European Commission Q&A on the interplay between the Clinical Trials Regulation and GDPR

07/16/2019
Client Alert

In response to the opinion of European Data Protection Board (EDPB) (see our alert), the European Commission has issued its Question and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) (Q&A). The non-binding Q&A offers some additional clarifications for data processing within clinical trials. However, the Q&A also falls short in other respects. In particular, it omits some core issues, deferring to national data protection authorities instead.

Key takeaways

The Q&A aligns with the opinion that he EDPB issued on the Q&A ahead of its publication on:

  • The legal justification within clinical trials and deterrent on using consent – Under the GDPR, the processing of personal data must be tied to one of the legal justifications/derogations (for sensitive data such as health data) listed in the GDPR. One of those justifications/derogations is consent, but there are also others, such as public interest or scientific research. In parallel, EU clinical trial rules generally require that clinical trial participants provide their informed consent to participate in a clinical trial. The Q&A confirms that consent under the GDPR (protecting privacy) should be distinguished from clinical trial informed consent (protecting ethics), and that consent is generally not the appropriate justification under the GDPR.
    • This is the case in particular, given the potential imbalance of power between participants and clinical trial investigators (so that consent would not be freely given) and because if a participant withdraws consent, personal data collected prior to the withdrawal may have to be deleted, which can lead to a host of issues, and threaten the quality and credibility of the clinical trial.
    • As a result, the Q&A recommends other legal justifications than consent, which it allocates depending on some core activities identified within clinical trials, namely “reliability and safety purposes” and “research activities” as the EDPB had suggested (see the table below). As we identified in our previous alert, while clarifying the absence of the need for consent under the GDPR is helpful, it can also cause tension where local privacy laws prescribe consent for reliance on scientific research[1], as in Ireland[2] or the Netherlands[3].
  • Secondary use – The Q&A also confirms the existence of a “presumption of compatibility” under the GDPR for further scientific research outside the study protocol. Within clinical trials, a “protocol” must be drafted to describe the clinical trial objectives among other details. Those objectives are then built into clinical trial documentation that is provided to the participants. That said, clinical trials may last several years and discoveries may prompt the need for research beyond the protocol. Under clinical trial rules, such prolonged use is allowed (CTR Art. 28.2) under certain conditions. The question therefore arises as to whether such prolonged use is also possible under the GDPR without having to obtain a new legal justification (or whether, conversely, a separate justification is required, which may require taking additional steps, such as re-notice/re-consent with individuals). The EDPB confirms that it is possible to rely on the initial justification for the scientific research also for the prolonged use. It should be noted, however, that secondary use is a complex issue under the GDPR, and that the EDPB already announced, in its opinion, that it will devote further attention and guidance to it in the future. There will, therefore, be additional considerations to look out for in the future.

The Q&A also provides some additional insights, for example:

  • Withdrawal of consent Where privacy consent is nevertheless used as a legal basis for processing data (alongside clinical trial consent), and a participant withdraws consent, it is up to the investigator to determine whether the withdrawal relates only to participation in the clinical trial or also to the processing of personal data. In other words, there is no automatic withdrawal of both consents. It is therefore useful to clearly split out the requests for privacy and clinical trial consent in participant documentation (e.g., separate document or section in the Informed Consent Forms), so as not to conflate both consents and risk losing the possibility of arguing that a participant only withdrew from the trial but not also from the processing of personal data (which as explained, may entail deleting the personal data).
  • Transfers When it comes to cross-border transfers, the Q&A indicates that companies may “adopt the approach that is most suitable for their specific situation”, which suggests there is no prescribed or favored transfer mechanism. The Q&A also explicitly mentions “public interest” as a transfer mechanism, which aligns with the legal basis for reliability and safety (see the table below) and may prove useful (e.g., for reporting to foreign public authorities where the public interest is shared between the EU and the foreign country’s legislation).

Where the Q&A falls short

  • Limited scope – There are a number of core issues in which the EDPB opinion did not address and that unfortunately are also not clarified by the Q&A. For example, it is known that there are local disparities amongst EU Member States as to what the qualifications of the investigator and the sponsor should be (e.g., joint controllers, independent controllers, or investigator as processor and sponsor as controller). The Q&A would have been a good opportunity for the European Commission to promote a harmonized approach, but the Q&A remains silent about this issue. Likewise, it is not clear how the territorial criteria of the GDPR apply to foreign-sponsored trials (e.g., where a non-EU sponsor uses an EU-based investigator to run a clinical trial using personal data from EU individuals). The Q&A only restates the general criteria for GDPR applicability without specifically clarifying them in the context of clinical trials and recommends that companies consult with data protection authorities for further details (which means that consistency should be promoted at the EDPB level).
  • Consent for ongoing trials – The Q&A also states that if privacy consent is requested from participants under the predecessor to the Clinical Trial Directive (Directive 2001/20), this legal basis cannot be changed into another legal basis (see question 11 of the Q&A) (and that if consent for ongoing trials does not meet the GDPR threshold, re-consent may be required). This interpretation seems to depart from guidance provided by the Article 29 Working Party and endorsed by the EDPB regarding consent that suggested that controllers may, as a one-off situation, be able to make the transition to another GDPR-compliant legal basis.

Conclusion

Although the European Commission’s Q&A offers some clarifications on personal data processing within clinical trials, especially in confirming that consent is not the appropriate justification for processing personal data, it nevertheless omits some core issues for which guidance would be useful. As a result, disparities are likely to remain and should be taken into account when implementing a clinical trial across various EU jurisdictions (e.g., additional time will be necessary to negotiate and adapt local agreements and notices). As noted in our previous alert, the EDPB intends to opine further on the issue of secondary use, and this may be an opportunity to advocate for further consistency for other issues. Finally, for additional details, a table showing the GDPR legal bases in the Q&A is set forth below (and it is slightly updated to the Q&A in comparison to our prior alert).

Processing

Legal Basis (GDPR Art. 6)

Derogation (GDPR Art. 9)

Reliability and Safety (safety, disclosures, archiving)

Legal obligation (6.1(c))

Public interest in the area of health (9.2(i))

Research Activities

Consent (6.1(a)) (under specific circumstances)

Explicit consent (9.2(a)) (under specific circumstances)

Public interest (6.1(e))

Public interest in the area of health (9.2(i))

Scientific research (9.2(j))

Legitimate interest (6.1(f)) (if public interest does not work)

Scientific research (9.2(j))

Emergencies (new compared to EDPB opinion)

Vital interests (6.1(c))

Vital interests (9.2(c))

 


[1] Although one could argue in that case that the GDPR’s legal basis is scientific research and additional consent is being sought only as a safeguard under GDPR Art. 89(1), and not as standalone GDPR consent.

[2] Section 3.e of the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018.

[3] Article 24.c of the Dutch Data Protection Act.

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