The EU rules on data protection seek to protect individuals by placing restrictions on the processing (collecting, storing or using) of their personal data. Under the new General Data Protection Regulation 2016/679/EU (“GDPR”), which will apply throughout the EU from May 25, 2018, these rules have been strengthened: data subjects have new rights to help ensure their data are processed securely and with adequate protections, and clearer responsibilities and obligations are placed on companies using such data.

However, these strengthened rights do not necessarily fit neatly with other sector specific legislation where large quantities of data are collected and processed. In particular, the GDPR raises some important questions for clinical trials, one of the fundamental aspects of which is the collection and analysis of sensitive personal data. Importantly, there are no transitional rules governing how data currently held and being collected will be dealt with once the GDPR becomes applicable, although guidance is expected before May 2018 to clarify how some of these provisions will operate.

While the implications for clinical trials are huge, this post focuses on the changes that affect the collection of data from data subjects, and their rights under the GDPR.

Which Data are covered?

Health data, which are usually at issue in clinical trials, are classed as sensitive personal data, and under both the current legislation and the GDPR, are subject to tighter conditions for processing compared to other types of personal data (e.g. contact details). However, the GDPR has widened the data that are classed as sensitive personal data, to specifically include biometric and genetic data, and introduces new compliance requirements for such data.

An important question for clinical trials is whether pseudonymized data are covered by the legislation, meaning data where a key is held so it is (theoretically) possible to re-identify patients using “anonymous” patient codes. Under the GDPR, pseudonymized data will be a form of personal data and will have to be protected accordingly. In reality, confidentiality and data security provisions are applied to such data in the context of clinical trials in any event. However, this clarification in the GDPR will mean additional steps may have to be taken with respect to such data.

How can Subjects Consent to Processing of their Data?

Although not the only legal basis for processing sensitive personal data under the GDPR, obtaining informed consent from clinical trial subjects before they participate in the trial is required by the Clinical Trials Directive 2001/20/EC and the new Clinical Trials Regulation 536/2014/EU, and is also best practice under the GDPR.

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Consent must be explicit, unambiguous, and freely given. It must be specific to each procedure, and only used for those purposes set out in the consent form. The GDPR also introduces stricter requirements including:

  • Enabling individuals to provide consent for different parts of collection and processing (granular consent)
  • Keeping records to show what individuals have consented to, what they were told, and when and how they consented
  • Making consent easy to withdraw, at which point the relevant processing activities will need to be reconsidered
  • Stricter consent requirements for minors or incapacitated data subjects

Under the GDPR, certain information must be provided to individuals before their personal data are obtained, such as the identity and contact details of the data controller (i.e. the sponsor), the contact details of the data protection officer, the purposes and legal basis for processing, the recipients of the data, how long the data will be stored, and the rights individuals have under the legislation. This will also have to be combined with the information required to be provided about the trial, as set out in the Clinical Trials Directive and Regulation, and will likely lead to very long and detailed consent forms – at a time when ethics committees are seeking to simplify such forms.

Under the GDPR, consent does not provide a legal basis for processing where there is a “clear imbalance” between the data subject and the controller, meaning it is unlikely that consent was freely given. What this means in practice, and its implications for patients and pharmaceutical companies during clinical trials, will need to be clarified.

Further, the status of consents validly provided under the current legislation is still unclear. As the requirements for consent are stricter under the GDPR, and as there are no transitional provisions covering how data currently collected will be dealt with – or specific guidance in relation to clinical trials – current consent forms should be reviewed and updated. However, it is unclear whether sponsors will need to obtain new consents from patients already involved in trials. Clarification on this issue would be welcome.

What New Rights do Clinical Trial Subjects have?

The new rights to erasure of personal data (the “right to be forgotten”) and to data portability could have far-reaching implications for clinical trials if not managed appropriately – by sponsors and regulators.

First, in accordance with the erasure right, the data controller (i.e. the sponsor) will have to delete personal data, and take all reasonable steps to tell third parties to do the same, if the data subject requests it. There are exceptions to this, such as where processing is necessary for reasons of public interest in the area of public health, or scientific or historical research purposes. While carving out these exemptions seems to be seeking to reconcile the competing values of privacy of patients and innovation by companies, further guidance on their scope is required.

Secondly, the right of data portability means that clinical trial subjects have the right to receive their personal data in a commonly used and machine-readable format, and transmit such data to another organization. This is not an unfettered right; there is the qualification that data portability should not adversely affect the rights and freedoms of others (which in this case, might include intellectual property or trade secrets of the sponsor), but businesses are expected to take steps to comply with a data portability request if received.

Again, the extent to which patients already enrolled in trials also benefit from these rights will hopefully be clarified before May 2018.

What New Compliance Measures do Companies Need to Consider?

As clinical trials involve the processing of sensitive personal data, the sponsor will need to carry out a data protection impact assessment, likely both for trials commenced after May 25, 2018, and for trials that are ongoing and data that are being processed at that date. This assessment must set out:

  • A description of the processing operations and the purposes of processing
  • An assessment of the necessity and proportionality of the processing
  • An assessment of the risks to the rights and freedoms of clinical trial subjects
  • The measures used to address those risks

Controller and processor organizations involved with the running of clinical trials (e.g. sponsors, CROs and investigators) will also likely need to appoint a data protection officer. It would be their responsibility to inform and advise their organization about its obligations under the GDPR, monitor compliance with the GDPR, provide advice where requested, and act as a point of contact for the relevant regulator. In addition, all organizations involved with clinical trials should maintain documentation evidencing any consents obtained and the steps taken to comply with the GDPR. Such documents will likely need to be contained in the trial master file, with other trial-related information, to show compliance with applicable laws.

Which Company is Responsible for Compliance?

Under the current rules, the data controller (i.e. sponsor) has full responsibility for compliance. This is changing under the GDPR, which allows for the appointment of joint data controllers, and also imposes obligations on data processors (i.e. CROs, investigators or statisticians). The Clinical Trials Regulation also provides the ability to have co-sponsors, and non-commercial sponsors, all of who will have obligations under the Clinical Trials Regulation and the GDPR.

What are the Sanctions for Non-compliance?

Penalties under the GDPR are substantial: national regulators will have the power to impose fines of up to €20 million or 4 percent annual global turnover, whichever is the higher. It is not yet clear how liability or any fines in the case of a data breach would be divided up between data controllers and data processors. However, it is clear that all organizations should consider their processes in light of the GDPR, and understand the remit of their compliance responsibilities, particularly for trials and data processing that have already started.