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Key Data • 2013
The Pharmaceutical
Industry in Figures
2
1999
6,675 6,527 6,461
6,2146,407 6,204 6,005
5,227 5,347
4,943
4,709
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
THE PHARMACEUTICAL INDUSTRY: A KEY ASSET
TO SCIENTIFIC AND MEDICAL PROGRESS
Thanks to advances in science and technology, the research-
based pharmaceutical industry is entering an exciting new
era in medicines development. Research methods are evolving
and we have many promising prospects on the horizon – from the
possibilities offered by personalised medicines, to the potential
offered by harnessing the power of big data. The innovative
pharmaceutical industry is driven by, and drives, medical
progress. It aims to turn fundamental research into innovative
treatments that are widely available and accessible to patients.
Already, the industry has contributed to significant improvements
in patient well-being. Today’s European citizens can expect to
live up to 30 years longer than they did a century ago. Some
major steps in biopharmaceutical research, complimented by
many smaller steps, have allowed for reductions in mortality, for
instance from HIV/AIDS-related causes and a number of cancers.
High blood pressure and cardiovascular disease can be controlled
with antihypertensive and cholesterol-lowering medicines; knee
or hip replacements prevent patients from immobility; and some
cancers can be controlled – or even cured – with the help of new
targeted treatments. European citizens can expect not only to
live longer, but to live better quality lives. Yet major hurdles
remain, including Alzheimer’s, Multiple Sclerosis, many cancers,
and orphan diseases.
Total number of deaths due to Human Immunodeficiency Virus [HIV]
disease in Europe (EU-27)
Source: Eurostat, May 2012
3
THE PHARMACEUTICAL INDUSTRY: A KEY ASSET
TO THE EUROPEAN ECONOMY
As well as driving medical progress by researching, devel-
oping and bringing new medicines that improve health
and quality of life for patients around the world, the research-
based pharmaceutical industry is a key asset of the European
economy. It is one of Europe’s top performing high-technology
sectors.
INDUSTRY (EFPIA Total)	 1990	 2000	 2011	 2012
Production	 63,010	 125,301	 205,622	 210,000 (e)
Exports (1) (2)	 23,180	 90,935	 288,573	 305,000 (e)
Imports	 16,113	 68,841	 212,135	 225,000 (e)
Trade balance	 7,067	 22,094	 76,438	 80,000 (e)
R&D expenditure	 7,766	 17,849	 29,192	 30,000 (e)
Employment (units)	 500,879	 534,882	 700,010	 700,000 (e)
R&D employment (units)	 76,126	 88,397	 115,695	 116,000 (e)
Pharmaceutical market value
at ex-factory prices	 41,147	 86,704	 160,603	 163,000 (e)
Pharmaceutical market value
at retail prices	 64,509	 140,345	 235,017	 238,500 (e)
Payment for pharmaceuticals
by statutory health insurance
systems (3)	 40,807	 76,909	 125,603	 126,800 (e)
Values in  million unless otherwise stated
(1)	Data relate to EU-27, Norway and Switzerland since 2005 (EU-15 before 2005);
Croatia and Serbia included since 2010; Turkey included since 2011
(2)	Data relating to total exports and total imports include EU-27 intra-trade
(double counting in some cases)
(3)	Since 1998 data relate to ambulatory care only
Source: EFPIA member associations (official figures) - (e): EFPIA estimate;
Eurostat (EU-27 trade data 1995-2012)
4
MAIN TRENDS
The research-based pharmaceutical industry can play a
critical role in restoring Europe to growth and ensuring
future competitiveness in an advancing global economy. In 2012
it invested an estimated € 30,000 million in R&D in Europe.
It directly employs 700,000 people and generates three to four
times more employment indirectly – upstream and downstream –
than it does directly. However, the sector faces real challenges.
Besides the additional regulatory hurdles and escalating R&D
costs, the sector has been severely hit by the impact of fiscal
austerity measures introduced by governments across much of
Europe since 2010.
■	There is rapid growth in the market and research environment
in emerging economies such as Brazil, China and India, leading
to a gradual migration of economic and research activities from
Europe to these fast-growing markets. In 2012 the Brazilian and
Chinese markets grew by 16% and 21% respectively compared to
an average market growth of minus 2% for the five major Euro-
pean markets and minus 1% for the US market (source: IMS Retail
Drug Monitor – February 2013).
■	In 2012 North America accounted for 41.0% of world pharmaceuti-
cal sales compared with 26.7% for Europe. According to IMS data,
62% of sales of new medicines launched during the period 2007-2011
were on the US market, compared with 18% on the European market.
■	The fragmentation of the EU pharmaceutical market has re-
sulted in a lucrative parallel trade. This benefits neither social
security nor patients and deprives the industry of additional
resources to fund R&D. Parallel trade was estimated to amount
to € 5,000 million (value at ex-factory prices) in 2011.
Geographical breakdown (by main markets) of sales of new
medicines launched during the period 2007-2011
Note:	New medicines cover all new active ingredients marketed for the first
time on the world market during the period 2007-2011
	Pharmerging comprises 17 countries ranked by IMS Health as high-growth
pharmaceutical markets (Argentina, Brazil, China, Egypt, India, Indone-
sia, Mexico, Pakistan, Poland, Romania, Russia, South Africa, Thailand,
Turkey, Venezuela, Vietnam and The Ukraine)
Source:	IMS MIDAS December 2012
62% USA 18% Europe 9%
Japan
9%
Rest
of the
World
2%
Pharmerging
5
Pharmaceutical R&D expenditure in Europe, USA and Japan
(million of national currency units*), 1990-2012
* Note: Europe: e million; USA: $ million; Japan: ¥ million x 100
(e): estimate
Source: EFPIA member associations, PhRMA, JPMA
5,161
6,422
7,462
10,477
6,803
11,874
21,364
30,969
36,374
11,484
1990 1995 2000 2005 2011
7,766
17,849
21,988
29,192
n.a.
12,299
2012
30,000(e)
36,810(e)
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
Japan
USA
Europe
Share of parallel imports in pharmacy market sales (%) – 2011
Source: EFPIA member associations (estimate)
0
2
4
6
8
10
12
14
16
18
20
22
24
26
14.8
SwedenNorway
2.6
13.5
The NetherlandsIreland
12.0
Belgium
1.3
Latvia
1.3
10.1
GermanyFinland
1.2
23.8
Denmark UK
7.8
6
Screening(10,000molecules)
Pre-clinical
developm
ent
C
linicaltrials
0 5 years 10 years 15 years 20 years 25 years
Patentapplication
Acute
toxicity
Pharm
acology
C
hronic
toxicity
Phase
I
Phase
IIPhase
III
Registration
/M
arketing
authorisation
Price
R
eim
bursem
ent
Pharm
acovigilance
1 medicinal product
10 years of R&D 2 to 3 years
of administrative procedures
Patent expiry SPC (supplementary
protection certificate) max.+ 5 years
PHARMACEUTICAL INDUSTRY RESEARCH AND
DEVELOPMENT IN EUROPE
All new medicines introduced into the market are the result of
lengthy, costly and risky research and development (R&D) con-
ducted by pharmaceutical companies:
■	 By the time a medicinal product reaches the market, an
average of 12-13 years will have elapsed since the first syn-
thesis of the new active substance;
■	 The cost of researching and developing a new chemical or
biological entity was estimated at € 1,172 million ($ 1,506
million in year 2011 dollars) in 2012 (Mestre-Ferrandiz et al,
Office of Health Economics, December 2012);
■	 On average, only one to two of every 10,000 substances syn-
thesised in laboratories will successfully pass all stages of
development required to become a marketable medicine.
Phases of the research and development process
7
PHARMACEUTICAL INDUSTRY RESEARCH AND
DEVELOPMENT IN EUROPE
EFPIA 2011	 € million
Austria	 193
Belgium	 1,907
Bulgaria	n.a.
Croatia	 40
Cyprus	 14
Czech Republic	 49
Denmark	 1,102
Estonia	n.a.
Finland	 264
France	 4,787
Germany	 5,318
Greece	 84
Hungary	 149
Ireland	 194
Italy	 1,250
Latvia	n.a.
Lithuania	n.a.
Malta	n.a.
Netherlands	 642
Norway	 141
Poland	 223
Portugal	 78
Romania	 218
Serbia	 n.a.
Slovakia	 n.a.
Slovenia	 91
Spain	 981
Sweden	 864
Switzerland	 4,972
Turkey	 43
United Kingdom	 5,588
Total	29,192
Note:	 The figures relate to the R&D carried out in each country.
