In a shock move Swiss drugmaker Roche has decided not to renew its membership of the Association of the British Pharmaceutical Industry, putting a question mark over the viability of self-regulation in the UK.

In the UK, the Medicines and Healthcare products Regulatory Agency possesses the legal power to take pharmaceutical groups to court for any wrongdoing, but generally it is the ABPI’s Precription Medicines Code of Practice Authority that deals out penalties to its member companies for bad behaviour.

Roche has been on the receiving end of ABPI sanctions before, after its membership was suspended for six months until February this year in connection with “serious breaches” of the Association’s Code of Practice, relating to the inappropriate sale of large quantities of its weight-loss drug Xenical (orlistat) to an operator of private diet clinics.

Now the company says that its time away from the ABPI gave it the opportunity to “reflect upon the nature” of its relationship with the trade body and consider 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 [but] will continue to review this situation,” the group said in an e-mailed statement to PharmaTimes UK News.

However, Roche was quick to stress that its decision does not affect its commitment to working within the bounds of the ABPI’s Code of Practice “to ensure compliance with the high standards of our industry”, and that it has fortified its procedures surrounding compliance through a dedicated team and staff training on the Code.

But the news will certainly come as a blow to the Association. Aside from the added muscle of having such a big name as Roche on its books, which has a substantial pharmaceutical operation in the UK, the ABPI reportedly gets a six-figure membership fee from the group the absence of which will no doubt hurt. Unforunately, a spokesperson for the organisation could only tell PharmaTimes UK News: "While discussions with the company continue we are not in a position to comment further".

ABPI putting up a fight?
According to an article in the Financial Times, however, the Association is more than unhappy with the decision and is even exploring the possibility that Roche doesn’t actually have the right to cancel its membership. “The ABPI doesn’t want to see any member company walk away…A unified front makes sense,” President Chris Brinsmead, head of AstraZeneca UK, told the newspaper.

Interestingly, the drugmaker has also been making similar waves across the Atlantic following its decision to resign from pharmaceutical industry trade group the Pharmaceutical Research and Manufacturers Association and sign up to the biotechnology regulator, the Biotech Industry Organisation, instead, according to a report in US publication Star Ledger.