Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier
On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. However, the CJEU indicated that certain information may be protected if the interested party can specifically show that the disclosure will cause it harm. This is the first time the CJEU has ruled on this matter, upholding the EMA’s approach to handling access to documents requests.
Supreme Court Clarifies Broad Interpretation of FOIA Exemption for Confidential Commercial Information
In a very significant FOIA decision for business, Food Mktg. Inst. v. Argus Leader Media, decided on June 24, 2019, the Supreme Court reversed 45 years of understanding that Exemption 4 only protects confidential business information whose disclosure by the government would cause “substantial competitive harm.”
Relying on the plain meaning of words in the statute – rather than what the Court majority characterized as muddled legislative history – the Court found that the D.C. Circuit had engrafted a condition on the Exemption that is not supported by the text. Rather, so long as the commercial or financial information obtained by the government is “private” or “secret” – the plain and ordinary meaning of “confidential” – it may be withheld from disclosure under FOIA.