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JOINT MEDICINES POLICY CONFERENCE 2011 HANDBOOK 30–31 AUGUST 2011 CANBERRA MEDICINES AUSTRALIA AND THE DEPARTMENT OF HEALTH AND AGEING PRESENT RD THE 3

AND THE DEPARTMENT THE RD 2011 - onq … · POLICY CONFERENCE 2011 HANDBOOK ... AUSTRALIA AND THE DEPARTMENT OF HEALTH AND AGEING PRESENT THE3 RD. WELCOME Welcome to the Third Joint

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J O I N T M E D I C I N E S P O L I C Y C O N F E R E N C E

2011

H A N D B O O K

3 0 – 3 1 A U G U S T 2 0 1 1

C A N B E R R A

M E D I C I N E S

A U S T R A L I A

A N D T H E

D E PA R T M E N T

O F H E A LT H

A N D A G E I N G

P R E S E N T

R DT H E3

W E L C O M E Welcome to the Third Joint Medicines PolicyConference, themed Health Technology Assessment for Future Generations.

We are delighted to have so many excellent presentersand such a broad range of delegates at this eventrepresenting a wealth of expertise and experience. Wewelcome the contribution each of you will make to theconference and look forward to lively and productivediscussion of issues that affect access to medicines byAustralians for generations to come.

We are very pleased to welcome the Minister for Healthand Ageing, the Hon Nicola Roxon MP to open theconference, once again demonstrating her interest inthis vital area of health policy.

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J O I N T M E D I C I N E S P O L I C Y C O N F E R E N C E

2011

M E D I C I N E S A U S T R A L I A A N D T H E D E PA R T M E N T O F H E A LT H A N D A G E I N G

P R E S E N T

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C O N T E N T S

4 Health technology assessmentfor future generations

6 Program8 Session outlines

14 Guest speaker14 International speakers15 Facilitator16 Speaker profiles

22 Social programGeneral information

Key outcomes of the 2008 Joint Medicines PolicyConference included initiatives to achieve timely accessto quality new medicines by the Australian public.Arrangements related to TGA/PBAC parallel processing,a managed entry scheme, PBS data tracking and horizonscanning were enshrined in the historic Memorandum ofUnderstanding signed between the Federal Governmentand Medicines Australia in May 2010.

This year’s conference is a great opportunity to lookahead, discuss challenges and opportunities and provideyour input to the shaping of key medicines policiesaffecting the health of our nation.

You will have the opportunity to listen to experts in theirfield both from Australia and overseas, and interact inpanel discussions on a range of issues.

You will also meet and engage with peers fromgovernment, industry, academia, consumer groupsand other stakeholders throughout the two days. Inaddition, the Conference Dinner will provide anopportunity to enjoy the company of other delegateswhile celebrating the people and partnerships thatdrive medicines policy in Australia.

We wish you an enjoyable and productive time at theThird Joint Medicines Policy Conference and lookforward to benefiting from your input and ideas overthe coming two days.

J O I N T M E D I C I N E S P O L I C Y C O N F E R E N C E 2011R DT H E3

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David Learmonth Will DelaatDE PU T Y SECRE TARY CH A I R M AN

DE PART MENT OF HE ALTH AN D AGE I NG ME D I C I NE S AU S TR AL I A

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Around the world,governments are turning to the tools of Health

Technology Assessment to guidetheir healthcare investmentdecisions. Faced with ageingpopulations and ballooninghealthcare costs, governments needto ensure that they invest judiciouslyand specifically in technologiesthat can be demonstrated to besafe, effective and value for money.

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This is especially relevant to Australia.A recent Australian Government reportinto Health Technology Assessment(HTA) recommended some significantchanges to improve the efficiency ofthe processes of health technology

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assessment of diagnostic tests, medicines, medicaldevices, prostheses and surgical procedures. In somerespects, however, it is clear that the government sees the evaluation and listing of medicines on thePharmaceutical Benefits Scheme (PBS) as a model for other areas to follow.

As far as medicines are concerned, Australia can beregarded as having a mature HTA system. Since 1993,the Pharmaceutical Benefits Advisory Committee(PBAC) has required that both the relative clinical andcost-effectiveness of a medicine be demonstratedbefore it can be funded on the PBS. This is far from astraightforward task and it has been a strength of theAustralian system that the government, the PBAC andthe pharmaceuticals industry have been able to worktogether to ensure a consistent approach to thepresentation and interpretation of clinical andeconomic evidence.

With maturity comes challenges. Medicines aremoving away from being simple chemical moleculesthat are expected to work equally well on all patients.The medicines in today’s R&D pipeline are more likelyto be complex biological molecules, derived from ourunderstanding of the genetic sciences, which aremore tailored to the needs of individual patients.These can be difficult to develop, difficult tomanufacture, and, potentially, high cost.

Australia needs to have a society-wide debate on how the government should continue to invest in such treatments. The evolving tools of HTA will play

an important role in determining the value of suchinvestment to the long-term health and economic wellbeing of Australia.

This conference is another example of how theAustralian government and the medicines industry work constructively together to meet these challenges.Whilst the topics range widely across a number ofsubject areas, the unifying theme is that of value: howis it measured and what tools do we need to do itwell? How are consumer values reflected in decisionsto fund medicines? What is value for money for thegovernment? And, how will awareness of these issuesshape the future of drug development itself?

Australia’s National Medicines Policy provides a usefulframework within which to conduct such debates. Thefour objectives of the National Medicines Policy are:

• timely access to the medicines that Australiansneed, at a cost individuals and the community can afford

• medicines meeting appropriate standards of quality, safety and efficacy

• quality use of medicines

• maintaining a responsible and viable medicinesindustry.

The challenge for all parties is to recognise the stronginterdependency between these objectives and towork together to achieve the objectives of the NationalMedicines Policy.

J O I N T M E D I C I N E S P O L I C Y C O N F E R E N C E 2011R DT H E3

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D A Y 1

T U E S D A Y 3 0 A U G U S T 2 0 1 1

8:00 AM REG I S TR AT I ON

SESSION 1 Welcome CO - CH A I R S Mr David Learmonth/Mr Will Delaat

9:00 AM WE LCO ME TO COUNTRY

Mrs Agnes O’Shea OAM, Ngunnawal Community Elder

9:05 AM WE LCO ME TO THE CON FERENCE

Mr David Learmonth, Deputy Secretary,Deparment of Health and AgeingMr Will Delaat, Chairman, Medicines Australia

9:10 AM O P EN I NG AD DRE S S

The Hon Nicola Roxon MP, Minister for Health and Ageing

9:25 AM OU TCO ME S OF THE 2008 CON FERENCE AND WOR K OF THE AC CE S S TO ME D I C I NE S WOR K I NG GROUP

Mr David Learmonth, Deputy Secretary,Deparment of Health and AgeingMr Will Delaat, Chairman, Medicines Australia

9:40 AM SE T T I NG THE S CENE

9:40 AM Prof Lloyd Sansom AO, Emeritus Professor, Divisionof Health Sciences, University of South Australia

9:45 AM Ms Carol Bennett, Chief Executive Officer,Consumers Health Forum

9:50 AM KE YN OT E A D DRE S S

CO MPAR AT I VE E FFECT I VENE S S RE SE ARCH I N THE U SA : P RO GRE S S AN D CH AL LENGE S

Dr Sean R. Tunis, Founder and Director of Centerfor Medical Technology Policy, Baltimore, Maryland

10:30 AM M O R N I N G T E A

SESSION 2 Future challenges to health technology assessment CH A I R Dr Sean R. Tunis, Founder and Directorof Center for Medical Technology Policy,Baltimore, Maryland

11:00 AM DATA REQU I REMENT S FO R THE F U T URE : H I G H CO S T/ H I G H LY TARGE TE D THER A P I E S

Prof Kathryn A. Phillips, Professor of HealthEconomics and Health Services Research,University of California, San Francisco

11:30 AM P OL I CY CH AL LENGE S

Prof Robyn Ward, Clinical Associate Dean, Princeof Wales Clinical School, University of NSW

12:00 PM E TH I C S I N DRU G DE VE LO PMENT P RO CE S S :SO C I E TAL P ER S P ECT I VE S

Ms Jennifer Doggett, Fellow, Centre for PolicyDevelopment

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12:30 PM Q & A PANE L D I S CU S S I ON

