Nothing in international intellectual property law constitutes a serious barrier to the publication of clinical trial data for the sake of public health.
In his letter to the European Ombudsman dated 22 May 2014, the Director of the European Medicines Mr Rasi refers to a “clear message” of the European Commission relating to the need to ensure compliance with national and international agreements, including, but not limited to, TRIPS and copyright legislation. It can be deduced that the EMA has received a “clear message” that its “proactive” clinical trial transparency policy could be violating international IPR law.
One cannot derive from TRIPs article 39.3, that refers to clinical data, any general obligation against the disclosure of clinical trial data.This is clear in the text itself:
‘Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.’
Moreover, a number of interpretations of TRIPs clarify that the disclosure of clinical trial data for the sake of transparency and public health cannot be considered “unfair commercial actvity” (which is not defined). A number of WHO/WTO documents insist that clinical trial disclosure and article 39.3 of TRIPs should be seen within the context of the Doha Declaration on flexibilities for Public Health. See this WHO document: http://www.who.int/medicines/areas/policy/protection_of_data.pdf and from the WTO http://wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf;
It is true that to date there is no case law precedence nor other very authoritative interpretations on the TRIPs articles referring to clinical trial data. But in this context it specially surprising that the European Commission (DG Trade and DG Enterprise) is pressuring the EMA to roll-back on its data transparency measures with the pretext of international patent, trademark and copyright concerns that are not backed up by a clear legal basis.