Tuesday, 12 March 2013

CJEU to decide on transparency of clinical-trial data

As our readers know the European Medicines Agency has been trying to convince pharmaceutical sector as well as regulators that there is a need for more clinical-trial data transparency (see Publishing clinical-trial data). The business sector so far thoroughly opposed any suggestions as to how to improve transparency, fearing supposedly for losing their competitive edge if clinical-trial data (which is seen as confidential and commercially-sensitive information) is pre-maturely (or so they see it) released (it claimed also e.g. violation of privacy of a company). While EMA is trying to convince the pharma companies of the need for transparency and get them involved in drafting new regulations, the pharmaceutical companies went for the more cut-throat approach and approached the CJEU for injunctions. The injunctions are to stop EMA from releasing certain clinical-trial data, which were to happen due to EMA receiving freedom of information requests about 'raw data' on certain drugs. Two major companies filed for these injunctions: AbbVie (case T-44/13, T-29/13) and InterMune (T-73/13), but they have immediately been supported in their claims by various other EU and US pharma bodies. (Pharma group sues European regulator over data) EMA on the other hand has support of some leading medical journals (which fear for biased decisions on drugs approval with only selected information being analysed) and hopefully more organisations will get involved and intervene on the side of the patients. These cases may be groundbreaking at the moment and determine the balance between the need for transparency of clinical research in order to improve patients' safety/healthcare and business' commercial interests (the majority of requests for clinical-trial data comes not from researchers who could use the data to further improve drugs etc. but from competitors of the pharma companies releasing the drug). It could determine whether EMA and other agencies will be able to release publicly data on drugs that have been approved or rejected for use in the EU.

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