Key Topic 3: Promotional or Non Promotional
It is important to be able to distinguish whether the type of asset and the planned use are promotional or non-‐promotional, as this will affect the way the rules apply to them. This is usually obvious, but sometimes an asset can be one or the other, depending on how it is to be used and who is going to use it. In addition, the impression created by the asset or associated activities can influence whether it is deemed promotional or not.
As a general rule, any activity conducted or attended by, or an asset utilized by sales personnel should be viewed as promotional.
In many cases when you have applied the principles relating to defining what you are reviewing
(Key Topic 1) the answer will be clear.
However in some cases it will be a matter of judgment so it is worth exploring the case studies and examples in this section to get an idea of the concepts.
One of the risks of getting this judgment wrong is the accusation of disguised promotion.
Consider these examples
ARIMIDEX mailing
AstraZeneca UK sent an approved promotional mailing about the 10th anniversary of ARIMIDEX to health professionals in the UK. The envelope containing the mailing resembled this image:
The flap on the back of the envelope showed the address to which the envelope should be returned if undelivered. There was no other information about the sender.
Assuming the contents of the envelope were fully compliant, which of these statements do you agree with?
- I would approve this as a promotional activity
- The mailer is promotional but the activity is non promotional because there is no product information on the envelope
- I would approve this if changes were made to the envelope
- I would not approve this as it is disguised promotion
Ruling
This was a true case and unfortunately the mailer happened to arrive on the complainant’s birthday! It was deemed to be disguised promotion because there was nothing on the envelope to indicate that it contained promotional material or that it came from a pharmaceutical company. It could be approved if changes were made to the envelope to make these aspects clear.
Novartis meeting in Australia
Consider the following scenario: Novartis market Lucentis (Ranibizumab) which is a product used by ophthalmology specialists to treat various types of macular pathology. Novartis organized and paid for a one day educational event for health professionals which provided presentation skills training in four areas as follows: ‘The presenter’s voice’, ‘Engaging others’, Physical presence’ and ‘Presentation’.
The Australian Code requires educational events organized and funded by pharmaceutical companies to have the primary purpose of enhancing medical knowledge and improving the quality use of medicines. In addition it states that “provision of training that will enhance the interaction of healthcare professionals with their peers or patients may be justifiable”.
The event was attended by three retinal specialist opthalmologists who were described in the Novartis invitation as ‘Novartis Retinal Fellows’.
Which of the following do you agree with?
- This seems like a good quality educational event which fulfills the requirements of the Australian Code
- The educational value of this event is questionable
- The educational objective is questionable given the number of attendees and their relationship with Novartis
- This could be viewed as disguised promotion
- This event could not successfully withstand public or professional scrutiny
- The event could be viewed as a ‘reward’ to those who prescribe Lucentis
Ruling
This event was deemed to breach the Australian Code regarding educational meetings and Novartis received a fine of $90,000. The Committee was concerned that the event was targeted at a group of specialist healthcare professionals who were Novartis retinal fellows, which gave the appearance that the event was a reward for those who prescribed Lucentis. Although the Committee didn’t formally label it as disguised promotion, this would be a legitimate concern to raise as a nominated signatory reviewing this meeting.
Think also about the principles of Key Topic 1 – the purpose of this meeting was questioned leading to its non promotional status being questioned.
Sponsored supplement
Consider the following scenario:
A TEVA sponsored article appeared in a supplement to a UK publication called ‘Guidelines in Practice’ entitled “Making an informed choice: A guide to changing to CFC-free beclometasone inhalers”. TEVA marketed the product Qvar (CFC-‐free beclometasone diproprionate) in the UK, and this product was discussed in the article.
TEVA had commissioned an agency to work with a key opinion leader on the article. The agency chose the author. TEVA agreed the initial brief with the agency, but after that had no part in creating the article. The agency was paid to complete the project, and the fee for the author was agreed between the agency and the author. The article was reviewed by TEVA and went through its approval process to ensure compliance with the UK Code. TEVA paid to have copies distributed as a supplement to ‘Guidelines in Practice’.
The supplement stated on the front cover that it was supported by an unrestricted educational grant from TEVA UK Ltd. Prescribing information for Qvar appeared on the inside back page.
Which of the following do you agree with?
- This article is promotional and should be treated as an advertisement for Qvar from a nominated signatory perspective
- This article is non promotional as TEVA did not author it or influence its content
- This article could be viewed as disguised promotion because TEVA’s involvement is not clear
- The sponsorship statement is misleading
- This was an ‘arms length’ arrangement so TEVA is not responsible for it
Ruling
This article was found to be disguised promotion because it appeared to be independent of TEVA which was not so. TEVA had commissioned it (albeit through an agency), had reviewed its content, and had paid for its distribution. Had there been a true ‘arms length’ arrangement the article could have been viewed as non promotional. But the involvement of TEVA and the lack of clarity about TEVA’s true level of involvement made it promotional and therefore ‘disguised’ promotion.
Press release Duaklir
You are asked to review and approve the following press release. It is a press release intended for medical media in Spain, and will be distributed by corporate affairs through the usual medical media channels along with the SmPC and a backgrounder on COPD. Click on the link to view the SmPC for this product to aid your review.
There are a number of reasons to consider this press release promotional Duaklir SmPC
Which of the following reasons do you agree with?
- The brand name is used excessively this is a matter of judgment but excessive use of a brand name can make a press release seem promotional. Stylized logos should also not be used.
- It contains too many product claims factual statements consistent with the SmPC are allowable, but you need to look at balance and general tone of these statements too. Even if they could be substantiated the tone of some of the statements is unsuitable for a press release. Also for balance there is no mention of adverse effects– click on those statements that you think are unsuitable
- The quote about a patient is not approvable because it exaggerates the clinical efficacy of Duaklir statements about patient responses should represent a typical response. Even if this statement were true and supportable, it would not be approvable in this piece
