EMA's guidance for protecting confidential information in clinical trials

Regulations 745/2017 on medical devices and 746/2017 on in vitro medical devices and Regulation 536/2014 on clinical trials of medicinal products for human use stipulate that the information entered in the CTIS and EUDAMED registries are accessible to the public, with the exception of commercial information of a confidential nature.

While the principle seems clear, from an operational point of view the identification of information that can actually be considered confidential and the material preparation of the records may not be straightforward, especially since the protection of confidentiality must be balanced with the transparency to which the establishment of the aforementioned records aspires.

The draft EMA Guidelines

Last April 7, 2022, the EMA published its "Guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS)," for the specific purpose of giving operational guidance on the management of commercially confidential information and personal data.

The definition of commercially confidential information

The Guidance considers commercially confidential information to be any information contained in the clinical trial application and provided during the life cycle of the trial that

1. is not in the public domain or publicly available, and
2. the disclosure of which may harm the legitimate economic interest or competitive position of clinical trial sponsors or applicants/marketing authorization holders.

Therefore, any information to be considered confidential must meet both of the above requirements.

As a first step, therefore, it is necessary to ascertain what information about product development is already known to the world of science.

The suggested method

For this reason, the Guidance suggests involving experts with relevant scientific and technical expertise in the process of identifying confidential information and following a consistent decision-making process, which it describes in 3 steps

1. Exclude that a particular piece of information is available or already in the public domain
2. If the information is not in the public domain determine in cooperation with experts whether the information is innovative and whether its disclosure could undermine the economic interests or competitive position of the owner of the information. If the information is innovative in that case it can be considered confidential and deleted from the documents to be published.
3. In exceptional cases, non-innovative information may still be considered confidential if its disclosure could harm the economic interests or competitive position of the information owner.

Confidential information should be identified early in the development plan so as to minimize its inclusion in trial-related documents intended for publication; this approach should be supported by the preparation of document templates as well as a list of websites and/or publications to check in order to identify information already in the public domain.

In addition, it is required that information identified as confidential be consistent in all documents published or for which deferred publication is requested.

The state of the art for medical devices

As is well known, at present, the EUDAMED IT system, developed by the European Commission to implement the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR), is operational only limited to certain modules, among which the module on clinical investigations is not included.

It is equally well known that Articles 73 para. 3 Reg. EU 745/2017 and 69 para. 3 Reg. EU 746/2017 provide for the

"protection of commercially confidential information, especially in the investigator's manual, especially taking into account the status of device conformity assessment, unless there is a public interest in disclosure."

By the time the module is operational, sponsors of a clinical investigation will need to determine what information is to be considered confidential and create the necessary internal protocols.

The indications, especially of method, contained in the Guidance published by EMA are certainly a good starting point to begin thinking about and elaborating all those useful procedures to identify from the start of the project the confidential information, draft the documentation accordingly and justify the request for protection in a coherent way.

Activating from now on will allow operators to be ready when the EUDAMED registry will also be active with respect to clinical investigations and at the same time to meet the requirements of Dir. 2016/943, transposed into Italian law by Articles 98 and 99 of the Industrial Property Code, according to which commercial information can be considered "secret" - and therefore can be suitably protected - only where it has been assessed as such and upstream and, consequently, has been subjected to measures that can be reasonably considered appropriate to keep it "secret."