Medical Device Compliance Congress:

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• Medical Device Compliance Congress
• Global Device Codes Roundtable - Australia
• Anne Trimmer

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Agenda

• Background to 3rd Edition
• Advertising and claims
• Dealings with healthcare professionals
• Company representatives
• Complaints
• Code monitoring

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Background to 3rd Edition

• Initial implementation 2 years ago
• First complaint and appeal
• Language issues
• Increased compliance focus globally
• Inconsistencies with AdvaMed Code and many member
  internal codes

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Headline news

• Law on ties between surgeons, device makers
  insufficient
• Kickback claims being taken 'very seriously'
• Hip bones and hip pockets
• Group calls for ethical conduct plan for
  Australian device makers

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Advertising 3 tiers

• Regulation
• Therapeutic Goods Act and Regulations, Trade
  Practices Act
• Co-Regulation
• Therapeutic Goods Advertising Code
• Self-regulation
• Company codes
• Voluntary industry codes
• MTAA/MIANZ Code

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Dealings with healthcare practitioners

• Definitions
• Healthcare Practitioner
• Other Professional
• Member-sponsored training and education
• Third party educational conferences
• Member-sponsored symposia
• Hospitality

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Dealings with healthcare practitioners

• Hospitality and gifts
• Consultancy arrangements
• Donations and philanthropic gifts
• Competitions for healthcare practitioners
• Market research

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Company representatives

• Requirement for ethical conduct
• Not compromise professional independence of
  healthcare practitioner
• Compliance with institutional standards, codes
  and laws
• Requirement for every representative within 6
  months and 3 year refresher
• Training must be approved by MTAA

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Code complaints

• Strengthened committee structure for complaints
  and appeals
• Panel of 12 and independent chair
• Healthcare practitioners
• Institutions
• Consumer representatives
• Industry

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Code complaints

• Complaints from industry and non-industry
• Industry must first raise with other member
• Complaints committee may call on expert
  assistance
• Breaches range from minor to serial
• Maximum fine of 75,000
• Power to notify regulator

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Code monitoring

• In addition to complaints process
• Proactive monitoring may call for material
• Independent chair
• May call for material or outline of activity

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