improving the competitiveness of the pharmaceutical industry
DESCRIPTION
Improving the competitiveness of the pharmaceutical industry. Dominique Limet Senior Vice-President and Area Director Southern and Eastern Europe. G10 - recognising the need for a competitive pharmaceutical industry. G10 Recommendations: the end of a process or the beginning of a change?. - PowerPoint PPT PresentationTRANSCRIPT
Improving the
competitiveness of the
pharmaceutical industry
Dominique LimetSenior Vice-President and Area Director
Southern and Eastern Europe
G10 - recognising the need for a competitive pharmaceutical industry
G10 Recommendations: the end of a process or the beginning of a change?
Pharmaceutical R&D expenditure - a comparison
(e): estimateSource: EFPIA member associations, PhRMA, JPMA
17,49518,800 (e)
10,958
8,000
5,342
9,078
26,384 (e)
21,631
2,810
5,221
7,499
n.a0
5000
10000
15000
20000
25000
30000
1990 1995 2000 2001
Europe
USA
Japan
1990-2001 € million
0%
2%
4%
6%
8%
10%
12%
14%
16%
Sh
are
of
R&
D (
%)
Pharmaceuticals TelecommsITElectronicsCarsAeronautics Services Interm. goodsConsumer GoodsAgro-foodPetro-Chemicals Media/Comms
Research-driven pharmaceutical companies invest up to 14% of their sales in R&D, which represents a higher percentage than any other industrial sector
R&D investment - driver of the pharmaceutical industry
73% 69%59%
26%26%
34%
1% 5% 7%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1990 1995 1999
Year
Rest of the World
USA
EU
Source: EFPIA, 2000
Location of R&D spending by EU companies
1990-1999
A call for ActionA competitive environment: key to a thriving
pharmaceutical industry in Europe
Competitive pricing for non-reimbursed medicines
Benchmarking for competitiveness
Principles of the Transparency Directive are key in finding solutions to accelerate market access
Transparency and predictability in Health technology assessments
The importance of pharmaceutical competitiveness for Europe
A knowledge-based economy
Provision of high-skilled jobs
Driver for innovation and investment
Provision of medical advances
~100 Discovery Approaches~100 Discovery Approaches
1 - 2 1 - 2 ProductsProducts
1 - 2 1 - 2 ProductsProducts
High Risk Process
12 - 15 years
Cost of development +800 Mo euro on average
High Risk Process
12 - 15 years
Cost of development +800 Mo euro on average
Drug discovery is a high-risk process
DiscoveryDiscovery Exploratory DevelopmentExploratory Development
IdeaIdea DrugDrug12 - 15 Years12 - 15 Years
Full DevelopmentFull Development
Phase I Phase II Phase III
00 151555 1010
Preclinical Pharmacology
Preclinical Safety
Millions ofCompounds Screened
Clinical Pharmacology& Safety
Attrition is High in the R&D Process
Note: Data have been expressed in € million at current exchange rates - Original data in $ million: 231 (1991), 359 (1993), 429 (1997), 610 (1999), 802 (2001)
Source: Di Masi J. et al., Tufts University, 1991; Office of Technology Assessment (OTA), 1993; Myers and Howe, 1997; Office of Health Economics & Lehman Brothers, U.K., 1999; Di Masi J., Tufts University - Centre for the Study of Drug Development, 2001
187307 378
572
895
0
200
400
600
800
1000
1991 1993 1997 1999 2001
Estimated full cost of bringing a new chemical or biological entity to market- € million
Our investment in R&D is a reflection of a high-risk development process
Comparison of product portfolios launched and in development (from 35 companies - source LEHMAN - BROTHERS) on the basis of size of targeted populations in OECD markets
0%
10%
20%
30%
40%
50%
small medium large verylarge
products launched
products indevelopment
Current and future profile of pharmaceutical innovation
Stimulating research into new medicines
Pharmaceutical industry R&D investments - 1962-1996
Etat des liens que les 6 plus gros labos phamaceutiques ont tissésAu 7 Juin 2002
Pfizer
Licensing-inCo-Promotion
ALZA
Delivery Systemfor Procardia XL
for Glucotrol
Pliva
ZithromaxAgouron
Viracept
ResponseRemune
Inhale Therapeutics
Exubera
Aventis
MerckUCB
Zyrtec
Reactine
PhytopharmObesity productPrinomastat
SunPharm
Denspm
CRCT Ltd.PARP Inh.
