An Introduction to Brexit
What is the current situation?
A referendum- a vote by anyone who is of voting age- took place Thursday June 23, 2016 to decide whether the United Kingdom should leave or remain in the European Union (EU). The majority of the UK population voted to leave the EU, and the UK is currently scheduled to exit the EU on March 29, 2019. Since the time of the vote, there have been ongoing negotiations about the processes under which the UK will leave the EU and how that may affect trade.
What are the possible outcomes?
The outcome of the negotiation that is currently underway may result in arrangements that are similar to those currently in place between the EU and Norway, Switzerland or the USA. The Fisher Clinical Services team has planned for a range of operating models to provide continuity of service under any scenario.
What should clinical trial sponsors be prepared for?
As negotiations are ongoing, the specific outcome is currently unknown. You should speak with your clinical supply service provider(s) to identify solutions for each possible scenario. Topics to discuss may include Qualified Person (QP) release, distribution footprint, and strategies to mitigate risk in your supply chain.
What does a Fisher Clinical Services roadmap to mitigate supply chain risk look like?
Our existing supply chain has the capacity to provide continuity for our clients and their patients under all Brexit scenarios. Fisher Clinical Services has full-service distribution in the UK, Germany and Switzerland with harmonized Qualified Person (QP) processes that address a range of scenarios that may result from the negotiations.
What is the potential impact for Qualified Person (QP) release?
In general, EU medicines legislation allows for distribution of pharmaceutical product across all EU member states. Once a QP certifies in the EU, there is unimpeded tariff free movement of medicines to pharmacies, hospitals and investigator sites, from any member state to any other member state. As the UK moves outside the EU, this may change the current relationship to the EU QP framework.
We are monitoring the situation as it evolves, and we are in consultation with clients to ensure that they are well-prepared. With 20 years of experience in Europe, we are prepared with a solution for any outcome. Please contact your Fisher Clinical Services client services team to discuss what this may mean for your studies.
How will Brexit affect me as a client?
We manage a global network of Fisher Clinical Services distribution facilities and we are committed to consistently maintaining high quality service levels in all regions. For example, we have an existing supply chain and capacity in Germany. This allows us to deliver into the EU from our packaging facilities outside the EU (Switzerland). We also have existing capability to deliver into the UK (Horsham). We’ve developed specific strategies that can be reviewed with study sponsors to evaluate their needs, and to establish the best possible solution in the context of a changing regulatory environment.
How can I find out more about Fisher Clinical Services solution to Brexit?
Feel free to reach out to your sales or clients service contact, complete the contact us form, or ask your questions below.
How can Fisher Clinical Services help me through Brexit?
The UK is an important market for Thermo Fisher Scientific and we remain focused on serving our clients’ needs and supporting the global clinical supply chain. Since the UK’s decision to exit the EU was made, our EU Regulatory Governance team has been deeply involved with assessing the potential supply chain impact to ensure we have appropriate plans in place to mitigate any risks. We have planned for a range of potential options to ensure continuity of service under any scenario.
The good news is our existing supply chain can provide continuity for our clients and their patients. Over a decade ago, we established a Fisher Clinical Services supply chain facility and capacity in Germany. This capability allows us to deliver into the EU from our packaging facilities outside the EU (Switzerland). We also have existing capability to deliver into the UK with our Horsham site. All sites have harmonized quality management systems and QP release processes.
As the industry leader, we have the scale and capabilities to navigate this environment. Whatever the outcome to the Brexit negotiations, we will take appropriate actions to make sure that we are in the best position to support our clients in the UK and across Europe.