Case Summary
This case was in relation to the Google search results that appeared when searching for Sialanar (glycopyrronium). The complainant alleged that the search results amounted to Proveca advertising to the public, and to promotional material. The complaint also concerned whether Proveca’s website provided sufficient information about Sialanar to the general public.
The outcome under the 2021 Code was:
|
No breach of Clause 16.1
|
Requirement that promotional material about prescription only medicines directed to a UK audience which is provided on the internet must comply with all relevant requirements of the Code
|
|
No breach of Clause 26.1
|
Requirement not to advertise prescription only medicines to the public
|
|
No breach of Clause 5.1 (x2)
|
Requirement to maintain high standards at all times
|
This summary is not intended to be read in isolation.
For full details, please see the full case report below.
CASE AUTH/3812/8/23 NO BREACH OF THE CODE
COMPLAINANT v PROVECA
Alleged promotion of Sialanar
CASE SUMMARY
This case was in relation to the Google search results that appeared when searching for Sialanar (glycopyrronium). The complainant alleged that the search results amounted to Proveca advertising to the public, and to promotional material. The complaint also concerned whether Proveca’s website provided sufficient information about Sialanar to the general public.
The outcome under the 2021 Code was:
|
No breach of Clause 16.1
|
Requirement that promotional material about prescription only medicines directed to a UK audience which is provided on the internet must comply with all relevant requirements of the Code
|
|
No breach of Clause 26.1
|
Requirement not to advertise prescription only medicines to the public
|
|
No breach of Clause 5.1 (x2)
|
Requirement to maintain high standards at all times
|
This summary is not intended to be read in isolation.
For full details, please see the full case report below.
FULL CASE REPORT
A complaint about Proveca was received from an anonymous contactable complainant.
COMPLAINT
The complaint wording is reproduced in below:
“I have tried to find information about Sialanar which can be found on [copy of weblink provided]. They have SEO [search engine optimisation] pointing me to this website but as a member of the public, I am unable to access it. They have not made any information available to me but have told me there is information on their website. Additionally, they are promoting to everyone on google which can be shown in the first supporting document. it is the second link in google when typing in Sialanar and is on the second page when typing in glycopyrronium where they are again, promoting their product. On any of the links shown, here is no link for either patients or public - i am forced to identify as a health care professional in order to find out more information about Sialanar or Glycopyrronium.”
When writing to Proveca, the PMCPA asked it to consider the requirements of Clauses 5.1, 16.1 and 26.1 of the Code.
RESPONSE
The response from Proveca is reproduced below:
“Complaint summary
The complaint appears to concern two allegations; a) that Proveca are promoting Sialanar (glycopyrronium) to the general public and b) that Proveca do not provide information about Sialanar, to the general public on our website.
In addressing these concerns we have referenced Clauses 5.1, 16.1, 26.1 and 26.2 of the ABPI Code of Practice. Having investigated this complaint, Proveca believes that the relevant webpages and method of website access are compliant with the ABPI Code of Practice. All cited webpages containing product information are promotional in nature and thus have the necessary restrictions in place to restrict access by non- healthcare professionals (nonHCP). Proveca confirms that we do not make information about Sialanar available to members of the public, and whilst making factual information is considered good practice, it is not obligatory.
a) Advertising Sialanar to the General public
The complainant, a member of the public (MOP), states they have performed Google searches for information on Sialanar. They appear to have used three specific Google search terms, as evidenced by the bold font in their provided screenshots. Initially ‘Sialanar’, and subsequently ‘glycopyrronium’ plus ‘2mg/5ml’.
Searching for ‘Sialanar’ brings up the Proveca website as the second link on Google. This is unsurprising since whilst Proveca does not currently employ search engine optimisation (SEO) (such use was discontinued in May 2023), it is likely that automatic website indexing has occurred on Google, since the brand name was specifically used.
When searching for both ‘2mg/5ml’ and ‘glycopyrronium’ in a single search, the Proveca website appears on the second page of Google. Once again, following the link leads directly to a HCP self declaration check.
If only ‘glycopyrronium’ is searched, the Proveca website does not appear until the 79th link/result on Google.
In each case, as stated by the complainant, following the links leads directly to a HCP self declaration check. This is in place to ensure that promotional material for a prescription only medicine is not available to MOPs, in compliance with Clause 26.1.
When a MOP clicks on any of the links above and states they are not an HCP, they are redirected to the Proveca Homepage, as demonstrated by the PMCPA’s own evidence. The Proveca Homepage provides information about Proveca and areas of therapeutic interest.
