Innovative Drug European Associates


It’s understandable that companies tend to be focused first on getting their products approved. But that’s just part of the battle. The other part is getting your products paid for. In July 2017, EMA began offering consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA).

The objective is to ensure that you not only have the data needed to approve your product for marketing authorisation, but also the economic effectiveness data to support reimbursement arguments.

To date, however, most companies have shied away from the joint consultation process. There are good reasons for this reticence. First, it’s a new process and many companies don’t know how to do it or what to expect. But perhaps a bigger barrier is that once you’ve had the parallel consultation, you can’t talk to the individual member states (to avoid potential for conflicting advice). This can feel like you’re shutting down your options. Another potential issue is if the regulatory and HTA recommendations conflict, which may sometimes be the case.

But by talking to both at the same time you can ensure you don’t just receive the green light to sell your product but also the support of the payers, and you are fully aware of any potential setbacks and problems. This allows you to plan your development strategy according to your priorities, with an understanding of where issues might arise in future. If you are entirely focused on getting MAA approval without considering reimbursement from early on, you could well spend precious years jumping through additional hoops to get it on the market post authorisation.

As with any process, any undesirable responses that arise during your conversations with EMA and the HTA representatives can be addressed if you start early enough. If your product is for a rare disease, you might be providing surrogate endpoints rather than the traditional pivotal endpoints. If that’s the case, you need to be looking at building patient-reported outcomes in your phase 2 trials, which will help with your economic analysis later. Having that conversation early and knowing what to expect may well improve your position later when it comes to the decision about reimbursement.

As I’ve stated before, the regulators want to get good products to patients – as do the HTA representatives. But they want to know that what they’re paying for will make a difference to patients compared with what is already on the market. And they need to understand how your product works. If you have a first-in-class molecule that requires HTA bodies to install new diagnostic equipment to diagnose the biomarker, they need to see the value of investing in your product. That’s a reasonable expectation. So, the sooner you discuss those needs with all the key stakeholders, the better your chances of getting your product on the market and starting to make money from it.

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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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