Case Summary
A former GlaxoSmithKline employee who no longer worked in the pharmaceutical industry, complained about an online cost calculator prepared for Relvar Ellipta (fluticasone furoate/vilanterol) by GlaxoSmithKline UK, which the complainant found using the search team 'GSK cost calculator'. The complainant alleged breaches of the Code as the page at issue did not include prescribing information, the non-proprietary name, an adverse event reporting statement or a black triangle to denote that additional monitoring was required. He/ she alleged that the material promoted prescription only medicines to the public and that high standards had not been maintained.
The page at issue promoted Relvar Ellipta 92/22mcg and claimed it was the cheapest.
The detailed response from GlaxoSmithKline is given below.
The Panel noted GlaxoSmithKline's explanation that in August 2016 that search engines were searching the company's internal hosting servers and that this was quickly resolved. On receipt of this complaint GlaxoSmithKline became aware that the fix put in place in August 2016 no longer prevented such searches. This appeared to be due to the continuous evolution of search engine technology; search engines were not obliged to share publicly when updates were made.
The Panel noted GlaxoSmithKline's submission that if the page of the website was accessed in the manner intended ie not via the internal hosting server but via the health professional site (hcp.gsk. co.uk) be that directly, via links from other materials or by searching for 'Relvar costs', 'Relvar cost calculator', 'GSK medicines' or similar, then all the obligatory information was available. It was clear to visitors that the site was for health professionals rather than the public which had its own site.
The Panel was sympathetic to the company's submission and considered that it had taken reasonable steps to ensure that its internal hosting server was not accessed by search engines. It also noted the submission regarding search engines tailoring search results to the individual user and that the complainant was an ex-employee with specialist knowledge. Although the Panel was concerned that material that did not appear to meet the requirements of the Code could be accessed, it seemed reasonable in this case to consider it as material on an internal company hosting server rather than that which was intended for UK health professionals. The Panel decided that the lack of obligatory information when searching on the internal company hosting server did not amount to breaches of the Code as alleged. It considered that health professionals would be supplied with the requisite information including the prescribing information, the non-proprietary name, the adverse event statement and the black triangle when using the websites for external use. It did not consider that the circumstances amounted to advertising a prescription only medicine to the public or that the company had failed to maintain high standards. No breaches of the Code were ruled.
CASE AUTH/2918/12/16 NO BREACH OF THE CODE EX-EMPLOYEE v GLAXOSMITHKLINE
Material on internal hosting server
A former GlaxoSmithKline employee who no longer worked in the pharmaceutical industry, complained about an online cost calculator prepared for Relvar Ellipta (fluticasone furoate/vilanterol) by GlaxoSmithKline UK, which the complainant found using the search team ‘GSK cost calculator’. The complainant alleged breaches of the Code as the page at issue did not include prescribing information, the non-proprietary name, an adverse event reporting statement or a black triangle to denote that additional monitoring was required. He/ she alleged that the material promoted prescription only medicines to the public and that high standards had not been maintained.
The page at issue promoted Relvar Ellipta 92/22mcg and claimed it was the cheapest.
The detailed response from GlaxoSmithKline is given below.
The Panel noted GlaxoSmithKline’s explanation that in August 2016 that search engines were searching the company’s internal hosting servers and that this was quickly resolved. On receipt of this complaint GlaxoSmithKline became aware that the fix put in place in August 2016 no longer prevented such searches. This appeared to be due to the continuous evolution of search engine technology; search engines were not obliged to share publicly when updates were made.
The Panel noted GlaxoSmithKline’s submission that if the page of the website was accessed in the manner intended ie not via the internal hosting server but via the health professional site (hcp.gsk. co.uk) be that directly, via links from other materials or by searching for ‘Relvar costs’, ‘Relvar cost calculator’, ‘GSK medicines’ or similar, then all the obligatory information was available. It was clear to visitors that the site was for health professionals rather than the public which had its own site.
