The EU Clinical Trials Regulation (EU-CTR) came into effect on 31st January 2022, replacing the previous EU Clinical Trials Directive (EU-CTD). One of the core aims of the EU-CTR was to increase public transparency of the way clinical trials are run. This was achieved by making almost all documents publicly available by default, with some provisions available for redaction or deferral of publication.
Partly in response to feedback from users of the system, e.g. trial sponsors, the European Medicines Agency (EMA) has introduced revised transparency rules which come into force on 18th June 2024. These revised rules simplify the publication system and aim to ensure that only documents of the ‘most interest’ are made publicly available. Importantly, by removing the deferral mechanisms, the revised rules place greater emphasis on the redaction of commercially confidential information. It will therefore be important that trial sponsors engage in-house or external IP counsel to ensure that documents are appropriately redacted so as to avoid negative consequences for pending or future patent applications.
This article will provide an overview of the ‘old’ rules and the ‘new’ rules before considering some practical tips for applicants and patentees.
What are the ‘old’ rules?
At the time of launch, in 2022, the EU-CTR required that nearly all information and documents submitted during the lifecycle of a clinical trial was, by default, published on the Clinical Trials Information System (CTIS) at the first opportunity. Where applicable, e.g. where a document contained commercially confidential information, a trial sponsor could request that publication was deferred for a fixed length of time. The time limit for deferral depended on the trial category (which takes into account the nature of the trial, the medicinal product under investigation (IMP) used in a trial, and how the IMP is being used) and on the category of information or type of document. Alternatively, or additionally, commercially confidential information could be redacted from documents intended for publication.
What is changing?
Revised rules governing the publication of documents submitted in clinical trials run in the EU are coming into force on 18th June 2024. Significantly, the deferral mechanism will no longer be available. Instead, commercially confidential information (and personal data) will have to be redacted in versions of documents that are for publication.
The publication of documents will now occur according to a set timeline. Again, the timing of publication will depend on the trial category, with publication occurring later in earlier stage trials. Additionally, only the documents of ‘most interest’ will be published. Some examples of the new publication timings are summarised below.
| Trial category | Document | Timing of publication |
| Category 1 (e.g. Phase 0 and Phase I trials) in paediatric populations | Protocol, synopsis, and patient-facing documents, if available | Together with the final summary of results, as soon as the results are submitted |
| Final summary of results, with a layperson summary | Upon submission | |
| SmPC | Never | |
| Informed consent form and patient information sheet | ||
| Recruitment arrangements | ||
| Category 1 trials (e.g. Phase 0 and Phase I trials) in adult populations
| Protocol, synopsis, and patient-facing documents, if available | 30 months after the end of the trial in the EU/EEA |
| Final summary of results, with a layperson summary | 30 months after the end of the trial in the EU/EEA | |
| SmPC | Never | |
| Informed consent form and patient information sheet | ||
| Recruitment arrangements | ||
| Category 2 and 3 trials (e.g. Phase I/II integrated trials, Phase III/IV integrated trials, and Phase II, Phase III, and Phase IV trials) | Protocol, synopsis, and patient-facing documents, if available | At the time of the decision on the clinical trial application is issued (i.e. when the decision is made to allow the trial in a Member State) |
| SmPC | ||
| Informed consent form and patient information sheet | ||
| Recruitment arrangements | ||
| Final summary of results, with a layperson summary | Upon submission |
When will the new rules apply?
Clinical trials that were submitted before 18th June 2024 will be considered ‘historical’ trials. For historical trials, no documents will be published, and structured data (including e.g. the title, phase, therapeutic area, sponsor details) will be published according to the revised rules. Documents relating to trial modifications might be published, however, if the modifications are submitted after 18th June 2024. Similarly, documents or trial results submitted after 18th June 2024 may also be published in line with the revised rules.
For clinical trials that are submitted on or after 18th June 2024, the revised rules will apply.
How does this affect patents and patent applications?
In our previous article, we explained that clinical trial disclosures can be problematic as prior art, especially in Europe. The revised rules do not change the longstanding advice to file patent applications before starting clinical trials to minimise the risk that the applicant’s own clinical trial disclosures become citeable as prior art. However, the revised rules at least make the publication of information more predictable, which can be helpful when deciding on a target filing date.
Under the new rules trial sponsors will need to carefully redact commercially confidential information from documents that are intended for publication. The EMA has indicated that redaction should be as minimal as possible, and so a heavy-handed approach might not be accepted. Sponsors could consider enlisting in-house counsel and/or external European counsel to review any redacted documents before they are submitted to the CTIS, to ensure that the unredacted technical information is not likely to prejudice any current or future patent applications.
