Andrea is a noted expert in professional discipline and healthcare regulatory law.
The main focus of her work is defending professionals at fitness to practise proceedings before their regulatory bodies, where her experience includes successfully defending doctors before the General Medical Council, dentists before the General Dental Council, paramedics and other allied health professionals before the Health & Care Professions Council, pharmacists before the General Pharmaceutical Council, teachers before the Teaching Regulation Agency, veterinary surgeons before the Royal College of Veterinary Surgeons and architects before the Architects Registration Board.
Andrea has also represented many student professionals in university fitness to practise investigations and qualified professionals in local-level processes including MHPS (Maintaining High Professional Standards in the Modern NHS) and ICB/performers list proceedings.
In terms of her healthcare regulatory work, Andrea represents healthcare professionals and providers who work in both the NHS and private sectors in connection with a wide range of non-disciplinary matters including Inquests, Public Inquiries, Care Quality Commission registration and enforcement action, patient complaints and claims, NHS England market entry processes, CESR applications and appeals, MHRA compliance and investigations, ARCP appeals, Judicial Review proceedings and LADO and Disclosure and Barring Service referrals. Her LADO, safeguarding and DBS expertise has also led to instructions from both schools and universities.
Andrea’s experience includes over 20 years acting for clients including medical and dental defence organisations, insurers, the NHS Litigation Authority (now NHS Resolution), the UK’s largest independent pharmacy chain and many individual professionals. She also spent three years as in-house legal adviser to the General Medical Council itself, giving her a unique insight into the workings and priorities of regulatory bodies.
Andrea is qualified to practise in both the jurisdictions of England & Wales and the Republic of Ireland.
In addition to her legal practice, Andrea teaches as a Visiting Lecturer on the MSc in Prehospital Medicine at Queen Mary University of London.
The past month you have held my hand and walked me through one of the most critical and painful times in my life. There is not a single point at which you have not risen to whatever was thrown at you, 3am emails reflecting your utter dedication. I have felt so held in the safety of your acumen which, to me as a legal lay person, has often bordered on wizardry. The course of my life changed yesterday because of you. A heartfelt sincere thankyou to you all.
Client, Consultant Doctor
You guys were great for me and to be honest saved my life and my reputation. I can’t tell you the difference you have made in our company, my personal life and my future. I will always be indebted to you and your staff. Worth every penny.
Client, Pharmacist
Forever my go-to recommendation for any healthcare professional needing the very best on their side. Not all heroes wear capes!
Client, Paramedic
I have no doubt whatsoever that you were highly instrumental in achieving the extremely lenient sanction. Your hard work, unbelievable levels of patience and good humour have all meant that the last two years have been very much less trying than they might otherwise have been.
Client, Veterinary Surgeon
Kind, approachable and incredibly helpful. We are very privileged to be able to access her support and wealth of knowledge.
Client, Paramedic
I am beyond happy to see this has finally come to an end. Thank you ever so much for your fantastic job in following the case until its conclusion. You have truly done an amazing job.
Client, Doctor
Thanks ever so much for all the hard work and your extremely high standards. It gives myself and the staff security and peace of mind going forward.
Client, Pharmacy Contractor
Can I say again how grateful I am to you for the way you have provided my legal support. The contrast with the manner in which you acted and that of [previous solicitors] couldn’t be more stark. Upsetting though it was to be named as a defendant, it turned out to be a stroke of luck because I then had you in my corner.
Client, Senior Police Officer
Expertise
- Fitness to practise
- MHPS (Maintaining High Professional Standards in the Modern NHS)
- Performers Lists
- Inquests
- Public Inquiries
- Care Quality Commission / CQC
- Patient complaints
- Patient claims / clinical negligence
- NHS England market entry processes
- CESR (Certificate of Eligibility for Specialist Registration)
- ARCP (Annual Review of Competence Progression)
- MHRA (Medicines & Healthcare Products Regulatory Agency)
- Judicial Review
- Disclosure and Barring Service
- LADO (Local Authority Designated Officer) safeguarding
Experience
Reported Cases
- Dr Odes v General Medical Council [2010] EWHC 552 (Admin)
- Dr Reddy v General Medical Council [2012] EWCA Civ 310
- Dr Aga v General Medical Council [2012] EWHC 782 (Admin)
- R (on the application of Pharmacy Care Plus Ltd) v Family Health Services Appeals Unit [2013] EWHC 824 (Admin)
- Roberts v The Attorney General & Anor [2016] EWHC 3219 (QB)
- R (on the application of The National Pharmacy Association) v The Secretary of State for Health [2017] EWHC 1147 (Admin)
- R (on the application of Well Pharmacy) v The Welsh Ministers & Others [2017] EWHC 1983 (Admin)
- Pharmacy2U Limited v The National Pharmacy Association [2018] EWHC 3408 (Ch)
- R (on the application of the National Pharmacy Association) v The Secretary of State for Health [2018] EWCA Civ 1925
- Professional Standards Authority for Health & Social Care v HCPC & Christopher Wood [2019] EWHC 2819 (Admin)
- Professional Standards Authority for Health & Social Care v HCPC & Andrew Roberts [2020] EWHC 1906 (Admin)
Healthcare & Life Sciences
- Successfully defended a Consultant Orthopaedic Surgeon and NHS Medical Director in MHPS proceedings and then before the GMC in connection with multiple allegations of misconduct and deficient professional performance arising from undertaking private work whilst second on call.
