Pharmaceutical Law Conference 2015 Brochure

PRESENTING THE 8TH ANNUAL

Pharmaceutical Law Conference

Key SpeaKerS:

Andrew Wiseman, Partner, allens

Professor John Skerritt, National Manager, Therapeutic Goods administration

Dr Wendy Lipman, Senior Research Fellow, Bioethics, University of Sydney

Dr Simone Mitchell, Partner, DLa piper

Murray Deakin, Partner, K & L Gates

Richard Vines, Chairman, rare Cancers australia

Thomas Faunce, Professor jointly in College of Law and College of Medicine, Biology and the Environment, aNU

Lynne Peach, Partner, Minter ellison

Peter Dwyer, Barrister, Maurice Byers Chambers

Wayne Condon, Partner, Griffith Hack

Dr. Teresa Nicoletti, Partner, piper alderman

Greg Williams, Partner, Clayton Utz

20th - 21st May 2015 | Sydney Harbour Marriott Hotel

www.informa.com.au/pharmalaw2015

Pharmaceutical Law Conference Wednesday, 20th May 2015 DAY 1


8.00 Registration and coffee

8.45 Speed networking session

9.00 Introduction from the chair

Andrew Wiseman, Partner, Allens

9.05 To tell or not to tell: Self-regulation or government regulation: Medicines australia, the aCCC and the U.S. Sunshine act

— The pharmaceutical company paying the health professional to promote a product

— Code of conduct

— Medicines Australia may walk away from the ACCC

— The US sunshine act

— Self-regulation of industry associations does not tackle non-members ie Indian generic drug companies

— Results of tests not being made public to protect or promote results

Dr Wendy Lipman, Senior Research Fellow, Bioethics, University of Sydney

9.45 recent Trends in pharmaceutical and Biotech patent Law

— Australian case law update: Recent decisions and important issues before the courts

— International trends: What is happening overseas and what can we expect to see in Australia?

— Interlocutory injunctions: What is the potential impact on the giving of undertakings?

— Developments in patent eligible subject matter: Recent cases and guidance

— Settling Patent Cases: Things you need to consider

Dr Simone Mitchell, Partner, DLA Piper

10.25 Morning tea

10.45 The role of pharmacy and the non-doctor in the health care system

This session looks at the broadening of health care providers with regard legal barriers, and professional indemnity and other legal issues resulting from the evolution of pharmacy in Australia. We also canvass the changes in medicine scheduling.

Panel members:

Carolyn Oddie, Partner, Allens

Ric Morgan, Senior Associate, Allens

Richard Vines, Chairman, Rare Cancers

12.15 Lunch

1.15 The Harper Competition policy review and its potential impact on the pharmaceutical industry in australia

— Australia’s intellectual property regime is a priority area for review. The Review Panel has recommended that the current exception for intellectual property licenses in the Competition and Consumer Act 2010 be repealed. The concern is that IP rights can establish barriers to entry, which when applied inappropriately, can reduce exposure to competition. This repeal could potentially affect the pharmaceutical industry given that the originator industry depends heavily upon patent rights and licensing arrangements.

— The Review Panel has also identified ‘pharmacy ownership and location rules’ as a priority area for reform. Although it is accepted that some level of regulation is justified by community safety, the Review Panel considers that the current pharmacy ownership and location rules should be removed and replaced with regulations to ensure access and quality of advice

Pharmaceutical Law Conference Wednesday, 20th May 2015

on pharmaceuticals that do not unduly restrict competition.

— The Review Panel considers that the primary prohibition in section 46 should be re-framed to prohibit a corporation that has a substantial degree of power in a market from engaging in conduct if the proposed conduct has the purpose, or would have or be likely to have the effect, of substantially lessening competition in that or any other market. This removes the original ‘taking advantage’ requirement and introduces an effects test. In order to mitigate concerns about the potential for over-capture, the Review Panel has proposed that a new defence be established to exclude a rational business decision without market power that is for the long-term interests of consumers from the scope of section 46. This reform has implications for the pharmaceutical industry.

— The Review Panel has recommended that the per se prohibition against ‘third line forcing’ be removed. Instead, such third line forcing conduct would only be prohibited if it had the purpose, or would have or be likely to have the effect, of substantially lessening competition. If this reform was implemented, it would enable pharma companies to be more aggressive in offering drug combination therapies, which lack anti-competitive effects.

Murray Deakin, Partner, K & L Gates

1.55 patients, patience and patents

Patient advocacy ought to be the primary focus and motivating factor when deciding on a course of treatment.

KPI’s, shareholder buy-in and an overseas head office should not determine who qualifies for medicines.

This session asks some serious questions regarding the scheduling of medicines, regulation and the rate of development and technology in the pharmaceutical industry in Australia.

