Code Conduct Annual Report 2007

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Medicines Australia

Code of ConductAnnual Report 2006/2007


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Medicines Australia Code of Conduct Annual Report 2006/2007 1

Foreword 2

Executive Summary 3

Definitions 6

1. Medicines Australia Code Committees and Secretariat 8 1.1 Code of Conduct Committee 8

1.2 Appeals Committee 9 1.3 Roles and Responsibilities 10 1.3 Code Secretariat 11

2. Promoting Understanding of the Code 12 2.1 International Federation of Pharmaceutical Manufacturers &

Associations12

2.2 Education in Australia 12 2.3 Presentations & Meetings 13 2.4 Continuing Education Program 14 2.5 Code Refresher Course 15

3. Complaints Process 16 3.1 Lodging a Complaint 16 3.2 Adjudication of Complaints 16 3.3 Sanctions 16 3.4 Appeals 16

4. Analysis of Complaints Data 17 4.1 Source of Complaints 17 4.2 Summary of Complaint Determinations 18 4.3 Code Sanctions & Principles for Determining Code Sanctions 19

4.3 Sections of the Code Alleged to be in Breach by Complainant 22 4.4 Timeframe for Finalisation of Complaints 23

5. Complaint Determinations 24 5.1 Code of Conduct Complaints Comparisons 1999 - 2007 24

5.2 Index of Complaints by Complaint Reference Number 256. Medicines Australia Monitoring Committee 150

6.1 Monitoring Committee 150 6.2 Roles and Responsibilities 151

7. Review of Materials by the Monitoring Committee 152 7.1 Overview 152 7.2 Summary of the Monitoring Committee Review of Materials

2002 - 2007153

7.3 Outcomes of the Monitoring Committee Review of Materials 154

TABLE OFCONTENTS


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MUCH OF THE

INFORMATION IN THIS

REPORT HAS BEEN

PUBLICLY RELEASED

THROUGHOUT 2006/2007 VIA

THE MEDICINES AUSTRALIA

WEBSITE. THIS IS THE FIRST

TIME, HOWEVER, THAT THE

DATA HAS BEEN

PRESENTED IN A

CONSOLIDATED REPORT.

MEDICINES AUSTRALIA

CONSIDERS THAT

COMPLIANCE WITH AN

INDUSTRY CODE OF

CONDUCT SHOULD BE A

CONDITION OF PRODUCT

LICENCE.

I am pleased to contribute to the Medicines Australia Code of ConductAnnual Report for 2006/2007, which contains comprehensive informationabout the activities of the Code, Appeals and Monitoring Committees andthe outcomes of all finalised complaints reviewed by the Code and AppealsCommittees.

The Board of Medicines Australia is responsible for the oversight of the Code

of Conduct. During the past 12 months the Board has examined itsgovernance arrangements to ensure that it provides appropriate leadershipand direction to the Code Committees.

The Board has built on initiatives to advance these governancearrangements by engaging with the Panel of Chairs to discuss matters ofprocedural fairness, natural justice and administration issues.

The introduction of the Guidelines for Determining Code Sanctions hasprovided a strong platform for informed discussion when members of theCode and Appeals Committees are considering sanctions when a companyhas been found in breach of the Code.

Good governance and a Code that sets a high standard will not guaranteegood practice, but they do provide a framework around whichpharmaceutical companies can develop and implement quality processesand compliance procedures.

Medicines Australia considers that compliance with an industry Code ofConduct should be a condition of product licence for prescription medicines.This will ensure consistency and effectiveness of a robust self-regulatoryregime for the industry.

This report is presented with a view to sharing lessons, encouragingincreased compliance by companies and providing baseline data from whichfuture improvements can be measured.

Ian ChalmersChief Executive, Medicines Australia

FOREWORD


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MEDICINES AUSTRALIA IS

COMMITTEED TO

CONTINUING TO WORKWITH ALL STAKEHOLDERS

TO ENHANCE

UNDERSTANDING AND

COMPLANCE WITH THE

CODE OF CONDUCT.

THE CODE SECRETARIAT

STRIVES TO MAINTAIN A

FRAMEWORK THAT

SUPPORTS GOOD

GOVERNANCE AND TO

SUPPORT AND IMPROVE

MEMBERS SERVICES,

INDUSTRY COVERAGE AND

OPENNESS TO NON-

INDUSTRY STAKEHOLDERS.

Medicines Australia is committed to enhancing and promoting the standingand role of the Code of Conduct in Australia. To do that, we seek toestablish the highest ethical and technical standards of conduct in themarketing and promotion of prescription medicines for all pharmaceuticalcompanies. Many individuals, companies and organisations have providedadvice and contributed to the process of ongoing review and continuousimprovement of the Code.

Pharmaceutical companies marketing prescription medicines in Australiamust comply with the following Acts and Regulations:

Therapeutic Goods Act 1989http://www.comlaw.gov.au/comlaw/management.nsf/lookupindexpagesbyid/IP200401372

Therapeutic Goods Regulations 1990http://www.comlaw.gov.au/ComLaw/Management.nsf/current/bytitle/470A4D2EDB75C676CA256F710006B348?OpenDocument&mostrecent=1

Trade Practices Act 1974http://www.austlii.edu.au/au/legis/cth/consol_act/tpa1974149/

Regulations for the Advertising of Therapeutic Goods in Australiahttp://www.tga.gov.au/docs/html/advreg.htm

In addition it is a condition of marketing approval for prescription medicinesissued by the Therapeutic Goods Administration (TGA) that companiescomply with the Medicines Australia Code of Conduct. Information on theMedicines Australia Code of Conduct can be found via the website at:http://www.medicinesaustralia.com.au/pages/page16.asp

The vast majority of pharmaceutical companies who interact with healthcareprofessionals and the general public do so responsibly. Nevertheless, onoccasion a potential breach of the Code is identified and a complaint is filedwith Medicines Australia. While breaches of the Code might never becompletely eliminated from the industry, important lessons from complaints

can be used as an educational tool in company training and auditing internalcompliance procedures.

Medicines Australia is not the adjudicator of complaints. Its role is to set andpromote high standards in the advertising and promotion of prescriptionmedicines and to provide advice and education to members and otherstakeholders.

EXECUTIVE SUMMARY


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A COMPLAINT UNDER THE

CODE OF CONDUCT MAY BE

LODGED BY AN INDIVIDUAL,

ORGANISATION OR

PHARMACEUTICAL

COMPANY.

RESULTS OF THE CODE OF

CONDUCT AND APPEALS

COMMITTEE DECISIONS ARE

PUBLISHED ON THE

MEDICINES AUSTRALIA

WEBSITE ON A QUARTERLY

AND ANNUAL BASIS.

The Code of Conduct and Appeals Committees role is to enforce thosestandards set by the Code by investigating complaints and where a breach isfound, imposing sanctions against those companies that breach the Code.The members of the Committees bring extensive experience in tradepractices law, public health, general practice, specialist medicine, consumeradvocacy and in evaluating the utility of drugs in a variety of research andclinical situations. The Committees review processes are fair, rigorous andindependent.

The complaints process is open to any company, organisation or individual.Medicines Australia does not charge a fee to make a complaint; however,there is a fee for a company to lodge an appeal against the findings of theCode of Conduct Committee. This fee is not applicable to non-industryappellants.

Financial sanctions imposed by the Code of Conduct Committee are paid toMedicines Australia and used for the following purposes: To defray the costs of the complaints process Code and Appeals

Committee meetings; Provide independent facilitators to assist non-industry complainants; For education services free seminars and presentations for all

stakeholders at no cost; Development and provision of Code of Conduct booklets; Development and production of resources to promote compliance with

the Code; and Public dissemination of outcomes of all complaints on the Medicines

Australia website.

Results of the Committees decisions are published on the MedicinesAustralia website on a quarterly and annual basis. This helps educatecompanies as well as demonstrating the transparency of the complaintsprocess.

2006/2007Introduction of Edition 15 of the Code of Conduct came into effect on 6December 2006. The revised and updated edition includes a number ofenhancements such as: Restrictions on the use of posters and abstracts as the sole source of

evidence (Section 1.2.2 of the Code); New requirements for advertisements and printed promotional material

(Section 3.1 and 3.3 of the Code); Restrictions on the placement of advertisements in prescribing software

(Section 3.9 of the Code); New provisions for the supply of starter packs (Section 5 of the Code); New requirements for Product Familiarisation Programs (Section 5.2 of

the Code); Appeal bond to be paid by an industry appellant increased to $20,000

(Section 13.1 of the Code); Addition of a permanent consumer representative to the Appeals

Committee (Section 13.2 of the Code); Addition of a permanent consumer representative to the Monitoring

Committee (Section 14.2 of the Code); and Reporting on all finalised complaints now on a quarterly basis (See

Section 16.2 of the Code).


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During 2006/2007 the Medicines Australia Code of Conduct website wasfurther developed by providing: New information on lodging a Code of Conduct complaint and

responding to a Code of Conduct complaint; and Publication of the Guidelines for Determining Code Sanctions.