1:00 PM L U N C H

SESSION 3 Data linkages and consumer engagement CH A I R Mr Laurie Wilson, President, NationalPress Club

2:00 PM U S I NG L I N KE D DATA SE T S TO I MP ROVEHE ALTH CARE DE L I VERY

Assoc Prof Libby Roughead, Future Fellow, Schoolof Pharmacy and Medical Science, University ofSouth Australia

2:30 PM SEN S I T I VE HE ALTH I N FOR M AT I ON AND P R I VACY

Mr Malcolm Crompton, Managing Director,Information Integrity Solutions P/L

2:45 PM I S SUE S FOR CON SUMER S

Ms Karen Carey, Consumer Advocate

3:00 PM B O O S T I NG P OL I CY RE LE VANT RE SE ARCH U S I NG L I N KE D ADM I N I S TR AT I VE DATA

Prof Louisa Jorm, Foundation Professor ofPopulation Health, University of Western Sydney

3:15 PM Q & A PANE L D I S CU S S I ON

3:30 PM A F T E R N O O N T E A

SESSION 4 Hypothetical ! A patient’s experience CH A I R Prof Philip Davies, Professor of HealthSystems and Policy, University of Queensland

4:00 PM PANE L

Mr Bruce Goodwin, Managing Director, JanssenMs Janne Graham AM, Healthcare ConsumerRepresentativeProf Christine Jenkins AM, Clinical Professor of Medicine, Sydney University; Senior StaffSpecialist, Concord HospitalAssoc Prof Malcolm Parker, Head of MedicalEthics, Law and Professional Practice, School of Medicine, University of QueenslandMr Kos Sclavos, National President, The PharmacyGuild of AustraliaAssoc Prof Rosalie Viney, Deputy Director, Centrefor Health Economics Research and Evaluation,University of Technology, SydneyDr Rob Walters, General Practitioner, Hobart,TasmaniaProf Robyn Ward, Clinical Associate Dean, Princeof Wales Clinical School, University of NSW

5:30 PM DAY 1 CLO SE S

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2011R DT H E3

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7:00 PM C O N F E R E N C E D I N N E R

THE GRE AT H AL L , PAR L I AMENT HOU SE

! People are the heart of the PBSS P E AKER S

Mr Will Delaat, Chairman, Medicines AustraliaMs Jane Halton PSM, Secretary, Department of Health and Ageing

D A Y 2

W E D N E S D A Y 3 1 A U G U S T 2 0 1 1

SESSION 5 The relevance of the National Medicines Policy in the futureCH A I R Prof Andrew J. McLachlan, Chair,National Medicines Policy Committee; Professorof Pharmacy, University of Sydney

9:00 AM L I N K AGE S BE T WEEN THE FOUR P I L L AR S OF THE N MP

Dr Lynn Weekes, Chief Executive Officer, NPS

9:15 AM LO O K I NG B AC K AN D LO O K I NG FO RWAR D: HOW D I D WE GE T HERE ?

Prof Lloyd Sansom AO, Emeritus Professor,Division of Health Sciences, University of SouthAustralia

9:30 AM THE I MP ORTANCE OF D O CUMENTAT I ON

Dr Ross Maxwell, Procedural Rural Doctor(Queensland), and Prescribing Expert on theNational Medicines Policy

9:45 AM WH AT DE VE LO PMENT S WI L L I MPACT ONME D I C I NE S P OL I CY I N THE F U T URE

Dr Brendan Shaw, Chief Executive, MedicinesAustralia

10:00 AM Q & A PANE L D I S CU S S I ON

10:30 AM M O R N I N G T E A

SESSION 6 Facilitating access to medicines for special patient groupsCH A I R Dr John Primrose, Medical Adviser,Pharmaceutical Evaluation Branch, Departmentof Health and Ageing

11:00 AM FO CU S ON I N D I GENOU S HE ALTH

Prof Alan Cass, Professor, Sydney Medical School,University of Sydney, and Director of the Renaland Metabolic Division, George Institute, Sydney

11:15 AM AC CE S S TO ME D I C I NE S : P OL I CY AFFECT I NGAB OR I G I N AL P EO PLE S

Dr Sophie Couzos, Public Health Medical Officer,Aboriginal community controlled health servicesand the National Aboriginal CommunityControlled Health Organisation

11:30 AM FO CU S ON PAE D I ATR I C HE ALTH

Dr Sean Beggs, Paediatrician and PaediatricClinical Pharmacologist, Royal Hobart Hospital

11:45 AM AC CE S S TO ME D I C I NE S FO R S P EC I AL PAT I ENT S AND TARGE T GROUP S

Ms Deborah Waterhouse, General Manager,GlaxoSmithKline Australia and New Zealand

12:00 PM Q & A PANE L D I S CU S S I ON

12:30 PM L U N C H

SESSION 7 The influence of HTA in shaping future drug developmentCH A I R Prof Kathryn A. Phillips, Professor of Health Economics and Health ServicesResearch, University of California, San Francisco

1:30PM INVESTMENT DECIS IONS IN DRUG DEVELOPMENT

Dr Steve J. Romano, Senior Vice President, Pfizer,New York

2:00 PM I N NOVAT I ON D I LEM M A : THE CA SE OFANT I M I CROB I ALS

Prof John Turnidge, Clinical Director of Microbiologyand Infectious Diseases for SA Pathology,Women’s and Children’s Hospital, Adelaide

2:20 PM VALU I NG I N NOVAT I ON : HTA P R ACT I SE AND THE I MPACT FOR F U T URE ME D I C I NE S

Mr Mendel Grobler, Director, Patient Access, Pfizer Australia

2:40 PM Q & A PANE L D I S CU S S I ON

SESSION 8 Wrap-up: Conference outcomes and key messagesCH A I R Mr Laurie Wilson, President, NationalPress Club

3:00 PM Ms Carol Bennett, Chief Executive Officer,Consumers Health Forum

3:10 PM Mr David Learmonth, Deputy Secretary,Department of Health and Ageing

3:20 PM Mr Will Delaat, Chairman, Medicines Australia

3:30 PM CON FERENCE CLO S I NG

Mr Laurie Wilson

D A Y 1 C O N T I N U E D

3 0 – 3 1 AU GUS T

HOTE L RE ALM , CAN BER R A

S E S S I O N 1K E Y N O T E A D D R E S S

TUESDAY, 30 AUGUST • 9:50–10:30 AM

Comparative effectiveness research in the USA: Progressand challenges

S P E AKER Dr Sean R. Tunis, Founder and Director ofCenter for Medical Technology Policy, Baltimore, Maryland

Comparing risks and benefits of different healthcarestrategies has been a longstanding goal of clinicalresearch and health technology assessment, and is alsofundamental to comparative effectiveness research(CER). CER includes a range of methods includingsyntheses of existing evidence, analyses of routinelycollected data, and the generation of new evidencethrough prospective registries and clinical trials. Thekey distinctive feature of CER compared to otherapproaches that compare the benefits, risks and costsof health interventions is the explicit emphasis ongenerating evidence that will help patients, clinicians,and payers make more informed clinical and healthpolicy decisions. The successful conduct of CER willrequire new approaches to priority setting, novelresearch methods, efficient use of research networksand data infrastructure, policy mechanisms thatpromote evidence development, and improvedtechniques for engaging stakeholders and decisionmakers in all phases of the research process.

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S E S S I O NO U T L I N E S

S E S S I O N 2F U T U R E C H A L L E N G E S T O H E A L T H

T E C H N O L O G Y A S S E S S M E N T

TUESDAY, 30 AUGUST • 11:00 AM–1:00 PM

CH A I R Dr Sean R. Tunis, Founder and Director of Center for Medical Technology Policy, Baltimore, Maryland

Australia has a mature HTA system. However, manymedicines that are currently in R&D pipelines arepotentially biologically targeted therapies. This sessionwill examine the challenges posed both locally andinternationally by the more complex trial designs in thecontext of medicines in development globally.Discussion of these issues is particularly relevant in thearea of co-dependant technologies. This session willalso examine the policy challenges for Australia invaluing these advancements and finally from theconsumers’ perspective, the need to ensure that ourhealth system continues to deliver ‘equity of access’.