Having our product name appear in a Google search, when specifically using the brand name is a feature of all internet search engines and cannot be construed as advertising to the public. Similarly when searching for the non-proprietary product name and associated concentration, the Sialanar brand comes up as part of the search (on the second page). This is unsurprising since we are currently the only licensed product with this specific concentration. When searching for just the non-proprietary name (glycopyrronium), the brand does not appear until page 8 of Google. In each case, the searcher is taken to the Proveca website and asked to confirm that they are a HCP before accessing further information.
b) Lack of information about Sialanar suitable for patients and/or the public
The complainant states that Proveca does not provide information about Sialanar suitable for patients or MOP on the Proveca website. In relation specifically to Sialanar, this is correct. As noted above, Google searches relating to Sialanar which link to the Proveca website require the searcher to identify as a HCP to find out product specific information. Proveca confirms that we do not make information about Sialanar available to the public. As per Clause 26.2 supplementary information, ‘pharmaceutical companies are not obliged to provide reference information, and whilst it is considered good practice to provide factual information, it is not mandatory’.
Proveca does provide information relating to therapy areas on the website. In addition, if a MOP requires further information, the Proveca website has a ‘Contact’ page which can be used to make an enquiry about Sialanar and/or glycopyrronium. It also provides contact details for Proveca Medical Information.
Summary
The above supports Proveca’s position that we are compliant with the ABPI Code of Practice in terms of Clauses 5.1, 16.1, 26.1 and 26.2.”
PANEL RULING
The Panel noted that the Constitution and Procedure stated that the complainant had the burden of proving their complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties.
The Panel considered this complaint under the following four headings:
1. Use of search engine optimisation (“SEO”) to promote Sialanar to the public.
2. Company website does not provide information about medicines to the general public.
3. Promotional material about prescription only medicines.
4. Failure to maintain high standards.
Clause 26.1 – use of SEO to promote Sialanar to the public
Clause 26.1 prohibits prescription only medicines being “advertised” to the public.
The Panel noted the complainant’s allegation that Proveca was ‘promoting to everyone’ on Google and reference to SEO. The Panel noted that the complaint was received in August 2023 and noted Proveca’s submission that it had stopped using SEO three months previously. The Panel did not know when the complainant undertook the searches in question and, in the absence of evidence in this regard, assumed that this was on or shortly before the date of the complaint.
For the public to find the website, they would have to search actively, using specific search terms on Google. The complainant provided two screenshots of their Google search results. As with most Google search results, these showed what would be the beginning of the first two sentences of the webpage. The Panel was concerned that indexing by Google, over which Proveca had no control in the absence of SEO, meant that content intended for healthcare professionals only, could be found via a Google search and might encourage the general public to access information that was not intended for them. However, the Panel considered Proveca’s explanation about the Google search terms and search results was not unreasonable and that the complainant had not established that Proveca was using SEO to promote Sialanar to the public at the relevant time as alleged.
The Panel considered that the two Google search results provided by the complainant reflected Google’s algorithms rather than any act or omission by Proveca.
In addition, the Panel noted that, to access the linked webpages, a user would have to confirm that they were a health professional.
Based on all of these factors, the Panel considered that the search results provided by the complainant did not amount to advertising to the public. The Panel therefore ruled no breach of Clause 26.1.
Clause 5.1 – Company website does not provide information about medicines to the general public
The Panel noted that the supplementary information to Clause 26.2 (Website Access) states that ‘a pharmaceutical company website or a company sponsored website providing information for the public as well as promotion to health professionals must have the sections for each target audience clearly separated and the intended audience identified. This is to avoid the public needing to access material for health professionals unless they choose to.’ The Panel noted that health professionals self-declared their professional status to access webpages directed to them.
The Panel noted Proveca’s reference to the supplementary information to Clause 26.2, (Reference Information) which includes the statement that ‘companies are not obliged to provide reference information but it is considered good practice to provide as a minimum the regulatory information…’. As the website that is the subject of the complaint contained promotional information for health professionals, the Panel considered that the provision of adequate information for the public was also required.
The Panel reviewed the material provided by Proveca that was accessible by the general public. The Panel only had access to certain webpages but noted the Homepage included links to information on therapy and disease areas separately from the webpages for health professionals. The Panel noted that the complaint was limited to the narrow point of adequacy of information available to the general public. On balance, and in the absence of further detail from the complainant, it appeared that adequate information had been provided. The Panel ruled no breach of Clause 5.1 on this point.
Clause 16.1 – promotional material about prescription only medicines
The Panel noted that Clause 16.1 provides that promotional material about prescription only medicines directed to a UK audience on the internet must comply with all relevant requirements of the Code.
The Panel did not consider Clause 16.1 to be relevant here because this complaint did not concern promotional material. On that basis, there was no “promotional material” that needed to be Code compliant and therefore the Panel ruled no breach of Clause 16.1.
Clause 5.1 – failure to maintain high standards
Given that the Panel had ruled no breach of Clauses 16.1 and 26.1, there had therefore been no failure to maintain high standards. The Panel ruled no breach of Clause 5.1.
Complaint received 16 August 2023
Case completed 25 November 2024
