Agenda

CONFERENCE DAY ONE
Monday 30th August 2010

DAY ONE | DAY TWO

8:30 Registration and Coffee

9:00 Opening Remarks from the Chair
Andrew Wiseman, Partner, Allens Arthur Robinson

Keynote Opening Address

9:10 PANEL DISCUSSION: Industry Codes - An In-Depth Discussion on Striking the Appropriate Level of Regulation and How This can Best be Achieved

> Recent Changes to the MA Industry Code of Conduct: Provisions for the Promotion of Prescription Drugs
> Review of the new GMiA Code
> ASMI supports self-regulation and would not want to see that compromised
> ASMI supports in principle the concept of a single code which would encapsulate universal principles but then also providing for sector specific (prescription medicines, non-prescription medicines, devices, etc) arrangements
> The Code should have universal coverage to ensure a level playing field
> The Code should also outline a complaints handling mechanism which can then be applied by the various industry bodies to ensure a degree of consistency

Deborah Monk, Director of Innovation and Industry Policy, Medicines Australia
Dr Deon Schoombie, Executive Director, Australian Self-Medication Industry (ASMI)
Kate Lynch, CEO, Generic Medicines Industry Association (GMIA)

10:30 Morning Tea

11:00 Registration of Biosimilars: Comparison between Australia, Europe and the US

• Current approaches to the registration of biosimilars in Australia
• Comparison with EU and proposed US approaches
• Import and export restrictions on Australian manufacturers
• Blocking registration of biosimilars in Australia

Tom Gumley, Partner, Freehills

11:40 INTERVIEW SESSION: Enforcement and Compliance for Pharma in Relation to the ACCC

> Background on the ACCC
> Criminal cartel provisions
> Information sharing regime in relation to criminal proceedings

Marcus Bezzi, Executive General Manager - Enforcement and Compliance Division, ACCC
Mr Bezzi will be interviewed on the above issues by conference chair, Andrew Wiseman

12:20 Lunch

1:20 Generics in Australia after the Memorandum of (Mis)Understanding

• The market now and in the future
• The emergence of biologics
• Changing business models
• Investment decisions
• Legal service requirements
• Are the lawyers "growing with their clients"?

James Sharkey, Head - Business Development and Licensing Asia Pacific Region, Sandoz Pty Limited

2:00 Challenges Around State Procurement Contracts

• Assessing risk
• Working with commercial teams
• Negotiating one-sided terms
• The role of Industry Associations in this process

Jeremy Levy, Corporate Counsel, Australia and New Zealand, Associate Director, Baxter

2:40 Afternoon Tea

3:10 PBS Reform - Trials and Tribulations of the WA DP Price Reduction Regime

• Experiences over the last 12 months relating to the implementation of PBS reform
• The pitfalls and deficiencies of the PBS reforms and the ways in which the legal system can be utilised
• Review of the price disclosure regime – the intent and the reality
• Implementation and disputes - working with the Department and the Courts
• A case example - judicial review of WADP-based price reductions
• Lessons learned - the challenges in implementing complex reform

Lynne Peach, Partner, Minter Ellison

3:50 The PBS, Pharma and Pricing

• When do you list a drug
• How do you list a drug?
• How do you determine the price?

Emeritus Professor Lloyd Sansom AO, Chair, Pharmaceutical Benefits Advisory Committee
Charles O’Sullivan, Head of Scientific Affairs, Hospira
Lynne Peach, Partner, Minter Ellison

4:30 Close of the Day from the Chair

4:40 Networking Drinks

7:00 Speakers and delegates are welcome to join us for a complimentary networking dinner at Wolfies Grill Restaurant, Circular Quay.

CONFERENCE DAY TWO
Tuesday 31st August 2010

DAY ONE | DAY TWO

8:30 Morning Coffee

9:00 Opening Remarks from the Chair
Andrew Wiseman, Partner, Allens Arthur Robinson

9:10 Case Management and Expert Evidence in Pharmaceutical Patent Cases
The Hon Kevin Lindgren QC, Former Judge of the Federal Court of Australia

9:50 Pharmaceutical Litigation - The Implications of Vioxx

• Product information dissemination to medical practitioners
• Marketing by sales representatives
• Compliance with the Therapeutic Goods Act
• Implied warranties under the TPA

Peter O'Donahoo, Partner, Allens Arthur Robinson

10:30 Morning Tea

11:00 The Emerging Understanding of Safety and its Application to Therapeutic Goods

"Safety" is one of the critical parameters for therapeutic goods. Its importance continues to rise and its meaning is evolving. This presentation will explore the broader view of safety including:

• Do you know about ACSOM, the new expert advisory medicines safety committee, and its approach to safety assessment?
• The TGA business practice reforms give increasing important to safety. What opportunities do they provide to industry?
• How does the focus on safety affect risk management, compliance, promotional activities and product liability?

Greg Williams, Partner, Clayton Utz

11:40 Pharmaceutical Industry Litigation

• Industry specific issues that arise for pharmaceutical companies in initiating or defending litigation whether that be:
  – Patent litigation
  – Regulatory related litigation
  – Product liability
• Insights on how pharmaceutical companies could do litigation differently (depending on the issue and objective) to better serve their company’s interests

Odette Gourley, Partner, Corrs Chambers Westgarth

12:20 Lunch

1:20 The Complexities of Vaccines – Production through to Policy Making

• The difference between the manufacture/production of vaccine products compared to pharmaceutical “pills and potions” – regulatory (TGA) requirements
• The public health differences/requirements related to vaccine demand (pandemic stockpile, National Immunisation Schedules, military needs, etc.)
• Snapshot of the key vaccine players in Asia Pacific
• Role of WHO in the vaccine world
• How WHO and the vaccine industry responded to the H1N1 public health crisis
• Developing vaccines for the future

Maija Burtmanis, Regional Counsel, Japan/Asia Pacific, Novartis Vaccines

2:00 Application of the Data Exclusivity Regime in Australia

• Basis of the regime
• Analysis of Section 25A of the Therapeutic Goods Act
• Limitations of the regime
• Relevant case law
• How Australia compares with other countries

Dr Teresa Schafer, Partner, Piper Alderman

2:40 Retail Pharmacy Sector - The Challenges and Opportunities Ahead

• The New National Regulation of Pharmacists (Health Practitioner Regulation National Law 2009 (Cwth)
• 5th Community Pharmacy Agreement and 2010 PBS Reforms - impact on the retail pharmacy sector
• Pharmacy Ownership Reforms - go west!
• Location, Location, Location - recent court decisions on the ACPA Pharmacy Location Rules; the competition is hotting up!

Hamish Rotstein, Founding Principal, RLR

3:20 Close of Conference from Chair

3:30 Afternoon Tea

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