Regulatory Focus™ > News Articles > UK Industry Group Sees More Complaints Against Pharma Members in 2016

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Posted 30 October 2017 | By Michael Mezher 

UK Industry Group Sees More Complaints Against Pharma Members in 2016

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the Association of the British Pharmaceutical Industry's (ABPI) code of practice, says it saw more complaints about drugmakers' promotional materials and activities in 2016 than in the previous year.

In 2016, PMCPA saw a 41% jump in the number of complaints it received over 2015, with 76 complaints compared to 54. These complaints led to 100 cases covering 420 individual matters, as many of the cases involved more than one drugmaker and raised multiple issues.

Just over half (57%) of the cases were found to be in breach of the ABPI code in 2016, up slightly from 2015. But when looking at individual matters raised in each case, PMCPA says that just 43% were in breach of the ABPI code in both years.

Of PMCPA's decisions on individual matters, only 33 were appealed either by the company or the complainant, with 15% of those appeals succeeding and 85% failing.

PMCPA also said it saw a 30% increase in violations of a particular clause of the ABPI code, which pertains to activities or materials that "bring discredit upon, or reduce confidence in, the pharmaceutical industry."

Companies found to be in breach of this clause two include the UK divisions of Astellas, AstraZeneca, Boehringer Ingelheim, Celgene, Eli Lilly, Gedeon Richter, Grunenthal, Hospira, Janssen, Pierre Fabre, Takeda and Vifor Pharma.

When a company is found to be in breach of the ABPI code it is required to stop the practice in question and take steps to ensure it does not happen again. PMCPA can also take additional steps such as auditing a company's procedures, requiring the company to issue a corrective statement or suspending or expelling the company from ABPI.

PMCPA says it required four companies to undergo audits in 2016 and suspended ABPI membership of one company, Astellas, for a year as a result of a breach. In June 2017, ABPI suspended Astellas for another year after a re-audit found the company did not have adequate oversight of nurses who delivered patient support programs.

PMCPA also touted its track record for handling the cases, saying that 99% of its rulings were accepted by both parties involved or upheld on appeal.

PMCPA 2016 Annual Report


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