The Panel was sympathetic to the company’s submission and considered that it had taken reasonable steps to ensure that its internal hosting server was not accessed by search engines. It also noted the submission regarding search engines tailoring search results to the individual user and that the complainant was an ex-employee with specialist knowledge. Although the Panel was concerned that material that did not appear to meet the requirements of the Code could be accessed, it seemed reasonable in this case to consider it as material on an internal company hosting server rather than that which was intended for UK health professionals. The Panel decided that the lack of obligatory information when searching on the internal company hosting server did not amount to breaches of the Code as alleged. It considered that health professionals would be supplied with the requisite information including the prescribing information, the non-proprietary name, the adverse event statement and the black triangle when using the websites for external use. It did not consider that the circumstances amounted to advertising a prescription only medicine to the public or that the company had failed to maintain high standards. No breaches of the Code were ruled.
A former GlaxoSmithKline employee who no longer worked in the pharmaceutical industry, complained about an online cost calculator (ref UK/ FFT/0232/15(1), date of preparation, April 2016) for Relvar Ellipta (fluticasone furoate/vilanterol) prepared by GlaxoSmithKline UK Limited. Relvar Ellipta was a combined inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) indicated for the treatment of chronic obstructive pulmonary disease (COPD).
COMPLAINT
The complainant stated that a search using the term ‘GSK Cost calculator’ on two search engines produced results top and second top hits to a page (address provided).
This page promoted Relvar Ellipta 92/22mcg and claimed it was the cheapest ICS/LABA for COPD patients. The complainant alleged breaches of the following:
Clause 4.1 – There was no prescribing information. Clause 4.3 – The non-proprietary name must appear immediately adjacent to the first or most prominent display of the brand name. Clause 4.9 – There was no prominent adverse event statement.
Clause 4.10 – There was no black triangle to denote that additional monitoring was required. Clause 9.1 – Promotion of medicines direct to the public was a failure to maintain high standards. Clause 26.1 – Promoting directly to the public. There was no request, as was normal for readers to confirm they were health professionals or other relevant decision makers. There was also a link from this page to contact GlaxoSmithKline representatives to discuss the financial impact of the wider Ellipta portfolio.
RESPONSE
GlaxoSmithKline stated that the Relvar Ellipta Cost Calculator was developed to provide health professionals treating COPD patients with a simple calculator to explore the savings opportunity with Relvar Ellipta 92/22 compared with other ICS/LABA options. Health professionals could input the number of COPD patients being treated by an ICS/LABA within their practices or areas and then select what their alternative ICS/LABA option would be. The potential monthly budget impact with Relvar 92/22 was then calculated on the website. If customers wanted to explore savings opportunities with Ellipta in more detail then there was a link below the calculator to build on this by contacting a GlaxoSmithKline health outcomes consultant. Appropriate disclaimers were also provided around costs and savings figures being for illustrative purposes only and were subject to assumptions outlined.
Representatives had not been briefed to use the Relvar Ellipta Cost Calculator with customers or to direct customers to it on the website; instead they had a similar but separately approved cost calculator on their iPads which they were trained and accredited to use. A Relvar price reduction email notification had previously been sent to all customers who subscribed to receive emails through third party providers on 14 July 2016. This notification contained a link to the Relvar Ellipta Cost Calculator on the GlaxoSmithKline website.
Background to the health professional website
GlaxoSmithKline stated that it had two websites: one for UK health professionals (hcp.gsk.co.uk) and one for members of the public (public.gsk.co.uk). The objective of the health professional website was to support the appropriate and rational use of GlaxoSmithKline prescription only medicines and vaccines through the provision of high-quality, upto-date information aligned to customer needs and GlaxoSmithKline business. All content on the health professional site was certified as promotional. The health professional website provided up-to-date GlaxoSmithKline product and therapeutic information, patient and professional resources and options to contact GlaxoSmithKline medical information teams. It also allowed health professionals to register for emails, sign up for webinars, order samples and patient materials and have a virtual chat with a GlaxoSmithKline medical information team member.
Metadata was data that described other data. In the case of a website, the metadata associated with a particular webpage provided information to search engines about the content on that webpage. Metadata for all webpages on the health professional website was approved and certified with the content before any content went live. GlaxoSmithKline used a standard format to create compliant metadata. Page title always included product and generic name, therapy area, company name (GlaxoSmithKline UK Pharma) and intended audience (health professionals). Meta description was a simple paragraph that outlined the content available on the page. Meta keywords were the search phrases/ words that users might enter in a search engine to obtain the information they were looking for.
