Case Summary
An anonymous, non-contactable complainant submitted a complaint about the Lincoln Medical website. The complainant stated he/she was a pharmacist and was concerned about the advertising of prescription medicines to the public.
The complainant provided a copy of the 'About us' page which stated, at the bottom of the page, that Lincoln Medical was the marketing authorization holder for the adrenaline (epinephrine) auto-injector Anapen used by patients at risk of anaphylaxis, the severe end of an allergic reaction, and that the company was also the distributor of Hidrasec (racecadotril), a pure intestinal anti-secretory agent used in targeting the underlying cause of diarrhoea in children, and Wakix (pitolisant), an H3 receptor antagonist for the treatment of narcolepsy with or without cataplexy.
The complainant stated that patients frequently asked him/her for items which they had read about and it was unhelpful that Lincoln Medical had placed the product name/generic name and indication without any additional information to contextualise it, even if it had been for professionals. It was inappropriate for the public to have access to this information and it did little for the pharmaceutical industry in the eyes of the complainant and his/her colleagues.
The detailed response from Lincoln Medical is given below.
The Panel noted that the 'About us' page included product names and indications for prescription only medicines; Hidrasec Granules and Wakix were available in the UK although the Anapen auto injector was not. The Panel considered that given the descriptions, this page advertised prescription only medicines to the public and the company had thus not complied with the relevant requirements of the Code. Breaches of the Code were ruled. The Panel noted that the company had immediately taken down the website. However advertising prescription only medicines to the public was a serious matter and thus the Panel ruled a further breach as high standards had not been maintained.
The Panel noted its rulings and comments above but did not consider that the circumstances were such as to warrant a breach of Clause 2 which was a sign of particular censure. No breach of Clause 2 was ruled.
CASE AUTH/2924/12/16 ANONYMOUS, NON CONTACTABLE PHARMACIST v LINCOLN MEDICAL
1 Statements on website
An anonymous, non-contactable complainant submitted a complaint about the Lincoln Medical website. The complainant stated he/she was a pharmacist and was concerned about the advertising of prescription medicines to the public.
The complainant provided a copy of the ‘About us’ page which stated, at the bottom of the page, that Lincoln Medical was the marketing authorization holder for the adrenaline (epinephrine) auto-injector Anapen used by patients at risk of anaphylaxis, the severe end of an allergic reaction, and that the company was also the distributor of Hidrasec (racecadotril), a pure intestinal anti-secretory agent used in targeting the underlying cause of diarrhoea in children, and Wakix (pitolisant), an H3 receptor antagonist for the treatment of narcolepsy with or without cataplexy.
The complainant stated that patients frequently asked him/her for items which they had read about and it was unhelpful that Lincoln Medical had placed the product name/generic name and indication without any additional information to contextualise it, even if it had been for professionals. It was inappropriate for the public to have access to this information and it did little for the pharmaceutical industry in the eyes of the complainant and his/her colleagues.
The detailed response from Lincoln Medical is given below.
The Panel noted that the ‘About us’ page included product names and indications for prescription only medicines; Hidrasec Granules and Wakix were available in the UK although the Anapen autoinjector was not. The Panel considered that given the descriptions, this page advertised prescription only medicines to the public and the company had thus not complied with the relevant requirements of the Code. Breaches of the Code were ruled. The Panel noted that the company had immediately taken down the website. However advertising prescription only medicines to the public was a serious matter and thus the Panel ruled a further breach as high standards had not been maintained.
The Panel noted its rulings and comments above but did not consider that the circumstances were such as to warrant a breach of Clause 2 which was a sign of particular censure. No breach of Clause 2 was ruled.
An anonymous, non-contactable complainant submitted a complaint about the Lincoln Medical Ltd website. The complainant stated he/she was a pharmacist.
The complainant provided a copy of the ‘About us’ page which stated, at the bottom of the page, that Lincoln Medical was the marketing authorization holder for the adrenaline (epinephrine) auto-injector Anapen used by patients at risk of anaphylaxis, the severe end of an allergic reaction, and that the company was also the distributor of Hidrasec (racecadotril), a pure intestinal anti-secretory agent used in targeting the underlying cause of diarrhoea in children, and Wakix (pitolisant), an H3 receptor antagonist for the treatment of narcolepsy with or without cataplexy.
COMPLAINT
The complainant stated that he/she was concerned about advertising on the website as prescription medicines should not be advertised to the public. The complainant was trying to find Lincoln Health Centre’s address when he/she came across the Lincoln Medical website. The page opened on the search at the ‘About us’ tab and this gave the information stated above. There was no warning screen for professionals before the product information was provided.
The complainant stated that patients frequently asked him/her for items which they had read about and it was unhelpful that Lincoln Medical had placed the product name/generic name and indication without any additional information to contextualise it, even if it had been for professionals. It was inappropriate for the public to have access to this information and it did little for the pharmaceutical industry in the eyes of the complainant and his/her colleagues.
