COVID-19 legal updates
Posted: Monday, May 11th, 2020
Unlawful COVID-19 testing kits
Chemist & Druggist has reported https://www.chemistanddruggist.co.uk/news/seven-online-pharmacies-received-gphc-warning-over-covid-19-tests that the GPhC has written to 7 pharmacies to request they remove illegal COVID-19 testing kits from sale. Home test kits are not lawful because none of them has a CE mark. Last month, the National Crime Agency arrested a Croydon pharmacist on suspicion of illegally selling coronavirus testing kits https://nationalcrimeagency.gov.uk/news/pharmacist-and-surveyor-arrested-over-coronavirus-testing-kits-thousands-of-pounds-seized-and-website-taken-down
Suspension of market entry applications in England
We reported recently the news that NHS England had suspended the handling of market entry applications. The PSNC has published clarification of the suspension https://psnc.org.uk/our-news/market-entry-suspension-clarified/
Deliveries by volunteers
Our member Noel Wardle has an opinion column in Pharmacy Network News https://www.pharmacynetworknews.com/opinion-risks-volunteers-delivery on the risks of using volunteers for to deliver medicines.
Fitness to Practise proceedings during lockdown
Noel has also published a blog on Fitness to Practise proceedings in lockdown. You can read it here https://www.charlesrussellspeechlys.com/en/news-and-insights/insights/healthcare/2020/fitness-to-practise-hearings-under-lockdown/
Misuse of Drugs Regulations amended during COVID-19 pandemic
Posted: Thursday, April 30th, 2020
The Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020 came into force today. The Regulations amend the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’) in order to allow pharmacists at a registered pharmacy business to supply, in a pandemic situation, medicines without a prescription, where the patient has been receiving a Schedules 2 or 3 or Part 1 of Schedule 4 controlled drug as part of ongoing treatment, and to supply Schedules 2 or 3 or Part 1 Schedule 4 controlled drugs under a Serious Shortage Protocol. The amendments also allow pharmacists, in a pandemic situation, to change the intervals on instalment prescriptions for Schedules 2 and 3 controlled drugs without the immediate need for a new prescription from an authorised prescriber under the 2001 Regulations provided this is agreed with the prescriber or their appointed representative.
The powers given to pharmacists will come into play if the Secretary of State makes an announcement setting out —
(i) in the area to which the announcement relates,
(ii) in the particular circumstances specified in the announcement, and
(iii) the period specified during which the powers can be used.
CMA report on profiteering, PPE judicial review and other COVID-19 legal and ethical news
Posted: Monday, April 27th, 2020
The Competition & Markets Authority (CMA) sent a letter to trade bodies in the food and pharmaceutical industries at the end of March, and set up a COVID-19 Taskforce to identify, monitor and respond to competition and consumer problems arising from coronavirus and the measures taken to contain it.
The CMA has just published a report from the Taskforce https://www.gov.uk/government/publications/protecting-consumers-during-the-coronavirus-covid-19-pandemic-update-on-the-work-of-the-cmas-taskforce/protecting-consumers-during-the-coronavirus-covid-19-pandemic-update-on-the-work-of-the-cmas-taskforce. The taskforce reports that:
- a large proportion of complaints it initially received related to price rises, particularly for personal hygiene goods such as hand sanitiser.
- Over time, however, there has been a decline in complaints about prices.
- The profile of price increase complaints has remained relatively stable over time, with food and drink fluctuating above hygiene and personal care.
- Medication complaints have hovered around 4-8%, with the exception of a peak on 9 April which reflects a spike in complaints about paracetamol and ibuprofen.
Also of interest, especially to pharmacists on the front line, will be the news that two doctors are bringing judicial review proceedings, challenging the guidance on the use of PPE https://www.bbc.co.uk/news/uk-england-beds-bucks-herts-52411814
Some of our members have published articles on COVID-related issues including:
- Andrea James' blog in Chemist & Druggist on the potential for claims arisng from the use of volunteers https://www.chemistanddruggist.co.uk/opinion/pharmacies-are-unfairly-risk-nhs-volunteers-delivering-drugs
- Rachel Warren's Chemist & Druggist blog on the duty of pharmacy owners to acquire PPE for their employees https://www.chemistanddruggist.co.uk/opinion/legal-view-contractors-health-safety-staff-ppe-masks
- David Reissner's Pharmacy Business column, commenting on ethical issues arisning during the pandemic https://www.pharmacy.biz/exclusive-no-single-right-or-wrong-answer-pharmacy-law-experts-tips-on-ethical-questions/
Regulatory questions during the pandemic and health & safety obligations of employers
Posted: Thursday, April 16th, 2020
The Covid-19 pandemic has been likened to a war, which brings to mind the words of one of our greatest twentieth century judges, Lord Atkin (who may be remembered for giving the leading judgment in Donaghue v Stevenson, the snail in the ginger beer bottle case). In a famous dissenting judgment in Liversidge v Anderson in 1942, Lord Atkin said “amid the clash of arms, the laws are not silent”.
