PLEA News
Veterinary medicines – new pricing rules
On 24 March 2026, the Competition and Markets Authority (“CMA”) published its final report on the market for Veterinary Services for Household Pets. The CMA concluded that there are certain features of the market for the retail supply of Veterinary Services for Household Pets by First Opinion Practices (FOPs) in
GPhC annual Fitness to Practise report
The General Pharmaceutical Council’s annual report and annual Fitness to Practise report have just been published for the period from April 2025 to March 2026. The report includes the following: “We saw a significant rise in both the number and complexity of concerns raised, with more than 9,500 concerns received
AI – Joint Statement by healthcare regulators
Following this month’s publication of recommendations by the National Commission into the Regulation of AI in Healthcare, the Professional Standards Authority and all the UK’s healthcare regulators, including the General Pharmaceutical Council, have published a Joint Statement of Intent on Supporting the safe, effective and ethical use of AI by
Letby Inquiry – new insulin requirements
Following convictions of Lucy Letby for murder, Lady Justice Thirlwall has just published the Report of the Public Inquiry into events at the Countess of Chester Hospital, 2015 to 2018. In relation to insulin, Lady Justice Thirlwall made recommendations, saying this: “4.10 Letby poisoned Baby F and Baby L by
Sexual misconduct in FtP cases – new PSA report
The Professional Standards Authority, which oversees all the statutory healthcare regulators in the UK, has just published a report on improving Fitness to Practise in relation to cases including allegations of sexual misconduct. Definition of sexual misconduct The PSA defines sexual misconduct as including: Unwelcome sexual advances or propositions Inappropriate
New NHS regulations – pharmacist prescribing and other changes
The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2026 have been laid before Parliament. These regulations, which apply to England, will amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (the 2013 Regulations) mostly on 1 October 2026. Independent prescribing The 2013
Pharmacy loses appeal: but has the First Tier Tribunal also lost its appeal?
Two appeal processes – Usually, market entry appeals in England are heard by NHS Resolution but, unusually, La Vie Health Care Limited v NHS England (South East London Integrated Care Board) [2026] UKFTT 01232 (HESC) is a decision of the First Tier Tribunal (FTT). Indeed, the Tribunal Chair, giving its
Congratulations, Bill Rial FRCPharm!
The Royal College of Pharmacy has appointed its inaugural cohort of Fellows, recognising 34 members for distinction in the profession of pharmacy. We are delighted that Bill Rial, our former Chair, is one of the appointed Fellows. Fellowship is one of the highest honours awarded by the College. Based on
Puberty blockers and clinical trials: new judicial review judgment
We have previously reported on litigation over the use of puberty blockers and and on the Orders made by the Secretary of State to restrict the prescription of puberty blockers. In R. (on the application of Bayswater Support Group) v Health Research Authority and others [2026] EWHC 2043 (Admin), Mr Justice
Healthcare regulators do not owe registrants a duty of care (Court of Appeal)
In April last year, we reported on a case in which the widow of a doctor sued the General Medical Council (GMC) because her husband had committed suicide after being informed that he was the subject of a misconduct allegation (details of which are set out below). The widow alleged
Prosecution for breaches of the Human Medicines Regulations 2012
There aren’t many prosecutions for breach of the Human Medicines Regulations (see our Members’ article of 14 July 2025). What’s more, each case depends on its own particular facts, but a recent case was even described by the Court of Appeal as “interesting”. In Mohammad Alazawi v Rex [2026] EWCA
Alleged breach of registration conditions leads to interim suspension despite CPS closing file
Almost every week, there is a steady stream of cases in which healthcare regulators ask the High Court to grant an extension of an interim suspension imposed by a Fitness to Practise Committee because the regulators are not ready to progress to a final hearing before the interim suspension runs
Health Bill – amendments relevant to pharmacy
The Health Bill (see our news item of 5 June 2026) is now being considered in committee in the House of Commons. A number of amendments of interest to pharmacy have been tabled. Government amendments It seems safe to expect that Government amendments will go through. These include: Rights of
