EU Trade Secrets Directive Threatens Scientific Open Data

Earlier this year I warned about a worrying attack on openness: a new EU Directive strengthening trade secrets. A recent joint paper from Corporate Europe Observatory, International Society of Drug Bulletins , and Medicines in Europe Forum provides excellent analysis about some specific threats, including the following to scientific open data:

A very broad definition of "trade secrets", including scientific data that is in the public interest

The definition of trade secrets proposed by the European Commission includes all non-public information with economic value, therefore any document or information that would harm the reputation of the company concerned if published by a journalist , whistle-blower or researcher (Article 2(1)) (h).

It is particularly worrisome that this definition does not allow for the exclusion of scientific data that is in the public interest, such as regulatory data (i). In fact, in early 2015, the MEP in charge of drafting the opinion of the European Parliament's Committee on the Internal Market and Consumer Protection suggested adding to this definition: "concerns trials, tests or other secret data which, in order to be developed, require a significant commitment and upon the submission of which marketing authorisation for chemical, pharmaceutical or agricultural products involving the use of new chemicals depends" (11).

In 2013 and 2014, pharmaceutical and food processing companies had already lodged complaints against the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) in order to prevent the disclosure of data they considered "commercially confidential" (3,12). Is it wise to offer companies wider means to oppose transparency of scientific data?

As that makes clear, the hard-won victory to make clinical trial data available as open data would almost certainly be undermined if the trade secret Directive were passed in its current form. And if that isn't bad enough, here's another likely effect:

the directive states that whistle-blowers can only use undisclosed information for the purpose of revealing "misconduct, wrongdoing or illegal activity" and only "provided that the alleged acquisition, use or disclosure of the trade secret was necessary for such revelation and that the respondent acted in the public interest" (m). Such a provision acts as a deterrent and prevents efforts to access and disclose information.

This will make whistleblowing even more risky at just the time when we should be encouraging more people to come forward with information in the public interest. The trade secrets Directive in its current is clearly not fit for purpose, and needs a radical overhaul of many aspects.

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