Jurisdiction
The main regulations and codes which apply to anyindividual website are those of the nation which hosts the website. Forexample, the British Medical Journal is clearly a British website and thereforeBritish regulations would apply both to the operation of the website by thepublisher and to the placement advertisements on that website by thepharmaceutical company concerned. This is true regardless of where the serverfor the BMJ is actually located. Similar principles apply to European titles orthose with wider international reach; the target audience is partially relevantto the determination of regulatory jurisdiction, but the primary determinantis that the host country of the publisher.
However, jurisdiction is not limited to the website hostcountry. The regulatory authority that considers any complaint may well includethe home country of the business entity of the client which places theadvertisement or which commissions the website. For example, an advert placedon a French-hosted European publisher’s website by a European head office basedin London may have to meet the requirements of the French code and the UK‘sABPI code
With regards to the use of language (for example Englishversus French versus Spanish language used in advertising campaigns) there isno consideration of this in the written regulations. The choice of language istypically regarded as more a matter of acceptability to the audience.
So what does the ABPI say?
• Association of theBritish Pharmaceutical Industry
• Based on the MHRA BlueGuidelines issued by UK Government
• Work with thePrescribed Medicine Code of Practice Authority (PMCPA)
• Covers the UK
• Covers all Europeanadvertising in English language booked in the UK on UK based publishers
• Benchmark for Globalex US advertising
Clause 16 Material and Distribution
16.1 (28.1) Promotional material about prescription onlymedicines directed to a UK audience which is provided on the internet mustcomply with all relevant requirements of the Code.
16.2 (28.4) A medicine covered by Clause 16.1 may beadvertised in a relevant, independently produced electronic journal intendedfor health professionals or other relevant decision makers which can beaccessed by members of the public.
Clause 16 Supplementary Information
Clause 16.1 (28.1) Website Access Unless access topromotional material about prescription only medicines is limited to healthprofessionals and other relevant decision makers, a pharmaceutical companywebsite or a company sponsored website must provide information for the publicas well as promotion to health professionals with the sections for each targetaudience clearly separated and the intended audience identified. This is toavoid the public needing to access material for health professionals unless theychoose to. The MHRA Blue Guide states that the public should not be encouragedto access material which is not intended for them.
Clause 16.2 (28.4) Advertisements in Electronic JournalsThe MHRA Blue Guide states that each page of an advertisement for aprescription only medicine should be clearly labelled as intended for healthprofessionals.
Within the United Kingdom, there is a general assumptionthat specialist HCP-facing websites (e.g. the BMJ) are only likely to bevisited by healthcare professionals, meaning the advertising on such a websitemeets the general principles of “HCP-targeted promotion”.
And what about the EFPIA?
• European Federation ofPharmaceutical Industries and Associations
• Covers the EU
• ARTICLE6 DISTRIBUTION OF PROMOTION
• Section6.01. Promotion must only be directed at those HCPs whose need for, or interestin, the particular information can reasonably be assumed.
Targeting using device id
The headline with respect to targeting using device id is
“In the absence of specific regulations and specificcertainty about the identity of a user, the risk that a non-HCP might beexposed to POM advertising is relatively high compared to reliance onwebsite-style access gateways.”
ie endemic publications are significantly lower risk thanusing device targeting across non-endemic sites.
Also “the main issue is, obviously, that pushinginformation to a device means it is no longer possible to be sure about theidentity of the user.” Also “no code of practice and no written nationalregulation currently addresses the suitability of pushing advertising to HCPdevices by their device.”
There are some subtleties around type of device. It mightbe assumed that mobile phones are less likely to be shared for internetbrowsing purposes and therefore there maybe more certainty around the user.Equally if desktops are clearly located in hospitals and used mostly formedical search then a higher degree of confidence maybe assumed. Tablets andlaptops will always have a much lower confidence level on who is the user.
There is also “a strong defence that the pharmaceuticalcompany should not be accountable for a non-HCP accessing the personal deviceof a known HCP”, however, this is weak as its post a problem andnot preventing one. I am also unsure that if the brand knew there was areasonable chance that the user was not an HCP then this cannot be a “strong”defence.
