Oliver O’Connor, CEO of Irish Pharmaceutical Healthcare Association (IPHA), discusses what the Brexit means for the pharmaceutical industry and what could be coming next for the EMA.
On June 23, 2016, the citizens of the UK voted to break away from the European Union (EU)—leading to what has been termed as the ‘Brexit’ (or British exit). One of the potential impacts of the Brexit is the relocation of the European Medicines Agency (EMA), which is currently headquartered in London.
Unable to be located in a non-EU member state, the EMA—should the UK formally notify the EU of its intention to separate—will be forced to relocate from London to another location. And many industry professional in Ireland are vying for that relocation to be to Dublin.
“If the United Kingdom precedes to leave the European Union, the EMA cannot remain in a non-EU member state,” said Oliver O’Connor, CEO, Irish Pharmaceutical Healthcare Association (IPHA). “If they [the UK] trigger their Article 50, which begins the two-year negotiation process to achieve withdrawal, the EMA has to make a plan to move.”
The greatest challenge for such a move, of course, isn’t just facilitating the relocation of 900+ employees, but moving in a timely manner that doesn’t hinder the day-to-day operations.
“An undisrupted EMA is good for the industry. The avoidance of any slow-down in terms of people working (processes, the day-to-day) is very important to avoid any impact on the EMA itself from the Brexit process,” said O’Connor. “An organization with 900 people or so, they have two years to organize a move with no disruption, which is quite a challenge.”
Why Dublin?
“The Irish government has signaled that it will be advocating very strongly” for the EMA’s relocation to Dublin, O’Connor said. The Minister for Health will be getting formal government approval and putting Ireland’s case to its other member states.
“One of strong arguments for Ireland will be the minimization of disruption because Dublin is an hour flying time away from London,” said O’Connor. “It’s [also] an English-speaking state in the European Union. A lot of people who are currently working in the EMA could continue to work in Dublin, have easy flying time, wouldn’t be a disruption to families, and so on.”
Other elements in favor of an EMA relocation to Dublin include, but are not limited to, the opportunity for continuity, Ireland’s strong pharmaceutical industry and international base, as well as the country’s longstanding history with the FDA, according to O’Connor.
“I think Ireland has a very strong pharmaceutical industry base in the country, which means we have a lot of familiarity with the FDA and the FDA is very familiar with Ireland. It would be an easy transition from a logistical point of view to be in Dublin, as opposed to other farther regions of the European Union,” said O’Connor.
He also adds that they feel there is a strong base of people and intellectual caliber in Ireland’s pharmaceutical industry.
Furthermore, for the companies who currently do business with the EMA, a relocation to Dublin would mean that there wouldn’t be a huge disruption in business operations, as Dublin isn’t as far of a distance as other locations in Europe.
What the Brexit Could Mean for the Pharma Industry
“There are potential impacts and it’s unclear what they might be,” said O’Connor. “In any respect, the reduction of the size of the single market in Europe can’t be good news for the free movement of goods, including medicines.”
One potential impact of the Brexit for the UK would be the research funding. If the UK is no longer part of the EU, it wouldn’t reap the benefits of the EU’s funding for research. In terms of clinical research, clinical collaborations could be negatively affected, according to O’Connor.
Most importantly, the speed of decision-making surrounding medicines, approvals, and so forth has the potential to be significantly impacted.
All of these are, at present, potential issues, said O’Connor, who breaks these problems down further into three categories.
“One is an overall business thing to do with single market, the second is to do with research, and the third is to do with potential regulatory disruption—all of which we want to avoid, but particularly the last one,” he said.
The Brexit: Going Forward
The first step is for the UK to signal its intention and formally notify the EU.
“Now, the UK is saying it won’t be doing that until the early part of next year [2017]—that’s the start of the Article 50 process. That would trigger all of the consequential preparations and changes in the European Union, among which is the EMA move. There’s a two-year deadline for that,” said O’Connor.
“While no one can make any decisions now in the absence of the UK notification, all of the people have to start thinking about it,” he said, adding that the Brexit isn’t a single-market issue. The scope is much broader, impacting huge operations such as the EMA which simply has to be in an EU-member state.
At this point, making preparations are key. Having a good relocation plan in place for the EMA so that the move isn’t a last minute arrangement is incredibly important, said O-Connor.
According to O’Connor: “The most important thing for the [pharmaceutical] industry is that the EMA functions well.”
Lead image editorial credit: Gordon Bell/Shutterstock.com.
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