Amsterdam meets all the criteria put forth by the EU, including good access to the rest of Europe, adequate office space, and multilingual education for the children of agency staff. The city is a good choice, according to René Nanninga, chairman of the ISPE Netherlands Affiliate and Director, Engineering & Technical Support at Xendo BV, a biopharmaceuticals, medical devices, and health-care consultancy and project-management company in the Netherlands.
“Amsterdam is a practical choice, given its proximity to London,” he said. “Critical to relocation will be enticing EMA personnel to continue to work with the agency. It will be possible to live in London and work in Amsterdam, at least during the transition phase.” In fact, 65% of current EMA staff were willing to relocate to Amsterdam, a factor that may have garnered votes. “The standard of living is high in the Netherlands, and this is reflected in the willingness to move.” The city also has an abundance of well-educated people capable of working at the EMA.
Amsterdam is easily accessed from the rest of Europe; Schiphol airport, one of the continent’s major transportation hubs, is a 20-minute drive from the city center. The Netherlands has excellent universities, university hospitals, scientific research, and a thriving biotechnology community. The Medicines Evaluation Board in nearby Utrecht is an independent health authority that regulates the quality, efficacy, and safety of drugs in the Netherlands; the country also acts as a Reference Member State∗ (or Rapporteur) for many medicines.
Concerns
Moving the EMA has the potential to disrupt European pharmaceutical manufacturing. Companies that have registered their products with the UK as the Reference Member State will have to think strategically about how, when, and to which European health authority to transfer their product procedures. Additionally, 60% of qualified persons for pharmacovigilance (QPPV) currently reside in the UK; EMA guidelines, however, state that a European QPPV must reside in the EU.1 There is also some concern that the EMA’s drug-approval process will be hampered by interruptions predicted as a result of the move.
“Whether approvals for new medicines will take longer entirely depends on whether the processes of the EMA will be interrupted,” Nanninga said. He believes it will be an enormous achievement if the agency is able to maintain all its processes while onboarding 900 people in Amsterdam. “Will they be able to get continuity of people? Will they get onboard sufficient people in time to be introduced to the products, processes, and procedures to provide continuity. Programs might be delayed or rescheduled.”
Benefits
Amsterdam’s estimated economic windfall is $1 billion. The city will benefit from 900 new jobs, an influx of people attending meetings of scientific committees and advisory groups, and the potential transfer of pharmaceutical company offices from companies with offices currently in the UK.
“The agency will bring many highly educated people to live in or around Amsterdam,” added Nanninga, “[plus] an additional 30,000 hotel nights per year—which will require the construction of at least one new hotel—as well as lots of foreign visitors. The economic impact will be phenomenal.
“While Brexit and the EMA relocation are two different issues, they are connected, and I think their impact on the pharmaceutical industry in the EU will be quite significant,” he continued. “Global pharma firms like their headquarters to be close to the EMA, or at least to have an affiliate close by, as happened in the past in the UK. If they don’t have a local office in the Netherlands now, I suspect they will.” Nanninga also anticipates that the move will be a boost for Dutch pharmaceutical affiliates, since they will have greater access to EMA meetings and symposia.
* A member state that evaluates marketing authorization application dossiers and prepares assessment reports on behalf of the Concerned Member States in mutual recognition (MR) and decentralized (DC) procedures.
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