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Data requirements for the future: High cost/highlytargeted therapies

Prof Kathryn A. Phillips, Professor of Health Economicsand Health Services Research, University of California,San Francisco

This presentation will address the growth of biologicsand co-dependent tests and treatments, the inevitabletrend towards personalised medicine, and observationsregarding the relevance to Australia of developments inthe United States. Four key challenges andopportunities will be discussed: negotiating shiftingindustry paradigms, balancing innovation andregulation, building an evidence base, and determiningvalue and reimbursement. The presentation will payparticular attention to ‘evidence’ and ‘value’, and useexamples to provide insights into these issues.

Policy challenges

Prof Robyn Ward, Clinical Associate Dean, Prince of Wales Clinical School, University of NSW

The Pharmaceutical Benefits Advisory Committee andthe Medical Services Advisory Committee wereestablished to provide advice to the Minister for Healthand Ageing on the circumstances under which publicfunding for drugs, medical technologies or proceduresshould be supported. Over the last few years experiencewith the assessment of various co-dependent cancertest/drug packages has exposed many of theimpediments to realising personalised medicine. Thispresentation will discuss examples of the healthtechnology assessment process for a number of cancermedicines and their associated tests to illustrate thepolicy and practical challenges of delivering newbiologically targeted therapies.

Ethics in drug development process: Societal perspectives

Ms Jennifer Doggett, Fellow, Centre for PolicyDevelopment

This presentation will draw on recent research into theneeds and priorities of consumers for access to qualitymedicines and how these can be used to inform thedevelopmental process for new medicines.

S E S S I O N 3D A TA L I N K A G E S A N D C O N S U M E R E N G A G E M E N T

TUESDAY, 30 AUGUST • 2:00–3:30 PM

CH A I R Mr Laurie Wilson, President, National Press Club

Advances in data storage and management haveopened new opportunities for researchers and policymakers to link and mine data sets to deliver a range ofhealth and economic benefits. One of the many ways to achieve this is through harnessing the potential of e-health; more specifically, integration of health andother data sets to provide information to improvedecision making in healthcare delivery. This session willlook at the experience so far with linking public datasources, examine the opportunities and barriers toachieving success and finally, from a consumerperspective, examine the importance of balancingsafeguards to protect an individual’s privacy with theneed for access to population health data.

Using linked data sets to improve healthcare delivery

Assoc Prof Libby Roughead, Future Fellow, School ofPharmacy and Medical Science, University of SouthAustralia

Australia’s system of universal healthcare, fundedlargely by government, has resulted in the availability ofsignificant data on healthcare utilisation that representthe whole population. These data can be used in anumber of ways to improve healthcare from consistencyof care, evidence-based guidelines and evaluation ofinterventions to the generation of new knowledge. Thispresentation will include examples of the use of data forthese purposes.

Sensitive health information and privacy

Mr Malcolm Crompton, Managing Director, InformationIntegrity Solutions P/L

Health information is sensitive. Legislation tells us thatit is, and people’s feelings tell us that it is. So, how dowe manage these feelings and how do we managehealth data while moving forward with health researchand development? Privacy requirements need not be athorn in our side; they can be an opportunity to buildcommunication flows with consumers.

This presentation offers thoughts about frameworks andtechnical solutions in Australia's health privacy space.The presenter will draw on his global experience inprivacy matters, the delivery of a large number ofPrivacy Impact Assessments to government and privatesector entities and his experience as PrivacyCommissioner of Australia.

Issues for consumers

Ms Karen Carey, Consumer Advocate

There is a constant tension between early access to newtherapies and taking the time to gather sufficientevidence to know that a treatment is safe, effective andcost effective. Early access is only reasonable when it iscombined with appropriate post-market surveillance,and electronic data linkage provides the bestopportunity to build the level of data that will provideeffective post-market surveillance. Through linking datawe can find out quickly whether treatments are safe,effective and cost-effective. The wider the datacollection, the more quickly trends will be disclosed. Butdata linkage comes with a price to consumers—privacy.The potential benefits of data linkage are great, so weneed to identify, minimise and mitigate the risk ofprivacy impacts. In the past decade debate about theseissues has helped define where the risks are greatest,who is the most vulnerable and the structure we need toensure that the cost isn’t borne by the most vulnerablein society.

Boosting policy relevant research using linkedadministrative data

Prof Louisa Jorm, Foundation Professor of PopulationHealth, University of Western Sydney

Linked administrative health data are a powerfulresource for research that can drive improvements inresource allocation, service quality and healthoutcomes. However, relatively little use of these data ismade to inform decision-making in Australia. Thispresentation will cover new approaches to managingdata and metadata including the Secure UnifiedResearch Environment (SURE) which has been built aspart of new national infrastructure for research usinglinked data; methods for analysing administrative datain combination with data from other sources includingcohort studies and clinical trials; and approaches tousing these data to facilitate policy change, throughmaking better use of context data and finding morepersuasive ways to communicate.

S E S S I O N 4H Y P O T H E T I C A L : A P A T I E N T ’ S E X P E R I E N C E

TUESDAY, 30 AUGUST • 4:00–5:30 PM

CH A I R Prof Philip Davies, Professor of Health Systemsand Policy, University of Queensland

The hypothetical ‘A patient’s experience’ provides anopportunity to gain new insights into pharmaceuticalpolicy in Australia. By stepping into the lives of theTheticals, an imaginary Australian family, you willexperience what it is like for ordinary Australians tonavigate the sometimes complex world of the PBS, tostruggle to figure out why we pay for prescriptions, andto try to understand why pharmaceutical companies andgovernment sometimes just don’t see eye to eye.

Your guides on this journey include leading clinicians,industry figures, academics, consumer representativesand policy specialists, all of whom will share theirinsights and attempt, with no preparation orforeknowledge, to tackle some of the thorny issues thatpatients face. It promises to be an enjoyable andinformative experience.

S E S S I O N 5T H E R E L E V A N C E O F T H E N A T I O N A L

M E D I C I N E S P O L I C Y I N T H E F U T U R E

WEDNESDAY, 31 AUGUST • 9:00–10:30 AM

CH A I R Prof Andrew J. McLachlan, Chair, NationalMedicines Policy Committee; Professor of Pharmacy,University of Sydney

Australia’s National Medicines Policy has provided auseful framework, but does it meet contemporaryneeds? Its objectives need to be integrated and arestrongly interdependent. However, tensions can and doexist between the arms of the policy. Balance is neededto harness the full potential of National MedicinesPolicy. This session will examine the tensions andinterdependencies between the four policy objectivesand explore ways of developing the Policy to achieve thisbalance.

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Linkages between the four pillars of the NMP

Dr Lynn Weekes, Chief Executive Officer, NPS

The National Medicines Policy (NMP) aims to meetmedication needs so that optimal health and economicimpacts are achieved. All policy partners shareresponsibility to varying degrees for all four arms of thepolicy and for ensuring that consumers are central to alldecisions. This shared responsibility is the basis forlinkages and interdependencies and where the linkagesare strongest so is the policy. The linkages andinterdependencies of NMP partners are not withouttensions and at best these are well recognised andopenly debated. There are excellent examples where allpartners have come together to address a medicinesdilemma and been able to agree on the way forward.This ability to problem-solve has been a hallmark of theNMP partnerships working at their best.

Looking back and looking forward: How did we get here?

Prof Lloyd Sansom AO, Emeritus Professor, Division ofHealth Sciences, University of South Australia

It has been over 20 years since the need for a NationalMedicines Policy in Australia was first recognised. The seed was planted at a joint conference of theConsumers Health Forum and the Australasian Societyof Clinical and Experimental Pharmacologists andToxicologists held in Newcastle in the late 1980s. From that genesis and with support from the thenGovernment, in particular Minister Peter Staples, camethe establishment of PHARM Committee and APAC.PHARM was an expert committee and was responsiblefor the creation of community awareness of medicinesuse. APAC was a multi-representative council chargedwith the development of a National Medicines Policy(NMP). Throughout the 1990s both groups worked tochange the culture of medicines and their use inAustralia and to develop links and dialogue betweenstakeholders. This culminated in 2000 with theadoption of the NMP whose guiding principles are stillrelevant today. The delivery of healthcare and the role ofmedicines will continue to evolve with an ever increasingdemand for goods and services and subsequent costs.The NMP must continue to form the framework forpolicy development and evaluation as we face these new challenges.

