European Switch Progresses, But Stronger Incentives Needed For OTCs

Europe needs to provide more incentives for consumer firms, otherwise the OTC industry will "make commercial decisions" that could reduce their presence in the area, suggested Manfred Scheske, Glaxo-SmithKline's Consumer Healthcare Europe president and VP of the Association of the European Self-Medication Industry, speaking at that organization's meeting in London Jan. 20.

The meeting's theme was competitiveness, but Europe's complex regulatory web is one reason that, despite the strong political support for more self-care, "the commercial prospects for OTC drugs in Europe are not as great as they seem," according to Scheske.

The U.K., for example, has only seen two significant OTC successes in the last six or seven years, which include Bayer's morning-after pill Levonelle (levonorgestrel), and GSK's recently launched weight-loss drug alli (orlistat), the first OTC product to be approved in Europe via the centralized switch process (¹ 'The Tan Sheet' Oct. 27, 2008).

Indeed, alli is the only one of five OTC products GSK launched in the U.K. that has succeeded commercially, according to Scheske.

Lack of Trust, Lack of Regulatory Expertise

Beside the fundamental structural hurdles of different OTC packaging, labeling and access regulations in each European member state - an issue which the centralized switch process does little to address -Scheske identified lack of trust as among the sector's other major problems in Europe. "There's a level of distrust of self-care among doctors," he pointed out.

Many doctors believe patients have difficulty understanding product labels, that they don't trust pharmacists to safely select appropriate medication, and that if patients do receive OTC products, they will stop going to the doctor, he said.

But when pressed on which of the various challenges he felt it was most important to address, Scheske pointed to what he sees as a lack of understanding of self-care among regulators at the European Medicines Agency level.

Granted, the advent of centralized switching and alli's approval in January 2009 is a huge step forward for European OTC. But the process was hardly easy.

"This was new ground for all of us, and required a willingness to engage stakeholders at every level. There were hurdles along the way, but we worked together to overcome them. That said, there were times when it seemed like a very long road, and we feared we might never reach our destination," said Scheske in an interview.

Since then, only one other drug, Nycomed's proton pump inhibitor Pantoloc Control (pantoprazole), has followed in alli's footsteps. Under a deal announced Jan. 26, Pantoloc Control will be co-marketed by Novartis in 14 European countries (see story p. 3).

The paucity of centralized switch approvals doesn't surprise Scheske, since "the eligibility criteria are being applied strictly," he says.

And even this centralized procedure is more de-centralized than it appears on the surface, given the many different individual opinions among members of the EMA's Committee for Medicinal Products for Human Use, who are drawn from European member states.

Scheske would like to see more OTC expertise at the CHMP level, pointing out in response to an audience question that current members have only dealt with new drugs. Yet the questions around OTC products are very different, he says, "and that is something that the new stakeholders [involved in the centralized switch process] need to learn."

In addition, most CHMP members are doctors, which again raises the trust issue - and some degree of conflict of interest, given that doctors' instinct is to protect their role in health care provision.

Lack of exclusivity in Europe for OTC products - in contrast, for instance, to the up-to-three years offered in the U.S. under the Hatch-Waxman Act - is another disincentive for firms operating in this field.

In theory, companies can get one year's worth of data exclusivity, but the data in question must be seen not only as relevant, but also "necessary," according to CHMP's Rafe Suvarna - meaning that it could not, for instance, be gleaned from existing data.

But comparing criticisms of the EU's OTC landscape with recent comments about FDA's conservatism on switches, it seems executives on both sides of the Atlantic may be looking at their neighbor's greener grass (² 'The Tan Sheet' Jan. 11, 2010).

Signs Of Policy, Regulatory Progress At EU Level

OTC drugs remain a very new area for EMA, as Executive Director Thomas Lönngren pointed out at AESGP. His talk was otherwise noticeably short of comment or detail on the sector and focused instead on wider changes within EMA as a whole.

Lönngren did, however, acknowledge AESGP's accusation of a lack of trust among CHMP members, saying the industry and regulators "must continue to push in that direction [of more self-medication] given that it will play an increasingly important role in future."

The European Commission also shared encouraging words on self-care policy. The EC's Martin Terberger described how the commission was addressing the various topics that AESGP put forward in 2007 in its "Smart Regulation 2015" road map document, focused on market access, communication, safety and pricing (³ 'The Tan Sheet' June 23, 2008).

Overall, he summarized, the points made "aren't unrealistic, and we hope we can constructively collaborate with the industry going forward."

There is only so far the EC can go, however. Addressing the issue of communication - specifically, AESGP's request that ads for OTC drugs are allowed, including leaflets and highly visible drug names -Terberger pointed out that although EC had endorsed this request, "we know that member state implementation isn't equal." In other words, individual countries can and do still impose their own restrictions on OTC drug advertising.

National Rules Still Trump European Ones

The problem is similar when it comes to the use of umbrella names and trade names, which companies would like to maintain across countries to facilitate product recognition but which not all member states allow, and in pricing and product safety, both dealt with nationally.

On product safety, although the EC is in line with AESGP in calling for no periodic safety update reports on well-established products, "not all states are happy with this proposal," Terberger acknowledged.

He was optimistic, though, that moves to simplify the PSUR package requirements would progress, even though countries should, in his view, maintain the right to ask for a PSUR on certain products if they wish.

Similarly, he pointed out, although legislation already allows "automatic recognition" of one country's OTC product approval by others, allowing them to save work on the basis of trust, "it's for each state to decide which level of trust to apply."

This situation - which makes a pan-European OTC launch very cumbersome, if not impossible - is one reason AESGP is calling for wider access to the centralized approval procedure.

But such a change would require a change in legislation, Terberger pointed out - as would any change in Europe's rules on data exclusivity. That means going through other European institutions and gaining a majority vote among country representatives.

As long as the OTC market remains largely nationally driven, industry will continue to call for EMA to further step up its role.

"EMA has become the default pathway for prescription drugs, but for consumer products, we have only just managed to open the door," Scheske summarized. "Only the future will tell if we can open it further."

- Melanie Senior ( ⁴ m.senior@elsevier.com )

This article first appeared in The Tan Sheet on Feb 1, 2010.