disclosure

Last week the Court of Justice of the European Union (“CJEU”) upheld a broad interpretation of the concept of “information that relates to emissions into the environment” that EU and Member State authorities (e.g., ECHA, EFSA, Commission, national environmental agencies) must disclose to the public.  According to the CJEU, the information that must be disclosed does not only relate to emissions from industrial installations, and must also include data allowing the public to: (i) know what is, or may be foreseen to be, released into the environment under normal or reasonable conditions of use of a product or substance; (ii) check the correctness of the assessment of the actual or foreseeable emissions on the basis of which product or substance is authorized; and (iii) understand the effect of those emissions on the environment.   This information must be disclosed to the public, upon request, even if it may affect the commercial interests of companies.

The CJEU’s decisions will have a significant impact on all companies that are required to submit regulatory filings to access the EU market under different EU legislation (e.g., REACH, Biocides, Plant Protection Products, Fertilizers, GMOs).  These companies must now assume that much of the data they submit may not be kept confidential.

Continue Reading The Court of Justice of the EU Adopts a Broad Interpretation of the Information on Emissions into the Environment that Authorities Must Disclose to the Public

On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070).  The latest Proactive Disclosure Guidance can be found here and focuses on:

  • Procedural aspects of submitting clinical reports.
  • The anonymisation of clinical reports.
  • The identification and redaction of commercially confidential information (CCI) in clinical reports, i.e. the disclosure of information that is not in the public domain and may undermine the legitimate economic interest of the applicant.

The Guidance is accompanied by a number of annexes, including template cover letters, template anonymisation reports and process flowcharts.
Continue Reading EMA Publishes Proactive Disclosure Guidance

Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post.

On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation (“MA”) application process (the “MA Documents”).  The MA Documents at issue included EMA Assessment Reports on similarity and superiority between Pari’s product (Vantobra) and Novartis’ product (TOBI Podhaler), which has an EU MA as an orphan medicine.  Novartis made the request to the EMA for access to the MA Documents under the Transparency Regulation 1049/2001.  The main case is currently pending before the General Court (Case T-235/15).

The thrust of Pari’s argument before the General Court was that the MA Documents contain Pari’s regulatory strategy for obtaining MA approval, disclosure of which might cause Pari serious and irreparable financial damage.  The President of the General Court acknowledged that the case raised complex issues in the area of confidentiality and stated that the main proceedings (rather than an interim hearing) is the appropriate forum to address such issues..  As such the President considered that the MA Documents fell under a presumption of confidentiality  and ordered the EMA not to disclose the MA Documents.
Continue Reading General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case