	 Denmark, France, Poland, Portugal, Slovenia, Turkey: 2010 data; Austria,
Czech Republic: 2009 data; Cyprus: 2007 data
	Belgium, Croatia, Denmark, France, Greece, Ireland, Italy, Netherlands,
Norway (LMI members), Poland, Romania, Slovenia, Sweden (LIF mem-
bers), Switzerland (Interpharma members): estimate
Source: EFPIA member associations (official figures)
8
Allocation of R&D investments by function (%)
Source: PhRMA, Annual Membership Survey 2013 (percentages calculated from
2011 data)
3.5
56.9
21.5
Uncategorized
8.3 Approval
9.8 Pharmacovigilance (Phase IV)
Pre-human/Pre-clinical
Clinical trials
Phase I
Phase II
Phase III
8.7
12.5
35.7
Number of new chemical or biological entities (1993-2012)
Source: SCRIP – EFPIA calculations (according to nationality of mother company)
61
29
15
90
68
48
1993-1997 1998-2002 2003-2007
0
10
20
30
40
50
60
70
80
90
100
110
66
77
66
6 4
15
26
65
17
Others
Japan
USA
Europe
2008-2012
55
9
Pharmaceutical R&D expenditure - Annual growth rate (%)
Source: EFPIA, PhRMA
USA
Europe
1998-2002 2003-2007 2008-2012
0
2
4
6
8
10
12
7.5
5.8
2.3
10.7
7.4
0.5
Estimated full cost of bringing a new chemical or biological
entity to market ($ million - year 2011 $)
Source: 	J. Mestre-Ferrandiz, J. Sussex
and A. Towse, The R&D cost of a
new medicine, Office of Health
Economics, December 2012 (Hansen,
1979; Wiggins, 1987; DiMasi et al,
1991; OTA, 1993; DiMasi et al, 2003;
Mestre-Ferrandiz et al, 2012)
199 226
1979 1987
451 625
1993
1,031
2003
1,506
2012
0
100
200
300
400
500
600
700
800
900
1,000
1,100
1,200
1,300
1,400
1,500
1991
IMPORTANCE OF PHARMACEUTICAL R&D
In 2011 the pharmaceutical industry invested about € 29,200
million in R&D in Europe. A decade of strong US market domi-
nance led to a shift of economic and research activity towards the
US from 1995-2005. Additionally, Europe is now facing increasing
competition from emerging economies: rapid growth in the market
and research environments in countries such as Brazil and China are
contributing to the move of economic and research activities to non-
European markets. The geographical balance of the pharmaceutical
market – and ultimately the R&D base – is likely to shift gradually
towards emerging economies.
10
Pharmaceuticals
& biotechnology
Software
& computer services
Technology hardware
& equipment
Leisure goods
Health care equipment
& services
Electronic
& electrical equipment
Automobiles & parts
Aerospace & defence
All sectors
Chemicals
Industrial engineering
General industrials
Banks
Fixed line
telecommunications
Food producers
Oil & gas producers
0 5 10 15 20
15,1%
9,5%
7,9%
6,7%
5,9%
5,1%
4,2%
4,1%
3,2%
3,1%
3,1%
2,7%
2,2%
1,7%
1,6%
0,3%
Ranking of industrial sectors by overall sector R&D intensity
(R&D as percentage of net sales – 2011)
Note:	 Data relate to the top 1,500 companies with registered offices in the EU,
Japan, The USA and the Rest of the World, ranked by total worldwide R&D
investment (with R&D investment above €34.9 million)
Source:	 The 2012 EU Industrial R&D Investment Scoreboard, European Commission,
JRC/DG Research & Innovation
According to EUROSTAT data, the pharmaceutical industry is the
high technology sector with the highest added-value per person
employed, significantly higher than the average value for high-tech
and manufacturing industries. The pharmaceutical industry is also
the sector with the highest ratio of R&D investment to net sales.
According to the 2012 EU Industrial R&D Investment Scoreboard the
pharmaceuticals and biotechnology sector amounts to 17.7% of total
business R&D expenditure worldwide.
11
PHARMACEUTICAL PRODUCTION
EFPIA 2011	  million
Austria	 2,541
Belgium	 7,714
Bulgaria	 157
Croatia	 433
Cyprus	 180
Czech Republic	 n.a.
Denmark	 7,672
Estonia	n.a.
Finland	 1,293
France	 19,578
Germany	 26,935
Greece	 846
Hungary	 2,665
Ireland	 19,700
Italy	 25,137
Latvia	 108
Lithuania	n.a.
Malta	n.a.
Netherlands	 6,180
Norway	 679
Poland	 2,623
Portugal	 1,533
Romania	 587
Serbia	 n.a.
Slovakia	 n.a.
Slovenia	 1,642
Spain	 14,022
Sweden	 6,582
Switzerland	 32,380
Turkey	 4,229
United Kingdom	 20,206
Total	205,622
Note:	 All data based on SITC 54
	Belgium: 2011 provisional data; Bulgaria, Cyprus, Ireland, Netherlands:
2010 data; Norway: 2007 data
	Czech Republic, Denmark, France (source: INSEE), Ireland, Italy, Nether-
lands, Norway, Portugal, Sweden, Switzerland: estimate
	Bulgaria, Croatia, Cyprus, France, Germany, Hungary, Ireland, Latvia,
Norway, Poland, Portugal, Romania, Switzerland: veterinary products ex-
cluded
Source: EFPIA member associations (official figures)
12
EMPLOYMENT IN THE PHARMACEUTICAL INDUSTRY
EFPIA 2011	Units
Austria	 11,175
Belgium	 32,167
Bulgaria	 9,300
Croatia	 6,000
Cyprus	 1,140
Czech Republic	 2,300
Denmark	 20,223
Estonia	 400
Finland	 5,436
France	 103,900
Germany	 105,435
Greece	 13,700
Hungary	 22,600
Ireland	 24,000
Italy	 65,000
Latvia	n.a.
Lithuania	 1,370
Malta	 445
Netherlands	 15,000
Norway	 4,000
Poland	 31,000
Portugal	 8,502
Romania	 22,000
Serbia	 n.a.
Slovakia	 3,000
Slovenia	 12,200
Spain	 37,971
Sweden	 13,185
Switzerland	 38,561
Turkey	 25,000
United Kingdom	 65,000
Total	700,010
Note:	 Austria, Denmark, Poland, U.K.: 2010 data; Czech Republic: 2009 data;
Cyprus: 2007 data; Malta: 2004 data
	 Austria, Belgium, Bulgaria, Croatia, France, Greece, Ireland, Italy, Malta,
Netherlands, Norway, Poland, Romania, Slovenia, Sweden, Switzerland,
United Kingdom: estimate
Source: EFPIA member associations (official figures)
13
Employment in the pharmaceutical industry (1990-2012)
The research-based pharmaceutical industry is one of Europe’s major
high-technology industrial employers. Recent studies in some countries
showed that the research-based pharmaceutical industry generates
three to four times more employment indirectly - upstream and down-
stream - than it does directly. Further, a significant proportion of these
are valuable skilled jobs, for instance in the fields of academia or clini-
cal science, which can help maintain a high-level knowledge base and
prevent a European “brain drain”.
Employment in pharmaceutical R&D (1990-2012)	
0
100,000
200,000
300,000
400,000
500,000
600,000
1990 1995
500,879
2000
500,699
2005
534,882
2010
634,924
2011 2012
668,806
700,010
700,000(e)
700,000
116,000(e)
20121990 1995 2000 2005 2010
117,035
2011
0
20,000
40,000
60,000
80,000
100,000
120,000
0
20
40
60
80
100
120
115,695
76,126
82,618
88,397
100,726
Note:	 Data includes Turkey (since
2011), Croatia and Lithuania
(since 2010), Bulgaria,
Estonia and Hungary (since
2009), Czech Republic
(since 2008), Cyprus (since
2007), Romania & Slovakia
(since 2005), Malta, Poland
and Slovenia (since 2004)
Source:	EFPIA member associations
(official figures) - (e): EFPIA
estimate
Note: 	 Data includes Poland (since
2010), Czech Republic,
Estonia and Hungary (since
2009), Romania (since 2005)
and Slovenia (since 2004)
	Bulgaria, Croatia, Cyprus,
Greece, Latvia, Lithuania,
Malta, Serbia, Slovakia, Tur-
key: data not available
Source: 	EFPIA member associations -
(e): EFPIA estimate
14
41.0%
26.7%
11.7%
14.7%
5.9%
North America (USA, Canada)
Europe
Japan
Africa, Asia (excluding Japan) & Australia
Latin America
41.0%
26.7%
11.7%
14.7%
5.9%
North America (USA, Canada)
Europe
Japan
Africa, Asia (excluding Japan) & Australia
Latin America
PRICE STRUCTURE
Distribution margins, which are generally fixed by govern-
ments, and VAT rates differ significantly from country to
country in Europe. On average, approximately 35% of the retail
price of a medicine reverts not to the manufacturer, but rather
to the distributors (pharmacists and wholesalers) and the State.
Breakdown of the retail price of a medicine, 2011 (%)
65.2%
Manufacturer
5.6%
Wholesaler
19.3%
Pharmacist
9.9%
65.2%
Manufacturer
5.6%
Wholesaler
19.3%
Pharmacist
9.9%
State (VATandothertaxes)
Note:	Non-weighted average for Europe (average estimate for 24 countries)
Source:	EFPIA member associations
Note:	Europe includes Turkey and Russia
Source:	IMS MIDAS, 2013 (data relate to the 2012 audited global retail pharma-
ceutical market at ex-factory prices)
PHARMACEUTICAL SALES
The world pharmaceutical market was worth an estimated
€ 667,653 million ($ 857,800 million) at ex-factory prices
in 2012. The North American market (USA & Canada) remained
the world’s largest market with a 41.0% share, well ahead of
Europe and Japan.
