EU regulator sparks drug data fight

The head of Europe&rsquo;s medicines regulator is digging in for a fight over data transparency, after being stopped from releasing information on drugs from two United States (US) companies by a court ruling.Defeat for the European Medicines Agency (EMA) at the hands of AbbVie and Intermune highlights a growing battle between campaigners for more openness and companies which fear it will harm their business.EMA Executive Director Guido Rasi believes the pharmaceutical industry will be the loser in the long run if it does not accept the need for greater transparency in the face of mounting public distrust.&ldquo;If the court decides we have to stop the release of data, I think that would be the worst possible boomerang for the industry,&rdquo; he said in an interview.&ldquo;The most powerful weapon we have to tackle distrust is transparency.&rdquo;The EMA said on Tuesday it intended to appeal the interim ruling by the European Union&rsquo;s general court preventing it from releasing documents until a final decision is given.The London-based watchdog has been on a collision course with some drug-makers since deciding to lift the lid on previously secret clinical trial data that is submitted by companies as part of the application process for new medicines.Since November 2010, the EMA has released 1,6 million pages of detailed clinical trial information - an approach it says reflects growing public demands for more openness to ensure that drug-makers cannot conceal adverse drug effects.Its policy was challenged, however, by both AbbVie and Intermune, which sought an injunction in cases relating to requests for the release of data about their drugs.In the case of AbbVie, information had been sought about its rheumatoid arthritis drug Humira, the world&rsquo;s top-selling medicine.One of those seeking the data was UCB, a rival Belgian drug company.The Intermune case related to information that was sought by academic researchers.An AbbVie spokeswoman said the US company supported transparency of clinical research for the benefit of patients, but was concerned that commercially confidential information contained in EMA filings could help competitors.Ben Goldacre, co-founder of the AllTrials campaign for data disclosure and author of &ldquo;Bad Pharma&rdquo;, a book criticising the industry, said the interim ruling was a &ldquo;disgrace&rdquo;.&ldquo;Forcing them (the EMA) to hide this information is nothing short of absurd,&rdquo; he said.Public distrust of drug companies and the regulatory authorities that police them has grown in recent years, following a series of scandals over the safety of drugs such as Merck &amp; Co&rsquo;s now withdrawn painkiller Vioxx and GlaxoSmithKline&rsquo;s (GSK) diabetes pill Avandia.

EU regulator sparks drug data fight

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Namibian Sun 2025-04-29

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EU regulator sparks drug data fight

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Namibian Sun 2025-04-29

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