The importance of documentation

Dr Ross Maxwell, Procedural Rural Doctor (Queensland),and Prescribing Expert on the National Medicines Policy

Timely access to, and affordability of, world-classmedicines is one of the factors contributing to theAustralian population’s good health outcomes and is akey objective of National Medicines Policy. The healthsystem has persistent cost pressures requiring continualreassessment of priorities. Consumers, healthprofessionals, the pharmaceutical industry andgovernment will benefit from a better understanding of the use and impact of medicines, particularly newmedicines in the Australian setting. At present thehealth system allows robust assessment of a medicine’sefficacy and cost-effectiveness at the time of registrationvia the TGA and PBAC. Quality use of medicines andquality and safety of medicines is also well establishedas key aspects of the NMP. The recent NMP PartnershipForum examined the opportunities for and challenges of establishing a post-market surveillance system inAustralia to systematically assess medicines safety,effectiveness and cost-effectiveness across the life of a medicine.

What developments will impact on medicines policy in the future

Dr Brendan Shaw, Chief Executive, Medicines Australia

The National Medicines Policy is a balancing act betweendifferent objectives which, when aligned successfully,deliver a policy framework that ensures Australians havecontinued access to medicines. For industry’s part,commercial pressures, technological development, shiftinggrowth patterns in international markets, governmentbudgetary cutbacks and declining commercial returnsare all presenting their own range of challenges andopportunities. The concern is that in the rush toeconomise, rationalise and prioritise the Government’sand community’s objectives, objectives of industry—soimportant to ensuring the medicines actually make it tomarket in the first place—need to be given sufficientrecognition. Predictability in policy frameworks, sufficientreturn to justify continued investment in developingnew medicines, the regulations and incentivesgoverning research and clinical trials, opportunities forfurther investment in Australian operations, and theimpact of reimbursement and HTA outcomes oninnovation and long-term industry investment decisionsare all issues that need to be considered in the contextof the National Medicines Policy.

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S E S S I O N 6F A C I L I T A T I N G A C C E S S T O M E D I C I N E S

F O R S P E C I A L P A T I E N T G R O U P S

WEDNESDAY, 31 AUGUST • 11:00 AM–12:30 PM

CH A I R Dr John Primrose, Medical Adviser,Pharmaceutical Evaluation Branch, Department ofHealth and Ageing

Using the examples of the need to deliver healthoutcomes to Indigenous and paediatric patients, thissession will look at the challenges involved in meetingthe needs of discrete populations within a PBS systemthat is primarily designed to meet the needs of thebroader community on a population basis.

Focus on indigenous health

Prof Alan Cass, Professor, Sydney Medical School,University of Sydney and Director of the Renal andMetabolic Division, George Institute, Sydney

This presentation will explore evidence-practice gaps in the screening and management of chronic vasculardisease in the Aboriginal and mainstream primary caresectors, and will discuss influences on access tonecessary health care, at the health system-, service-and individual-level, for Indigenous Australians withchronic diseases.

Access to medicines: Policy affecting Aboriginal peoples

Dr Sophie Couzos, Public Health Medical Officer,Aboriginal community controlled health services andthe National Aboriginal Community Controlled HealthOrganisation

Access to essential medicines is a core element of ournation’s obligation towards the right to health for allAustralians. The PBS provides capped patient co-payments and a safety net scheme to improvemedicines access, but disparities in access betweenAboriginal and non-Aboriginal Australians are stillsubstantial. A range of health programs and policieshave been developed to improve access and improvequality use of medicines in remote and non-remoteAustralia. This presentation will describe aspects ofthese programs, compare and contrast, refer to successfactors, and make suggestions for ways in whichmedicines access can be further improved.

Focus on paediatric health

Dr Sean Beggs, Paediatrician and Paediatric ClinicalPharmacologist, Royal Hobart Hospital

Children have long been disadvantaged in relation totheir access to medications. The majority ofmedications on the Australian market have not beenstudied in children. It is often quoted that ‘children arenot simply small adults’. Nowhere does this statementhold more true than in relation to therapeutics. Thesmall size of the paediatric pharmaceutical market andthus lack of financial incentives means that the marketoften fails children. There is an obvious need and desireto address the issue in Australia. The PaediatricMedicines Advisory Group (PMAG) brings togetherrepresentatives from Government, pharmaceuticalindustry, TGA, PBAC, paediatric pharmacists, andpaediatricians to identify gaps and potential solutionswhile working within the current regulatory framework.

Access to medicines for special patients and target groups

Ms Deborah Waterhouse, General Manager,GlaxoSmithKline Australia and New Zealand

There are multiple challenges in meeting the needs of discrete populations within a PBS system that isprimarily designed to meet broad community needs.Providing a perspective from the pharmaceuticalindustry, this session will address how difficulties incatering for discrete populations within the PBS act asan early indication of the challenges for delivering themedicines of the future. This highlights the need forgreater flexibility within regulatory and reimbursementpathways, both to meet the needs of particular patientpopulations now and ensure the system can adapt inthe future to make the potential of personalisedmedicine a reality.

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S E S S I O N 7T H E I N F L U E N C E O F H T A I N S H A P I N G

F U T U R E D R U G D E V E L O P M E N T

WEDNESDAY, 31 AUGUST • 1:30–3:00 PM

CH A I R Prof Kathryn A. Phillips, Professor of HealthEconomics and Health Services Research, University of California, San Francisco

HTA is increasingly used around the world as a tool forassessing a medicine’s clinical and cost-effectiveness.Governments and other payers use it to makejudgements about whether a medicine can be deemed‘value for money’. Much of the discussion aboutmedicines policy rightly focuses on ensuring that newmedicines are affordable to both the consumer andtaxpayer, and the policies and programs that are neededto deliver these. There is a need for serious debate,however, about how HTA based systems, in turn, arelikely to shape the future drug development process; inparticular, by creating incentives or disincentives toinvest in specific therapeutic areas at the expense ofothers. This session explores how the industry mayrespond to market signals set by governments andpayers, and how this will inform the development ofmedicines to meet the health needs of futuregenerations.

Investment decisions in drug development

Dr Steve J. Romano, Senior Vice President, Pfizer, New York

While investment into pharmaceutical R&D hasincreased significantly over the last 10 years, the outputin terms of new molecular entities reaching the markethas until recently declined. When making investmentdecisions, most pharmaceutical manufacturers nowadvance new investigational compounds only when theyare considered to have sufficient potential to delivermeaningful clinical differentiation to standard of care.As we investigate more complex and novel mechanismsof action in disease areas of high unmet need, dialoguemust be expanded with HTA institutions and otherstakeholders to align expectations regarding whatevidence can be delivered in clinical development tosupport or accelerate access to new medicines.

Innovation dilemma: The case of antimicrobials

Prof John Turnidge, Clinical Director of Microbiologyand Infectious Diseases for SA Pathology, Women’s andChildren’s Hospital, Adelaide

As the world witnesses a growing number ofantimicrobial-resistant bacteria causing disease, therehas been a steady decline in the number of newantimicrobials being developed and reaching themarket. Recently, new models for antimicrobial agentdevelopment have emerged. Ultimately though, we arecaught by a paradox. New agents, especially those withnovel mechanisms of action, are often kept in reserveafter release, rather than widely used. This providesongoing disincentive for the industry to invest in theirdevelopment, given the limited return on investment.Innovative ways of finding incentives to invest in furtherdrug discovery are needed, and are currently beingdiscussed on the global stage.

Valuing innovation: HTA practise and the impact for future medicines

Mr Mendel Grobler, Director, Patient Access, Pfizer Australia

This presentation will primarily deal with a largelyunresearched aspect of Health Technology Assessment(HTA): its emerging impact on the future supply of newtechnology. Medical progress in the treatment ofdisease is dependent on innovation. In turn, innovationin any field is dependent on incentives. In thecommercial world the incentive to commit capital torisky projects is the return on that capital, and in themodern world fiduciary responsibility requires the useof financial analytic techniques that explicitly balancerisk with return. Now that HTA is beginning to influencethe supply of future technology, it is both important andtimely to consider how to use this influence to bestserve society’s needs.