Breakdown of the world pharmaceutical market – 2012 sales
15
PHARMACEUTICAL MARKET VALUE (at ex-factory prices)
EFPIA 2011	 € million
Austria	 3,096
Belgium	 4,536
Bulgaria	 753
Croatia	 611
Cyprus	 203
Czech Republic	 2,090
Denmark	 2,124
Estonia	 204
Finland	 2,006
France	 27,491
Germany	 26,122
Greece	 4,867
Hungary	 2,111
Iceland	 106
Ireland	 1,708
Italy	 20,272
Latvia	 291
Lithuania	 487
Malta	 77
Netherlands	 4,713
Norway	 1,550
Poland	 5,062
Portugal	 3,136
Romania	 2,524
Serbia	 564
Slovakia	 1,119
Slovenia	 514
Spain	 13,941
Sweden	 3,411
Switzerland	 3,941
Turkey	 7,172
United Kingdom	 13,801
Total	160,603
Note:	 Medicinal products as defined by Directive 2001/83/EEC
	Cyprus, Denmark, Finland, Iceland, Latvia, Lithuania, Norway, Slovenia,
Sweden: pharmaceutical market value at pharmacy purchasing prices
	 Malta: 2007 data
	Belgium, France, Germany, Ireland, Italy, Malta, Norway, Spain, U.K.: esti-
mate
Source:	EFPIA member associations (official figures) – Bulgaria, Croatia, Czech Re-
public, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia,
Slovenia: IMS
The figures above are for pharmaceutical sales, at ex-factory prices, through all
distribution channels (pharmacies, hospitals, dispensing doctors, supermarkets,
etc.), whether dispensed on prescription or at the patient’s request. Sales of
veterinary medicines are excluded.
16
VAT rates applied to medicines
Country Standard VAT rate (%)
Prescription (%) OTC (%)
Austria 20.0 10.0 10.0
Belgium 21.0 6.0 6.0
Bulgaria 20.0 20.0 20.0
Croatia 25.0 5.0 25.0
Cyprus 18.0 5.0 5.0
Czech Republic 21.0 15.0 15.0
Denmark 25.0 25.0 25.0
Estonia 20.0 9.0 9.0
Finland 24.0 10.0 10.0
France (1) 19.6 2.1 7.0
Germany 19.0 19.0 19.0
Greece 23.0 6.5 6.5
Hungary 27.0 5.0 5.0
Iceland 25.5 25.5 25.5
Ireland (2) 23.0 0.0 - 23.0 0.0 – 23.0
Italy 21.0 10.0 10.0
Latvia 21.0 12.0 12.0
Lithuania (3) 21.0 5.0 - 21.0 5.0 - 21.0
Luxembourg 15.0 3.0 3.0
Malta 18.0 0.0 0.0
Netherlands 21.0 6.0 6.0
Norway 25.0 25.0 25.0
Poland 23.0 8.0 8.0
Portugal 23.0 6.0 6.0
Romania 24.0 9.0 9.0
Serbia 20.0 8.0 8.0
Slovakia 20.0 10.0 10.0
Slovenia 20.0 8.5 8.5
Spain 21.0 4.0 4.0
Sweden 25.0 0.0 25.0
Switzerland 8.0 2.5 2.5
Turkey
United Kingdom
18.0 8.0 8.0
20.0 0.0 20.0
VAT RATES APPLICABLE TO MEDICINES
The table below shows the VAT rates applied to medicines
in European countries as of 1 January 2013.
(1)	France: reimbursable medicines 2.1%; non-reimbursable medicines 7.0%
(2) 	Ireland: oral medication 0%; other medication 23.0%
(3)	Lithuania: reimbursable medicines 5.0%; non-reimbursable medicines 21.0%
17
15.0
Slovenia
21.0
Switzerland
Poland
Portugal
Romania
62.2
Norway 16.5
Netherlands 11.8
Latvia
Lithuania
Turkey
UK
0 5 10 15 20 25 30
%
35 40 45 50 55 60
Finland
France
35.2
Germany
Greece
32.2
Hungary
Ireland
Italy
Denmark
21.7
21.9
Austria 24.9
Belgium 13.0
Bulgaria 39.1
42.5Croatia
26.2
30.6
Estonia
13.6
18.0
12.1
42.3
51.7
20.0
28.7
52.0
26.0
Slovakia
12.6Spain
9.8
Sweden
39.2
GENERICS
The term ‘generic’ is widely used but its definition is not always
consistent between countries. Generics are usually produced by
a manufacturer who is not the inventor of the original product, and are
marketed when intellectual property protection rights are exhausted.
The market share of generics is significantly higher in new EU Member
States with historically low levels of intellectual property protection.
Share (estimate - in %) accounted for by generics in pharma-
ceutical market sales value (at ex-factory prices), 2011
Note:
Croatia, Denmark, Finland, Estonia, Greece, U.K.: share of generics in pharmacy
market sales
Austria, Belgium, Bulgaria, France, Germany, Hungary, Ireland, Italy (as referred
to transparency lists), Portugal, Slovenia, Spain: share of generics in reimbursable
pharmacy market sales
Latvia, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, Sweden, Swit-
zerland, Turkey: share of generics in total market sales
France: data relate only to those active substances listed on the official list of
medicines
Definition: ‘generic’ means a medicine based on an active substance that is out
of patent and which is marketed under a different name from that of the original
branded medicine (generics data do not include those generics marketed by the
originator).
Source: EFPIA member associations
18
PHARMACEUTICAL EXPORTS
EFPIA 2011	  million
Austria	 6,540
Belgium	 35,524
Bulgaria	 565
Croatia	 323
Cyprus	 223
Czech Republic	 1,317
Denmark	 7,559
Estonia	 47
Finland	 1,146
France	 24,469
Germany	 50,818
Greece	 864
Hungary	 3,459
Ireland	 26,645
Italy	 14,679
Latvia	 306
Lithuania	 268
Luxembourg	 148
Malta	 206
Netherlands	 15,994
Norway	 507
Poland	 1,658
Portugal	 593
Romania	 732
Slovakia	 361
Slovenia	 1,917
Spain	 9,843
Sweden	 6,384
Switzerland	 48,846
Turkey	 407
United Kingdom	 26,225
Total	288,573
Note:	 All data based on SITC 54
	Croatia, Norway, Switzerland: veterinary products excluded
Source:	Eurostat (COMEXT database – December 2012)
	Croatia: Business Monitor International; Norway: Statistics Norway;
Switzerland: Swiss Federal Customs Administration
19
PHARMACEUTICAL IMPORTS
EFPIA 2011	  million
Austria	 6,033
Belgium	 26,757
Bulgaria	 818
Croatia	 501
Cyprus	 237
Czech Republic	 3,046
Denmark	 2,762
Estonia	 272
Finland	 1,685
France	 21,435
Germany	 37,027
Greece	 3,125
Hungary	 2,906
Ireland	 4,402
Italy	 18,087
Latvia	 453
Lithuania	 623
Luxembourg	 478
Malta	 113
Netherlands	 10,916
Norway	 1,392
Poland	 4,451
Portugal	 2,196
Romania	 2,338
Slovakia	 1,566
Slovenia	 789
Spain	 11,670
Sweden	 3,213
Switzerland	 20,408
Turkey	 3,350
United Kingdom	 19,086
Total	212,135
Note:	 All data based on SITC 54
	Croatia, Norway, Switzerland: veterinary products excluded
Source:	Eurostat (COMEXT database – December 2012)
	Croatia: Business Monitor International; Norway: Statistics Norway;
Switzerland: Swiss Federal Customs Administration
20
PHARMACEUTICAL TRADE BALANCE
EFPIA 2011	  million
Austria	 507
Belgium	 8,767
Bulgaria	 - 253
Croatia	 - 178
Cyprus	 - 14
Czech Republic	 - 1,729
Denmark	 4,797
Estonia	 - 225
Finland	 - 539
France	 3,034
Germany	 13,791
Greece	 - 2,261
Hungary	 553
Ireland	 22,243
Italy	 - 3,408
Latvia	 - 147
Lithuania	 - 355
Luxembourg	 - 330
Malta	 93
Netherlands	 5,078
Norway	 - 885
Poland	 - 2,793
Portugal	 - 1,603
Romania	 - 1,606
Slovakia	 - 1,205
Slovenia	 1,128
Spain	 - 1,827
Sweden	 3,171
Switzerland	 28,438
Turkey	 - 2,943
United Kingdom	 7,139
Total	76,438
Note:	 All data based on SITC 54
	Croatia, Norway, Switzerland: veterinary products excluded
Source:	Eurostat (COMEXT database – December 2012)
	Croatia: Business Monitor International; Norway: Statistics Norway;
Switzerland: Swiss Federal Customs Administration
21
EU-27 trade balance - High technology sectors ( million) - 2012
Source: Eurostat, COMEXT database, May 2013
The European Union’s top 5 pharmaceutical trading partners - 2012
EU exports	 EU imports
Source: Eurostat, COMEXT database, May 2013
16,545
1,281
-40,409
- 48,454
33,530
54,401
-40,000
-50,000
-30,000
-20,000
-10,000
0
10,000
20,000
30,000
40,000
SITC 54 Pharmaceutical products
SITC 71 Power generating machinery and equipment
SITC 75 Office machines and computers
SITC 76 Telecommunication, sound, TV, video
SITC 77 Electrical machinery
SITC 87 Professional, scientific, controlling material
50,000
60,000
29.0%
10.4%
7.0%
42.3%
6.7%
4.6%
USA
Switzerland
Russia
Japan
China
Others
37.8%
35.4%
6.3%
12.3%
4.2%
4.0%
USA
Switzerland
Singapore
China
Israël
Others
37.8%
35.4%
6.3%
12.3%
4.2%
4.0%
USA
Switzerland
Singapore
China
