Innovative Drug European Associates


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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I’m a huge believer that even in the very worst of circumstances, there is always a silver lining (or two) to be found. We  have already seen some of these playing out during this pandemic in the many ways people are coming together to spread hope and goodwill between and across communities. One positive that the coronavirus might bring specifically to regulatory processes for medicine and medical devices, is a shortening of response times from the regulatory authorities and better ways to share information simultaneously between global authorities, leading to improved harmonisation. The COVID-19 pandemic has forced regulators to find new ways of communicating on global projects and to act urgently to deal with this unpredictable and critical situation.

To address the coronavirus effort, regulators have adopted new processes and are making use of interoperable databases and systems to share information. They are using these systems and processes to ensure studies and data from coronavirus research are widely and rapidly shared in order to speed up the process of bringing vaccines and treatments to patients.

I certainly hope – and expect — that there will be some trickle down from those learnings once this crisis is over. Allowing the life sciences industry and academia to push forward with efforts to improve global harmonisation when it comes to sharing data and study results. More rapid, harmonised approaches will ensure that everyone in the research community is aware of what is working and what is not in each disease category so that discovery efforts and clinical trials aren’t focused on areas that have been shown to be ineffective elsewhere.

These next few months will be crucial for achieving the breakthroughs needed to tackle the pandemic, and good regulatory processes will be key to advancing those objectives. Times of crisis are often the catalyst for positive change and there’s every reason to be optimistic that this current sense of urgency will help us improve the regulatory landscape and lead to better processes for all breakthrough therapies in the future.

The fact is that, as an industry, we’re good at recording what we do day-to-day. It is what researchers do, and it’s part of our Good Practices – we carefully record data because if we don’t write down what we did and what we observed, it didn’t happen (according to the audit trail at least). If we record the learnings we gain from this period and transfer those to regulatory processes more generally, we can at least say that some good has come out of a very dark period in our history.

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