Vacca González Claudia Patricia, Fitzgerald James F, Bermúdez Jorge A Z
Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Universidad Nacional de Colombia, Santa Fe de Bogotá, Colombia.
Rev Panam Salud Publica. 2006 Nov;20(5):314-23. doi: 10.1590/s1020-49892006001000004.
To characterize current regulatory practices and trends relating to competing medications in 14 Latin American and Caribbean countries.
Between July 2004 and April 2005 we collected information on national regulations and policies that established or contained a definition of "generic drug" and related terms in 14 Latin American and Caribbean countries: Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, and Venezuela. We also compiled information on the incentives to register and produce competing medications, promotion of the use of International Nonproprietary Names (INNs) for pharmaceutical substances, the regulation of bioequivalence studies, and the replacement of prescription medications with less expensive alternatives.
We noted three patterns in the regulations: (1) countries that encourage financial support for competing medications, extensively promote the use of INNs, and place no restrictions on the replacement of innovative (proprietary) medications with competing products (Argentina, Colombia, Costa Rica, Ecuador, and Paraguay); (2) countries with policies aimed at showing therapeutic equivalence, which limits substitutions to approved products from a list of authorized competing medications that must be prescribed by their INN and must use distinctive labeling (Brazil, Mexico, Panama, and Venezuela); and (3) countries at a beginning stage in the process of regulation (Barbados, Bolivia, Guatemala, Nicaragua, and Peru). This variety leads to difficulties in characterizing pharmaceutical markets, and can lead to misleading categorizations.
Efforts to harmonize policies should consider the possible relationship among definitions adopted in different countries, the development of national pharmaceutical markets, and national policies to stimulate competition.
描述14个拉丁美洲和加勒比国家与竞争性药物相关的现行监管做法及趋势。
在2004年7月至2005年4月期间，我们收集了14个拉丁美洲和加勒比国家（阿根廷、巴巴多斯、玻利维亚、巴西、哥伦比亚、哥斯达黎加、厄瓜多尔、危地马拉、墨西哥、尼加拉瓜、巴拿马、巴拉圭、秘鲁和委内瑞拉）有关建立或包含“仿制药”及相关术语定义的国家法规和政策的信息。我们还汇编了有关注册和生产竞争性药物的激励措施、促进使用药物国际非专利名称（INN）、生物等效性研究的监管以及用成本较低的替代药物替代处方药的信息。
我们在法规中发现了三种模式：（1）鼓励对竞争性药物提供财政支持、广泛推广使用INN且对用竞争性产品替代创新（专利）药物不设限制的国家（阿根廷、哥伦比亚、哥斯达黎加、厄瓜多尔和巴拉圭）；（2）旨在证明治疗等效性的国家，其替代限于来自授权竞争性药物清单的已批准产品，这些产品必须按其INN开具处方且必须使用独特标签（巴西、墨西哥、巴拿马和委内瑞拉）；（3）处于监管进程初始阶段的国家（巴巴多斯、玻利维亚、危地马拉、尼加拉瓜和秘鲁）。这种多样性导致难以描述药品市场特征，并可能导致误导性分类。
协调政策的努力应考虑不同国家采用的定义之间可能的关系、国家药品市场的发展以及刺激竞争的国家政策。
