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. For a comprehensive and practical overview of regulatory enforcement, compliance obligations and dispute resolution mechanisms in the life sciences sector across the UK and EU, see Practice Note: Regulatory enforcement and disputes in the life sciences sector. This note addresses Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP), with detailed guidance on inspection processes, compliance escalation, enforcement notices and sanctions. It further considers competition law enforcement trends, advertising and promotion rules, and anti-bribery, corruption and economic crime risks affecting life sciences companies, highlighting the cumulative enforcement, financial and reputational exposure that can arise from overlapping...