Medicines Australia has developed a number of initiatives to enhance theCode and Code processes to meet our obligations within the self-regulatoryframework that governs the pharmaceutical industry such as: Biannual meetings between the Medicines Australia Board and the

Panel of Chairs; Enhanced information on lodging and responding to a complaint; and Development and publication of the Guidelines for Determining Code

Sanctions.

The success of the Code of Conduct, Appeals and Monitoring Committeescan be attributed to the participation and dedication of their Chairmen andmembers. Medicines Australia is very grateful to these individuals for theircontinued commitment and diligence in administering the Medicines

Australia Code of Conduct.

Thanks also go to the Medicines Australia Code Secretariat who ensuresthese Committees are supported in a professional, impartial, responsive andtimely manner.

Deborah MonkMedicines Australia Director responsible for the Code of Conduct


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THE DEFINITIONS INCLUDED

IN THIS LIST APPLY ONLY TO

TERMS USED IN THIS

ANNUAL REPORT.

A MORE EXTENSIVEGLOSSARY OF TERMS IS

INCLUDED IN EDITION 15 OF

THE CODE OF CONDUCT.

Advertisement means any communication which promotes or discouragesthe use, sale or supply of products (whether or not in conjunction with thesupply of services, and whether or not the communication identifiesparticular products or services).

Australian approved name means the active ingredients or chemicalcomponents of a medicine.

Brand name has the same meaning as proprietary name which is theregistered trade mark of the therapeutic product or the unique nameassigned to the product.

Brand name reminder (BNR)means such items of low monetary value whichare intended to remind healthcare professionals of the existence of aproduct.

Complainant means an individual, organisation or company who lodges acomplaint under the Code of Conduct.

Consumers and the general public are persons other than healthcareprofessionals.

Healthcare professional (HCP) includes members of the medical, dental,pharmacy or nursing professions and any other persons who, in the courseof their professional activities, may prescribe, supply or administer amedicine.

Hospitalitymeans the provision of food and/or beverages.

Indicationsmean the registered therapeutic use of a medicine as approvedby the Therapeutic Goods Administration.

Medical representativemeans a person expressly employed by a companywhose main purpose is the promotion of the companys products to

healthcare professionals.

Membermeans a company holding membership of Medicines Australia.

PBS means the Pharmaceutical Benefits Scheme of the CommonwealthDepartment of Health and Ageing.

Patient support programmeans a program run by a company, with or withoutinvolvement from a health consumer organisation, with the aim of increasingpatient compliance and positive health outcome.

DEFINITONS


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Product familiarisation program (PFP)means a program run by the companywith the aim of allowing the medical profession to evaluate and becomefamiliar with the product.

Product Information (PI) means a document submitted to the TGA whichincludes the following information: description, pharmacology, clinical trials,indications, contraindications, precautions, adverse reactions, dosage andadministration.

Promotional materialmeans any representation concerning the attributes ofa product conveyed by any means whatever for the purpose of encouragingthe usage of a product.

Starter packmeans a quantity of a product supplied without cost to medicalpractitioners, dentists and hospital pharmacists. Starter packs are alsoreferred to as samples by healthcare professionals.

Subject company means a pharmaceutical company against whom acomplaint under the Code of Conduct has been lodged.

Therapeutic Goods Administration (TGA) is the Division of theCommonwealth Department of Health and Ageing that is responsible for theregulation of therapeutic goods in Australia.

Trade packmeans a package of a product which is sold by the company.


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PANEL OF CHAIRS

A PANEL OF SIX SUITABLY

QUALIFIED AND

EXPERIENCED LAWYERS

HAS BEEN APPOINTED BY


BOARD.

THE CHAIRMAN FOR A

PARTICULAR CODE

COMMITTEE MEETING IS

APPOINTED FROM THE

PANEL TAKING INTO

CONSIDERATION THAT THEPERSON HAS NO CONFLICT

OF INTEREST.

Current MembersBrief biographies are available on the Medicines Australia websitehttp://www.medicinesaustralia.com.au/pages/page96.asp for current members ofthe Panel of Chairs and the Code of Conduct and Appeals Committees.

Conflict of InterestA person must not have a conflict of interest with the therapeutic area/s or

company/ies against which a complaint has been lodged or with theComplainant. This also extends to financial or perceived bias with any of thematters being considered at the meeting which they have been invited toattend.

Code of Conduct Commi ttee Members (Edition 15)

Full Members (Voting rights) Independent Lawyer (Chairman)

Representatives nominated by: Australian General Practice Network (AGPN)

(Formerly Australian Divisions of General Practice) Australian Medical Association (AMA) Australasian Society of Clinical and Experimental Pharmacologists and

Toxicologists (ASCEPT) Consumers Health Forum of Australia (CHF) Royal Australian College of Physicians (RACP) Royal Australian College of General Practitioners (RACGP) Therapeutic Goods Administration (TGA) Medicines Australia Association Representatives (maximum 3) Medicines Australia Medical/Scientific Directors (maximum 2)

Observers (No voting rights) Medicines Australia member companies employees (maximum 2)

Observer nominated by Medicines Australia (maximum 1)

Advisors (No voting rights) Secretary, Code of Conduct Committee Medicines Australia officer responsible for Scientific and Technical

Affairs Medicines Australia Chief Executive Officer

MEDICINES AUSTRALIACODE COMMITTEES and

SECRETARIAT

1

1


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THE PANEL OF CHAIRS

HOLD BIANNUAL MEETINGSWITH THE MEDICINES

AUSTRALIA BOARD TO

DISCUSS STRATEGIC

ISSUES IN RELATION TO THE

ADMINISTRATION OF THE

CODE OF CONDUCT.

Code of Conduct Committee Meeting Attendance

The following table indicates the attendance of the external (non-MedicinesAustralia member company) members of the Committee. Edition 15 of theCode of Conduct requires the participation of an ASCEPT member at eachCode Committee meeting to form a quorum.

Figure 1: Code of Conduct Committee Meeting Attendance

AGPN

AMA

ASCEPT

CHF

RACGP

RACP

TGA

1 2 3 4 5 6 7 8 9 10 11 12

Number of Meetings

Appeals Committee Members (Edit ion 15)

Full Members (Voting rights) Independent Lawyer (Chairman)

Representatives nominated by:

The College and/or Society associated with the therapeutic class of theproduct subject to appeal

The target audience to which the activity was directed eg: AMA,RACGP, AGPN

Consumers Health Forum of Australia (CHF) Australasian Society of Clinical and Experimental Pharmacologists and

Toxicologists (ASCEPT) Medicines Australia Association Representatives (maximum 2) Medicines Australia Medical/Scientific Director (maximum 1)

Advisors (No voting rights) Secretary, Code of Conduct Committee Medicines Australia Chief Executive Officer or delegate


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MEMBERS MUST BE FULLY

CONVERSANT WITH ALL

PROVISIONS OF THE

CURRENT EDITION OF THE

MEDICINES AUSTRALIA

CODE OF CONDUCT.

Roles and Responsibilities of the Code of Conduct andAppeals Committee Members

The Committee members must fulfill the following roles and responsibilities.

To be fully conversant with:

All provisions of the current edition of the Medicines Australia Code ofConduct: Membership and nominating bodies for the Code and Appeals

Committee as set out in Sections 11.2 and 13.2 of the Code ofConduct;

Provisions relating to the administration of the Code as set out inSection 11 and Appendix 1; and

Provisions relating to the Appeal process as set out in Section 13. The sanctions that can be imposed by the Committee where a breach

of the Code of Conduct has been found by the Code and AppealsCommittees: Provisions relating to the imposition of sanctions on companies

found to be in breach of the Code by the Code and Appeals

Committees as set out in Section 12. The Constitution of Medicines Australia, specifically those which refer to

the disciplining of members and their right of appeal as set out inAppendix 2.

As a Committee member they must: Establish and maintain an effective working relationship with Medicines

Australia; Participate in the scheduled Code and Appeals Committee meetings:

Ensuring that they understand the procedures for the meeting; Establishing the details of what is subject to complaint; Ensuring that all the items subject to complaint are addressed; Providing appropriate and sufficiently detailed information for

discussion by all members of the Code or Appeals Committee toenable the minutes to reflect the decisions; Ensuring that matters outside the scope of the Code of Conduct

or aspects not subject to complaint are not taken into accountwhen making a determination; and

Ensuring confidentiality is maintained until the complaint isfinalised.

Be aware of all voting procedures under the provisions of the Code ofConduct: All permanent members of the Code of Conduct Committee are

entitled to vote eg. observers to the meeting and members ofthe Code Secretariat do not have voting rights as set out inSection 11.2; and

Should the vote be deadlocked the deciding vote is taken by theChairman of the Code or Appeals Committee.

Declare any conflict or potential conflict of interest to the CodeSecretariat prior to any agenda papers being circulated andconsideration of the complaint.


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Code Secretariat

Ms Deborah Monk Director, Scientific and Technical Affairs Ms Heather Jones Manager, Code of Conduct

Secretary, Code of Conduct Committee Ms Lara Winther Code Administration Officer (Part time)

Role of the Medicines Australia Code Secretariat

The Code Secretariat at Medicines Australia means the staff withinMedicines Australia with responsibility for Code and related matters.

