Transcript Bedeutung der Pharmaindustrie für die Schweiz

The pharmaceutical industry
March 27th 2014, University of Zurich
Fabienne Heimgartner, Interpharma
What it needs for one drug
1 000 000 000 CHF investment
7 000 874 working hours
6 587 experiments
423 scientists
1 drug
Quelle: Helsana
A long way to go…
Overview
 Interpharma
 Economic impact of the pharmaceutical industry
 Research & Development
 Market access
- Counterfeiting
 Medical progress – some examples
 Social responsibility
 Main challenges for the pharmaceutical industry
Interpharma
 … is the association of research-based pharmaceutical companies in
Switzerland
 … was founded 1933
 … wants to create conditions conducive to innovation so as to
promote pharmaceutical research, development and production
 … supports efforts to create a social, economic and political environment
that strengthens Switzerland as a center of pharmaceutical research
and production
 Member companies: Actelion, Novartis, Roche, AbbVie, Alcon, Amgen,
Bayer, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead,
Janssen, Merck Serono, Pfizer, Sanofi, UCB and Vifor
Interpharma partners
World
OECD
WHO
IFPMA
PhRMA
Europe
EU
EMA
Switzerland
EFPIA
•EMEA EMEA EMEA
Economic impact of the pharmaceutical
industry
Switzerland: most competitive economy in the
world
Source: World Economic Forum: The Global Competitiveness
Index 2013–2014
Worldwide market shares 2013
Source: Interpharma mit Datenbasis IMS Health Schweiz
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The pharmaceutical industry matters…
Pharmaceutical industry
More than 169’800 employees
32% of total Swiss exports
 Direct: 39‘500
 Indirect: 130’300
 64.1 Mia CHF (2012)
 Multiplier: 4.3
Gross added value: 6.0% of GDP
(35.5 Mia. CHF, 2012)
 Direct: 3.3%
 Indirect: 2.7%
 Multiplier: 1.8
4x more productive compared to
overall economy
(workplace productivity in 2012)
 Employee pharma: CHF 488’000
 Employee overall economy: CHF 124’000
Source: The Importance of the Pharmaceutical Industry for Switzerland, study by Polynomics on behalf of Interpharma, October 2013.
What the Swiss say about the pharmaceutical
industry..
Research & Development
Worldwide R&D expenditures
R& D Investments
Portion of R&D costs on sales
25%
21.0%
20%
19.0%
17.3%
15%
16.5%
13.3%
13.3%
11.4%
10%
5.8%
5%
0%
Roche
Holding
Intel
Merck
Novartis Microsoft
Source: Booz & Co, The 2012 Global Innovation 1000 Study, 2013.
Pfizer
Johnson & Samsung
Johnson
Which therapeutic areas are studied?
Preclinical and clincal studies
Active ingredients are tested for safety and efficacy
Source: www.ipmglobal.org
Global framework for clinical research
Helsinki-Declaration (1964): important ethical framework
 informed consent of probands/patients
 outweigh the risks and burdens to the research subjects
 independent assessments by Research Ethics Committees
„Good Clinical Practice“ GCP-Guidelines
 scientific quality standards for clinical trials
 have to be embodied in national laws
Biomedicine-Convention (1997) und additional protocols
 Minimum standards to protect human right and dignity in medicine and
biology
Recommendations of the Council of Europe
…
National Laws
 Humanforschungsgesetz / Heilmittelgesetz
Probability of success to market
Source: CMR International 2012 Pharmaceutical R&D Factbook
Bottlenecks: Reasons for failure
Market access
Drug approval /authorisation
 Efficacy, safety, quality
 Examination of submitted documents (clinical data on efficacy, safety, quality,
purity ..)
 Check whether international guidelines have been followed (On-site
inspections)
After approval
 continuous surveillance
of safety
Pricing and reimbursement
 Swiss Federal Office for Public Health (BAG)
 Relative efficacy, suitability, efficiency
 Therapeutic comparison with comparable drugs on the market
 International price referencing
every three years
Country basket: Austria, Germany, Denmark,
France, UK and the Netherlands

 Federal Medicines Commission as
an advisory committee to BAG includes
experts and stakeholders
 List of pharmaceutical specialties (SL)
International drug prices
The cooperation between industry & government in Switzerland
What is a fair price for a drug?
„ I see more creative pricing models as we
go forward, and these pricing models will
always be specific to the individual countries
because the needs, resources and healthcare
delivery systems are very specific to those
countries. We are prepared to go for not
only
differentiated
pricing
across
countries, but also within countries.
..But for this kind of system to work,
solidarity between rich and poor countries is
needed..“
Severin Schwan, CEO Roche
Globalised provision of drugs
Production
„Good Manufacturing
Practice“
Supply chain
(whole sale, storage)
Pharmacy, hospital,
doctors office
patient
Globalised production and
distribution
Negative impacts
Safety of drug, safety of supply, safety of dosage..
Illegal drug
imports
Falsified
medicines
(Counterfeits)
Difficulties in delivery
supply bottlenecks
Medication
mistakes
Illegal drug imports in Switzerland on the
rise
Stopped drug delivieries (Source: Swissmedic)
 2008: 687
 2010: 1861
Source: Pfizer
 Swissmedic anticipates over 50‘000 illegal deliveries each year
Counterfeit medicines – Some facts
 Approximately 10% of all drugs are falsified globally
- over 30% in some countries of Latin America, Southeastern Asia and Africa
(WHO,OECD )
 Multi-billion sales for globally organised criminals
 Over 50 % of all drugs, illegaly sold from the internet, are falsified (WHO)
 High health risk
 > 200‘000 annual deaths (WHO)
Fight against counterfeiting
Medicrime Convention of the Council of Europe
 Safeguarding of public health through penal measures
against criminal behaviors, protection of victims
 promotion of cooperation at national and international
levels
Stop Piracy (www.stop-piracy.ch)
 Public education
 Public sector: Swissmedic, IGE, seco, EDA, …
economy: pharma, watches, software,food..
Interpol
 Public Awareness Campaign against internationally
organised crime
Medical progress – some examples
Medical progresses
HIV/ AIDS
 In 1994, 50x more people died in Switzerland than today
 Today: >30 HIV drugs available
Medical progresses
Multiple sclerosis
 2011: first therapy for MS in tablet form is approved (escalation-therapy)
 2013: European approval of two tablets for the treatment of relapsing-remitting
MS
 for the first time, there is an oral MS-therapy available (rrMS)
Medical progresses
Rheumatoid arthritis
 Autoimmune disease
 50-60% of patients do not respond to broad-acting drugs
 To date, 5 biologicals (mostly antibodies) are registered, more to follow..
 2/3 of severe RA-patients respond very well to biologicals
- fast and targeted efficacy
- few adverse events
- prevention of joint-destruction
- reduction of morning stiffness
Biologicals
= Biopharmaceuticals . Produced with biotechnical processes in living cells
(e.g. hamster cells, bacteria)

