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Pharmaceutical industry

Breaches of ABPI code of practice rise sharply, according to report

A number of leading pharmaceutical companies were found to be in breach of the Association of the British Pharmaceutical Industry code of practice in 2016.

Breaches to the Association of the British Pharmaceutical Industry (ABPI) code of practice have risen sharply, a report has found.

Published this October, the Prescription Medicines Code of Practice Authority’s (PMPCA) annual report shows the number of complaints it received rose from 54 in 2015 to 76 in 2016. This led to 100 cases compared with 66 in 2015.

Some complaints gave rise to more than one case, as they involved more than one company. The total of number of matters ruled upon by the code of practice panel rose from 198 in 2015 to 420 in 2016.

Complaints are received from a variety of sources, including health professionals and pharmaceutical companies.

According to the PMCPA, the most common cause of complaint is around claims companies make about their medicines. Under the ABPI code these need to be accurate, balanced, fair and up to date and must not mislead. Misleading claims amount to a breach of clauses 7.2 and 7.4.

Companies in breach of the code, following complaints received in 2016, include Astellas Pharmaceuticals UK — whose ABPI membership was suspended June 2016 — AstraZeneca UK, Eli Lilly, GlaxoSmithKline UK, Merck Sharp & Dohme, Novartis Pharmaceuticals UK, and Roche Products.

Commenting on the rise in complaints in 2016, a spokesperson for the PMPCA said it represented “a jump” from the 54 it received in 2015 and the 51 it had in 2014.

The spokesperson said the rise in complaints in 2016 was “not an unprecedented number”. “The PMCPA annual reports show we received 80 complaints in 2013, with 78 in 2012 and 84 in 2011,” they said.

Complaints nominally attributed to PMCPA director Heather Simmonds, nearly doubled (15 in 2016 versus eight in 2015), which she said was “mostly due to an increase in the number of companies making voluntary admissions”, which was 13 in 2016 versus four in 2015.

“The fact that companies make voluntary admissions indicates the seriousness with which the industry takes the code,” she added.

The number of complaints submitted anonymously decreased in 2016, at 36% compared with 2015 at 41%. “Given that the complaints system is designed to allow both parties to participate fully, it is regrettable that many of the anonymous complainants did not provide any contact details,” Simmonds said.

An ABPI spokesperson said the report “underlines the PMCPA’s role in holding the pharmaceutical industry to account in its dealings with healthcare professionals and the public”.

They added: “Any potential breach of the Code is treated seriously — and the fact that the PMCPA has effectively dealt with a rise in the number of complaints should give everyone confidence that we have a robust framework in place to support high quality patient care.”

The PMCPA asked individuals who have concerns to contact

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203858

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