Temporary controlled drugs
The Government has temporarily made certain synthetic opioids which are being misused as new psychoactive substances subject to additional controls. The Misuse of Drugs Act 1971 (Temporary Class Drug) Order 2026 comes into force on 11 June 2026 and will remain in effect for one year. The substances are: Cychlorphine
Fitness to practise – interim suspensions
In Nursing and Midwifery Council v Pestano [2026] EWHC 1412 (Admin), Simon Tinker, sitting as a Deputy Judge of the High Court, ruled on important issues in cases where healthcare regulators make interim suspension orders pending a final fitness to practise hearing. Issues In particular, the judge dealt with: Whether
The Mann review on antisemitism and other forms of racism in the NHS
The Mann review on antisemitism and racism in the NHS was published a few days ago. Amongst the recommendations are: NHS boards and leaders should be held accountable for race equality and staff experience metrics, as part of the recently added score in the NHS Oversight Framework (NOF) that will support compliance
Clinical negligence, consent, and hospital prescribing
The recent judgment of HH Judge Richard Roberts, sitting as a Deputy High Court Judge, in Alexander v (1) HCA International Limited and (2) Dr David Reffitt [2026] EWHC 1284 (KB) deals with the need for consent when administering diclofenac, and with compliance with the requirements of the Human Medicines Regulations
Changes to NHS laws
Health Bill Following this year’s King’s Speech, the Health Bill has been introduced in Parliament. When passed, it will enact changes to the National Health Service Act 2006, including: The abolition of NHS England and transfer of its functions to either Integrated Care Boards (ICBs) or the Department of Health and
Counterfeit medicines – first civil injunctions to block websites
Semaglutide seems to be the drug of the century so far, and it is throwing up many legal and ethical issues because of its widespread use and the amount of money being generated – global sales of GLP-1 products in 2024 were over £17bn. Given the financial success of semaglutide
Non-surgical procedures for under-18s – Scotland
The Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Act 2026 has now received the Royal Assent. The Act is awaiting a date when it will come into force. The Act bans the provision of non-surgical procedures to under-18s and restrictions on where they may be carried out. Authorised officers
Informed consent and fitness to practise
A patient’s consent must be informed in order to be valid. A lack of consent may give rise to a clinical negligence claim or, if physical contact is involved, lack of consent may be a battery giving rise to civil or criminal proceedings. A recent case involving an obstetrician highlights
Weight management medicines – GPhC review and recommendations
The GPhC has published a review of weight management medicines based on its inspections. You can access the review and the GPhC’s recommendations here.
GPhC position statement on AI
The GPhC has published a position statement on AI. You can access it with this link.
Clinical trial regulations amended
In case you missed it, the Medicines for Human Use (Clinical Trials) Regulations 2004 were amended significantly on 28 April. For more details, see news item no.565 which we published on 17 December 2024.
Weight-loss medication: two regulators deal with advertising complaints against pharmacies
Cases involving weight-loss medication could feature in several chapters in a pharmacy and medicines law textbook. Notably, advertising complaints are being handled by different regulators. Presumably that’s because although both the Medicines and Healthcare products Regulatory Agency (MHRA) and the Advertising Standards Authority (ASA) both handle complaints about the advertising
Supervision – Welsh NHS terms of service amended
Even though regulation 220 of the Human Medicines Regulations 2012 stipulates that Prescription Only Medicines and Pharmacy medicines may only be sold or supplied by a pharmacist or if the transaction is supervised by a pharmacist, the NHS terms of service in each of the home nations also require prescribed
Northern Ireland – PSA review, consultation on standards for prescribers, prosecution for unlicensed medicines
There are three Northern Ireland news items to report this week. Annual review of PSNI performance The Professional Standards Authority (PSA) has published its annual review of the performance of the regulator, the Pharmaceutical Society of Northern Ireland (PSNI). Last year, the PSNI failed 7 out of 18 Standards. This
NHS medicines supplies: what does “reasonable promptness” mean?
