Butterworth Laboratories Ltd, a UK-based a contract analytical chemistry testing laboratory working principally in the pharmaceutical market, has been continuously monitoring Brexit and its potential outcome over the last 12 months.
As part of our responsibility to ensure we can continue to provide the high levels of service to our clients once the UK leaves the EU, we have performed a risk assessment to identify the areas most likely to be affected.
The most significant risk we have identified is a misinterpretation concerning medicines regulation. Once the UK leaves the EU, medicines destined for the EU market will need to be released in the EU, including the supporting QC testing. However, this does not apply to raw materials and APIs. Therefore, we wish to make it clear that there are no regulatory barriers to clients in the EU from sending us Raw Materials and APIs for testing. As far as we are concerned, it is business as usual.
The second area of risk relates to the potential delay and additional costs involved in sending samples to the UK from the EU. At Butterworth’s, we regularly receive samples from countries outside of the UK and EU and our experience is that this is a painless exercise provided the sender declares the items as having “no commercial value” and will be tested to destruction or securely disposed of afterwards.
The third area is the potential increase in charges due to an increase in the cost of supplies coming from the EU and also possible delays in turnaround times due to a restricted supply of critical materials. We have discussed these risks with our major suppliers and they have informed us that, in rare cases, we might see a very minimal increase in the cost of consumables, if any at all.
Furthermore, because they have invested in increased warehousing, they do not anticipate that we should encounter delays to commonly used materials. Should any material be identified as being at risk of delay, this will either be sourced from an alternative supplier or held in larger stock levels to ensure its availability. We do not expect that you will see Brexit related price increases or additional delays in receiving results.
Finally, there is the issue of GDPR and the transfer of personal data between the EU and the UK. We will be shortly providing an appendix to our EU clients’ agreements which contain EC approved data protection Standard Contractual Clauses (SCC), allowing for the transfer of personal data between the EU and ourselves in the absence of an adequacy agreement.
We hope this communication addresses the concerns you might have. Naturally, we will keep you informed should anything which affects this position change or come to light. We would be more than happy to visit you so that we can discuss this in more detail face to face if needed. If you would like to arrange a visit, please fill out the enquiry form attached to this page.