The Code Secretariat has responsibility for: Providing advice to any healthcare professional, member of the general

public, pharmaceutical company or agency on Code related matters; Providing educational seminars, training and briefings to companies

and other stakeholders; Providing the administrative support to the Code, Appeals and

Monitoring Committees: Preparing the agenda papers for the Committees; Recording the minutes for the Committees; Providing copies of the minutes to the Complainant and Subject

Company; and Preparing reports for publication; and

Developing and implementing the administrative procedures for theCode process.


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CODE IS BASED ON THE

PROVISIONS OF THE IFPMA

CODE.

IN 2006 AN INTERNATIONAL

CODE COMPLIANCE

NETWORK WAS

ESTABLISHED TO BRING

TOGETHER COMPLIANCE

OFFICERS.

International Federation of Pharmaceutical Manufacturersand Associations (IFPMA)

The IFPMA is a non-profit, non-government organisation representingpharmaceutical companies and industry associations from both developedand developing countries. Member companies of the IFPMA are globalresearch-based pharmaceutical and vaccine companies.

The Medicines Australia Code is based on the provisions of the IFPMACode. An updated version of the IFPMA Code of Pharmaceutical MarketingPractices entered into force on 1 January 2007. The new Code, whoseapplicability extends to every country and is required of all IFPMA members,imposes even stricter and clearer requirements on pharmaceuticalcompanies, to ensure the ethical promotion of their products to healthcareprofessionals.

In 2006 the IFPMA Code Compliance Network was established to bringtogether compliance officers from member companies and industryassociations, to share best practice in informing company sales andmarketing people about compliance with the IFPMA Code, with an emphasis

on teaching respect for the spirit as well as the letter of the rules of the Code.

Medicines Australia is participating in this network and Ms Deborah Monkpresented at an international IFPMA Code roll out conference in Hong Kongin January 2007 and will be a keynote presenter at a regional Asia PacificCode training seminar in July 2007.

Education in Australia

Educational seminars and meetings are provided by Medicines Australiathroughout the year to increase industry and stakeholder awareness of andadherence to the Medicines Australia Code of Conduct. Presentations were

made to member and non-member companies; advertising, marketing andpublic relations agencies; conference organisers and health consumer,pharmacy and medical organisations.

Medicines Australia has also developed printed brochures to promoteawareness and understanding of the Code of Conduct and has madeavailable further information on the Code and Code processes via theMedicines Australia website.

Online education programs are also available through the MedicinesAustralia Continuing Education Program.

PROMOTINGUNDERSTANDING of the CODE

2


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2 KEYNOTE

PRESENTATIONS AT

INTERNATIONAL MEETINGS

20 PRESENTATIONS IN

AUSTRALIA

696 INDIVIDUALS ATTENDEDPRESENTATIONS

9 MEETINGS SPECIFICALLY

DEDICATED TO THE CODE

CODE TRADE DISPLAY AT

MEDICAL CONFERENCES

DOWNLOADS FROM CODE

WEBSITE

CODE OF CONDUCT 70,333

CODE GUIDELINES 21,964

CODE REPORTS 39,334

Presentations and Meetings

Table 1: Code Education 2006/2007

Print Materials Available

Code of Conduct Edition 15: Information for members of the generalpublic

Code of Conduct Edition 15: Information for healthcare professionals

Medicines Australia Website

Information available from the Medicines Australia website:http://www.medicinesaustralia.com.au/pages/page5.asp

Code of Conduct Edition 15 Guidelines to Edition 15 Guidelines for Determining Code Sanctions Code of Conduct Committee Meeting Dates Committee Membership Frequently Asked Questions

Lodging and Responding to a Complaint Code of Conduct Reports Briefing Papers

Audience No AttendeesPresentations

Member Company 5 182Non-member Company 0 0External (Advertising/PR/Conference) 7 43Healthcare Professional (Medical/pharmacy) 2 100Health Consumer Organisation 0 0Seminars 6 371Total 20 696

Code related meetingsMedical Software 2 4Politicians 3 6Companies 2 4Others 2 4

Total 9 18

Code Trade Display at Medical Conference700 registered healthcare professionals and 300 enquiries/discussions rethe Code of Conduct


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CEP PROGRAMS

1. CODE OF CONDUCT

2. PHARMACEUTICAL AND

HEALTHCARE INDUSTRY

3. INTRODUCTION TOPHARMACOLOGY

4. UNDERSTANDING

PRODUCT INFORMATION

5. UNDERSTANDING

CLINICAL EVIDENCE

Continuing Education Program (CEP)

Medicines Australias Continuing Education Program (CEP) is designed toeducate company representatives to a recognised industry standard in orderto provide healthcare professionals with accurate, balanced information in anethical manner that will enhance the quality use of medicines.

The CEP is offered in distance learning and online modalities through UQHealth Insitu which is the life long learning arm of the Centre for Health,Innovation and Solutions (CHIS), a centre of the University of QueenslandsFaculty of Health Sciences. The course is tailored for adult learning anddesigned to provide flexibility for participants in full time employment.

Section 4 of the Code of Conduct states:All medical representatives entering the Australian prescriptionpharmaceutical industry for the first time must enrol in the Code of Conductcomponent of the endorsed Medicines Australia education program withinthe first six months of employment and must complete the full programrequirements for medical representatives within two years.

Any person who is directly involved in the development, review and approvalof promotional materials and educational materials for the general public(this includes Product Managers, medical, marketing or sales staff); or hasdirect interaction with healthcare professionals for the purpose of promotinga prescription medicine, whether part time or full time, must complete theCode of Conduct component of the endorsed Medicines Australia educationprogram within the first 12 months of commencement of employment.

For more information regarding the CEP content, please contact MedicinesAustralia on 02 6282 6888. For enrolment details, please visit the CEPwebsite at http://ma.healthinsitu.uq.edu.au

CEP in 2006/2007

Enrolments in Semester 2 2006 (some candidates may be enrolled in morethan one program in the semester eg Programs 1 and 2) Program 1 452 Program 2 280 Program 3 251 Program 4 261 Program 5 211

Number of individuals who completed the CEP in Semester 2 2006 198

Enrolments in Semester 1 2007 (some candidates may be enrolled in morethan one program in the semester eg Programs 1 and 2) Program 1 507 Program 2 279 Program 3 249 Program 4 207 Program 5 213

Number of individuals who completed the CEP in Semester 1 2007 207


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EACH YEAR AWARDS ARE

MADE TO INDIVIDUALS FOR

OUTSTANDING

ACHIEVEMENTIN THE CEP.

98% SATISFACTION RATE

WITH THE CEP

CODE REFRESHER COURSE

DOWLOADED 4,026 TIMES

CEP Awards

2006 Top Ten CEP achievers acknowledges outstanding medicalrepresentatives who have completed the CEP Jane Trotter (Boehringer Ingelheim) Kerryn Gamble (Sanofi aventis)

Rhys Hosgood (Altana Pharma) Kylie Myers (Novo Nordisk Pharmaceuticals) Nicola Ruijne (Lundbeck Australia) James Dummett (AstraZeneca) Jill Blackwood (Merck Sharp and Dohme Australia) Thomas Ferguson (Boehringer Ingelheim) Theodore Holland (Solvay Pharmaceuticals) Sean Remedios (AstraZeneca)

Module 1 Code of Conduct candidate whose work in this important moduleis outstanding with demonstrated knowledge and practical application of theMedicines Australia Code of Conduct David Cheng (Bristol-Myers Squibb Australia)

UQ Health Insitu Active Learning Prize is based on the level and quality ofparticipation in group discussions and personal reflections in online tutorials Anita Flint (Valeant Pharmaceuticals) Andrew Corbett (Eli Lilly Australia)

CEP Evaluation

Each person enrolled in the CEP is asked to complete an evaluation form.Medicines Australia is pleased that the majority of students undertake thistask with the overall satisfaction rate over 80%.

Overall Student Satisfaction Exceeded 39% Met 59% Did not meet 2% N/A 0%

Code Refresher Course

This course is designed to highlight the key changes to the MedicinesAustralia Code of Conduct Edition 15 and update the knowledge of staffinvolved in the development, review and approval of promotional materialsfor healthcare professionals and educational materials for the general public.

The course is designed to be self-directed, so each person can work at theirown pace.

The course is available in two formats: Online accessed at:http://ma.healthinsitu.uq.edu.au/products/MA4911/MA4911_brochure.cfm Downloadable PDF Document accessed at:http://www.medicinesaustralia.com.au/pages/page105.asp


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THE CODE OF CONDUCT

COMMITTEES

DETERMINATION IS BASED

ON A REVIEW OF THE

WRITTEN SUBMISSIONS

FROM THE COMPLAINANT

AND SUBJECT COMPANY

Lodging a ComplaintIn addition to intercompany complaints a non-industry Complainant (forexample a member of the general public, healthcare professional, academic,Therapeutic Goods Administration) may lodge a complaint in relation to theactivities of, or materials developed by, the Australian sponsor of aprescription medicine.

