{"id":6221,"date":"2023-02-06T11:09:40","date_gmt":"2023-02-06T09:09:40","guid":{"rendered":"https:\/\/sites.uef.fi\/kmru\/?p=6221"},"modified":"2023-02-06T11:26:36","modified_gmt":"2023-02-06T09:26:36","slug":"eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains","status":"publish","type":"post","link":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/","title":{"rendered":"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains"},"content":{"rendered":"\n

For further information, please contact Mirella Miettinen, Senior Researcher<\/strong><\/a>. First published in the UEF News and Events on 9 January 2023<\/em>.<\/a><\/p>\n\n\n\n

EU regulation pertaining to good manufacturing practices and environmental risk assessment of pharmaceuticals does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from the University of Eastern Finland concludes.<\/p>\n\n\n\n

Published by the European Commission in 2020, the Pharmaceutical Strategy for Europe<\/a> highlights the need to revise the EU\u2019s general pharmaceutical legislation (Directive 2001\/83<\/a> and Regulation 726\/2004<\/a>) with regard to environmental risk assessment, and to improve the supervision and transparency of global manufacturing supply chains. The European Commission’s initiative to revise the EU\u2019s pharmaceutical legislation is currently in preparation<\/a>.<\/p>\n\n\n\n

Publishing their findings in Review of European, <\/em>Comparative & International Environmental Law, <\/em>the researchers analysed how good manufacturing practices (GMPs) and environmental risk assessment (ERA) address critical stages of the manufacturing supply chain with regard to environmental emissions, and what kind of challenges these instruments face in regulating the global manufacturing supply chain. The study was carried out as part of the Sustainable Drug Discovery and Development with End-of-Life Yield (SUDDEN)<\/a> project funded by the Strategic Research Council at the Academy of Finland.<\/p>\n\n\n\n

Challenges include limited scope and weight of regulation, and lack of competence among inspectors<\/h2>\n\n\n\n

According to the researchers, the scope of GMP and ERA regulation is limited, and they do not prevent the release of pharmaceuticals into the environment along the manufacturing supply chain.<\/p>\n\n\n\n

\u201cFor example, ERA focuses exclusively on the risks associated with the use of the product and does not address the emissions associated with manufacturing in third countries,\u201d Senior Researcher Mirella Miettinen<\/strong>, one the authors, of the University of Eastern Finland, points out.<\/p>\n\n\n\n

\u201cMoreover, in the EU, it is not possible to refuse the marketing authorisation of human pharmaceuticals based on environmental reasons. For veterinary pharmaceuticals, this is possible, but extremely rare,\u201d Miettinen says, shedding light on the weight of ERA in current regulation.<\/p>\n\n\n\n

The EU Member States are responsible for ensuring that the manufacturing sites of medicinal products, their active substances, or intermediate products in third countries comply with GMPs, if they are to be imported into a Member State. So far, however, environmental considerations have been largely ignored in inspections.<\/p>\n\n\n\n

\u201cA committee of experts appointed by the World Health Organization has encouraged the inclusion of environmental emissions in these inspections, but they\u2019ve also noted that inspectors may lack adequate training to do so,\u201d Miettinen says.<\/p>\n\n\n\n

\u201cSince environmental emissions from manufacturing are currently not taken into account in GMP inspections, the practical impact of the EU\u2019s GMP regulation on the manufacturing of active substances of medicinal products \u2013 which carries the highest risk of environmental emissions \u2013 remains minor,\u201d Miettinen adds.<\/p>\n\n\n\n

EU\u2019s phar\u00adma\u00adceut\u00adic\u00adals legislation should secure a minimum level of en\u00advir\u00adon\u00adment\u00adally sustainable production<\/h2>\n\n\n\n

Currently, subcontracted producers based in third countries have little incentive to reduce their environmental emissions. This being the situation, EU-based customers play an important role in incentivising measures hoped to be taken by third countries.<\/p>\n\n\n\n

\u201cThe<\/a> inclusion of environmental considerations and related verification requirements in the EU\u2019s GMPs would be a way to encourage authorities in third countries to support the achievement of a minimum level of environmentally sustainable pharmaceutical production,\u201d Miettinen says.<\/p>\n\n\n\n

\u201cAs our recommendation, we\u2019ve also suggested that the weight of ERA in the marketing authorisation process should be strengthened, and environmental emissions outside the EU should be included in the assessment,\u201d Miettinen concludes.<\/p>\n\n\n\n

For further information, please contact:<\/strong><\/p>\n\n\n\n

Senior Researcher Mirella Miettinen, University of Eastern Finland Law School, tel. +358 50 4720510<\/p>\n\n\n\n

Research article:<\/strong><\/p>\n\n\n\n

Anita Kittery \u2013 Mirella Miettinen, Environmental considerations in the European Union’s pharmaceuticals legislation: Key instruments and their challenges in addressing global manufacturing supply chains. RECIEL 2022;1\u201315. https:\/\/doi.org\/10.1111\/reel.12488<\/a>.<\/p>\n\n\n\n

Photo by Raimond Klavins<\/a> on Unsplash<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

