Equality Act and withdrawing pharmacy services
Posted: Friday, August 30th, 2019
In an article just published in Chemist & Druggist, David Reissner looks at the Equality Act implications of withdrawing pharmacy services. The article can be accessed here: https://www.chemistanddruggist.co.uk/opinion/legal-view-what-consider-stopping-free-deliveries-or-mds
GPhC Publication and disclosure policy in FtP cases
Posted: Sunday, August 25th, 2019
Last Summer, we responded to a GPhC consultation on its Publication and disclosure policy. The new policy has now been published https://www.pharmacyregulation.org/sites/default/files/document/gphc-publication-and-disclosure-policy-gphc0034-august-2019.pdf.
As well as setting out the GPhC’s new policy for publishing the reports of pharmacy inspections, the policy includes:
- Registrants will usually be told if a concern about their fitness to practise has been received unless the GPhC thinks telling the registrant would adversely affect an investigation.
- The identity of an informant will not be disclosed without the informant’s agreement.
- A registrant’s employer may be informed that a concern has been received if the GPhC thinks this is in the public interest.
- An informant will not routinely be informed of the registrant’s response to any request for information, but it may be disclosed on a case-by-case basis. An informant will be informed of the outcome of an investigation.
- Fitness to Practise Committee decisions will be searchable on the GPhC website for 12 months if a registrant’s fitness to practise has been found to be impaired. (This does not include health cases or cases where an interim order has been made, because these cases are heard in private.)
- Varying lengths of time a Fitness to Practise determination appears on the online register. In the case of removal, the period will be 5 years and (the person’s entry on the register showing that they have been removed will remain for 10 years). In the case of suspensions, the determination will appear on the online register for the period of suspension plus 2 years.
Court rules on whether there is a right to silence in Fitness to Practise proceedings
Posted: Thursday, August 15th, 2019
In The Queen (on the application of Evgeniy Kuzmin) v GMC  EWHC 2129 the High Court addressed the question of whether a medical practitioner had a right to silence when appearing before the Medical Practitioner Tribunal and whether adverse inferences could be drawn from silence. As explained below, the significance of the case is not limited to proceedings involving medical practitioners.
Dr Kuzmin was working for an out-of-hours service. He was accused, amongst other things, of poor record keeping. Pending a final hearing, conditions were placed on his registration. These conditions included a requirement to notify any out-of-hours service of the conditions. Dr Kuzmin did not notify an employer of the conditions. No misconduct was found in relation to the original allegations, but it was alleged that the failure to notify the out-of-hours service of the conditions on his registration was misconduct.
In fitness to practise proceedings before the Medical Practitioner Tribunal, Dr Kuzmin filed a written statement, strenuously denying dishonesty and said that any failure was a “complete oversight”. At the conclusion of the GMC’s presentation of its case, Dr Kuzmin’s barrister submitted that there was no case to answer. That submission was unsuccessful. Dr Kuzmin then withdrew his statement and declined to give evidence.
The GMC argued that the Tribunal could draw an adverse inference from the refusal to give evidence and that there was no innocent explanation for the doctor’s failure to inform the out-of-hours service of the conditions imposed on his registration. The Tribunal decided it could draw inferences from silence. The case was then adjourned so that Dr Kuzmin could apply to the High Court for judicial review.
The High Court (Lord Justice Hickinbottom and Mr Justice Butcher) held:
- Disciplinary proceedings are civil, not criminal proceedings (in which a defendant has different rights and protections);
- Ordinarily the public would expect a professional man to give an account of his actions – there is no right to silence in disciplinary/fitness to practise cases;
- It would not be unfair if the possibility that an adverse inference might be drawn makes a healthcare professional feel obliged to give evidence;
- Whether an adverse inference is drawn in any particular case will be “highly dependent upon the facts of the particular case”;
- No inference will be drawn unless:
- a prima facie case to answer has been established;
- the individual has been given appropriate warning that if he does not give evidence than an inference may be drawn; and an opportunity to explain why it would not be reasonable for him to give evidence, and, if it is found that he has no reasonable explanation, an opportunity to give evidence;
- There is no reasonable explanation for his not giving evidence;
- There are no other circumstances in the particular case which would make it unfair to draw such an inference.
The significance for pharmacists and other healthcare professionals
The significance of this decision is not limited to cases against medical practitioners. The Court cited an earlier judgment concerning a pharmacist - R (Panjawani) v Royal Pharmaceutical Society of Great Britain  EWHC 1127 (Admin) as authority for its decision (1) that there is no right to silence in professional disciplinary proceedings; and (2) that adverse inferences can be drawn from silence in proper circumstances. That was a case in which a pharmacist was accused of failing to account for a quantity of Viagra, but had failed to explain what had become of it. In fact, the pharmacist successfully argued that an adverse inference should not have been drawn because the regulator had never given him a proper opportunity to explain what had happened to the Viagra.