Background to the certification process for website content
The certification process in Zinc and ‘build’ process for webpages on the GlaxoSmithKline website was as follows:
Step 1: A job bag was created in Zinc for the webpage.
Step 2: A pdf of the webpage and the metadata for the webpage were approved by the nominated medical signatory.
Step 3: The webpage was then built on a staging website that was password protected.
Step 4: The certification round was then started for the job bag in Zinc. The job bag item, screen shot of the webpage on the staging website and a link to the staging website were sent to the nominated medical signatory. The medical signatory checked that all 3 (job bag item, screenshot of staging website and the webpage on the staging website) were the same in both content and format, checked the metadata, checked that the ‘pop-up’ appeared requesting visitors to confirm they were health professionals, checked that all links on the webpage in the staging website were correct and that all necessary disclaimers appeared.
Step 5: The medical signatory certified the final form of the webpage if all the above checks were correct.
Step 6: The certified webpage was published to live on the website with its metadata.
There were limited instances where interactive content appeared on the health professional website. The way in which this interactive content was designed was such that the content was uploaded to the GlaxoSmithKline internal hosting server and this content was pulled into the relevant page on the website through an ‘I-frame’. The webpage on the website containing the I-frame also contained all the mandatory regulatory and compliance information.
In this specific example relating to the Relvar Cost Calculator, when the item was accessed in the way it was intended (on the health professional website) the following information was displayed on the webpage and fulfilled Code requirements: a link to the most up-to-date prescribing information; the nonproprietary name appeared immediately adjacent to the first mention of the brand name; a prominent adverse event statement and a black triangle at the first mention of the brand name. Moreover visitors to this website were immediately asked to confirm by way of a pop-up that they were health professionals, at the top of the webpage the intended audience was clearly stated ‘For UK Healthcare Professionals’ as well as the following statement ‘Not a healthcare professional? Visit our public site [link to the public site]’. The certified metadata for the health professional website webpage on which the Relvar Cost Calculator was provided.
The internal hosting server was maintained by GlaxoSmithKline’s global digital platforms department. This server was intended and used solely as a content storage repository for any interactive content that appeared on the website. It was not promoted by GlaxoSmithKline and contained no metadata. GlaxoSmithKline understood that search engines could not search or ‘crawl’ and therefore display content that sat on GlaxoSmithKline’s internal hosting server.
Sequence of events and actions taken
In August 2016 GlaxoSmithKline’s digital team searched for ‘Relvar Cost Calculator’ in Google and discovered that results from the internal hosting server were being displayed. This was the first time that the company realised that search engines could crawl GlaxoSmithKline’s internal hosting server. The GlaxoSmithKline global digital platforms department was contacted immediately and the next day reported that the issue had been resolved. GlaxoSmithKline UK checked this by searching for
‘Relvar Cost Calculator’ and confirmed on 17 August 2016 that the internal hosting server no longer appeared in the search results.
When GlaxoSmithKline received this complaint it became aware the issue had reoccurred and that the fix put in place in August 2016 would not prevent search engines from being able to re-crawl its internal hosting server. After further technical investigation by GlaxoSmithKline’s global digital platforms department it had now resolved the issue again and to ensure that it would not reoccur it had:
- Blocked all content that sat on GlaxoSmithKline’s internal hosting server from appearing in search engine results through the search engine’s ‘webmaster tool’. This involved instructing the search engines not to display historical search results that previously appeared related to this URL.
- Proactively inserted a line of code into both the content source code and search engine’s webmaster tool which would block search engines from being able to crawl any new content hosted on this URL in the future.
Following the completion of the above, GlaxoSmithKline checked to ensure the Relvar cost calculator and any other content hosted on the internal hosting server no longer appeared in search results. This was confirmed the day after receiving the complaint. GlaxoSmithKline had now also included a new check into its regular quality control monitoring for the health professional website to ensure that any content on the internal hosting server could not be found in search engine results.
