How Will EMA’s Third Phase of Its Brexit Preparedness Plan Impact the Pharma Industry?

As the European Medicines Agency (EMA) continues to prepare for its post-Brexit move out of its London, England headquarters, the agency’s activities will be scaled-back even further. As of the start of the month, the EMA entered the third stage of its Brexit preparedness business continuity plan, which includes a decrease in the regulator’s development of new guidelines and revision of existing documents.

The Brexit preparedness plan is designed to help the EMA continue its core activities of evaluating and approving new and existing drugs, however it’s unlikely that the regulator – and pharmaceutical companies that fall under its jurisdiction – will emerge from the aftermath of Brexit entirely unscathed. In addition to impacting its ability to perform certain regulatory functions, the EMA’s move to Amsterdam will result in the loss of vital staff members who will need to be replaced.

“EMA will now temporarily suspend or scale back additional activities to ensure that resources can be redeployed so that its core activities can continue without interruption and to the same quality,” commented Noël Wathion, EMA’s Deputy Executive Director. “Over the next few months, EMA will continue to carefully monitor staff intentions to relocate and the anticipated impact on its activities whilst planning for the critical time period when the Agency will be moving to its new premises in Amsterdam.”

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With the exception of seven key guidelines currently in development by the EMA, the regulator will cease activity on any new, non-urgent guidance documents after the first of November. While meetings of product-related working parties will not be cancelled as a result of the change in activities, all other working party meetings will be put on hold.

The agency anticipates it will complete phase three in January of 2019, however further reductions in the EMA’s regulatory activities will be implemented as part of phase four of the Brexit preparedness plan. Normal activities are scheduled to commence as of July of 2019, but the EMA says it will reassess the situation in April after it has completed the move to a temporary building in Amsterdam before moving to its more permanent headquarters.

The EMA started limiting its activities in August when the regulator disclosed it could face staff losses up to 30 percent as it moves its operations from London to Amsterdam. At that time, pharmaceutical companies like Sanofi and Novartis started stockpiling medications in the UK in preparation for a no-deal Brexit.

While UK Prime Minister Theresa May has said the UK would like to remain under the EMA’s jurisdiction post-Brexit, it’s unclear whether that will be possible after the UK ceases to be an EU member state. Late last year, it was announced that Amsterdam had the winning bid to host the EMA after Brexit, however the regulator’s temporary home in the Netherlands will reportedly be half the size of their current London headquarters, which could impact their operations.