Anonymous complaints will not be accepted. However, on request of theComplainant, the Code Secretariat will withhold the name of theComplainant from the Subject Company and will not publish their name inthe Code of Conduct Annual Report.

A Complaints Submission Formcan be found at:http://www.medicinesaustralia.com.au/pages/page34.asp

Adjudicat ion of ComplaintsComplaints are adjudicated upon by the Code of Conduct Committee. Formembership of this Committee please refer to page 8. The Committeesdetermination is based on a review of the written submissions from theComplainant and Subject Company.

SanctionsThe Code of Conduct Committee, with medical, legal and consumerrepresentatives, has the power to direct withdrawal of advertising, requirecorrective letters or advertisements and impose fines on companies forbreaches of the Code. The Committee will take a range of factors intoconsideration when determining an appropriate sanction.The Guidelines for Determining Code Sanctions can be found athttp://www.medicinesaustralia.com.au/pages/page16.asp

AppealsUnder Edition 15 of the Code, an appeal may be lodged by either theComplainant or Subject Company. Both the Complainant and SubjectCompany are permitted to be in attendance at the Appeals Committeemeeting to make a presentation and hear the presentation of the other party.The Appeals Committee is independent of the Code of Conduct Committee no member of the Appeals Committee may have also been a member of theCode of Conduct Committee that made the determination subject to appealFor membership of the Appeals Committee please refer to page 9.

A complaint is not deemed finalised until the Complainant and SubjectCompany have advised Medicines Australia that they will not appeal thedecision of the Code of Conduct Committee decision (following circulation ofthe Code minutes) or in the case of an appeal the minutes of the AppealsCommittee meeting have been provided to both parties.

3 COMPLAINTS PROCESS


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MEDICINES AUSTRALIA

RECEIVED 42 NEW

COMPLAINTS IN 2006/2007.

DETAILS OF THE

DETERMINATIONS OF THE

CODE OF CONDUCT AND

APPEALS COMMITTEES CAN

BE FOUND IN SECTION 5 OF

THIS REPORT.

Summary of Complaints

This section of the Code Annual Report contains information on the source ofcomplaints, outcomes from the determination of complaints and sanctionsimposed by the Code of Conduct and Appeals Committees.

The number of complaints in 2006/2007 was 42 (27 in 2005/2006) with 55%lodged by pharmaceutical companies. Table 2 provides information on thesource of complaints in 2006/2007. In 17.6% of new and finalised complaintsall aspects of the complaints were found to be in breach of the Code. In 41.2%of complaints no aspect of the complaint was found to be in breach of theCode. In the remaining 41.2% of complaints the complaints were partly foundin breach; that is some aspects of a complaint were found to be in breachwhereas other aspects were not found in breach. Table 5 provides informationon complaints considered in 2006/2007.

Appeals were lodged in relation to 12 complaints. The Appeals Committeeupheld one appeal, upheld some aspects of two appeals and did not upholdany aspect in relation to nine appeals (that is, the Code Committees decisionswere confirmed in 9 out of 12 appeals).

Source of Complaints

Table 2: Source of complaints 2006/2007

ANALYSIS OF

COMPLAINTS DATA

3

4

Complainant NumberHealthcare Professionals

General Practitioner 4Doctor in a hospital 2Physician/Specialist 2Pharmacist 1Nurse 2

Academic 1

Pharmaceutical Company

Medicines Australia Member Company 21Non-member Company 2

OrganisationsTherapeutic Goods Administration 4Medical College/Society 0Consumer Organisation 1

OthersMembers of the general public 0

Academic (non-healthcare professional) 2

Total new complaints in 2006/2007 42


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Summary of Complaint Determinations

Table 3: Complaints received by Medicines Australia in 2005/2006 andfinalised in 2006/2007

Table 4: Complaints received by Medicines Aust ralia in 2006/2007

Complaints finalised from 2005/2006 No. %

Number of complaints held over from 2005/2006 and finalised in2006/2007

7*

Code of Conduct Committee Decision

Where all aspects of a complaint were found to be in breach 0 0

Where someaspects of a complaint were found to be in breach 4* 100%

Where no aspects of a complaint were found to be in breach 0 0

*4 complaints pertain to the same matter and were consideredtogether with one decision and sanction applied

Number of appeals pertaining to complaints held over from2005/2006 and finalised in 2006/2007

3

Appeals Committee Decision

Where all aspects of an appeal were upheld 0 0

Where someaspects of an appeal were upheld 2 66.6%

Where no aspects of an appeal were upheld 1 33.3%

Complaints received in 2006/2007 No. %

Number of complaints received by Medicines Australia 42* 100%

Complaints considered by the Code of Conduct Committee 34* 80.9%

Complaints considered by the Code of Conduct Committee subjectto appeal in 2007/2008 (not finalised)

3 7.1%

Complaints not considered by the Code of Conduct Committee

Complaint withdrawn 1 2.4%

Complaint referred to the TGA 2 4.8%

Complaint returned to complainant with request for furtherinformation

1 2.4%

Complaint received after cut off date for June Code meeting 1 2.4%

*2 complaints pertain to the same matter and were consideredtogether with one decision and sanction applied


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COMPANIES SHOULD

FOCUS THEIR EFFORTS ON

GOOD REGULATORY

COMPLIANCE RATHER THAN

RELIANCE ON THE

COMPLAINTS PROCESS.

Table 5: Outcomes of complaints received and considered in 2006/2007

Code Sanctions

In the context of the Code a sanction is an imposition on a company inresponse to finding it has breached the Code. The three main types ofsanction are to: Cease the activity and withdraw the materials found in breach (the

minimum sanction); Issue a corrective letter or advertisement; and Pay a monetary fine.

The specific purposes of sanctions are to: Encourage compliance with the Code; Ensure that any materials found in breach are not used again or any

activity found in breach is ceased; and Ensure that incorrect or misleading information is corrected.

The minimum sanction that is consistently applied when a company has beenfound in breach of the Code is to require the company to cease the activity orwithdraw the materials from further use. This sanction cannot be applied if theactivity found in breach was a single occurrence and not an ongoing activity.The principles for determining a sanction should be transparent to both theComplainant and Subject Company.

The principles are not a list of procedural rules but the foundation on which thedetermination of the level of sanction is based. Sanctions should be based

upon clear principles and applied in a predictable and consistent mannerwithout unnecessary rigidity.

Compliance with the Code is most effective when companies develop internalprocedures for the development and approval of company activities andmaterials and ensure operations are based on an explicit risk managementstrategy. Companies should focus their efforts on good regulatory compliancerather than reliance on the complaints process.

Code of Conduct Committee Decision No. %

Where all aspects of a complaint were found to be in breach 6 17.6%

Where someaspects of a complaint were found to be in breach 14 41.2%

Where no aspects of a complaint were found to be in breach 14* 41.2%

Number of appeals pertaining to complaints received in 2006/2007 12

Where all aspects of an appeal were upheld 1 8.3%

Where someaspects of an appeal were upheld 2 16.6%

Where no aspects of an appeal were upheld 9 75%

*1 outcome relates to two complaints pertaining to the same matterwhich were considered together with one outcome and sanction


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THE PRINCIPLES ARE NOT A

LIST OF PROCEDURAL

RULES BUT THE

FOUNDATION ON WHICH

THE DETERMINATION OF

THE LEVEL OF SANCTION IS

BASED.

Principal Factors in Determining a Sanction

The following is a set of principal factors which will be taken into considerationby the Code of Conduct and Appeals Committees in determining a sanctionfollowing a finding of breach/es of the Code of Conduct.

The nature and extent of the activity/material Whether the breach should have been clearly evident to the Subject

Company; Breadth of activity or campaign; Length of time that the materials have been in use; The number and type of alleged breach/es; Circumstances in which the activity took place any explanation offered

by the Subject Company; and Level of the breach technical, minor, moderate, serious, repeat breach,

bringing industry into disrepute.

Other considerations Extent of breach how misleading, damaging, disparaging;

Potential for patient harm such breaches usually require correctiveaction and may attract a higher sanction;

Direct to consumer advertising or misleading information to the generalpublic in general, activities directed to the consumer found in breach ofthe Code attract a higher sanction. Direct to consumer advertising is inbreach of the Therapeutic Goods legislation;

Promotion of an unapproved indication or product also attracts a highersanction in recognition that this would also breach the Therapeutic Goodslegislation;

Extent of dispute resolution dialogue demonstration of significantattempts to resolve a complaint prior to proceeding to the Code Committeemay result in a lower sanction being applied;

Potential costs to be incurred by a company for corrective action the

Committee will consider the overall monetary cost of the package ofsanctions, for example the cost of issuing a corrective letter in combinationwith a fine; and

Company history.

Double Jeopardy

The Code of Conduct Committee will not rehear a complaint against aparticular section or sections of the Code in relation to the same activity orsame material irrespective of whether there was a finding of a breach of theCode, unless there is an allegation that the material has not been withdrawn orthe activity has not ceased. If a complaint is received in relation to an activity

or material already considered by the Code of Conduct Committee theComplainant will be referred to the outcome of the previous complaint.


