At the DIA Annual Meeting this year, Jonathan Mogford, director of policy, Medicines and Healthcare products Regulatory Agency (MHRA) said regulators are preparing to ensure the protection of public health, expertise, and business continuity as well as the relocation of staff, their families, and IT systems to a different country – which is yet to be determined.
“Clearly one of the things that everybody has in the forefront of their minds … is how do we work responsibly and professionally to make sure that the challenge of Brexit is managed in as smooth a way as possible,” explained Mogford during a session at the meeting, which took place last month in Chicago, IL.
“It is entirely possible to pile up all the problems and all the things that could go wrong ... and get to something that looks like a deeply catastrophic situation,” he added.
However, switching to an empty slide, Mogford stressed that many decisions have not been made. The big message for the afternoon’s session is that nothing has been decided, he said, though the challenge is making sure the industry is looking seriously at how to “manage and minimize” the potential risks Brexit poses.
“If you look at what is being put in place by way of preparation, essentially, legally, what is happening is that the UK government is preparing to move EU legislation and reapply it domestically as UK legislation,” Mogford explained, “with relatively small changes in certain situations.”
Bottom line, regardless of what happens with the technical framework, “we’re not talking day one about something that the UK is going to be doing completely different [from the EU as it pertains to regulations],” he said.
Moving an agency
Following Brexit, the EMA must also move its location – including 900 people and their families, most of whom moved to the UK to work. “For us this a big deal,” said Saint-Raymond.
Additionally, the EMA is preparing for some “renewal of staff,” as not all current employees will follow to the new location, which Saint-Raymond said the EMA is very interested in knowing. “The decision is not ours,” she noted, as it will be made by the EU Heads of State and Government in the European Council.
A decision is expected by October 2017, but there is no certainty a location will be chosen at this time.
“We need to be able to function so there is no disruption ... we want to continue protecting public health,” added Saint-Raymond.
“For all the noise and turbulence of what we’re going to see over the next two years – and there will be a lot of noise and turbulence – there actually no reason what so ever, if the will is there, why an EU regulator framework can’t be evolved to become at least, at the technical level, a Europe-wide regulatory framework,” added Mogford.
As for the two-year timeline, Virginia Lee Acha, PhD, MSc, executive director, Research, Medical and Innovation, Association of the British Pharmaceutical Industry (ABPI), commented that she doesn’t think anybody feels confident that this timeframe is anywhere near sufficient.
“It’s just the volume of change that in itself is daunting,” she said. “We all need to get to some better understanding as soon as possible, or all of the good intentions we may have may just time out.”
Stepping up to the job
Agnès Saint-Raymond, MD, head of international affairs (ad interim), head of portfolio board, EMA said the EU wants to maintain “a good level of expertise,” as it prepares for the impact of the UK’s departure from the EU – and with it, a knowledge base and contributors to the EMA’s peer-review system.
The system is meant to safeguard the accuracy and validity of the Committee for Medicinal Products for Human Use (CHMP), the EMA’s committee responsible for human medicines.
“The UK is a very active contributor to the peer review of almost every new medicine that is licensed in Europe,” added Mogford, who noted that this will be a bigger issue longer term.
As such, Saint-Raymond said the remaining 27 EU member states have to “step up and take up the job.”
“We are asking them to think about stepping up and building capacity – and to adapt procures and systems in order to do this,” she said. “Pharma companies need to have the right information and know how to prepare and what to do,” she added, stressing that the industry cannot wait two years.