Generic
Medicines .
# of Market Authorization
Manufacture Site Origin.
2.405
193
27
17
13
8
9
20
Brazil
India
Germany
Canada
Israel
Austria
Argentina
Others
Source: IMS Health
88,6% are developed and
manufactured locally in
Brasil.
Market Survey – Evolution Index
Source: IMS Health
Generic Medicines growth rate is much higher than those for
the total market.
Generic Medicines Market Share Market Survey – Evolution Index
Generic Medicines has constantly gaining market share
4 companies out of 10 largest pharmaceutical companies are
generic medicines producers.
Source IMS Health
PHARMACEUTICAL MARKET BRASIL - 10 TOP COMPANY RANKING
COMPANYMoving Annual Total - March
% Part.1999 2005 2006 2007 2008 2009
EMS 29° 5° 3° 2° 1° 1° 6,59
SANOFI-AVENTIS 1° 1° 1° 2° 2° 2° 6,24
ACHÉ 3° 2° 2° 3° 3° 3° 5,68
MEDLEY (SA) 32° 7° 6° 4° 4° 4° 5,67
NOVARTIS 2° 4° 4° 5° 5° 5° 4,1
EUROFARMA 28° 9° 8° 6° 6° 6° 3,90
PFIZER 7° 3° 5° 6° 7° 7° 3,06
BAYER SCHERING 23° 6° 7° 7° 8° 8° 2,86
ASTRA ZENECA 19° 22° 20° 15° 12° 9° 2,37
BOEHRINGER 11° 8° 9° 9° 9° 10° 2,24
Generic Medicines have contributed to
the development of the local companies.
RESULTS
AND
EARNINGS
Generic medicines must be 35% cheaper
than reference products (inovators).
Actually they have been 50% cheaper.
Generic Medicines - Increase access to
reliable products while saving money for
the patients.
Quite effective in providing more access to
reliable and cheaper medicines while
expanding the market.
3.6
00
4.7
51
6.1
01
7.2
79
8.4
90
10
.2
21
11
.4
32
3.109
3.612
4.297
4.856
5.197
5.798
6.743
3.267
2.887
2.681
2.459
2.329
2.178
2.041
9.9
76
11
.2
50
13
.0
79
14
.5
95
16
.0
15
18
.1
98
20
.2
16
2,003 2,004 2,005 2,006 2,007 2,008 2,009
GENERICOS SIMILARES MARCAS REFERENCIA TOTAL
ATENOLOL = million units
56
,5
%
brand referencegenerics
Generic 65% cheaper than reference product(Atenol®)
Patent expired in Feb 07. Legal actions
delayed Generic launch
26
7,8
13
32
6,6
74
40
4,0
17
54
7,9
66
45
9,6
85
21
2,4
50
0 0 0 0 36
4,8
48
1,0
53
,2
28
96
,2
70
15
4,0
39
21
0,9
55
22
9,2
74
19
2,0
80
28
4,1
86
36
4,0
83
48
0,7
13
61
4,9
72
77
7,2
40
1,0
16
,6
13
1,5
49
,8
64
2,004 2,005 2,006 2,007 2,008 2009
CLOPIDOGREL – Market evolution afteGeneric
launching.
Referência Genérico Marca Similar Total
36,1%
56,5%
brandreference Generic
Generic is 57% cheaper than reference product – Quickly took
leadership while doubling market size.
Most prescribed medicines in Brazil.
Source: Close Up- Abr09
Only Generic medicine can substitute the reference product.
Rivotril
Amoxycillin
Lexotan
Enalapril
Atenolol
Sibutramine
Metformin
Cephalexin
Bromazepam
Nimesulide
•Physicians are more and more prescribing Generics. 8 out of the10 top prescribed medicines in Brasil are Generics.
•Public awareness campaign among physicians informing aboutGeneric availability would contribute to increase prescriptions.
•Advertising activities among public hospitals and health centreswould contribute for the correct instruction about therapeutic andeconomic benefits of Generic medicines.
•Pharmacists play important role regarding substitution forGeneric medicines, therefore they are target for educationalprograms in order to dispense Generic Medicines accordingly
Generic medicine definitely increase access to medicine and
resulted in R$12,1 billion savings for the Brazilian population.
Savings for the population has reached
around US$ 6,0 bn.
Generic Medicines are also good tax payers.
VAT collected = US$ 2, 0 bn.
Fonte: Empresas Associadas – Pró Genéricos
0.074 0.236 0.470
0.797
1.226
1.796
2.528
3.438 3.672
2001 2002 2003 2004 2005 2006 2007 2008 2009
CHALLENGES
Source: IMS Health
Generic medicines have bigger market share where governments play a
key role in providing medicines.
60%
18%
45%
83%
30%
60%
35%
51%
44%
60%
7%
70%
63%60%
26%
14%
22%
55%
13% 13% 14%
20%
29%26%
4%
53%
31%34%
Units US$
Increasing Generic Medicines market Share
Challenges
Law enforcement: medicines prescribed by physicians can only
be changed by generic medicines.
Market research made as “secret customer” – the researcher shows the prescriptionor ask for the medicine by name and observe the pharmacist.
Source: Research Ipsos/Opinion – Dez/03
Results:
In 67% client receive the correct medicine.
In 33% client receive another type of product and, in this
case, 78% the suggested product was not generic.
Challenges
Increase the access to reliable and efficient
drugs
Public tenders
Law 9787 force the prescription by generic
name in public hospitals and health centers.
Law 8.666 force that the public tenders must
acquire medicines by the lowest price.
That is the reason why generic medicines have
poor participation in public tenders.
To qualify the public acquisitions in health
sector is the objective of PL 3536/04.
Challenges
Increase the access to reliable and cost
effective medicines.
To make sure that the pharmacists will follow the law
therefore dispensing generic medicines accordingly.
• To include new products and therapeutic classes in the
Health Ministry program Farmacia Popular would
expand the access to medicines to the population who
need it most.
• At the present the program offers 8 therapeutic
classes. The products included in the program are
subsided and the users co-participate with around 10%
of the public price.
To reduce the high taxes on medicine is
mandatory to enhance access.
Products Final price % tax.
Human
Medicines
35,7%
Salt 29,4%
Egg 21,8%
Meat 18,7%
Rice and bean 16,5%
Wheat flour 15,5%
Milk 13,8%
Reduction of tax increase the access and reduce the informal practice.
Public Price for medicines is
controlled by the
government. Among many
others, only VAT accounts
for 17% of the public price.
High taxes lead to
misappropriation and
informal practices , while
keeping high prices which
means a barrier to access
to medicines.
Intelectual Property Law instead of being an incentive to
innovation has become an excuse to extend period of
protection for product already on the public domain.
To guarantee the enforcement of the law.
To avoid patent extension or any other attempt aiming at
extending the period of protection and exclusivity
determined by law.
More and more companies are seeking for extra protection
time by using legal actions.
All those actions already in course have caused delays for
the introduction of generic version.
Obedience to the Intelectual Property Law would avoid legal disputes and
uncertainties on the right time to start commercialization of Generic
version.
PRÓ GENÉRICOSAssociação Brasileira das Indústrias de Medicamentos Genéricos
Rua Alvorada, 1280 – V. Olímpia - São Paulo
Tel.: +55-11-38979767
Website: www.progenericos.org.br
E-mail: progenericos@progenericos.org.br
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