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European Commission Publishes Guidance on Interplay between Clinical Trials Regulation and General Data Protection Regulation

  • 12/04/2019
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The European Commission published on 10 April 2019 a Question & Answer document on the interplay between General Data Protection Regulation 2016/679 (the GDPR), which entered into force on 25 May 2018, and Clinical Trials Regulation 536/2014 (the CTR), which is currently expected to enter into force in 2020.

The Q&A document provides clarifications in areas where the interplay between both sets of rules, which apply simultaneously, is complicated. It recalls that under the GDPR, it will be for data controllers to demonstrate that personal data are processed in accordance with the GDPR. Satisfying this obligation implies respecting the data protection principles, providing adequate information to clinical trial participants, appointing a Data Protection Officer (if required), maintaining records of processing activities and facilitating the exercise of individual’s rights, along with meeting other requirements.

The controller should also determine the legal basis for the various processing activities. In this task lies a common misunderstanding which the Q&A document seeks to rectify: the informed consent required under the CTR serves as an ethical standard and procedural obligation, and this should not be confused with consent as a legal basis for the processing of personal data under the GDPR.

As regards the legal basis under the GDPR, the Q&A document explains that various processing operations involving the use of clinical trial data, which include operations related to research as well as operations that are required for the protection of health, may rely on a different legal basis. Requesting consent from the participants (in addition to the consent required under the CTR) may be one option, but the Q&A document also offers alternative options, depending on the situation at hand. It will be for the controller to assess and implement the most adequate legal basis. In that regard, if clinical trial data are used for further research outside the scope of the protocol (secondary use), another legal basis may be required.

The Q&A document also assesses the impact of the entry into application of the GDPR on ongoing clinical trials which are governed by Clinical Trials Directive 2001/20/EC. In particular, the European Commission indicates that additional information may have to be provided to the clinical trial participants. In principle, the legal basis that was valid under national data protection rules implementing Directive 2001/20/EC prior to the GDPR remains applicable. However, if the processing of clinical trial participant data relies on the participant’s consent, it must be assessed whether such consent satisfies the stricter requirements of the GDPR. If this is not the case, a renewed consent may prove necessary.

The full text of the Q&A document can be found here and is also attached.


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