The recent Kuzmin case is also of importance to all healthcare professionals because Lord Justice Higginbottom suggested it might be useful for all healthcare regulators to give guidance on the existence of the power to draw adverse inferences and how it might be used in fitness to practise cases.
Hub & Spoke - change to pharmacy law announced
Posted: Tuesday, July 23rd, 2019
In its announcement yesterday of a new funding package for community pharmacy, the Governement also announced that it will will "pursue legislative change to allow all pharmacies to benefit from more efficient hub and spoke dispensing, enabling increased use of automation and all the benefits that that brings".
The Government also proposes to amend the NHS market entry regulations to make it easier for two pharmacies to merge and then close one of them with less risk that someone else will apply for a new pharmacy "contract" to replace the one that closed.
Annual GPhC Fitness to Practise report
Posted: Monday, July 15th, 2019
The General Pharmaceutical Council has published its annual Fitness to Practise report. Amongst other things, the report contains the following information:
By far, the biggest source of concerns came to the GPhC from members of the public – 1439 out of 2,674 (an increase of 345 on the previous year).
167 concerns came from employers, 264 came from inspectors and 360 from other healthcare professionals.
Overall, 1,027 cases were closed at the triage stage in 2018/19 (39% of all concerns raised) compared with 791 in 2017/18 (34% of all concerns raised). The reduction may be the result of using more senior oversight, and the GPhC is currently evaluating the impact of adding more senior oversight into the triage process.
736 cases ended with a letter of advice, and of those that went to a Fitness to Practise Committee hearing the sanctions were –
37 suspensions from the register
13 removals from the register.
Promoting professionalism, reforming regulation – the Governments’ consultation response
Posted: Thursday, July 11th, 2019
The UK Government and the devolved governments have published their response following their consultation on promoting professionalism and reforming the regulation of healthcare professionals - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/815261/promoting_professionalism_reforming_regulation_-_eds_HW.pdf.
The structure of healthcare regulation and regulatory bodies
The original consultation paper suggested that there should be some rationalisation of the 9 current healthcare regulators. However, opinions in the responses from consultees were divided and the governments say more work needs to be done on this, so there will be a further consultation. Regardless of the outcome of the further consultation, there will be structural changes to all the healthcare regulators. Their councils will become boards which comprise executive and non-executive directors, appointed on the basis that they have the skills, knowledge and expertise to ensure the regulator discharges its functions effectively. The non-executive directors will always form the majority of the board. Current and former registrants may be appointed to the board, but they will not form a majority. The governments have dropped a proposal for employers to be represented on the regulatory bodies' board, but expects regulatory bodies to actively seek and consider the views of employers.
Fitness to practise processes
The governments say the aim of reform is “to enable the regulators to place a greater emphasis on supporting the professionalism of all registrants, while continuing to take appropriate action to manage concerns about a minority of professionals…At the heart of these changes is the much-needed modernisation of fitness to practise processes.”
The governments believe that regulatory bodies manage complaints about professionals in a largely reactive way, focussing much of their effort and resources on managing concerns about a minority of registrants at the expense of supporting the professionalism of the majority. Investigations into allegations will, they say, always be central to delivering public protection. However, they regard these processes as
“bureaucratic and lengthy, which can be frustrating and stressful for patients and their families, registrants and employers. They are also legalistic and adversarial, and this can be detrimental to the development of a learning culture. Fitness to practise concerns need to be handled in a timely, efficient and proportionate manner to ensure safe, high quality healthcare delivery”.
Future processes will be “more collaborative and less adversarial”, and there will be requirements to update patients and family members on the progress of fitness to practise cases in which they have an interest.
New FtP powers
The most significant changes will enable regulators to resolve fitness to practise cases without the need for a full panel hearing where it is appropriate to do so.
Regulators will be able to:
- use case examiners to consider complaints and, where appropriate, resolve them on a consensual basis;
- include mediation as part of their fitness to practise processes if they wish; and
- remove registrants from the register automatically where they have been convicted of a very serious criminal offence – murder, rape or sexual offences involving children - in the UK.
Regulators have an existing duty to co-operate and the governments will explore whether this needs to be strengthened to enable them to work even more closely together with one another and with other organisations in the health and care system in the exercise of their functions.
