UK to become a third country as of 30 March 2019


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Preparing for a hard Brexit and its impact on clinical trials

The pharmaceutical and biotechnology sector is being forced into hard Brexit choices. As discussed in the media recently, a last-minute political deal will come too late to ensure supplies won’t be disrupted after 30 March 2019.

Many pharmaceutical companies running clinical trials in Europe work with contract research organizations (CROs) and contract manufacturing organizations (CMOs) based in the UK.

Following Brexit, the UK and UK-based CROs and CMOs will legally no longer be part of the EU which will have a dramatic effect on the European portion of the global ecosystem of testing or distributing investigational medicinal products (IMPs).

The impact on the supply chain of clinical trials could completely derail the development of a new drug, with significant negative financial and economic consequences.

The complexity of the European supply chain means that arrangements need to be made NOW to avoid shortages or delays to medicines reaching patients in the UK and mainland Europe.

Qualified Persons

Many companies outsource services around the manufacturing, packaging and labeling of their drug product to third-party vendors and rely on external consultants for certification.

The most important of these external roles is the Qualified Person (QP) who, in accordance with EU regulations, certifies every batch of a medicinal product before it can be released for use. About 25% of QPs in the EU are UK-based. In the future, they will not be allowed to release drug products for the EU.

Some experts are projecting an overall shortage of QPs in the EU, with the consequence that demand will increase for the services of the remaining EU-based QPs.

Thus, companies currently working with UK-based QPs should start looking elsewhere in the EU now to ensure a seamless transition for their clinical trials in post-Brexit Europe.

Changing QPs may impact the existing qualified and audited supply chain, for both ongoing and planned clinical studies. If a firm needs to switch QPs mid-trial, it may be necessary for the new QP to re-qualify the entire supply chain, with significant financial and efficiency costs.

Financial implications

Small to mid-sized companies who do not have established facilities outside of the UK in other EU member states may have the highest impact of the Brexit since their ability to move operations to other locations is limited.

Another change post-Brexit will be the movement of drug products between the UK and the EU. Currently, they can be moved and distributed without import or export duties. After 2019, drug products manufactured in the UK may be subject to import duties on top of the value-added tax (VAT) if shipped into the EU. Thus, drug products currently stored in the UK should be transferred to an EU country now to avoid future import duties and VAT on existing inventories.

The Brexit clock is ticking

For all of these reasons, pharmaceutical and biotech companies should be planning now for all trials including those already underway, those that begin prior to 30 March, 2019, and those that begin after. In order to avoid costly delays and disruptions of your trial, it would be vastly beneficial to transition to a provider of clinical trial services with established facilities in post-Brexit EU.

CSM is well positioned to serve post-Brexit needs as it has EU GMP facilities outside of the UK in both Brussels, Belgium and Frankfurt, Germany that are staffed with certified QPs who can support drug product EU release and batch certification. Both facilities have decades of experience and outstanding quality and regulatory track records.

The Brexit clock is ticking. To support the preparation process and to ensure business contingency, a prepared and proactive approach is advised. CSM is prepared to handle drug products for new clinical trials without any risk of disruption at any time during the study.

How can we help you face the Brexit challenges? Schedule your 20-minute, no-cost consultation with a clinical supplies services expert at CSM.

CSM is already positioned for post-Brexit operations. Learn more in our case study, EU Release and the importation of IMPs in the European Union.