Medicines Australia Code of Conduct

1. Medicines AustraliaCode of Conduct Heather Jones Manager, Code of Conduct 22 April 2010

2. Overview • Medicines Australia • Code of Conduct • What’s new in the Code? • Code Guidelines • Educational Event Reporting • Q & A

5. First edition 1960 –12 pages Celebrating 50 years of the industry Code of Conduct Edition 16 – 160 pages Code reviewed every 3 years Adherence to the Code is a condition of marketing approval by the TGA

6. Scope of the Code Relations with General Public Relations with HCOs Relations with HCPs Senior Management Advisory Boards & Consultants Education Events ACCC Reporting Clinical Research External Affairs Standards of conduct for marketing prescription medicines Good clinical practice Hospitality & Travel Sponsorship, grants & financial support Man, GMP, TG Regs, Labelling Transparency Disclosure Government Relations

7. Themes and trends - external • Level playing field – ongoing discussion with Government • Self-regulation • Level of fines – but accepted by ACCC • Greater transparency – ACCC directions for the future

8. Transparency ACCC 5.138 The ACCC considers public reporting and transparency around the relationships between pharmaceutical companies and healthcare professionals is important for the Code’s effectiveness. The ACCC encourages Medicines Australia, in consultation with industry, to explore further avenues for increasing transparency in other areas of the Code, such as sponsorship of healthcare professionals by pharmaceutical companies to attend educational events.

9. Promotional Material • Level of substantiating data • False and misleading claims • Qualifying statements • Comparative statements • Applies to print, websites, audiovisual and social media

10. Promotional Material

11. Prescribing software • No advertisements for prescription medicines in prescribing software • May provide education, information for the general public or health professionals

12. Brand name reminders & company branded items

13. Brand Name Reminders – must be relevant to the practice of medicine or pharmacy • Intention remain within the practice • < $20 • May include brand name & company name • Medical education< $20 (eg USBs) can be product branded • Company brand items – medical education • > $20 • Must include company name – no product branding

14. Pens, notepads, bags & lanyards • Company name/division only

16. Information for healthcare professionals which include pharmaceutical company advertising must be password protected

17. Relationship with HCPs • Section 9 • Company educational events • Sponsored educational events • Trade displays • Sponsorship of individual HCPs to attend educational events • Consulting arrangements • Advisory Boards • Company supported medical practice activities • Grants and financial support • Gifts and offers • Discredit to the industry

18. Sponsorship of Healthcare Professionals to attend Educational Events Food & Beverages Accommodation $ & Nights $ Agreement Travel Economy – AUS Economy/Business - INT Partners & Family Reporting Other healthcare professionals

19. Sponsorship of Educational Events Education Content Venues Conducive to education – no banned list Travel Partners & Family Economy Food & Beverages Accommodation $ $& Nights

20. Reporting Educational Events Edition16 April – September by 30 October October – March by 30 April

21. Gifts and offers • No gift, benefit in kind or pecuniary advantage shall be offered or given to healthcare professionals or to administrative staff as an inducement to recommend, prescribe, dispense or administer a company’s product.

22. Requests from practices • A practice cannot ask for or demand that a representative provide meals for all members of the practice or that food be purchased from a specific venue – hospitality can only be provided in association with education • A practice cannot ask for or demand gifts (financial or in-kind) from a representative or company for access to the practice – companies cannot provide gifts

23. Relationship with the General Public Blogs, twitter, facebook, YouTube Websites Disease education activities Media releases

24. Relationship with HCOs & Patients Patient aids – branded if used within the home Transparent Ethical Patient Support Programs Enhance compliance – no rewards

25. Social Media – must comply with the Therapeutic Goods Act (illegal to advertise prescription medicines to the general public)

26. Complaints process • Complaints accepted from any individual, organisation or company • Will not accept anonymous complaints but can with hold the name of the complainant from the company • Complaints considered by the Code of Conduct Committee – chaired by trade practices lawyer, 3 GPs (AGPN, AMA, RACGP), 1 physician (RACP), pharmacologist, consumer + TGA

27. Fines

28. Where does the fine money go? • Management of the code processes – no fee to lodge a complaint, obtain copies of the Code, staff to present at any meeting or conference free of charge, complaints process (Code Committee members are paid for their time, Committee meeting venues), publications etc • Any funds remaining at the end of each financial year is placed in a special purpose fund • Currently funding the building of a mobile dialysis unit for the western desert in the NT, healthy foods program in indigenous communities in the Top End and scholarships for indigenous students to attend medical school

29. Need Assistance? Heather Jones heather.jones@medicinesaustralia.com.au 02 6122 8590 Deborah Monk deborah.monk@medicinesaustralia.com.au 02 9415 2244