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It should come as no surprise that the marketing of pharmaceutical products is regulated – and that even advertisements of such products are regulated. But how would these regulations apply when advertisements take on a life of their own and become “earned media”?
“What is Earned Media”?
While there is no clear legal definition of “earned media” in Singapore, a quick search on the guidelines for interactive marketing communication and social media guidelines[1] published by the Advertising Standards Authority of Singapore (“ASAS”)[2] does provide the following definition ““Earned media” is media that is driven by consumers’ sharing and engagement, and is not sponsored. While it may be the result of a marketer’s owned and paid media efforts, it should not be considered a form of marketing communication as the consumer is not paid. Examples include “likes”, “retweets”, reviews and other forms of user generated content and sharing that are not paid for.”[3]
Based on the abovementioned ASAS’ definition of “earned media”, it seems to refer to advertisements that are not sponsored and are driven by consumers’ sharing and engagement, emphasis being this refers to advertisements that are not sponsored by any company.
Regulated Advertisements
Pharmaceutical companies are generally regulated when it comes to advertising as they will need to ensure that their marketing does not come across as being a direct to patient marketing. Such restrictions can be found in Health Products (Advertisement of Specified Health Products) Regulations 2016[4] and further guidelines can be found in Explanatory Guidance to the Health Products (Advertisement of Specified Health Products) Regulations 2016)[5] (the “Guide”) for therapeutic product advertisements.
However, with the advent of many new marketing techniques, it may start to blur the line around how pharmaceutical companies are liable for the different media articles that are being published. One such marketing article relates to what is termed as “earned media article”.
This is where it can get risky.
The Teva Case
With the definition of “earned media” in mind, we can look at the first case that appeared before the Prescription Medicines Code of Practice Authority (“PMCPA”) – where the authority looked at what is potentially a decision around “earned media” and pharmaceutical companies’ responsibilities around such media when the PMCPA has to decide the issues in the complaint raised in AUTH/3656/6/22 – Health professional v Teva (“Teva Case”)[6].
To be clear, PMCPA is a self-regulatory body which administers the Association of the British Pharmaceutical Industry (“ABPI”) Code of Practice for the Pharmaceutical Industry, independently of the ABPI[7]. Even though the PMCPA’s decision is not binding on Singapore pharmaceutical companies, it is still interesting to understand what are the potential considerations around such advertisements that is the subject of the ABPI Code which have similar restrictions as our local regulations.
In the Teva Case, the facts were slightly different from the usual marketing type cases. In this particular case, the article in question was published by a magazine, p3 Pharmacy and it was in relation to an interview of one of Teva’s senior leader.
Given the nature of the magazine, it was understood at the start that the article was more of a “biographical profile item” than on product-related items. However, notwithstanding, PMCPA ruled that the article was in breach of the ABPI Code and Teva was liable for the breach.
On the facts, the interview for the article followed a new product launch by Teva but the launch was not part of the interview questions. No payments were made by Teva for the article and no advertising space was secured alongside it or paid for. However, the Teva Corporate Communications Team was provided with drafts of the article for review though the final document was not submitted for review prior to publication.
Was the article considered promotional in nature?
The PMCPA referred to the definition of promotion under the APBI Code which refers to promotion “as any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicine.”
The PMCPA further referred to a “well-established principle that, in general, the product name (brand or generic), particularly if alongside its indication, was likely to be seen as promotional and, depending on the context, a product could be promoted with either the product name or indication, or even without its name ever being mentioned”.
On the facts, the article did have reference to the newly launched product by name and the article provided details of the disease that the product was meant to address. Accordingly, PMCPA ruled that the article was indeed promotional in nature.
Did it matter whether Teva have the opportunity to review drafts of the article?
On the facts, Teva did have the opportunity to review the draft of the final article (though not the article that was published) and even though the draft did mention about the name of the newly launched product, Teva did not request for any changes to be made. This further strengthened PMCPA’s ruling on Teva.
Would the same decision have been reached under the regulations in Singapore?
As mentioned, the decision of this case does not have any precedential value for Singapore but it is still worth exploring if a similar decision would have been reached under the relevant regulations in Singapore.
There does not seem to be an equivalent reference to “promotion” in the local regulations except in the context of sales promotion as set out in the Guide which is defined to mean “any advertisement in the form of a sales campaign (including door to door sales), exhibition, competition or any activity meant to introduce, publicise or raise the profile or public awareness or visibility of any therapeutic product for the purpose of promoting the sale or use of the product”[8].
However, the context in which sales promotion is being referred to in the explanatory guidance is more akin to promotion relating to the sales of a product such as linking a therapeutic product with the offer of a medicinal / health product.
In contrast, the reference to “advertisement” is closer to the reference to promotion under the ABPI code. Advertisement is defined under both the explanatory guidance and the Health Products Act (“HPA”). For the purpose of our discussion, we shall refer to the definition in the explanatory guidance as it is being used in the context of the restriction to advertisements of prescription only medicines which is the subject of the Teva Case.
Advertisement is defined to mean “the publication, dissemination or conveyance of any information for the purpose of promoting whether directly or indirectly, the sale or use of that health product by any means or in any forms” (emphasis added) and “feature of the name, identity, pack shot, tagline or logo associated with the TP, with the intent or purpose of promoting the TP and its use shall be deemed as an advertisement for purpose of the HPA and the Regulations” (emphasis added)[9].
There must be a finding of intent or purpose of promotion before a publication can be viewed as advertisement. Unlike in the Teva Case, where the PMCPA ruled on established principle that the “the product name (brand or generic), particularly if alongside its indication, was likely to be seen as promotional”, under Singapore context, this may not be entirely sufficient.
On the facts of the Teva Case, it was not disputed that Teva did not pay for the article to be created nor did Teva pay for any advertising space with the publication of the article. At first blush, this did not seem to be consistent with an intent or purpose of advertising its product since it paid no value in trying to do so.
However, the subsequent facts which suggested that Teva knew about the reference to its product including mention about its indications and how it was also mentioned about the efficacy of the product and did nothing about such references, seem to suggest that Teva by turning a blind eye to such references in the product could potentially give rise to such intent or purpose of promoting.
As mentioned above, it still remains to be seen how our local regulators will view the use of earned media but there are ways we can look at to ensure that such media will remain compliant with local regulatory requirements.
Author: Frederick Tay
Footnotes
[1] Guidelines for Interactive Marketing Communication and Social Media (web).pdf (asas.org.sg)
[3] Paragraph 2.1(d) of the Guidelines for Interactive Marketing Communication and Social Media (web).pdf (asas.org.sg)
[4] Health Products (Advertisement of Specified Health Products) Regulations 2016 – Singapore Statutes Online (agc.gov.sg)
[5] tp-advert-guidance_21-aug-2023.pdf (hsa.gov.sg)
[6] AUTH/3656/6/22 – Health professional v Teva (pmcpa.org.uk)
[8] Paragraph 1.2 of tp-advert-guidance_21-aug-2023.pdf (hsa.gov.sg)
[9] Paragraph 1.2 of tp-advert-guidance_21-aug-2023.pdf (hsa.gov.sg)