Israël
Others
22
TOTAL SPENDING (PUBLIC AND PRIVATE) ON HEALTH-
CARE AS A PERCENTAGE OF GDP AT MARKET PRICES
	 1960	 1970	 1980	 1990	 2000	 2010
Austria	 4.3	 5.2	 7.4	 8.4	 10.0	 11.0
Belgium	 -	 3.9	 6.3	 7.2	 8.1	 10.5
Czech Republic	 -	 -	 -	 4.5	 6.3	 7.5
Denmark	 -	 -	 8.9	 8.3	 8.7	 11.1
Estonia	 -	 -	 -	 -	 5.3	 6.3
Finland	 3.8	 5.5	 6.3	 7.7	 7.2	 8.9
France	 3.8	 5.4	 7.0	 8.4	 10.1	 11.6
Germany	 -	 6.0	 8.4	 8.3	 10.4	 11.6
Greece	 -	 5.5	 5.9	 6.7	 8.0	 10.2
Hungary	 -	 -	 -	 -	 7.2	 7.8
Iceland	 3.0	 4.7	 6.3	 7.8	 9.5	 9.3
Ireland	 3.7	 5.0	 8.2	 6.0	 6.1	 9.2
Italy	 -	 -	 -	 7.7	 8.0	 9.3
Luxembourg	 -	 3.1	 5.2	 5.4	 7.5	 7.9
Netherlands	 -	 -	 7.4	 8.0	 8.0	 12.0
Norway	 2.9	 4.4	 7.0	 7.6	 8.4	 9.4
Poland	 -	 -	 -	 4.8	 5.5	 7.0
Portugal	 -	 2.4	 5.1	 5.7	 9.3	 10.7
Slovakia	 -	 -	 -	 -	 5.5	 9.0
Slovenia	 -	 -	 -	 -	 8.3	 9.0
Spain	 1.5	 3.5	 5.3	 6.5	 7.2	 9.6
Sweden	 -	 6.8	 8.9	 8.2	 8.2	 9.6
Switzerland	 4.9	 5.5	 7.4	 8.2	 10.2	 11.4
Turkey	 -	 -	 2.4	 2.7	 4.9	 6.1
United Kingdom	 3.9	 4.5	 5.6	 5.9	 7.0	 9.6
Europe	 3.5	 4.9	6.9	 7.1	 7.9	9.6
USA	 5.1	 7.1	 9.0	 12.4	 13.7	 17.6
Japan	 3.0	 4.4	 6.4	 5.8	 7.6	 9.5
Note: 	 Japan, Luxembourg: 2009 data; Turkey: 2008 data
	Europe: non-weighted average (24 countries) – EFPIA calculations
Source:	OECD Health Data 2012, October 2012
23
PAYMENT FOR PHARMACEUTICALS BY COM-
PULSORY HEALTH INSURANCE SYSTEMS AND
NATIONAL HEALTH SERVICES (ambulatory care only)
EFPIA 2011	 € million
Austria	 2,275
Belgium	 3,664
Bulgaria	 419
Croatia	 379
Cyprus	 90
Czech Republic	 1,387
Denmark	 876
Estonia	 95
Finland	 1,262
France	 22,909
Germany	 29,556
Greece	 3,979
Hungary	 1,367
Iceland	 59
Ireland	 1,459
Italy	 10,225
Latvia	 117
Lithuania	 182
Malta	n.a.
Netherlands	 5,225
Norway	 1,165
Poland	 2,143
Portugal	 1,328
Romania	 1,049
Serbia	 248
Slovakia	 894
Slovenia	 302
Spain	 10,817
Sweden	 2,106
Switzerland	 3,886
Turkey	 6,524
United Kingdom	 9,616
Total	125,603
Note:	 Iceland: 2010 data; Czech Republic: 2009 data
	France, Ireland, Netherlands, Norway, Spain, Sweden, United Kingdom: estimate
Source: EFPIA member associations (official figures)
24
Causes of death by major disease areas in
Europe (EU-27)
4.6%
25.9%
0.5%
7.7%
39.1%
Certain infectious and parasitic diseases
Neoplasms
Diseases of the blood(-forming organs) and immune mechanism disorders
Endocrine, nutritional and metabolic diseases
Mental and behavioural disorders
Diseases of the nervous system and the sense organs
Diseases of the circulatory system
Diseases of the respiratory system
Diseases of the digestive system
Diseases of the skin and subcutaneous tissue
Diseases of the musculoskeletal system and connective tissues
Diseases of the genitourinary system
Others (non-disease directly related causes of deaths)
3.3%
2.9%
0.3%
0.2%
1.4%
1.9%
9.7%
2.6%
Data source: Eurostat, data relate to year 2010 (non-disease directly related cau-
ses of deaths: EFPIA calculations – Percentages do not add due to rounding)
25
In-patient care (hospital)
Outpatient care & others
Pharmaceuticals & other medical non-durables
35.7%
47.7%
16.6%
77.0
76.5
76.0
75.5
75.0
74.5
74.0
73.5
73.0
72.5
0
Life Expectancy
(years)
+1.74 years
2009Contribution
of Innovative
Medicines
73%
Other
27%
2000
Contribution of innovative medicines to increase in life
expectancy (2000-2009)
Source: Lichtenberg, F: Pharmaceutical innovation and longevity growth in 30 deve-
loping OECD and high-income countries, 2000-2009 (2012)
THE ADDED VALUE OF MEDICINES IN HEALTHCARE
Medicines constitute only a small part of healthcare costs
with, on average, 16.6% of total health expenditure in
Europe being spent on pharmaceuticals and other medical non-
durables. In costly diseases such as cancer and rheumatoid
arthritis, medicines account for even less than 10% of the total
disease costs. Medicines can also generate additional savings,
for example by substantially reducing costs in other areas of
healthcare, including hospital stays and long-term care costs.
Breakdown of total health expenditure in Europe – 2010
Source: OECD Health Data 2012 – EFPIA calculations (non-weighted average for 20
EU & EFTA countries)
ASSOCIATIONS WITH LIAISON STATUS
Bulgaria: Association of Research-based Pharmaceutical Manufacturers in Bul-
garia (ARPharM)
Croatia: Croatian Association of Research-based Pharmaceutical Companies
(CARPC)
Cyprus: Cyprus Association of Pharmaceutical Companies (KEFEA)
Czech Republic: Association of Innovative Pharmaceutical Industry (AIFP)
Estonia: Association of Pharmaceutical Manufacturers in Estonia (APME)
Hungary: Association of Innovative Pharmaceutical Manufacturers (AIPM)
Latvia: Association of International Research-based Pharmaceutical Manufac-
turers (AFA)
Lithuania: The Innovative Pharmaceutical Industry Association (IFPA)
Malta: Maltese Pharmaceutical Association (PRIMA)
Romania: Association of International Medicines Manufacturers (ARPIM)
Serbia: Innovative Drug Manufacturers’ Association (INOVIA)
Slovakia: Slovak Association of Research-based Pharmaceutical Companies (SAFS)
Slovenia: Forum of International Research and Development Pharmaceutical
Industries (EIG)
Ukraine: Association of Pharmaceutical Research and Development (APRaD)
EFPIA MEMBER ASSOCIATIONS
Austria
Fachverband der Chemischen
Industrie Österreichs (FCIO)
Denmark
Laegemiddelindustriforeningen
The Danish Association of the
Pharmaceutical Industry (Lif)
France
Les Entreprises du Médicament
(LEEM)
Greece
Hellenic Association of Pharma-
ceutical Companies (SFEE)
Italy
Associazione delle Imprese del
Farmaco (Farmindustria)
Norway
Legemiddelindustriforeningen /
Norwegian Association of Pharma-
ceutical Manufacturers (LMI)
Portugal
Associação Portuguesa da Indústria
Farmacêutica (Apifarma)
Spain
Asociación Nacional Empresarial
de la Industria Farmacéutica
(Farmaindustria)
Switzerland
Scienceindustries
Belgium
Association Générale de l’Industrie
du Médicament (pharma.be)
Finland
Lääketeollisuus ry
Pharma Industry Finland (PIF)
Germany
Verband Forschender Arzneimittel-
hersteller (VfA)
Ireland
Irish Pharmaceutical Healthcare
Association (IPHA)
Netherlands
Vereniging Innovatieve Genees-
middelen Nederland (Nefarma)
Poland
Employers Union of Innovative
Pharmaceutical Companies (Infarma)
Russia
Association of International Pharma-
ceutical Manufacturers (AIPM)
Sweden
Läkemedelsindustriföreningen
The Swedish Association of the
Pharmaceutical Industry (LIF)
Turkey
Arastirmaci Ilac Firmalari Dernegi
(AIFD)
United Kingdom
The Association of the British
Pharmaceutical Industry (ABPI)
26
MEMBER COMPANIES
Full Members
Abbott	USA
AbbVie	USA
Almirall	 Spain
Amgen	USA
Astellas Pharma Europe	United Kingdom
AstraZeneca (AZ)	United Kingdom / Sweden
Baxter	USA
Bayer HealthCare	 Germany
Biogen Idec	USA
Boehringer Ingelheim	 Germany
Bristol Myers Squibb	USA
Chiesi Farmaceutici (Chiesi)	 Italy
Daiichi-Sankyo Europe	 Germany
Eisai	 Japan
Eli Lilly (Lilly)	USA
Esteve	 Spain
Genzyme	USA
GlaxoSmithKline (GSK)	United Kingdom
Grünenthal	Germany
Ipsen	France
Johnson & Johnson	USA
H. Lundbeck	 Denmark
Menarini	Italy
Merck	Germany
Merck, Sharp & Dohme (MSD)	USA
Novartis	 Switzerland
Novo Nordisk	 Denmark
Orion Pharma (Orion)	Finland
Otsuka	 Japan
Pfizer	USA
Roche	 Switzerland
Sanofi	France
Servier	France
Takeda	 Japan
UCB	Belgium
Affiliate Members
Bial	Portugal
Celgene	USA
Cubist	USA	
Shire	United Kingdom
Vifor Pharma	 Switzerland
27
EFPIA (The European Federation of Pharmaceutical Industries
and Associations) represents the research-based pharmaceutical
industry operating in Europe.
