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Competition law breaches - should the NHS advise GPs to prescribe cheaper products?

Posted: Friday, February 25th, 2022

In Secretary of State for Health v Servier Laboratories and others [2022] EWHC 369 (Ch), The Secretary of State and various health bodies across the UK are claiming damages from Servier Laboratories for breaches of UK and EU competition law that resulted in the NHS paying more for perindopril than if those breaches had not been committed.

The breaches involved Servier making substantial payments to generic companies in return for their agreement not to challenge Servier’s perindopril patents, thereby avoiding the risk of generic entry into the market and a substantial fall in price. The purpose of the applicable competition rules is to prevent such agreements which sought to ensure that prices for perindopril remained high.

Appeals are currently pending against an EU Commission decision. Pending the outcome of those appeals, the High Court was asked to determine preliminary issues in proceedings brought by UK health bodies. In particular, and perhaps somewhat ironically, Servier argued that any losses the UK health bodies could provide to have suffered because of breaches of competition law should be reduced because those health bodies had failed to mitigate their losses.

Servier argued that perindopril should not have been prescribed in the UK to the extent that it was and that the various NHS bodies should reasonably have encouraged the prescribing of alternative ACEIs to perindopril

Mr Justice Roth had to determine whether the public health authorities who paid high prices for perindopril acted unreasonably in not making greater efforts to persuade prescribers to select an alternative drug. Much of the argument centred on whether guidance should have been given to GPs and other prescribers. Here are some extracts from the judgment that members may find of interest:

“In my judgment, if in certain circumstances a prescriber could reasonably consider, in the light of the knowledge and understanding at the time, that perindopril offered a real advantage for her or his patients compared to other ACEIs, then it would not have been reasonable or appropriate for them to prescribe another ACEI. By ‘advantage’ I include the possibility that the clinical benefit of perindopril was better established than for the alternatives such that the prescriber could, objectively viewed, be more confident of its likely effectiveness; and I also include non-clinical benefits such as convenience.”

In relation to the possibility of switching existing perindopril patients to alternative, cheaper medication that might require additional visits by patients to their GP:

“I think that having to get the patient to attend the GP surgery several times, even if seen only by a practice nurse not the GP, would reasonably be seen by GPs as an inconvenience and cost. Where a patient was frail or elderly, this could be a burden on the patient which I consider the GP could legitimately take into account.”

In relation to an allegation that the Secretary of State should have told, or requested, NICE to include guidance on prescribing alternatives to perindopril:

“ministers never sought…to influence [NICE’s] findings or recommendations or to give it directions to give guidance on the use or non-use of specific licensed drugs. I regard that position as entirely reasonable and, in my judgment, it cannot be said that the ‘duty’ to mitigate required ministers to depart from this policy and, exceptionally, to have “directed” NICE to include a recommendation on the lines suggested”

On whether local pharmaceutical advisers should have given prescribing guidance on perindopril:

“there were other priorities in prescribing on which pharmaceutical advisers could reasonably have chosen to concentrate in their limited meetings with GPs and the setting of targets under the QOF. Accordingly, I do not think that it was in any way unreasonable if they chose not to make ACEI prescribing a priority.

As for the QOF and incentive schemes, there was also the issue of timing and, above all, of priorities. For all the reasons set out above, I think it was not unreasonable if a PCT or Health Board did not introduce a switching programme to discourage perindopril prescribing”

The irony referred to above (or is it chutzpah?) is encapsulated in this passage from the judgment:

“in my judgment, when assessing what the Claimants should have done to mitigate the damages which they can claim from Servier as the result of Servier’s anti-competitive conduct, the Claimants were not reasonably required to do precisely what Servier made sustained and calculated efforts to dissuade them from doing.”

There is a lot going on in the NHS and resources are finite, as the judge acknowledged here:

“It is well-known that the NHS in all four nations is under constant financial pressure. To the extent that priorities, and the expected effectiveness of potential measures which therefore fed into the setting of priorities, were affected by limitation on financial resources, the allocation of more resources to one area meant a corresponding reduction in the resources available for another.

I do not consider that the Claimants from any of the four nations failed unreasonably at national level to take steps to encourage clinicians to prescribe other ACEIs instead of perindopril.”

