It is not a secret anymore, many in the industry now know that Health Canada is working on a new version of the policy entitled: The Distinction Between Advertising and Other Activities, dated more than 20 years ago. Earlier this week, Health Canada provided some insights about the reformed policy and offered target timelines for publication and entry into force.
The new Distinction Policy should be published in a draft format before the end of this month, in late June 2019. Publication of the draft will be followed by a 90-day consultation period during which stakeholders will be invited to submit comments and questions.
The pharmaceutical industry recognizes the importance of the Distinction Policy, which effectively forms the backbone of Health Canada's interpretation of Canadian drug advertising restrictions. Due to the prominence of this policy and the anticipated impact of the reform, Health Canada assured that the consultation period would be followed by a session, likely in the form of a webinar, during which the regulator would explain the outcomes of its consultation. We anticipate that this session should be held around November 2019.
Following the aforementioned timelines, Health Canada expects the new Distinction Policy to be adopted and made effective in early December 2019.
At this time, Health Canada remains discreet. They did however offer some insight regarding the contents of the new policy earlier this week:
First, the current Distinction Policy dated 1996 is considered outdated, because of the numerous technological developments since the early 00's. The new Distinction Policy will be more focused on current communication tools. The use of the Internet and more particularly social media platforms will be central in the next policy.
Second, the Distinction Policy will better align with the legislation and regulations that came into force over the course of the last decade. By way of example, we know that a condition for a non-promotional help-seeking message under the current policy is that no manufacturer's name be included. This regulatory requirement is inconsistent with Canada's Anti-Spam Law, which expressly requires that the name of the person seeking to send commercial electronic messages be included in any request for consent. The next Distinction Policy will address these types of legal inconsistencies.
Finally, Health Canada announced that its new policy would provide more clarity on Other Learning Events (OLAs), with the intent to ensure these events remain truly non-promotional. The next Distinction Policy will clarify Health Canada's position regarding the responsibilities of the industry with respect to OLAs, including any involvement sponsors may have with the conference materials developed by healthcare professionals.
Given Health Canada's announcements and the insights provided earlier this week, pharmaceutical companies, drug advertising consultants and other stakeholders should get ready for the publication of the draft version of the new Distinction Policy in late June 2019. Those who want to offer comments or ask questions during the 90-day consultation period may be glad to hear that Health Canada will follow-up with a session to explain the outcomes of its consultation prior to entry into force of the new Distinction Policy. Following entry into force, stakeholders may also want to consider reviewing their promotional and non-promotional strategies for compliance.