Founded in 1978, its members comprise 33 national pharma-
ceutical industry associations and 40 leading pharmaceutical
companies undertaking research, development and manufactur-
ing of medicinal products in Europe for human use.
Its mission is to promote pharmaceutical research and develop-
ment and the best conditions in Europe for companies to bring
to market medicines that improve human health and the quality
of life around the world.
Through its membership, EFPIA represents the common views of
1,900 large, medium and small companies including the entire
European research-based pharmaceutical sector whose interests
also include an important part of the generics segment. Two
specialised groups have been created within EFPIA to address
specific issues relating to vaccines (Vaccines Europe, formerly
EVM – European Vaccine Manufacturers) and the needs of bio-
pharmaceutical companies (EBE - European Biopharmaceutical
Enterprises).
Further details about the Federation and its activities can be
obtained from:
EFPIA
Leopold Plaza Building, Rue du Trône 108 - B-1050 Brussels -
Belgium
Tel.: +32.(0)2.626.25.55 - Fax: +32.(0)2.626.25.66
www.efpia.eu

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efpIA Figures key data_2013

  • 1. Key Data • 2013 The Pharmaceutical Industry in Figures
  • 2. 2 1999 6,675 6,527 6,461 6,2146,407 6,204 6,005 5,227 5,347 4,943 4,709 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 THE PHARMACEUTICAL INDUSTRY: A KEY ASSET TO SCIENTIFIC AND MEDICAL PROGRESS Thanks to advances in science and technology, the research- based pharmaceutical industry is entering an exciting new era in medicines development. Research methods are evolving and we have many promising prospects on the horizon – from the possibilities offered by personalised medicines, to the potential offered by harnessing the power of big data. The innovative pharmaceutical industry is driven by, and drives, medical progress. It aims to turn fundamental research into innovative treatments that are widely available and accessible to patients. Already, the industry has contributed to significant improvements in patient well-being. Today’s European citizens can expect to live up to 30 years longer than they did a century ago. Some major steps in biopharmaceutical research, complimented by many smaller steps, have allowed for reductions in mortality, for instance from HIV/AIDS-related causes and a number of cancers. High blood pressure and cardiovascular disease can be controlled with antihypertensive and cholesterol-lowering medicines; knee or hip replacements prevent patients from immobility; and some cancers can be controlled – or even cured – with the help of new targeted treatments. European citizens can expect not only to live longer, but to live better quality lives. Yet major hurdles remain, including Alzheimer’s, Multiple Sclerosis, many cancers, and orphan diseases. Total number of deaths due to Human Immunodeficiency Virus [HIV] disease in Europe (EU-27) Source: Eurostat, May 2012
  • 3. 3 THE PHARMACEUTICAL INDUSTRY: A KEY ASSET TO THE EUROPEAN ECONOMY As well as driving medical progress by researching, devel- oping and bringing new medicines that improve health and quality of life for patients around the world, the research- based pharmaceutical industry is a key asset of the European economy. It is one of Europe’s top performing high-technology sectors. INDUSTRY (EFPIA Total) 1990 2000 2011 2012 Production 63,010 125,301 205,622 210,000 (e) Exports (1) (2) 23,180 90,935 288,573 305,000 (e) Imports 16,113 68,841 212,135 225,000 (e) Trade balance 7,067 22,094 76,438 80,000 (e) R&D expenditure 7,766 17,849 29,192 30,000 (e) Employment (units) 500,879 534,882 700,010 700,000 (e) R&D employment (units) 76,126 88,397 115,695 116,000 (e) Pharmaceutical market value at ex-factory prices 41,147 86,704 160,603 163,000 (e) Pharmaceutical market value at retail prices 64,509 140,345 235,017 238,500 (e) Payment for pharmaceuticals by statutory health insurance systems (3) 40,807 76,909 125,603 126,800 (e) Values in  million unless otherwise stated (1) Data relate to EU-27, Norway and Switzerland since 2005 (EU-15 before 2005); Croatia and Serbia included since 2010; Turkey included since 2011 (2) Data relating to total exports and total imports include EU-27 intra-trade (double counting in some cases) (3) Since 1998 data relate to ambulatory care only Source: EFPIA member associations (official figures) - (e): EFPIA estimate; Eurostat (EU-27 trade data 1995-2012)
  • 4. 4 MAIN TRENDS The research-based pharmaceutical industry can play a critical role in restoring Europe to growth and ensuring future competitiveness in an advancing global economy. In 2012 it invested an estimated € 30,000 million in R&D in Europe. It directly employs 700,000 people and generates three to four times more employment indirectly – upstream and downstream – than it does directly. However, the sector faces real challenges. Besides the additional regulatory hurdles and escalating R&D costs, the sector has been severely hit by the impact of fiscal austerity measures introduced by governments across much of Europe since 2010. ■ There is rapid growth in the market and research environment in emerging economies such as Brazil, China and India, leading to a gradual migration of economic and research activities from Europe to these fast-growing markets. In 2012 the Brazilian and Chinese markets grew by 16% and 21% respectively compared to an average market growth of minus 2% for the five major Euro- pean markets and minus 1% for the US market (source: IMS Retail Drug Monitor – February 2013). ■ In 2012 North America accounted for 41.0% of world pharmaceuti- cal sales compared with 26.7% for Europe. According to IMS data, 62% of sales of new medicines launched during the period 2007-2011 were on the US market, compared with 18% on the European market. ■ The fragmentation of the EU pharmaceutical market has re- sulted in a lucrative parallel trade. This benefits neither social security nor patients and deprives the industry of additional resources to fund R&D. Parallel trade was estimated to amount to € 5,000 million (value at ex-factory prices) in 2011. Geographical breakdown (by main markets) of sales of new medicines launched during the period 2007-2011 Note: New medicines cover all new active ingredients marketed for the first time on the world market during the period 2007-2011 Pharmerging comprises 17 countries ranked by IMS Health as high-growth pharmaceutical markets (Argentina, Brazil, China, Egypt, India, Indone- sia, Mexico, Pakistan, Poland, Romania, Russia, South Africa, Thailand, Turkey, Venezuela, Vietnam and The Ukraine) Source: IMS MIDAS December 2012 62% USA 18% Europe 9% Japan 9% Rest of the World 2% Pharmerging
  • 5. 5 Pharmaceutical R&D expenditure in Europe, USA and Japan (million of national currency units*), 1990-2012 * Note: Europe: e million; USA: $ million; Japan: ¥ million x 100 (e): estimate Source: EFPIA member associations, PhRMA, JPMA 5,161 6,422 7,462 10,477 6,803 11,874 21,364 30,969 36,374 11,484 1990 1995 2000 2005 2011 7,766 17,849 21,988 29,192 n.a. 12,299 2012 30,000(e) 36,810(e) 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 Japan USA Europe Share of parallel imports in pharmacy market sales (%) – 2011 Source: EFPIA member associations (estimate) 0 2 4 6 8 10 12 14 16 18 20 22 24 26 14.8 SwedenNorway 2.6 13.5 The NetherlandsIreland 12.0 Belgium 1.3 Latvia 1.3 10.1 GermanyFinland 1.2 23.8 Denmark UK 7.8
  • 6. 6 Screening(10,000molecules) Pre-clinical developm ent C linicaltrials 0 5 years 10 years 15 years 20 years 25 years Patentapplication Acute toxicity Pharm acology C hronic toxicity Phase I Phase IIPhase III Registration /M arketing authorisation Price R eim bursem ent Pharm acovigilance 1 medicinal product 10 years of R&D 2 to 3 years of administrative procedures Patent expiry SPC (supplementary protection certificate) max.+ 5 years PHARMACEUTICAL INDUSTRY RESEARCH AND DEVELOPMENT IN EUROPE All new medicines introduced into the market are the result of lengthy, costly and risky research and development (R&D) con- ducted by pharmaceutical companies: ■ By the time a medicinal product reaches the market, an average of 12-13 years will have elapsed since the first syn- thesis of the new active substance; ■ The cost of researching and developing a new chemical or biological entity was estimated at € 1,172 million ($ 1,506 million in year 2011 dollars) in 2012 (Mestre-Ferrandiz et al, Office of Health Economics, December 2012); ■ On average, only one to two of every 10,000 substances syn- thesised in laboratories will successfully pass all stages of development required to become a marketable medicine. Phases of the research and development process
  • 7. 7 PHARMACEUTICAL INDUSTRY RESEARCH AND DEVELOPMENT IN EUROPE EFPIA 2011 € million Austria 193 Belgium 1,907 Bulgaria n.a. Croatia 40 Cyprus 14 Czech Republic 49 Denmark 1,102 Estonia n.a. Finland 264 France 4,787 Germany 5,318 Greece 84 Hungary 149 Ireland 194 Italy 1,250 Latvia n.a. Lithuania n.a. Malta n.a. Netherlands 642 Norway 141 Poland 223 Portugal 78 Romania 218 Serbia n.a. Slovakia n.a. Slovenia 91 Spain 981 Sweden 864 Switzerland 4,972 Turkey 43 United Kingdom 5,588 Total 29,192 Note: The figures relate to the R&D carried out in each country. Denmark, France, Poland, Portugal, Slovenia, Turkey: 2010 data; Austria, Czech Republic: 2009 data; Cyprus: 2007 data Belgium, Croatia, Denmark, France, Greece, Ireland, Italy, Netherlands, Norway (LMI members), Poland, Romania, Slovenia, Sweden (LIF mem- bers), Switzerland (Interpharma members): estimate Source: EFPIA member associations (official figures)
  • 8. 8 Allocation of R&D investments by function (%) Source: PhRMA, Annual Membership Survey 2013 (percentages calculated from 2011 data) 3.5 56.9 21.5 Uncategorized 8.3 Approval 9.8 Pharmacovigilance (Phase IV) Pre-human/Pre-clinical Clinical trials Phase I Phase II Phase III 8.7 12.5 35.7 Number of new chemical or biological entities (1993-2012) Source: SCRIP – EFPIA calculations (according to nationality of mother company) 61 29 15 90 68 48 1993-1997 1998-2002 2003-2007 0 10 20 30 40 50 60 70 80 90 100 110 66 77 66 6 4 15 26 65 17 Others Japan USA Europe 2008-2012 55
  • 9. 9 Pharmaceutical R&D expenditure - Annual growth rate (%) Source: EFPIA, PhRMA USA Europe 1998-2002 2003-2007 2008-2012 0 2 4 6 8 10 12 7.5 5.8 2.3 10.7 7.4 0.5 Estimated full cost of bringing a new chemical or biological entity to market ($ million - year 2011 $) Source: J. Mestre-Ferrandiz, J. Sussex and A. Towse, The R&D cost of a new medicine, Office of Health Economics, December 2012 (Hansen, 1979; Wiggins, 1987; DiMasi et al, 1991; OTA, 1993; DiMasi et al, 2003; Mestre-Ferrandiz et al, 2012) 199 226 1979 1987 451 625 1993 1,031 2003 1,506 2012 0 100 200 300 400 500 600 700 800 900 1,000 1,100 1,200 1,300 1,400 1,500 1991 IMPORTANCE OF PHARMACEUTICAL R&D In 2011 the pharmaceutical industry invested about € 29,200 million in R&D in Europe. A decade of strong US market domi- nance led to a shift of economic and research activity towards the US from 1995-2005. Additionally, Europe is now facing increasing competition from emerging economies: rapid growth in the market and research environments in countries such as Brazil and China are contributing to the move of economic and research activities to non- European markets. The geographical balance of the pharmaceutical market – and ultimately the R&D base – is likely to shift gradually towards emerging economies.
