Disputes and regulatory enforcement

Regulatory enforcement and actions against regulators

The highly regulated nature of the life sciences industry gives rise to the potential for a myriad of regulatory enforcement action for breach of the strict rules governing the sector. Similarly, organisations affected by decisions taken by the regulators responsible for regulating the sector may also wish to take action against those decisions. Regulatory enforcement and action against regulators is possible at both at UK and EU level, depending on the nature of the issue in dispute.

Disputes arising out of the EMA’s approach to transparency

Article 15 of the Treaty on the Functioning of the European Union (TFEU) requires EU institutions, bodies, offices, and agencies to conduct their work as openly as possible and extends the public right of access to documents of all the Union institutions, bodies, offices and agencies. This is often referred to as the principle of transparency. Transparency can be pursued by institutions either by granting access to documents or information upon request (reactive disclosure) or by making documents and information publicly available on their own motion, mainly by publishing it on their websites (proactive disclosure).

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