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Pharmaceuticals Industry Strategy Group

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Title: Pharmaceuticals Industry Strategy Group


1
Pharmaceuticals Industry Strategy Group
  • 3 December 2008
  • Peter Chesworth
  • General ManagerPharmaceuticals and Enabling
    Technologies Branch
  • Department of Innovation, Industry, Science and
    Research

2
Pharmaceuticals Industry Strategy Group(PISG)
  • Announced in April 2008 by the
    Minister for Innovation, Industry
    Science and Research, Senator the Hon Kim Carr
  • 24 members from across the pharmaceuticals
    industry
  • Co-chairs
  • Dr Brian McNamee, CEO of CSL
  • Mr Craig Pennifold, Head of Innovation Division,
    Department of Innovation
  • To develop 10 year strategic plan to increase
    investment in RD, clinical trials and
    manufacturing.

3
Pharmaceuticals Industry Strategy GroupTerms of
Reference
  • Develop a strategic plan to increase
    pharmaceuticals investment in Australia
  • Examine drivers and barriers
  • Identify strategies to
  • overcome impediments and capitalise on
    opportunities
  • build on Australia's competitive strengths
  • Provide a case for suggested actions
  • including how they create net economic and social
    benefit

4
Pharmaceuticals Industry Strategy GroupProcess
to Directions Paper
  • Six meetings, one every month since July 2008
  • Directions Paper released in September 2008
  • Available at www.innovation.gov.au/pisg
  • Final report to Minister Carr by end of 2008 for
    his consideration

5
PISG Directions PaperThe Australian
Pharmaceuticals Industry
  • Australia's 2nd largest manufacturing export
  • 3.9 billion in 2007
  • Employs over 40,000
  • Made up of
  • local and multinational companies
  • originators, generics and biotechnology companies
  • RD, clinical trials and manufacturing

6
PISG Directions PaperChallenges
  • Industry is global in scope
  • Changing business model
  • 'Blockbusters' ? personalised medicine
  • Biotechnology companies play an increasingly
    important role
  • Many medicines coming off patent
  • Global rationalisation
  • Current profile of the Australian industry is not
    sustainable

7
PISG Directions PaperAustralia's Strengths
Include
  • World class medical research base
  • Infrastructure in universities, medical research
    sectors hospitals
  • Highest possible safety standards
  • Efficient effective regulatory approval
  • Specialised/niche manufacturing expertise
  • Build on these strengths

8
PISG Directions PaperKey Drivers of Investment
  • The changing nature of medicines
  • RD
  • Quality scientific medical research
    infrastructure
  • Strength of the intellectual property regime
  • Clinical Trials
  • Availability of clinical trial sites and patients
  • Speed in regulatory approval
  • Cost
  • Manufacturing
  • scale, cost, IP protection, quality, high level
    skills and specialised capability for niche
    production

9
PISG Directions PaperKey Barriers to Investment
  • Tax
  • Australia's corporate tax rate higher than OECD
    average
  • RD
  • lack of critical mass
  • infrastructure gaps
  • few globally significant discovery companies
  • Clinical Trials
  • small population
  • increasing difficulty in identifying and
    recruiting patients
  • declining cost speed of study start-up
    competitiveness
  • Manufacturing
  • not cost competitive
  • lower incentives than other jurisdictions

10
PISG Directions PaperVision for a Sustainable
Industry
  • Australian pharmaceutical industry has the
    potential to create a sustainable future by
    building on strengths
  • high quality RD
  • clinical trials
  • high value added specialised/niche manufacturing
  • The transition will depend largely on the efforts
    of industry
  • Government has a role in facilitating this future

11
Considering the Role for Government Action
  • Appropriateness Activity is directed to areas
    where there is a role for government to fill a
    gap left by the market
  • Effectiveness Activities to have clear and
    consistent objectives and represent value for
    money for the expenditure of taxpayer funds
  • Efficiency Government programs to be
    administered and delivered in the most efficient
    way achievable, taking into account both short
    and long term economic and fiscal consequences
  • Integration A whole of Government approach to
    consistently deliver the Government's policy
    objectives within clearly defined lines of
    responsibility
  • Performance assessment Government activity to
    be subject to robust performance assessment and
    measurement
  • Strategic Policy Alignment Proposals to address
    whether the activity is consistent with the
    Government's strategic long term policy
    priorities

12
Considering the Role for Government Action
  • Net economic and/or social benefit

13
PISG Directions PaperA Sustainable Pharma
Industry Requires
  • Predictable, timely and transparent regulation
    and
  • reimbursement systems
  • A clear and streamlined path to market
  • An appropriate and balanced intellectual property
    regime
  • Strong and effective capital markets
  • Competitive taxation arrangements
  • An appropriately resourced tertiary education
    sector producing high quality, job ready
    graduates
  • Strong, effective collaboration between industry
    and academia

14
PISG Directions PaperSuggested Role for
Government includes
  • Maintain Australia's strong medical research
    base.
  • Ensure graduates have the appropriate skills
    base.
  • Create regulatory environment that supports high
    quality RD and does not unduly obstruct clinical
    trial activity.
  • Assist companies to make investments with
    significant net economic social benefit a
    sustainable annuity

15
PISG Directions PaperReview of the National
Innovation System
  • PISG supports the recommendations that will help
    provide capital for early stage biotechnology
    companies.
  • Competitive Innovation Grants
  • Improved access to venture capital
  • Recommendations may not be sufficient to
    encourage the necessary development of the
    industry.

16
PISG Directions PaperProposals for Further
Consideration
  • A significant fund to encourage substantial
    strategic pharmaceuticals industry investment.
  • Improving the regulatory framework for clinical
    trials including streamlining approval processes
    and accelerating use of e-health to improve the
    efficiency of clinical trials in Australia.
  • Making the skills education system more
    responsive to industry.

17
PISG Directions PaperThe Process Ahead
  • Strategy Group has consulted with others in
    industry
  • Now refining proposals
  • Final meeting 5 December
  • Provide Final Report to Minister Carr by end of
    2008
  • Government will consider the Group's findings

18
  • Department of Innovation, Industry,
  • Science and Research
  • Industry House
  • 10 Binara Street
  • Canberra City, ACT 2601, Australia
  • Telephone 61 2 6213 6000
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