{"id":94563,"date":"2022-03-08T03:00:59","date_gmt":"2022-03-08T02:00:59","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=94563"},"modified":"2022-03-04T12:54:29","modified_gmt":"2022-03-04T11:54:29","slug":"health-eu","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/health-eu\/","title":{"rendered":"Negotiations for the international treaty on pandemics"},"content":{"rendered":"<p><strong>The Council adopted a decision to authorise the opening of negotiations for an international agreement on pandemic prevention, preparedness and response. The decision also clears the way for negotiating complementary amendments to the International Health Regulations.<\/strong><\/p>\n<p><a href=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-scaled.jpg\"><img decoding=\"async\" class=\" wp-image-98471 aligncenter\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-scaled.jpg\" alt=\"\" width=\"702\" height=\"465\" srcset=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-scaled.jpg 2560w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-300x199.jpg 300w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-1024x678.jpg 1024w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-768x509.jpg 768w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-1536x1017.jpg 1536w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2022\/03\/patrick-c-freyer-qHTBlOyMljs-unsplash-2048x1356.jpg 2048w\" sizes=\"(max-width: 702px) 100vw, 702px\" \/><\/a><\/p>\n<p>The decision authorises the Commission, for matters falling within Union competence, to negotiate an international agreement on pandemic prevention, preparedness and response. The negotiating directives, annexed to the decision, outline the objectives and principles of the agreement. The negotiating directives can be revised and further developed as appropriate depending on the evolution of the negotiations.<\/p>\n<h4>Response to COVID-19<\/h4>\n<p>COVID-19 illustrated the need for enhanced preparedness and closer cooperation at global level. Improved collaboration between research centers around the globe and better coordination of international funding could improve monitoring of risks and knowledge-sharing about new infectious deseases. Global coordination of stockpiling could ensure countries have access to essential supplies. A pandemic agreement could also lead to better response mechanisms and tackle inequities in access to vaccines, medicines and diagnostics.<\/p>\n<p><strong>Source: <a href=\"https:\/\/www.consilium.europa.eu\/en\/press\/press-releases\/2022\/03\/03\/council-gives-green-light-to-start-negotiations-on-international-pandemic-treaty\/\" target=\"_blank\" rel=\"noopener\">European Council<\/a><\/strong><\/p>\n<h4>Regulation on EMA\u2019s extended mandate becomes applicable<\/h4>\n<p>Moreover, the EMA is now responsible for monitoring drug shortages that may lead to a crisis situation, as well as reporting on critical drug shortages during a crisis. The Agency will also coordinate EU\/EEA countries&#8217; responses to shortages of critical medical devices and in vitro diagnostics in crisis situations, following an initial transition period until February 2, 2023.<\/p>\n<p>In preparation for the application of the new regulation, EMA has set up the permanent secretariat to support 12 medical device expert panels established by the\u00a0<a class=\"ecl-link--external\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=uriserv:OJ.L_.2017.117.01.0001.01.ENG\" target=\"_blank\" rel=\"noopener\">Medical Devices Regulation<\/a>\u00a0in order to improve the safety of medical devices marketed in the EU \/ EEA. The expert panels, previously managed by the Commission\u2019s Joint Research Centre, provide opinions and views to\u00a0<a id=\"glossary-term-57391\" class=\"ecl-link glossary-term\" title=\"An accredited body that conducts conformity assessments for medical devices\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/notified-body\" target=\"_blank\" rel=\"noopener\">notified bodies<\/a>\u00a0on the scientific assessment of clinical and performance evaluations of certain high-risk medical devices and in-vitro diagnostics.<\/p>\n<p>In addition, in order to ensure a robust response to major events in relation to shortages, the legislation establishes an Executive Steering Group on Shortages and Safety of\u00a0<a id=\"glossary-term-43242\" class=\"ecl-link glossary-term\" title=\"A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/medicinal-product\" target=\"_blank\" rel=\"noopener\">Medicinal Products<\/a>\u00a0(also known as the Medicines Shortages Steering Group, MSSG).<\/p>\n<p>The Emergency Task Force (ETF) is expected to start operating under the new rules from mid-April. Its responsibilities include: providing\u00a0<a id=\"glossary-term-43177\" class=\"ecl-link glossary-term\" title=\"The provision of advice by the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medicine.\u00a0 More information can be found under\u00a0'Scientific advice and protocol assistance'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/scientific-advice\" target=\"_blank\" rel=\"noopener\">scientific advice<\/a>\u00a0on the development of products intended for use during a public health emergency, reviewing scientific data, providing recommendations on the use of unauthorised medicines, and coordinating independent vaccine effectiveness and safety monitoring studies. The composition and Rules of Procedure of the MSSG and ETF will be considered for endorsement by EMA\u2019s Management Board in March.<\/p>\n<p><strong>Source: <a href=\"https:\/\/www.ema.europa.eu\/en\/news\/regulation-emas-extended-mandate-becomes-applicable\" target=\"_blank\" rel=\"noopener\">EMA<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Council adopted a decision to authorise the opening of negotiations for an international agreement on pandemic prevention, preparedness and response. The decision also clears the way for negotiating complementary amendments to the International Health Regulations. The decision authorises the Commission, for matters falling within Union competence, to negotiate an international agreement on pandemic prevention, [&hellip;]<\/p>\n","protected":false},"author":101011,"featured_media":98472,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[4093,346,4092],"tags":[1488,437],"class_list":{"0":"post-94563","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-diseases","8":"category-eu-news","9":"category-health","10":"tag-european-commission","11":"tag-health","12":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Negotiations for the international treaty on pandemics | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda<\/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:\/\/www.cde.ual.es\/sanidad-ue\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Negotiations for the international treaty on pandemics | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"og:description\" content=\"The Council adopted a decision to authorise the opening of negotiations for an international agreement on pandemic prevention, preparedness and response. 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