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.
High Court upholds PSA appeal against GPhC Fitness to Practise decision
Posted: Friday, July 2nd, 2021
In Professional Standards Authority for Health and Social Care v General Pharmaceutical Council and Ali ( EWHC 1692 (Admin), the PSA has successfully appealed against a decision of the GPhC’s Fitness to Practise Committee in the case of Mr Nazim Hussain Ali, who was accused of broadcasting antisemitic comments in public.
Mr Ali led an Al Quds Day rally in central London in June 2017. Al Quds refers to the status of Jerusalem which Palestinians regard as being occupied by the State of Israel. Using a loudhailer, he shouted, amongst other things:
“It’s in their genes. The Zionists are here to occupy Regent Street. It’s in their genes, it’s in their genetic code…European alleged Jews…They are responsible for the murder of the people in Grenfell. The Zionist supporters of the Tory Party.”
The GPhC’s Standards for pharmacy professionals require professional behaviour at all times. Mr Ali’s case calls to mind the judicial review application made by the PDA when the Standards were due to be introduced. In R (on the application of Pitt) v General Pharmaceutical Council  EWHC 809 (Admin), the PDA argued that the Standards went too far because they required professional standards to be observed during the private lives of pharmacy professionals, not only when working. Mr Justice Singh rejected the argument and gave, as an example of conduct that might infringe the Standards, a racist rant on Twitter.
Mr Ali’s was referred to a Fitness to Practise Committee at which he was accused of making antisemitic remarks. Mr Ali admitted that his words were offensive but he denied that they were antisemitic.
The Fitness to Practise Committee referred to a dictionary definition that defined “antisemitism” as “hostile or prejudiced against Jewish people”. The Fitness to Practise Committee then asked itself how the words would be understood by a “reasonable person”. They took into account Mr Ali’s good character and decided that a reasonable person would have no particular characteristics. They considered what Mr Ali intended his words to mean (he, himself had been unable to explain them). The Committee analysed each of the individual statements Mr Ali admitted using, and concluded that the words were not antisemitic.
The Fitness to Practise Committee decided that Mr Ali’s comments
“brought disgrace upon the profession. The comments…regarding Grenfell Tower were particularly offensive then and now, alleging as they do, without foundation, that specific groups of people had ‘murdered’ the victims of the fire. The Committee accordingly judged that the Registrant’s comments did amount to serious misconduct.”
The Committee gave Mr Ali a warning.
It is rare for the PSA to appeal against a GPhC decision. The only previous occasion on which a PSA appeal against a GPhC decision reached the High Court was in 2014. However, the PSA has decided to appeal against the decision in Mr Ali’s case. Mr Ali opposed the appeal but the GPhC did not.
Mr Justice Johnson held that:
- In order to decide whether the words used were antisemitic, it was necessary for the Fitness to Practise Committee to consider the meaning of the words.
- The assessment of meaning is an objective test that does not depend on the intention of the author or speaker.
- The Fitness to Practise Committee had sought to apply an objective test. However, it erred by taking account of what it considered to be Mr Ali’s intention.
- The Fitness to Practise Committee had erred in taking Mr Ali’s character into account in deciding whether the words he used were antisemitic. His good character could be taken into account when assessing the credibility of his evidence but was not relevant to the meaning of the words he used.
- The Fitness to Practise Committee had erred in not taking into account the cumulative impact of the language used. (He had used the word “Zionist” in a context that did not appear to have anything to do with the State of Israel which gave rise to an allegation that the word was used to refer to Jews).
The judge held that Mr Ali’s intention and character were relevant to whether using the words in question amounted to misconduct, to whether his fitness to practise was impaired and any sanction.
The Fitness to Practise Committee’s errors were serious irregularities. Mr Ali’s counsel argued that the case should not be sent back to the Fitness to Practise Committee for re-determination because, even if the allegations were found proved, the sanction – a warning – was likely to be the same. However, Mr Justice Johnson concluded that:
“This case does…engage significant questions of public confidence. It is vitally important that all sections of the community are able to place trust and confidence in advice given by pharmacists…[T]hat is vividly illustrated by the current pandemic, and the need that all communities are able to have confidence in advice given by pharmacists and other professionals about the risks and benefits of vaccination”
The judge considered that the Fitness to Practise Committee was far better placed than the court to make an assessment of the appropriate sanction. He directed that in re-determining the case, the Committee should assess the objective meaning of Mr Ali’s words without taking into account his subjective intention or good character.
