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www.efpia.eu
Committed to Health!
The contribution of the research-based companies to better health for European patients and sustainable healthcare systems
Bulgaria EU PresidencyMarch 6, 2018Sofia
Boris AzaïsDirector Public PolicyMSD
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Scientific advances and unmet medical needs are the key drivers of
pharmaceutical innovation.
Governments need to put in place strong “enablers”, such as IP rights, R&D
incentives, rapid access to market and a stable pricing environment.
IP
RIghts
MEDICAL NEEDS
SCIENTIFIC
PROGRESS
What drives pharmaceutical innovation?
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15.Augustyn C, Walker B, Goss TF; Boston Healthcare Associates. Recognizing the value of innovation in the treatment of rheumatoid arthritis. http://www.phrma.org/sites/default/files/pdf/BHARAWhitepaperMarch2013.pdf. Published March 2013. Accessed May 2017.
16.Centers for Disease Control and Prevention (CDC), National Center for Health Statistics. Health, United States, 2015: with special feature on racial and ethnic health disparities. https://www.cdc.gov/nchs/data/hus/hus15.pdf. Published May 2016. Accessed May 2017.
HIV/AIDS: Treatment Advances Over Time
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Medicines have transformed HIV/AIDS from a Death sentence to a manageable disease
0
2
4
6
8
10
12
14
16
1993 1998 2003 2008 2013
ASD
R p
er 1
00
,00
0
USA
Spain
Italy
France
Canada
Australia
Germany
United Kingdom
* Or latest year of available data: Italy (2012), France (2011), Canada (2011), Australia (2011), Germany (2011).
Note: HIV/AIDS ASDR extrapolated for Italy in 2004-2005 and Australia in 2005.
Source: Health Advances analysis; WHO Mortality Database (accessed February 2016).
Country
Decline in
ASDR
(1995-2013*)
-88%
-92%
-87%
-94%
-87%
-88%
-82%
-73%
HIV/AIDS Age-Standardized Death Rates (ASDR) By Country
HAART combinations introduced
HIV/AIDS
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Pawlotsky JM, et al. J Hepatol 2016; 62: S87–99; Manns M, et al. Nat Rev Dis Primers 2017;3:1–19.
The DAA Era
TVR
BOC
SMV
SOF
Identification
of HCV
IFN + RBV
The Interferon Era
IFN Peg-IFN + RBV
3rd Wave of DAA
SOF/VEL G/P
SOF/VEL/VOX
DCVLDV/SOF
OBV/PTV/r + DSV
EBR/GZR
2nd Wave of DAA
non-A, non-B
hepatitis
1984 1989 1998 2001 2013 2014 2015 2016 2017…2011 Elimination?
Hepatitis CFrom Discovery to Elimination in our Lifetime?
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Behind this success story, 77 investigational medicines failed in clinical trials and only 12 new medicines were approved between 1998 and 2014.
Source: Twenty-Five Years of Progress Against Hepatitis C: Setbacks and Stepping Stones; PhRMA 2014
HCV cure reduces risk of liver cancer
DAA-induced SVR is associated with a 71% reduction in HCC risk
Progress in HCV cure rates and improved treatments are supporting the global elimination strategy
2001-2010 2011-2013 2013-2014 2014-2016
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Pharmaceutical Research and Manufacturers of America (PhRMA). Researching Alzheimer’s medicines: setbacks and stepping stones.http://phrma.org/sites/default/files/pdf/alzheimers-setbacks-and-stepping-stones.pdf. Published 2015. Accessed May 2017.
What it means to be working at the frontier of science
Number of Alzheimer's Drugs in Development, 1998-2014
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With over 7000 medicines in development, medical innovation will play a key role in
addressing the challenges faced by patients and healthcare systems
Source: Health Advances analysis; Adis R&D Insight Database. March 2015, compiled by PhRMA
Where our R&D is focused
www.efpia.euSources: 1: Dirk Calcoen el al. 2014; 2: Biotech M&A Review, Windhover information 2008; 3: International Trade
Commission, 2016, Top Markets Report
Only 2 out of 10 marketed medicines generate returns that exceed average R&D costs.3
Attrition profiles across therapeutic areas
High Attrition Rates through the R&D Pipeline
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+ 2 + 1
EU=European Union; IP=intellectual property; RDP=regulatory data protection; SPC=supplementary protection certificateSource: 1. EFPIA, About IP incentives (2017)
IP incentives run in parallel and drive R&D to address unmet
medical needs
Patent (20 years)
RDP (8 years)
SPC (max.5 years)
Product available for patientsClinical trials (phases 1-3)
Orphan medicine (10 years market exclusivity)
Effective patent time lost
Paediatric research
Orphan designation
Timeline: -12 0 8 10 13 years
Paediatric extension(+ 6 months)
Paediatric extension(+ 2 years)
Research
For all medicines
For orphan medicines
The product is granted marketing
authorisation
The marketing authorisation is updated
for paediatrics
The patent is filed Generics enter the market after patent expiry
P&R delays
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Leading drug classes in 1995 were cardiovasculars, antibacterials, hypertension, pain, and a broad group of gastrointestinal products
All of these classes have been reduced to a much lower share of new and existing protected brand spend by 2015
However, existing protected brands is less than 50% of total expenditure
Latest innovation (<24months) has been less than 10% since 1996 [1]
Sources: [1] QuintilesIMS Institute (2017), Understanding the Dynamics of Drug Expenditure. Shares, Levels, Compositions and Drivers
Headroom for innovation:Last year’s innovation makes room for today’s
A complex policy framework requires partnership
TOGETHER
SUPPORT
Investment in Science:
- Academic centers
- Basic Science
- Higher education
- Promotion of partnerships
with industry
Investment in Healthcare:
- Financing
- Evidence-based medicine
- Focus on value
Favorable Environment:
- Intellectual Property Rights
- Smart regulatory framework
- Reward for innovation
- Rapid access to market
- Research tax credits
- Stability of the regulation
SCIENCE
POLICY
HEALTHCARE
POLICY
INDUSTRIAL
POLICY
Investments
in
Science
Investments
in
Public Health
Favorable
Business
Environment
Better Health
Human capital creation
Higher productivity
Economic growth
Policy Outcomes
New Drugs
Rapid Uptake
Sales
Cash Flow
R&D
Policy Decisions
Pharmaceutical innovation is the result of a strong partnership between science,
healthcare and industry.
13
Thank You!