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Record W2948324016 · doi:10.54648/leie2019010

Approaching Judgment Day: The Influence of Brexit on the EU Pharmaceutical Framework

2019· article· en· W2948324016 on OpenAlex

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

aboutThe title or abstract carries a Canadian signal from the geographic lexicon.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

Bibliographic record

VenueLegal Issues of Economic Integration · 2019
Typearticle
Languageen
FieldMedicine
TopicScience, Research, and Medicine
Canadian institutionsnot available
Fundersnot available
KeywordsBrexitEuropean unionLegislationBusinessAuthorizationPharmaceutical industryInternational tradeMarket accessPoliticsDirectiveMember stateMember statesPolitical scienceInternational economicsEconomicsLawMedicine

Abstract

fetched live from OpenAlex

Though the plans for Brexit keep changing daily at the time of writing of this article, it seems useful to identify and discuss the differences between various types of EU trade agreements with third countries as possible models for a future EU–UK relationship, whatever the outcome. At some point after all the political drama, civil servants and negotiators will need to get down to business and find practical solutions for the new situation. This article examines the impact of such a transition on the integrated EU pharmaceutical industry. First, a state of play chapter details the EU and UK legislation regarding Brexit, possible future agreements and an overview of the pharmaceutical regulatory framework. The focus of the analysis itself is the level of participation in the European Medicine Association on the basis of a European Economic Area (EEA) Agreement (Norway), a Bilateral Agreement (Switzerland), and a Free Trade Agreement (Canada). Within this framework, key regulatory complications of the EU pharmaceutical framework (Market Authorization, Research & Development and Safety Monitoring) are investigated. Finally, the article demonstrates some of the dilemmas and diverging demands of the EU and UK as new trading partners in the pharmaceutical sector.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.931
Threshold uncertainty score0.279

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.044
GPT teacher head0.368
Teacher spread0.324 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it