The role of NHS bodies in promoting medicines management was acknowledged here:

“Unless Servier can show that the Claimants, at least to some extent, failed unreasonably to observe clear standards in the provision of medicines management which applied at the time, then given Servier’s efforts not only to persuade clinicians to prescribe perindopril but to forestall any initiatives by [NHS bodies] to dissuade them from prescribing perindopril, I consider that it would not be fair or reasonable or just to reduce by reason of Servier’s prescribing argument the amount which the Claimants would otherwise recover for purchasing perindopril at the higher prices which resulted from Servier’s actions to delay generic entry. Far from finding that there was such a failure to do what was reasonably required, I found that the evidence from all four nations demonstrated a considered and thoughtful effort to apply the evolving approach of medicines management to promote more cost-effective prescribing, within the limits of their resources and taking account of national and local considerations and priorities.”

If a registrant denies misconduct, should it be held against them?

Posted: Thursday, February 17th, 2022

In Sawati v General Medical Council [2022] EWHC 283 (Admin), Mrs Justice Collins Rice wrestled with an issue that has been the subject of a number of cases in recent years: to what extent should a fitness to practise tribunal take into account when deciding on sanction the fact that a registrant has disputed the allegations at the fitness to practise hearing.

Dr Sawati had faced allegations relating to six separate incidents over a period of four years between January 2014 and January 2018. She also faced an allegation of deficient professional performance. The allegations of misconduct were not necessarily the most serious. They included:

 

 

 

The GMC had accepted that workplace stress and panicked responses were the context for all the incidents.

The Medical Practitioner Tribunal found misconduct and that the registrant had acted dishonestly in relation to each of them. Dr Sawaiti had persistently denied misconduct up to and including the sanctions stage, and the Tribunal concluded that Dr Sawati’s insight was underdeveloped and incomplete. Amongst other things, the Tribunal held that her failure to tell the truth at the hearing was further evidence of her lack of insight.

Mrs Justice Collins Rice emphasised that all cases are fact-sensitive. She reviewed a number of recent cases. On the one hand, there is a duty to protect the public from practitioners who cannot accept or dealing with findings of fault. On the other hand, the Tribunal has to ensure the practitioner has a fair hearing and apply legal principles correctly when properly assessing the evidence. The judge gave guidance that tribunals should look at:

  1. whether the primary allegation involves dishonesty, such as deceit, fraud or dishonesty (or a deliberate or knowing state of mind). “A rejected defence of dishonesty may be more fairly relevant to an overall assessment of conduct” in such cases. The position may be different when the registrant has done something that is not itself dishonest, but does it in a dishonest way.

 

  1. what, if anything, the registrant is positively denying. There is a difference between denying primary facts and denying secondary facts – looking at what the registrant did or did not do, as distinct from denying secondary facts and making an evaluation of what the registrant knew or thought and the choices available to them.

 

 “Resistance to the objectively verifiable is potentially more problematic behaviour (and more relevant to sanction) than insistence on an honest subjective perspective…If a [registrant] denies their state of mind with a defence at the unreal, unreasonable or ‘frankly ludicrous’ end of the           spectrum, that may be more fairly relevant to sanction than one where the only thing being denied is that dishonesty rather than honest mistake gives the better account of things.”

 

  1. Whether there is evidence of lack of insight other than the rejected defence.

 

  1. The nature and quality of the rejected defence. Not telling the truth to the tribunal, must be more than a failure to admit an allegation, especially when the allegation is not one of primary dishonesty, but of something that was done dishonestly.

 

“It is likely to have to amount to more than offering an ‘honest’ alternative explanation of events alleged to be explicable as dishonesty.”

For example, was the defence a blatant and manufactured lie, a genuine act of dishonesty, deceit or misconduct in its own right? Did it wrongly implicate and blame others or brand witnesses as deluded or liars, or just a failed attempt to tell the story in a better light than eventually proved warranted.

Mrs Justice Collins Rice observed that before a tribunal can be making fair use of a rejected defence to aggravate sanctions, it needs to remind itself that registrants are properly and fairly entitled to defend themselves.

Dr Sawati had not done things that were of themselves dishonest, but she had been found guilty of doing things in a dishonest way. She had admitted the actions underlying the allegations but denied that her actions were dishonest.

The judge also found that the tribunal had not properly assessed the seriousness of each act of dishonesty they found.

“Dishonesty – of any sort whatever – is unquestionably at least a yellow card issue for a doctor. But whether it is a red card issue in any case is a matter for the Tribunal to evaluate. Erasure for dishonesty is not automatic, so it is not exempt from the general requirement to assess the seriousness of misconduct in every case before a sanction is imposed. The nature and extent of dishonesty may be variable, and must be evaluated on a case by case basis.”

