Consent, Gillick competence and case examiners
Posted: Wednesday, September 15th, 2021
Consent, Gillick ccmpetence and the role of case examiners were considered in two recent cases.
AB v CD  EWHC 741 (Fam) concerned X, a 15-year-old who wished to continue her hormone treatment to suppress puberty. Following the earlier decision in Bell v Tavistock and Portman NHS Foundation Trust  EWHC 3274 (in which an appeal to the Court of Appeal is currently pending), NHS England issued guidance that a child under 16 could only consent to treatment after an assessment and an application to the court. In X’s case, this would have caused an unacceptable delay in treatment. The court held that X’s parents retained the legal ability to consent to X’s treatment. In view of the decision in Bell, this judgment seems controversial because it appears to enable the NHS England guidance to be circumvented.
We will report further on Bell when the Court of Appeal judgment is available.
In B v General Medical Council  CSOH 85, a complaint had been made to the GMC by a child’s parents about a doctor who wrongly concluded that they were responsible for their child’s illness. The doctor made a safeguarding, referral resulting in the child being taken into care for a period. The GMC’s case examiners decided not to refer the case for fitness to practise proceedings and the child’s parents challenged this decision.
Based on earlier authorities, the parties agreed that case examiners have a limited, filtering, role. They may examine whether the complaint has any real prospect of being established, and in so doing may themselves conduct an investigation into its prospects. They may then refuse to refer the allegation on for a full hearing if satisfied that it has no real prospect of being established, but they must do so with the utmost caution (or, at least, with caution).
The case examiners noted that an expert had not identified any aspects of Dr C’s care “that fell below, or seriously below” the standard of the reasonably competent consultant paediatrician and lead consultant paediatrician for child protection. They also noted that the expert had confirmed that the doctor had followed the guidance issued by the Royal College of Paediatrics and Child Health.
It was also alleged that there had been a failure to obtain the parents consent to some of the child’s treatment in hospital, but, the judge, Lord Harrower, held that the case examiners had not made any error of law when they concluded that the parents, by bringing their child to the Hospital, had given implied consent to her ongoing treatment. To succeed in this allegation, the parents would have had to point to the implied consent being withdrawn at some point.
The case may be of further significance in view of the proposal by the Department of Health and Social Care in England to allocate greater decision-making powers to case examiners – a proposal PLEA commented on in responding to the recent consultation on healthcare regulation, pointing out the difficulty in overturning decisions of case examiners. Our response can be found on the Notice Board on the home page of our website www.plea.org.uk.
Changes to NHS terms of service and to Human Medicines Regulations
Posted: Tuesday, August 24th, 2021
The PSNC, DHSC and NHS England & Improvement (NHSE&I) have announced agreement for year 3 of the 5-year Community Pharmacy Contractual Framework in England. The agreement includes an announcement of regulatory changes to be made to the NHS terms of service in the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 and changes to the Human Medicines Regulations. The changes will relate to:
- the clinical governance provisions. Pharmacies will be required to comply with recommendations from government or NHSE&I aimed at protecting staff and patients during a pandemic.
- the market entry provisions to enable NHSE&I to reject Pharmaceutical Needs Assessment-based applications if they provide only a minor increase in opening hours in the area and otherwise additional pharmaceutical services capacity is not needed in an area.
In addition, the PSNC, DHSC and NHSE&I have agreed:
- to continue further conversations regarding the regulation of dispensing and supply of medicines taking into account novel ways of undertaking these activities, while, at the same time, ensuring the integrity of the market entry system, based on Pharmaceutical Needs Assessments.
- to continue discussions on a suitable process to deal with suspected prescription direction issues.
- to seek as soon as possible changes to medicines legislation to enable original pack dispensing and the wider use of hub and spoke dispensing to improve efficiencies and better use of the skill mix in pharmacy teams so that the clinical skills of pharmacists can be directed to helping patients.
PSA to cease annual reviews of healthcare regulators - correct link
Posted: Thursday, August 19th, 2021
We are resending this news item with the correct link. Apologies to anyone who tried to use the link in our earlier email.
The Professional Standards Authority (PSA) carries out annual reviews of 10 healthcare regulators including the GPhC. In its last report on the GPhC, as we reported at the time, the PSA concluded that the GPhC had not met three standards relating to fitness to practise - see PLEA News of 4 November 2020 on our website.
The PSA has just published its response to a consultation on its approach to performance reviews of healthcare regulators https://www.professionalstandards.org.uk/publications/detail/how-we-approach-the-performance-review-process---report-on-consultation . The PSA is considering:
- Ceasing annual reviews.
