PhRMA Wants US To Use TAFTA/TTIP To Stop EU Releasing Basic Drug Safety Information | Techdirt 2014-07-05


"Back in February, we reported that PhRMA, the Pharmaceutical Research and Manufacturers of America, was pushing to have the EU put on the US's 'Priority Watch List' for its plans to disclose basic safety information about drugs. Now a letter from PhRMA obtained by the German newsapaper Der Tagesspiegel shows that US pharmaceutical companies are trying to use TAFTA/TTIP to undermine the new EU rules on making clinical trial data available ... It's hard to see how the problem can be 'eliminated.' Back in April, the European Parliament adopted the Clinical Trials Regulation by a huge majority. Effective from 2016, it states that information from clinical study files 'should not generally be considered commercially confidential' and must be made publicly available -- exactly what PhRMA is lobbying against.  What's worrying is that there's already been one attempt to water down these requirements. Der Tagesspiegel suggests this may have been as a result of pressure from the European Commission, concerned about US reaction to them. It will be interesting to see how the Commission reconciles any US demands during the TAFTA/TTIP negotiations to remove the requirement to publish drug safety information with the new EU regulation that requires it."


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oa.clinical_trials oa.policies oa.usa oa.ema oa.medicine oa.tafta oa.ttip oa.treaties oa.comment ru.sparc oa.europe oa.pharma

Date tagged:

07/05/2014, 08:41

Date published:

07/05/2014, 04:43