In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001.

PTC Therapeutics International Limited (“PTC”) had argued before the General Court that a clinical study report it submitted to the EMA in support of marketing authorisation for its ultra-orphan drug Translarna was presumptively confidential and should not be disclosed to a competitor.  However, this position was dismissed by the General Court of the EU in early 2018.

On appeal to the Court of Justice, however, PTC argued that the General Court had erred in arriving at that decision, raising a number of grounds, including that on a proper interpretation of the relationship between the Regulation No 726/2004 and Regulation No 1049/2001, the report at issue is covered in its entirety by a general presumption of confidentiality.  In his opinion, AG Hogan disagreed with the General Court’s assessment of the relevant legislation, noting in particular that Article 39(3) of the TRIPs Agreement provides that data must be protected against disclosure unless steps are taken to ensure that such data are protected against unfair commercial use.  On this point, the General Court stated in paragraph 91 of the judgment under appeal that ‘potential misuse of the report at issue by a competitor is not in itself a ground for considering that information is commercially confidential under Regulation No 1049/2001’.  AG Hogan explained that while this statement is correct so far as it goes when it comes to considering the ‘commercial confidentiality’ exception in the first indent of Article 4(2) of Regulation No 1049/2001, it did not ensure that release of undisclosed data would not undermine the data and marketing exclusivity of the originator company, particularly in countries outside the EU.

As such, AG Hogan considered that the General Court had erred in law in so far as it concluded that there was no general presumption that CSRs should not be disclosed by reference to the first indent Article 4(2) of Regulation No 1049/2001.  AG Hogan also considered that the General Court had erred in law in so far as it concluded that the disclosure of the report at issue would not compromise the appellant’s commercial interests for the purposes of the first indent of Article 4(2) of Regulation No 1049/2001.  The AG added, however, that the EMA does not need to rely on the presumption of confidentiality.  In practice, though, this would likely make a finding by the EMA that certain data are not commercially confidential more difficult in cases of detailed and individualised assessment of clinical study reports.  The AG opinion is non-binding and it will now be for the Court of Justice to assess the case in light of this opinion.

The opinion can be accessed here.

Another appeal brought by a veterinary pharmaceutical company in relation to pre-clinical study reports was heard in parallel and AG Hogan reached the same conclusion.  That case can be accessed here.

Covington acted for the appellants in both cases. If you have any questions concerning the material discussed in this blog post, please contact the following members of our life sciences team: Brian Kelly, Grant Castle, Sarah Cowlishaw or Katharina Ewert.

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Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs.

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Brian is an honorary lecturer at University College London.

Photo of Katharina Ewert Katharina Ewert

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing…

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing regulatory environment. Katharina is a member of Covington’s Diversity and Inclusion Committee.

Katharina is a member of Covington’s Diversity and Inclusion Committee.

  • In her work with a broad range of life sciences companies, Katharina regularly:
  • advises clients on all aspects of food development and marketing, including the regulation of ingredients, labelling and advertising;
  • helps companies in evaluating health and nutrition claims for foods and food supplements, as well as marketing claims for cosmetics;
  • provides strategic advice to major companies in the medicines and device space on national and EU public procurement considerations;
  • assists clients in navigating the implications of Brexit; and
  • represents clients in administrative proceedings in the national and EU courts.

Katharina’s pro bono work includes advising charities on corporate, commercial and public procurement matters.

Katharina gained valuable experience during a secondment the in-house legal team of a global pharmaceutical company.