In Europe, Centralized OTC Switch Still Has A Few Bugs

The European Union's diversity means that when it comes to the new centralized procedure for Rx-to-OTC switches, there are several details yet to be ironed out, according to OTC industry executives.

The first switch licensed under the European Medicines Agency's centralized regulatory pathway procedure, GlaxoSmithKline's weight-control drug alli is approved for nonprescription sale in all 28 member states. EMEA cleared the drug in January (¹ (Also see "Alli Pioneers EU Centralized Process For Nonprescription Switch" - Pink Sheet, 27 Oct, 2008.), p. 3).

However, alli (orlistat) is currently available in 25 of the 27 member states, Manfred Scheske, president of GSK Consumer Healthcare, Europe, pointed out June 4 at the annual meeting of the Association of the European Self-Medication Industry in Vienna, Austria.

Like many firsts, the alli centralized switch was a challenge, he said.

"It was hard work not only for the sponsor, it was likewise hard work for the EMEA, for the [Committee for Medicinal Products for Human Use], and for the regulatory agencies at the member states," in particular for the U.K. and Greek authorities that acted as rapporteur and co-rapporteur for the product, Scheske said.

And it is not just the act of switching, but all the unfamiliar baggage that comes with it.

"EMEA before has only looked at new chemical entities ... and now all of a sudden they have to look at subjects and matters like an OTC brand name, like Web site references and graphics and pack colors, just to mention a few," Scheske said.

"Where we've arrived is a pan-European license which allows us to market in 27 countries. But this is what Europe's about: When it comes to the implementation details, we are back at the national level, back to the regulatory agency level and it's complicated," he added.

"It's a constant dichotomy between uniformity and diversity."

EU Members' Autonomy

EMEA's switch decisions extend only to whether a product should be available prescription or nonprescription.

EU member countries retain authority over the sub-categorization or distribution channel for a product, including whether a nonprescription drug is sold from pharmacies, over the counter or general sales.

Among the regulatory and legislative proposals AESGP wants the EU to adopt by 2015, it advocates for a revised centralized process for true OTC status (² (Also see "EU Needs OTC Regulatory Overhaul, Automatic Product Approval – AESGP" - Pink Sheet, 23 Jun, 2008.), p. 4).

Other executives at the AESGP meeting noted they would prefer a bit more uniformity.

"When the European decision has been made there should be some adaptation on the local level, where they should integrate the European processes and decision," said Nycomed's OTC head, Etienne De Laroulliere.

Nycomed's proton pump inhibitor Pantozol Control (pantoprazole) awaits a final decision by EMEA after receiving CHMP's recommendation for approval earlier this year (³ (Also see "Nycomed Prepares To Launch First Nonprescription PPI With EU-Wide Approval" - Pink Sheet, 18 May, 2009.), p. 5).

"This change in the procedures could lead to considerable acceleration to introduction of innovation in the OTC market," De Laroulliere said.

EMEA Decides, Implementation Lags

In cost-conscious Europe, national payers are more than aware that self-medication generally means self-pay as well, and this should accelerate improvements to implementing EMEA decisions.

Dagmar Roth-Behrendt, a member of the European Parliament from Germany, said a more uniform regulatory landscape would help increase the number of self-medication products available to EU consumers.

Commenting on when an EU member's agency conducts its own evaluations following EMEA consumer product decisions, such as on herbal monographs, Roth-Behrendt sees several problems. "One, that national agency is under-worked, they must not have enough work ... and the second one is that the national agency doesn't trust EMEA," she said.

If EU members do not question EMEA's decisions, they should "simply accept what EMEA does," Roth-Behrendt added.

But how EU members respond to EMEA decisions is not the only area with room for improvement. Changes at EMEA also may be needed to enhance innovation in the European OTC marketplace, Roth-Behrendt said.

"I sometimes have the feeling that the CHMP ... thinks of itself as the creme de la creme of committees" and does not prioritize reviewing OTC switches, she observed.

Meanwhile, In England

Some EU members are more forward thinking than others.

"We're appointing a specialist in self-medication," said June Raine, director of the U.K. Medicines and Healthcare products Regulatory Agency's post-licensing division, at the AESGP meeting.

"The announcement's not out yet but it will be very soon. And this is to provide what we know from business practice - that voice, that champion across a large organization ... someone who really understands and knows the issues," she said.

MHRA also will conduct discussions with all relevant stakeholders in the fall for input on revising its switch guidelines.

"We hope to be fostering wider research on what we fundamentally believe is the public health value of the contribution of switching," said Raine. "We need the evidence to back up the belief."

Evidence is one thing, but change based on that evidence is quite another. "Shifting attitudes takes a long time," Raine said.

However, she noted the alli experience is a catalyst for a lot of people to make rapid adjustments in how they think about OTC switching.

"There is quite rightly a risk aversion among regulators and going for the best possible level of safety has a downside. It inhibits access," she said.

"We have to do that balancing act that enables access and to trust people to manage their own risks. But Europe needs to reach the same level of understanding. Things like alli will help us do that."

- Christopher Morrison ([email protected])