The UK approach to nonprescription switches is moving beyond the scope of self-medication, Paul Stoneham, managing director, Boots Healthcare International asserted at a recent assembly of the world consumer healthcare industry in Geneva.

Stoneham cited the switch of Zocor Heart-Pro (simvastatin 10 mg) to pharmacy status and consumers' limited ability to self-diagnose for high cholesterol as an example.

Stoneham spoke on a panel of executives at the World Self Medication Industry (WSMI) general assembly/Association of the European Self-Medication Industry (AESGP) annual meeting June 1.

The statin switch was the focus of debate among the industry leaders over the appropriateness of the UK reclassification strategy as a model for other states.

"One of the issues I may be worried about on switches is: are we losing the focus of what OTCs are?" Stoneham asked.

"OTCs are supposed to be very, very safe self-medicated products," he maintained. "Statins...are not one of the products that the consumer actually knows how to do. You can't tell yourself that you have high cholesterol; you have to have a blood test."

"One of the concerns I have with some of the UK agenda is actually going very, very broad, beyond the things where it is actually self-medication."

Britain's Medicines & Healthcare products Regulatory Agency has been considering a number of drugs and categories for reclassification from Prescription Only Medicine (POM) to Pharmacy (P) since the 2002 release of a list from the Royal Pharmaceutical Society of Great Britain identifying potential switches.

MHRA plans to review a range of medications for reclassification, including several antibiotics and an antihypertensive treatment, the agency said in a recent business plan (¹ Also see "MHRA Looks To Triptans, Anti-Hypertensives As Next Switch Categories" - Pink Sheet, 6 June, 2005., p. 4). The health authority approved an antibiotic ophthalmic treatment for conjunctivitis June 8.

Stoneham stressed the role of the pharmacists as "critical in this area where you have delegated authority from the doctor."

The statin selection issues also have presented a marketing challenge, he added. "Statins are sort of a key area there where people are getting blood tests from places like Boots the Chemists, where they then decide to do different therapy apart actually from a statin. Then they go see the doctor."

"There's actually very little take-up there, because it's such a serious drug at this point in time, which potentially probably should have stayed Rx as opposed to being switched OTC."

"That's one of the things we looked at as a company both for BHI as well as Boots the Chemist. And we decided not to launch 18 months ago because we looked at A, the therapy and indications with it and B, also the commercial viability wasn't high enough."

Stoneham does not oppose the statin switch, he clarified. "We have actually led the statin switch in the UK as well, and looked at it very seriously and invested quite a few million dollars in looking at a switch from 10 to 40 mg on the simvastatin as well."

"I think the issue is that we are into new territory right now, and we have to have a new set of rules." Given the more complicated profile of most chronic therapies, "we need to make sure we have our eyes wide open and there is a healthcare practitioner involved in monitoring the person's health," he emphasized.

Manfred Scheske, president of GlaxoSmithKline Consumer Healthcare Europe, also cited revenue potential in challenging the position of some panelists that the UK could serve as a role model for Rx-to-OTC switch environment.

"The UK trade environment [for OTCs] is more liberal than the rest of Europe," Scheske pointed out.

However, "the switch favor is pretty much on the surface," he said. "None of the switches in the last couple of years which has been kicked off in the UK has made it to a decent size."

"At the end of the day if you compare what we've achieved with switches in Europe compared to the U.S., it's tiny, and I think we as an industry are being asked to find ways and means to really truly unlock the potential which is behind switches for all of Europe."

Other panelists cited the presence of DTC advertising for a drug prior to its switch as the primary force behind difference in strength between U.S. and European switches.

UK Switch Plan Questioned As European Role Model

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