- Represented a paramedic in the first fitness to practise case arising from delayed patient treatment due to lack of appropriate PPE during the Covid-19 pandemic. The case attracted widespread national and international attention. Ultimately established that the paramedic’s actions did not amount to misconduct.
- Successfully conducted a Medical Act section 40 High Court appeal against the GMC, overturning a finding that the doctor (a Consultant Anaesthetist) was culpable for his actions whilst suffering from an episode of psychosis caused by an adverse reaction to prescribed medication.
- Defended a Radiographer before the HCPC in connection with lack of competence allegations regarding 146 patients – no impairment found.
- Acted for doctors in specialisms including Psychiatry, Trauma & Orthopaedic Surgery and Cardiothoracic Surgery to overturn the GMC’s refusal of their applications for specialist registration/CESR.
- Successfully conducted a high-profile Judicial Review against NHS England, challenging its interpretation of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. The case has been described as of ‘wide national significance’.
- Represented numerous specialty trainee doctors in successfully challenging ARCP Outcome 3/4 decisions and adverse CSA results.
- Retained healthcare regulatory solicitor to the UK’s largest independent pharmacy chain, advising on all issues ranging from advertising of medicines to prescription direction.
- Currently representing a Core Participant in the Scottish Covid-19 Inquiry.
- Represented one of the UK’s Top 50 providers of residential homes and hospitals for individuals with learning disabilities, mental health issues, behaviours that challenge and autism in CQC, HIW and NMC investigations – all resulting in no action against the provider or its staff.
- Successfully challenging CQC Notices of Proposal and Notices of Decision for residential and nursing home providers across England, including many successful First Tier Tribunal appeals quashing CQC Notices of Decision to cancel registration. Instructed by both owners and third parties including restructuring and insolvency practitioners.
- Represented a community pharmacy contractor in successfully appealing the decision of the NHS Business Services Authority to not reimburse the pharmacy’s additional costs incurred in responding to the COVID19 pandemic. On appeal to NHS Resolution, the Adjudicator preferred our interpretation of the relevant Drug Tariff Regulations and ordered the NHS Business Services Authority to repay our client in full – a sum exceeding £120,000.
- Represented a senior paramedic in (i) an IOPC investigation, (ii) a complex Article 2 (Human Rights Act Right to Life) Inquest before a Jury and (iii) HCPC fitness to practise proceedings arising from the death of a detainee in Police custody. Succeeded in getting HCPC proceedings struck out as an abuse of process.
- Successfully defended a Superintendent Pharmacist before the MHRA and General Pharmaceutical Council (GPhC), in a case which ran from 2018 until the final Committee hearing in 2023 and concluded with no criminal charges or adverse regulatory findings.
Education
- Defended teachers from a number of the UK’s leading public schools in NCTL and Teaching Regulation Agency proceedings arising from allegations ranging from exam cheating to alcohol misuse to failure to maintain appropriate professional boundaries. 100% record of success in avoiding the imposition of a Prohibition Order and/or Interim Prohibition Order.
- Advised a red-brick university throughout the conduct of fitness to practise and disciplinary proceedings against a medical lecturer who had committed plagiarism in their international research publications.
- Represented a Choir School’s Director of Music in both a Diocesan investigation and DBS ‘minded to bar’ proceedings, resulting in no barring.
- Acted for medical, pharmacy and paramedic science students in appeals against university decisions to terminate their studies for reasons ranging from exam cheating to adverse health to convictions.
- Successfully challenged the NCTL’s legal jurisdiction to pursue proceedings against a teacher who had not been engaged in teaching at the time of their alleged misconduct.
- Successfully defended an Oxbridge student in University fitness to practise proceedings. Returned to studies following 18 month suspension.
Recognition
Recognised by the Legal 500 2025 for Professional Discipline
“Andrea James is very experienced and takes no nonsense from anyone that potentially prejudices her clients or their interests.” The Legal 500 2025
“Andrea James is an expert in both professional discipline and healthcare regulatory law.” The Legal 500 2025
Recognised in The Legal 500 2019 – 2024 for Health, Professional Discipline and Dispute Resolution
Named in Thomson Reuters Stand-Out Lawyers List 2024
Named in the Pro Bono Recognition List of England & Wales 2024
Awarded an Honorary Fellowship of the College of Paramedics
Committee member of the Pharmacy Law & Ethics Association
Member of the Association of Regulatory & Disciplinary Lawyers
Member of the Dental Law & Ethics Forum
Member of The Medico-Legal Society
Contributing author – The Mental Health and Wellbeing of Healthcare Practitioners: Research and Practice
“Andrea James knows more case law than any solicitor I’ve ever worked with in the field of professional discipline. She works tirelessly for every client and never leaves a point unchallenged.”
The Legal 500 2022
“Andrea is just a force of nature! She is an incredible advocate, fearless but compassionate. She provides a deeply personal service to our members, making them feel valued and engaged.”
The Legal 500 2022
“Andrea is an expert in Pharmacy law and regulation – she provides advice in a very straightforward way and resolves our issues quickly.” Thompson Reuters Stand-out Lawyers 2024
Career
Andrea qualified as a solicitor in 2004. Prior to joining Keystone Law in 2023, she worked at the following firms and organisations:
- Brabners
- Knights plc
- Shoosmiths
- Mills & Reeve
- General Medical Council
- BLM
- Matheson (Republic of Ireland)
- Hill Dickinson