VAT change for medicines prescribed by EEA health professionals
Posted: Friday, July 3rd, 2020
Medicines prescribed by medical practitioners are zero-rated, but only if the prescriber is registered with the General Medical Council. Although it has for some time been lawful for prescriptions written by doctors registered in EEA countries to be dispensed in the UK, the medicines dispensed have not been zero-rated. The distinction seems arbitrary and has led to large claims for VAT for some UK pharmacies, mainly ones providing online services. In 2016, Pearl Chemist received a demand for £156,782.41. They unsuccessfully challenged the lawfulness of the restriction of zero-rating for supplies prescribed by doctors not on the GMC register - Pearl Chemist v Revenue and Customs Commissioners  UKFTT 264.
HMRC have just published an amended notice on zero-rating https://www.gov.uk/guidance/health-professionals-pharmaceutical-products-and-vat-notice-70157 adding EEA health professionals to the list of practitioners who can prescribe zero-rated medicines.
COVID life assurance, Amazon, vaping & medical devices
Posted: Wednesday, July 1st, 2020
Recent published articles by our members include:
- Andrea James in Chemist & Druggist on the criteria for COVID-19 life assurance eligibility https://www.chemistanddruggist.co.uk/opinion/what-criteria-60000-covid-19-life-assurance-payout
- Noel Wardle (with Peter Byrd) in Chemist & Druggist on the legal implications of Amazon’s applications for trademarks for “Amazon Pharmacy” https://www.chemistanddruggist.co.uk/opinion/possible-next-steps-amazon-pharmacy
- David Reissner in Chemist & Druggist on the difference between lawful and unlawful COVID-19 tests, and the CE marking of medical devices https://www.chemistanddruggist.co.uk/opinion/legal-view-difference-between-lawful-and-unlawful-covid-19-tests
- Susan Hunneyball’s article on vaping in P3, now available on the Gordons Partnership website https://www.gordonsols.co.uk/vaping/
- The Charles Russell Speechlys Pharmacy Brief https://communications.crsblaw.com/17/2268/uploads/pharmacy-brief---june-2020.pdf
GPhC and CMA complain of profiteering
Posted: Tuesday, June 30th, 2020
The General Pharmaceutical Council and the Competition & Markets Authority have issued a joint letter about profiteering during the COVID-19 pandemic https://www.pharmacyregulation.org/sites/default/files/document/cma_and_gphc_joint_letter_june_2020_v2.pdf .
The two bodies say they have received reports alleging that a small minority of pharmacies are seeking to benefit from the coronavirus pandemic by charging unjustifiably high prices for essential products – including hand sanitiser, face masks and paracetamol.
The CMA recognises that pharmacies may be facing higher operational costs at this time and may be paying higher prices to wholesalers for high-demand products but asserts that these do not justify a pharmacy owner increasing its own percentage mark-up on the wholesale price. The CMA considers that higher costs justify the disproportionate increasing of mark-ups on essential products unless the additional costs specifically relate to those products.
The CMA says it has launched investigations into four retailers, including pharmacies, which it suspects have charged excessive and unfair prices for hand sanitiser products.
The GPhC says it has written to a number of registered pharmacies and, in some cases, they have asked the pharmacy to review the price they are charging for a particular item.
Cannabis-based Epidyolex to be added as Schedule 5 CD
Posted: Friday, June 5th, 2020
The Misuse of Drugs Regulations were amended with effect from 1 November 2018 to allow cannabis-based products for medicinal use in humans to be prescribed by clinicians on the GMC’s specialist register (or doctors acting under their direction).
Epidyolex is a cannabis-based medicine licensed for the treatment of rare forms of epilepsy. It had been granted a marketing authorisation in September 2019. The Advisory Committee on the Misuse of Drugs advised the Secretary of State that because THC is present in Epidyolex only as an impurity and as it has a low risk of abuse potential, low risk of dependency and low risk of diversion, it should be placed in Schedule 5 to the Misuse of Drugs Regulations 2001.
The Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2020 have been laid before Parliament and will come into force on 24 June 2020. These Regulations amend the Misuse of Drugs Regulations by adding Epidyolex to Schedule 5 – products exempt from importation.
Dishonesty, entrapment and fitness to practise cases
Posted: Friday, June 5th, 2020
It isn’t easy to challenge a Supreme Court judgment, especially in a lower court, but that’s exactly what the defendant in a recent criminal case tried to do. In R v Barton  EWCA Crim 575 the Court of Appeal was asked to ignore the Supreme Court’s ruling in Ivey v Genting Casinos (UK) Ltd  UKSC 67. In Ivey v Genting, the Supreme Court had overturned the legal definition of dishonest that had been used since 1982, replacing it with an objective test based on whether the defendant’s actions were dishonest according to the standards of ordinary decent people. However, Ivey v Genting was a case about cheating in a casino and not about the test of dishonesty. The defendant in R v Barton therefore argued that the Ivey decision was not binding and that the courts should continue to follow the law as it had been since 1982.
Unsurprisingly, the defendant in Barton was unsuccessful. The courts have been following Ivey v Genting, and so have fitness to practise tribunals. This was reiterated in a recent case, Naqvi v Solicitors Regulation Authority  EWHC 1394 (Admin), in which a solicitor appealed against a striking off decision by the Solicitors Disciplinary Tribunal.
The facts have resonances for some pharmacy fitness to practise cases, a number of which in recent years have arisen from undercover reporting. In Mr Naqvi’s case, a television reporter was investigating bogus immigration applications based on sham marriages. The reporter, pretending to be a client, had carried out undercover interviews in which the solicitor said he would make applications knowing that the marriages in question were not genuine.
Amongst other things, the solicitor argued that the case against him should have been dismissed because he had been entrapped. The Court drew a parallel with the decision in The Council for the Regulation of Healthcare Professionals v General Medical Council and Saluja  EWHC 2784 (Admin) concerning a doctor who had offered in return for payment to provide a fake sick note to a journalist posing as a patient. In that case, the judge had rejected the argument that for a journalist to go into a doctor's surgery and pretend to be a patient is similar to abuse of power by an agent of the state. Cases of entrapment of the kind that sometimes involve undercover police officers were different to proceedings brought against a doctor by his regulator in order to protect the public, uphold professional standards and maintain confidence in the profession.
In the Naqvi case, the solicitor argued that he should not have been found to have been dishonest because, based on the subjective 1982 test of dishonesty, he had not appreciated that what he had done was dishonest. The court rejected this argument, holding that once his actual state of knowledge is established, the question whether his conduct was honest or dishonest is to be determined by applying the (objective) standards of ordinary decent people.
The solicitor also argued that he did not have knowledge that the marriages in question were a sham: the most he had done was turn a blind eye. The court rejected this argument, too. Blind-eye knowledge could be the basis of a finding of dishonesty.
Lexon to appeal against nortriptyline fine imposed by CMA
Posted: Tuesday, June 2nd, 2020
The pharmacy press has reported that Lexon intend to appeal to the Competition Appeal Tribunal against a financial penalty imposed by the Competition and Markets Authority (CMA) in early March.
The CMA found that King Pharmaceuticals Ltd and Auden Mckenzie (Pharma Division) Ltd shared out between them the supply of the antidepressant drug, nortriptyline, to a large pharmaceutical wholesaler in 2014 and 2015. The two companies agreed that King would supply only 25mg tablets and Auden Mckenzie only 10mg tablets. They also colluded to fix quantities and prices. King and Auden Mckenzie admitted breaching competition law and were respectively fined £75,573 and £1,882,238. Accord-UK (which had taken control of Auden-Mckenzie’s nortriptyline business) and Auden McKenzie agreed to make a £1m payment to the NHS.