Our member, Noel Wardle, answered a number of questions about regulatory issues during the pandemic in a recent Pharmacy Business article https://www.pharmacy.biz/digitaledition/from-a-regulatory-perspective/ including whether pharmacies can supply POMs in place of out of stock over-the-counter medicines, whether P medicines can be supplied off-label and whether the exceptional circumstances would be taken into account if a superintendent pharmacist makes a mistake.
In the latest Charles Russell Speechlys Pharmacy Brief https://www.charlesrussellspeechlys.com/en/news-and-insights/insights/healthcare/2020/pharmacy-brief---march-2020 Noel answers further questions, including what steps employers should take during the pandemic.
Our member, Rachel Warren, has published a blog https://blog.charlesrussellspeechlys.com/post/102g48i/covid-19-employers-must-still-comply-with-health-and-safety-obligations pointing out that employers must still comply with health and safety obligations during the pandemic.
Responsibility for volunteers - joint GPhC and RPS statement
Posted: Thursday, April 16th, 2020
The General Pharmaceutical Council and the Royal Pharmaceutical Society have issued a joint statement on the responsibility of pharmacy professionals for volunteers who deliver medicines during the Covid-19 pandemic - https://www.pharmacyregulation.org/news/joint-statement-rps-and-gphc-use-nhs-volunteers-deliver-medicines-england?utm_campaign=nhs-volunteers-joint-statement&utm_source=twitter&utm_medium=social
Specifically, the statement says:
"Pharmacy professionals acting in accordance with the standards and using NHS Volunteer Responders in good faith in line with the service specifications of the Pandemic Delivery Service
will not be regarded as responsible for actions of other people outside of their control."
The statement has prompted some discussion on Twitter because, taken at its face value, the statement might be understood to mean that if a volunteer was negligent or committed some other tort, a pharmacy professional would not be held liable to compensate an injured party. The question of any such laibility is a matter of law for the courts to determine on the facts of any given case, so despite the broad wording, the joint statement is best regarded as limited to questions of professional conduct and fitness to practise.
New services, volunteers and profiteering - recently-published members' articles
Posted: Wednesday, April 15th, 2020
A number of our members have had articles published recently, including -
Andrea James' detailed overview of new commissioned services in community pharmacy http://insights.brabners.com/post/102g4qw/new-essential-advanced-services-for-community-pharmacy
David Reissner's Chemist & Druggist blog on how pharmacies should deal with volunteers https://www.chemistanddruggist.co.uk/opinion/-declaration-nhs-medicines-delivery-volunteers-sign
Susan Hunneyball's Chemist & Druggist blog on profiteering during the Covid-19 pandemic https://www.chemistanddruggist.co.uk/opinion/profiteering-from-hand-sanitiser-could-lead-to-sanctions
David Reissner's Pharmacy Business column on potential liabilities for volunteers https://www.pharmacy.biz/volunteers-delivering-medicines-is-fraught-with-risks-says-senior-pharmacy-solicitor/
CJEU holds that paroxetine settlement agreement was anti-competitive
Posted: Monday, April 13th, 2020
The Court of Justice of the European Union (CJEU) has struck down as anti-competitive an agreement not to put generic paroxetine on the market.
In Generics (UK) Ltd v Competition and Markets Authority (Case C-307/18), the CJEU examined an agreement to settle patent litigation between GlaxoSmithKline, the original manufacturer of the antidepressant paroxetine, and a number of generics manufacturers. Under the terms of settlement, the generics manufacturers undertook not to put generic versions on the market for a specified period. In return, it was agreed that they would receive significant transfers of value.
The CMA had imposed fines of £45m on the companies involved.
In considering whether competition rules had been breached, the CJEU drew a distinction between whether the restriction on competition was the object of the agreement or the effect of the agreement. If it was the object, there was no need to investigate further and the agreement would be struck down. If the restriction was the effect of an agreement, it would be necessary to determine whether an agreement “displayed a sufficient degree of harm to competition”.
In the present case, involving an agreement by the patent holder to make a significant transfer of value to its competitors, the sole consideration for which was their undertaking not to enter the market and to end their challenge to the validity of the patent for paroxetine, restriction on competition was the object of the agreement.
When do convictions for violence merit striking off in fitness to practise cases?
