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

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

Background to 3 rd 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

Headline news Law on ties between surgeons, device makers insufficientLaw 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 makersGroup calls for ethical conduct plan for Australian device makers

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

Dealings with healthcare practitioners Definitions – Healthcare Practitioner –Other Professional Member-sponsored training and education Third party educational conferences –Member-sponsored symposia –Hospitality

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

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

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

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

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