Rasi On Brexit: ‘EMA Is Well-Oiled Machine That We Cannot Afford To Start Stuttering’
Executive Summary
European Medicines Agency head Guido Rasi tackles issue of Brexit in agency’s 2016 annual report, saying EMA is “core building block of the common market for medicines in the EU” that operates like “well-oiled machinery.”
European Medicines Agency Executive Director Guido Rasi says the body he leads is a “well-oiled machine” that cannot be allowed to “start stuttering” as a consequence of the UK’s decision leave the EU.
Rasi tackles the issue of Brexit in the introduction to the EMA’s recently released 2016 annual report. The EMA is “a core building block of the common market for medicines in the EU”, he writes, likening the agency to “well-oiled machinery that works like an assembly line bringing together the best experts from across the EU to do the right job at the right time with the right people in the right room”.
“Our scientific recommendations are vital to protect the health of EU citizens, provide them with effective, safe and high-quality medicines, and enable an environment in which European pharmaceutical companies can thrive to develop new medicines and create high-quality jobs across the EU,” Rasi continues. “We cannot afford for this machine to start stuttering.”
“We want to be ready for a smooth move once the decision has been taken.” – EMA Executive Director Giuido Rasi
Rasi refers to the EMA task force that is assessing the likely impact of Brexit on agency operations and identifying the parameters that are “essential for us to continue our operations efficiently in a new location”. (Also see "Brexit: Scenario Planning Well Under Way At EMA" - Pink Sheet, 7 Apr, 2017.) (Also see "Brexit: EMA Could Lose Up To Half Its Staff If It Has To Move" - Pink Sheet, 2 Dec, 2016.) By identifying the EMA’s requirements, writes the EMA head, the task force is expected to contribute to the decision that member states will take on the agency’s new host country and city. “We want to be ready for a smooth move once the decision has been taken.”
“Unprecedented level of uncertainty”
EMA management board Chair Christa Wirthumer-Hoche writes in the foreword to the agency’s annual report that the outcome of the UK referendum on the country’s membership of the EU brings “an unprecedented level of uncertainty” regarding the EMA’s future operations and location.
“I am committed together with the Board to supporting EMA to ensure we achieve the right circumstances in which the Agency can continue its valuable work to protect public and animal health and support innovation in Europe,” says Wirthumer-Hoche, who is also head of Austrian drug and device regulator AGES.
Austria is among the countries that has said it wants to host the EMA in the wake of the agency’s Brexit-enforced relocation. (Also see "Race Hots Up For EMA After Brexit" - Pink Sheet, 21 Apr, 2017.) The UK is set to leave the EU at the end of March 2019.
From the editors of Scrip Regulatory Affairs.