{"id":31688,"date":"2014-06-02T12:12:55","date_gmt":"2014-06-02T11:12:55","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=31688"},"modified":"2014-06-02T12:14:32","modified_gmt":"2014-06-02T11:14:32","slug":"jim-murray-policy-making-behind-closed-doors","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/06\/02\/jim-murray-policy-making-behind-closed-doors\/","title":{"rendered":"Jim Murray: Policy making behind closed doors"},"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>Campaigning for transparency on clinical trial results at EU level is getting to be like playing snakes and ladders, and I&#8217;ve just spotted three snakes. I&#8217;ve been trying to \u201cdeconstruct\u201d the EMA\u2019s <a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2014\/05\/WC500167426.pdf\">reply by letter<\/a> to the Ombudsman\u2019s concerns about the <a href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/05\/27\/jim-murray-volte-face-by-the-european-medicines-agency\/\">agency\u2019s volte-face<\/a> on transparency. The results worry me\u2014a lot.<\/p>\n<p>The EMA says that the new transparency policy is, in effect, an initiative of the agency itself, quite distinct from the access to documents regime under Directive 1049\/2001, and also distinct from arrangements to be put in place under the new clinical trials regulation. I thought that was probably the case, although it\u00a0does not alter my concern about the recent changes to the agency\u2019s initiative.<\/p>\n<p>It is also clear from the letter that the agency\u2019s most recent policy has been drawn up in the light of a \u201cclear message\u2019\u2018 from the European Commission that the EMA must comply with \u201c national and international obligations that all European institutions have to comply with, including but not confined to TRIPS and copyright laws.\u201d<!--more--><\/p>\n<p>As a general principle that is true, but what does it mean in this case? What was the clear message from the Commission? We do not know, because we do not know what the Commission said to the agency. We do not know how exactly the Commission interprets obligations under TRIPS and copyright law in relation to clinical trial results.<\/p>\n<p>There may be worse to come. The agency is in \u201congoing discussions\u201d with the Commission on its policy on access to documents under Directive 1049\/2001. What is all this about? The rules here seemed to have been well established, and the agency had accepted various recommendations of the Ombudsman on the right of access to documents. Will the rules be changed now? How will the exercise of the right of access to documents in future be affected by the Commission\u2019s interpretation of obligations under TRIPS and copyright law? Why are there ongoing discussions with the Commission on something that had seemed to be settled?<\/p>\n<p>Further down the line, how will the Commission\u2019s position affect the (Commission\u2019s) implementation of the transparency provisions of the new clinical trials regulation?<\/p>\n<p>We don\u2019t know that either. This is policy making behind closed doors.<\/p>\n<p><em><strong>Jim Murray<\/strong>\u00a0is a former director of BEUC<span style=\"font-style: normal\">\u2014<\/span><\/em><em>the European Consumers Organisation<span style=\"font-style: normal\">\u2014<\/span>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>Campaigning for transparency on clinical trial results at EU level is getting to be like playing snakes and ladders, and I&#8217;ve just spotted three snakes. I&#8217;ve been trying to \u201cdeconstruct\u201d [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/06\/02\/jim-murray-policy-making-behind-closed-doors\/\">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],"tags":[],"class_list":["post-31688","post","type-post","status-publish","format-standard","hentry","category-jim-murray","category-open-data"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Jim Murray: Policy making behind closed doors - 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\/06\/02\/jim-murray-policy-making-behind-closed-doors\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jim Murray: Policy making behind closed doors - The BMJ\" \/>\n<meta property=\"og:description\" content=\"Campaigning for transparency on clinical trial results at EU level is getting to be like playing snakes and ladders, and I&#8217;ve just spotted three snakes. 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