{"id":37772,"date":"2025-03-31T07:30:45","date_gmt":"2025-03-31T12:30:45","guid":{"rendered":"https:\/\/www.sucre.net\/?p=37772"},"modified":"2025-03-26T14:56:35","modified_gmt":"2025-03-26T19:56:35","slug":"importacion-paralela-de-medicamentos-en-panama-cambios-en-el-mercado-farmaceutico","status":"publish","type":"post","link":"https:\/\/www.sucre.net\/en\/importacion-paralela-de-medicamentos-en-panama-cambios-en-el-mercado-farmaceutico\/","title":{"rendered":"Parallel Importation of Medicines in Panama: Changes in the Pharmaceutical Market."},"content":{"rendered":"<p>In an effort to ensure access to essential medicines at more affordable prices, the Government of Panama, through Law 462 of March 18, 2025, adds new articles to Law 419 of 2024, which regulates medicines, other products for human health, and the public procurement of medicines, to incorporate the procedure for the parallel importation of medicines. This measure aims to expand the availability of pharmaceuticals within Panama's public health system. <strong><a href=\"https:\/\/www.gacetaoficial.gob.pa\/pdfTemp\/30238\/111149.pdf\">Ley 462 del 18 de marzo de 2025<\/a>, <\/strong>adiciona nuevos art\u00edculos a la <strong>Ley 419 de 2024<\/strong>, que regula los medicamentos, otros productos para la salud humana y, la adquisici\u00f3n p\u00fablica medicamentos, para incorporar el <strong><u>procedimiento de importaci\u00f3n paralela de medicamentos<\/u><\/strong>. Esta medida busca ampliar la disponibilidad de f\u00e1rmacos en el sistema de salud p\u00fablica en Panam\u00e1.<\/p>\r\n<h2><strong>\u00bf<u>What is the Parallel Importation of Medicines?<\/u>?<\/strong><\/h2>\r\n<p>It is a mechanism that allows public health institutions to acquire\/import patented essential medicines in Panama directly from other countries where the medicine is available at a more accessible price, without the intermediation of exclusive distributors. The importation will be carried out for the purpose of distribution and supply within Panama\u2019s health systems, provided the requirements established by law are met and without contravening the provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and other binding international regulations. <strong>Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual Relacionados con el Comercio (ADPIC) de la OMC<\/strong>, as\u00ed como otras normativas internacionales vinculantes.<\/p>\r\n<h3><strong>\u00bf<u>What medicines can be imported under this mechanism?<\/u>?<\/strong><\/h3>\r\n<p>According to the new legislation, parallel importation applies exclusively to:<\/p>\r\n<ul>\r\n<li>Medicamentos incluidos en la <strong>lista de medicamentos b\u00e1sicos y esenciales<\/strong> determinada por la <strong>\u2022\tMedicines included in the list of essential medicines determined by the World Health Organization (WHO).<\/strong>.<\/li>\r\n<li><strong>Productos innovadores<\/strong> con patente reciente que hayan demostrado costo efectividad, que sean de <strong>Recently patented innovative products that have proven to be cost-effective, are in high demand, and are necessary to treat highly prevalent diseases in the Panamanian population, especially those that affect public health.<\/strong> y necesarios para tratar enfermedades <strong>de alta prevalencia<\/strong> en la poblaci\u00f3n paname\u00f1a, especialmente aquellas que afectan a la salud p\u00fablica.<\/li>\r\n<\/ul>\r\n<h3><strong>\u00bf<u>Who can import and under what conditions?<\/u>?<\/strong><\/h3>\r\n<p>Importation is only authorized for the Ministry of Health and the Social Security Fund (CSS), without the involvement of exclusive distributors. The National Directorate of Pharmacies and Drugs will issue a Parallel Import Permit for Essential Medicines (PIPME) to authorize the importation, which will be subject to the following conditions: <strong>el Ministerio de Salud<\/strong> y la <strong>Caja de Seguro Social (CSS)<\/strong>, sin intervenci\u00f3n de distribuidores exclusivos. \u00a0La Direcci\u00f3n Nacional de Farmacias y Drogas expedir\u00e1 un <strong>Permiso de Importaci\u00f3n Paralela de Medicamentos Esenciales (PIPME) <\/strong>para autorizar la importaci\u00f3n, el cual estar\u00e1 sujeto a las siguientes condiciones:<\/p>\r\n<ul>\r\n<li>The medicine must be essential and listed by the WHO.<\/li>\r\n<li>It must be guaranteed that the imported medicines are of the same quality and effectiveness as the patented and marketed medicines in Panama.<\/li>\r\n<li>The price must be significantly lower than that available in the Panamanian market.<\/li>\r\n<li>The importer must be exclusively a public health institution.<\/li>\r\n<li>Permit validity: 2 years, extendable for one additional year.