  • 10. 10 Pharmaceuticals & biotechnology Software & computer services Technology hardware & equipment Leisure goods Health care equipment & services Electronic & electrical equipment Automobiles & parts Aerospace & defence All sectors Chemicals Industrial engineering General industrials Banks Fixed line telecommunications Food producers Oil & gas producers 0 5 10 15 20 15,1% 9,5% 7,9% 6,7% 5,9% 5,1% 4,2% 4,1% 3,2% 3,1% 3,1% 2,7% 2,2% 1,7% 1,6% 0,3% Ranking of industrial sectors by overall sector R&D intensity (R&D as percentage of net sales – 2011) Note: Data relate to the top 1,500 companies with registered offices in the EU, Japan, The USA and the Rest of the World, ranked by total worldwide R&D investment (with R&D investment above €34.9 million) Source: The 2012 EU Industrial R&D Investment Scoreboard, European Commission, JRC/DG Research & Innovation According to EUROSTAT data, the pharmaceutical industry is the high technology sector with the highest added-value per person employed, significantly higher than the average value for high-tech and manufacturing industries. The pharmaceutical industry is also the sector with the highest ratio of R&D investment to net sales. According to the 2012 EU Industrial R&D Investment Scoreboard the pharmaceuticals and biotechnology sector amounts to 17.7% of total business R&D expenditure worldwide.
  • 11. 11 PHARMACEUTICAL PRODUCTION EFPIA 2011  million Austria 2,541 Belgium 7,714 Bulgaria 157 Croatia 433 Cyprus 180 Czech Republic n.a. Denmark 7,672 Estonia n.a. Finland 1,293 France 19,578 Germany 26,935 Greece 846 Hungary 2,665 Ireland 19,700 Italy 25,137 Latvia 108 Lithuania n.a. Malta n.a. Netherlands 6,180 Norway 679 Poland 2,623 Portugal 1,533 Romania 587 Serbia n.a. Slovakia n.a. Slovenia 1,642 Spain 14,022 Sweden 6,582 Switzerland 32,380 Turkey 4,229 United Kingdom 20,206 Total 205,622 Note: All data based on SITC 54 Belgium: 2011 provisional data; Bulgaria, Cyprus, Ireland, Netherlands: 2010 data; Norway: 2007 data Czech Republic, Denmark, France (source: INSEE), Ireland, Italy, Nether- lands, Norway, Portugal, Sweden, Switzerland: estimate Bulgaria, Croatia, Cyprus, France, Germany, Hungary, Ireland, Latvia, Norway, Poland, Portugal, Romania, Switzerland: veterinary products ex- cluded Source: EFPIA member associations (official figures)
  • 12. 12 EMPLOYMENT IN THE PHARMACEUTICAL INDUSTRY EFPIA 2011 Units Austria 11,175 Belgium 32,167 Bulgaria 9,300 Croatia 6,000 Cyprus 1,140 Czech Republic 2,300 Denmark 20,223 Estonia 400 Finland 5,436 France 103,900 Germany 105,435 Greece 13,700 Hungary 22,600 Ireland 24,000 Italy 65,000 Latvia n.a. Lithuania 1,370 Malta 445 Netherlands 15,000 Norway 4,000 Poland 31,000 Portugal 8,502 Romania 22,000 Serbia n.a. Slovakia 3,000 Slovenia 12,200 Spain 37,971 Sweden 13,185 Switzerland 38,561 Turkey 25,000 United Kingdom 65,000 Total 700,010 Note: Austria, Denmark, Poland, U.K.: 2010 data; Czech Republic: 2009 data; Cyprus: 2007 data; Malta: 2004 data Austria, Belgium, Bulgaria, Croatia, France, Greece, Ireland, Italy, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Sweden, Switzerland, United Kingdom: estimate Source: EFPIA member associations (official figures)
  • 13. 13 Employment in the pharmaceutical industry (1990-2012) The research-based pharmaceutical industry is one of Europe’s major high-technology industrial employers. Recent studies in some countries showed that the research-based pharmaceutical industry generates three to four times more employment indirectly - upstream and down- stream - than it does directly. Further, a significant proportion of these are valuable skilled jobs, for instance in the fields of academia or clini- cal science, which can help maintain a high-level knowledge base and prevent a European “brain drain”. Employment in pharmaceutical R&D (1990-2012) 0 100,000 200,000 300,000 400,000 500,000 600,000 1990 1995 500,879 2000 500,699 2005 534,882 2010 634,924 2011 2012 668,806 700,010 700,000(e) 700,000 116,000(e) 20121990 1995 2000 2005 2010 117,035 2011 0 20,000 40,000 60,000 80,000 100,000 120,000 0 20 40 60 80 100 120 115,695 76,126 82,618 88,397 100,726 Note: Data includes Turkey (since 2011), Croatia and Lithuania (since 2010), Bulgaria, Estonia and Hungary (since 2009), Czech Republic (since 2008), Cyprus (since 2007), Romania & Slovakia (since 2005), Malta, Poland and Slovenia (since 2004) Source: EFPIA member associations (official figures) - (e): EFPIA estimate Note: Data includes Poland (since 2010), Czech Republic, Estonia and Hungary (since 2009), Romania (since 2005) and Slovenia (since 2004) Bulgaria, Croatia, Cyprus, Greece, Latvia, Lithuania, Malta, Serbia, Slovakia, Tur- key: data not available Source: EFPIA member associations - (e): EFPIA estimate
  • 14. 14 41.0% 26.7% 11.7% 14.7% 5.9% North America (USA, Canada) Europe Japan Africa, Asia (excluding Japan) & Australia Latin America 41.0% 26.7% 11.7% 14.7% 5.9% North America (USA, Canada) Europe Japan Africa, Asia (excluding Japan) & Australia Latin America PRICE STRUCTURE Distribution margins, which are generally fixed by govern- ments, and VAT rates differ significantly from country to country in Europe. On average, approximately 35% of the retail price of a medicine reverts not to the manufacturer, but rather to the distributors (pharmacists and wholesalers) and the State. Breakdown of the retail price of a medicine, 2011 (%) 65.2% Manufacturer 5.6% Wholesaler 19.3% Pharmacist 9.9% 65.2% Manufacturer 5.6% Wholesaler 19.3% Pharmacist 9.9% State (VATandothertaxes) Note: Non-weighted average for Europe (average estimate for 24 countries) Source: EFPIA member associations Note: Europe includes Turkey and Russia Source: IMS MIDAS, 2013 (data relate to the 2012 audited global retail pharma- ceutical market at ex-factory prices) PHARMACEUTICAL SALES The world pharmaceutical market was worth an estimated € 667,653 million ($ 857,800 million) at ex-factory prices in 2012. The North American market (USA & Canada) remained the world’s largest market with a 41.0% share, well ahead of Europe and Japan. Breakdown of the world pharmaceutical market – 2012 sales
  • 15. 15 PHARMACEUTICAL MARKET VALUE (at ex-factory prices) EFPIA 2011 € million Austria 3,096 Belgium 4,536 Bulgaria 753 Croatia 611 Cyprus 203 Czech Republic 2,090 Denmark 2,124 Estonia 204 Finland 2,006 France 27,491 Germany 26,122 Greece 4,867 Hungary 2,111 Iceland 106 Ireland 1,708 Italy 20,272 Latvia 291 Lithuania 487 Malta 77 Netherlands 4,713 Norway 1,550 Poland 5,062 Portugal 3,136 Romania 2,524 Serbia 564 Slovakia 1,119 Slovenia 514 Spain 13,941 Sweden 3,411 Switzerland 3,941 Turkey 7,172 United Kingdom 13,801 Total 160,603 Note: Medicinal products as defined by Directive 2001/83/EEC Cyprus, Denmark, Finland, Iceland, Latvia, Lithuania, Norway, Slovenia, Sweden: pharmaceutical market value at pharmacy purchasing prices Malta: 2007 data Belgium, France, Germany, Ireland, Italy, Malta, Norway, Spain, U.K.: esti- mate Source: EFPIA member associations (official figures) – Bulgaria, Croatia, Czech Re- public, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia: IMS The figures above are for pharmaceutical sales, at ex-factory prices, through all distribution channels (pharmacies, hospitals, dispensing doctors, supermarkets, etc.), whether dispensed on prescription or at the patient’s request. Sales of veterinary medicines are excluded.
