AMBIENTUM BIOETHICA BIOLOGIA CHEMIA DIGITALIA DRAMATICA EDUCATIO ARTIS GYMNAST. ENGINEERING EPHEMERIDES EUROPAEA GEOGRAPHIA GEOLOGIA HISTORIA HISTORIA ARTIUM INFORMATICA IURISPRUDENTIA MATHEMATICA MUSICA NEGOTIA OECONOMICA PHILOLOGIA PHILOSOPHIA PHYSICA POLITICA PSYCHOLOGIA-PAEDAGOGIA SOCIOLOGIA THEOLOGIA CATHOLICA THEOLOGIA CATHOLICA LATIN THEOLOGIA GR.-CATH. VARAD THEOLOGIA ORTHODOXA THEOLOGIA REF. TRANSYLVAN
The STUDIA UNIVERSITATIS BABEŞ-BOLYAI issue article summary
The summary of the selected article appears at the bottom of the page. In order to get back to the contents of the issue this article belongs to you have to access the link from the title. In order to see all the articles of the archive which have as author/co-author one of the authors mentioned below, you have to access the link from the author's name.
Authors: SEBASTIAN FLORIN TELECAN.
DOI: 10.24193/SUBBiur.62(2017).3.2
Published Online: 2017-09-30
Published Print: 2017-09-30
pp. 29-59
VIEW PDF
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.
Keywords: health law, comparative health law, European Medical Agency, market gatekeeper, BREXIT, pharmacovigilance, public health, biotechnology, genomics revolution, centralized procedure, EU law, Directives, Regulation, Food and Drug Administration (FDA).