<\/li>\r\n<\/ul>\r\n<h3><strong><u>Impact and benefits of this regulation<\/u><\/strong><\/h3>\r\n<p>The implementation of parallel importation in Panama seeks to generate a positive impact on access to essential medicines, allowing for:<\/p>\r\n<ul>\r\n<li><strong>Cost reductions for the public healthcare system.<\/strong> para el sistema de salud p\u00fablica.<\/li>\r\n<li><strong>Greater availability of essential medicines for the population.<\/strong> de medicamentos esenciales para la poblaci\u00f3n.<\/li>\r\n<li><strong>Guaranteed quality and effectiveness, ensuring that imported products comply with required health standards.<\/strong>, asegurando que los productos importados cumplan con los est\u00e1ndares sanitarios exigidos.<\/li>\r\n<\/ul>\r\n<h3><strong><u>Conclusion<\/u><\/strong><\/h3>\r\n<p>The parallel importation of medicines represents progress in Panama\u2019s public health policy, aligning with international models that have proven effective in reducing costs and improving access to essential treatments.\nWith this measure, the country strengthens its capacity to guarantee the right to health for its population without violating international intellectual property commitments.\n\nIn this context, the government, through its public policy initiatives, opens the door to the participation of pharmaceutical laboratories committed to public health. Parallel importation not only promotes competition and cost reduction but also represents a strategic opportunity for pharmaceutical sector stakeholders interested in expanding their presence in the market. <strong>laboratorios farmac\u00e9uticos<\/strong> comprometidos con la salud p\u00fablica.\u00a0 La importaci\u00f3n paralela no solo promueve la competencia y reducci\u00f3n de costos, sino que tambi\u00e9n representa una oportunidad estrat\u00e9gica para aquellos actores del sector farmac\u00e9uticos interesados en ampliar su presencia en el mercado. <a href=\"https:\/\/www.sucre.net\/en\/contact\/\">If you are interested in exploring this opportunity or would like more details on how to participate in the parallel importation process with the government, feel free to contact us. We are ready to assist you with any inquiries!<\/a><\/p>\r\n\r\n<div class=\"wp-block-spacer sc_height_medium\" style=\"height: 100px;\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<div class=\"wp-block-columns is-not-stacked-on-mobile post-autor-combo has-background is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\" style=\"background-color: #ffffff;\">\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis: 15%;\">\r\n<figure class=\"wp-block-image size-medium is-style-default\"><img decoding=\"async\" class=\"wp-image-34413\" src=\"https:\/\/www.sucre.net\/wp-content\/uploads\/2024\/03\/Veronica-P-Nativi-Nicolau-840x970.jpg\" alt=\"\" \/><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis: 85%;\">\r\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-03639cc5c891afd18c737678b652ca96\" style=\"color: #333333;\">Authorship: <strong><a href=\"https:\/\/www.sucre.net\/en\/team\/veronica-p-nativi-nicolau\/\">VERONICA P. NATIVI<\/a><\/strong><\/h3>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons has-custom-font-size has-small-font-size is-content-justification-left is-layout-flex wp-container-core-buttons-is-layout-fdcfc74e wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button has-custom-font-size has-small-font-size\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.sucre.net\/en\/team\/veronica-p-nativi-nicolau\/\">PROFILE<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button has-custom-font-size is-style-outline has-small-font-size is-style-outline--1\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.sucre.net\/en\/tag\/veronica-p-nativi-nicolau \/\">CONTENTS<\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","protected":false},"excerpt":{"rendered":"<p>En un esfuerzo por garantizar el acceso a medicamentos esenciales a precios m\u00e1s accesibles, el Gobierno de Panam\u00e1 mediante la Ley 462 del 18 de marzo de 2025, adiciona nuevos&hellip;<\/p>","protected":false},"author":3,"featured_media":37773,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[297],"tags":[413,404,380,393],"class_list":["post-37772","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-asuntos-regulatorios","tag-bufete-de-abogados-en-ciudad-de-panama","tag-servicios-legales","tag-servicios-legales-cerca-de-mi-en-ciudad-de-panama"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Importaci\u00f3n paralela de medicamentos en Panam\u00e1: Cambios en el mercado farmac\u00e9utico. - Sucre Arias Reyes<\/title>\n<meta name=\"description\" content=\"Conoce c\u00f3mo la importaci\u00f3n paralela de medicamentos transformar\u00e1 el mercado farmac\u00e9utico en Panam\u00e1 seg\u00fan la Ley 462 de 2025.\" \/>\n<meta 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