Richard Vines, Chairman, Rare Cancers Australia

2.30 Afternoon tea

3.00 Joint ventures and alliances: key transaction drivers and considerations by reference to recent transactions.

In this session we will discuss the rationale for and importance of effectively structuring and documenting joint ventures between life science companies, as well as consider the key issues commonly negotiated by parties to a joint venture arrangement

Kate Jefferson, Partner, Baker McKenzie

3.40 CaSe STUDy: The Lundbeck ruling

In a decision which brings to an end a battle of many years, in a 3:2 majority, the High Court has ruled in Alphapharm Pty Ltd v H Lundbeck A-S that remedial provisions under the Patents Act are available to extend the time in which to apply to extend the term of a pharmaceutical patent. This session will examine the decision and its implications.

Sarah Matheson, Partner, Allens

4.20 Closing comments from the chair

4.30 Close of day one and networking drinks

Pharmaceutical Law Conference Thursday, 21st May 2015 DAY 2


8.00 Registration and coffee

8.45 Speed networking session

9.00 Introduction from the chair

Andrew Wiseman, Partner, Allens

9.05 a survey of the pharmaceutical law landscape since the accession of the abbott government

Taking a broad and deep rush this summary canvasses some crucial elements of pharma law and shines a light on the actions of the current Liberal government.

Topics covered:

— Changes to the PBS

— Abolishing the pricing tribunal

— Patent law

— The TGA

— The TPP

— Update on the Australian Anti-False Claims Act

Thomas Faunce, Professor jointly in College of Law and College of Medicine, Biology and the Environment, ANU

9.45 The aCCC vs pfizer ruling; case analysis and comments

This session looks at the implications of the ACCC/Pfizer ruling and delves into misuse of market power and anti-competitive behaviour.

Lynne Peach, Partner, Minter Ellison

Katrina Groshinski, Partner, Minter Ellison

10.25 Morning tea

10.45 International legal developments in the life sciences sector – lessons for australia

This session covers legislative, treaty, and case law developments overseas in the life sciences sector which have relevance and potential impact for Australia.

Wayne Condon, Partner, Griffith Hack

11.25 Opportunities for reform of the regulation of pharmaceuticals in australia

The Therapeutic Goods Act (1989) is now 25 years old. While a number of amendments have been made over the last two decades, including some significant changes that led to the inclusion of devices, in vitro diagnostic tests and biologicals into the Australian regulatory framework, it is timely that the regulatory framework is systematically reviewed so that the level of, and approach to regulation can be best matched to the characteristics of different types of product.

On 24 October 2014, the Government announced an external Review of medicines and medical devices regulation. Apart from benchmarking TGA regulatory arrangements against trusted international authorities, the Review will make recommendations to ensure there is an appropriate balance between risk and benefit in the regulation of prescription, over-the-counter, complementary medicines and medical devices, as well as access for individuals to unapproved medicines and medical devices. The Review will assess opportunities to simplify and streamline the approval processes undertaken by TGA, potentially including fast tracking approvals processes; opportunities for working together with trusted regulators in other jurisdictions; and exploring how evaluations by other regulators can be used more extensively by TGA. In addition, work on a number of other reform programs is continuing, particularly those providing improvements to business processes and external communication.

Professor John Skerritt, National Manager, Therapeutic Goods Administration

12.15 Lunch

1.15 DISCUSSION paNeL: The rx to OTC switch: a new era in 2015 and beyond?

Could rescheduling of the most commonly used prescription medicines to over-the-counter (OTC) status save the Australian healthcare system approximately $2.1b a year?

Pharmaceutical Law Conference Thursday, 21st May 2015

So claims the Australian Self Medication Industry (ASMI). Not only does Rx to OTC switch produce significant healthcare cost savings, other benefits include increased consumer access to treatment, an increase in OTC education and more consumer-friendly medicine labels. However, is the Australian regulatory landscape less conducive to switch, in comparison to other overseas jurisdictions?

This session explores this and other issues relating to switch further, drawing upon key industry stakeholders for opinion and prediction.

Lisa Kurian, Legal Adviser, Pfizer (Panel facilitator)

Steve Scarff, Regulatory and Scientific Affairs Director, Australian Self Medication Industry (ASMI)

Frances Drummond, Partner, Norton Rose Fulbright

Bernard O’Shea, Partner, Norton Rose Fulbright

Natalie Gauld, Reclassification specialist, Director, Pharma Projects Ltd (NZ)

1.45 The use of cannabis for medicinal purposes

— The regulation of cannabis for medicinal purposes – understanding the real issues

— How would cannabis be regulated?

> Regulation by the TGA

> Regulation by State Health Departments

— The use of cannabis itself as opposed to products derived from cannabis

— What can we learn from experiences with legalisation overseas?

