Citizen pressure has made a big difference for transparency and must now focus on EU member states who will negotiate final text with Parliament.
First non-technical short reaction to Clinical Trial Regulation vote on transparency issues.
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Commercial confidentiality
While it is true that consolidated legislative amendment 40 was not adopted, consolidated amendment 41 with the same wording was approved as a recital despite massive big pharma lobbying against it. Both speak of not using commercial confidentiality as a reason for concealing clinical trial data. In other words, there is a Parliament opinion that post-market authorization clinical trial data should be public. Furthermore, ITRE 61 was also adopted that refers to European Medicine Agency guidelines on commercial confidentiality, precisely one of the reasons big pharma is challenging the EMA in the European Court of Justice. This can lend a pro-transparency interpretation of other parts of the text as the Parliament must now negotiate the final text of the law with the Council of EU member states. Therefore, it could be argued that the Parliament feels that there is no commercially confidential data in post authorization clinical trial data.
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More robust data requirements
There has been a strengthening of the data required in summaries of clinical trials that have not been authorized and the requirement of the publication of a clinical trial report on clinical data once a drug is authorized.
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Commercial, non-commercial and “low-risk” trials
There are significantly fewer requirements with regards to reporting results for non-commercial or academic clinical trials. There are also few requirements for so-called “low-risk trials”, often with trials on medicines already authorized. There are significant concerns about the not very clear definitions of a “non-commercial” trials and “low-risk trials” and the possible abuse of these exceptions to robust reporting.
4. All Trials: the glass is half full or half empty. While significantly more data will be required to be published than at present we are still a long way from “all trials, all results”. No complete raw data publication requirements are in the Regulation and there seem to be many loopholes that might be used by Big Pharma.