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).

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest Life Sciences News

OpenAI, X, Google can use legitimate interest for AI models, EDPB says

MLEX: OpenAI, X, Google and Meta will be able to use legitimate interests as a legal basis for processing personal data for developing and deploying AI models provided that adequate mitigation measures are in place, the European Data Protection Board (EDPB) said in an influential opinion today. The EDPB opinion also touched upon how to address unlawful data processing for AI model development, and in what circumstances AI models can be considered anonymised.

Life Sciences weekly highlights—19 December 2024

This week's edition of Life Sciences weekly highlights includes news analysis on emerging trends in the Unified Patent Court. Also included, is news that long-awaited legislation was introduced by MHRA which will overhaul the UK’s clinical trials regulatory framework, the MHRA also revised its roadmap outlining the implementation timeline for the future medical devices regulatory framework in the UK, the European Commission has initiated a public consultation to evaluate the EU medical devices regulatory framework and whether further urgent reform is required, MedTech Europe has voiced concerns regarding the Health Technology Assessment Regulation and its implementation which begins 12 January 2025, the US FDA has established the CDER Center for Real-World Evidence Innovation to streamline the use of real-world data and real-world evidence in regulatory decision-making and the ASA has sanctioned several companies for misleading medical or health claims in breach of the advertising code, among other stories.

ASA rulings—18 December 2024

The Advertising Standards Authority (ASA) has this week upheld 20 complaints, and informally resolved a further 14 complaints, for misleading advertising practices.

MedTech Europe calls for HTA implementation roadmap and guidance

MedTech Europe has voiced concerns regarding the Health Technology Assessment (HTA) Regulation and its implementation. The organisation has called for a comprehensive roadmap to address uncertainties throughout the HTA's implementation phase which will begin to apply from 12 January 2025. MedTech Europe emphasises the need for clarity on Joint Clinical Assessment (JCA) processes, multi-stakeholder participation, and definitions within implementing acts. The specified several points of clarification required in the JCA process such as regarding the identification and planned reporting on emerging health technologies and the capacity to deal with evidence plans, and, particularly how Member States’ differing reimbursement regimes will use JCA reports and how this improves value versus existing national HTA processes. The organisation stresses that such guidance is crucial to ensure the HTA contributes to innovation, competitiveness, and timely access to novel care technologies for European patients and healthcare systems.