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.                        

Search options for completed cases can be found below, please scroll down.

Please note that abbreviations/acronyms can only be searched under the Text search.

Where searching under clause number please look under sub clause where one exists, eg Clause 6.1 not just 6.

Click on the blue arrow below to search completed cases.  Searches can be run by free Text, Case number, Respondent, Complainant or Clause Number.

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Please Note:

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

 

 

 

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An anonymous, contactable doctor complained about the travel arrangements, made by DaiichiSankyo, for a speaker at a meeting in June 2018. Daiichi-Sankyo marketed Lixiana (edoxaban) which was indicated for the prevention of stroke and systemic embolism in high risk adults with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. The complainant explained that the meeting was organised by a...

Breach Clause(s): Clause 6, 9.1 and 22.1

No breach Clause(s): Clause 2, 2.1

Applicable Code: 2016

Received: 17 July 2018

Completed: 22 May 2019

Astellas UK and Astellas Europe respectively voluntarily admitted breaches of the Code with regard to the content of prescribing information for seven medicines promoted by Astellas in the UK.  Whilst the voluntary admission was made under the self-regulatory system, given the potential impact on patient safety, the companies informed the Medicines and Healthcare products Regulatory Agency (MHRA) which was advised that the PMCPA was dealing with the matter as a complaint under the Code. As Paragraph 5.6...

Applicable Code: 2016

Received: 21 February 2017

Completed: 22 May 2019

  Astellas UK voluntarily admitted breaches of the Code with regard to patient support programmes and the conduct of a third party agency.  The patient support programmes, Fresh Start and VIP related to Betmiga (mirabegron) and Vesicare (solifenacin succinate) respectively.  Both medicines were for the symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as might occur in patients with overactive bladder syndrome. As Paragraph 5.6 of the Constitution and Procedure required the Director...

Applicable Code: 2016

Received: 18 October 2016

Completed: 22 May 2019

  An anonymous and non-contactable complainant who appeared to be an employee of Astellas complained about the truthfulness of Astellas’s response to Case AUTH/2747/1/15 which concerned the arrangements for an Astellas Pharma Europe meeting held in Milan in February 2014.  In that case the company was ruled in breach of the Code including Clause 2 and was required by the Appeal Board to issue a corrective statement to all UK attendees. The complainant stated that Astellas colleagues...

Breach Clause(s): 2 (x2), 9.1 (x2)

Applicable Code: 2015

Received: 08 July 2015

Completed: 22 May 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 Novartis.  The complainant stated that the ABPI had, inter alia, published news of the collaboration.  The complainant had not seen relevant details published on Novartis’ website, noting that an executive summary should be published before such projects start. ...

Applicable Code: 2016

Received: 01 June 2018

Completed: 22 May 2019

A complainant who described him/herself as a concerned UK health professional, complained about a Seretide Evohaler (fluticasone/salmeterol) advertisement in Pulse, which he/she had accessed via an iPad and a laptop. The complainant noted that he/she could not see the ingredients of Seretide at the top of the advertisement.  He/she noted that it might be below the product logo at the bottom of the advertisement, but it was not legible; it was no better on a laptop...

Breach Clause(s): 4.3

No breach Clause(s): 9.1

Applicable Code: 2019

Received: 09 January 2019

Completed: 20 May 2019

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...

Applicable Code: 2016

Received: 12 September 2018

Completed: 15 May 2019

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...

Applicable Code: 2016

Received: 12 September 2018

Completed: 15 May 2019

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...

Applicable Code: 2016

Received: 12 September 2018

Completed: 15 May 2019

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...

Applicable Code: 2016

Received: 12 September 2019

Completed: 15 May 2019

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