Wednesday 4 January 2017

EMA Admits Brexit May Cause Significant Disruption

Guido Rasi, Executive Director of the European Medicines Agency (EMA), has conceded that the planned exit of the U.K. from the European Union (EU) could have a major impact on the activities of the EMA.

“The extent of the impact of Brexit on the Agency’s operations and location is uncertain and will depend on the future relationship between the EU and the UK,” he told the EMA’s Management Board. “Depending on the outcome of the negotiations, this could cause significant disruption to the Agency’s operations and business continuity plans will need to be in place.”

As part of its preparedness, EMA will continue carrying out impact assessments to identify the main risks and propose measures to maintain its ability to protect public health, Rasi added.

Speculation about a possible new location for EMA is likely to continue throughout 2017, however. Denmark, Germany, Ireland, Italy and Sweden have expressed a keen interest in accommodating the agency, according to a report in The Guardian newspaper on August 1st, 2016.

Despite the uncertainty caused by the outcome of the U.K. referendum, EMA remains committed to carrying on with its responsibilities as usual, according to Rasi. The Board has adopted a budget of 322 million euros for 2017, a 4.4% increase over the previous year. This is expected to cover the 5.4% increase in its fee-financed workload and will also allow the EMA to focus on priority areas such as antimicrobial resistance, supporting innovation and access to both human and veterinary medicines, increasing and improving regulatory capacity and capability as well as its continued commitment to increased transparency, he stated. The work program is being finalized and will be published by the end of January 2017.

Also, the Board endorsed an extension of the concept of multinational assessment teams to post-authorization assessments. EMA has encouraged the formation of assessment teams not by country but by expertise since 2013, initially for the assessment of new medicines. Following the endorsement by the Board, assessment teams made up of experts from several member states will be able to evaluate applications for extensions of marketing authorizations of existing medicines as of April 2017.

The Board approved the launch of a public consultation to revise the agency’s policy on access to documents. The revision seeks to take account of the experience gained since the current policy came into effect in 2010 and to extend its scope to include both access to documents that relate to human or veterinary medicines as well as to corporate information. The launch of the consultation, including the publication of the consultation documents, is expected in January 2017.

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