  • 16. 16 VAT rates applied to medicines Country Standard VAT rate (%) Prescription (%) OTC (%) Austria 20.0 10.0 10.0 Belgium 21.0 6.0 6.0 Bulgaria 20.0 20.0 20.0 Croatia 25.0 5.0 25.0 Cyprus 18.0 5.0 5.0 Czech Republic 21.0 15.0 15.0 Denmark 25.0 25.0 25.0 Estonia 20.0 9.0 9.0 Finland 24.0 10.0 10.0 France (1) 19.6 2.1 7.0 Germany 19.0 19.0 19.0 Greece 23.0 6.5 6.5 Hungary 27.0 5.0 5.0 Iceland 25.5 25.5 25.5 Ireland (2) 23.0 0.0 - 23.0 0.0 – 23.0 Italy 21.0 10.0 10.0 Latvia 21.0 12.0 12.0 Lithuania (3) 21.0 5.0 - 21.0 5.0 - 21.0 Luxembourg 15.0 3.0 3.0 Malta 18.0 0.0 0.0 Netherlands 21.0 6.0 6.0 Norway 25.0 25.0 25.0 Poland 23.0 8.0 8.0 Portugal 23.0 6.0 6.0 Romania 24.0 9.0 9.0 Serbia 20.0 8.0 8.0 Slovakia 20.0 10.0 10.0 Slovenia 20.0 8.5 8.5 Spain 21.0 4.0 4.0 Sweden 25.0 0.0 25.0 Switzerland 8.0 2.5 2.5 Turkey United Kingdom 18.0 8.0 8.0 20.0 0.0 20.0 VAT RATES APPLICABLE TO MEDICINES The table below shows the VAT rates applied to medicines in European countries as of 1 January 2013. (1) France: reimbursable medicines 2.1%; non-reimbursable medicines 7.0% (2) Ireland: oral medication 0%; other medication 23.0% (3) Lithuania: reimbursable medicines 5.0%; non-reimbursable medicines 21.0%
  • 17. 17 15.0 Slovenia 21.0 Switzerland Poland Portugal Romania 62.2 Norway 16.5 Netherlands 11.8 Latvia Lithuania Turkey UK 0 5 10 15 20 25 30 % 35 40 45 50 55 60 Finland France 35.2 Germany Greece 32.2 Hungary Ireland Italy Denmark 21.7 21.9 Austria 24.9 Belgium 13.0 Bulgaria 39.1 42.5Croatia 26.2 30.6 Estonia 13.6 18.0 12.1 42.3 51.7 20.0 28.7 52.0 26.0 Slovakia 12.6Spain 9.8 Sweden 39.2 GENERICS The term ‘generic’ is widely used but its definition is not always consistent between countries. Generics are usually produced by a manufacturer who is not the inventor of the original product, and are marketed when intellectual property protection rights are exhausted. The market share of generics is significantly higher in new EU Member States with historically low levels of intellectual property protection. Share (estimate - in %) accounted for by generics in pharma- ceutical market sales value (at ex-factory prices), 2011 Note: Croatia, Denmark, Finland, Estonia, Greece, U.K.: share of generics in pharmacy market sales Austria, Belgium, Bulgaria, France, Germany, Hungary, Ireland, Italy (as referred to transparency lists), Portugal, Slovenia, Spain: share of generics in reimbursable pharmacy market sales Latvia, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, Sweden, Swit- zerland, Turkey: share of generics in total market sales France: data relate only to those active substances listed on the official list of medicines Definition: ‘generic’ means a medicine based on an active substance that is out of patent and which is marketed under a different name from that of the original branded medicine (generics data do not include those generics marketed by the originator). Source: EFPIA member associations
  • 18. 18 PHARMACEUTICAL EXPORTS EFPIA 2011  million Austria 6,540 Belgium 35,524 Bulgaria 565 Croatia 323 Cyprus 223 Czech Republic 1,317 Denmark 7,559 Estonia 47 Finland 1,146 France 24,469 Germany 50,818 Greece 864 Hungary 3,459 Ireland 26,645 Italy 14,679 Latvia 306 Lithuania 268 Luxembourg 148 Malta 206 Netherlands 15,994 Norway 507 Poland 1,658 Portugal 593 Romania 732 Slovakia 361 Slovenia 1,917 Spain 9,843 Sweden 6,384 Switzerland 48,846 Turkey 407 United Kingdom 26,225 Total 288,573 Note: All data based on SITC 54 Croatia, Norway, Switzerland: veterinary products excluded Source: Eurostat (COMEXT database – December 2012) Croatia: Business Monitor International; Norway: Statistics Norway; Switzerland: Swiss Federal Customs Administration
  • 19. 19 PHARMACEUTICAL IMPORTS EFPIA 2011  million Austria 6,033 Belgium 26,757 Bulgaria 818 Croatia 501 Cyprus 237 Czech Republic 3,046 Denmark 2,762 Estonia 272 Finland 1,685 France 21,435 Germany 37,027 Greece 3,125 Hungary 2,906 Ireland 4,402 Italy 18,087 Latvia 453 Lithuania 623 Luxembourg 478 Malta 113 Netherlands 10,916 Norway 1,392 Poland 4,451 Portugal 2,196 Romania 2,338 Slovakia 1,566 Slovenia 789 Spain 11,670 Sweden 3,213 Switzerland 20,408 Turkey 3,350 United Kingdom 19,086 Total 212,135 Note: All data based on SITC 54 Croatia, Norway, Switzerland: veterinary products excluded Source: Eurostat (COMEXT database – December 2012) Croatia: Business Monitor International; Norway: Statistics Norway; Switzerland: Swiss Federal Customs Administration
  • 20. 20 PHARMACEUTICAL TRADE BALANCE EFPIA 2011  million Austria 507 Belgium 8,767 Bulgaria - 253 Croatia - 178 Cyprus - 14 Czech Republic - 1,729 Denmark 4,797 Estonia - 225 Finland - 539 France 3,034 Germany 13,791 Greece - 2,261 Hungary 553 Ireland 22,243 Italy - 3,408 Latvia - 147 Lithuania - 355 Luxembourg - 330 Malta 93 Netherlands 5,078 Norway - 885 Poland - 2,793 Portugal - 1,603 Romania - 1,606 Slovakia - 1,205 Slovenia 1,128 Spain - 1,827 Sweden 3,171 Switzerland 28,438 Turkey - 2,943 United Kingdom 7,139 Total 76,438 Note: All data based on SITC 54 Croatia, Norway, Switzerland: veterinary products excluded Source: Eurostat (COMEXT database – December 2012) Croatia: Business Monitor International; Norway: Statistics Norway; Switzerland: Swiss Federal Customs Administration
  • 21. 21 EU-27 trade balance - High technology sectors ( million) - 2012 Source: Eurostat, COMEXT database, May 2013 The European Union’s top 5 pharmaceutical trading partners - 2012 EU exports EU imports Source: Eurostat, COMEXT database, May 2013 16,545 1,281 -40,409 - 48,454 33,530 54,401 -40,000 -50,000 -30,000 -20,000 -10,000 0 10,000 20,000 30,000 40,000 SITC 54 Pharmaceutical products SITC 71 Power generating machinery and equipment SITC 75 Office machines and computers SITC 76 Telecommunication, sound, TV, video SITC 77 Electrical machinery SITC 87 Professional, scientific, controlling material 50,000 60,000 29.0% 10.4% 7.0% 42.3% 6.7% 4.6% USA Switzerland Russia Japan China Others 37.8% 35.4% 6.3% 12.3% 4.2% 4.0% USA Switzerland Singapore China Israël Others 37.8% 35.4% 6.3% 12.3% 4.2% 4.0% USA Switzerland Singapore China Israël Others
  • 22. 22 TOTAL SPENDING (PUBLIC AND PRIVATE) ON HEALTH- CARE AS A PERCENTAGE OF GDP AT MARKET PRICES 1960 1970 1980 1990 2000 2010 Austria 4.3 5.2 7.4 8.4 10.0 11.0 Belgium - 3.9 6.3 7.2 8.1 10.5 Czech Republic - - - 4.5 6.3 7.5 Denmark - - 8.9 8.3 8.7 11.1 Estonia - - - - 5.3 6.3 Finland 3.8 5.5 6.3 7.7 7.2 8.9 France 3.8 5.4 7.0 8.4 10.1 11.6 Germany - 6.0 8.4 8.3 10.4 11.6 Greece - 5.5 5.9 6.7 8.0 10.2 Hungary - - - - 7.2 7.8 Iceland 3.0 4.7 6.3 7.8 9.5 9.3 Ireland 3.7 5.0 8.2 6.0 6.1 9.2 Italy - - - 7.7 8.0 9.3 Luxembourg - 3.1 5.2 5.4 7.5 7.9 Netherlands - - 7.4 8.0 8.0 12.0 Norway 2.9 4.4 7.0 7.6 8.4 9.4 Poland - - - 4.8 5.5 7.0 Portugal - 2.4 5.1 5.7 9.3 10.7 Slovakia - - - - 5.5 9.0 Slovenia - - - - 8.3 9.0 Spain 1.5 3.5 5.3 6.5 7.2 9.6 Sweden - 6.8 8.9 8.2 8.2 9.6 Switzerland 4.9 5.5 7.4 8.2 10.2 11.4 Turkey - - 2.4 2.7 4.9 6.1 United Kingdom 3.9 4.5 5.6 5.9 7.0 9.6 Europe 3.5 4.9 6.9 7.1 7.9 9.6 USA 5.1 7.1 9.0 12.4 13.7 17.6 Japan 3.0 4.4 6.4 5.8 7.6 9.5 Note: Japan, Luxembourg: 2009 data; Turkey: 2008 data Europe: non-weighted average (24 countries) – EFPIA calculations Source: OECD Health Data 2012, October 2012