Dr. Teresa Nicoletti, Partner, Piper Alderman

2.15 analysis of the expert panel review of Medicines and Medical Device regulation

On 24 October 2014, the Minister for Health announced an independent review of the regulation of medicines and medical devices in Australia. The review, which will be conducted by an eminent panel, has a wide ranging brief to

making recommendations to the government about removing ineffective regulation and encouraging competition and innovation and is the perhaps the first overarching review of medicines and medical device regulation in Australia for at least twenty years.

The review is due to report and make its recommendations on 31 March 2015. This presentation will provide an opportunity to examine the review’s recommendations and their implications for industry shortly after their publication.

Greg Williams, Partner, Clayton Utz

2.45 Afternoon tea

3.00 Intellectual property Laws amendment Bill 2014 & the Trans-pacific partnership

— TRIPS Agreement and the supply of generic versions of patented pharmaceutical items to developing countries

— AU/NZ patent application single entry point and attorney harmonisation

— Trans-Pacific Partnership (TPP) patent and IP proposals

James Lawrence, Partner, Piper Alderman

3.40 Getting the most from your expert witness

This session will address the need for adequate preparation prior to selection of the appropriate expert including precise identification of issues needing expert assessment and opinion; and the critical importance of preparation relevant to the expert’s preliminary view, formal report and oral evidence, including presentation, examination–in-chief, cross-examination and other court or tribunal, procedures.

Peter Dwyer, Barrister, Maurice Byer Chambers

4.20 Closing comments from the chair

4.30 Close of conference


Pharmaceutical Law Conference Welcome

The 8th annual pharmaceutical Law Conference brings together leading figures in pharma law in Australia. All the key players from government, associations, academia, not-for-profit, pharma corporate and major law firms converge for this industry-led summit where the best speakers present the hottest topics. Don’t miss this exciting, must-attend summit where you can network and learn from the best and also pick up those valuable CPD points. Never short on controversy this event promises in 2015 to deliver a top shelf educational experience full of regulatory updates, case studies and the latest thinking and trends from academia, government and private practice.

Topics covered include:

– To tell or not to tell: Self-regulation or government regulation: Medicines Australia, the ACCC and the U.S. Sunshine Act.

– Trends in recent pharmaceutical infringement cases

– The Harper Competition Policy Review and potential impacts on pharmaceuticals in Australia

– A survey of the pharmaceutical law landscape since the accession of the Abbott government

– The ACCC vs Pfizer ruling: Case analysis and comment

– International legal developments in the life sciences sector – lessons for Australia

– Opportunities for reform of the regulation of pharmaceuticals in Australia

– Analysis of the Expert Panel Review of Medicines and Medical Device Regulation

– The Intellectual Property Laws Amendment Bill 2014 and how it relates to pharmaceutical companies

– The role of pharmacy and the non-doctor in the health care system

I look forward to meeting you at the conference.

Kind regards,

Andrew Vallentine

Conference Producer

Pricing Detailsregister early & Save early Bird rate

Book & pay on or before 20/3/15Standard rate Book & pay from 21/3/15

Conference package prICe GST TOTaL SaVe prICe GST TOTaL

Two day conference $2295 $229.50 $2524.50 $330 $2595 $259.50 $2854.50

Pharmaceutical Law Conference 20th - 21st May 2015 | Sydney Harbour Marriott Hotel

SpONSOrSHIp aND eXHIBITION OppOrTUNITIeS

Sponsoring or exhibiting at the 8th Annual Pharmaceutical Law Conference is your opportunity be at the forefront of this industry event.

Engage with key decision makers from leading pharmaceutical companies, law firms, federal government departments, industry associations and consultancy firms.

Packages can be tailored to meet your specific objectives.

To discuss further, please contact:

Damian Dulanovic

Phone: (02) 9080 4042

Email: [email protected]

VENUE DETAILS

Sydney Harbour Marriott Hotel 30 Pitt Street, Sydney NSW 2000

phone: (02) 9259 7000

www.marriott.com.au/Sydney

Use your QR Reader App on your smartphone and scan this code to take you directly to the website

For full terms and conditions, please visit: www.informa.com.au/pharmalaw2015

Pharmaceutical Law Conference 20th - 21st May 2015 | Sydney Harbour Marriott Hotel

reLaTeD UpCOMING eVeNTS:

If undeliverable return to: PO BOX Q1439, SYDNEY NSW 1230


COMMeNTS frOM LaST yearS eVeNT:

“Great networking opportunity and source of information on current industry issues”

Pfizer

“Very interesting topics with expert knowledge”

Roche

“Excellent choice of presenters! They were all qualified in their fields”

Southern Cross University

24th annual Medico Legal Congress

19-20 March 2015 | Sydney Harbour Marriott

7th annual Obstetric Malpractice Conference

June 2015 | Melbourne

6th annual Correctional Services Healthcare Summit

August 2015 | Melbourne

12th annual future of the pharmaceutical Benefits Scheme Summit

September 2015 | Melbourne

3 Easy Ways to Register

WeBwww.informa.com.au/pharmalaw2015

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