Regulatory Law | Healthcare 


Our team supports healthcare professionals and practices encountering regulatory difficulties, to manage risk and to respond effectively to regulatory scrutiny and enforcement action. This typically includes: 

  • Early advice and risk management, including triage of issues and strategy at the outset. 

  • Regulator engagement and responses to information requests, audits and inspections. 

  • Managing investigations and enforcement action, including drafting representations and negotiating outcomes. 

  • Support through hearings and decision-making processes, and advice on appeals and legal challenge where appropriate. 

  • Managing the broader consequences of regulatory issues, including disputes between partners/owners, employment matters, data protection issues and reputational management. 


GPs and GP Practices

Our lawyers have extensive experience acting for GPs and GP practices, and for LMCs, in connection with regulatory difficulties: 

  • At practice level, our lawyers regularly assist in dealing with the following: 

  • Contractual enforcement action by NHSE/ICBs, in connection with primary care contracts, through remedial, breach and termination notices; 

  • CQC action following inspection, ranging from required improvement measures to suspension or removal of registration. 

  • At individual GP level, our lawyers regularly assist with: 

  • Performers List Regulations actions; and 

  • GMC investigations and other enforcement steps. 

In addition to supporting practices and practitioners throughout these processes, our team are experienced in mounting legal challenges in respect of the conduct of regulators during investigations and enforcement action.  


Pharmacists & Pharmacies

Pharmacists and pharmacies operate within a complex regulatory framework, which requires interaction and compliance with multiple regulators, and sometimes also law enforcement.   

Our lawyers benefit from experience in both healthcare and pharmaceutical regulation, so are well placed to assist clients to manage the following types of regulatory difficulties: 

  • GPhC enforcement action (often in parallel) in respect of: 

  • individual pharmacists (under the Fitness to Practice regime) and/or  

  • pharmacy practices (from the imposition of action plans to improvement plans/conditions or other sanctions) 

  • NHSE contractual enforcement action, e.g. with the exercise of remedial, breach or termination notices.  

  • MHRA enforcement action: see our Pharmaceutical page 


Other health and social care professionals and practices

We also have considerable experience in assisting other healthcare professionals and practices to deal with regulatory difficulties, from small dental practices to large private hospitals. 

 

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