The UK's decision to exit the European Union has far-reaching implications for US pharmaceutical companies trying to break into the EU drug market. The lack of regulatory clarity during this negotiation period between the UK and the EU makes it difficult to plan and execute long-term clinical strategies in the EU. Sherpa Clinical Packaging will be convening a panel of experts to advise on future milestones that pharmaceutical companies should carefully consider as they solidify their plans to bring potential life-saving therapies to the EU clinical research market.
Sherpa will be hosting its second annual Sherpa Summer Seminar on August 10 from 2-6 pm at its headquarters in San Diego. The company's President, Mark Paiz says, "With a significant number of our clients planning larger clinical trials in the EU, we are seeing a growing desire to better understand potential implications for their clinical trials as Brexit's launch date of March 2019 approaches."
The expert panel on Brexit will consist of: Elisabeth Lackner, CEO and Qualified Person (QP) of ABF/GBA Pharma; John Shillingford, independent consultant; Sascha Sonnenberg, VP Commercial Operations Americas and EMEA, Marken, and Mark Paiz.
"With Brexit necessitating the move of the European Medicines Agency (EMA) from the UK to an EU member country by March 2019, it is near inevitable that there will be a period of frustration for the global clinical research community trying to conduct clinical trials in the EU as the EMA looks to re-establish systems," says Shillingford.
Sonnenberg, who has closely evaluated the potential outcome of Brexit negotiations on the European market says, "Non-EU countries must keep a close watch on Brexit to determine if the UK will continue to be a viable entry point into the EU clinical trials market. If negotiations break down and the UK is not included in the EU's planned one portal clinical trial assessment and approval system (EU Regulation 536/2014), non-EU countries (such as the US) that currently import their clinical supplies into the UK in order to be distributed throughout the EU will definitely need to reconsider their clinical import strategy."
One area of major concern is the impact of Brexit on the Qualified Person (QP) process. This is the process that all investigative products must pass in order to enter the EU for clinical trials. "While we don't expect any changes to the QP process during the negotiation period that will end in March 2019" says Lackner, "effective immediately after Brexit, if the UK and the EU do not have mutual recognition agreements in order, it will be imperative for non-EU pharmaceutical companies to work with an EU-based QP as opposed to a UK-based QP."
Life sciences companies interested in attending the Sherpa Summer seminar event to learn more about the impact of Brexit on the clinical research community should register here.