For further information, please contact Mirella Miettinen, Senior Researcher. First published in the UEF News and Events on 9 January 2023. EU regulation pertaining to good manufacturing practices and environmental risk assessment of pharmaceuticals does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from the University of […]<\/p>\n","protected":false},"author":210,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[196,682,282],"tags":[1070,1076,1073,1079,1067,1064],"class_list":["post-6221","post","type-post","status-publish","format-standard","hentry","category-environmental-law","category-eu-law","category-trade-and-the-environment","tag-environmental-emissions","tag-environmental-risk-assessment","tag-eu-regulation","tag-eus-pharmaceutical-legislation","tag-global-manufacturing-supply-chains","tag-pharmaceuticals"],"acf":[],"yoast_head":"\nEU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains - The Center for Climate Change, Energy and Environmental Law<\/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:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains - The Center for Climate Change, Energy and Environmental Law\" \/>\n<meta property=\"og:description\" content=\"For further information, please contact Mirella Miettinen, Senior Researcher. First published in the UEF News and Events on 9 January 2023. EU regulation pertaining to good manufacturing practices and environmental risk assessment of pharmaceuticals does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from the University of […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/\" \/>\n<meta property=\"og:site_name\" content=\"The Center for Climate Change, Energy and Environmental Law\" \/>\n<meta property=\"article:published_time\" content=\"2023-02-06T09:09:40+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-06T09:26:36+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/\"},\"author\":{\"name\":\"\",\"@id\":\"\"},\"headline\":\"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains\",\"datePublished\":\"2023-02-06T09:09:40+00:00\",\"dateModified\":\"2023-02-06T09:26:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/\"},\"wordCount\":664,\"keywords\":[\"environmental emissions\",\"environmental risk assessment\",\"EU regulation\",\"EU's pharmaceutical legislation\",\"global manufacturing supply chains\",\"pharmaceuticals\"],\"articleSection\":[\"Environmental Law\",\"EU Law\",\"Trade and the Environment\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/\",\"url\":\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/\",\"name\":\"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains - The Center for Climate Change, Energy and Environmental Law\",\"isPartOf\":{\"@id\":\"https:\/\/sites.uef.fi\/cceel\/#website\"},\"datePublished\":\"2023-02-06T09:09:40+00:00\",\"dateModified\":\"2023-02-06T09:26:36+00:00\",\"author\":{\"@id\":\"\"},\"breadcrumb\":{\"@id\":\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/sites.uef.fi\/cceel\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sites.uef.fi\/cceel\/#website\",\"url\":\"https:\/\/sites.uef.fi\/cceel\/\",\"name\":\"The Center for Climate Change, Energy and Environmental Law\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sites.uef.fi\/cceel\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"\",\"url\":\"https:\/\/sites.uef.fi\/cceel\/author\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains - The Center for Climate Change, Energy and Environmental Law","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/","og_locale":"en_US","og_type":"article","og_title":"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains - The Center for Climate Change, Energy and Environmental Law","og_description":"For further information, please contact Mirella Miettinen, Senior Researcher. First published in the UEF News and Events on 9 January 2023. EU regulation pertaining to good manufacturing practices and environmental risk assessment of pharmaceuticals does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from the University of […]","og_url":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/","og_site_name":"The Center for Climate Change, Energy and Environmental Law","article_published_time":"2023-02-06T09:09:40+00:00","article_modified_time":"2023-02-06T09:26:36+00:00","twitter_card":"summary_large_image","twitter_misc":{"Written by":"","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/#article","isPartOf":{"@id":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/"},"author":{"name":"","@id":""},"headline":"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains","datePublished":"2023-02-06T09:09:40+00:00","dateModified":"2023-02-06T09:26:36+00:00","mainEntityOfPage":{"@id":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/"},"wordCount":664,"keywords":["environmental emissions","environmental risk assessment","EU regulation","EU's pharmaceutical legislation","global manufacturing supply chains","pharmaceuticals"],"articleSection":["Environmental Law","EU Law","Trade and the Environment"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/","url":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/","name":"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains - The Center for Climate Change, Energy and Environmental Law","isPartOf":{"@id":"https:\/\/sites.uef.fi\/cceel\/#website"},"datePublished":"2023-02-06T09:09:40+00:00","dateModified":"2023-02-06T09:26:36+00:00","author":{"@id":""},"breadcrumb":{"@id":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/sites.uef.fi\/cceel\/eu-regulation-does-not-adequately-consider-environmental-emissions-of-pharmaceuticals-in-global-manufacturing-supply-chains\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/sites.uef.fi\/cceel\/"},{"@type":"ListItem","position":2,"name":"EU regulation does not adequately consider environmental emissions of pharmaceuticals in global manufacturing supply chains"}]},{"@type":"WebSite","@id":"https:\/\/sites.uef.fi\/cceel\/#website","url":"https:\/\/sites.uef.fi\/cceel\/","name":"The Center for Climate Change, Energy and Environmental Law","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sites.uef.fi\/cceel\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"","url":"https:\/\/sites.uef.fi\/cceel\/author\/"}]}},"_links":{"self":[{"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/posts\/6221","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/users\/210"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/comments?post=6221"}],"version-history":[{"count":0,"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/posts\/6221\/revisions"}],"wp:attachment":[{"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/media?parent=6221"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/categories?post=6221"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sites.uef.fi\/cceel\/wp-json\/wp\/v2\/tags?post=6221"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}