Download - The pharmaceutical industry
The pharmaceutical industryMarch 27th 2014, University of Zurich Fabienne Heimgartner, Interpharma
What it needs for one drug
CHF investment
working hours experiments
scientists
drug
1 000 000 000
7 000 874
6 587
423
1
A long way to go…
Quel
le: H
elsa
na
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
• EMEA EMEA EMEA
SwitzerlandIFPMA
PhRMAEFPIA
EUEurope
OECDWHO
EMA
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
9Source: Interpharma mit Datenbasis IMS Health Schweiz
The pharmaceutical industry matters…
Source: The Importance of the Pharmaceutical Industry for Switzerland, study by Polynomics on behalf of Interpharma, October 2013.
More than 169’800 employees Direct: 39‘500 Indirect: 130’300 Multiplier: 4.3
Pharmaceutical industry
32% of total Swiss exports 64.1 Mia CHF (2012)
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 tooverall economy(workplace productivity in 2012) Employee pharma: CHF 488’000 Employee overall economy: CHF 124’000
What the Swiss say about the pharmaceutical industry..
Research & Development
Worldwide R&D expenditures
R& D Investments
Portion of R&D costs on sales
Roche H
olding Int
elMerc
k
Novartis
Microso
ftPfi
zer
Johnso
n & Jo
hnson
Samsun
g0%
5%
10%
15%
20%
25%21.0%
19.0%17.3% 16.5%
13.3% 13.3%11.4%
5.8%
Source: Booz & Co, The 2012 Global Innovation 1000 Study, 2013.
Which therapeutic areas are studied?
Preclinical and clincal studies
Source: www.ipmglobal.org
Active ingredients are tested for safety and efficacy
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
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
Drug approval /authorisation
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 asan advisory committee to BAG includes experts and stakeholders
List of pharmaceutical specialties (SL)
Pricing and reimbursement
International drug prices
The cooperation between industry & government in Switzerland
„ 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
What is a fair price for a drug?
Globalised provision of drugs
Production„Good Manufacturing
Practice“Supply chain
(whole sale, storage)Pharmacy, hospital,
doctors office patient
Difficulties in deliverysupply bottlenecks
Safety of drug, safety of supply, safety of dosage..
Nega
tive
impa
cts Falsified
medicines(Counterfeits)
Illegal drug imports
Globalised production and distribution
Medication mistakes
Stopped drug delivieries (Source: Swissmedic)
2008: 687 2010: 1861 Swissmedic anticipates over 50‘000 illegal deliveries each year
Illegal drug imports in Switzerland on the rise
Sour
ce: P
fizer
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)
Counterfeit medicines – Some facts
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..
Fight against counterfeiting
Interpol Public Awareness Campaign against internationally
organised crime
Medical progress – some examples
Medical progressesHIV/ AIDS
In 1994, 50x more people died in Switzerland than today
Today: >30 HIV drugs available
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 progressesMultiple sclerosis
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
Medical progressesRheumatoid arthritis
„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…
Biologicals
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= Biopharmaceuticals . Produced with biotechnical processes in living cells (e.g. hamster cells, bacteria)
Bio- and genetically engineered products
CancerRheumaMultiple sclerosisEye complaintsDiabetesHematopoiesisVaccinesGrowth hormonesothers
Benefit of drugs: 40-percent accountability for increased life expectancy
Due to novel drugs Total
Social responsibility
The pharmaceutical industry supports…
Access programs: donations, education & training, pricing schemes, transfer of technology, capacity building
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
Social responsibility
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
Unhealthy lifestyles
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.
Aging world population
demand for medical care is growing, which is forcing the funding organizations to take aggressive cost-containment measures.
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Causes of death now and then
1980: 2011:
Cardiovascular systemTumorsRespiratory systemAccidents and violenceDigestive systemMetabolism and bloodSuicideNervous systemInfectionsPsycheOthers
Cardiovascular systemTumorsPsycheRespiratory systemNervous systemAccidents and violenceDigestive systemMetabolism and bloodSuicideInfectionsOthers
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
What drives innovation?
Medical need Scientific advances Market incentives Innovation-friendly
regulatory, economic and IPR framework
Stable and predictable environment
Medical Need
Scie
ntifi
c A
dvan
ces
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