The NHS terms of service* for pharmacies say that prescribed medicines must be supplied “with reasonable promptness”. It is not the kind of statutory provision that lends itself to definition. However, the issue came up recently in a Parliamentary question to the Pharmacy minister, Stephen Kinnock MP, in the context
New PSA Standards for Healthcare Regulators
The Professional Standards Authority has published new Standards for Healthcare Regulators. You can access the Standards here.
Law v Ethics
Nandhra v Lothian Health Board Although the recent judgment in the Scottish case of Nandhra v Lothian Health Board [2026] CSIH 11 concerned a dentist who had been providing NHS services, the law is equally applicable to pharmacy owners in Scotland and England (read on). The case sheds an interesting light on
612 – Supervision in Parliament – more questions than answers
2025-10-26 14:44:53 Both Houses of Parliament have recently debated the draft Order that would amend the Human Medicines Regulations so as to allow pharmacists to authorise pharmacy technicians to supervise the supply of medicines, to allow previously dispensed medicines to be supplied in the absence of a pharmacist, and to enable
610 – Medicinal cannabis supplies
2025-10-24 17:01:53 The General Pharmaceutical Council has published a review on areas of good practice in supplying medicinal cannabis, as well as areas for improvement, and has made recommendations around four principles in the GPhC Standards for Registered Pharmacies: governance staff training and development premises safe and effective delivery of
609 – Further regulation of NHS pharmaceutical services?
2025-10-24 10:09:51 The pharmacy press have repeated reported in recent months on issues relating to pharmacies trading as “Jhoots”. The issues have included branch closures and unpaid and underpaid staff. The matter was raised in Parliament recently, and the Pharmacy Minister, Stephen Kinnock, is reported by the Pharmaceutical Journal to
606 – New laws for non-surgical procedures in Scotland
2025-10-10 13:15:22 The Scottish Government has introduced the Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Bill into the Scottish Parliament. When the Bill is passed, it will not be lawful to provide specified procedures to persons under the age of 18. The procedures covered by the Bill are ones
605 – Hub and spoke dispensing – law change from 1 October 2025
2025-10-01 10:56:27 Changes to the Medicines Act 1968 and the Human Medicines Regulations 2012 have taken effect on 1 October 2025 to allow hub and spoke dispensing. In order to allow hub and spoke dispensing, conditions have to be met and aspects of the law unrelated to the outsourcing of dispensing have also
604 – NHS Control of entry in Scotland
2025-09-28 12:16:17 The NHS control of entry procedures came under consideration by Lord Lake in the Court of Session (Outer House) in a judicial review application by LP North 16 Limited t/a Dears Pharmacy [2025] CSOH 91. Applications for NHS contracts (for inclusion in a Health Board’s pharmaceutical list) are
603 – GPhC fails PSA FtP standards – again
2025-09-28 10:36:53 Earlier this year, PLEA responded to an invitation from the Professional Standards Authority (PSA) to comment on the performance of the General Pharmaceutical Council (GPhC). Last week, the PSA published its annual report https://www.professionalstandards.org.uk/sites/default/files/attachments/Performance%20Review%20-%20GPhC%202024-25.pdf . It found that the GPhC met 17 out of the PSA’s 18 standards.