When is a failure to accept allegations an aggravating factor in FtP proceedings?
Posted: Thursday, May 20th, 2021
If a healthcare professional contests allegations that are found proved, should the fact that the allegations have been contested be held against them in Fitness to Practise proceedings? That is a question that Mr Justice Mostyn grappled with in
Towuaghantse v General Medical Council  EWHC 681 (Admin).
In another case recently decided by Mr Justice Mostyn – Bux v General Medical Council  EWHC 762 (Admin) - the judge considered the reliance in Fitness to Practise proceeding on expert evidence.
In Towuaghantse v General Medical Council a doctor was accused of mishandling the treatment of a baby born with a rare and complicated medical condition, and of contributing to the baby’s death. There were no other complaints concerning the doctor. The Medical Practitioner Tribunal found that his fitness to practise was impaired and directed his removal from the medical register.
When determining whether the registrant’s fitness to practise was impaired, the Tribunal had taken into account that he had failed to accept findings made by the coroner at the inquest into the baby’s death and had sought to blame others for what had gone wrong in the baby’s treatment.
Mr Justice Mostyn noted that the doctor’s pleas of not guilty (in effect) were clearly regarded by the MPT as evidence of an incapacity to remediate and therefore of a risk to the public, as well as an aggravating feature contributing to the award of the ultimate penalty. The judge was not impressed with the Tribunal’s reasoning. He said:
“In my judgment it is not procedurally fair for a registrant to face the risk of enhanced sanctions by virtue of having robustly defended allegations made against him before the MPT, or before another court…
…where a registrant has doughtily defended allegations against him in the fact-finding phase. It surely leads to say that it is…oppressive for that defence by the registrant to be used against him in the impairment and sanctions phases.
…an accused professional has the right to advance any defence he or she wishes and is entitled to a fair trial of that defence without facing the jeopardy, if the defence is disbelieved, of further charges or enhanced sanctions.
Mr Justice Mostyn had to reconcile his views with those of Mrs Justice Yip in Yusuff v GMC  EWHC 13 (Admin), That case concerned a review hearing which was held some time after the initial sanction was imposed. Referring to the GMC’s Sanctions Guidance, Mrs Justice Yip had observed that “refusal to accept the misconduct and failure to tell the truth during the hearing will be very relevant to the initial sanction.” She further observed that a want of candour and continued dishonesty may be taken into account by the Tribunal in reaching its conclusions on impairment.
Mr Justice Mostyn endeavoured to square his ruling with that or Mrs Justice Yip by saying:
“In my judgment a distinction should be drawn between a defence of an allegation of primary concrete fact and a defence of a proposed evaluation (or exercise of discretion) deriving from primary concrete facts. The former is a binary yes/no question. The latter requires a nuanced analysis by the decision-maker with a strong subjective component. If a registrant defends an allegation of primary concrete fact by giving dishonest evidence and by deliberately seeking to mislead the MPT then that forensic conduct would certainly say something about impairment and fitness to practise in the future.
Equally, if the registrant admits the primary facts but defends a proposed evaluation of those facts in the impairment phase then it would be Kafkaesque … if his defence were used to prove that very proposed evaluation. It would amount to saying that your fitness to practise is currently impaired because you have disputed that your fitness to practise is currently impaired.
In my opinion the capacity of the registrant to remediate sincerely should be judged by reference to evidence unconnected to his forensic stance in the fact-finding phase (unless the fact-finding decision included findings of blatant dishonesty by the registrant).”
In Bux v General Medical Council a doctor who had been writing medical reports on an industrial scale to support personal injury claimants. Amongst other things, the doctor was accused of dishonesty and of acting in disregard of a conflict of interest.