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Dr Sean Tunis is the Founder and Director of theCenter for Medical Technology Policy (CMTP) inBaltimore, Maryland. CMTP’s main objective is toimprove the quality and relevance of clinical researchby providing a neutral forum for collaboration amongexperts, stakeholders and decision makers.

Dr Tunis was a member of the Institute of MedicineCommittee on Initial National Priorities for ComparativeEffectiveness Research. He advises a range of domesticand international public and private healthcareorganisations on issues of comparative effectiveness,evidence based medicine, clinical research,reimbursement and health technology policy.

Until September 2005, Dr Tunis was the Director of the Office of Clinical Standards and Quality andChief Medical Officer at the Centers for Medicare and Medicaid Services (CMS). He also served as theDirector of the Health Program at the CongressionalOffice of Technology Assessment and as a healthpolicy advisor to the US Senate Committee on Laborand Human Resources.

He received a degree in Biology and History of Sciencefrom the Cornell University School of Agriculture, and a medical degree and Masters in Health ServicesResearch from the Stanford University School ofMedicine. He is board certified in Internal Medicineand holds adjunct faculty appointments at JohnsHopkins, Stanford and the University of California,San Francisco Schools of Medicine.

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! M I N I S T E R F O R H E A LT H A N D A G E I N G

The Hon Nicola Roxon MP has been the Minister forHealth and Ageing since the Labor Government waselected in November 2007.

Minister Roxon has been a member of FederalParliament since 1998, representing the Melbournewestern suburbs seat of Gellibrand.

Before entering Parliament Minister Roxon was an associate to the nation’s first female High CourtJustice, Mary Gaudron, and an industrial lawyer who acted in the high profile waterfront dispute.

Minister Roxon has a First Class Honours Law degree and Arts degree from Melbourne University,and graduated top of her law class in 1990.

Since becoming Health Minister, she has been busy undertaking crucial reforms to build a betterhealth and hospitals system for the future.

Minister Roxon has presided over a 50% increase inhealth funding for the Nation’s Hospitals; a massiveinvestment in workforce, including a commitment todouble the number of GP training places; improvingelective surgery capacity and throughput; investmentin taking pressure off the Nation’s EmergencyDepartments and the largest single year investment in Preventative Health.

G U E S TS P E A K E R

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P R O F E S S O R K AT H R Y N A . P H I L L I P SDr Kathryn Phillips is Professor of Health Economics andHealth Services Research at the University of California,San Francisco (UCSF) and Founder/Director of the UCSF Center for Translational and Policy Researchon Personalised Medicine (TRANSPERS). She is also thePrincipal Investigator for the TRANSPERS Center, which is a multi-million dollar effort focusing on the translationof personalised medicine into practice and policy. She has appointments in the UCSF Department of ClinicalPharmacy, the UCSF Institute for Health Policy Studies,and the UCSF Comprehensive Cancer Center.

Dr Phillips’ research focuses on the use of quantitativetools to examine policy issues relevant to how healthcare is organised, delivered, and financed in the US. She hasserved as an adviser to many groups (e.g. Institute ofMedicine, President’s Council of Advisors on Science andTechnology, GenomeCanada, FDA). She also consults witha number of biotech start-ups, companies, and venturecapital firms and serves on the Novartis MolecularDiagnostics Advisory Board.

Dr Phillips holds degrees from the University of California-Berkeley, Harvard, and the University of Texas at Austin andpreviously spent eight years working for the United StatesFederal Government.

D R S T E V E N J . R O M A N ODr Steven Romano, MD, is Senior Vice President, Head ofMedicines Development Group for Pfizer’s Primary CareBusiness Unit. He has been in the pharmaceutical industryfor over 15 years, and has been involved in all phases ofclinical drug development. Recent positions held at Pfizerhave included Vice President, Medical Affairs Head for thePrimary Care Business Unit and prior to that DevelopmentHead, Neurosciences and Vice President, Global Medical,Neuroscience, Pain and Inflammation. He is a boardcertified psychiatrist and serves on the executive orscientific committees of a number of professionalorganizations, including the International Society for CNSClinical Trials and Methodology (ISCTM), on which hecurrently holds the position of Chair, Scientific Committee.

After receiving his undergraduate degree at WashingtonUniversity in St. Louis, Dr Romano obtained his medicaldegree at the University of Missouri, Columbia. Hecompleted his internship, residency in psychiatry, andpsychiatry fellowship at The New York Hospital-CornellMedical Center, New York City and Westchester Divisions.Dr Romano continued on the faculty of Cornell UniversityMedical College for six years prior to joining industry, andwas Director of the Outpatient Eating Disorders Clinic andPartial Hospitalization Program at the New York Hospital-Cornell Medical Center-Westchester Division in WhitePlains, New York. His main areas of focus at Cornellincluded the treatment and management of anorexia,bulimia, and obesity, and the psychopharmacology ofmajor psychiatric conditions.

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M R L A U R I E W I L S O NMr Laurie Wilson is President of the National Press Club of Australia and has over 30 years experiencein the media as a political journalist, commentator and consultant. Laurie is a contributor to A-PAC,the Australian Public Affairs Channel broadcast by Sky News.

His company, Laurie Wilson and Associates Pty Ltd, was established in 1993 and specialises instrategic communications advice, facilitation and presentation skills training.

He is a graduate in Journalism and Economics (Canberra) and has postgraduate qualifications in Business Administration (Swinburne).

Laurie chaired the two previous Joint Medicines Policy Conferences.

P R O F E S S O R A L A N C A S SProfessor Alan Cass is Senior Director of the Renal andMetabolic Division in the George Institute for Global Healthand Professor in the Sydney Medical School, University ofSydney. He is Chief Investigator of the Kanyini VascularCollaboration and the Inaugural Chair of the ScientificCommittee of the Australasian Kidney Trials Network. Alan works with Aboriginal community and health servicepartners to develop strategies to improve access to healthservices and to improve health outcomes for people withchronic disease.

D R S O P H I E C O U Z O S N O T P I C T U R E D

Dr Sophie Couzos is a public health physician with 19 yearsexperience working within both Aboriginal community-controlled health services (ACCHSs) and the NationalAboriginal Community Controlled Health Organisation(NACCHO), occupying the position of Public HealthMedical Officer since 1998. She spent 14 years in remoteAustralia, with seven years as a GP in the Kimberley regionof WA. Within NACCHO, she instigates and influencesnational policies and programs towards achieving healthequity for the Aboriginal population through ACCHSs. She has developed clinical practice guidelines, undertakenaward winning research (NACCHO Ear Trial), and is editor and author of Aboriginal Primary Health Care: Anevidence-based approach (3rd edition, published by OxfordUniversity Press).

She is an adjunct Associate Professor, James CookUniversity, School of Public Health and Tropical Medicine,Townsville, Qld.

M R M A L C O L M C R O M P T O NMr Malcolm Crompton is Managing Director of InformationIntegrity Solutions P/L. He is also the Asia Pacific basedDirector of the International Association of PrivacyProfessionals (IAPP). Information Integrity Solutions P/Lhas advised Australian Government departments andagencies, Australian financial services institutions andmany leading global ICT companies on developing trustand delivering privacy to customers. Mr Crompton was

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D R S E A N B E G G S Dr Sean Beggs is a paediatrician and paediatric clinicalpharmacologist. He currently works at the Royal HobartHospital and is a Senior Lecturer at the School ofMedicine, University of Tasmania. One of his principleareas of interest is the quality use of medicine in children,including improving their access to appropriatemedications, both in Australia and developing countries.He has performed a number of reviews for the WHO’s‘make medicines child size’ initiative and is a member of the Paediatric Medicines Advisory Group to theDepartment of Health and Ageing, and to thePharmaceutical Benefits Advisory Committee.

M S C A R O L B E N N E T TMs Carol Bennett is the Chief Executive Officer of theConsumers Health Forum of Australia (CHF), the peakorganisation for health consumers in Australia. Ms Bennettleads CHF’s work to ensure a strong consumer voice andconsumer participation in health reform through advocacy,policy development and consumer research. Safety andquality, access, regulation and funding of therapeuticgoods are key interest areas. Ms Bennett has worked at theexecutive level in health organisations for the last 15 years,including as CEO of peak national and state health bodies,and major consultancy roles with organisations includingbeyondblue. She has a Masters in Public Policy from theAustralian National University.

