Staff Writer

PHILADELPHIA – Questions about running clinical trials in U.K. and Horizon 2020 took center stage at the MedTech Conference Tuesday, with one audience member expressing doubt that a no-deal Brexit is unlikely.

"It isn't nothing, but equally it's not everything," said Lord James Richard O'Shaughnessy, Parliamentary Under Secretary of State at the Department of Health, in a session that sought to emphasize that the U.K. will remain open for business, irrespective of Brexit. He attempted to explain what to expect ahead of the March 29, 2019, Brexit date.

"I spent a huge amount of time with my EU colleagues – health ministers, people with the commission – and I think there's actually very deep understanding about what's at stake, particularly in health care because of the benefits that the EU and U.K. working together bring," he noted. He highlighted manufacturing, research and regulations as examples. He added that there is uncertainty, which affects investing and purchasing decisions, "and we want to get beyond that point." O'Shaughnessy noted that the negotiating parties are getting to the final stage of discussions. In addition, while the U.K. and EU will continue to have a strong relationship, the former will be able to create an independent trade policy.

Expect the unexpected

While noting that he did not think there would be a no-deal Brexit, calling it an "unlikely scenario," he said that the government had starting planning for that eventuality and started sending out specific information to companies in order to be prepared.

That said, in August, the U.K. government advised pharma companies to build a six-week stockpile and prepare to import drugs that have a short shelf life by air in case of a no-deal Brexit. (See BioWorld MedTech, Aug. 24, 2018.) There also have been discussions about recognition of the CE mark and the free flow of goods, something that the government has sought to address.

Matthew Hancock, U.K. secretary of state for health and social care, had given pharma companies until Sept. 10 to confirm in writing they have plans in place. "[We] ask you to indicate how you propose to ensure continuity of supply of your products to the National Health Service in the event of a no-deal Brexit," Hancock wrote.

Despite the hopeful picture O'Shaughnessy painted, audience members expressed concerns, with clinical trials being one issue. "Running clinical trials in the U.K. [is] expensive and very slow," said one participant regarding costs small and medium companies face and referenced Horizon 2020. She asked that companies be allowed to spend U.K. grants for clinical trials in Europe. "For me to run a clinical trial solely in the U.K. is difficult," she emphasized. Small-and-medium-sized enterprises (SMEs) have been urged to participate in Horizon 2020, the EU's research and innovation funding program. O'Shaughnessy answered that the government is actively working the clinical trials situation through its life sciences: industrial strategy to make improvements. "In terms of your funding/Horizon 2020 point, I think [it's] important to say that we will continue to be part of that program to its conclusion. And also the deal that we're proposing with Europe would be that we were part of the next funding round," he added. He pointed out that countries that are not part of the EU have participated in Horizon 2020, so there is a precedent.

Another participant asked O'Shaughnessy how he could be so sure that a no-deal Brexit was unlikely. He noted that Liam Fox, the U.K.'s secretary of state for international trade, said that possibility of such a deal stood at 60 percent. The participant also noted that the process is going to be a mess, and companies with distribution operations in the U.K. will be in trouble. Further, U.K. companies already are making decisions, relocating distribution to Europe. At the same time, EU companies are opening small distribution centers in the U.K. in order to stay in that important market.

"I certainly think everybody should be preparing for every outcome, and I know devices companies are," O'Shaughnessy responded. He also acknowledged that SMEs are facing challenges due to capacity constraints, but the government is communicating with them directly and via trade associations to prepare for any eventuality. He disagreed that the probability of no-deal Brexit was so high, but agreed that companies need to take measures to be ready.

Scientist concern

While O'Shaughnessy appeared optimistic, others have expressed reservations. During a session at the Euroscience Open Forum, scientists lamented the impact it could have on relationships forged over the years. (See BioWorld MedTech, July 16, 2018.)

"I've not heard a scientist in any country saying, 'great, more money; we can lead projects.' No one says, 'hurray, hurray, hurray, they are going.' On the contrary, scientists are in dismay," said Robert-Jan Smits, who until stepping down in April, was EU director-general for research and innovation, the EU's most powerful civil servant in science policy.

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