„novel“ revolutionary substance class

Big, highly complex molecules

not easy to copy ≠ generics (Biosimilars)

Insulins, antibodies, proteins to stimulate bloodcells

To treat MS, cancer, diabetes…
33
Bio- and genetically engineered products
Cancer
Rheuma
Multiple sclerosis
Eye complaints
Diabetes
Hematopoiesis
Vaccines
Growth hormones
others
Benefit of drugs: 40-percent accountability for
increased life expectancy
Due to novel drugs
Total
Social responsibility
Social responsibility
The pharmaceutical industry supports…
 Access
pricing
building
programs: donations, education & training,
schemes, transfer of technology, capacity
 Numerous multinational initiatives: e.g. Global Fund,
GAVI, WHO, UNITAID
 Company
programs: e.g. African Comprehensive
HIV/AIDS Partnership (ACHAP) in Botswana (Merck);
AmpliCare for diagnosis and therapy of HIV-positive
mothers and their newborns (Roche)
 Good governance: good manufacturing practices,
ethical standards, guarantee high quality, safety &
efficacy of medicines and vaccines, comply with
regulatory requirements
London Declaration 2020
Collaborative programme of various private and public
partners against neglected tropical diseases (NTDs)
Goal
 Eradication of 5 NTDs and control over 10 NTDs by 2020
Approach
 Sustain, expand and extend drug access programmes
 Advance R&D through partnerships and provision of funding
 Enable adequate funding with endemic countries to implement NTD programmes
Examples
 Novartis : long-term commitment to leprosy treatment and control by donating
multidrug therapy (Rifampicin, Clofazimin & Dapson)
 Pfizer : donations of Azithromycin for trachoma until at least 2020
Projects against diseases in developing countries
Source: IPFMA, Status Report, R&D for “Diseases of the
Developing World (DDW)”, 2011
Quelle: IFPMA Facts and Figures. Issue 2012.
Partnership-Directory
http://partnerships.ifpma.org/pages/
The industry appeals as well to..
 Governments in low/middle income countries
-
to support the development
to create conducive frame conditions for global partner companies
 High-income countries
-
to financially support healthcare-systems in developing countries
to promote vaccine programmes
Challenges
 Donations of drugs are of no use, when infrastructure is missing
 Sanitary conditions prevent certain therapies (clean water..)
 Corruption, political instability
 Missing engagement of governments in the fight against diseases:
lack/gap of information
Source: Technology Transfer: a Collaborative Approach to Improve Global Health, IFPMA ,2011.
Main challenges for the pharmaceutical
industry
Changes in healthcare systems
Aging
world
population
Unhealthy
lifestyles
demand for medical care is growing,
which is forcing the funding organizations
to take aggressive cost-containment
measures.
increase in chronic diseases.
Emerging
markets
allowing
the
populations
of
these
countries greater access to healthcare
services.
Advances in
science and
technology
innovative medicines, but also increase
in innovation costs.
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Causes of death now and then
1980:
2011:
Cardiovascular system
Tumors
Respiratory system
Accidents and violence
Digestive system
Metabolism and blood
Suicide
Nervous system
Infections
Psyche
Others
Cardiovascular system
Tumors
Psyche
Respiratory system
Nervous system
Accidents and violence
Digestive system
Metabolism and blood
Suicide
Infections
Others
Demographic change
Source: WHO, 2005
Great demand for research persists
 There are still no therapies for 2/3 of all diseases
 Aging population  more chronic diseases
 Cancer  most probably the most common future cause of death
 Challenge dementia  triplication of diagnoses until 2050
Scientific Advances
What drives innovation?
 Medical need
 Scientific advances
 Market incentives
 Innovation-friendly
regulatory, economic and
IPR framework
 Stable and predictable
environment
Medical Need
Other challenges for the industry
 Policy makers becoming increasingly concerned about health
expenditure and cost of innovation
 Debate too much focused on cost and not on efficiency
 Growing concern over possible ineffective (or harmful) use of
untested technology
 Need for enlightened tools for assessing value of health
care services
Thank you for your attention!
[email protected]
phone: 061 264 34 44