The GPhC has published its response to the governments’ conclusions which you can read here: https://www.pharmacyregulation.org/sites/default/files/document/gphc_response_to_promoting_professionalism_reforming_regulation.pdf
Report on 2019 seminar published in Pharmacy magazine
Posted: Wednesday, July 10th, 2019
David Reissner's report on our annual seminar has been published in Pharmacy magazine. You can read it here https://www.pharmacymagazine.co.uk/pharmacy-law-and-ethics-update
Social media and fitness to practise - Ngole decision overturned - university criticised
Posted: Wednesday, July 3rd, 2019
Barrister Kenneth Hamer gave a fascinating presentation at our annual seminar on Social media and professional conduct”. At the time, the Court of Appeal had heard the appeal in The Queen (on the application of Ngole) v The University of Sheffield  EWCA Civ 1127, but had not handed down its judgment. The judgment has just been published. Not only has the Court of Appeal overturned the decision of the University authorities to exclude Mr Ngole from an MA course that would have led to registration as a social worker, but the University came in for considerable criticism and was itself found to have lacked insight.
Mr Ngole is a devout Christian for whom the Bible is the authoritative word of God. He posted on Facebook in response to a US news story a series of comments such as:
“… [S]ame sex marriage is a sin whether we accept it or not”
“…Homosexuality is a sin, no matter how you want to dress it up”
“…[Homosexuality] is a wicked act and God hates the act”
The University of Sheffield brought fitness to practise proceedings against Mr Ngole. Mr Ngole was told that whilst he was entitled to hold his views about homosexuality being a sin, he was never entitled to express such views on social media or in any public forum. Mr Ngole was found to have lacked insight and excluded from his course.
Social workers are regulated by the Health and Care Professions Council (HCPC) and the Court of Appeal considered that the issues were likely to be applicable across all healthcare regulators. The HCPC has published guidance for students. Amongst other things, this says:
“You should keep high standards of personal conduct - You should be aware that conduct outside of your programme may affect whether or not you are allowed to complete your programme or register with us.
You should make sure that your behaviour does not damage public confidence in your profession - You should be aware that your behaviour may affect the trust that the public has in your profession. - You should not do anything which might affect the trust that the public has in your profession.”
The HCPC has also published guidance for registrants, as well as students, about use of social media, designed to explain how to use social media in a way which meets HCPC standards. It reminds registrants as to the importance of ensuring that use of social networking sites is consistent with appropriate professional standards. It states:
“You may use social networking sites to share your views and opinions. Again, this is not something that we would normally be concerned about. However, we might need to take action if the comments posted were offensive, for example if they were racist or sexually explicit.
You may use social networking sites to share your views and opinions. Again, this is not something that we would normally be concerned about. However, we might need to take action if the comments posted were offensive, for example if they were racists or sexually explicit. Social networking sites are a part of many registrants' and students' everyday life. We do not have any concerns about you using these sites, so long as you do so within the standards that we set. …”
“You must make sure that your conduct justifies the public’s trust and confidence in you and your profession. This means you need to think about who can see what you share. … Even on a completely personal account, your employer, colleagues or service users may be able to see your posts or personal information. It is best to assume that anything you post online will be visible to everyone.”
The Court of Appeal pointed out that
“the obligation to maintain confidence cannot extend to prohibiting any statement that could be thought controversial or even to have political or moral overtones. No social worker could be sanctioned for arguing in public that social work was under-funded. The expression of such views in offensive language, however, might well damage confidence. The prevention of the latter would fall within the legitimate aim of the system of professional regulation, prevention of the former would not. The existence of a broad legitimate aim … cannot extend to preclude legitimate expression of views simply because many might disagree with those views: that would indeed legitimise what in the United States has been described as a “heckler’s veto”.
On the other hand, the Court held that the
“legitimate aim of regulation must extend so far as to seek to ensure that reasonable service users, of all kinds, perceive they will be treated with dignity and without discrimination. Social work service users cannot usually choose their social worker. The use of aggressive or offensive language in condemnation of homosexuality, or homosexual acts, would certainly be capable of undermining confidence and bringing the profession of social work into disrepute. As the Guidance makes clear, [Mr Ngole] had an obligation not to allow his views about a person’s lifestyle to prejudice his interactions with service users by creating the impression that he would discriminate against them.”
It became clear during the Court of Appeal hearing that the stance which the University adopted from the time of the fitness to practise hearing amounted to a blanket prohibition against Mr Ngole voicing his religious views on sexual ethics and homosexuality at all in a public forum. In effect, any expression of disapproval of same-sex relations – however mildly expressed – which could be traced back to the person making it, would be a breach of the professional guidelines for social workers as far as the University was concerned.
