Completed cases

Complaints considered by the Code of Practice Panel are judged on the evidence provided by both parties. Once concluded a case report is published on this website. Good compliance decisions rely on both the interpretation of the Code and an understanding of its application, published case reports help in this regard and set precedent in a particular set of circumstances. When making decisions on compliance with the Code, knowledge gained from previous case reports can be beneficial.                        

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Cases can only link to clauses in the interactive 2019 or 2016 Codes.

 

 

 

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A study published online in the British Medical Journal (12 September 2018) was entitled ‘Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource’ (Goldacre et al 2018). The study objectives included assessing compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) posted results to the registry within 12 months of completion (final compliance date 21 December 2016). The study objectives...

Received: 12 September 2019

Completed: 18 September 2019

An anonymous, contactable health professional who described themselves as a general practitioner complained about a presentation on Entresto (sacubitril and valsartan) delivered by a local consultant cardiologist at an event organised and sponsored by Novartis Pharmaceuticals UK.  Entresto was indicated for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction. The complainant alleged that the presentation on heart failure and Novartis’ new product, Entresto, was not fair or balanced.  Only the positive...

Applicable Code: 2016

Received: 14 March 2019

Completed: 17 September 2019

Gilead Sciences Europe complained about materials being used by ViiV Healthcare to promote Tivicay (dolutegravir) and Juluca (dolutegravir/rilpivirine).  The detailed response from ViiV is given below. 1 Alleged off-label promotion of Tivicay Gilead stated that during the HIV Drug Therapy conference held in Glasgow, 28-31 October 2018, ViiV promoted results from the GEMINI-1 and GEMINI-2 studies which investigated the efficacy and safety of dolutegravir (DTG) in combination with one other antiretroviral (ARV) agent, lamivudine (3TC), for the...

Applicable Code: 2016

Received: 22 February 2019

Completed: 16 September 2019

On being informed of the outcome of Case AUTH/3148/1/19, the complainant, who described him/herself as a concerned UK health professional, raised matters which had arisen from GlaxoSmithKline’s response. It appeared that material that was not certified was used by an agency working for the company. The material at issue in Case AUTH/3148/1/19 was a dynamic digital banner advertisement for Seretide Evohaler (fluticasone/salmeterol). The material was certified as a rotating four frame advertisement. However, unbeknown to GlaxoSmithKline,...

Applicable Code: 2016

Received: 02 April 2019

Completed: 16 September 2019

A complaint was received from a contactable member of the public who indicated that he/she worked for a body contouring company. The complainant alleged that a named representative from Merz Pharma UK Ltd had used an Instagram account to promote Bocouture (botulinum toxin type A). Bocouture was indicated for the temporary improvement in the appearance of certain upper facial lines. The complainant provided copies of images downloaded from an Instagram account in which a representative from...

Breach Clause(s): 9.1, 15.2, 26.1

No breach Clause(s): 2

Applicable Code: 2019

Received: 19 June 2019

Completed: 12 September 2019

An anonymous contactable health professional complained that no attendance certificates were available following a meeting organised and sponsored by Novartis Pharmaceuticals UK Ltd. In an email subsequent to the event, the representative asked when might be a suitable time to come and see the complainant with his/her certificate and an evaluation form.  The representative was unable to email the certificate.  The complainant responded by suggesting that the representative drop the certificate at the surgery reception, however,...

Applicable Code: 2016

Received: 12 March 2019

Completed: 12 September 2019

Boehringer Ingelheim admitted breaches of the Code in that e-learning material for the Respimat device, was made live on a third party agency’s website before it had been certified.  In addition, the agency involved which was contracted by Boehringer Ingelheim emailed health professionals on its database alerting them to the material.  Boehringer Ingelheim had no prior knowledge of, nor had it approved/certified, the promotional email.  The email sent by the agency did not contain prescribing...

Breach Clause(s): 4.1, 4.3, 4.8, 4.9, 14.1

Applicable Code: 2019

Received: 11 June 2019

Completed: 10 September 2019

An anonymous, non-contactable individual who described him/herself as an asthma patient, complained about a peak flow diary produced by GlaxoSmithKline UK Limited. The complainant noted the date on the peak flow diary (July 2016) and stated that it would appear that the material had not been certified in the last two years. The detailed response from GlaxoSmithKline is given below. The Panel noted GlaxoSmithKline’s submission that the peak flow diary was originally certified in October 2016 and recertified,...

No breach Clause(s): 2, 9.1, 14.5

Applicable Code: 2019

Received: 20 June 2019

Completed: 06 September 2019

An anonymous, contactable complainant considered that a cancer data project, operating in a named Scottish region, appeared to be a joint working project although it had not been declared as such by the four companies involved including AstraZeneca.  The complainant stated that the ABPI had, inter alia, published news of the collaboration.  The complainant had not checked AstraZeneca’s website but noted that he/she had not seen details published on the other three companies’ websites.  The...

Applicable Code: 2016

Received: 01 June 2018

Completed: 27 August 2019

An anonymous non-contactable individual who described him/herself as being employed by a third party sales organisation which had a contract with Cipla, complained about the conduct of a named senior manager at Cipla who had been in post for some time but had little or no knowledge of the Code and little regard for it.  Despite this, he/she controlled the day-to-day workings of representatives. The complainant stated that representatives were asked to put pressure on surgeries...

No breach Clause(s): 2, 3.2, 9.1, 16.3, 19.2

Applicable Code: 2019

Received: 09 May 2019

Completed: 20 August 2019

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