- Undertaking full reviews of each regulator at predetermined time periods (probably between three to five years).
- In the years in between full reviews, the PSA would continue to monitor the performance of each regulator, including looking at any individual areas which suggested concerns and examining the impact of any significant changes introduced by the regulator.
The PSA will develop a model of how the new processes would work and will conduct a further consultation this autumn with a view to deciding on implementation in January 2022.
MHRA consulting on amending the law for point of care manufacturing
Posted: Wednesday, August 18th, 2021
The MHRA is conducting a consultation on Point of Care (“POC”) manufacturing https://www.gov.uk/government/consultations/point-of-care-consultation/consultation-on-point-of-care-manufacturing
According to the MHRA, new types of innovative products are increasingly being manufactured at the point where a patient receives care, eg personalised medicines made for the patient either within or very close to the healthcare setting. Technology enables the creation of new types of medicinal product that have features such as very short shelf lives, unlike typical current products with shelf lives measured in years. Medicines regulation supports the latter, geared to manufacture in factories for global distribution. POC products do not fit the standard model of regulation.
The MHRA is considering a new regulatory framework to enable the safe development of POC products for supply to patients through clinical trial studies and then on to licensing through a marketing authorisation. The MHRA proposes to use new powers in the Medicines and Medical Devices Act 2021 to amend the law.
The regulatory system is proposed to be based on a Control Site. This will be the primary focus of regulatory controls by MHRA. The Control Site will be a physical site that will be named on the clinical trial or marketing authorisation application. The Control Site would be responsible for overseeing all aspects of the POC manufacturing system including the addition of new manufacturing sites and control of each manufacturing location and their activities.
Remote FtP hearings and the demeanour of witnesses - recent cases
Posted: Tuesday, August 17th, 2021
In the GPhC’s recent consultation on its Fitness to Practise strategy, it sought views on when to use remote hearings and what impact they may have. In our response, we set out what we saw as the advantages and disadvantages of remote hearings. We concluded that the default position should be that hearings should not be remote unless the registrant agreed.
One of the potential disadvantages of remote hearings concerns the ability of a tribunal to assess the demeanour of a witness in order to form a view of credibility. However, in three recent fitness to practise cases, the courts have expressed varying views about reaching conclusions based on the perceived demeanour of a witness.
In The Queen (on the application of Dutta) v General Medical Council  EWHC 1974 (Admin), Mr Justice Warby said: “Reliance on a witness’s confident demeanour is a discredited method of judicial decision-making.”
In Khan v General Medical Council  EWHC 374 (Admin), the Medical Practitioner Tribunal found that the Dr Khan had behaved in an inappropriate and sexually motivated way towards three female members of staff. Mr Justice Julian Knowles upheld Dr Khan’s appeal. The Tribunal had approached disputed evidence by first considering whether a witness was credible. The judge criticised this approach and followed Mr Justice Warby’s decision in Dutta (above).
In Byrne v General Medical Council  EWHC 2237 (Admin), Mr Justice Morris heard an appeal by a registrant whose name had been erased from the medical register because of an inappropriate sexual relationship with a vulnerable patient. The medical practitioner had denied having such a relationship. Differing from Mr Justice Julian Knowles and Mr Justice Warby in the other recent cases, Mr Justice Morris gave this guidance on assessing evidence:
- First, the credibility of witnesses must take account of the unreliability of memory and should be considered and tested by reference to objective facts, and in particular as shown in contemporaneous documents. Where possible, factual findings should be based on objective facts as shown by contemporaneous documents.
- Secondly, nevertheless, in assessing the reliability and credibility of witnesses, whilst there are different schools of thought, I consider that, if relevant, demeanour might in an appropriate case be a significant factor and the lower court is best placed to assess demeanour: Despite the doubts expressed in Dutta and Khan , the balance of authority supports this view.
- Thirdly, corroborating documentary evidence is not always required or indeed available. There may not be much or any such documentary evidence. In a case where the evidence consists of conflicting oral accounts, the court may properly place substantial reliance upon the oral evidence of the complainant (in preference to that of the defendant/appellant). There is no rule that corroboration of a patient complainant’s evidence is required.
GPhC warns about provision of online services
Posted: Friday, August 13th, 2021
The GPhC has written to pharmacy owners and pharmacy professionals, reminding them of the need to follow its guidance on providing pharmacy services at a distance, including on the internet.
