Biotech Healthcare Manifesto

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Biotech Healthcare Manifesto Press
Lunch September 22nd 2005
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Biotech Healthcare Manifesto Introduction Jo
Vanhemelrijck Secretary General EuropaBio
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Biotech Healthcare Manifesto Presentation
Andrea Rappagliosi Chairman EuropaBio
Healthcare Council
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Healthcare Manifesto Mission To promote a
patient-oriented, innovative and dynamic
economic and regulatory environment for
healthcare biotechnology in Europe.
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From Lisbon ... The competitive knowledge based
economy ..to Stockholm Summits conclusion to
utilize the full potential of biotechnology and
strengthen the European biotechnology sector's
competitiveness ....and to the Commissions
Communication Life-Sciences and
Biotechnology But the March 2005 European
Council stated that Five years after the Lisbon
Strategy,the results are mixed ...there is a high
price to be paid for delayed or incomplete
reforms... urgent action is therefore called
for
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Introduction to Healthcare Biotechnology

...Delivering on promises

• Facts Benefits
• Biotech medicines account for 20 of all marketed
  medicines and 50 of those in clinical trials
• 324 Biotech new
• medicines and vaccines
• today being tested for
• nearly 150 diseases
• More than 250 million
• patients have benefited
• from already approved
• biotech medicines

Source PhRMA 324 Biotechnology Medicines in
Testing Promise to Bolster the Arsenal Against
Disease October 2004
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Innovation for the benefit of patients

Human Insulin First application of Biotech in
medicine Recombinant human growth hormone First
Synthetic human growth hormone with no risk of
CJD infection Recombinant interferon beta
Enabled real progress in treating Multiple
Sclerosis Recombinant erythropoietin
(EPO) Revolutionized the treatment of anemia as
a result of Kidney failure and chemotherapy with
cancer patients Monoclonal antibodies for the
treatment of cancer Development of drugs
targeting specific types of cancer cells
Herceptin (Trastuzumab) for breast cancer
.
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Why a Manifesto?
To assess the vital role that Healthcare biotech
will play in achieving the goal set by the Lisbon
Agenda and To engage the EU Commission on a
single platform to promote biotechnology in
Healthcare for the benefit of patients.
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• 3 Policy Pillars , 7 principles
• In the best interests of patients,
• translating the Lisbon agenda
• 1 Innovative Healthcare
• Orphan Medicinal Products
• Advanced Therapies Products
• Diagnosis and Innovative Medicines
• 2 Public Commitment
• Improving patient access to innovation
• Bioethics
• Biosimilars
• 3 Health for Wealth
• Friendly environment for Biotech Industries

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• Innovative Healthcare
• Promoting access to innovation
• Orphan Medicinal Products completing a European
  dream
• Ensuring policy continuity from designation to
  patient access
• Building awareness about rare diseases
• Guaranteeing regulatory certainty
• Facilitating diagnostic networks and a European
  system for compassionate use
• Advanced Therapies Products reaching for new
  medical frontiers
• Guaranteeing safety and access with a robust
  European regulatory framework
• Diagnosis and Innovative Medicines improving
  the role of genetics
• and pharmacogenetics in preventing and
  understanding the causes
• of diseases.

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• Public Commitment
• Engaging with Society
• Improving patient access to innovation
• Promoting public health by rewarding innovation
• Improving access regardless of income or disease
  rarity
• Involving patients and healthcare professionals
  in evaluation and decision making
• Bioethics, a continuous debate to promote
  societal understanding
• Transparent information on technologies and their
  applications
• Biosimilars, for a patient-centered,
  science-based legislation
• For biotech products, the manufacturing process
  is an integral part of the product
• Stringent assessments to guaranty Safety, Quality
  and Efficacy

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• Health for Wealth
• Healthcare Biotechnology,
• improving quality of life, jobs and growth
• Friendly environment for Biotech industries
• Making Europe the most attractive place for
  innovative companies
• Campaigning for Young Innovative Company status
  for SMEs

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For more information visit www.healthcare-manife
sto.org
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Industry Participants List of participants from
industry Mr. Andrea Rappagliosi, Serono Ms.
Wills Hughes-Wilson, Genzyme Europe Mr. Thomas
Bols, Amgen Mr. Gil Beyen, Tigenix Mr. Jean-Marie
Stassen, Thromb-X