M S K A R E N C A R E YMs Karen Carey is an experienced and respected consumeradvocate who works to improve consumer health outcomesby contributing a strong consumer voice to health policy atthe national level. She has an extensive understanding ofthe consumer issues and contextual environment intherapeutic goods regulation and health technologyassessment.

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M R M A L C O L M C R O M P T O N

S P E A K E RP R O F I L E S

Australia’s Privacy Commissioner for five years until April2004. He led the implementation of Australia’s privatesector privacy law. Between 1996 and 1999, he wasManager of Government Affairs in Canberra for AMP Ltd.In the previous 20 years, he held senior executive positionsin the Australian Public Service. He has degrees inChemistry and Economics.

P R O F E S S O R P H I L I P D AV I E S Professor Philip Davies was appointed as Professor ofHealth Systems and Policy in the School of PopulationHealth at the University of Queensland in 2009. Prior totaking up his current position he worked for six and a halfyears as a Deputy Secretary in the Australian GovernmentDepartment of Health and Ageing where he was responsiblefor several key areas of health policy and financing as wellas corporate management of the Department.

In November 2009 Professor Davies was elected to theBoard of GPpartners, one of Australia’s largest andlongest-established Divisions of General Practice.

M R W I L L D E L A ATMr Will Delaat has been the Chairman of MedicinesAustralia, since 2008, following his retirement asManaging Director of Merck Sharp & Dohme (MSD)Australia and Merck’s Regional Director for Australia andNew Zealand, a position he held for 11 years. Will has over35 years experience in the pharmaceutical industry, havingheld a variety of roles both in Europe and Australia, andacross three different multinational companies.

In June 2008, Will was appointed as a Director to theBoard of Pharmaxis, a local specialist pharmaceuticalcompany involved in developing therapeutic products forchronic respiratory and autoimmune diseases. In 2010, he was appointed to the Board of Medicines Australiamember company, iNova Pty Ltd.

He has an Honours Science degree from London University and a background in sales and marketing and business development.

M S J E N N I F E R D O G G E T TMs Jennifer Doggett is a Fellow of the Centre for PolicyDevelopment and a consultant working in the health sectorfor a number of professional, industry and consumer groups.She has previously worked within the Federal Departmentof Health, as a political advisor on health issues and for a peak medical organisation. She is the author of A NewApproach to Primary Care for Australia and Out of pocket:Rethinking co-payments in health, and a co-author ofMore than Luck: Ideas Australia needs now.

M R B R U C E G O O D W I NMr Bruce Goodwin is the Managing Director for JanssenAustralia & New Zealand, a role he has held since January2009 having previously been the VP of Sales and Marketing.He has a strong record in talent management and focusesstrongly on building greater organisational capabilities andon the accelerated development of key individuals. Hiscareer with Johnson & Johnson spans 27 years andincludes experience across three countries and multiplefunctions. He has held Management Board positions insales and marketing and in finance as well as havinggained valuable experience in business development andglobal portfolio management. His service with Johnson & Johnson outside of Australia has included postings toJanssen Belgium and Janssen-Cilag United Kingdom. Mr Goodwin is a Board Member of Medicines Australia.

M S J A N N E G R A H A M A M

Ms Janne Graham has a 30-year history of involvement as a health consumer spokesperson, advocate andrepresentative. She has been awarded membership of theOrder of Australia for her services to the health consumermovement and the National Health and Medical ResearchCouncil. She has been active in the development,articulation and promotion of the National Medicines Policywithin government forums and professional and industryconferences. She currently represents health consumerson national and local (ACT) committees relating toprofessional standards, health technology and safety andquality issues.

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M R M E N D E L G R O B L E RMr Mendel Grobler is the Director, Patient Access at PfizerAustralia and is responsible for reimbursement strategy for the company’s products in Australia and New Zealand,as well as advising Pfizer Inc. on regional and globalapproaches to Health Technology Assessment. He hasbeen working in the field of healthcare funding andfinancing for more than 20 years and also has extensiveexperience across the pharmaceutical industry includingmanufacture, product development, registration,distribution and community/hospital pharmacy. He haspreviously represented the industry on the Economic Sub-Committee of PBAC and also served as adviser to the Australian Department of Veterans’ Affairs.

M S J A N E H A LT O N P S M

Ms Jane Halton is Secretary of the Australian Departmentof Health and Ageing. She is responsible for all aspects of the operation of the Department including the provisionof advice on and administration of Medicare, thePharmaceutical Benefits Scheme, Aged and CommunityCare, Population Health, regulation of Therapeutic Goods,plus hospital financing and Private Health Insurance. Shealso has responsibility for leadership on health securityissues, including matters related to bioterrorism.

Ms Halton is a member of the board of the AustralianInstitute of Health and Welfare, a board member of theNational E-Health Transition Authority and a Commissionerof the Australian Commission on Safety and Quality inHealth Care. She is also on the executive board of theInstitute for Health Metrics and Evaluation at the Universityof Washington, on the Advisory Boards of the Centre forApplied Philosophy and Public Ethics (CAPPE), on theMelbourne Institute Advisory Board, and is chair of theOECD’s Health Committee.

P RO FE S SO R C H R I S T I NE JE N K I NS AM

Professor Christine Jenkins is Clinical Professor ofMedicine, Sydney University and Senior Staff Specialist inThoracic Medicine at Concord Hospital, Sydney. She has astrong clinical and research interest in the management ofasthma and COPD and is head of the Airways Group at theWoolcock Institute of Medical Research, Sydney. She chairs

the Education program in the Co-operative ResearchCentre for Asthma and Airways and is actively involved in research translation to primary care and allied healthprofessionals. Professor Jenkins is a member of the GOLD Executive and Chairs the Dissemination andImplementation task group of GOLD and has participatedin the formulation of Australian Asthma and COPD clinicalguidelines. In 2001 she received an AM in the Order ofAustralia for services to respiratory medicine, especially as a physician, administrator and educator, in the field of asthma education.

P R O F E S S O R L O U I S A J O R MProfessor Louisa Jorm is the Foundation Professor ofPopulation Health at the University of Western Sydney. She also holds the position of Principal Scientist at the Sax Institute. She is an epidemiologist who has worked in senior roles both in government and academia. Herareas of expertise include data linkage, use of largeadministrative data sets and facilitating the policy andpractice uptake of research. She currently leads thedevelopment of the NSW/ACT node of the PopulationHealth Research Network (the emerging nationalinfrastructure for data linkage research). In her role at theSax Institute, Professor Jorm is part of the managementteam for the 45 and Up Study, Australia’s largest study ofhealthy ageing, which includes 265,000 participants aged45 years and over from across NSW and incorporateslinkage to PBS, MBS and other administrative datasets.

M R D AV I D L E A R M O N T HMr David Learmonth is a Deputy Secretary with theDepartment of Health and Ageing. His current portfolioincludes Medical Benefits, Pharmaceutical Benefits, PrivateHealth Insurance, Aboriginal and Torres Strait IslanderHealth, the Queensland State Office and the ACT Office.

Mr Learmonth joined the Australian Department of Healthand Ageing in November 2003 as the First AssistantSecretary, Primary Care Division. He was responsible forimplementing the Strengthening Medicare Package andfor a range of programs including divisions of generalpractice, GP training, after hours programs, quality, allied health, nursing, GP collaboratives, research andworkforce measures.

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P R O F E S S O R A N D R E W J . M c L AC H L A NProfessor Andrew McLachlan is a pharmacist, academicand researcher with experience in clinical andexperimental pharmacology and research into the qualityuse of medicines. He is Professor of Pharmacy (Aged Care)in the Faculty of Pharmacy at the University of Sydneybased at Concord Hospital and the Centre for Educationand Research on Ageing (CERA) at Concord Hospital, andis currently the Associate Dean (Research) in the Faculty of Pharmacy, University of Sydney. Previously he served as Associate Dean (Postgraduate) for five years.

Professor McLachlan’s particular expertise is in the field of clinical and experimental aspects of pharmacokineticsand pharmacodynamics.

Professor McLachlan serves as the Inaugural Chair ofAustralia’s National Medicines Policy Committee and is a member of the Pharmaceutical Subcommittee of theAustralian Advisory Committee on Prescription Medicines(ACPM). He is the current president of the AustralasianPharmaceutical Science Association and is a member ofthe Australian Sports Antidoping Authority. He is amember of the executive of the Commonwealth PharmacistsAssociation (CPA) representing the Pacific Region.

