European OTC Market Conference In Brief

Countries expand nonprescription sales: Italy and Hungary ease regulations for sales of nonprescription drugs. Drug companies and stores in Italy now can price nonprescription drugs as they wish as long as the amounts do not exceed prices set in December 2006 and are visible at points of sale, Guido Rasi, director general of the Italian Medicines Agency, said at the Association of the European Self-Medication Industry's (AESGP) Nov. 5 conference in Paris. Rasi added that retail prices also can be discounted. Through October 2008 in Hungary, 701 licensed non-pharmacy outlets were selling nonprescription products, including analgesics and vitamins, said Zsuzanna Szepezdi, director general of the country's National Institute of Pharmacy. She explained that Hungary eased nonprescription sales regulations in early 2007 so that some products can be sold outside the pharmacy if they are stored in closed cupboards and information about the products is available via electronic information systems.

More liberal pack design: The European Medicines Agency and the European Commission are considering a preliminary guideline on package design proposed by AESGP, said Noel Wathion, the EMEA's head of the unit for post-authorization evaluation of medicines for human use, and Martin Terberger, the EC head of unit pharmaceuticals and directorate-general of enterprise and industry. The guideline suggests that member states allow drug firms to include more creative symbols, designs and Web site addresses on the outside of nonprescription product packaging to help consumers differentiate products in a competitive environment, said AESGP Director General Hubertus Cranz. "The point we were trying to make with EMEA was not to say we would like to have nice pictures to be competitive, [but that] different pack designs is a very helpful element with regard to public health and consumer safety," Cranz said, adding that "an over critical attitude of the package design may be exactly against the interest of people." The guideline does not seek to harmonize the use of symbols or pictograms on package leaflets among European Union members, Cranz clarified in response to concerns that consumers can interpret symbols multiple ways, which can lead to confusion and a lack of compliance.

France's open access one year later: A year after French President Nicolas Sarkozy announced the government's free access initiative for nonprescription drugs, in which consumers can access products on store shelves, roughly 18 percent of the country's pharmacies have organized direct-access space and 40 percent intend to do so either voluntarily or when their competitors make the change, said Jean Marimbert, director general of the French Agency for the Safety of Health Products. Marimbert said 272 products are available through direct access - 239 allopathic medicines, 12 herbal and 21 homeopathic. About half of 65 pending product submissions for direct access have been evaluated, but the French agency has yet to render those decisions. Most products address tobacco addiction, asthenia, pain, skin problems, throat aches, coughs and gastric troubles. The number of medicinal products available on store shelves exceeds the 200 previously expected to be available by the end of 2008 (¹ (Also see "French Revolution Gives Freedom To Nonprescription Drug Sales" - Pink Sheet, 19 May, 2008.), p. 13). Before the initiative, France required consumers to access all drugs - even nonprescription products - through pharmacists.

Long wait for drug reviews: Companies seeking approval of nonprescription drugs through the Mutual Recognition and Decentralized Procedure processes face long waits for "slots" in which participating EU members - "reference member states" - consider the products and requests. Review agencies for many of the reference members are booked through 2010, and some are booked as far out as 2013 for reviews of specific types of products because of limited resources and a lack of experts. Christa Wirthumer-Hoche, a member of the EU's coordination group for MR and DP procedures for human drugs, linked the long waits in part to several EU members not participating as reference member states. Wirthumer-Hoche also chastised companies for booking slots with reference members' agencies only to cancel at the last minute, which prevents other firms from using those times and undermines the requirement to schedule time with review agencies. She added that only 4.4 percent of the OTC products approved for marketing in EU member states used these procedures.

Centralized procedure update: The EU's centralized procedure for approving drugs is picking up steam with the approval of 34 of 36 eligible requests based on therapeutic and technical innovations so far, the EMEA's Wathion said. In addition, 20 of 32 eligible requests under the Interest of Patients' Health at Community Level were granted, including six for nonprescription medicines, Wathion said. However, he said only three of six eligible nonprescription products successfully navigated the process of having a centralized procedure application evaluated and communicated to the EMEA. In the first centralized OTC switch decision, the EMEA's CHMP has recommended authorizing GlaxoSmithKline's weight-loss drug alli for nonprescription status, but EU member countries do not agree on how the decision will impact national decisions on drug marketing (² (Also see "Europe Will Clarify Centralized Switch Process As Alli Switch Looms" - Pink Sheet, 17 Nov, 2008.), p. 6).