The dreaded B word – will Brexit have an impact on EU clinical trials?
With only weeks until the cutoff date for Brexit and a no-deal scenario looking more likely by the day, many involved in healthcare are concerned about the future of EU clinical trials and the impact Brexit is going to have on the pharmaceutical industry as a whole. Fortunately, though, the pharmaceutical industry has been keeping a close eye on negotiations to try and get an insight into the potential regulatory framework of the UK post-Brexit.
Are medicine shortages a genuine worry?
Recent news reports have raised the possibility of a medicine shortage once Brexit hits. Given the complexity of the pharmaceutical supply chain, it’s no wonder companies are examining alternative transport routes and solutions. While little has been publicly announced, many companies have already started to set up hubs in the Republic of Ireland to ensure that they remain in the EU but are still close enough to the UK. As clinical trial supplies in the EU were traditionally supplied via Northern Ireland, moving down south to the republic could be the most sensible move they can make right now.
The industry is still waiting for answers
At present, it’s very hard for anyone to have a concrete picture of the impact of Brexit on the pharmaceutical industry. Apart from some minor pieces of information, it seems that the overall situation will only become clear once Brexit actually happens. To date, there is no regulatory clarity on how Brexit is going to affect EU clinical trials, and with the European Medicines Agency (EMA) having been moved to Amsterdam, there’s speculation as to whether the UK will even remain a member. In that case, the MHRA (Medicines and Healthcare Products Regulatory Agency) might well take over. Currently, it’s still unknown how the clinical trial application process will affect new investigational medicines.
While there are changes to the EU clinical trial regulations scheduled for 2019, it’s still very unclear as to whether the UK is going to implement these or not. If the UK chooses not to introduce these amendments, there is a chance that they could be excluded from the continent-wide IT portal which allows pharmaceutical companies to access EU trial data.
Despite the lack of information at present, as a UK company specialised in medical translation, we’re doing all we can to keep regularly updated. If you have any questions about your pharmaceutical translation needs in light of Brexit, feel free to get in touch and we’ll do our best to help.