 

The workplace stress and panicked responses by Dr Sawati did not excuse dishonesty, but was potentially relevant to its seriousness. The judge held that “The incidents all had the quality of improvised and unsophisticated fibs under pressure.”

The judge allowed the appeal against sanction and remitted the case to a differently constituted tribunal.

Are pharmacy owners liable for the negligence of self-employed locums?

Posted: Tuesday, February 15th, 2022

In Hughes v Rattan [2022] EWCA Civ 107, the Court of Appeal has ruled on the liability of the owner of a dental practice when dental associates negligently cause injury to a patient. The status of self-employed dental associates bears similarities to the status of locum pharmacists.

The Court was asked to rule whether the owner of a dental practice had a non-delegable duty of care to patients, so that breach of the duty of care by an associate was to be treated as if the owner had been negligent. The court was also asked to rule whether the owner of a dental practice was vicariously liable for the negligence of dental associates who worked there.

Non-delegable duty of care

The holders of NHS dental contracts are expressly allowed to sub-contract their obligations under the contract or to employ or engage other dentists to carry out dental treatment. In the leading case on non-delegable duty of care, Woodland v Swimming Teachers Association [2013] UKSC 66, there was no employer who could be held vicariously liable and the Supreme Court had held that there were certain types of case where, even though an activity may be delegable, its delegation made no difference to the legal responsibility for the performance of the activity. A non-delegable duty arises because of a special relationship between a claimant and the alleged tortfeasor. A particular example given in the cases is where the claimant is a patient. The point has been argued in claims against hospitals. The non-delegable duty in these cases is a positive duty to protect the patient from injury, not simply to avoid acting in a way that foreseeably causes injury. It involves cases where there is an element of control over the patient.

Vicarious liability

The Court of Appeal’s decision on vicarious liability may surprise some readers. The first instance judge had held that the owner of a dental practice was vicariously liable for the negligent acts or omissions of dental associates. The Court of Appeal overruled this decision. It looked at the Supreme Court decision in Barclays Bank plc v Various Claimants [2020] UKSC 13 (see PLEA News, 6 April 2021) and sought to apply the test of whether the tortfeasor was “in a relationship akin to employment with the defendant”. Amongst other things, the Court of Appeal took into account:

These features are also common to many arrangements between pharmacy owners and locum pharmacists. Indeed, they are criteria commonly used to determine whether locums are correctly treated as self-employed. If not, HMRC may claim that the locums are, in reality, employees. The approach of the Court of Appeal seems to have been not whether the relationship between owner and dental associates was “akin to employment” but whether the law would designate the dental associates as employees or self-employed – and, if self-employed – the owner would not be vicariously liable.

Strictly speaking, the Court of Appeal’s view on vicarious liability in Rattan was obiter because the court’s principal decision was that there was a non-delegable duty of care and a further ruling on vicarious liability was not strictly necessary. If the decision in Rattan were to be followed in a case of a negligent locum pharmacist, it seems possible that the owner of a pharmacy who has not been negligent may be held to owe a non-delegable duty of care to a patient who is injured as a result of negligence by a locum pharmacist. However, the position is uncertain because the cases in which the existence of a non-delegable duty of care has been argued have been brought against hospitals on the basis that the hospitals had undertaken to care for their patients. In the Rattan case, the Court of Appeal left open the question whether the non-delegable duty of care applied only to the treatment of a patient or whether it would also extend to negligent advice. The Rattan decision gives rise to uncertainty that a pharmacy owner may be held not to owe a non-delegable duty of care when a locum pharmacist is negligent, and may not be vicariously liable for the locum’s negligence either.

 

GPhC fails two out of five PSA FtP Standards

Posted: Tuesday, February 8th, 2022

The Professional Standards Authority has just published its review of the General Pharmaceutical Council’s performance for the period 1 March 2020 to 28 February 2022. The full report is here https://www.professionalstandards.org.uk/docs/default-source/publications/performance-reviews/performance-review-gphc-2020-21.pdf?sfvrsn=b32d4820_6

You may remember that we have reported in previous years on deficiencies found by the PSA. In the year under review, the GPhC was found to have met all standards in all areas except (again) Fitness to Practise where only two out of five standards were met.

Criticisms of GPhC rejected

Amongst other things, the PSA rejected criticisms of the GPhC’s statement on profiteering during the pandemic and rejected criticisms of the GPhC’s advice not to sell rapid antibody tests because, the PSA found) the GPhC was following the guidance at the time and its actions were directly relevant to its role in protecting the public.