Posted: Monday, April 13th, 2020
It is extremely unusual for a pharmacy fitness to practise case to reach the highest court, so the 2016 case of Khan v General Pharmaceutical Council  UKSC 64 is a rarity. The result of the appeal against the sanction of striking off mayhave surprised at least some of our members. Khan had been convicted of offences involving serious domestic violence including threats to kill, and the GPhC’s Fitness to Practise Committee directed the removal of his name from the register.
The Supreme Court, noted that the offences “did not relate to [Khan’s] professional performance. No patient had been, or was likely to be, put at risk” and considered that the sanction of removal was disproportionate. The Court observed that the Fitness to Practise Committee should have taken into account Khan’s (a) no prior disciplinary history; (b) genuine insight into misconduct; (c) open admissions at an early stage; (d) no actual or potential harm to patients or the public; (e) genuine expression of remorse to committee; and (f) steps taken to prevent recurrence. The Supreme Court held that the appropriate sanction was a 12-month suspension.
Last week’s judgment of Mr Justice Murray in General Medical Council v Saeed  EWHC 830 (Admin) is an interesting contrast to the Khan case. Dr Saeed had been convicted of offences of Controlling and Coercive Behaviour and Assault Occasioning Actual Harm committed against his wife. A prison sentence was imposed, suspended for two years. The Medical Practitioner Tribunal (MPT) imposed a 12-month suspension. The GMC appealed to the High Court against the suspension, arguing that it was unduly lenient. The GMC is one of the few healthcare regulators to have such a right of appeal, and the GMC was criticised by many in the medical profession for exercising this right in the Bawa-Garba case[i] – indeed, the review conducted by a committee chaired by Professor Sir Norman Williams into gross negligence manslaughter after the Bawa-Garba case[ii] recommended that the GMC should lose its right of appeal.
Dr Saeed did not attend the MPT hearing but sent a bundle of documents with a four-page statement in which he acknowledged that his conviction impaired his fitness to practise because of its effect on public confidence in the profession. He recognised that any abuse and aggression, physical or emotional affected public confidence, though he did not admit the allegations leading to his conviction. He had undergone counselling on relationships with a clinical psychologist and provided a certificate to that effect. The MPT found that although Dr Saeed had not demonstrated significant insight, his statement showed he was” able to proactively identify and take steps in order to reflect on and begin to address his unacceptable behaviour.”
Dr Saeed did not attend the hearing of the GMC’s appeal in the High Court, but sent a bundle of documents for the judge to consider. According to the GMC’s indicative sanctions guidance, offences involving violence indicate that erasure from the medical register is appropriate. Mr Justice Murray found that the MPT decision was flawed because it did not explain why the Tribunal had departed from the indicative sanctions guidance and failed to identify the relevant mitigating factors that led to its decision and what weight it gave to each of those factors so as to justify a lesser sanction than erasure.
The GMC’s indicative sanctions guidance, reflecting the High Court decision in Council for the Regulation of Health Care Professionals v General Dental Council, Fleischmann[iii], says “As a general principle, where a doctor has been convicted of a serious criminal offence or offences, they should not be permitted to resume unrestricted practice until they have completed their sentence.”
The GMC’s appeal against the sanction of suspension was also successful because by the time of the MPT hearing Dr Saeed’s suspended sentence had not expired and the MPT had not provide sound reasons for departing from this aspect of the guidance.
The judge stopped short of finding that the only possible outcome was erasure, and sent the case back to the MPT to redetermine the sanction.
[i]  EWCA Civ 1879
[iii]  EWHC 87 (Admin)
Ethical guidance for pharmacists and pharmacy technicians during the Covid-19 pandemic
Posted: Thursday, April 9th, 2020
The Royal Pharmaceiutical Society has published guidance on ethical, professional decision-making during the Covid-19 pandemic. You can access the guidance here https://www.rpharms.com/resources/pharmacy-guides/coronavirus-covid-19/coronavirus-information-for-pharmacists-and-teams/ethical-decision-making . The working group that produced the guidance was chaired by our Vice Chair, Matthew Boyd. Other contriburtors included our members Prof Steve Howard and David Reissner.
Pharmacy market entry applications suspended
Posted: Monday, April 6th, 2020
Since 1987, market entry (sometimes called "control of entry") has been a significant aspect of the pharmacy regulatory scene, dealing with the grant or refusal of applications for inclusion in pharmaceutical lists - colloquiallly referred to as NHS pharmacy contracts. Despite an obligation to determine applications as soon as possible, there have often been delays in processing applications. Now, the Coronavirus has brought processing to a halt in England, with an announcement that the processing of applications has been suspended https://pcse.england.nhs.uk/services/market-entry/
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.