China Ethical Promotion

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China Ethical Promotion History, Trends and
Challenges Jeff Schultz, Managing Director,
RDPAC RD-Based Pharmaceutical Industry
Association of China
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• Agenda
• Why a China Code? Why MRC?
• Overview
• Looking Ahead

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• The Underlying Agenda
• Raise the ethical bar for members and the broader
  industry
• Distinguish the RD-based industry as an ethical
  leader
• Enhance communications with key domestic
  stakeholders

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• Why MR Certification?
• Concept first introduced in China by
  multinational pharma companies in 1980s
• Industrys response to
• Extremely negative MR image
• MR corruption blamed as major factor in overall
  healthcare malaise
• Banning of MRs from some hospitals in many cities
  in 2007
• Industry recognition that
• Staggering unmet medical needs in China call for
  more professional MRs
• The government be forced to step in as regulator
• MR professionalism must be enhanced to protect
  the image of the entire pharma industry

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• Why Now?
• China saw its first MRs in early 1980s
• Swing from tight market regulation to Wild West
  environment in 1990s
• Fierce competition led to growth of low margin
  generics, counterfeiting
• Recent highly publicized kickback scandals led to
  strong government response by 2006
• Code and MRC Program launched in midst of
  anti-commercial bribery campaign of 2006
• Accelerated international trend toward
  self-regulation coincided with local regulatory
  push
• Innovation gaining traction among Chinese
  priorities Self-regulation and innovation two
  sides of same coin

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Evolution of Chinas Code

• First edition, 1999
• Second edition, 2002
• IFPMA model
• Third edition, 2006
• Following IFPMA revision
• Specific limits (Att. 1 Standards of
  Promotional Practice)
• Increased transparency (Att. 2 Complaints and
  dispute resolution)
• Issued in parallel with rollout of MR
  certification program
• Active participation in CCN
• Regular Coordinator meetings

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Objectives

• Facilitate the understanding of the role of MR
  of the RD pharma industry, the spirit and
  principle of the Code, and the high ethical
  standards required for the promotion of
  innovative medicines
• Refresh basic medical and pharmaceutical
  expertise, knowledge of the functioning of
  medical system and pharmaceutical industry in
  China
• Enhance the ethical marketing practice to the
  entire pharma industry of China RAISE THE BAR

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Timeline
Over 7,400 were tested by end of Dec, 2007 In
12 cities in China More members Participation (26
/39)
Medical School of Beijing Univ
Dec. 2006 171/181 Passed In Beijing only
Jan 2006 39/45 pass
Training Materials Drafting
Small Scale Trial
Full Roll Out

• Project WG
• Expert Committee
• Professional Authors

• - Survey of MRC in other countries
• U.K
• Japan
• Hong Kong
• Set up RDPAC Project
• Framework

1st Certificate Issuing Ceremony In 2007
Training manuals revised and test Qs expanded
Beijing
Need govt endorsement
Test on Computer

• In 2008 to certify 10,000 MRs
• Objective complete tests in 2007 2008 (2
  years)

• Materials revised
• Rules on MRC Standards
• Rules on MRC Tests

2005
2003
2008
2004
2006
2007
Now
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First MRC Training Manual (2005)

• Chapter One Overview of China Medicine and
  Health
• Chapter Two Composition and Status Quo of China
  Medical Institutions
• Chapter Three Overview of China
  Pharmaceutical Industry
• Chapter Four Code of Conduct of Drug Promotion
  and New Laws and Regulations on Medicines
  since 2003
• Chapter Five Description of Human Body
• Chapter Six Pathogen and Protection Mechanism
• Chapter Seven Pharmacology Appendix to
  Chapter Seven Clinic Pharmacology
• Chapter Eight Circulatory System
• Chapter Nine Respiratory System

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• Chapter Ten Nervous System
• Chapter Eleven Digestive System
• Chapter Twelve Skeleton and Muscle Systems
• Chapter Thirteen Incretion Metabolism System
• Chapter Fourteen Urinary System
• Chapter Fifteen Reproductive System
• Appendix Anatomy and Physiology of Female
  Reproductive System
• Chapter Sixteen Skin
• Chapter Seventeen Special Sense Organs

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Roll-out to all members in July, 2007

• Over 7,400 MRs were tested by end of 2007
• Over 3,600 participated in tutorials
• Test and tutorials organized in 12 cities cross
  China
• 26 out of 38 members have a concrete MRC plan

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• Test Participants

• Astellas
• AZ
• BI
• BMS
• CSL Biotherapies
• GSK
• Ipsen
• Lilly
• MSD
• Novartis

• Novo Nordisk
• Pfizer
• Roche,
• Sankyo
• Sanofi- Aventis
• Schwarz ()
• Schering Plough
• Servier
• Solvay
• Wyeth

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Pre-test Tutorial Participants

• Novo-Nordisk
• Pfizer
• Roche
• Sankyo
• Sanofi-Aventis
• ScheringPlough
• Schwarz
• Servier
• Solvay
• Wyeth
• Xian-Janssen

• Astellas
• AZ
• Bayer
• BI
• BMS
• CSL Biotherapies
• GSK
• Ipsen
• Lilly
• MSD

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Training Manual Purchasers

• Novo-Nordisk
• Pfizer
• Roche
• Sankyo
• Sanofi-Aventis
• ScheringPlough
• Schwarz
• Servier
• Solvay
• Takeda
• UCB
• Wyeth
• Xian-Janssen

• Altana
• Astellas
• AZ
• Bayer
• BI
• BMS
• CSL Biotherapies
• Daiichi
• GSK
• Ipsen
• Lilly
• Merck KgaA
• MSD

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2008 Plan

• Train and certify additional 10,000 MRs
• Broaden stakeholder endorsement
• Continue to share with domestic industrywithout
  proselytizing or building out program beyond
• Joint Self-Discipline event planned with
  Doctors Assn, Hospital Assn, China Pharma
  Industry Assn

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• Test Venues ( Dec 2007)

• Beijing
• Shanghai
• Guangzhou
• Hangzhou
• Changsha
• Nanjing

• Chengdu
• Shenyang
• Wuhan
• Jinan
• Xian
• Fuzhou

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Cooperation with the Domestic Industry

• Nanjing, Zhejiang, Guangdong have selectively
  emulated the RDPAC concept, materials and
  methodology with our encouragement
• Units of local Bureaus of Labour and Social
  Security have taken lead
• Similar though not identical approaches
• Self-regulation concept continues to spread in
  China

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Early Learnings

• Pilots and clear feedback critical. Steering
  Committee and expert panel critically important
• Training cannot be rushed planning is all
• Need to accommodate members with varied
  capabilities, resources for training, compliance
• Train the trainer works for many, outside
  resources very helpful
• Value in combining MRC and company training
• Having a program is not enough need to
  communicate the value to all relevant
  stakeholders in a systematic way.

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Issues for 2008

• Calibrating test difficulty striking a balance
• Compliance adding teeth
• Paper SOP reviews at company level?
• Surprise audits?
• Escalating levels of enforcement
• Interpretation of no stand-alone entertainment
  in the Chinese context

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Issues for 2008

• Standardization of service fees based on
  authentic service contract, reasonable service
  fees ( IFPMA Code Art. 1.3)
• Extend the spirit of the code of financial
  management practices
• Logistical issues

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• THANK YOU