RESOLVED, that IPO opposes the data disclosure policy of the European Medicines Agency, for at least the following reasons:
- It lacks an appropriate process for determining whether a requested document should be released, by, for example, failing to include a presumption that non-public, non-clinical and clinical data and information in Marketing Authorisation applications is “Commercially Confidential Information” unless the sponsor of the application indicates otherwise, and a mechanism for the requestor to overcome that presumption or demonstrate a legally permissible “overriding public interest;”
- As a result, it does not achieve an appropriate balance between the need for institutional transparency and the societal interest in promoting innovation;
- It fails to protect innovators’ legitimate trade secrets and other confidential information from disclosure to competitors and from loss of trade secret status in other jurisdictions; and
- It is inconsistent with provisions of the TRIPS Agreement and the Treaty on the Functioning of the European Union.