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Table 6: Frequency of sanctions imposed by the Code and AppealsCommittees on companies found in breach of the Code

Table 7: Summary of sanctions imposed by the Code and AppealsCommittees on companies found in breach of the Code

Complaintsfinalisedfrom2005/2006

Complaintsreceivedandfinalised in2006/2007

Sanctions

Withdraw/cease only 0 4

Withdraw & corrective letter/advertisement 1* 0

Withdraw & corrective letter/advertisement & fine 2 7

Fine only 0 1

Withdraw & fine 0 8

Other & withdraw/cease & fine 1 0

*1 sanction relates to four complaints pertaining to the same matter which wereconsidered together with one decision and sanction

Complaintsfinalisedfrom

2005/2006

Complaintsreceivedand

finalised in2006/2007Sanctions

Withdraw/cease using material/activity found inbreach

3 21

Corrective Letter/ Corrective Advertisement 3 7

Other (eg. update internal review processes) 1 0

Fines

$0 $24,999 1 6

$25,000 $49,999 0 4$50,000 $74,999 0 1

$75,000 $99,999 0 2

$100,000 $149,999 1 3

$150,000 $200,000 1 0

Total value of fines $260,000 $695,000


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Sections of the Code alleged by Complainants to be inbreach

One complaint may include a number of allegations of a breach of the Codeagainst different materials or several separate aspects of a single promotionalitem under different sections of the Code. For example there may be 3 claims

in one promotional item alleged to be in breach.

Example:

Claim 1 breach of Sections 1.1, 1.2 and 1.3

Claim 2 breach of Sections 1.1, 1.2, 1.3 and 1.7

Claim 3 breach of Sections 1.1, 1.3 and 1.7

In the 34 complaints finalised during the 2006/2007 period (Table 9 excludesthe 8 complaints that were withdrawn, not heard or not finalised in 2006/2007),217 alleged breaches were considered by the Code of Conduct and AppealsCommittees. Of these a total of 96 breaches were found.

Table 9: Alleged and Actual Breaches of Code Sections 2006/2007

This table sets out the alleged breaches and the actual breaches by sectionfound by the Code of Conduct and Appeals Committees.

Section of the Code Alleged Breach No Breach

1.1 20 13 71.2 24 11 131.3 50 30 201.4 3 1 21.5 5 0 51.7 22 8 141.9 1 0 12.1 1 0 13.3 2 0 23.5 1 0 1

4.1 2 1 14.2 2 0 24.3 1 0 14.4 1 0 14.8 1 0 15.3 1 1 05.9 1 0 16.1 1 0 16.2 2 1 16.3 1 0 16.4 3 2 16.6 1 0 16.8 1 0 17.1 9 1 88.2 1 1 0

9.2 3 1 29.3 1 1 09.4 8 4 49.5 22 13 99.6 1 0 19.7 1 0 19.8 7 4 310 3 0 310.1 2 0 210.2 3 1 210.5 8 2 6

Total 217 96 121


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Timeframe for finalisation of complaint

The time taken to consider and finalise a Code of Conduct complaint iscalculated from the date the complaint is received at Medicines Australia to thedate of the Code of Conduct Committee or Appeals Committee Meeting.

The date for each scheduled meeting and information on the cut off dates foreach months meeting can be found on the Medicines Australia website athttp://www.medicinesaustralia.com.au/pages/page92.asp

While the Committees deal with each complaint as expeditiously as possiblethe finalisation of some complaints may be delayed due to requests by theCode Secretariat or the Code of Conduct Committee for further information; ordelays in hearing appeals due to matters relating to finding a mutuallyacceptable Appeals Committee meeting date for the Subject Company andComplainant and the sourcing of external experts for the meetings.

The following table provides a summary of the time taken to resolve acomplaint.

Table 8: Length of time to resolve all finalised complaints

Length of time to resolve complaints Number ofworkingdays

Shortest 13

Longest 101

Average 41

Average for complaints not subject to appeal 28

Average for complaints subject to appeal 66


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The Code of Conduct Annual Report makes available detailed information on each complaint considered by theCode of Conduct and Appeals Committees.

Medicines Australia is committed to continuing work with stakeholders in raising their awareness of the Code ofConduct and how a company, organisation or individual can lodge a complaint in relation to the activities of apharmaceutical company marketing a prescription medicine in Australia.

Table 10: Code of Conduct Complaint Comparison 1999 2007

5 COMPLAINTDETERMINATIONS

Year CodeEdition

Complaints Outcomes

Finalisedfrom

previousyear

NewComplaints Withdrawn

Notfinalised Not Heard A B C

99/00 12 & 13 44 6 4 28 6

00/01 13 37 4 6 10 7 10

01/02 13 2 49 9 2 2 14 15 9

02/03 13 & 14 2 48 5 7 2 17 11 8

03/04 14 7 36 6 2 11 10 12

04/05 14 2 51 4 3 20 16 10

05/06 14 3 27 7 2 7 4 10

06/07 14 & 15 7* 42 1 3 4 6 18 13

2 complaints pertain to the same matter and were considered together with one outcome and sanction applied

*4 complaints pertain to the same matter and were considered together with one outcome and sanction applied

A Where all aspects of a complaint were found to be in breach of the Code

B Where someaspects of a complaint were found to be in breach of the Code

C Where no aspects of a complaint were found to be in breach of the Code


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Table 11: Code of Conduct Complaints July 2006 June 2007This table provides a brief outline of each complaint finalised in 2006/2007. To view the detailed report on thecomplaint outcome please click on the complaint number.

Information on the content of the provisions (Sections) of the Code can be accessed at:http://www.medicinesaustralia.com.au/pages/page16.asp

Code of Conduct Complaints July 2006 June 2007

No. SubjectCompany

Material/Activi ty Product Complainant Outcome(Sections of theCode where one

or morebreaches found)

Sanction

826 Schering Material for thegeneral public

Betaferon Biogen IdecAustralia

Breach 1.3, 1.7,6.4, 9.4, 9.5,9.5.1, 9.5.2,9.5.6, 9.5.7, 9.8

Withdraw Corrective letter Fine - $150,000

827 AbbottAustralasia

Promotionalmaterial

Lucrin Mayne Pharma Breach 1.2.2, 1.3 Withdraw Corrective letter Fine - $10,000

828 Bayer Healthcare Promotionalmaterial

Levitra AustralianConsumersAssociation

Breach 10.5 Withdraw Corrective letter Corrective

advertisement



See 828

830 Schering Material forgeneral public

Betaferon Sanofi Aventis Breach 1.2.2,1.3, 6.4, 7.1.1,9.4, 9.5, 9.5.1,9.5.2, 9.5.6,9.5.7, 9.8

Dont usematerials again

Fine - $100,000



See 828



See 828

833 GlaxoSmithKlineAustralia

Competition forhealthcareprofessionals

Infanrix Healthcareprofessional

No breach/esfound

N/A


Competition forhealthcareprofessionals

Infanrix Healthcareprofessional

See 833

835 Roche Products Hospitality N/A TGA Breach 6.2, 10.2,10.5

Fine - $75,000


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No. SubjectCompany

Material/Activity Product Complainant Outcome(Sections of theCode where one


Sanction

836 AllerganAustralia Promotionalmaterial Lumigan Pfizer Australia Breach 1.2, 1.3,1.4, 1.7


837 Allpharmaceuticalcompanies

Relationship withhealthcareprofessionals

N/A Healthcareprofessional

No breach/esfound

N/A

838 Baxter Relationship withhealthcareprofessionals

Desflurane Healthcareprofessional

No breach/esfound

N/A

839 Merck Sharp &Dohme (Aust)

Promotionalmaterial

Zocor Healthcareprofessional

No breach/esfound

N/A


Promotionalmaterial

Avandia TGA No breach/esfound

N/A

841 Amgen Australia Relationship withhealthcareprofessionals

N/A RocheProducts

No breach/esfound

N/A

842 AstraZeneca Promotionalmaterial

Crestor Pfizer Australia Breach 1.3, 1.7 Withdraw Corrective letter Fine - $40,000