  • 23. 23 PAYMENT FOR PHARMACEUTICALS BY COM- PULSORY HEALTH INSURANCE SYSTEMS AND NATIONAL HEALTH SERVICES (ambulatory care only) EFPIA 2011 € million Austria 2,275 Belgium 3,664 Bulgaria 419 Croatia 379 Cyprus 90 Czech Republic 1,387 Denmark 876 Estonia 95 Finland 1,262 France 22,909 Germany 29,556 Greece 3,979 Hungary 1,367 Iceland 59 Ireland 1,459 Italy 10,225 Latvia 117 Lithuania 182 Malta n.a. Netherlands 5,225 Norway 1,165 Poland 2,143 Portugal 1,328 Romania 1,049 Serbia 248 Slovakia 894 Slovenia 302 Spain 10,817 Sweden 2,106 Switzerland 3,886 Turkey 6,524 United Kingdom 9,616 Total 125,603 Note: Iceland: 2010 data; Czech Republic: 2009 data France, Ireland, Netherlands, Norway, Spain, Sweden, United Kingdom: estimate Source: EFPIA member associations (official figures)
  • 24. 24 Causes of death by major disease areas in Europe (EU-27) 4.6% 25.9% 0.5% 7.7% 39.1% Certain infectious and parasitic diseases Neoplasms Diseases of the blood(-forming organs) and immune mechanism disorders Endocrine, nutritional and metabolic diseases Mental and behavioural disorders Diseases of the nervous system and the sense organs Diseases of the circulatory system Diseases of the respiratory system Diseases of the digestive system Diseases of the skin and subcutaneous tissue Diseases of the musculoskeletal system and connective tissues Diseases of the genitourinary system Others (non-disease directly related causes of deaths) 3.3% 2.9% 0.3% 0.2% 1.4% 1.9% 9.7% 2.6% Data source: Eurostat, data relate to year 2010 (non-disease directly related cau- ses of deaths: EFPIA calculations – Percentages do not add due to rounding)
  • 25. 25 In-patient care (hospital) Outpatient care & others Pharmaceuticals & other medical non-durables 35.7% 47.7% 16.6% 77.0 76.5 76.0 75.5 75.0 74.5 74.0 73.5 73.0 72.5 0 Life Expectancy (years) +1.74 years 2009Contribution of Innovative Medicines 73% Other 27% 2000 Contribution of innovative medicines to increase in life expectancy (2000-2009) Source: Lichtenberg, F: Pharmaceutical innovation and longevity growth in 30 deve- loping OECD and high-income countries, 2000-2009 (2012) THE ADDED VALUE OF MEDICINES IN HEALTHCARE Medicines constitute only a small part of healthcare costs with, on average, 16.6% of total health expenditure in Europe being spent on pharmaceuticals and other medical non- durables. In costly diseases such as cancer and rheumatoid arthritis, medicines account for even less than 10% of the total disease costs. Medicines can also generate additional savings, for example by substantially reducing costs in other areas of healthcare, including hospital stays and long-term care costs. Breakdown of total health expenditure in Europe – 2010 Source: OECD Health Data 2012 – EFPIA calculations (non-weighted average for 20 EU & EFTA countries)
  • 26. ASSOCIATIONS WITH LIAISON STATUS Bulgaria: Association of Research-based Pharmaceutical Manufacturers in Bul- garia (ARPharM) Croatia: Croatian Association of Research-based Pharmaceutical Companies (CARPC) Cyprus: Cyprus Association of Pharmaceutical Companies (KEFEA) Czech Republic: Association of Innovative Pharmaceutical Industry (AIFP) Estonia: Association of Pharmaceutical Manufacturers in Estonia (APME) Hungary: Association of Innovative Pharmaceutical Manufacturers (AIPM) Latvia: Association of International Research-based Pharmaceutical Manufac- turers (AFA) Lithuania: The Innovative Pharmaceutical Industry Association (IFPA) Malta: Maltese Pharmaceutical Association (PRIMA) Romania: Association of International Medicines Manufacturers (ARPIM) Serbia: Innovative Drug Manufacturers’ Association (INOVIA) Slovakia: Slovak Association of Research-based Pharmaceutical Companies (SAFS) Slovenia: Forum of International Research and Development Pharmaceutical Industries (EIG) Ukraine: Association of Pharmaceutical Research and Development (APRaD) EFPIA MEMBER ASSOCIATIONS Austria Fachverband der Chemischen Industrie Österreichs (FCIO) Denmark Laegemiddelindustriforeningen The Danish Association of the Pharmaceutical Industry (Lif) France Les Entreprises du Médicament (LEEM) Greece Hellenic Association of Pharma- ceutical Companies (SFEE) Italy Associazione delle Imprese del Farmaco (Farmindustria) Norway Legemiddelindustriforeningen / Norwegian Association of Pharma- ceutical Manufacturers (LMI) Portugal Associação Portuguesa da Indústria Farmacêutica (Apifarma) Spain Asociación Nacional Empresarial de la Industria Farmacéutica (Farmaindustria) Switzerland Scienceindustries Belgium Association Générale de l’Industrie du Médicament (pharma.be) Finland Lääketeollisuus ry Pharma Industry Finland (PIF) Germany Verband Forschender Arzneimittel- hersteller (VfA) Ireland Irish Pharmaceutical Healthcare Association (IPHA) Netherlands Vereniging Innovatieve Genees- middelen Nederland (Nefarma) Poland Employers Union of Innovative Pharmaceutical Companies (Infarma) Russia Association of International Pharma- ceutical Manufacturers (AIPM) Sweden Läkemedelsindustriföreningen The Swedish Association of the Pharmaceutical Industry (LIF) Turkey Arastirmaci Ilac Firmalari Dernegi (AIFD) United Kingdom The Association of the British Pharmaceutical Industry (ABPI) 26
  • 27. MEMBER COMPANIES Full Members Abbott USA AbbVie USA Almirall Spain Amgen USA Astellas Pharma Europe United Kingdom AstraZeneca (AZ) United Kingdom / Sweden Baxter USA Bayer HealthCare Germany Biogen Idec USA Boehringer Ingelheim Germany Bristol Myers Squibb USA Chiesi Farmaceutici (Chiesi) Italy Daiichi-Sankyo Europe Germany Eisai Japan Eli Lilly (Lilly) USA Esteve Spain Genzyme USA GlaxoSmithKline (GSK) United Kingdom Grünenthal Germany Ipsen France Johnson & Johnson USA H. Lundbeck Denmark Menarini Italy Merck Germany Merck, Sharp & Dohme (MSD) USA Novartis Switzerland Novo Nordisk Denmark Orion Pharma (Orion) Finland Otsuka Japan Pfizer USA Roche Switzerland Sanofi France Servier France Takeda Japan UCB Belgium Affiliate Members Bial Portugal Celgene USA Cubist USA Shire United Kingdom Vifor Pharma Switzerland 27
  • 28. EFPIA (The European Federation of Pharmaceutical Industries and Associations) represents the research-based pharmaceutical industry operating in Europe. Founded in 1978, its members comprise 33 national pharma- ceutical industry associations and 40 leading pharmaceutical companies undertaking research, development and manufactur- ing of medicinal products in Europe for human use. Its mission is to promote pharmaceutical research and develop- ment and the best conditions in Europe for companies to bring to market medicines that improve human health and the quality of life around the world. Through its membership, EFPIA represents the common views of 1,900 large, medium and small companies including the entire European research-based pharmaceutical sector whose interests also include an important part of the generics segment. Two specialised groups have been created within EFPIA to address specific issues relating to vaccines (Vaccines Europe, formerly EVM – European Vaccine Manufacturers) and the needs of bio- pharmaceutical companies (EBE - European Biopharmaceutical Enterprises). Further details about the Federation and its activities can be obtained from: EFPIA Leopold Plaza Building, Rue du Trône 108 - B-1050 Brussels - Belgium Tel.: +32.(0)2.626.25.55 - Fax: +32.(0)2.626.25.66 www.efpia.eu