On June 23, 2016 the U.K. decided to leave the EU, a decision which comes into effect on March 29, 2019. Since the U.K. government gave the green light a year and a half ago leaders from each industry have tried to plan for every case possible; hard Brexit, soft Brexit and even a no Brexit.
With such high levels of uncertainly and lack of clarity on behalf of the government, most companies have opted for the worst possible scenario to ensure that come March 29, 2019, their supply chains do not come to a stand-still affecting their operations.
Minimizing the Effects of a Potential Hard Brexit
The pharmaceutical industry has closely been watching the ping-pong game between the Department for Brexit (DexEU) and the European Commission (EC) attentive to any indication that might shed light on the future regulatory status the U.K. will hold vis-à-vis the remaining 27 member states.
Given the complexity of the pharmaceutical supply chain, ensuring drugs are available to enable the continuation of clinical trials is paramount for all companies both big and small. Consequently, many companies are looking at alternatives in their supply chain to prevent the kind of delays and overruns that are so common in the clinical supply chain. For many pharma companies, the onus of complying with Brexit rests more on their suppliers than on their own teams given that many outsource components of the supply chain.
Almac recently announced a decision to build a packaging site in the Republic of Ireland to minimize the effects a hard Brexit might have on their ability to package and ship clinical trial supplies to other EU countries given how historically their operation has been based in Northern Ireland. The decision by such a large contract manufacturer highlights how this uncertainty has required that industry take active decisions while the verbal to and fro between Brussels and London continues. Many other large CROs and CMOs will have to ensure they are prepared to invest in new developments given how historically their advantage versus their competitors has rested on their ability to receive, package and release investigational products from the U.K. to the rest of the 27 member states.
With Brexit, Many Questions Remain Unanswered
Additionally, to having to redesign the supply chain and find alternative routes for carrying out trials in the U.K. and continental Europe, there is still no regulatory clarity on how Brexit will impact the U.K. With the departure of the European Medicines Agency (EMA) to Amsterdam, questions remain unanswered on whether the U.K. will remain within the agency or if the Medical and Healthcare Regulatory Agency (MHRA) will take over all these responsibilities. At the same time, it remains unclear how the application process to carry out clinical trials will affect sponsors abilities to test new drugs. Given that bringing a drug to market is a decades-long enterprise, any delays affects the ability of new drugs being commercialized, which ultimately affects patients’ access to new life-changing medicines.
With upcoming changes to the EU Clinical Trial Regulation, due to come into effect in 2019, it remains unclear as to whether the U.K. will implement these or op-out given that this change will take place during the transition period that has been agreed by the U.K. government and Brussels. While it appears the U.K. will honor this agreement there is no certainty the EU will reciprocate. If this were the case, the U.K. would be excluded from the continent-wide IT portal which allows pharma companies to access data on a pan-European scale. At the same time, it remains unclear if this regulation will manage to come into effect in 2019 given how the EMA is struggling to get this regulation ready for its release, and that’s not to mention the logistical complexities of relocation from London to Amsterdam.
Given the above, it is no surprise that one of the most pressing issues clinical supply teams are facing both in the U.K. and the rest of Europe has to do with what will happen on March 29, 2019. With six months to go until that date, there is little certainty other than the best thing sponsors and solution providers alike can take is plan for the worst and diversify their supply chain to ensure minimal disruptions are caused when the clock strikes midnight on March 28 next year.