D R R O S S M A X W E L LDr Ross Maxwell is the prescribing expert on the NationalMedicines Policy Committee. He is a procedural ruraldoctor in Dalby, South East Queensland, where he hasworked for the last 19 years. He has worked in a number of health organisations during this time, including theSouthern Queensland Rural Division of General Practice,the Australian Medical Association and the Rural DoctorsAssociation, and has served as both Queensland andAustralian President during this time. Dr Maxwell iscurrently a member of the Professional Programs andServices Advisory Committee and the Australian MedicalAssociation Rural Reference Group. He was also a memberof the board of the National Prescribing Service and is acurrent board member of Health Workforce Queensland.

P R O F E S S O R M A L C O L M PA R K E RProfessor Malcolm Parker is Associate Professor of MedicalEthics and Head of the Discipline of Medical Ethics, Lawand Professional Practice in the School of Medicine,University of Queensland. He teaches ethics, law andprofessional issues in the MBBS program. He hasqualifications in medicine, philosophy and health law, and was in general medical practice for over 30 years. He chairs UQ’s Human Experimentation Ethical ReviewCommittee, and is a member of the Queensland HealthClinical Ethics Committee and the AMAQ EthicsCommittee. He is also a director of the PostgraduateMedical Council of Queensland, and a member of theHealth and Performance Committee of the Qld Board ofthe Medical Board of Australia. He is the current presidentof the Australasian Association of Bioethics and HealthLaw, and is a member of the editorial boards of fourjournals in bioethics, medical law and medical education.

D R J O H N P R I M R O S E N O T P I C T U R E D

Dr John Primrose joined the (then) CommonwealthDepartment of Health in 1990 as a Senior Medical Advisor. Since that time, he has worked in the areas of pharmaceutical benefits, rational use of medicines,Medicare benefits and health technology assessment.

He is currently Medical Advisor to the PharmaceuticalBenefits Division and is involved in the evaluation ofpharmaceuticals for listing on the Pharmaceutical BenefitsScheme, as well as the operational aspects of the Scheme.

Dr Primrose graduated with First Class Honours from theUniversity of Sydney in 1978 and underwent postgraduatetraining in radiation oncology at Royal Prince Alfred andWestmead Hospitals. He was admitted as a Fellow of the Royal Australasian College of Radiologists in 1983. Dr Primrose was a staff specialist at St Vincent’s Hospitalfrom 1983 to 1985 and then Director of RadiationOncology at Woden Valley Hospital from 1985 to 1990.

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P R O F E S S O R L I B B Y R O U G H E A DProfessor Libby Roughead’s research interests includepublic policy concerning medicines, quality use ofmedicines, pharmacoepidemiology and adverse drugevents. She has a future fellowship funded by theAustralian Research Council and is co-director of anational prescriber intervention and feedback programtargeting Australian general practitioners and veterans.She is currently a member of the Drug Utilisation Sub-Committee of the Pharmaceutical Benefits AdvisoryCommittee, the Medication Safety Reference Group of the Australian Safety and Quality Commission and a Board member of Therapeutic Guidelines Ltd.

E M E R I T U S P R O F E S S O R L L O Y D S A N S O M A O

Professor Lloyd Sansom played a major role in thedevelopment of Australia’s National Medicines Policy andis Editor of the Australian Pharmaceutical Formulary andHandbook (APF) and a member of the Editorial AdvisoryBoard of the Australian Medicines Handbook. He has saton numerous government and industry advisory groups,including the Pharmaceutical Benefits Advisory Committee(Chair 2001–2011).

Professor Sansom’s research interests are in the areas ofpharmacokinetics, biopharmaceutics and the quality use of medicines.

Professor Sansom graduated in pharmacy in 1962 andcompleted his PhD in Biophysical Chemistry at theUniversity of Adelaide in 1972. In 2006 he was awardedhonorary doctorate degrees by Newcastle, Griffith andQueensland universities.

The University of South Australia granted ProfessorSansom the title of Emeritus Professor in 2001, afterserving as a Professor of Pharmacy from 1990 andheading the University’s School of Pharmacy and MedicalSciences from 1995 to 2000. In 2004 the Universityrecognised his significant contributions by naming theSansom Institute for Health Research in his honour.

M R K O S S C L AV O SMr Kos Sclavos has been National President of ThePharmacy Guild of Australia since 2005. Before becomingthe Guild’s President, he spent nine years as theQueensland Guild Branch President, and six years asNational President of the Australian Institute of PharmacyManagement (now ACPPM). He is driving pharmacy’sexciting new IT agenda in eHealth and already has manysuccesses with projects such as Project Stop to track sales of pseudoephedrine and prevent suspicious sales. Mr Sclavos serves on a variety of industry bodies andcommittees. He has been a driving force behind a numberof industry initiatives including the Advanced Diploma ofCommunity Pharmacy Management and the Quality CarePharmacy Program. In 2008 he was awarded a Doctor ofUniversity of Griffith University for his services to pharmacy.

D R B R E N D A N S H A WDr Brendan Shaw has been Chief Executive of MedicinesAustralia since January 2010. He has been instrumental in guiding the pharmaceutical industry through reforms tothe Pharmaceutical Benefits Scheme, the PharmaceuticalBenefits Advisory Committee processes and theTherapeutic Goods Administration. He has drivenMedicines Australia’s research program and MedicinesAustralia’s contribution to the international debate onhealth technology assessment.

Prior to taking up his appointment with MedicinesAustralia in January 2004, Dr Shaw was adviser to thethen Shadow Minister for Innovation, Industry and Trade,Dr Craig Emerson MP. He has an honours degree ineconomics from the University of Queensland and a PhD in management from Monash University.

P R O F E S S O R J O H N T U R N I D G EProfessor John Turnidge is Clinical Director ofMicrobiology and Infectious Diseases for SA Pathology,based at Women’s and Children’s Hospital in Adelaide. Heis an Infectious Disease Physician and Microbiologist whohas had a long career in Adelaide and Melbourne workingwith antibiotic resistance and appropriate antibiotic use.Professor Turnidge was inaugural president of the WesternPacific Society of Chemotherapy, and co-founded theAustralian Society for Antimicrobials. He has served on the

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scientific program committees of the InterscienceConference on Antimicrobial Agents and Chemotherapy,and the European Congress for Clinical Microbiology andInfectious Diseases. At a local level, Professor Turnidgehas been involved with a range of committees related tothe management of antimicrobial resistance, includingJETACAR (the Joint Expert Technical AdvisoryCommittee on Antimicrobial Resistance) and the ExpertAdvisory Group on Antimicrobial Resistance and theAntimicrobial Resistance Advisory Committee of theNational Health and Medical Research Council.

P R O F E S S O R R O S A L I E V I N E Y Professor Rosalie Viney is Associate Professor of HealthEconomics and Deputy Director of the Centre for HealthEconomics Research and Evaluation at the University ofTechnology, Sydney. She is the Chair of the EconomicsSub-Committee of the Pharmaceutical Benefits AdvisoryCommittee and a member of PBAC. She is the teamleader for the Cancer Research Economics Support Teamat CHERE, which is contracted to provide healtheconomics advice and support to the Cancer AustraliaCancer Clinical Trials Groups. She is also a ChiefInvestigator on the NHMRC Capacity Building Grantwhich is aimed at building capacity in innovativeapproaches to health technology assessment.

D R R O B W A LT E R SDr Rob Walters is a practising General Practitioner inHobart. From November 2002 to November 2005, hewas the Chair of the Australian Divisions of GeneralPractice (ADGP now AGPN), the national organisationthat represented 117 local Divisions of General Practice.He is also a medico-legal adviser and case manager forthe Medical Indemnity Protection Society (MIPS) inTasmania and regularly presents to medical practitionersnationally on matters related to Medical Indemnity andMedicine and the law. He has served and continues toserve on a number of boards and councils representingGeneral Practice including the boards of Headspace,General Practice South, the National Advisory Council onMental Health, the Beyondblue Clinical ReferenceCouncil and DVA’s LMO Advisory Committee. Dr Waltersalso has an interest in Occupational Medicine and is theMedical Director on the Tasmanian Work Cover Board aswell as a past Chair of the Cancer Council of Tasmania.