Promotionalmaterial

Rotarix CSL Limited Breach 1.1,1.2.2, 1.3

Withdraw Corrective letter

Fine - $25,000

844 BoehringerIngelheim

Promotionalmaterial

Buscopan Healthcareprofessional

Breach 1.3 Withdraw Fine - $10,000

845 Roche Products Promotionalmaterial

NeoRecormon AmgenAustralia

No breach/esfound

N/A


Promotionalmaterial

Seretide BoehringerIngelheim &Pfizer Australia

Withdrawn N/A

847 AstraZeneca Promotionalmaterial

Nexium Janssen-Cilag Breach 1.3, 1.7 Withdraw Fine - $75,000

848 Octapharma Promotionalmaterial

Octanate CSL Limited Breach 1.3,1.3.1, 1.7


849 BoehringerIngelheim

Promotionalmaterial

Mobic Pfizer Australia Breach 1.2, 1.3 Withdraw Corrective letter Fine - $25,000

850 AlconLaboratories

Promotionalmaterial

DuoTrav Pfizer Australia Breach 8.2.2 Cease program Fine - $10,000


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No. SubjectCompany



Sanction

851 CSL Limited Promotionalmaterial Biostate Octapharma Breach 1.3

Withdraw


Promotionalmaterial

GSKRespiratoryCare Program

Healthcareprofessional

No breach/esfound

N/A


Promotionalmaterial

GSK AdultImmunisation

Healthcareprofessional

No breach/esfound

N/A

854 Schering Starter packs Angeliq OrganonAustralia

Breach 5.3 Ceasedistribution of

trade packs

855 CSL Limited Representativebehaviour

N/A Healthcareprofessional &Octapharma

Breach 1.1,1.2.2, 1.3, 1.7,4.1

Withdraw Fine - $15,000


Promotionalmaterial

Twinrix Healthcareprofessional

No breach/esfound

N/A

857 Janssen-Cilag Promotionalmaterial

Pariet AstraZeneca Breach 1.1, 1.2,1.3, 1.7

Withdraw Fine - $100,000

858 GenRx Promotionalmaterial

Perindopril ServierLaboratories

Referred to TGA

859 Sanofi Aventis Promotionalmaterial

Stilnox Healthcareprofessional

Breach 1.1, 1.3 Withdraw Fine - $5000

860 Pfizer Australia Promotionalmaterial

Celebrex BoehringerIngelheim

Breach 1.1, 1.3 Withdraw Fine - $100,000

861 Merck Sharp &Dohme

Promotionalmaterial

Fosamax Plus Servier Breach 1.1, 1.2,1.3

Withdraw

862 Janssen-Cilag Starter pack Pariet TGA No breach/esfound

N/A

863 Janssen-Cilag Promotional

material

Pariet Altana Pharma Breach 1.2.2, 1.3 Withdraw Other sanctions

covered inPariet 857

864 CNS Pharma Esipram Healthcareprofessional

Referred to TGA

865 Pfizer Australia Promotionalmaterial

Xalacom AlconLaboratories

Breach 1.1, 1.3 Withdraw Corrective letter Fine - $50,000


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No. SubjectCompany



Sanction

866 Pfizer Australia Information inReaders Digest Celebrex Healthcareprofessional Breach 9.4, 9.5.2

Do not publishthis article againin publication togeneral public

Fine - $100,000


Media releaseand sponsorshipof a lay mediajournalist

Tykerb RocheProducts

Breach 9.2.1 Provide nomedia releasesuntil medicineregistered

Fine - $40,000

868 AstraZeneca Acronym used inpromotionalmaterial

SymbicortTurbuhaler

TGA No breach/esfound

N/A


Education event N/A Healthcareprofessional

No breach/esfound

N/A

4


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Betaferon (826)

Subject Company:Schering Pty Ltd (Schering)

Complainant:Biogen Idec Australia (Biogen)

Product: Betaferon

Complaint:Materials distributed at a MS Conference, whichwas attended by members of the general public,contained information about unapprovedindications for Betaferon and that the informationwas promoting a prescription medicine tomembers of the general public.

Sections of the Code:Materials alleged to be in breach of the followingSections of the Code: 1.3 False or misleading claims 1.7 Comparative statements 4.4 Medical representatives 4.8 Medical representatives 6.3 Involvement in Educational Symposia,

Congresses and Satellite meetings Behaviour

6.4 Sponsorship or involvement inAustralasian Congresses and SatelliteMeetings

9.4 Promotion to the General Public 9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7 Patient

Education

9.8 Discredit to, and reduction of confidencein, the industry

Code of Conduct and Appeals Committeedecision: Unanimous breach of Sections 1.3, 9.4, 9.5,

9.5.1, 9.5.2, 9.5.6, 9.5.7 and 9.8 (Decisionconfirmed by the Appeals Committee)

Breach of Section 1.7 (Decision confirmed bythe Appeals Committee)

Majority breach of Section 4.4 (Decisionconfirmed by the Appeals Committee)

Majority no breach of Sections 4.8 and 6.3

Breach of Section 6.4 (Decision amended bythe Appeals Committee no breach of Section6.4 of the Code)

Sanctions:(Decision confirmed by the Appeals Committee) Cease distribution of all materials found in

breach of the Code Recall materials found in breach of the Code

Corrective letter to all members of the generalpublic who attended MS 2006

Corrective letter to all healthcare professionalswho received the materials found in breach ofthe Code

Fine $150,000

Consideration of the complaint:

Code of Conduct CommitteeThe Committee reviewed the printed materials andDVD provided by Schering at the Multiple Sclerosis50th Celebration Meeting which was attended bypeople with MS, families, researchers, medicalpractitioners, allied health professionals, non-profitorganisations and community groups. Membersacknowledged that patients with MS and theircarers are interested in seeking further informationon the condition and available treatments; howevergovernment legislation and the Medicines AustraliaCode of Conduct prohibit advertising prescriptionmedicines to the general public or distributingpatient education materials containing promotionalor comparative information. Further, the promotionof a non-approved indication to either healthcareprofessionals or members of the general public isnot permitted.

The Committee also noted that there is a distinctionbetween materials prepared by a pharmaceuticalcompany and information prepared and distributedby a health consumer organisation (HCO) such asthe Multiple Sclerosis Society.

Some members of the Committee also commentedthat as Betaferon is an expensive medicine therewere significant benefits to a company inencouraging patients to ask their doctor to switch tothis medicine. The Committee was of the view thatthe presentation of the brochure Moving thetreatment goalposts in Multiple Sclerosis, with aphoto of eight experts in the field of MS couldpersuade a patient to believe that this must be thebest treatment for MS. Members were also of theview that whilst patients and their carers may bewell educated, they would not consider whether the

information was a peer reviewed report orunpublished data or whether it was balanced.Rather it would encourage them to ask their doctorwhy arent I on this new treatment?

In relation to the argument by Schering that byusing the name interferon beta-1b 250mcg theywere not referring to a specific prescriptionmedicine, the Committee commented that the useof the generic name was clearly an identifier forBetaferon and was equivalent to the use of the


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(Betaferon 826 contd)brand name, particularly where this is the onlybeta-1b medicine available.

The Committee considered the Moving thetreatment goalposts in Multiple Sclerosis brochureand DVD under each section of the Code allegedto be in breach by Biogen.

Section 1.3The Committee noted that the approvedindications for Betaferon were:Ambulatory patients with relapsing-remittingmultiple sclerosis (MS) characterised by at leasttwo attacks of neurological dysfunction over a twoyear period followed by complete or incompleterecovery. Betaferon is also indicated for thereduction of frequency and severity of clinicalrelapses, and for the slowing of progression ofdisease in patients with secondary progressive

multiple sclerosis.

The expert panel discussion recorded during the18th World Congress of Neurology, Sydney 9November 2005, presented on the DVD andsummarised in the brochure, was discussing newinformation on MS treatment, including a new trialknown as BENEFIT which was in relation to earlydetection via an MRI scan and the early treatment(after 1 episode) with interferon beta-1b 250mcg.

Members were of the view that the materials werepromoting a non-approved indication of a

prescription medicine, interferon beta 1b. TheCommittee also commented that the material wasnot balanced as it did not discuss the range oftreatment options available for MS but focusedsolely on interferon beta 1b and was promotionalwhich is not permitted in information provided tomembers of the general public. The Committeehighlighted the provisions in Section 1.3 of theCode which explicitly state that companies mustnot promote non-approved indications tohealthcare professionals. Healthcare professionalsmay request copies of materials discussing non-approved indications, such as a copy of

information on the BENEFIT Study. However acompany must not proactively promote availabilityof this information nor initiate its distribution.

Some members of the Committee were alsoconcerned that should a patient ask their doctorwhether they could receive this treatment theywould have to be advised that it was not anapproved indication, therefore not listed on thePBS, and consequently they would have to pay for

it as a private script. This contributed to theCommittees concern that Schering had not beentransparent or balanced in the information providedto patients or carers.

The Committee did not accept Scherings defencethat it is stated in the brochure Moving theTreatment Goalposts that interferon beta 1b is notapproved by the TGA or listed on the PBS.Whether TGA approval or PBS listing is stated inthe material or not, it is not permissible to promotenon-approved indications for a prescriptionmedicine to healthcare professionals attending an

Australia congress, and it is not permissible toprovide promotional information to members of thegeneral public and particularly not about non-approved indications.

In a unanimous decision the Committee found abreach of Section 1.3 of the Code as the Moving

the treatment goalposts in Multiple Sclerosisbrochure and DVD displayed and distributed bySchering at the MS Conference was not balancedand was promoting a non-approved indication.

Section 4.4In relation to the complaint that the Scheringrepresentatives present at the stand should havebeen aware of the requirements of the Code andwere advised by Biogen representatives that thematerials being distributed were in breach of theCode, members noted that they did not removethem and continued to distribute them to members

of the public. Members commented that theSchering representatives at the conferenceprobably did not develop or approve the materials;however they should have been aware that thematerials were promoting a prescription medicine tothe general public which is not permitted under theCode or therapeutic goods legislation. Membersconsidered the representatives should have actedmore promptly in working with senior managementwithin the company to consider the matter.