602 – Advertising POMs for weight loss – updated enforcement notice
2025-09-25 19:06:12 Together with the Medicines and Healthcare products Regulatory Agency and the Advertising Standards Authority, the General Pharmaceutical Council has just issued an updated enforcement notice that gives guidance on the law governing the advertising of medicines and how breaches of the law and of the GPhC’s guidance will
601 – Timeline for supervision law changes
2025-09-25 18:44:12 Members will be aware that the Department of Health and Social Care (DHSC) plans to change the law of supervision. DHSC summarises the core changes as: enabling pharmacists to authorise registered pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, and sale and
600 – Proposed HMR amendments: community pharmacist dispensing flexibilities
2025-09-21 13:15:44 Prescription flexibilities proposed to meet medicines shortages The Department of Health and Social Care (DHSC) has launched a consultation on proposals to provide community pharmacists with flexibility in making certain supplies in order to cope with medicine shortages. Current law Currently, regulation 214 of the Human Medicines Regulations
599 – Consultation on extending administration and prescribing rights
2025-08-29 13:25:36 This month, the Department of Health and Social Care launched a consultation on: extending the list of medicines that paramedics can administer in emergency situations using exemptions within medicines legislation extending the list of controlled drugs that physiotherapist independent prescribers are legally able to prescribe enabling operating department
596 – Regulation of NHS managers
2025-08-10 11:48:24 The Department of Health and Social Care (DHSC) has launched a consultation on proposals to regulate NHS managers https://www.gov.uk/government/consultations/leading-the-nhs-proposals-to-regulate-nhs-managers/leading-the-nhs-proposals-to-regulate-nhs-managers#policy-proposal-for-consultation The proposals are prompted by a series of reviews into high-profile NHS scandals and failures such as Mid Staffordshire Foundation Trust which were addressed in the Francis report in
595 – Fitness to practise reforms
2025-07-23 17:27:02 A number of reforms to fitness to practise procedures have been announced in recent weeks. The Professional Standards Authority (PSA) which oversees all the stautory healthcare regulators, including the General Pharmaceutical Council (GPhC), has announced that the regulators will have new powers to use a less adversarial and
593 – Supervision law changes
2025-07-18 10:18:24 The Government has now published the amendments that will be made to amend the law on supervisiona across the UK. These are in the draft Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025. In a letter to PLEA as a responder to its consultation,
590 – Accepted outcomes in Fitness to Practise cases
2025-07-06 13:57:05 In anticipation of the government making regulations to enable all healthcare regulators to dispense with hearings in fitness to practise cases if there is an “accepted outcome”, the Professional Standards Authority has just published guidance to regulators on when to proceed on the basis of accepted outcomes. The
588 – Supplying medicines for personal use
2025-06-11 11:53:42 Mentioning VAT risks sending many members to sleep, but a recent decision of the First Tier Tribunal throws up some points of interest. In Clatterbridge Pharmacy Limited v Commissioners for Revenue and Customs [2025] UKFTT 00661 (TC), Clatterbridge Pharmacy Limited (CPL) was a wholly owned subsidiary of the
588 – Supplying medicines for personal use
2025-06-11 11:53:42 Mentioning VAT risks sending many members to sleep, but a recent decision of the First Tier Tribunal throws up some points of interest. In Clatterbridge Pharmacy Limited v Commissioners for Revenue and Customs [2025] UKFTT 00661 (TC), Clatterbridge Pharmacy Limited (CPL) was a wholly owned subsidiary of the
586 – Distance selling pharmacies – law changes
2025-06-03 11:53:26 We reported on 31 March 2025 that as result of agreement between the Department of Health and Social Care and Community Pharmacy England on a new Community Pharmacy Contract Framework, distance selling pharmacies would no longer be able to provide advanced or enhanced services to patients on the
586 – Distance selling pharmacies – law changes
2025-06-03 11:53:26 We reported on 31 March 2025 that as result of agreement between the Department of Health and Social Care and Community Pharmacy England on a new Community Pharmacy Contract Framework, distance selling pharmacies would no longer be able to provide advanced or enhanced services to patients on the
