Leo loses appeal against UK's most serious drug marketing breach as it’s censured for 'extremely concerning matter'

An unusual internal case at Leo that involved allegations of coercion and “unethical behaviour” between an employee and a manager has landed the dermatology pharma in hot water with the U.K.’s drug marketing body the PMCPA.

The case is focused on allegations from an internal staffer at Leo. The employee filed a complaint with the PMCPA alleging that Leo was trying to gain a competitive advantage through unethical means for the pharma’s plaque psoriasis drug Kyntheum.

The crux of the recently published case is that a Leo senior manager, who remains anonymous, allegedly put pressure on the employee to "gain a competitor's confidential [drug] discount information," and that information allegedly "informed Leo's strategy" for Kyntheum.

Leo said it had undertaken an internal investigation into this issue prior to receiving the complaint, but the PMCPA found there were “some differences in the parties’ accounts.”

Leo did confirm, however, that the company’s manager in question had requested from NHS staff “certain information” about a competitor product in relation to the discounted drug price offered to the U.K. taxpayer-funded health service, which was for the purposes of Leo preparing a submission to NICE, England’s drug pricing watchdog. The PMCPA did not disclose the name of the competitor in its published report. 

Pharma companies will often go to NICE with a discounted price for their drugs to pass its high bar of value for a new medicine; these discounts are, however, confidential in nature. Therefore, the PMCPA’s panel that oversaw this case said that it “considered that such information about a medicine was commercially sensitive and likely to be confidential.”

Because of the manager’s actions, the panel said it “was wholly unacceptable” for a pharma company employee to ask an NHS employee for commercially sensitive or confidential information about a competitor product, specifically for the purposes of its own company’s commercial interests.

The panel said it was also irked by how long it took Leo to create additional training after being made aware of the issue. The panel also noted the seniority of the manager, given the “important role that senior employees’ had in shaping the culture of an organisation.”

Leo was, therefore, found in breach of Clause 2 of the ABPI Code, the formal U.K. pharma trade lobby group, which sets the drug marketing rules for the PMPCA to police, and the most serious of all breaches: Bringing disrepute and reducing confidence in the pharma industry.

The PMCPA said this was “a serious and extremely concerning matter” and upheld the breach of Clause 2 despite an appeal of the decision by Leo.