Triage processes

Many of the PSA’s concern about Fitness to Practise centred on the GPhC’s triage process. Owing to the PSA’s significant queries about the robustness of the GPhC’s triage process in previous years, the PSA conducted a targeted review because it wanted to understand if the high proportion of cases closed at triage and low proportion of decisions made by the Investigating Committee indicated that cases were closed sooner than was appropriate.

The PSA’s audit allayed concern that cases were being closed inappropriately, but inconsistencies were found between the GPhC’s internal guidance on triaging cases and what happened in practice. This meant that different thresholds may be applied to triage decisions. This is not transparent and does not appear to support a consistent understanding of what factors can or should be considered when making triage decisions.

Reasons for triage decisions were not recorded in 40% of the triage decisions that were examined. This resulted in a lack of transparency, leaving uncertainty about consistency in decision-making.

The PSA considered that most outcomes were reasonable, but some decisions were based on flawed reasoning.

Threshold criteria

The GPhC applies threshold criteria to decide whether to refer a case to the Investigating Committee. In just over half of the cases examined by the PSA, the reasons for the decision were not always fully and accurately recorded or they were flawed in some way. For example, in some cases it was recorded that there was a lack of evidence when there was a conflict of evidence.

Communication with parties

Communication with parties remains a problem. Parties are still not routinely updated on the investigation and not always notified of the outcome of their cases.

Delays

The time taken for the GPhC to progress cases had been identified as an issue in previous years and the GPhC had adopted an action plan to address this. Despite the action plan, the time period was deteriorating before the pandemic, and timeliness declined again in 2020/21. The PSA concluded that it did not know whether it would have seen improvements in timeliness had it not been for the pandemic and noted that the deterioration in timeliness is significant with some timeframes increasing by nearly 20 weeks or more.

Cases where there is a serious risk to the safety of patients or service users

The PSA was satisfied that the GPhC met its standard in relation to cases where there was a serious risk to the safety of patients or service users. However, it noted that there was a delay in applying for an interim order, such as a suspension, in one case because the recommendation for an application was missed. In another case, an interim order lapsed because it was not reviewed in time. In two linked cases we have previously reported on, the High Court refused an application to extend the interim order because of delays by the GPhC.

Misuse of confidential information and vicarious liabilit

Posted: Wednesday, February 2nd, 2022

In News exactly one year ago today, we reported on the Supreme Court decision in Various Claimants v Wm Morrison Supermarkets plc [2020] UKSC 12. An employee of the supermarket business had published the confidential information of numerous fellow employees who sought to hold Morrisons vicariously liable.  The Supreme Court dismissed the claims.

The High Court has now considered the application of the Supreme Court’s decision in a health and social care setting.

In Ali v Luton Borough Council [2022] EWHC 132, the Claimant’s marriage had run into difficulties. There were two children and the marital problems led to the Defendant’s social services department becoming involved. The Claimant made a complaint to the police about the conduct of her husband and this led to a multi-agency referral by the police to the Council. A few weeks later, the Claimant began to suspect that information relating to her had been leaked. Her family and friends began asking her questions about why she had involved the police. When the Claimant asked about the source of their information, it emerged that her husband was saying that he had been told by an individual who worked for the Council whom he was seeing.

The Council instigated a data audit which revealed that an employee with whom the husband had a relationship had accessed the Claimant’s file held by the Council, including data of a highly sensitive nature. It also became apparent that the employee had provided the husband with pictures of the information and quotes of conversations held by Social Services. The husband had shown people these records. The employee was convicted of an offence under section 1 of the Computer Misuse Act 1990 and sentenced to 3 months’ imprisonment, suspended for 12 months, and ordered to carry out 150 hours of community service. The sentencing judge described the employee’s conduct as “deliberate, planned and goes against every professional code of conduct…and put the family at risk of harm.”

The Claimant brought a claim against Luton Borough Council on the basis that it was vicariously liable for the acts of its employee. The case came before Mr Richard Spearman QC, sitting as a Judge of the Queen’s Bench Division dismissed the claim. He found that the employee had been properly trained on GDPR and data protection, and there was nothing the Council could have done differently to have prevented what its employee did. In terms of vicarious liability, the Supreme Court had held in the Morrisons case that to establish liability “…the wrongful conduct must be so closely connected with the acts the employee was authorised to do that, for the purposes of the liability of the employer to third parties, it may fairly and properly be regarded as done by the employee while acting in the ordinary course of his employment.” The Claimant argued that the fundamental question was whether the wrongful act was sufficiently related to conduct authorised by the employer to justify the imposition of vicarious liability; and that the Council’s functions had afforded the employee to abuse her power. However, the judge rejected these submissions, holding that:

“Although [the employee] gained the opportunity to access and process data relating to the Claimant (and the children) by reason of the unrestricted access to the [Council’s software] system which she was required to be afforded in order to perform her role as a contact centre worker, it formed no part of any work which she was engaged by the Defendant to do to access or process those particular records.

