On October 6 2015 the European Court of Justice (ECJ) ruled that the European Commission decision on the adequacy of the EU-US safe harbour framework is invalid.
Computer hacker silhouette of hooded man with binary data and network security termsECJ Decision
In Maximillian Schrems v Data Protection Commissioner (Case C-362/14) the ECJ held that the competent data protection authorities of individual EU member states can investigate complaints from a data subject which alleges that its personal data has been transferred to a third country that does not protect its privacy, fundamental rights or freedoms.
The ECJ declared the commission’s safe harbour decision to be invalid. The decision was based on the ECJ’s conclusion that national security, public interest or law enforcement requirements in the United States grant the authorities public access to the personal data of data subjects that is transferred from the European Union to entities in the United States. The ECJ held that US public authorities are entitled to disregard the principles of the EU-US safe harbour framework without limitation where they conflict with national law requirements. Access by such authorities therefore compromises the essence of the fundamental right to respect for private life.
Clinical Trial Data
The ECJ decision could have far-reaching consequences for clinical trial sponsors that have relied on the framework to justify the transfer of patients’ personal data and personal health data from clinical trial sites in the European Union to the United States. In light of this, pharmaceutical and medical device companies must adopt an alternative legal basis on which to transfer such data to the United States. One issue will be the decision’s implications for marketing authorisations granted for medicinal products and conformity assessments of medical devices that were based on clinical data transferred to the United States for processing based on the grounds of safe harbour.
Transfer of Clinical Data
One consequence of the ECJ decision is that sponsors of clinical trials conducted in the European Union will no longer be permitted to rely on the framework as a valid legal basis to permit the transfer of clinical trial data to the United States for processing. Clinical trial sponsors must therefore adopt an alternative legal basis on which to transfer such data. For instance, such sponsors could obtain the trial patient’s unambiguous consent to transfer the data to the United States.
It is unclear what, if any, implications the ECJ decision will have for clinical data that has been exported to the United States in reliance on the framework and subsequently relied on to support medicinal product marketing authorisation or demonstration of compliance by medical devices with applicable EU rules.
For further information on this topic please contact Elisabethann Wright or Ciara Farrell at Hogan Lovells by telephone (+32 2 505 0911) or email ( or The Hogan Lovells website can be accessed at
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