I've written a few times about open data in the context of clinical trials – the information that must be provided when new drugs seek approval. As I noted, there is a growing movement to make such basic safety data freely available, the idea being that it could then be analysed by third parties, perhaps finding new applications of drugs, overlooked problems, or even wilful concealing of adverse effects.
In addition to the UK's moves in this area, the EU is also considering how to provide more access to clinical trials data. The main European Commission page on revising the clinical trials directive is rather opaque; more helpful are posts on the blog of the European Parliament's rapporteur for this area, Glenis Willmott. Here's a very brief but useful summary of what she is proposing:
Mrs Willmott wants greater transparency of the results of all clinical trials. She is calling for a pan-European database, with full publication of trials, and financial penalties for those who delay.
She said: "Too many results from clinical trials are misleading, biased or missing. It is time that all pharmaceutical companies and researchers made the full results of studies on new and existing drugs publicly available."
Numerous academic studies have found that around half of all trials are never published, usually those with negative or disappointing results.
"For too long unflattering studies have gone undisclosed," said Mrs Willmott. "It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective or even dangerous.
I have heard from one of my MEPs that the vote in the European Parliament on this matter will take place next Wednesday. If you have not already done so when I mentioned this last month, I urge you to write to your MEPs and ask them to support Willmott's proposals. Here's what I have sent to mine:
I am writing to you in connection with the meeting of the Committee on the Environment, Public Health and Food Safety next week, during which the issue of clinical trials will be discussed. As you know, this is a crucially important topic that has implications for the health of all European citizens; it also has the potential to help governments and the public to save billions of Euros each year.
I would therefore be grateful if on my behalf you could please urge your colleagues to take the following actions when considering this matter:
(a) to support amendments that require the public disclosure of a complete clinical study report (CSR) as proposed b ENVI rapporteur MEP Glenis Willmott, rather than any less complete versions;
(b) to reject amendments strengthening the protection of so called "commercially confidential" or "commercially sensitive" information which would undermine the accountability of the European pharmaceutical regulation system.
It's important to remember that this is purely safety information – there is nothing commercially sensitive, except insofar as companies may be trying to cover up the presence of unannounced side-effects. Indeed, the only reason for keeping this vital data secret is if pharmaceutical companies have something to hide.
Assuming they do not, they should be welcoming this opportunity to show their readiness to do everything to promote the health and well-being of the public, which is their core business. Anything less would be a betrayal of the trust 500 million Europeans place in their products.