Some Important Practical Points For ISO 14155 Compliant Clinical Trial Agreements In The EU, Part 2

Author:Mr Erik Vollebregt
Profession:Axon Lawyers

In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to mind and if so, I will devote a next post to those.

Agree on IP rights on the research data

If the clinical trial is to produce results in the form of data that the manufacturer of the investigational device wants to use to complete its technical file with a view to CE marking the device, it is critical for the manufacturer to own or at least have unfettered use of the data produced.

First of all, it is important to get the transfer of rights completely right. In the EU two types of rights come into play: copyrights on documentation created for the purpose of the trial and database rights under the EU databases directive on the databases used. Any assignment of rights must be broad enough or specific enough to encompass these rights.

Secondly, a problem with the database directive is that the sui generis database right accrues to the natural persons creating the database (i.e. the investigators) and only accrues to the legal entity the manufacturer is likely contracting with if national law of the EU member state concerned so permits. The same is true for copyright: it can differ from member state to member state whether employees' rights to creation automatically accrue to their employer and how it works with works for hire if the investigators are not employed by the clinical facility (e.g. because they are self-employed or employed by a CRO). A little due diligence into local copyright and database law is therefore required to decide if the investigators should co-sign the agreement for the purpose of the IP rights transfer. Keep in mind that the law governing this transfer is not necessarily the same as the law governing the agreement - you cannot choose the law under which copyright and database rights come into existence.

Manage termination and investigator replacement rights

With the entry into force of the EUDAMED database for the EU is has become important that disagreement with an investigator or CRO does not lead to termination or suspension of a clinical investigation, as this will be a reportable event that will go into the EUDAMED database and will be instantly available to the authorities in the whole EU. For that reason, it is important to include replacement rights for the manufacturer that may provide for the replacement of certain...

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