P R O F E S S O R R O B Y N W A R DProfessor Robyn Ward heads the Prince of Wales ClinicalSchool, University of NSW and is the Director of Area CancerServices for the South Eastern Sydney and Illawarra AreaHealth Service. At the same time she leads the adult cancerresearch program at the Lowy Cancer Research Centre. Hertraining as a medical oncologist has strongly informed herresearch objectives, which focus on improving themanagement of cancer through research, be it in thelaboratory, at the bedside, or in the realm of health servicesresearch. She has been a longstanding member of thePharmaceutical Benefits Advisory Committee (PBAC) and in2009 was appointed the Chair of the CommonwealthMedical Services Advisory Committee.

M S D E B O R A H W AT E R H O U S E Ms Deborah Waterhouse is the General Manager ofGlaxoSmithKline (GSK) Australia and New Zealand and hasbeen with the company since 1996. Her experience is broad,having progressed through increasingly senior positions inSales, Marketing, Human Resources and Research andDevelopment, in the UK, Europe and Australasia. She becameGeneral Manager of GSK Australia and New Zealand inAugust 2008. Ms Waterhouse believes that it is a privilegeand responsibility as a successful company to give back to the community across the world. And that ethical practiceis the foundation of everything we do in this industry.GlaxoSmithKline is a global, research-based pharmaceuticaland healthcare company with a long, proud history in Australia.Ms Waterhouse is a Board Member of Medicines Australia.

D R LY N N W E E K E SDr Lynn Weekes is the inaugural Chief Executive Officer ofthe NPS. She originally trained as a pharmacist, doing herundergraduate degree at Sydney University and going on to practise in community, hospital, policy and researchsettings. She worked at St Vincent’s Hospital in Sydneybefore taking up the position of Executive Officer at NSWTherapeutic Assessment Group.

She has a strong professional interest in quality assurance,behaviour change and pharmacoepidemiology. Dr Weekesbelieves her pharmacy training has provided an excellentbase for achievement of public health changes as they relateto medicines. She has a MSc in pharmaceutics and a PhD in community medicine.

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! People are the heart of the PBS

T H E G R E A T H A L L , P A R L I A M E N T H O U S E

TIME 7:00 pm–10:30 pmPre-dinner drinks 7:00 pmDinner 7:30 pm

DRESS Business attire

SPEAKERS Mr Will Delaat, Chairman, Medicines Australia

Ms Jane Halton PSM, Secretary, Department of Health and Ageing

If you have not indicated that you wish to attend theDinner and now wish to do so, please indicate yourinterest to the Registration Desk. Similarly, to assist uswith catering, please advise staff at the RegistrationDesk if you are no longer able to attend the Dinner sothat someone else may be able to attend in your place.

Shuttle buses will deliver delegates to Parliament Houseand return delegates to nominated hotels with the firstbus departing when full from 10:00 pm.

Preliminary pick up schedules are noted below. If these timings should change, you will be notified at the conference. For enquiries, please ask at theRegistration Desk.

Please be ready at the front of the hotel early and allowfive minutes either side of the time notes below.

6:40 pm The Hotel Realm6:35 pm Brassey Hotel 6:40 pm Rydges Capital Hill6:40 pm Bentley Suites (please walk over the road

to Rydges Capital Hill entrance)6:50 pm Hyatt Hotel

G E N E R A LI N F O R M A T I O N

All Conference sessions will be in the National Ballroom,Level 1, Hotel Realm, 18 National Circuit, Barton.Registration and arrival tea and coffee will be availablefor delegates from 8:00 am in the Level 1 Foyer on bothTuesday and Wednesday. Morning tea, lunch andafternoon tea will also be located in the Level 1 Foyer.

Please direct all your enquiries to the ConferenceRegistration Desk, Level 1 Foyer.

N A M E B A D G E S

Your name badge is your entry to all sessions, lunch,morning and afternoon teas, and should be worn in the venue at all times. Please also bring your namebadge with you to the Dinner.

D R E S S

Business attire is the dress code for the Conference.The Conference venue is air conditioned, so we dosuggest wearing layered clothing during sessions.Business attire is the dress code for the ConferenceDinner.

P A R K I N G

Hotel Realm offers secure undercover parking to guests and visitors to the hotel. Access to theundercover parking is via the laneway off Bourke Street.All day parking costs will be $15 per day (24 hours) for guests and $10 per day (8 hours) for non-guests.There is also pay parking located around the hotel with a two-hour limit.

R E G I S T R A T I O N D E S K

The Conference Registration Desk will be located in the Level 1 Foyer of Hotel Realm and will be open eachday of the Conference from 8:00 am.

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S P E C I A L R E Q U I R E M E N T S

Every effort is made to cater for people with specialrequirements. Should you require special assistance,please see the staff at the Registration Desk so that we can make your time in Canberra a pleasant andcomfortable experience.

L O S T O R F O U N D P R O P E R T Y

Please report any lost or found property to theRegistration Desk.

M E D I C A L E M E R G E N C Y

In case of an emergency, please contact any staffmember of Hotel Realm or the Registration Desk staff.

M E S S A G E S

Any messages received will be posted to the noticeboard next to the Registration Desk. Please check the notice board regularly to ensure you receive allmessages.

M O B I L E P H O N E S A N D P A G E R S

As a courtesy to other delegates, please ensure allmobile telephones and pagers are turned off or in‘silent’ mode during all sessions and social functions.

P A R T I C I P A N T L I S T

The participant list has been included in theConference satchel. Those delegates who haveindicated on their registration form that they do not want their name and organisation to appear on the participant list have not been included.

I N T E R N E T A C C E S S

Delegates wishing to connect to the internet maypurchase wireless access codes from the HotelReception on the ground floor. The cost is $10 for 24 hours usage. The Hotel Realm Business Centre, also located on the ground floor offers computers and printing services for delegates attending theConference.

T W I T T E R T A G

#jmpc3

T A X I S

Canberra Cabs TELEPHONE 13 22 27. Alternatively,please see the staff at the Hotel Reception to assist you with taxi bookings from Hotel Realm.

A I R P O R T C O A C H T R A N S F E R

Complimentary coach transfers are provided todelegates for transfer to the airport. Departure times are displayed at the Registration Desk. Should you wish to use this service and you have not pre-booked,please visit the staff at the Registration Desk to checkavailability and book.

J O I N T M E D I C I N E S P O L I C Y C O N F E R E N C E 2011R DT H E3

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J O I N T M E D I C I N E S P O L I C Y C O N F E R E N C E

2011R DT H E3

M E D I C I N E S A U S T R A L I A

www.medicinesaustralia.com.au

D E PA R T M E N T O F H E A LT H A N D A G E I N G

www.health.gov.au www.jmpc3.com.au #jmpc3

Department of Health and Ageing! Ms Diana Macdonell, Director, PBAC Secretariat

(until mid-August 2011)! Ms Adriana Platona, Director, Pharmaceutical

Evaluation Branch! Mr Andrew Mitchell, Strategic Adviser, Health

Technology Assessment! Ms Maxine Robinson, Secretary, Drug Utilisation

Sub Committee! Mr Paul Storey, Director, Publishing, Industry

Liaison and Listing Section! Ms Rocio Larroque (until May 2011)

Medicines Australia! Mr Andrew Bruce, Executive Director, Health Policy

and Research! Ms Donna Edman, Executive Director, Public Affairs! Ms Katie Whitehead, Director, Corporate Services

(until May 2011)! Mr Amish Chaturvedi, Research Manager! Ms Julie Johnson, Public Affairs Officer! Ms Janelle Andre Morgan, Executive Officer

(until February 2011)

THA NK YOU TO THE TH IRD JO INT MEDIC INES P OL ICY CONFERENCE PL A NNING COMMIT TEE

! Professor Lloyd Sansom, Emeritus Professor, Division of Health Sciences, University of South Australia! Prof Andrew J. McLachlan, National Medicines Policy Committee; Professor of Pharmacy, University of Sydney! Ms Carol Bennett, Chief Executive Officer, Consumers Health Forum

CON FERENCE ORGAN I SER ! Ms Doreen Culliver, On Q Conference Support

!