In December 2017, the so-called ‘Phase 1’ of the Brexit negotiations between the EU and UK came to a close, with the two sides coming to a high level agreement on the sum the UK will have to pay the EU upon exiting the bloc, on the status of Ireland and on citizens’ rights.
With this agreement, the two sides can now progress to ‘Phase 2’ discussions on the future relationship and a transition deal. This will establish the parameters of the relationship between the UK and EU during a transition period of what is likely to be just under 2 years, following formal withdrawal of the UK on the 29th March 2019, and before the eventual permanent arrangements commence. This is essential in providing certainty to businesses and avoiding a ‘cliff-edge’ exit for the UK.
Doris Schernhammer and Chris Lowry, from Lilly’s EU and UK Government Affairs teams respectively, discuss the key considerations for Lilly and patients across the UK and EU as talks progress.
Why is Brexit an important issue for Lilly?
Chris: At Lilly, we rely on the predictable environment that has stemmed from years of close integration between EU member states. Our operations in the UK are heavily interlinked with the EU, and we have built our UK presence with this close relationship at its core.
The doors opened to the first Lilly site in the UK in 1934, and our UK presence has now become Lilly’s biggest research operation outside of the US. We are one of the only pharmaceutical companies to operate with all three parts of the value chain in the UK: R&D, manufacturing and sales & marketing, all of which could be impacted by Brexit.
Doris: Let me give you a few concrete examples: Approximately one third of our worldwide clinical trials take place in Europe, many of them also in the UK. So questions we are looking at today include: How will this system work post Brexit? Lilly has a significant presence in Europe, with major research and manufacturing sites in UK, Spain, France, Italy and Ireland. Supply chains are extremely complex and highly integrated. If there are going to be border controls in place, there will be disruption to our supply chain of medicines. How can we ensure that patients on both sides of the channel can continue to receive timely access to the medicines they need? How do we avoid medicines that are temperature sensitive, requiring cold-chain, sitting for days at the border?
What are the issues at stake?
Chris: The issues which make a good environment for developing medicines, such as regulation of our products and clinical trials, our ability to move products easily between the UK and the EU, and our ability to attract and retain the best talent, are all affected by Brexit.
The EU regulatory system means medicines only require regulatory approval once to be licensed for the whole of the EU. Now that the EMA move from London to Amsterdam is confirmed, it’s not known whether a duplicate regulatory system will be developed in the UK. Independent analysis by the Office of Health Economics has found that should no agreement be reached, significant delays will be experienced in regulatory approval and thus patients’ access to treatments, with predicted delays of 2-3 months or more for applications submitted in the UK.
Doris: The shared EU system has created a truly broad and dynamic global community for knowledge sharing, and scientific exchange that is fundamental to advances in innovation. There are currently 1,500 ongoing EU clinical trials with the UK as the sponsor which could be impacted by the loss of EU-UK collaboration. In general we are calling for the strong scientific research collaboration between the UK and EU to be maintained after Brexit.
What does Lilly want to see happen?
Chris: We have been encouraged by members of the UK Cabinet emphasising the importance of a broad and dynamic co-operation with the EU for the life sciences industry. As with all international companies, Lilly will be seeking as much certainty as possible from the negotiations. It’s important that the transitional arrangements agreed between the UK and the EU provide certainty to allow businesses in both the UK and EU to plan ahead and understand the environment they will be operating in. For the final deal, alignment with the EMA on medicines regulation will be key to allowing EU approved treatments to be adopted by the NHS in the UK without additional delays.
Doris: This close cooperation would deliver the best outcome to ensure patients’ access to treatment is not impacted. A trade and customs arrangement that sees the EU easily able to continue importing British products, and vice versa, be they finished medicines or active ingredients, will be essential to avoid disruption in medicines supply for patients. There are currently 45 million patient packs supplied from the UK to the EU every month; with 37 million moving in the opposite direction.
It is important that we avoid a scenario where medicines safety, scientific research, and the medicines supply chain are detrimentally affected by Brexit and we are working close together, in the UK and the EU, to ensure that doesn’t happen.