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What do you mean? You may ask.
As I alluded to in my previous blog post, “Part Two – The Power of the Product Monograph,” inheriting global marketing materials to adapt for the Canadian market can often be challenging.
In theory, it should be an easy enough task, since everything is already written and referenced. Then, you uncover what lies beneath, when you download all the references, examine the types of references, and read the excerpts that are used by the global marketing agency to substantiate a claim.
How bad can it be?
To fully understand our challenges, you must first understand the rigid parameters within which we have to play in.
Any promotional material meant to influence a healthcare professional with the purpose of increasing the sale of a health product should adhere to the principles set out by the Pharmaceutical Advertising Advisory Board (PAAB) in the PAAB code.
What does the PAAB code say about references?
You can find a complete list of criteria in PAAB code section 3, Making Statements: Claims, Quotes & References.
To summarize:
- Brand claims must be consistent with the Canadian product monograph (Section 3.1) (see Part Two Blog)
- Any direct or indirect product claims and/or quotes from scientific literature must include complete listing of scientific references (Section 3.1)
- Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated (Section 3.1.1)
This means the following are not regarded as high level of evidence to support clinical or therapeutic claims:
- Review articles
- Pooled data
- Meta-analyses
- Post-hoc analyses
- Conference abstracts, posters, or presentations
Also, consensus guidelines can only be used to support product claims relating to place in therapy and claims of special status. For example, “Product X is recommended as first-line therapy for the treatment of disease ABC.” Guidelines, however, may not be used to support efficacy or safety claims, either directly or indirectly.
Furthermore, published consensus guidelines have a hierarchy (see PAAB Medical Opinion & Practice guidance document). Canadian consensus guidelines first, U.S. guidelines only if no Canadian consensus guidelines exist, and international guidelines only if recognized or endorsed by a Canadian authoritative medical body as evidenced by a letter on official Canadian authoritative medical body letterhead.
So, this is what our expertise tells us…
When we adapt global pieces to the Canadian market, we often have to omit large sections of content because unacceptable reference types were used. Often, we are also required to invest substantial time into conducting literature searches to re-write these sections using PAAB-approvable references. Occasionally there are even excerpts used to support global claims that feel like a bit of a stretch. Not only would they not be PAAB-approvable, but they would also not meet our own standards for scientific integrity and rigour.
Sometimes we muse that it may be faster just to start from scratch than to retrofit PAAB-approvable content to the originally intended global messaging.
In the end, how can we work together with our clients to make the process of adapting global pieces a smoother journey?
- Master the rules: remember that branded Canadian promotional materials will almost always be different from global pieces, but understanding the rules means we can craft the most compelling story within the Canadian parameters
- Audit global content early: to identify potentially challenging claims and associated references
- Partner with medical experts early: whether internal or external (eg, HCPs) to help with sourcing high-quality references to support promotional claims
- Be patient with the PAAB process: negotiations will often require a lot of give and take depending on the claim and the quality of evidence
Would you like to hear more above and beyond marketing insights?
We would be more than happy to connect. Share with us your questions/comments.