Code of Conduct - Question & Answers

11. Service Oriented Items - January 2006

Question 1:
Has Rx&D provided any guidance on the monetary value of appropriate Service-Oriented Items?

Response:
Rx&D believes that the monetary value of appropriate Service Oriented Items (SOI) is relevant to the determination of what constitutes an appropriate SOI, but this consideration is secondary to it's underline purpose. All SOI irrespective of monetary value must conform to requirements that are set out in Section 11.2 regarding their primary goal.

Question 2:
We would greatly appreciate if you could confirm our following interpretation. In the context of pre and post-registration clinical studies, is has been demonstrated that it is acceptable to provide to patients material (such as magnet with next appointment information or a scheduler) to support the conduct of the study. The distribution of this type of material is not at all intended to promote any products, but on the contrary, support the proper execution of the study.

If yes, we would also obtain a confirmation that these items (and again, only those that are demonstrated to support the proper execution of the study) can bear the study logo? (provided that the study logo has no direct relationship to the Company logo or product logo)

Similarly, the material provided to the participants at the investigator's meeting (i.e. protocol, patients' binders) is packaged in a plastic briefcase. Can the briefcase bear the logo of the study?

Response:
The current version of the Code only addresses post-registration studies i.e. post NOC where brand names can pose some advertising issues given that the products may be commercialized. From a Code perspective, pre-registration studies widely differ in that they may not benefit from any commercial efforts while abiding to a number of federal/provincial legislation and regulations.

That being said, it is up to the member company to decide if a current program, or supportive study material, is in line with both the Guiding Principles and the various Code sections.