GlaxoSmithKline had always used the most up-to-date technical measures to prevent its internal hosting server from being crawled by search engines. However, search engines were continuously evolving their search technology and search algorithms. As they were not obliged to share publicly when and how they updated their search technology and search algorithms, it was theoretically possible that in the future GlaxoSmithKline might not know about a new search engine generated issue as soon as it happened. This was out of GlaxoSmithKline’s control. However, as demonstrated by the sequence of events above, as soon as it became aware of such an issue it fulfilled its responsibilities as the website owner by taking immediate, remedial actions. Furthermore, GlaxoSmithKline now had a search engine results monitoring plan in place so when it became aware of such an issue in the future it would work to resolve it immediately.
Consideration for potential breaches of Clauses 4.1, 4.3, 4.9, 4.10, 9.1 and 26.1
GlaxoSmithKline submitted that the ‘GlaxoSmithKline Cost Calculator’ was a very specific search term that would not usually be used by a health professional or member of the public seeking general information on Relvar. Furthermore, searches for ‘Relvar costs’, ‘Relvar Cost Calculator’, ‘GSK medicines’ or similar would direct the searcher to the appropriate webpages on the professional or public websites. To find content on the internal hosting server took specialist knowledge which the complainant might have as a former GlaxoSmithKline employee.
GlaxoSmithKline noted that search results could differ for individuals as explained by Google itself:
‘Google search results are different on different computers. There are many factors that affect the Google search results you see. Google seeks to provide the best results for individual users. This means that they want and expect search results to be different from person to person and that people searching in the same office may see different search results.’
When accessing the document in the manner in which it was intended, all obligatory information was available (Clauses 4.1, 4.3, 4.9, 4.10). In addition, this information was only available to health professionals; the public was redirected to an appropriate website (Clause 26.1). As such, GlaxoSmithKline maintained high standards at all times for all digital content within its control (Clause 9.1). GlaxoSmithKline therefore refuted any breaches of the Code.
In view of the above, GlaxoSmithKline submitted this anomalous and temporary, technical issue had now been resolved and that the Relvar Cost Calculator content, when accessed as intended on the health professional website, had always complied with the Code and had not prejudiced patient safety.
PANEL RULING
The Panel noted the explanation from GlaxoSmithKline regarding search engines. The company used an internal hosting server and in August 2016 it became aware that search engines were searching the company’s internal hosting servers. This was quickly resolved. On receipt of the complaint GlaxoSmithKline became aware that the fix put in place in August 2016 no longer prevented search engines from searching the company’s internal hosting server. This appeared to be due to the continuous evolvement of search engine technology and that search engines were not obliged to share publicly when updates were made to technology and algorithms. In these circumstances it could be considered unreasonable to expect companies to continuously monitor search engines as some search engine activities appeared to be outside the company’s control. The Panel noted that GlaxoSmithKline now had a monitoring plan to ensure that content on the internal hosting server could not be found in search engine results.
The Panel noted GlaxoSmithKline’s submission that if the page of the website was accessed in the manner intended ie not via the internal hosting server but via the health professional site (hcp. gsk.co.uk) be that directly or via links from other materials or by searching for ‘Relvar costs’, ‘Relvar cost calculator’, ‘GSK medicines’ or similar, all the obligatory information was available. It was clear to visitors that the site was for health professionals rather than the public which had its own site.
The Panel was sympathetic to the company’s submission and considered that taking all the circumstances into account the company had taken reasonable steps to ensure that its internal hosting server was not accessed by search engines. It also noted the submission regarding Google’s position in tailoring search results to the individual user and that the complainant was an ex-employee. Although the Panel was concerned that material that did not appear to meet the requirements of the Code could be accessed, it seemed reasonable in this case
to consider it as material on an internal company hosting server rather than that which was intended for UK health professionals. The Panel decided that the lack of obligatory information when searching on the internal company hosting server did not amount to breaches of the Code as alleged. It considered that health professionals would be supplied with the requisite information including the prescribing information, the non-proprietary name, the adverse event statement and the black triangle when using the websites for external use. It therefore ruled no breach of Clauses 4.1, 4.3, 4.9 and 4.10. It did not consider that the circumstances amounted to advertising a prescription only medicine to the public and therefore ruled no breach of Clause 26.1. Given its rulings and the specific circumstances of this case the Panel did not consider that the company had failed to maintain high standards. No breach of Clause 9.1 was ruled.
Complaint received 19 December 2016
Case completed 3 February 2017
