Open Medicine EU

These are my notes for a speech I made today in the European Parliament on the proposal for a directive on trade secrets.
1 I will not say anything here about the proposal itself in terms of its principal objective but will talk about some possible indirect effects.
– in relation to journalists, whistleblowers and activists such as consumer advocates who may see, and wish to disclose, information or documents that are trade secrets as defined in the proposal.
– in relation to access to information under 1049/2001 and related measures.

2 On clinical trial results there have been two pieces of good news recently.
-The EMA announced a new policy of greater transparency, including publication of “Clinical Study Reports” received in applications for medicines approvals. In taking their initiative the EMA followed a careful analysis by the Ombudsman as to what was and was not commercially confidential information in this context. Two companies, Abbvie and Intermune, have taken legal action to block publication of the CSRs.
-In the revision of the Clinical Trials Directives the Parliament inserted an amendment to require that CSRs be placed on a central database/portal within one month of a decision on an application for a medicines approval. The Parliament also inserted a recital to the effect that CSRs should not generally be considered as commercially confidential – thereby opening the way for access to the CSRs under 1049/2001.
CSRs have scientific value and in many cases would fit the definition of trade secret in the current proposal.
Crucial to both these initiatives is the definition of commercially confidential information. If you can widen the definition from that set out by the Ombudsman you can limit access to Clinical Study Reports.
3 The industry, on both sides of the Atlantic, were strongly opposed to the requirement to publish CSRs. They argued that the TTIP should “establish harmonized list of clinical trial result data fields & agree on which may be disclosed to public (uniform protection of confidential commercial info & trade secrets)” . More generally they will seek to widen the definition of what is commercially confidential information, with the aim of restricting disclosure under 1049/2001.

4 The proposal on trade secrets explicitly states in recital 9 that disclosure under 1049/2001 or other laws on access to information “should not be considered unlawful..”. However, this still leaves open the possibility that the definition of trade secrets in the current proposal may have the effect of changing what is seen as commercially confidential information under 1049/2001 and similar measures.
5 The remedies in the proposal can clearly be used against journalists, whistleblowers and activists/advocates in certain cases — to demand the return or destruction of documents and for damages in certain cases.
However Article 4.2 requires member states to block remedies under the proposal when disclosure is
-for making legitimate use of the right of freedom of expression and information
-for revealing an applicant’s misconduct, wrongdoing, or illegal activity
-for protecting a “legitimate interest”..
Is this enough?
6 Possible Problems
In relation to journalists will the proposal reduce national protections in some (of the more progressive) member states?
Will the burden of proof be on the respondent/journalist to prove “legitimate use of the right of freedom of expression”?
Will this affect procedural law or protections in (some) member states?
What is the scope and implication of the reference to a legitimate interest?
Does it include the public interest in knowing that some medicines (or other product) do not work in certain circumstances?
Is the advancement of science, or human health, a legitimate interest – or should it be?
7 Possible amendments
Give more positive protection (an exemption is hardly possible) to journalists, whistleblowers, and activists without any commercial interest in disclosure.
No damages/compensation for disclosure in the absence of a commercial motive.
Exclude disclosure to a competent public authority.
Allow a wider public interest defence.END

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