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Autori: SEBASTIAN FLORIN TELECAN.
DOI: 10.24193/SUBBiur.62(2017).3.2
Published Online: 2017-09-30
Published Print: 2017-09-30
pp. 29-59
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The United Kingdom’s BREXIT decision on June 23, 2016 triggered a movement to relocate the European Medical Agency (EMA)—the EU’s market gatekeeper and overseer entrusted with the mission to ensure the safety and efficacy of prescription medications—from its London base. Several EU countries have begun vying to become the new home of the EMA, and existing skilled and experienced EMA staff are relocating and leaving positions that linger as unfilled. The biopharmaceutical sectors and enormous related professional infrastructure that towers over the EMA, anchored in London from its beginning, now stands on shifting soil. Among the enormous EU human health and economic implications, this paper focuses on an immediate concern: ensuring no disruption of ongoing regulatory oversight of prescription medications available to patients across Europe for treatment with EMA assurances of safety and efficacy. This paper proposes that the EU prioritize and implement regulatory reform measures to protect this particular mission and function of the EMA during the Agency’s state of post-BREXIT transition. The paper proposes that pharmacovigilance is distinguishable and should be prioritized given the ongoing reliance of health care providers and their patients on these products under the regulatory assurances of safety, efficacy, and ongoing oversight that have made them available for treatment use. The paper introduces a law and policy proposal to accomplish this goal.
Cuvinte-cheie: drept medical, drept medical comparat, Agenția Europeană pentru Medicamente, BREXIT, farmacovigilență, sănătate publică, biotehnologie, revoluția genomică, Procedura Centralizată, Dreptul UE, Directive, Regulamente, Agenția pentru Alimente și Medicamente.
