Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted?

Abstract

This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information-the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs, and the interests that are at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA's policies.

Off‐label prescriptions of drugs used for the treatment of Crohn’s disease or ulcerative colitis

“…The regulations of off‐label prescribing are not harmonised across the world. Even in Europe, each country has established its own regulations . Comparing results on off‐label prescribing between countries is therefore difficult, but the need of better understanding and proper prescribing of off‐label drugs has been universally acknowledged.…”

Transparency in Medicines Regulatory Affairs - Reclaiming Missed Opportunities

“…Despite this approach, the policy has been challenged in the European courts, [22] and remains contested. [23] The UK Freedom of Information Act Section 1 of the UK Freedom of Information Act of 2000 [23] states that:…”