SUBMISSION OF COMMENTS ON: Draft Implementing technical guidance - List of fields for result-related information to be submitted to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No
EuropaBio welcomes the draft guidance which will facilitate public disclosure of the results of clinical trials conducted in Europe and conducted outside Europe when part of a paediatric investigation plan.
We thank the European Commission for the extensive mapping of EudraCT fields to existing fields in ClinicalTrials.gov which facilitates preparation for the implementation.
While overall we very much support this policy objective we do have some important concerns over the manner in which the Commission is proposing to implement certain technical aspects, as set out in the draft guidance.
We would like to emphasise that our concerns are not related to the act of publication of these data, indeed we fully support the principle of making this information publicly available. We believe that there should be an appropriate balance that benefits public health while maintaining an environment that protects inventions and intellectual property.