NewDirections Editor’s Comment: EU Clinical Trials

NDNWEditorsHeadersThe news that the European Parliament has passed a law requiring all new EU clinical trials to be published in a publicly accessible database is a step forward for the transparency that is all-important for patients, the public, researchers and healthcare practitioners alike.

However, some don’t feel that the legislation goes far enough. Co-founder of AllTrials, Dr Ben Goldacre said: “The new EU legislation is only concerned with new trials. It does not address the far bigger problem, that we still don’t have full reporting for all trials on the medicines we are using right now, today, medicines which we will continue to use for the foreseeable future.”

Patient safety has been the driver of another piece of legislation that was agreed upon last week, which will toughen up medical device regulations — something that has been of concern across the European Union since the PIP breast implant scandal that began in December 2011. Meanwhile, a gap in the diagnostics market is to set to appear in the UK as the government has approved the sale of regulated HIV-self testing kits. The objective is to encourage those who feel afraid to use existing testing services to self-test, so that they can get better treatment. Currently there are no such tests approved for self-use, but according to HIV charity, The Terence Higgins Trust, which expects the first kits to arrive on the market at the end of this year, or in early 2015.

Nicola Watts

Editor, OTC.NewDirections

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