EU Centralized Switch Process Needs Longer Exclusivity, More Trust - Execs

Limited data protection and a lack of trust between industry and regulators are dampening enthusiasm for the European Union's centralized switch process, according to industry leaders.

At the 46 annual meeting of the Association of the European Self-Medication Industry in Dubrovnik, Croatia, several Big Pharma executives acknowledged switching prescription products to nonprescription simultaneously in all 27 EU countries is one driver of the OTC market, but they complained the centralized switch process does not offer enough protection from competition.

Currently companies receive one year of protection on the data used in their switch submissions, before other companies can use it to support submissions. To qualify for exclusivity, the data must be relevant, necessary and unable to be gleaned from existing data (¹ (Also see "European Switch Progresses, But Stronger Incentives Needed For OTCs" - Pink Sheet, 1 Feb, 2010.)).

Etienne de Laroulliere, head of the international OTC strategic business at Swiss firm Nycomed, said the one year of exclusivity is too short for a company to recoup its investment in initiating a centralized EU switch.

De Laroulliere called for a much longer duration of data exclusivity, possibly three years - as allowed in the U.S. under the Hatch-Waxman Act.

Pantoloc Control Exclusivity Lasts One Month

De Laroulliere's suggestion may stem from Nycomed's experience with centralized switch of its Pantoloc Control (pantoprazole 20 mg). The proton pump inhibitor received the European Commission's approval for nonprescription sales June 12, 2009, but lost exclusivity in 12 European countries one month later (² (Also see "Novartis To Launch Nycomed's PPI Pantoloc Control In 14 European Countries" - Pink Sheet, 1 Feb, 2010.)).

Although competition with other OTC PPIs has been manageable in most countries, Germany has been a particular problem. More than 27 other companies launched PPI products there, causing confusion among pharmacists and consumers, de Laroulliere observed.

Longer data exclusivity also is necessary at the national level for switched products.

Sheila Kelly, chief executive of the Proprietary Association of Great Britain, pointed out educational campaigns for pharmacists and consumers on switches require a huge investment by companies.

James Hallatt, general manager of GlaxoSmithKline Consumer Healthcare UK, agreed that firms need longer exclusivity under centralized switch.

Further, the "the regulations governing centralized switching need to be more efficient and predictable," Hallatt said.

For example, even if a drug is switched centrally, individual countries still choose whether the new nonprescription product can be sold over-the-counter (general sales) or behind-the-counter (pharmacy only) (³ (Also see "Centralized Switch Can Be Improved Via Practice, Practical Strategy" - Pink Sheet, 15 Feb, 2010.)).

Hallatt also expressed concern about the attitude of regulators to companies taking part in the switching process.

There is a sense that regulators think the industry is "trying to pull a fast one," he said.

"This could not be further from the truth. I have never sat in a meeting where there has been a sense other than trying to do the right thing for consumers and patients," he said.

GSK in 2008 became the first firm to successfully switch a product in the EU's centralized process, with weight-loss drug alli (orlistat 60 mg) (⁴ (Also see "Alli Pioneers EU Centralized Process For Nonprescription Switch" - Pink Sheet, 27 Oct, 2008.)).

Firms Question CHMP's Scientific Bias

Company executives also are uneasy about the role of the European Medicines Agency's Committee for Medicinal Products for Human Use in deciding centralized switches.

That committee is made up of researchers and scientists. Executives say people with skills such as an appreciation of consumer marketing also should be involved in switch decisions.

They noted since late 2008 CHMP has questioned two proposed centralized switches that the sponsors later withdrew.

Following CHMP questions, Wyeth (now Pfizer) withdrew its application to switch ibuprofen plus diphenhydramine product for the treatment of mild to moderate pain in adults who experience sleeplessness as a result of the pain.

Pfizer also withdrew its application to switch the erectile dysfunction drug Viagra (sildenafil) in late 2008 (⁵ (Also see "Pfizer Pulls Back On European Viagra Switch As Questions Linger" - Pink Sheet, 24 Nov, 2008.)).

The company said in a release it wished to "fully consider the comments from the CHMP, recognizing that there were some concerns regarding the proposed supply of Viagra 50 mg tablets without a prescription in the pharmacy setting across the EU."

Pharmacists' Role Considered

Martin Terberger, head of the EC's pharmaceuticals unit, explained part of CHMP's role in the centralized switch process is to consider the pharmacy practices in all EU countries, and the risks of a switched product being available through pharmacists in each of those countries.

The suggestion that not all pharmacists in the EU are up to the task of selling switched products earned a swift rebuke at the conference from Ian Banks, president of the European Men's Health Forum, a non-profit organization.

"Pharmacists are trained health care professionals, and it is being unfair to them," he said.

Banks also argued that the launch of an OTC statin in the UK in 2004, McNeil's Zocor Heart-Pro (simvastatin), has not been much of a success because pharmacists were not trained sufficiently to have enough confidence in what they were doing.

Those pharmacists were directing patients to see their doctors rather than selling them Zocor Heart-Pro, he said, adding that self-care should be added to the training curriculum of doctors and pharmacists.

The Time To Voice Concerns

Now, at the start of a new EC session, is the best time to bring forward legislative or regulatory changes, Terberger said.

He said the commission, which started work in February, and new EU Commissioner for Health and Consumer Policy John Dalli, who also was appointed in February, still are sorting mandates.

However, Terberger questioned whether the pharmaceutical industry really wants to re-open a debate on data protection.

The compromise agreements between legislators and companies on data protection were central to the reforms of EU health care policy in 2004, and he wondered whether "microsurgery" on the legislation was feasible.

Terberger said the industry also must address some of the concerns expressed by other groups involved in the regulatory and legislative process. For example, he asked, why did European consumer groups oppose the first centralized switches, and why are European regulators not happy with websites being displayed on OTC medicine packs?

- John Davis ( ⁶ [email protected] )