Guidance
Code Info Sessions
Notes from the Help Desk
5:42 How is scientific exchange defined?
12:49 In what contexts is scientific change appropriate?
25:58 Internal scientific congresses
40:14 Sharing materials
47:22 Pipeline development
51:34 Clinical trials
Legitimate scientific exchange between appropriate Company personnel and healthcare professionals, the scientific community and other relevant stakeholders (such as payors, government officials) must be for the purposes of enhancing scientific understanding, improving patient care, improving access to medicines (including compassionate access), supporting quality use of medicines or assisting research and/or stakeholder budgetary planning.
The intent of such activities must be non-promotional with a focus on exchange being two-way communication.
- It is reasonable where healthcare professionals or other relevant stakeholders are seeking clarity and/or additional information on products not approved in Australia and/or subjects not covered in the Australian Product Information, for Companies to provide such information.
- It is reasonable for Companies to anticipate the needs of appropriate stakeholders for scientific and medical information. Such information/material must only be provided or made available to those stakeholders whose need for or interest in can reasonably be assumed for the conduct of their role. Material should be tailored to the audience to whom it is directed.
- The Company Medical Department may engage in scientific exchange regarding unregistered products, uses or other off label topics. In some instances, non-promotional roles, such as market access, regulatory affairs, may be permitted to engage in Scientific Exchange. Such exchange must be non-promotional in intent, content and nature and must be distinguished from promotional activities.1 2 3
- Scientific Exchange activities must be overseen by the Company Medical Director or their delegate.4
- Any information relating to unregistered products or off label topics must be clearly identified as such and must meet the requirements of this Code. Such materials must be approved by the Company Medical Director or their delegate.
- In digital medical information applications, it is appropriate to provide healthcare professionals with information on unapproved products and uses when this information is only viewable after the healthcare professional executes a search that includes specific search terms relating to the unapproved product or use.