585 – Remote prescribing of non-surgical cosmetic medicines by nurses and midwives
2025-05-16 15:23:39 The Nursing and Midwifery Council (NMC) is updating its guidance for nurses and midwives on the remote prescribing of non-surgical cosmetic medicines, including certain anti-wrinkle injections and aesthetic emergency kit items – https://www.nmc.org.uk/news/news-and-updates/nmc-to-update-position-on-remote-prescribing-of-non-surgical-cosmetic-medicines/. From 1 June 2025, nursing and midwifery prescribers will be required to consult with people face-to-face before issuing
582 – Enforcement Notice – weight management POMs
2025-04-17 10:08:55 The Advertising Standards Authority (through the Committee of Advertising Practice – CAP), working with the General Pharmaceutical Council and the Medicine and Healthcare products Regulatory Agency has issued an Enforcement Notice in relation to the advertising of Prescription Only Medicines for the weight management https://www.asa.org.uk/static/120ba987-d795-48ec-9b3f10008348fbcf/Enforcement-Notice-Prescription-only-medicines-used-for-weight-management.pdf . Regulation 284(1)
581 – Sexual misconduct, Fitness to Practise and the Equality Act 2010
2025-04-16 10:44:14 Mr Justice Kerr has dismissed an appeal by the General Medical Council against a suspension imposed for sexual misconduct. Of particular interest is the way the judge dealt with allegations that the registrant’s conduct amounted to sexual harassment under section 26 of the Equality Act 2010. In General
580 – 2025 Annual Seminar & AGM Follow up
2025-04-10 16:52:03 A huge thank you to everyone who was able to join us for the annual seminar and AGM in Birmingham yesterday at Aston University. There were over 50 PLEA members present with a most informative set of talks and some great discussions. Details of the talks including PDFs
579 – Do healthcare regulators owe a duty of care to registrants?
2025-04-08 13:00:32 In Suresh v General Medical Council [2025] EWHC 804 (KB), Marcus Pilgerstorfer KC, sitting as a judge of the High Court, had to determine whether a healthcare regulator, the General Medical Council in this tragic case, owed a duty of care to registrants when exercising its fitness to
578 – Scotland – pharmacists – regulated roles – children and protected adults
2025-03-31 17:15:07 Under section 44 of the Protection of Vulnerable Groups (Scotland) Act 2007, Ministers must maintain a scheme for collating and disclosing information about individuals who carry out, or wish to carry out, regulated roles with children or protected adults. The scheme allows pharmacy owners to check that their
577 – NHS Regulations in England and Scotland
2025-03-31 17:11:50 The newly-announced Community Pharmacy Contract Framework in England will involve changes to the NHS terms of service. In Scotland, the Court of Session has recently heard a case involving the labyrinthine control of entry regulations. Further details are below. NHS terms of service in England An agreement between the
576 – 2025 Annual Seminar and AGM – It’s nearly here! Register by 31 March
2025-03-26 16:26:37 The PLEA Annual Seminar and AGM will be held on Wednesday 9 April in Birmingham. If you haven’t registered already and are planning to attend, please do so by no later than 31 March to allow us time to confirm arrangements for catering. If you were planning to
574 – FtP – When is a suspension not a suspension?
2025-02-10 16:53:28 In a news item on 18 December 2023, we reported on the case of Aga v General Dental Council. In that case, the GDC’s fitness to practise panel had decided after a final hearing to suspend the practitioner. All healthcare regulators have an overarching objective of the protection
572 – 2025 Annual Seminar now open for registration
2025-02-05 17:43:05 The PLEA Annual Seminar and AGM will be held on Wednesday 9 April in Birmingham Full details of the seminar, including the programme and registration, are available on the PLEA website: https://plea.org.uk/events.htm Attendance for members is free, however places must be booked as there is a
571 – When is it misconduct if healthcare professionals break the law?
2025-01-22 17:39:20 Dr Sarah Benn is a climate activist. She took part in Just Stop Oil protests despite High Court injunctions forbidding her from doing so. As a result, the High Court imposed a prison sentence for contempt of court. She then appeared before the Medical Practitioners’ Tribunal where she
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