The Court of Appeal made it clear that the mere expression of religious views about sin does not necessarily connote discrimination against service users; otherwise, no Christian believing as Mr Ngole did would be secure in a healthcare profession, unless they resolved never to express their views on this issue other than in private. Even then, the Court asked rhetorically: what if a private expression of views was overheard and reported?
The right to freedom of expression in Article 10 of the European Convention of Human Rights is not an unqualified right: if Mr Ngole’s comments had been abusive, if he had used inflammatory language of his own, or made a personal attack, such words would fall to be regarded in the same way as would racist views, or inappropriate sexually explicit language. However, the University’s stance that any expression of disapproval of same-sex relations (however mildly expressed) on a public social media or other platform which could be traced back to the person making it, was a breach of the professional guidelines was “untenable”, disproportionate, and an incursion into Mr Ngole’s right to freedom of expression. Moreover, the University’s position went much further than the HCPC guidance.
With regard to the sanction - expulsion from his course - the Court of Appeal held that this was disproportionate. The University should have considered the possibility of a lesser sanction and tried to give Mr Ngole guidance on what he could and could not say when expressing his beliefs. Because the Court was not in a position to decide what Mr Ngole would have said if he had been given advice, the case will now have to be reconsidered by a University fitness to practise panel.
Having excoriated the University, the Court concluded with words that all Universities should heed, especially in times of concern about the expression of unpopular views and about no-platforming:
“We recognise that a more prolonged exploration of a resolution here might well have proved unpopular with some. However, University authorities have an obligation, as do all regulators, to exercise care and restraint, and to take unpopular decisions, if such represent the just and proportionate result.”
Reflection and Fitness to Practise
Posted: Monday, July 1st, 2019
Reflection is a core part of the GPhC’s revalidation model, and pharmacy professionals are encouraged to reflect with others through peer discussion. The position is similar in other healthcare professions.
The use of reflective material in fitness to practise cases was an issue examined by the panel chaired by Professor Sir Norman Williams which was set up by the then Secretary of State to review of the Bawa Garba manslaughter case. The panel heard “widespread fears from healthcare professionals and representative groups that personal reflection where things have gone wrong, and in particular written reflection, might be used as evidence against them in criminal or regulatory proceedings".
The panel was also “concerned to learn that some clinicians are choosing not to engage with reflective learning for fear it could be used against them.”
The Williams report recommended that the General Medical Council and General Optical Council should no longer be able to require registrants to provide reflective material when investigating fitness to practise cases. The panel considered that such a change would help ensure healthcare professionals are not afraid to use their notes for open, honest reflection which supports improvements in patient care.
On 18 June, the GPhC announced that it had issued a statement jointly with the UK’s other 8 healthcare regulators, entitled “Benefits of becoming a reflective practitioner”[i]. The joint statement includes this passage:
“We will not ask those who are on our registers to provide their personal written reflections in order to investigate a concern about them. Registrants can choose to offer them as evidence of insight into their practice.”
New NHS terms of service for SSPs
Posted: Sunday, June 30th, 2019
The NHS terms of service for pharmacies[i] are amended with effect from 1 July 2019, to enable medicines to be supplied under a serious shortage protocol (SSP).
Ordinarily, a pharmacy owner must supply a prescribed product with reasonable promptness. If the prescribed product is the subject of a SSP:
- the pharmacy owner must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription and may refuse to supply what is on the prescription.
- the pharmacy owner may provide a different product or different quantity to what is prescribed if –
- this can be done with reasonable promptness;
- it is in accordance with the SSP; and
- the supply is by or under the direct supervision of a pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity is reasonable and appropriate.
If a supply is made under an SSP –
- prescriptions must be endorsed appropriately for remuneration purposes
- pharmacy owners must notify prescribers of a supply under a SSP if DHSC has published a recommendation to do so
- patients must be informed of the different supply by including information on the dispensing label.
If an SSP is in place, pharmacy owners do not have to use it. If a pharmacy owner is of the opinion in the exercise of his or her professional skill and judgement that supplying a different product or quantity is unreasonable or inappropriate and is able to supply the prescribed product or quantity within a reasonable timescale, they are allowed to do this and are absolved from the requirement to supply with reasonable promptness. It is to be inferred that “reasonable timescale” involves a longer period than “reasonable promptness”, but the actual period on either case would necessarily depend on the precise facts and circumstances.
Similarly, if a pharmacist is of the opinion, in the exercise of his or her professional skill and judgement that supplying a different product or quantity under a SSP is unreasonable or inappropriate and is unable to provide a different product within a reasonable timescale, a supply under the SSP can be refused. In that case, the patient must be referred back to the prescriber.
[i] Schedule 4 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013
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.