Transcript Document

GIRP
GIRP
the vital link in healthcare
Challenges and Changes in the European
Distribution of Medicines
René Jenny
GIRP President
Monika Derecque-Pois
GIRP Secretary General
Brussels, 29th March 2006
29 March 2006
GIRP
What is GIRP?
 Founded in 1960, GIRP is the umbrella
organisation of pharmaceutical full-line
wholesalers in Europe.
 The members of GIRP:
 employ about 140.000 staff
 hold products on stock from over 3.500
manufacturers
 supply above 100.000 medicines
 distribute medicines throughout the whole
continent to more than 133.000 pharmacies
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 GIRP and its members ensure that
medicines are delivered in a timely, safe and
efficient way and thereby guarantee the
access to medicines for patients throughout
Europe.
GIRP
What is a full-line Wholesaler?
 Pharmaceutical full-line wholesalers…
 Hold a full range of medicines, including
seldom used, but vital medicines
 Hold the necessary stock for their area of
activity
 Make medicines continuously available: 24
hours a day, 365 days a year (European
average delivery time: 2-4 hours)
 Deliver to ALL pharmacies in their region
 Recognize a public service obligation to supply
many slow-moving medicines which are often
vital to meet the complete needs of patients
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Full-line wholesalers ensure that even the most isolated
patients can receive the most specialized medicines via
their pharmacist in a safe and timely manner!
GIRP
GIRP Membership
 Full Members
 National associations of pharmaceutical fullline wholesalers and the 4 largest European
companies/groups in EU and EFTA countries
 Associated Professional Members
 National associations/companies of
pharmaceutical full-line wholesalers in Europe
 Associated External Members
 Companies/organisations whose business
interests are related to the distribution of
medicines
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GIRP
GIRP
the vital link in healthcare
The concept of
pharmaceutical full-line
wholesaling
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GIRP
prescribes
& advises
The typical perception...
Doctor
makes a diagnosis
communicates
innovation
Pharmaceutical
Company
Pharmacist
dispenses & advises
Patient has an
illness
develops and
manufactures drugs
… ever thought why the medicines are readily
available when and where you need them?
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GIRP
prescribes
& advises
The right perception...
Doctor
makes a diagnosis
communicates
innovation
Pharmaceutical
Company
Pharmacist
dispenses & advises
Patient has an
illness
develops and
manufactures drugs
PHARMACEUTICAL FULL-LINE WHOLESALERS ARE
THE VITAL LINK IN HEALTH CARE
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GIRP
Full-line Wholesaling
3.500 manufacturers
INDUSTRY
INDUSTRY
FULL-LINE WHOLESALER
PHARMACY
PHARMACY
INDUSTRY
FULL-LINE WHOLESALER
PHARMACY
133.000 retail pharmacies in the EU-22
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INDUSTRY
PHARMACY
GIRP
Short Line Wholesaling
3.500 manufacturers
INDUSTRY
INDUSTRY
SHORTLINER
FULL-LINER
PHARMACY
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INDUSTRY
SHORTLINER
FULL-LINER
PHARMACY
SHORTLINER
FULL-LINER
PHARMACY
INDUSTRY
FULL-LINER
PHARMACY
133.000 retail pharmacies in the EU-22
PHARMACY
GIRP
Single Channel System
3.500 manufacturers
INDUSTRY
INDUSTRY
FULL-LINE
WHOLESALER
PHARMACY
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PHARMACY
INDUSTRY
FULL-LINE
WHOLESALER
PHARMACY
INDUSTRY
FULL-LINE
WHOLESALER
PHARMACY
133.000 retail pharmacies in the EU-22
PHARMACY
GIRP
The vital link in healthcare
The vital link in healthcare
MANUFACTURER
WHOLESALER
PHARMACIST
CONSUMER
If the vital link breaks, the safe and
continuous distribution and supply of
medicines CANNOT be guaranteed!!!
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GIRP
Ways for further expansion
WHOLESALER
Integration
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PHARMACIST
Vertical integration
downwards:
Wholesalers buying
pharmacies
GIRP
Ways for further expansion
Integration
MANUFACTURER
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WHOLESALER
Vertical integration
upwards
Wholesalers buying
a manufacturer (generic)
GIRP
Ways for further expansion
SERVICES
Integration
Integration
SERVICES
WHOLESALER
Horizontal integration
Wholesalers buying
Other wholesalers,
Services providers (IT, pre-wholesaling,…)
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GIRP
GIRP
the vital link in healthcare
Economic Aspects of
pharmaceutical full-line
wholesaling
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GIRP
Economic Aspects
 Study on:
 « The European Pharmaceutical Wholesale
Industry: Structure, Trends and socioeconomic Importance »
• Can be downloaded from
www.girp.org
 The wholesale industry not only creates
value added, but also has direct, indirect
and induced effects on employment.