The letter https://www.pharmacyregulation.org/sites/default/files/document/patient-safety-concerns-relating-to-online-prescribing-services-letter-august-2021.pdf sent by the GPhC’s Director of Insight, Intelligence and Inspection (who spoke at the last PLEA seminar) highlights that since April 2019, the GPhC has taken enforcement action against over 40 pharmacies concerning the provision of online services. The majority of the pharmacies involved were working with online prescribing services that were prescribing medicines liable to misuse and overuse on the basis of online questionnaires. According to the letter, a significant minority of pharmacies and pharmacy professionals are not meeting standards and following guidance.
2021 PLEA Annual Essay Competition Winner Announced
Posted: Wednesday, July 28th, 2021
Each year PLEA runs a law and ethics essay competition to foster wider thinking on issues of the day by students at UK and Ireland schools of Pharmacy.
This years competition title for consideration was "The legal and ethical implications of using volunteers to supply medicines during the COVID-19 pandemic" Discuss
We received 12 entries from 9 schools of pharmacy.
The winners were from the following schools:
Winner – Nottingham
2nd place – Huddersfield
3rd place - Keele
Congratulations to Saz Karim from the University of Nottingham School of Pharmacy who wins £500 and the two runners up who each receive £250
GPhC annual FtP report 2020/21
Posted: Wednesday, July 21st, 2021
The GPhC has published its annual fitness to practise report for 2020/21. Amongst other things, the report refers to:
- 46 enforcement notices were served on pharmacies (45 were improvement notices and 5 imposed conditions).
- In the case of 35 pharmacies, enforcement action followed “intelligence-led” inspections revealing inappropriate, unusually high volumes of sales of codeine linctus.
- 2,998 concerns raised about pharmacy professionals (of which 1,756 came from members of the public).
- COVID-19 related concerns included
- concerns about professionals failing to follow self-isolation advice from PHE when they were suspected to have COVID-19 symptoms;
- concerns either from members of the public or pharmacy staff over the use and deployment of PPE, including face masks and gloves;
- concerns about pharmacies charging unjustifiably high prices for essential products (the report does not mention that, in the event, no evidence was found to substantiate these concerns).
- Because of the pandemic, the GPhC switched resources away from inspections (there were 276 routine inspections) “to focus on supporting registered pharmacies with their arrangements and plans to help manage pressures and challenges during the pandemic”.
- Emergency powers were used to grant 3459 pharmacists and 2984 pharmacy technicians temporary registration.
- In virtual fitness to practise hearings, registrants attended in 85% of cases, compared to 65% pre-lockdown.
- 2,380 fitness to practise cases were closed with no further action in 1,062 cases.
- Of 333 cases that were investigated, no further action was taken in 214 of them.
- Out of 35 fitness to practise hearings, there were:
- 10 removals from the register;
- 9 suspensions;
- 8 warnings;
- 4 conditions on registration;
- 3 cases in which no further action was taken; and
- 1 case in which advice was given.
- Moving to online hearings was not considered to have affected case outcomes.
Product liability for health advice in a newspaper
Posted: Monday, July 19th, 2021
Directive 85/374/EEC – the Product Liability Directive - was designed to harmonise product liability laws across what is now the EU. In the UK, this gave rise to the Consumer Protection Act 1987. Under the Directive and the Act, liability for defective products is strict and a claimant does not have to prove negligence. The question of liability under the Directive in a healthcare context came before the Court of Justice of the European Union (ECJ) recently in VI v KRONE – Verlag Gesellschaft mbH & Co KG (C-65/20)
An advice column in a newspaper owned by KRONE was written by an expert in herbal medicine. According to the article, fresh, coarsely grated horseradish applied to the skin for two to five hours could help alleviate rheumatic pain. However, there was a misprint in the article and the length of time for applying the horseradish poultice should have been given as two to five minutes. An Austrian citizen who applied a horseradish poultice for two to five hours claimed to have experienced severe pain due to a toxic skin reaction. She sued the newspaper owner, claiming that the owners were liable under the Product Liability Directive. The Austrian court referred the case to the ECJ.
The ECJ held that, for the purposes of the Product Liability Directive, a “product” meant something “movable” that was industrially produced or which was used in the construction of something immovable. The Directive did not cover services. The ECJ drew a distinction between the newspaper – the physical item – and the advice it contained. Advice was not part of the inherent characteristics of the printed newspaper and inaccurate advice fell outside the scope of the Directive so that neither the publisher nor the printer nor the author could be held liable under the Directive. The ECJ observed that, depending on the applicable domestic law, liability could still arise if there were a contractual obligation such as a warranty, or there if was a relevant tort.
These news items are not exhaustive but are selected according to their relevance to pharmacy practice, NHS community pharmacy contracts and the regulation of the pharmacy profession. If you wish to add any items that you think we have missed, contact our news editor.