[open-science] Data sharing at the European Medicines Agency

Thu May 9 09:33:52 UTC 2013

Hello all,

We rarely seem to have discussions of open data in medicine - where, in my opinion, the benefits are most tangible - so am sharing a link to a blog about recent events at the European Medicines Agency. The Agency seems far from implementing an OKF-compliant open data policy but is establishing a process to allow greater access - "proactive publication", whatever that means - to data supporting drug license applications in the EU.

My blog/report is here:
http://blog.f1000.com/2013/05/07/one-step-forward-for-better-evidence/

And within the recently-published, widely-sought advice to the EMA (I was amongst ~200 contributors) there are some issues relevant to the open science community now.

Such as, copyright, sui generis database rights, and Creative Commons CC0 (Dryad, figshare are mentioned) for data - within the legal discussions document: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04/WC500142857.pdf

Also, data standards and formats (unfortunately some interested parties continue to recommend PDF for some data):
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04/WC500142850.pdf

And probably others within the documents, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001778.jsp&mid=WC0b01ac058004d5c1

See my blog for further thoughts. I encourage the open science community to read and comment on the EMA's draft policy when it is published next month. This is a chance to make medical evidence - albeit slowly - better with more open science.

Best regards,

Iain

Iain Hrynaszkiewicz
Outreach Director

FACULTY of 1000
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