What is the recipe for keeping business momentum in clinical trials despite Brexit? Plan future distribution ahead, ensure access to regulatory resources, and set up a broader sourcing network.
With the outcome of Brexit negotiations looking increasingly uncertain, stakeholders in the UK life sciences sector are starting to get anxious, with concern about the impact of a no-deal Brexit mounting. From stockpiling supplies to relocating regulatory teams to mainland Europe, many companies are already starting to take steps to try and mitigate the impact of Brexit, in whatever form it takes. In most cases, these initial steps are costly, and the lack of clarity about possible long-term solutions is making investors twitchy. But is this an overreaction?
At Inceptua we are continuously assessing how companies - whether based in the UK, in the US, or elsewhere in the world - can prepare for any Brexit scenario and ensure that the likely changes cause minimal disruption to their supply chains. The key areas of concern below are pinch points for many companies but planning ahead and re-gearing their operations early can help them to circumnavigate these issues and continue to deliver care to patients in need.
Plan future distribution ahead
Increased border control will make the movement of drugs between the UK and EU more difficult. Stockpiling treatments will provide a short-term safety net, but companies also need to look at how they ensure longer-term supply isn’t disrupted.
One way of predicting how post-Brexit supply chains might work is to consider how movement of medicinal products between the EU and existing third countries like Switzerland works at present. Based on this, we can reasonably assume that customs procedures will be more time-consuming, and distributors will need to ensure they have the appropriate customs licenses in place in order to navigate hard borders. Planning now to make sure additional time and paperwork is factored into future distribution arrangements, will help mitigate delays and disruption to future supply chains.
Ensure access to regulatory resources – in both the EU and UK
Particularly pertinent for sponsors of clinical trials - who may not have the flexibility to change product formulation or source without risking the integrity of their trial data - is how to ensure they are able to use UK products in ongoing EU trials, and vice versa.
Post-Brexit, UK products will no longer be considered as also being EU products - but having access to regulatory personnel in both the EU and UK to be able to release products from either region, will allow sponsors the flexibility to continue using the stock required. For example, ensuring access to a Qualified Person in the UK would allow companies to re-test and re-release EU stock to continue their trial uninterrupted in the UK, if that is what their trial protocol demands.
Set up a broader sourcing network – outside of the UK
A broad sourcing network will be another supporting element which companies can start considering now. Alternatives to UK product may be plentiful, but many companies will not have direct access to it, not having needed to rely on it in the past. Finding distributors at this point, and ensuring the necessary regulatory checks and test runs are completed early, will help companies rest easy that they can continue to access the products they need in the future.
Brexit remains an uncertainty, but with a proper plan in place, stakeholders in drug supply chains can rest assured that they will be able to continue operating with minimum disruption, even in the event of a no-deal Brexit.
Ann Gidner is Head of Clinical Trial Services at Inceptua.
Feature image © danielsbfoto – stock.adobe.com