Unigen
Oral Calcitonin
GSK
Shionogi
S 8510S 0139
S 1746
NeurocineBiosciences
CRF Pgm
Yuhan
CRF Pgm
Adolor
Alvimopan
Tanabe
TR 14035
Alkermes
Delivery system HGS
repifermin
TaishoZybanJapon
Sepsicure LLC
GR270773
VertexAgenerase
Shire
TrizivirEpivirCombivir
GW810781
Gilead
adefovir
Relenza
RelenzaCoutler
Bexxar
Immunogen
SB 408075
Cytokinetics
NobexOral Insulin
TexasBiotech
Argatroban
Scios
NatrecorEU
Unigene
Oral hormone
FIC Niesseria Vaccine
Powderject
Corixa
MPLHer-2Mammaglobin
Prostate Tuberculose
Chlamydia
Kyorin
Noroxin
AstraZeneca
SGP
SingulairJapon
Claritin
Biogen
Anti VLA
SibiaSIB 1553
SIB 1508
Bany
KRP 297
GLX ZomigNIcOx
AZD3582NOSAID-II
Oxis Tubuhaler
device
SkyePharma
pulmicourt
Matastron
Matastron
Sugen
Iressa
Sepracor
AllergaInflazyme
IPL512602Transkary
otic
Dynepo
Yakut Honsha
Campto
Genta Genasense
Therion
Alvac
ViroPharma
Picovir
Pralnascan
Axys
cathepsinMilleniumTechnology
transfert
Noven
Combipatch
Peptide therapeutics
Helico...
Karo BioStrat. All.
BMS KosNistat
AvaproJapan
Dura
Azactam
Toyama
Garenoxacin
Imclone
ErbituxOtsuka
apipriprazole
Oncologytherapeutic
Network
apipriprazole
Joint VentureCo development
Légende
The pharmaceutical industry’s investment in the life-science sector
Increasing competitiveness: a dual approach
Meeting the pharmaceutical sector’s needs:
– Rewarding innovation and improving the science base
– Addressing structural issues
– Improving market access
Creating the right conditions for a competitive industry
Increasing competitiveness: a dual approach
Meeting society’s health objectives:
– Bringing innovative approaches to healthcare
– Addressing health gaps and priorities
Operating in a manner that responds to Europe’s health needs
Europe’s ageing population
Denmark
Germany
Spain
Spain
France
France
Italy
Netherlands
Finland
United Kingdom
United Kingdom
0
5
10
15
20
0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 95+
Age groups
Av
era
ge
ex
pe
nd
itu
re p
er
he
ad
ex
pre
ss
ed
as
a s
ha
re o
f G
DP
pe
r c
ap
ita
(%)
Source: Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations”
The limits of cost-containment
An increase in pharmaceutical spending largely due to ageing and the launch of innovative medicines
Pharmaceutical spending is an easy target but only represents a part of overall healthcare spending
A continuous focus on short-term cost-containment will not resolve long-term structural issues and challenges of healthcare systems in Europe
Avoiding the vicious circle
Ad hoc emergencymeasuresshort-termism
Access delays
Healthcarerationing
Budgetary pressures
Less access for patients to innovative treatments Higher costs in other healthcare budget silos, i.e.hospitalisation
Pharmaceutical industry must take measures to deal with abrupt changes
Renewing the ‘social contract’
Managing healthcare budgets
Ensuring access for patients toinnovative treatments
Optimising healthcare intervention
Predictability, communication, transparency
R&D investment in medicinesthat count
Business Planning for long-term supply ofmedicines
Recognising the benefits of innovation
Next steps
Cost considerations are key
Long-term value is critical
Balancing the relationship to ensure that European pharmaceutical industry meets Europe’s needs in a changing world