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GIRP
Percentage of Medicines (Quantity) distributed by
full-line Wholesalers, EU-22, 2004
Demand
Supply
Wholesaler (100%)
87,7%
0,2%
8,5%
2,4%
1,2%
Retail
pharmacies
Drugstores
Hospital
pharmacies
Others
Dispensing
doctors
90,7%
0,4%
7,7%
0,3%
0,8%
Patients (100%)
source: IPF
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GIRP
Transactions of pharmaceutical
wholesalers
source: IPF
The coninuous supply of medicines involves more than 28
billion transactions between pharmacies, wholesalers and
manufacturers. Without wholesalers, this number would
increase to 528 billion transactions per year!
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GIRP
Aggregate multiplying effects on
employment and value addeed
Pharmaceutical Wholesaling
29
MarchIPF
2006
source:
Economy as a whole
1 Euro
2.23
Euro
1 Job
2.61
Jobs
GIRP
Who is paying for medicines in
Europe?
 Pricing and reimbursement issues underlie
the principal of “subsidiarity”
 The social security systems of the Member
States decide upon the pricing and
reimbursement of medicines
 Pricing and reimbursement varies widely in
the EU
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 In some Member States products can only
be placed on the market after the pricing
and/or reimbursement decision has been
taken
GIRP
The European Market
– Regulated wholesale margins –
AUSTRIA
YES
BELGIUM
ESTONIA
FRANCE
DENMARK
FINLAND
GERMANY
GREECE
IRELAND
ITALY
LATVIA
NORWAY
LUXEMBOURG
NETHERLANDS
POLAND
PORTUGAL
SPAIN
SWEDEN
SWITZERLAND
LITHUANIA
UNITED KINGDOM
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SLOVENIA
NO
GIRP
60
Top 5 pharmaceutical wholesalers
worldwide (sales 2004, in billion €)
57.1
53.9
50
43.2
40
30
19.2
20
16.2
10
0
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McKesson
CardinalHealth
Amerisource
Bergen
Celesio
Phoenix
GIRP
20
Top 3 pharmaceutical wholesalers in
Europe (sales 2004, in billion €)
19.2
18
16.2
16
12.7
14
12
10
8
6
4
2
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0
Celesio
Phoenix
Alliance UniChem
GIRP
Market Share of the top-3 European
Full-line wholesalers in the EU-22
46.5%
Pan-European wholesalers
53.5%
Others
Source: Alliance UniChem, Celesio, Phoenix, GIRP 2004
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GIRP
Number of full-line wholesalers in
2004
140
133
120
100
80
58
60
40
16
20
11
9
7
5
FR
NL
0
IT
ESP
GER
UK
AUT
FR: Wholesalers operating overseas not considered
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source: IPF
GIRP
Number of warehouses of full-line
wholesalers in 2004
300
250
254
191
200
189
150
129
100
54
50
0
25
IT
ESP
FR
GER
UK
FR: Warehouses overseas not considered
source: IPF
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AUT
18
NL
GIRP
Share of different distributors in the
pharmacy market, 2004
EU-22
EU-15
AUT
ESP
FR
GER
IT
NL
UK
source: IPF
0%
10%
20%
Full-line wholesaler
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30%
40%
50%
Short-line wholesaler
60%
70%
80%
Direct distribution
90% 100%
Others
GIRP
Pharmaceuticals and non-pharmaceutical
products on stock (in thousand), 2004
100
90
90
76
80
70
60
54
50
50
40
33
25
30
33
28
28
21
14
20
18
12
10
10
0
GER
source: IPF
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IT
AUT
Products on stock
NL
FR
UK
Pharmaceuticals on stock
ESP
GIRP
GIRP
the vital link in healthcare
Legislation governing
our sector
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GIRP
EU Pharmaceutical Legislation
 The pharmaceutical legislation is lying under the
Treaty principle of free movements of goods
 The Community Code relating to pharmaceutical
products for human use is Directive 2001/83/EC
 Amended in 2004 after a 2-year review process by
Directive 2004/27/EC
 Both Directives have to be implemented in the national
legislations of the 25 Member States by 31st October
2005
 The Guidelines on Good Distribution Practice (94/C
63/03) guarantee the quality of the medicines
delivered
 Unlike a directive, guidelines are only recommendations
and therefore not binding
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GIRP
EU Pharmaceutical Legislation
 Provisions on wholesale of pharmaceutical
products are to be found in Title VII
 Distribution authorisations
 Distribution and storage requirements
 Public service obligation
 New provisions especially concern
 The storgage of products in any Member
State if the products have 1 marketing
autorisation (article 76)
 The obligation of continuous supply of
products from manufacturers to wholesalers
and distributors to pharmacies (article 81)
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GIRP
Implementation of Directive
2004/27/EC
 Article 81 – paragraph 2
 The holder of a marketing autorisation for a
medicinal product and the distributors of the
said medicinal product actually placed on the
market in a Member State shall, within the
limits of their responsibilities, ensure
appropriate and continued supplies of that
medicinal product to pharmacies and persons
authorised to supply medicinal products so
that the needs of patients in the Member
State in question are covered.