A few members were of the view that an individualrepresentative could not be held personally

responsible for materials produced by the companyand Product Managers, Marketing and MedicalDirectors should be held accountable.

However should a medical representative have anyconcerns in relation to their companies materials,there should be a culture within companies whichencouraged questioning and compliance with theCode.


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Betaferon 826 (contd)A minority view was expressed that it was notappropriate to hold the representatives at theconference responsible for the materials they weredistributing but rather responsibility lies withSchering management. Further, senior managershad been involved in determining whether thematerials should be removed or not.

By a majority the Committee found a breach ofSection 4.4 of the Code as the high degree ofprofessionalism expected of medicalrepresentatives was not discharged.

Section 4.8The Committee was of the view that as Scheringdid not consider the material was promotional theywould not have expected that they should providea copy of the Product Information (PI) forBetaferon. However a minority of members were

of the view that the material distributed bySchering was clearly promotional. A companyshould be aware that if they provide informationabout a non-approved indication (on request) theymust provide a clear and prominent statement tothat effect and a copy of the Australian approvedPI.

By a majority the Committee did not find a breachof Section 4.8 of the Code as membersconsidered that it would not be appropriate toprovide a PI to members of the general public asthey had not been prescribed the medicine and it

would be more appropriate to give a ConsumerMedicine Information (CMI) to a patient once themedicine had been prescribed rather than from theconference stand.

Section 6.3Members were of the view that this section whichrefers to the conduct of company representativeswas broader than Section 4.4 which only referredto medical representatives. As noted in thediscussion pertaining to Section 4.4, theCommittee was of the view that all medical andcompany representatives should ensure that their

behaviour does not bring discredit to the industryand should be beyond reproach and that stafffurther up the line from the medical representativeshould have addressed the concerns immediately.

The Committee was concerned that Scheringwithdrew the materials from their stand after alengthy delay only to reinstate them the next day.The materials were also taken from the Scheringstand and distributed from the MS Society stand.

By a majority the Committee found no breach ofSection 6.3 of the Code.

Section 6.4Members emphasised that they did not haveconcerns with a pharmaceutical companysponsoring a health consumer organization (HCO)event or other reputable educational events on thecondition that the guidelines for awarding thesponsorship were open and transparent and withinappropriate boundaries.

The Committee also considered that it was notrelevant for Schering to claim that the MS Societyhad said they had no issues with the Scheringmaterials. It is Scherings responsibility to ensureits activities and materials comply with the Code ofConduct, not the conference organisers.

Members also commented that there was a

difference between the Moving the treatmentgoalposts in Multiple Sclerosis brochure and DVDwhich were Schering materials and the brochuredeveloped by the MS Society. It was noted that theSchering brochure and DVD were included in thewelcome bags provided to registrants at theconference.

The Committee found a breach of Section 6.4 of theCode as this type of activity could bring discredit tothe industry and reflect poorly on the relationshipbetween the industry and a HCO.

Sections 9.4, 9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7 and 9.8In a unanimous decision the Committee found abreach of all of these sections of the code:

Information brochure and DVD were promotinga prescription medicine to the general public.

Information brochure and DVD related to a non-approved indication.

Information brochure and DVD were notbalanced and were non-compliant as patienteducational material due to the focus on asingle treatment and were promotional.

Information brochure and DVD may cause

unnecessary alarm or misunderstanding in thecommunity as the indication was not approvedin Australia, not available on the PBS andtherefore costly to a patient. The material mayraise expectations beyond what is deliverable interms of treatment outcomes and availability ofthe medicine.


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Betaferon 826 (contd) Information brochure and DVD may also

cause alarm to a newly diagnosed patient whomay expect immediate access to the newtreatment but has to wait up to 6 months tosee a neurologist.

Section 9.8In having found a number of breaches of the Codein relation to the provision of promotional materialsto the general public, the Committee was of theview that these were serious breaches of the Codeand could bring discredit to and reduce confidencein the industry. By unanimous decision theCommittee found Schering in breach of Section9.8.

Section 1.7The Committee was of the view that the claim 10years of the most prescribed MS treatment in

Australia on the Schering banner and othermaterials on display at the MS Conference was ahanging comparison and in breach of Section 1.7of the Code which states Hanging comparatives those which merely claim that a product is better,stronger, more widely prescribed must not beused.

SanctionsHaving found a number of breaches of the Code,including a serious breach, the Committeeconsidered an appropriate sanction.

The Committee determined that it was its intentionthrough the sanctions imposed to: Cease further distribution of the materials

found in breach. Recall the materials from healthcare

practitioners who had been provided with thematerials; and from the MS Society or anyother organisation who may be distributing thematerials.

Issue a corrective letter to all members of thegeneral public who attended the MSConference in March 2006 and any othermember of the public who may have received

the materials from Schering or the MS Society. Issue a corrective letter to all healthcare

professionals who attended the MS SocietyConference and any other healthcareprofessional to whom the materials weredistributed by Schering or the MS Society orused in representative detailing.

The Committee resolved that Schering should takeimmediate action for the prompt withdrawal of the

material found in breach and should permit nofurther appearance of it in its present form.

Schering should also recall the materials found inbreach of the Code (Moving the treatmentgoalposts in Multiple Sclerosis brochure and DVD)from the MS Society and specialist neurologists. Aletter of explanation should be provided to the MSSociety outlining the reasons for the recall. The MSSociety should be advised to remove any access tothe DVD or brochure from its website.

The Committee further resolved that Scheringshould be required to distribute a corrective letter toall participants at the MS Conference, bothmembers of the public and health professional, andany general or specialist medical practitioner whowas detailed with the brochure and DVD found inbreach. The Committee recognised that thecorrective letter to consumers should differ from that

distributed to healthcare professionals. In particularthe letter to members of the public should explainwhat the Code is and why the material was in foundin breach but should not cause alarm to a patient bysuggesting that there was any problem with theirmedication. The corrective letters will list all of thebreaches of the Code found. The corrective lettersare to be approved by the Chairman and membersof the Code of Conduct Committee.

Recognising that it may not be appropriate, forprivacy reasons, for Schering to have access to thenames and contact details of all conference

registrants, the company should provide thecorrective letters to the conference organiser or theMS Society and ask that they be mailed to allregistrants on the conference data base. The cost ofmailing the letters should be met by Schering.

If it is not possible to identify all members of thepublic that have been provided with the brochureand DVD found in breach of the Code, Scheringshould request that the MS Society publish thecorrective letter in the next edition of the Societynewsletter.

Acknowledging that the MS Society may not beinclined to distribute the corrective letter asdetermined by the Committee, Schering shallprovide advice to the Committee confirming whetheror not the corrective information has beendistributed as directed. If it has not been distributedby the MS Society, Medicines Australia will write tothe Society explaining the reasons for the actionsand encourage the Societys cooperation.


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Betaferon 826 (contd)In relation to the claim 10 years of the mostprescribed MS treatment in Australia Scheringshould take immediate action for the promptwithdrawal and should permit no furtherappearance of it in its present form or a mannerwhich conveys the same meaning.

It was agreed that a fine of $150,000 should beimposed on Schering as there were a number ofserious breaches in relation to the promotion of anunapproved indication for a prescription medicineto the general public.

The Committee noted Biogens proposal thatSchering should be banned from participating in orholding a patient focused event for one year.Sanctions of this type are not available to theCommittee.

Appeals CommitteeAn appeal was lodged by Schering against thefindings of the Code of Conduct Committee.

The following summarises the main pointspresented by Schering representatives in favour ofits appeal: The material supplied at the MS Conference

was educational and not promotional. Schering acted promptly on the concerns

raised by Biogen at the MS Conference Schering did not display a cavalier attitude assuggested by Biogen.

Attendees at the MS Conference were notmembers of the broad general public butpatients with MS and carers. It is acceptableto direct materials to patients with MS which isa life long and debilitating disease.

The content of brochure is not Scheringsviews but extracts from an expert paneldiscussion convened at the behest of the MSSociety.

There was minimal editing of the expert paneldiscussion presentation shown on the DVDMoving the treatment goalposts. The

A4brochure was written by Schering but

closely reflects the statements in the DVD. The brochure and DVD were endorsed by the

MS Society. The provision of materials at a trade display in

the setting of the MS Society meeting isdifferent to a normal trade display as theattendees are more informed than members ofthe general public.

The fine imposed was punitive and excessive Schering takes the Code very seriously and

have never been found in breach of the Code.

The following summarises the main pointspresented by Biogen Idec representatives inresponse to the Schering appeal: The pamphlet Moving the treatment goalposts

in Multiple Sclerosis was provided in the

conference welcome bag which went to allmeeting participants. It was also freely availableon the Schering stand, with an accompanyingDVD of the same title. The pamphlet was notsimply a transcript of the panel discussion but asummary of certain points of that discussionwhich Schering elected to highlight.

