Canadian Pharma/Healthcare Regulatory Guideline Revisions – Jan 2010

Love them or hate them, as a medical marketer, you have a ton of regulatory guidelines to follow.  And they seem to change on a regular basis (some guidelines change more frequently than others).  In this blog post, you will find a list of some of the Canadian healthcare guidelines with links that will lead you to the document(s) of interest. The only revisions that took place in January 2010 are in the Rx&D code (see below for details of these changes).  A few other revisions for other sets of guidelines are expected over the next couple of months.  Although the details on the other revisions have not been shared with me, I made a note of when the revisions are expected to take place.

NOTE: If you have marketing collaterals or campaigns that need pre-clearance, but you are not sure which regulatory body to contact, take a look at yesterday’s post; Algorithm on choosing the appropriate Canadian healthcare regulatory guidelines.

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New 2010 Rx&D Code of Ethical Practices (not yet posted on the Rx&D website, but coming soon). Here’s a peak at the upcoming changes.  Only section 15 has been revised in the 2010 code:

Section 15.4 Penalties

• In 2009, the 1st, 2nd and 3rd code infractions were published in the Rx&D Update.  As of 2010, these infractions will be published on the Rx&D website.  All postings will remain on the website for 24 months from the date of the final decision.

New section 15.4.1 Compliance Statement (3 statements as part of this new section)

• Within ninety (90) days of the final decision date with respect to any Code infraction, the Member must clearly indicate in writing to Rx&D that they have halted the activity or otherwise addressed the issue that caused the infraction. A copy of this compliance statement will be posted on the Rx&D website with the relevant decision of the IPRC.

• In the event that Rx&D determines that the Member has not complied with this requirement, the Member will be deemed to have deliberately contravened one of the Guiding Principles, and the penalties set out in Section 15.3, 15.5.1 and 15.5.2 will apply.

• In exceptional circumstances, a Member, acting in good faith, may believe that more than ninety (90) days will be required to comply with this Section 15.4.1. In this case, the Member must file a written extension request with Rx&D within ten (10) days of the decision date, providing a detailed supporting rationale for the request, and an estimate of the time required. Rx&D will forward the extension request to the IPRC who will evaluate the extension request and make a recommendation to the Rx&D Executive Committee (EC) within ten (10) days of its receipt. The EC, in its sole discretion, may elect to grant such an extension to the Member.

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Pharmaceutical Advertising Advisory Board (PAAB)

• Several supplementary guidelines to the PAAB code exist.  A recent example; “Guidance for Advertising/Promotional Systems (APS) Which Are Openly Visible in Healthcare Professional (HCP) – Patient Interaction Areas”
• Recently, PAAB has implemented the Health Canada document Interim Guidance on Fair Balance in Direct-to-Consumer Advertising of Vaccines
• You might also want to look at the PMCQ website for a list 100+ PAAB FAQs.
• No changes in the PAAB code.
• No changes in prescription DTCA guidelines
  

Canadian Association of Medical Publishers
It does not appear as though any new guidelines have been posted, since at the bottom of the CAMP advertising guidelines page, the last update appears to have been on May 11 2009.

MEDEC-Canada’s Medical Technology Companies
Revisions scheduled for March 2010.

Consumer Health Products Canada (previously NDMAC)
No changes, but expect some to come once their new website (along with new organizational name) gets launched within the next month or so.

Advertising Standards Canada (ASC)

• Any change in ASC guidelines would be from a result of changes with the Health Canada documents.  Since there have been no changes for the Health Canada documents, there have not been any changes for the ‘Consumer Drug Advertising Clearance’ documents of either the Prescription drugs or the Non-prescription / Natural health products (see the two boxes on the left of the ASC screen which allow you to choose the documents required based on the product type).

Health Canada’s documents regarding direct-to-consumer (DTC) advertising of prescription drugs

• Note that both PAAB and the ASC can provide an advisory opinion on DTC collaterals and campaigns.
• No changes for any of the following documents.

• The Distinction Between Advertising and Other Activities
• Advertising Campaigns of Branded and Un-branded Messages
• Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers

Health Canada’s documents regarding direct-to-consumer (DTC) advertising of non-prescription drugs

• ASC and MIJO can provide preclearance services with respect to consumer advertising of non-prescription drugs and natural health products.
• No changes for any of the following documents.

• Consumer Advertising Guidelines for Marketed Health Products (for non-prescription drugs, including natural health products)
• Therapeutic Comparative Advertising: Directive and Guidance Document
• Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products

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Note that I am not a pharmaceutical regulatory expert.  I am providing these resources as a service to my blog’s readers.  If you have specific regulatory questions, please contact the appropriate organization.

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Natalie

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