EMA’s Implementation of Policy 0070: Highlights From Year One
The European Medicines Agency (EMA) published its first report on the implementation of Policy 0070 for the publication of clinical data. As of October 2016, the EMA publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralized procedure. The 27-page report, published July 16, 2018, covers one year from the launch of EMA’s clinical data website on October 20, 2016.
Highlights from year one:
- There has been full compliance with the policy in the first year.The number of commercially confidential information (CCI) redactions in the published documents was very low, appearing in only 0.01% of the total pages published.
- Most respondents to an online survey agree that the initiative has begun to achieve its goals of increasing public trust in EMA’s decision-making and of allowing the secondary analysis of clinical data.
- In the reporting period, 19 procedures (35%) failed to submit final redaction packages that were suitable for publication. The most common reason was that the protected personal data (PPD) redactions were not applied or incorrectly applied.
- 76% of procedures published in the first year were anonymized using redaction.
- Case narratives were fully redacted in 27 of the 54 published procedures and only partially redacted in 11 procedures.
- Although no instances of patients’ re-identification were reported, in 2017 one technical issue was reported to the Agency. The concerned document package provided by the Marketing Authorization Holder (MAH) for publication contained a non-locked redaction, resulting in a see-through redacted version being published. On the day following publication, the Agency was notified by a member of the public and the documents were removed within a few hours and subsequently the MAH provided a new final package with the redactions locked.
- Further delays: The Agency launched the first phase of its business continuity plan (BCP) in 2017. As a result, work in some areas has been temporarily reprioritized, suspended or postponed to resource Brexit preparedness activities and safeguard core activities. The second half of 2018, as well as 2019, will see a further reduction in the operation of EMA’s proactive publication of clinical data in line with a revised prioritization of its activities to take due account of the consequences of the relocation. EMA will do its utmost to resume the proactive publication of clinical data to the level outlined at the start of the policy once the relocation is complete.
Mitigating risk with Synchrogenix
Synchrogenix redacted and prepared almost 30% of all submissions published during year one. By combining expertise and artificial intelligence technology, we can identify and redact sensitive information with more than 99% accuracy. We have now processed over 6500 reports and have completed, or are in process, with 70+ EMA Policy 0070 submissions.
There are two key reasons why many of the procedural reasons stated above are mitigated when working with Synchrogenix’s anonymization service. The first is that Synchrogenix’s AI-enabled process provides consistency and repeatability. The second is Synchrogenix’s regulatory insight, expertise, and thought leadership ensures that many of the pitfalls are averted early in the process. A key example is the assurance that there is little, if any risk at all, of redactions not being applied or being applied incorrectly – the reason 35% of procedures failed! Synchrogenix also guides its sponsors as early on as possible to consider the impact of intellectual property being included in clinical reports and providing feedback on where there may be pushback from the EMA on sponsor-proposed omissions.