In doing what she did, [the employee] was engaged solely in pursuing her own agenda, namely divulging information to the Claimant’s husband with whom she had some relationship. Further, that was to the detriment of the Claimant (and the children) whose safety and interests as users of the Defendant’s services it formed part of [the employee’s] core duty to further and protect.”

The employee had:

“not been tasked in any shape or form with either accessing or disseminating the information in question…[Her] wrongful conduct was not so closely connected with acts which she was authorised to do that, for the purposes of the Defendant’s liability to third parties, it can fairly and properly be regarded as done by her while acting in the ordinary course of her employment.”

Using terminology from early case law on vicarious liability, the judge held that this was a classic case of the employee being on a “frolic of her own”.

GPhC consultation on remote hearings

Posted: Wednesday, January 26th, 2022

The GPhC is currently (until 8 February 2022) consulting on a proposal to allow Fitness to Practise hearings to be held remotely, extending indefinitely an arrangement that was introduced on an time-limited basis during the pandemic. A response to the consultation has been submitted on behalf of PLEA. The consultation paper is here https://www.pharmacyregulation.org/get-involved/consultations/remote-hearings-consultation 

You can read our response here ADMIN/uploads/PLEA consultation GPhC remote hearings Jan 22 formatted (002).pdf

In short, we have concluded that remote hearings should only take place if the registrant consents, unless the registrant has failed to engage with the Fitness to Practise process. The key advantages of remote hearings are time and cost savings. Fitness to Practise Committees make life-altering decisions and unless the registrant consents to a remote hearing, the advantages of of a remote hearing are outweighed by the disadvantages.

Fitness to practise, interim orders and freedom of expression

Posted: Sunday, December 5th, 2021

In Dr Samuel White v General Medical Council [2021] EWHC 3286 (Admin), the High Court considered an interim order that curtailed freedom of expression, following the posting of views on social media, including a seven-minute video on Instagram. Although healthcare fitness to practise tribunals have considered numerous cases involving social media, this appears to be a rare case in which an interim order was sought and the Court found that different considerations apply to interim order applications where an order is sought that would curtail freedom of expression. The judge also commented on how allegations in such cases should be framed.

Dr White was alleged to have posted misinformation on social media platforms about the Covid-19 virus, vaccinations and PCR testing and to have encouraged people not to wear masks or take the vaccine

An Interim Orders Tribunal considered that:

 

 

The Tribunal concluded:

 

 

The Tribunal did not suspend Dr White from practising, but conditions restricting him to not posting or sharing his views on the Covid-19 pandemic and its associated aspects on any social media platforms and required previous posts to be removed.

Dr White sought a review of the Tribunal’s decision, relying amongst other things on Article 10 of the European Convention on Human Rights which deals with freedom of expression. The Convention was incorporated into law in the UK by the Human Rights Act 1998.

The GMC submitted that freedom of expression under Article 10 is a qualified right and one of the qualifications specifically identified within the Article is the legitimate aim of pursuing public safety and the protection of health.

Dr White relied on section 12 of the Human Rights Act which provides that no relief is to be granted so as to restrain publication before trial unless the court or tribunal is satisfied that the applicant is likely to establish that publication should not be allowed.

Mr Justice Dove held that the effect of section 12 is that although a tribunal dealing with an application for an interim order would not normally make findings of fact in relation to the allegations made by the regulator, the Tribunal did have to decide whether the regulator is likely to establish at a final hearing that publication should not be allowed, or normally that success at a final hearing must be shown to be more likely than not.

Mr Justice Dove held that the Tribunal had not directed itself to the tests required by section 12 (its decision had not mentioned section 12 of the Human Rights Act). This was an error of law and a clear misdirection in the Tribunal’s decision-making process. It followed that the Tribunal’s decision was clearly wrong and could not stand.

The GMC asked the judge to make his own assessment under section 12, but he held that the court did not have power to do so. It remained open to the GMC to make a fresh application to an Interim Orders Tribunal.

Finally, the judge expressed the view that if an interim order is sought that would have the effect of curtailing freedom of expression, in order to be proportionate, it is likely to need to be specific as to what views or opinions the person subject to the order is precluded from expressing.  

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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.