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WFPMM LAYS GROUNDWORK FOR LATIN AMERICAN OTC MANUFACTURERS UMBRELLA GROUP

This article was originally published in The Tan Sheet

Executive Summary

WFPMM LAYS GROUNDWORK FOR LATIN AMERICAN OTC MANUFACTURERS UMBRELLA GROUP that is expected to be established within the next 16 months, the World Federation of Proprietary Medicine Manufacturers announced Oct. 29 at its 11th General Meeting in Acapulco, Mexico. The first regional meeting between Mexico and select Central and South American countries in the industry alliance is tentatively slated for the spring of 1995, WFPMM said. Preliminary discussions took place at the general meeting. The central goals of the group will include the promotion of "harmonization of regulatory approaches and market liberalization for nonprescription medicines," according to WFPMM. However, the federation emphasized that specific tactics have not yet been outlined. "Latin America seems the natural place to work on a converging regulatory process," WFPMM Director-General Jerome Reinstein, PhD, stated, noting that the region presently has 21 distinct regulatory systems which "[slow] down the process and thus (reduce] access to these products for peoples of the region." He suggested that the benefits of "few languages in the region and a similar culture" relative to Europe could facilitate the group's work in the approximately $ 12.2 bil. marketplace. Currently, the two working groups involved in preliminary discussions of the Latin American branch are divided along existing economic alliance lines: the northern alliance of Mexico, Venezuela, Colombia, and the Central American union, CACM, including the Dominican Republic and all Central American countries except Belize; and the southern alliance of Brazil, Argentina, Uruguay, Paraguay, and Chile. The establishment of the Latin American branch is part of a larger WFPMM campaign to form now nonprescription drug associations in countries where either none exist or previous groups have been dismantled. By the end of October, WFPMM had 43 associated groups in six continents. Following a springtime campaign by WFPMM in Latin America, Venezuela's CAVEME joined the federation, while Guatemala reactivated its nonprescription group and joined WFPMM in October. In addition, Brazil's ABIFARMA group and the recently formed Argentinian group will both join WFPMM by the spring of 1994. Harmonizing Latin American markets was a recurrent theme in speeches given before the WFPMM general assembly. Procter & Gamble-Latin America Product Safety and Regulatory Affairs Associate Director Frank Anastasia told the group that "lack of harmonization between [Latin American] countries is one of the biggest reasons why we have inefficiencies and needless duplication of effort that in the end costs the consumer more money and denies them access to the best medicines in a timely fashion." Anastasia suggested to the Latin American countries that they "get the best of what is already available" in the U.S., Canadian, Japanese, and European Community systems and "adapt and adopt" it into a larger, harmonized framework for the region by 1998. "Individual member states can no longer afford to run de novo registration systems that are independent of each other," Anastasia told the group. He recommended that the countries "start harmonization using available economic alliances," including the Caribbean Common Market, the Pacto Andino (Columbia, Peru, Venezuela, Ecuador, and Bolivia), the Grupo de los Tres (Mexico, Columbia, Venezuela), Mercosur (Brazil, Argentina, Uruguay, Paraguay) and CACM. "Our current economic alliances are the key to our successes in the future," he maintained. "The dream must be to harmonize the regulations and registration systems in all of Latin America so that one drug dossier meets the needs of all boards of health and one approval means approval in all countries," Anastasia said. Anastasia pointed out that Mercosur has already set 1995 as their target deadline for a uniform regulatory system, and ministers of health from the Pacto Andino countries began harmonization discussions in October and will continue them in November. Countries in the Grupo de los Tres will also meet in December. "After decades of state health care, [these countries] are starting to run short of funds to meet the increasing health care needs and demands in their countries," he said. "Years of consumer research" have shown that the "almost half a billion" Latin American citizens have "on average" similar health care "habits and practices . . . regardless of where they live," Anastasia asserted. "We have a veritable plethora of regulatory systems in Latin America that, if harmonized, would give all our consumers the best possible products and alternatives in a timely fashion," he concluded. However, according to Enrique Fefer, MD, of the Pan American Health Organization branch of the World Health Organization, "there are two broad ongoing processes in Latin America" that need to be considered. One is the harmonization activity "at the intercountry (subregional) level [which] has as its goal the creation of expanded pharmaceutical markets within free trade zones," and the second, "which takes place at the national level, aims at deregulating the market." Fefer asserted that "the two processes are not always compatible." While the "overriding concern" in Latin America "is to expand the market, to increase the availability of pharmaceutical products, hoping to create greater competition and thereby moderating price increases," Fefer said that "government officials are painfully aware of their limitations to monitor the quality of drugs presently produced or imported into their countries." Fefer cited certain countries' "automatic registration of products that have been approved and marketed in select countries"; in many cases, regulatory authorities "have just a few weeks" to register the product. "The pressure to meet such deadlines will ensure that most products will not be properly evaluated," he said. Furthermore, Fefer said, the decision to harmonize will be made by government officials and Latin American presidents, who "will proceed without waiting for the Health Ministries to have the infrastructure or the resources to ensure the timely review and resolution of the many legal, administrative and technical problems that will surely appear." He warned the audience to "expect ad hoc decisions and temporary measures during the transition" as a result. World Health Organization Assistant Director-General Fernando Antezana suggested that another complicating factor in Latin American harmonization is the different cultural experience and understanding of OTC medications from country to country. Antezana classified the types of OTC experiences into two categories. "One is self-medication within the national health care system" such as "venta libre" drugs in Mexico, while "the other is self-medication as part of informal health care," he explained to the WFPMM audience. The informal health care experience is prevalent in developing countries, he said, where "approximately 50% of drug consumption . . . is in one way or another related to some form of self- medication." In these developing countries, "the line between prescription and over-the-counter products is very fine . . . Self-medication can be of great concern if the products involved are highly potent, very sensitive to dosage variations, or require close clinical surveillance," he maintained. Antezana urged WFPMM to undertake an education campaign in those countries where to date, OTCs have existed only in the absence of any regulatory structure. He asked the nonprescription drug manufacturers to think of product promotion in terms of the "possible ways in which you might use your privileged access to the public to an educational purpose." In entering these new OTC marketplaces, manufacturers should use their resources "to facilitate the development of the health care infrastructure wherever you establish your markets," Antezana concluded. Mexico's Deputy Minister of Health, Mercedes Juan, MD, told the group that in the process of harmonizing and revising its regulatory system, Mexico has turned an eye to the U.S. as well as to other Latin American countries. She said that SSA, Mexico's regulatory body, remains in constant contact with FDA, and has allowed FDA's recent rulings on labeling for antacids, antidiarrheals, and analgesics to guide its own decisions. Currently in Mexico, there are 200 OTC products registered with SSA, using approximately 100 different active ingredients.
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