Biogen considers that whilst the DVD portrays adiscussion by experts, as soon as a companytakes the expert opinions and place it on theirstand, they take responsibility for it, regardlessof who wrote it.

The generic name interferon beta-1b isreferenced on the second page of the A4Pamphlet (the first page with substantive text)to the title of the "BENEFIT" study on the backpage. "Betaferon" provides the foundation forthe anagram used to describe that trial.Therefore there is a clear link to Betaferonbrand.

Interferon beta-1b appears 25 times in thepamphlet. Schering's logo also appearsprominently on both the front and back cover ofthe DVD: an obvious link between Schering andBetaferon / interferon beta-1b.

There are two references to Betaferon by amember of the expert panel in the DVD.

The use of the generic name interferon beta-1bwas clearly an identifier for Betaferon and wasequivalent to the use of the brand name,particularly where there is only one interferonbeta-1b medicine available.

The A4 pamphlet International MS Researchand Management and the corresponding DVDof the same title were also freely available onracks on the Schering stand for conferenceparticipants to help themselves to. The DVDwas playing on the flat screen television in theSchering stand.

This brochure included a table comparing

Betaferon and Avonex, noting for all 3endpoints listed that Betaferon was stronger.

Whilst these materials are identified asproduced by the MS Society, their appearanceon the Schering stand requires that Scheringtakes responsibility for them.

The Moving the treatment Goalposts brochureand DVD found in breach were not balanced they focused on one treatment Interferonbeta-1b.


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Betaferon 826 (contd) The indication being promoted in the materials

is not approved in Australia. The material is unbalanced they do not

mention a product which is approved for earlyuse in MS Avonex for mono-focal

symptomatic MS. Educational materials for the general public

must not be promotional or containcomparative claims, as these materials do.

Biogen agrees that the statement Mostprescribed treatment in Australia is a hangingcomparative and a clear breach of Section 1.7.

Reaction of Schering's representatives wasinappropriate as they did not take immediatesteps to remove the materials from the stand.

Schering withdrew the materials after alengthy delay only to reinstate them on thestand the next day. Biogen considers that this

was a breach of Section 4.4 and 6.3. Material still appears on the Multiple Sclerosis

Australia ("MSA") website. Biogen considers it irrelevant that the MS

Society was not concerned by the material.MS Australia is not required to monitorcompliance with the Code.

Biogen Idec believes the materials to bepromotional and not educational, and focus onone product and therefore in breach ofSections 9.4, 9.5.1, 9.5.2, 9.5.6, and 9.5.7.

The materials may cause alarm for any patientwho had not been placed on therapy after thefirst event to meet the sense of urgencysuggested in the materials.

It also raises expectations beyond what isdeliverable in terms of treatment outcomesand availability of interferon beta-1b for theindication which is not approved or reimbursed

The materials stimulate demand for interferonbeta-1b 250mcg which does not have TGAapproval for this indication nor PBSreimbursement.

Biogen considers the breaches to be flagrantand bring discredit on the industry, andtherefore in breach of Section 9.8.

Materials potentially in breach of section 22(5)of the Therapeutic Goods Act 1989(advertising an unapproved indication).

Biogen considers the sanctions imposed wereappropriate, and suggested that the AppealsCommittee should impose additionalsanctions.

Consideration of the AppealThe Appeals Committee agreed that patients andcarers should be able to access reliable, balanced

and non promotional information about a specificcondition or disease. However members werecognisant that there is a difference betweencompany developed materials such as the Movingthe treatment goalposts DVD and pamphlet andinformation that is prepared and developed by ahealth consumer organisation (HCO). A HCO candevelop information on all available treatments for aparticular condition or disease and include thebrand names for the medicines. This information,whether a pamphlet, DVD or website can beprovided by the HCO to all members of theirassociation irrespective of whether they have beenprescribed a specific medicine. The Code ofConduct does not apply to the materials or activitiesof a HCO.

In contrast a pharmaceutical company cannotdevelop or distribute material that focuses on aparticular product to members of the general public.

If a patient has been prescribed a medicine theycan be provided with company producedinformation on that medicine, described as aPatient Aid under the Code, which may assist inunderstanding the particular condition or diseaseand aiding compliance. As set out in the provisionsof the Code these materials must not includecomparative statements or promotional claims.

The Committee noted that the definition of generalpublic or consumers in the Code is persons otherthan healthcare professionals. This definition isbroad and includes both a sub group of the public,

such as members of a HCO, or every member ofthe general public. Members also commented thatnot all persons registered for the MS Societyconference were patients who had been prescribedBetaferon.

The Committee discussed whether the materialshould be considered as promotional material ornon-compliant educational material. Whilstacknowledging that if it contained promotionalstatements it could not be educational material asdefined in the Code, members were of the view thatthe Code Committee had not been in error to review

them against the provisions of the Code as PatientEducation. It was noted that these provisions (eg.9.5.1, 9.5.2) reflected many of the same concernsas were covered in Section 1 of the Code (eg. 1.3,1.7) such as whether material is balanced orincludes comparative statements. The fact that thesame material, if regarded as non-complianteducational material under Section 9 might be foundnot to comply did not mean a Member was exposedto double jeopardy if consideration was also givento the material under the corresponding provisions


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Betaferon 826 (contd)of Section 1, provided this was recognised whendetermining any sanction.

Section 1.3The Appeals Committee unanimously concurredwith the Code of Conduct Committees decisionthat the materials were in breach of Section 1.3 ofthe Code as it is not permissible to promote non-approved indications for a prescription medicine tohealthcare professionals attending an Australiancongress, and it is not permissible to providepromotional information to members of the generalpublic and particularly not to promote non-approved indications.

Section 1.7Following discussion on the definitions forhanging comparison and superlatives the

Appeals Committee did not uphold the appeal in

relation to a breach of Section 1.7 for the use of10 years of the most prescribed MS treatment in

Australia. The Committee agreed that mostprescribed is ambiguous and could be interpretedin several ways.

Section 4.4The Committee discussed at length who hasresponsibility for materials that are distributed at atrade display. Members were of the view thatwhile having knowledge of the Code, medicalrepresentatives would not have the authority toremove items that had been approved by senior

company staff. The Committee acknowledged thatthere was a disparity between the complainantand respondent on the length of time taken torespond to Biogens concerns and the behaviourof company representatives at the conference.The Committee did not consider that there was abreach of Section 4.4 of the Code.

The Committee upheld the appeal by Schering inrelation to the breach of Section 4.4 of the Code.

The Committee was of the view that Section 6.3was more relevant to the activities of all company

representatives, including senior management,and may have upheld a finding of a breach inrelation to this section of the Code. However, asthe Code of Conduct Committee had elected tofind no breach of Section 6.3, the Committee didnot take this into consideration when determiningthe sanction.

Section 6.4The Committee did not uphold the appeal inrelation to Section 6.4 as members were of the

view that it is the responsibility of a pharmaceuticalcompany to ensure that all materials that theyproduce or distribute from their trade display arecompliant with the Code and can withstand publicscrutiny and are intended to support the quality useof medicines.

Sections 9.4, 9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7Having previously discussed whether the materialswere promotional material or non compliant patienteducation, members agreed that as Schering hadargued that the intent was educational the AppealsCommittee considered that the materials did notcomply with the requirements for educationalmaterials and therefore did not uphold the Schering

Appeal in relation to Sections 9.4, 9.5, 9.5.1, 9.5.2,9.5.6, 9.5.7.

The Committee did not accept Scherings argumentthat the materials were not broadcast to the general

public. The definition of general public doesntmean all members of the public have to be exposedto the material. Also, even if the sub-group ofpatients is well-informed, a company may notpromote a particular medicine to them.

As set out in the minutes of the Code of ConductCommittee meeting members concurred that theinformation brochure and DVD Moving thetreatment goalposts were: Promoting a prescription medicine to the

general public; Promoting a non-approved indication;

Not balanced; and Non-compliant as patient educational material

due to the focus on a single treatment and werepromotional.

Members also noted that the materials may: Cause unnecessary alarm or misunderstanding

in the community as the indication was notapproved in Australia, not available on the PBSand therefore costly to a patient. The materialmay raise expectations beyond what isdeliverable in terms of treatment outcomes andavailability of the medicine.

Also cause alarm to a newly diagnosed patientwho may expect immediate access to the newtreatment but may have to wait up to 6 monthsto see a neurologist.

Section 9.8The Committee did not uphold the Schering appealin relation to the breach of bringing the industry intodisrepute as the Therapeutic Goods Act and theCode clearly state that prescription medicines mustnot be promoted to the general public. In addition


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Betaferon 826 (contd)non-approved indications must not be promoted tohealthcare professionals or members of thegeneral public.

The provision of promotional material to membersof the general public is seen as an activity thatwould bring discredit upon the industry or reduceconfidence in the industry and is treated as asevere breach.

SanctionsHaving not upheld all but one aspect of the appealthe Committee then reviewed the sanctionsi

Code Conduct Annual Report 2007

Documents

Transcript of Code Conduct Annual Report 2007