The British arm of the Swiss company Roche has decided not to renew its membership of the Association of the British Pharmaceutical Industry (ABPI), it was announced in June 2009.
Roche’s move follows a six-month suspension for a serious breach of the ABPI’s code of practice, related to selling its slimming drug Xenical (orlistat) to private clinics. Roche was also criticised for failing to stop a programme which offered incentives for patients to take its treatment for cystic fibrosis, but, in light of the suspension, no further action was taken. The suspension ended in February 2009.
Although Roche has pledged to continue to comply with the ABPI’s Code of Practice, it removes the option for the ABPI to order similar sanctions if the company breaks the code in the future.
The Medicines and Healthcare Regulatory Products Agency (MHRA) can prosecute drug companies, but up until now the majority of disciplinary action has been taken by the Prescription Medicines Code of Practice Authority, run by the ABPI.
In a statement, Roche said: “In line with any commercial business we continually review our operations, and our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs in the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being. We will continue to review this situation.”
It also noted: “This decision in no way affects our commitment to our working practices and we are still committed to, and will be accountable for, working within the ABPI Code of Practice to ensure compliance with the high standards of our industry.”
The statement also said that a set of new processes and procedures for compliance had been put in place, with a team of eight staff dedicated to compliance, and training is now given to staff so that they fully understand the Code of Practice and the company’s internal policies for complying with it.
However the ABPI, which receives a six-figure subscription from Roche, is disputing the company’s right to leave, and crucially, the decision has raised questions over the organisation’s ability to regulate the industry at arm’s length.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the regulatory environment and the ABPI, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)