{"id":31394,"date":"2014-04-16T17:12:57","date_gmt":"2014-04-16T16:12:57","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=31394"},"modified":"2014-10-29T12:36:30","modified_gmt":"2014-10-29T11:36:30","slug":"jim-murray-abbvie-withdraw-case-against-european-medicines-agency","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/04\/16\/jim-murray-abbvie-withdraw-case-against-european-medicines-agency\/","title":{"rendered":"Jim Murray: Abbvie withdraw case against European Medicines Agency"},"content":{"rendered":"<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/2013\/10\/31\/jim-murray-the-emas-efforts-to-widen-access-to-clinical-trial-results\/jim_murray\/\" rel=\"attachment wp-att-29744\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-thumbnail wp-image-29744\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2013\/10\/jim_murray-150x150.jpg\" alt=\"jim_murray\" width=\"150\" height=\"150\" \/><\/a><a href=\"http:\/\/www.bmj.com\/content\/348\/bmj.g2632\">AbbVie have withdrawn their legal challenge<\/a> against the release of certain company documents on Humira (adalimunab) by the EMA. This followed an offer by the agency to redact parts of the document originally intended for release.<\/p>\n<p>Is this good news? There are those who think it is, but we cannot be entirely sure at this stage, and may never know for certain unless someone manages to see the parts that were redacted. <!--more--><\/p>\n<p><a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/04\/news_detail_002060.jsp&amp;mid=WC0b01ac058004d5c1\/\">According to the agency<\/a>, \u201cThe very limited redactions proposed by AbbVie were consistent with the agency\u2019s redaction practices and also had no significant impact on the readability of the reports. Therefore, a decision accepting that new set of documents was notified to the company.\u201d<\/p>\n<p><a href=\"http:\/\/www.bloomberg.com\/news\/2014-04-03\/abbvie-drops-eu-court-bid-to-block-clinical-trial-data-release.html\">According to a Bloomberg report<\/a>, AbbVie decided to withdraw its lawsuits after the EMA accepted redacted documents from the company and also its \u201crationale for removing certain commercially confidential information from the clinical study reports that are at the center of the litigation.\u201d<\/p>\n<p>\u201cA significant portion of data will be disclosed while protecting the information that is commercially sensitive,\u201d AbbVie said in an e-mailed statement.<\/p>\n<p>Some might say that this seems like a win for Abbvie, but this may not be so\u2014corporations always present the outcome of legal proceedings in the best possible light.<\/p>\n<p>Those with more expertise than me will assess the version of the documents that the EMA will finally release and will, I hope, assess if these documents are of scientific and clinical value. This after all is the reason for transparency of clinical trial results.<\/p>\n<p>The settlement may (we don\u2019t know) set a new and narrower standard for what is to be considered as commercially confidential information (CCI), but it also means that the European Court will not rule on the interpretation of CCI in this case\u2014although the case taken by Intermune is still ongoing.<\/p>\n<p>The definition of what is commercially confidential remains key to the EMA policy on transparency and to the new regulation on the revision of the clinical trials directive. The narrower the definition of CCI the more transparency.\u00a0 I will say more about this in my next blog.<\/p>\n<p>Competing interests: I declare that that I have read and understood the BMJ Group policy on declaration of interests and I have no relevant interests to declare.<\/p>\n<p><em><strong>Jim Murray<\/strong> is a former director of BEUC\u2014the European Consumers Organisation, having previously been the first director of Consumer Affairs and Fair Trade in Ireland. He writes here in a personal capacity. During his time with BEUC, he was a founder and one time president of the Transatlantic Consumer Dialogue. Currently he is a member of the European Commission\u2019s High Level Group on Administrative Burdens, and president of the European Foundation for Financial Inclusion.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>AbbVie have withdrawn their legal challenge against the release of certain company documents on Humira (adalimunab) by the EMA. This followed an offer by the agency to redact parts of [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/04\/16\/jim-murray-abbvie-withdraw-case-against-european-medicines-agency\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5746,5744,1357],"tags":[],"class_list":["post-31394","post","type-post","status-publish","format-standard","hentry","category-jim-murray","category-open-data","category-us-health-care"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Jim Murray: Abbvie withdraw case against European Medicines Agency - The BMJ<\/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:\/\/blogs.bmj.com\/bmj\/2014\/04\/16\/jim-murray-abbvie-withdraw-case-against-european-medicines-agency\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jim Murray: Abbvie withdraw case against European Medicines Agency - The BMJ\" \/>\n<meta property=\"og:description\" content=\"AbbVie have withdrawn their legal challenge against the release of certain company documents on Humira (adalimunab) by the EMA. 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