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November 24, 2010
Last month, I posted an article about the removal of the MSWatch.ca online forums. Many people around the world responded to me stating that they felt it was the MS patients who had lost the most from this changed website. I agreed. On Monday November 15 2010, I was delighted to receive another e-mail from MSWatch.ca, this time welcoming me to the new MSWatch Oasis:
|Tell your friends:|
|Keep track of your treatments and help manage your appointments in a fun and engaging way.|
|Perch in the tree where you can find resources in the birdhouses and check in on fellow Oasis members.|
|Chirp others in the tree and check in on your buddies.|
|Earn badges just by keeping up with appointmens and therapy.|
|Update your profile to connect with others in the MS community. Add links to your Facebook, Twitter, blog and website.|
|Join in to help manage your treatments, connect with other patients and caregivers, and access learning resources and helpful tools. Help build a world of understand and support.|
January 21, 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. ------------------------------------------ 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.
- 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.
- 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
- 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).
- 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
- 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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