607 - Does a HCP-directed website for a Schedule D vaccine need to be gated?

  • The fact that the vaccine (Schedule D) website is intended for HCP’s does not, in and of itself, trigger the requirement for gating (BUT it does trigger the requirement for PAAB preclearance). The piece would require review under the PAAB code for HCP advertising with the consumer as a secondary audience. In addition to being clear that HCP’s are the intended audience, this also means that it would also be reviewed under the Health Canada Therapeutic Comparative Advertising: Directive and Guidance document and the Policy: Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products. Some changes may be required to the HCP messaging to address the consumer regulations. One example would be that therapeutic claims in the consumer realm require the support of two separate RCTs. This will likely mean the removal of the therapeutic comparisons in the piece (even if they were previously approved in HCP advertising). The alternative, of course, would be to add a gate.