DUBLIN—As we reported in the July 2016 issue of DDNews, in the article “Brexit could mean big changes for EMA,” the European Medicines Agency (EMA) was not likely to remain in the United Kingdom given that nation’s pending exit from the European Union (EU).
And that’s virtually a certainty now, with the EU issuing draft criteria in May to make the decision about the EMA’s new home. Comments on those draft criteria are due back in July and a decision is to be made by October of this year, with the planned implementation for the move set for October 2019.
“The U.K. government said, ‘Well, look guys, if you want to leave it here, we're welcome to you doing that,’ but the commissioner said 'No'—that obviously, a European Union agency cannot be in a country that is outside of the European Union,” Rory Mullen, vice president for biopharma and food at IDA Ireland, tells DDNews. IDA Ireland is the agency responsible for the attraction and development of foreign direct investment in Ireland. “It is the safety of European Union citizens and the safety of the medicines that are sold throughout the European Union that are imperative. It’s imperative that it be sorted as quickly as possible. Clinical trials are taking place all of the time. Pharmaceutical companies, both European and outside of Europe, need that certainty to know, ‘How are things going to be managed?’”
Ireland is, not surprisingly, among those EU member states eager to jockey for position in the quest to host the EMA and its roughly 900 employees. In fact, while many nations are making their cases, Ireland seems to be one of the most vocal so far, if the email inboxes at DDNews are any indication.
In fact, in early May Ireland stepped up its bid to host the EMA with an official announcement delivered and reiterated by Minister of Health Simon Harris. As the Irish government notes, one of its strengths lies in the close relationship that the country’s Health Products Regulatory Authority (HPRA) has established with the EMA and the wider network of medicines regulatory agencies throughout the EU. The HPRA, officials point out, has been an integral part of this regulatory system since the EMA was founded more than two decades ago.
At last count, Mullen put the current crop of contenders at 20 of the 27 EU member nations, with 10 or 12 making the most energetic cases so far.
“We really believe that we are the solution that can provide a seamless transition for the agency,” Mullen says. “Dublin, like London, is an English-speaking location. It has an excellent quality of life. It’s a very efficient operation base with a can-do attitude and makes things happen. It’s a very international city. There are people from all over Europe and the world working in some of the technology companies and the life-sciences companies that have multi-jurisdictional, multilingual operations in Ireland.”
“It’s really around that seamless transition,” he emphasizes. “[It’s] only a 40-minute flight between Dublin and London. You could ensure complete continuity of service if you wanted to. It’s really around the quality of life, the vibrant life-sciences sector in Ireland and the fact that you could move it without any of the consumers essentially noticing.”
“Dublin is in many respects the natural destination for the EMA. Our excellent existing relationship with the agency will be further strengthened by the move here,” echoed Lorraine Nolan, chief executive of the HPRA, in a news release. “The HPRA already is a natural partner and contributes significantly to the processes and work of the EMA. If the agency relocates to Dublin, the closer working proximity will mean that we can deliver business continuity, which is so critical given the EMA’s role in securing the public health of citizens across the EU. The extensive range of health products we regulate set us apart in terms of our capability to best support the EMA for now and into the future given the way that innovation in medicines will progress over the coming years.”
As Mullen notes, where the EMA goes will ultimately be a political decision made by the heads of states of the 26 European Union countries, so the next six months after applications are submitted will see a great bit of lobbying by many EU member states. And it’s not just European nations with much at stake. As he points out, Europe is the second-largest market for pharmaceuticals after the United States, so U.S. firms want continuity and clarity as well. And that is another reason he thinks Ireland is the best choice, with various U.S. pharma companies currently building out their capacity in Ireland, among them Regeneron, Alexion, Bristol-Myers Squibb and Shire.