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GIRP
GIRP
the vital link in healthcare
The distribution of
medicines in Europe
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GIRP
There is NO EUROPEAN
DISTRIBUTION of medicines…
it is still a regional or at the most a
national business…
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GIRP
Distribution of medicines in the EU
 Marketing authorisations are either granted:
 for each Member State and then mutually
recognised or
 centrally granted by the EMEA for the new
innovative products. The EMEA authorisation is
valid throughout the EU Member States.
 Although the EMEA (European Medicines
Agency) has celebrated its 10th anniversary
there is still NOT A SINGLE PRODUCT, WHICH
CAN BE DISTRIBUTED THROUGHOUT THE EU,
without additional authorisations.
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 In order to make consumers and patients
benefit from the immediate accessibility of the
most innovative medicines, pharmaceutical
wholesalers ask the European institutions to
allow them to distribute the centrally registered
medicines without additional authorisations.
GIRP
GIRP
the vital link in healthcare
Threats for full-line
wholesalers
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GIRP
Threats for full-line wholesalers
 Erosion of margins
 Liberalisation of retail markets
 New distribution channels to patients and
consumers
 Internet and mail-order pharmacies
 Direct distribution
 Increasing generic penetration
 Counterfeit Medicines
 Supply Quotas
 Attempts to use wholesalers as logistic
providers – “The Pfizer Approach”
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GIRP
Development of Margins
Index, Year 1989 =100
Development of Wholesale Margins on Pharmacy
Purchase Prices
120
100
80
60
40
20
0
1
source: IPF
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2
3
4
from 1989 index 100
to 2004 margin 71.6
5
6
GIRP
Direct sales
Increase in direct sales from manufacturers
to pharmacies
16
14
12
10
8
2003
6
2004
4
2
0
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y
ce
n
n
a
a
r
m
F
er
U
K
i
a
Sp
n
d
n
ria
t
la
s
r
u
I
A
(source: IMS)
GIRP
The Pfizer Approach in Europe
 Pfizer has challenged Spain with the introduction of
the « new distribution system »
 Pfizer now tries to implement their initial plan,
selecting some wholesalers and using them as
logistic providers, in Germany and the UK!
 If wholesalers do not agree to Pfizer’s proposal,
Pfizer threatens to use a logistic company to
compete with wholesalers.
Which country will be the next
one ?
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GIRP
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Supply quota systems

Manufacturers in Europe
impose supply quotas on
wholesalers in an attempt to
curb parallel trade and
protect their innovative
potentialities

Full-line wholesalers
therefore regularly
experience shortage on their
geographic markets
GIRP
Counterfeit medicines
 GIRP Members are committed to a « zero
tolerance » towards counterfeits in the legal
supply chain
 Measures against counterfeits include
 Regulation of Internet/mail order pharmacies
and information to consumers about possible
risks
 Stringent control of licenses and GDP
comppliance for non-full-line distributors
 No more « spot markets » for medicines
 No supply quota systems creating shortages
 GIRP is in favour of a close collaboration
between authoritites, manufacturers,
wholesalers and pharmacies to develop an
efficient early warning and tracking system.
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GIRP
The only way to avoid counterfeit
medicines
Develop a close, interlinked fast track
information system involving authorities
and ALL partners of the supply chain!
Pharmacist
Wholesaler
Manufacturer
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AUTHORITIES
GIRP
GIRP
the vital link in healthcare
Thank you for your
attention !
GIRP – The European Association of
Pharmaceutical Full-line Wholesalers
13B, Avenue de Tervuren
B – 1040 Brussels
+32 (0) 2 777 99 77
www.girp.org
29 March 2006