Mr Justice Mostyn held:
“It was difficult to see how medical practitioners tribunals would be assisted by opinions from medically qualified professionals in understanding the legal test for conflict of interest and the concomitant duty of disclosure, and whether that legal test was satisfied on the facts. The questions were legal and factual, not medical or technical. Judges and those acting in a judicial capacity should be capable of answering them without expert assistance. The tribunal should have ruled that the reports were inadmissible or should have refused to read them on the ground that they were irrelevant. There was an urgent need for an equivalent to [the Civil Procedure Rules that govern court proceedings] to be inserted into the procedural rules governing regulatory proceedings”
Two Bills affecting pharmacy announced in The Queen's Speech
Posted: Thursday, May 13th, 2021
The Queen’s Speech this week announced two pieces of legislation that will probably affect pharmacy practice. There will be a Health and Care Bill which will presumably implement the proposals in the Government’s recent White Paper, including subsuming Clinical Commissioning Groups into Integrated Care Systems. A Professional Qualifications Bill has already been introduced in the House of Lords. The Department of Business, Energy and Industrial Strategy says in a Policy Statement:
“We are proposing a framework that allows highly skilled professionals from all around the world to practise in the UK. This will end the systematic disparity in treatment of professional qualification holders from the EU, Norway, Iceland and Liechtenstein (European Economic Area (EEA) compared to those from other countries. Instead, the UK Government and devolved administrations can make sure that employers can access suitably qualified professionals from all around the world where there is a demand for their services.”
NICE clarifies cannabis guidelines so as not to deter prescribing
Posted: Wednesday, March 31st, 2021
According to a report in the Guardian https://www.theguardian.com/society/2021/mar/28/parents-of-boy-with-severe-epilepsy-drop-cannabis-challenge , the parents of a three-year-old have dropped a judicial review claim against NICE in which they intended to argue NICE guidelines on the prescribing of medicinal cannabis which, they said “put doctors off prescribing ‘live-saving treatment’”
Prescribing cannabis was legalised subject to certain conditions in 2018. The judicial review claim was dropped because NICE has now clarified its guidance which says there is insufficient evidence to support a recommendation relating to the whole population of people with severer treatment-resistant epilepsy. The clarification says the NICE guidelines:
“should not however be interpreted by healthcare professionals as meaning that they are prevented from considering the use of unlicensed cannabis-based medicinal products where that is clinically appropriate in an individual case. Patients in this population can be prescribed cannabis-based medicinal products if the healthcare professional considers that that would be appropriate on a balance of benefit and risk, and in consultation with the patient, and their families and carers or guardian.”
Pharmacies required to disclose results of lateral flow tests
Posted: Sunday, March 21st, 2021
Last year, COVID-19 was added to the list of notifiable diseases in Schedule 1 to the Health Protection (Notification) Regulations 2010. This Schedule lists diseases that doctors must notify to Public Health England if a case is detected in a patient. The addition of COVID-19 to the list did not have any immediate significance for pharmacies, because the GPhC had banned pharmacies from selling lateral flow tests.
On 15 February 2021, the GPhC changed its position, allowing pharmacies to sell lateral flow tests. This brought Regulation 4A of the Health Protection (Notification) Regulations into play.
Regulation 4A imposes a duty on point of care test providers to notify Public Health England of the results of tests for the detection of the SARS-CoV-2 virus or influenza virus. A “point of care test” is a defined as a diagnostic test which is not carried out in a diagnostic laboratory. A “test provider” is defined very widely and would include any pharmacy carrying out point of care tests for the detection of SARS-CoV-2 or influenza virus.
Notification to Public Health England can be made electronically and must be made in writing within 24 hours of the time when a positive or indeterminate SARS-CoV-2 test result is received by the test provider. If the test is negative or void, notification must be made within seven days. In the case of influenza virus, notification must be made within seven days of the test result being received by the test provider.
The details to be notified include, insofar as they are known to the test provider, the patient’s name, sex, date of birth, NHS number, ethnicity, current address (including postcode), and, in the case of a test for SARS-CoV-2 that is positive or indeterminate, a telephone number and email address The test provider must notify its name, the nature of the establishment, specimen identification number (if applicable), specimen type, specimen date, test method, result of test, date on which the test was carried out, and the name of the testing equipment manufacturer.
Failure to notify in accordance with the Regulations without reasonable excuse is an offence punishable on summary conviction by a fine.
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.