When regulations change there are always a few aspects where the careful reader finds themselves asking “did they really mean that?”. In that vein there is a somewhat ominous clause in the new Clinical Trial Regulation, at least from the point of view of the legal representative.

Article 74 of the regulation states: “Such legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Regulation, …..”. What that means is the EU legal representative now takes on the role of overseeing the sponsor’s compliance and potentially the role of “whipping boy” if the sponsor fails to fully step up to the line.

When the regulation was first published many believed that the decision of whether to require an EU legal representative would be made on a country-by-country basis. However, when asked about the basis on which the decision would be made the European Medicines Agency recently replied  “…the decision to appoint or not a legal representative in the EU, should the sponsor not to be based in the EU, will apply on trial-by-trial basis and would be at the discretion of the Concerned member states (CMS) where the sponsor intends to conduct the clinical trials”. This raises the very real possibility that the member states will look at the sponsor, and, based on their evaluation of them, decide an EU legal representative might only be needed in cases where there are concerns about compliance.

Perhaps not surprisingly, several of the larger and more risk aware clinical trial outsourcing companies (CROs) are starting to set strict stipulations regarding the role of the EU legal representative. They are declining to take on the role of the legal representative unless all clinical trial activity is carried out by them.

This cautious approach is understandable, especially for large businesses which have a lot to lose. Companies seeking legal representative support in the EU typically are smaller companies and have no presence in Europe.. Add to that the possibility that EU legal representatives will only be required for “riskier” trials then should something go wrong – however unlikely that is – the CRO partner stands joint and severally responsible for the failings of the sponsor. And that could be extremely costly.

Given that the EU legal representative role is not by any manner or means the most lucrative aspect service delivery to trials, it does seem like an unbalanced risk/reward profile for all but the most specialist providers to take on this role.

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The long-awaited new Clinical Trials Regulation looks set to be introduced in 2020. Initially adopted in 2014 and due to go into force soon afterwards, it was held up by technical difficulties with the database, which is necessary to underpin the new environment. The latest testing suggests these problems have been resolved.

The new regulation will provide a far more streamlined process for sharing clinical trial information, create a more efficient assessment process, and facilitate trials being conducted across multi-member states.

There is, however, one subtle, and easily overlooked consequence of the regulation, which is with regards to the EU legal representative. At the moment, any trial where the sponsor is outside of Europe requires a formal legal representative in the EU. Once the regulation is implemented, this will change – either making life easier for the sponsor or potentially adding a layer of complication that many have not foreseen.

If, on one hand, all the regulators who are dealing with the trial agree to do so, they can waive the requirement to have a legal representative requiring only a contact person instead. However, if they don’t agree then the EU legal rep will become a more significant role than it has been previously.

Under the new regulation, the legal representative will be responsible for the sponsor’s compliance with the regulations. In practice, what that means is the EU legal representative will have to provide quality assurance oversight across the full extent of the trial, including not only aspects conducted in the EU, but also those potentially conducted outside the EU but linked to the trial.

If we look at many of the life sciences companies that will need a legal representative – the small biotech companies with no presence in the EU – the reason for this change becomes clearer. These companies can have immature systems in place and are typically led by someone relatively new to the industry, or at least to their level of responsibility. The likelihood of something major going wrong is low, but far higher than if the sponsor was a major multi-national. Making the legal representative responsible for the sponsor’s compliance is a way for EU regulators to ensure that there is someone to pursue in all circumstances

That said, those companies offering EU legal representative services will need to closely assess the potential risks involved as the regulation moves closer to implementation and the portal goes live…

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FAO: ALL UK-BASED SPONSORS OF EU CLINICAL TRIALS

If you are a UK-based sponsor with a clinical trial in the rest of the EU, Brexit could have a profound impact on the legal status of your study.

Clinical trials in the EU are governed by the Clinical Trials Directive 2001/20/EC. According to Article 19 of this Directive, the sponsor of a clinical trial or a legal representative must be established in the EU. As a UK-based sponsor you currently meet this requirement. However after Brexit, unless you have a legal presence elsewhere in the EU, you will no longer meet the requirement.

If you do not have an office or registered address in the EU, and you wish to perform clinical trials in the EU, you must have a legal representative who is established within the EU. Without a legal representative the trial will not be approved, or may be suspended, by the regulatory or ethics authorities.

The legal representative acts on your behalf to ensure compliance with your legal obligations under the Regulation and handles any request related to the conduct of a clinical trial. The representative forms a local point-of-contact for the EU regulatory authorities to address formal correspondence and where, if necessary, notice of due process can be served.

The European Commission has issued a notice to confirm that from the Brexit withdrawal date, as a sponsor established in the United Kingdom and conducting a clinical trial with sites in the EU-27, you must have a legal representative who is established in the EU.

While the withdrawal negotiations are still in progress, the European Medicines Agency (EMA) expects you to work on the assumption that the UK will leave the EU and, in order to avoid any disruption, prepare for that eventuality. National competent authorities are issuing warnings to sponsors (you may well have received one) asking them to prepare for Brexit now, or risk facing a suspension of their clinical trials after the withdrawal date.*

IDEA Regulatory is highly experienced in providing EU legal representative services to non-EU clinical trial sponsors. Setting up legal representation for a sponsor usually takes 2-4 weeks. However, we are currently offering an express service to get you Brexit-ready from our Dublin office in under 1 week.

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*Taken from: The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Web article “Consequences of “Brexit”: BfArM’s preparations.


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