When writing to Lincoln Medical, the Authority asked it to respond to Clauses 2, 9.1, 26.1 and 28.1.
RESPONSE
Lincoln Medical stated that it did not intend to promote prescription medicines to the public. However, it took this notification very seriously and the company accepted that the website required update and review. As a corrective measure, the website was immediately taken down upon receipt of the complaint and would not be republished until updated content had been fully certified via its copy approval system.
The company also launched an investigation. Lincoln Medical was unable to replicate the circumstances described by the complainant. Any search engine hits were directed to the ‘Home’ page, which did not contain any promotional information.
Results of searches performed using the UK versions of three search engines (accessed 3 January 2017) were as follows:
- ‘Lincoln health centre’ (and center)
No hits for Lincoln Medical Limited within the first 10 search pages for any search engine.
- ‘Lincoln health centre (and center) address’
No hits for Lincoln Medical Limited within the first 10 search pages for any search engine.
- ‘Lincoln medical centre’ (and center)
One hit on the second search page for all search engines.
- ‘Lincoln medical centre (and center) address’
One hit on the lower half of the first search page for all search engines.
None of the identified hits contained a direct link to the ‘About us’ page identified by the complainant.
Lincoln Medical stated that the ‘Home’ page linked to other website pages, including the ‘About us’ page. As noted in the complaint, the ‘About us’ page carried promotional text:
‘Lincoln Medical is a UK based pharmaceutical company founded in June 2000, dedicated to the development, manufacturing, and supply of prescription-only medication throughout the world.
A subsidiary of Bioprojet Pharma Sarl, Lincoln Medical are the Marketing Authorisation Holders for the adrenaline (epinephrine) auto-injector Anapen used by patients at risk of anaphylaxis, the severe end of an allergic reaction. Lincoln Medical are also distributors of the Hidrasec (racecadotril) product range in the UK, a pure intestinal anti-secretary agent used in targeting the underlying cause of diarrhoea in children, and Wakix (pitolisant), an H3 receptor antagonist for the treatment of narcolepsy with or without cataplexy.’
Similar wording also appeared on the ‘Products’ page.
Whilst Lincoln Medical agreed that the information about its products did not comply with the Code with respect to patients, it was clearly stated that the company supplied prescription only medicines. Product information was also restricted to the brand name, the international non-proprietary name and a brief statement of intended use. Lincoln Medical submitted that the impact was somewhat mitigated by the following:
- Anapen and Hidrasec capsules were not currently sold or marketed in the UK
- Web traffic was directed to the ‘Home’ page, which was non-promotional
- Information supplied on specific products was restricted
- Web traffic volumes for the site were relatively low, with around 4,400 hits per annum.
Lincoln Medical submitted that it took this issue very seriously and would review the Code and make any necessary amendments to the website in order for it to be compliant.
PANEL RULING
The Panel noted that the complainant was anonymous and non-contactable. The Constitution and Procedure stated that anonymous complaints would be accepted, but that like all other complaints, the complainant had the burden of proving his/her complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties. The complainant could not be contacted for more information.
The Panel was concerned about the complaint, particularly given Lincoln Medical’s submission that its research showed that searches for ‘Lincoln Health Centre’ did not immediately identify the company’s website and that if they did it would open on the ‘Home’ page and not the ‘About us’ page as alleged.
The Panel noted that Clause 26.1 prohibited the advertising of prescription only medicines to the public (other than approved vaccination campaigns). Clause 28.1 stated that promotional material about prescription only medicines directed to a UK audience which was provided on the Internet must comply with all relevant requirements of the Code. The supplementary information to Clause 28.1 stated that:
‘Unless access to promotional material about prescription only medicines was limited to health professionals and other relevant decision makers, a pharmaceutical company website or a company sponsored website must provide information for the public as well as promotion to health professionals with the sections for each target audience clearly separated and the intended audience identified. This was to avoid the public needing to access material for health professionals unless they choose to. The MHRA Blue Guide stated that the public should not be encouraged to access material which was not intended for them.’
The Panel noted that the ‘About us’ page included product names and indications for prescription only medicines; Hidrasec Granules and Wakix were available in the UK although the Anapen autoinjector was not. The Panel considered that given the descriptions, this page advertised prescription only medicines to the public and ruled a breach of Clause 26.1. The company had thus not complied with the relevant requirements of the Code and a breach of Clause 28.1 was ruled. The Panel noted that the company had immediately taken down the website. However advertising prescription only medicines to the public was a serious matter and thus the Panel decided that high standards had not been maintained. A breach of Clause 9.1 was ruled.
The Panel noted its rulings and comments above but did not consider that the circumstances were such as to warrant a breach of Clause 2 which was a sign of particular censure. No breach of Clause 2 was ruled.
Complaint received 21 December 2016
Case completed 30 January 2017
