The UK Prescription Medicines Code of Practice Authority (PCMPA) has come under strong criticism for the way it scrutinises drugmakers’ compliance with the industry’s system of self-regulation.
A major complaint is that, when PCMPA officials receive media reports of possible breaches of the code, they discuss the issue with the company concerned but not with the individuals or groups bringing the complaint, according to a report in The Times this morning. “It has also been argued that journalists themselves often may not have, or do not wish to provide, further information to help the inquiry,” the report adds.
Journalists and the complainants which they have quoted say they have been “powerless” to defend themselves against counter-claims made by the companies, the report notes, although it also points out that some drugmakers claim that the PCMPA has investigated them more than once for very similar allegations. Moreover, companies believe that the defence which they present to the Authority may put them at risk if the case leads to prosecution.
A review of the Code is now reportedly underway, even though a new, tougher version was introduced on January 1, 2006, following a major consultation exercise with stakeholders including medical professional bodies, patient groups and the Medicines and Healthcare Products Regulatory Agency. With the new version, the process of considering complaints has been made more transparent, and the Association of the British Pharmaceutical Industry has undertaken a major campaign to increase awareness of the Code’s existence.
“Self-regulation is by far the most effective means of ensuring that the industry's relationship with the NHS and others is conducted in a responsible and ethical manner,” Andrew Hotchkiss, ABPI board member and managing director of Lilly UK, who was in charge of the Code’s revision, said at the time of its launch. The Code of Practice has been “the gold standard for pharmaceutical industry regulation throughout the world for many years,” he said, but added: “ultimately, society will judge us on our actions and behaviour.”