The whistleblowing drama behind Astellas’s suspension from the ABPIBMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l4353 (Published 02 July 2019) Cite this as: BMJ 2019;366:l4353
- Deborah Cohen, freelance journalist1,
- Shai Mulinari, associate professor2,
- Piotr Ozieranski, assistant professor3
- 1London, UK
- 2Department of Sociology, Lund University, Lund, Sweden
- 3Department of Social and Policy Sciences, University of Bath, UK
- Correspondence to: D Cohen
When Astellas was reprimanded by the Association of the British Pharmaceutical Industry (ABPI) in June 2016, for “deception on a grand scale which was appalling and shocking,” it received the harshest punishment ever levied by the membership organisation: two non-concurrent one year suspensions (see box 1).
MHRA, ABPI, and PMCPA
The UK’s prescription drug marketing oversight system is formally a coregulatory arrangement involving the medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, and the Prescription Medicines Code of Practice Authority (PMCPA).
The PMCPA was set up in 1993 by the Association of the British Pharmaceutical Industry (ABPI), a trade body, to administer the ABPI’s code of practice.
The MHRA is formally tasked with investigating potential breaches of advertising and other relevant legislation, but it strongly recommends referral to the PMCPA for complaints about companies that have accepted the industry code.1
Companies in breach pay administrative charges to cover the costs of processing complaints. These are typically £3500 but increase to £12 000 if the ruling is unsuccessfully appealed.
In cases of serious wrongdoing the PMCPA can also publicly reprimand a company or require it to issue a corrective statement. For both sanctions the company pays £4000 towards the cost of advertising that fact in the medical (The BMJ), pharmaceutical (Pharmaceutical Journal), and nursing (Nursing Standard) press.
In severe cases the PMCPA can also undertake compulsory audit of a company, which costs £15 000 to £20 000 depending on complexity.
In extraordinary cases the PMCPA can …