The IVD Australia Code of Conduct Edition 2.1

What is the IVD Australia Code of Conduct? The Code promotes ethical and responsible business conduct for Members within the in vitro diagnostics sector of the healthcare industry The Code covers aspects of advertising, marketing and promotion of in vitro diagnostics. The IVD Australia Code of Conduct provides the ethical framework for the interaction between Members, Healthcare Professionals and others in a position to influence purchasing decisions. The 2nd edition of the Code was approved by members in 2013. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 2 of 14

Why do we need a Code of Conduct? The Code ensures high standards and integrity of behaviour across the in vitro diagnostics Industry. This enables Consumers and Healthcare Professionals to have confidence in the integrity of the in vitro diagnostics Industry and its wide range of products. The purpose of the IVD Australia Code of Conduct is to ensure high standards and integrity of behaviour across the IVD industry and enhance the Industry’s reputation. This enables both Consumers and Healthcare Professionals to have confidence in the integrity of the industry and its wide range of products. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 3 of 14

Over the past couple of years there has been an increased global media focus on the activities of the medical technology Industry, of which the IVD industry is a part. As an industry, we are concerned to demonstrate our commitment to ethical standards Over the past couple of years there has been an increased global media focus on the activities of the medical technology Industry, of which the IVD industry is a part. As an industry, we are concerned to demonstrate our commitment to ethical standards. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 4 of 14

Do we have to abide by the Code of Conduct? The Code is compulsory for all IVD Australia Members. All Member Companies must ensure that their Company Representatives understand & abide by the Code Some Member Companies have corporate Codes that may contain stricter requirements than the IVD Australia Code. Where there is conflict, the stricter Code applies. The Code does not take precedence over any law. If there is a conflict between the Code and a law, the law takes precedence. The Code is compulsory for IVD Australia members. Companies in Australia that are not IVD Australia members, but which are engaged in the Industry and accept the importance of ethical standards are encouraged to accept and observe the Code. IVD Australia supports the adoption of the Code as a mandatory requirement for licensing an IVD product in Australia. The Code does not take precedence over any law. If there is a conflict between the Code and a law, the law takes precedence. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 5 of 14

<Company> Advertising and Marketing Approval Mechanisms Insert your company’s approval mechanisms here Each Member Company should have mechanisms in place to ensure compliance with the Code, e.g. by requiring approval to be obtained before offering hospitality to a healthcare professional. Outline your company’s approval mechanisms on this slide. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 6 of 14

Interactions with Healthcare Professionals 7.1 Product Education, Demonstration and Training 7.2 Hospitality 7.3 Third Party Conferences 7.4 Sales and Promotional Meetings 7.5 Consulting Agreements 7.6 Gifts 7.7 Donations & Grants 7.8 Advertising and Promotion 7.9 Company Commissioned Articles (CCA) 7.10 Competitions 7.11 Market Research Those company personnel who have direct contact with healthcare professionals must read and become familiar with the relevant sections of the Code. This slide lists the main types of interactions with healthcare professionals that are covered by the Code. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 7 of 14

HOSPITALITY You may only provide hospitality to Healthcare Professionals in conjunction with the provision of training or education or in support of a third-party educational conference. The hospitality should be limited to those who actually participated in the meeting, be modest in nature and not include entertainment. You must not pay for travel or accommodation for a spouse, partner or guest of such Healthcare Professional, or for any other person who does not have a bona fide professional interest in the information being provided during the training. The areas covered in the next few slides have been selected as those in which company representatives are most likely to be engaged. Please note that this is not a complete coverage of all sections of the Code. All company representatives are required to abide by the Code in its entirety. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 8 of 14

THIRD PARTY CONFERENCES Members may provide support to the conference organisers to cover: Reasonable travel & accommodation expenses of healthcare professionals, medical /scientific professionals in training, faculty members etc. Hospitality – Members may provide financial support to the conference organisers in the form of payment for meals and hospitality for attendees. Providing that: The conference is primarily dedicated to objective medical & scientific educational activities The conference organisers control the program content, AND The nature of the support is fully documented and acknowledged in the Conference proceedings IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 9 of 14

SALES & PROMOTIONAL MEETINGS Such meetings should be held at a training facility, medical institution, laboratory, or other appropriate facility. You may pay for modest hospitality for attendees. You may pay for reasonable travel costs You may not pay for a Healthcare Professional’s partner or guest IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 10 of 14

GIFTS You may give a gift to a healthcare professional if it is modest in value and of an educational nature. Company or branded promotional items are allowed if they are of minimal value (eg Pens) You may not give a gift to a Healthcare Professional if it can be used for non-educational activities (e.g. iPad). These items may be given to a Healthcare Professional’s Department, but conditions apply (7.6c) IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 11 of 14

Help is available … The CEO of IVD Australia can provide Member Companies with guidance & interpretation of the Code in relation to particular situations, with the advice of the Code Administration Committee (CAC) The CAC will provide guidance documents to members The CAC can refer matters of concern to the Complaints Committee IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 12 of 14

Tell your customers about the IVD Australia Code Guide to the Code of Conduct For you to distribute to explain the Code and its restrictions to your customers Available online Print copies available from IVD Australia A copy of the Guide is available in your Code pack. Multiple copies are available from IVD Australia Note that this document can be very useful in explaining to customers why your company is unable to support a particular activity (eg golf day) IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 13 of 14

Resources The Code can be accessed from the IVD Australia website www.ivd.org.au To download a copy of the Code, you can click the Code of Conduct tab under ABOUT US where you will find the latest edition along with a number of other support materials, or click on QUICK CLICKS on the Home Page. IVD Australia Code of Conduct Edition 2.1 – Training Presentation Version 20170104.1 Slide 14 of 14