At AESGP, Challenges Temper Optimism As Leaders View Future Of OTC

At the 45th annual meeting of the Association of the European Self-Medication Industry, executives reflected on the challenges of the European market even as OTC business units enjoy increased prominence within global and diversified organizations.

At the 45th annual meeting of the Association of the European Self-Medication Industry, executives reflected on the challenges of the European market even as OTC business units enjoy increased prominence within global and diversified organizations.

One undercurrent evident at the early June meeting in Vienna, Austria, was that even if consumer medicines have not yet emerged from the shadow of much larger prescription drug operations, they are at least a bright spot for diversified pharmaceutical companies facing difficult Rx futures.

But during a June 3 panel discussion on industry responses to change, executives voiced concerns about pharmaceutical standards being applied to various sections of the consumer medicine area in Europe and beyond, and discussed the need for modernization and harmonization of European and global OTC processes.

Perhaps most familiarly, the industry representatives called for transparency in regulatory decision-making and uniform implementation of European decisions and directives at the national level across the continent.

A Renaissance In Self-Medication?

The news for industry was far from gloomy. Rx-to-OTC switches such as GlaxoSmithKline's alli and Johnson & Johnson's Zyrtec have rejuvenated European and U.S. markets and driven growth, the panelists noted. And continued success in OTC switching could drive innovation in consumer health going into the next decade, they said.

Nycomed's OTC pantoprazole (a 20 mg dose of the drug to be sold as Pantozol Control ) recently received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use ¹ ('The Tan Sheet,' May 18, 2009, p. 5). That CHMP recommendation should result in EMEA approval this summer, Nycomed head of OTC Etienne De Laroulliere said in an interview at AESGP (see ² following story ).

Boehringer Ingelheim's worldwide head of consumer care, Hans Regenauer, noted global OTC sales in 2008 for the first time grew at a faster pace than sales of prescription drugs, albeit from a much lower base.

Demographic and economic drivers, including the rising importance of emerging markets and an aging population, should ensure this trend continues, he said.

Executives from companies well-positioned to capitalize on these trends they anticipated during leaner OTC times deserve credit for success today.

"Back then," said Bayer consumer care president Gary Balkema, referring to the early days of Bayer's modern consumer health efforts in the mid-1990s, "it wasn't so glamorous to be in the diversified anything business."

Companies that have committed to striking a balance between prescription and nonprescription health care are now reaping the rewards, he said.

Bayer strives for a one-third to two-thirds OTC-to-prescription ratio and has grown its consumer health business from 700 million euros in 1994 ($855.2 million under 1994 exchange rates) to 2.8 billion euros in 2008 ($3.98 billion under current rates), said Balkema.

"We weren't even ranked in the top 10 in 1994," he said, noting that Bayer is now the second-largest OTC player in the world, behind Novartis.

Holding OTC To An Rx Standard

Nevertheless, Europe's OTC players face challenges stemming from higher standards on OTC product claims, said the executives.

None of the panelists presented the challenges more starkly than Merck KGaA Consumer Health Care Managing Director Peter Shotter, who titled his talk "Health Claim Regulation in Europe: A threat to innovation?"

"There's increasing concern at what seems to be near blanket rejection" of health claims for disease reduction and children's development and health, said Shotter.

He cited guidance adopted in 2007 by the European Food Safety Authority designed to help applicants seeking approval (³ 'The Tan Sheet,' Aug. 27, 2007, p. 14).

"The evidence that seems to us to be demanded is moving more toward the Rx drug standards for approval. Clearly, if unchallenged, that poses some pretty significant challenges and dangers for all of us from consumers, customers, companies themselves and governments," Shotter said.

He described Merck's difficulties in securing claims for docosahexaenoic acid in brain and visual development in unborn and breast-fed children. There was a causal link validated by a European Union consensus paper, which was peer-reviewed and published in the literature, and adopted by the EU, he said, which should have meant smooth sailing for the claims.

"When we submitted our claims to EFSA, firstly the consensus paper was endorsed. Then we were told we needed actually to validate the causal link for our products," when an EFSA panel rejected Merck's claims and claims from another manufacturer, Martek Biosciences, in April, said Shotter.

"As you can imagine if you take that to its ultimate conclusion, we're talking tens of millions of investment in clinical trials" to establish the link for our particular products, he said. "If you multiply that by all the companies and all the products in the supplements industry, it's unsustainable."

But higher standards can present opportunities for consumer health companies as well, Cavan Redmond, president of Wyeth Consumer Healthcare, pointed out during his own presentation.

At the close of Pfizer's takeover of Wyeth, Redmond is slated to head up Pfizer's diversified business unit, which will oversee Wyeth's consumer health and nutrition businesses as well as both Pfizer's and Wyeth's animal health businesses (⁴ 'The Tan Sheet' April 13, 2009, p. 12).

Ensuring quality and avoiding manufacturing mishaps should increase consumer confidence and thus drive growth, said Redmond. "Those are issues that on the OTC side threaten our very businesses, and we need to raise our own standards above where governments and agencies want us to go," he said.

This may be particularly true in communicating to consumers as transparently as possible through effective labeling and packaging about ingredients, health claims, and how products work. "It's no longer sufficient to have on the box what's required by the governments," he said.

"We need new ways, new formats, new processes to communicate with consumers so they can clearly understand" what's in an OTC product and what other medicines they can take concomitantly, he said.

Consumers need to be educated about when and how a particular product should be used, and when it should not, "and what individual ingredients really do for you in clear and concise language that everybody can understand within the family," said Redmond.

A Call To Modernize

Although Redmond and other executives accepted that individual European nations and Europe as a whole are working hard to deliver safe and effective self-medication to consumers on the continent, the globalization of product information often means European consumers are ahead of the game.

As such, there is an opportunity now to look at how associations, governments and businesses "can drive toward a modernization process to allow more clarity across the globe, and more standardization across the globe, in terms of manufacturing, in terms of claims, in terms of content and in terms of where we want self- medication to go throughout the world," said Redmond.

"I see a world where more people have access to information and are looking for solutions that can get applied broadly. I see a world where information travels quickly from country to country, regulator to regulator, company to company" to more effectively address the issues that arise in consumer health care, he said.

Bayer's Balkema agreed. While allowing for local behaviors and tailored communication to specific populations, because of the way consumers get information - largely via the Internet - "If we're not consistent, if there's a crack in the trust we've earned, I think we have a problem."

- Christopher Morrison (c.morrison@elsevier.com)

This article first appeared in The Tan Sheet on June 14, 2009.