{"id":5495,"date":"2016-04-21T22:21:46","date_gmt":"2016-04-21T22:21:46","guid":{"rendered":"https:\/\/www.olartemoure.com\/web\/en\/om-weekly-digest-21-04-2016\/"},"modified":"2017-04-26T14:28:49","modified_gmt":"2017-04-26T14:28:49","slug":"om-weekly-digest-21-04-2016","status":"publish","type":"post","link":"https:\/\/olartemoure.com\/en\/om-weekly-digest-21-04-2016\/","title":{"rendered":"OM Weekly Digest (21-04-2016)"},"content":{"rendered":"<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-6258\" src=\"https:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01.jpg\" alt=\"\" width=\"800\" height=\"108\" srcset=\"https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01.jpg 800w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-300x41.jpg 300w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-768x104.jpg 768w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-461x62.jpg 461w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-260x35.jpg 260w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-50x7.jpg 50w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-150x20.jpg 150w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>PERU | Regulatory | Health Minister approved Policy Guidelines on Access to Biotechnological Products<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">On 15 April 2016, the Peruvian Health Minister issued Resolution <span style=\"text-decoration: underline;\"><a href=\"http:\/\/busquedas.elperuano.com.pe\/normaslegales\/aprueban-documento-tecnico-lineamientos-de-politica-de-acce-resolucion-ministerial-no-259-2016minsa-1369373-1\/\">No. 259-2016\/MINSA<\/a><\/span> by means of which the \u201cTechnical Document: Guidelines on Access to Biotechnological Products\u201d was approved. The approved Technical Document purportedly seeks to improve access to safe and efficient biotechnological products, through a rational use, and ensuring financial sustainability for health institutions.<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>COLOMBIA<\/strong> <strong>| Patents | Compulsory Licensing: The Ministry of Health and Social Protection makes a formal price offer in the imatinib (Glivec<\/strong><sup>\u00ae<\/sup>) <strong>case<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">On 12 April 2016, the Ministry of Health and Social Protection issued a <span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/04\/Procedimiento-declaratoria-interes-licencia-obligatoria-imatinib-Glivec.pdf\">communication<\/a><\/span> to Novartis, by means of which it made a formal price offer on the current Administrative Process for the Declaration of Public Interest (DPI) seeking a Compulsory License for a patent covering the <strong>\u03b2 polymorph of imatinib<\/strong> (Glivec<sup>\u00ae<\/sup>).The offer was made following the recommendation issued by the Technical Committee in the DPI procedure. The price offered by the Ministry was COP 140\/mg of imatinib, which constitutes a 60% price reduction.<\/p>\n<p style=\"text-align: justify;\">Imatinib is already offered by two other non-infringing suppliers in the Colombian market, and additionally Glivec<sup>\u00ae<\/sup> has been subject to government price control since 2011.<\/p>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>COLOMBIA<\/strong><strong> | Regulatory | The Colombian Regulatory Authority (INVIMA) reduced the clinical protocol evaluation from 4.5 to 2 months<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">On 12 April 2016, the Colombian Regulatory Authority (INVIMA) announced a time reduction, from 4.5 to 2 months, of clinical protocol evaluations for human drugs approval. This reduction was achieved through 2 main changes aimed at improving evaluation efficiency: i) the simultaneous performance of the technical evaluation of the clinical protocol and the drug quality evaluation; and ii) the Clinical Research Team, from the Drugs and Biological Products Office, will now perform the technical evaluation of clinical protocols, instead of the Special Team for Drugs and Biological Products. For further information, click <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.invima.gov.co\/invima-reduce-el-tiempo-de-evaluaci%C3%B3n-de-protocolos-de-investigaci%C3%B3n-a-dos-meses\">here<\/a><\/span>. (Only in Spanish)<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>COLOMBIA | Consumer Law | The government sanctioned a Decree that allows consumers to revert an online purchase<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">On 11 April 2016, the Government sanctioned <span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/04\/DECRETO-587-DEL-11-DE-ABRIL-DE-2016.pdf\">Decree 587<\/a><\/span> of 2016 which allows consumers to revert any purchase made through an e-commerce mechanism, such as internet, PSE, call center or any other instrument of teleshopping or virtual store, if and when: (i) the payment mechanism used is a debit or credit card, or any other electronic payment system;(ii) the provider of the product and the issuing company of the payment mechanism must be notified within 5 business days counted from the reversion request; and (iii) both the provider and the issuing company of the payment mechanism must be domiciled in Colombia.<\/p>\n<p style=\"text-align: justify;\">This right can be exercised in any of the following scenarios: (i) when the consumer has been a victim of fraud; (ii) when the purchase has not been requested; (iii) when the product has not been received; (iv) when the delivered product is different from the requested one, or does not match the characteristics offered by the provider; and (v) when the product is defective.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>PERU | Regulatory | Health Minister approved Policy Guidelines on Access to Biotechnological Products . On 15 April 2016, the Peruvian Health Minister issued Resolution No. 259-2016\/MINSA by means of which the \u201cTechnical Document: Guidelines on Access to Biotechnological Products\u201d was approved. The approved Technical Document purportedly seeks to improve access to safe and efficient [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6260,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[],"tags":[],"class_list":["post-5495","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>OM Weekly Digest (21-04-2016) - OlarteMoure | Intellectual Property<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/olartemoure.com\/en\/om-weekly-digest-21-04-2016\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OM Weekly Digest (21-04-2016)\" \/>\n<meta property=\"og:description\" content=\"PERU | Regulatory | Health Minister approved Policy Guidelines on Access to Biotechnological Products . 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