The CMA also fined King, Lexon (UK) Ltd and Alissa Healthcare Research Ltd for illegally sharing commercially sensitive information to try to keep nortriptyline prices up when the cost of the drug was falling between 2015 and 2017. King and Alissa admitted breaking the law and were fined £75,573 and £174,912 respectively. Lexon did not admit to breaking the law and were fined £1,220,383.
COVID-19 and advertising complaints & latest articles
Posted: Thursday, May 14th, 2020
COVID-19 advertising infringements
The Advertising Standards Authority has upheld a complaint against PCK Skin (Manchester) Ltd (who trade as SkinspaceUK), an aesthetic clinic. SkinspaceUK sent a promotional email with the subject line “40% off! In the fight against viruses”. Text in the body of the email stated “Its (sic) time to boost your immunity! In the fight against viruses! Book in for your vitamin D & B12 shots! Supports your immune system, lung function and aids faster recovery from illness and viruses!”
Skinspace sought to justify the advert, but the ASA held that all licensed forms of injectable vitamin D and vitamin B12 were Prescription Only Medicines and the promotion of POMs to the general public breached the Code.
In addition, the ASA ruled that references to viruses were likely to give consumers the impression that the injections being sold were effective in helping to prevent or treat coronavirus/COVID-19 even though Vitamin D and Vitamin B12 were not indicated for the prevention of coronavirus/COVID-19.
Skinspace were told that the advert must not appear again.
In a separate case, the ASA upheld a complaint about a poster ad and a website ad for The Chuckling Goat, a food products provider. The poster ad, seen on buses in Reading town centre and in Yorkshire featured an image of a goat and the claim, “The Gut Health Experts”. Larger text stated “What’s your best defence against any virus? Boost your immune system” followed by “Quick and free – Live gut health advice” and a web link. The website featured pages titled “The Flu” and “Viruses”, referring to boosting gut health and products said to be suitable for people who wish to improve their gut health in order to boost immunity, such as “Probiotic Goats Milk Kefir”, “Complete Prebiotic” and “CG oil”.
The Advertising Standards Code held that claims which stated or implied a food could prevent, treat or cure human disease are prohibited. The advertiser was told to ensure that future ads did not repeat the breach.
Recent published articles by our members include:
Susan Hunneyball’s Chemist & Druggist blog on the legal requirements for getting a COVID-19 vaccine on the market https://www.chemistanddruggist.co.uk/opinion/legal-view-challenges-pharmacists-delivering-covid-19-vaccines.
David Reissner’s Chemist & Druggist blog on legal challenges to the Government over PPE guidance and availability https://www.chemistanddruggist.co.uk/opinion/-government-facing-legal-challenge-over-ppe-supply
PPE litigation, confidential patient information, and re-use of medicines
Posted: Tuesday, May 12th, 2020
Sky News https://news.sky.com/story/coronavirus-doctors-launch-legal-action-over-governments-ppe-guidance-11977869 and the BBC https://www.bbc.co.uk/news/uk-england-beds-bucks-herts-52411814 have reported that two doctors are launching legal action against the government's advice over personal protective equipment (PPE). Meenal Viz and Nishant Joshi, who are married and expecting a baby, have been exposed to patients with COVID-19. They claim that current PPE guidance and availability is inadequate to protect them from infection; and that the Government is failing in its duty to protect health workers.
Public Health England, which responded to the legal action on behalf of the government, said UK government guidance was consistent with advice given by World Health Organisation; and that the UK guidance, written with NHS leaders and agreed by all four Chief Medical Officers, in consultation with royal and medical colleges, recommends the safest level of PPE.
On 9 May, the same solicitors who act for Dr Viz and Dr Joshi wrote to the Secretary of State for Health on behalf of the Doctors Association UK (who represent NHS doctors); and the Good Law Project (who unsuccessfully challenged the lawfulness of serious shortage protocols) under the judicial review protocol. They demanded an independent public inquiry under the Human Rights Act 1998 and Article 2 of the European Convention on Human Rights – the right to life – referring to a requirement promptly to investigate the deaths of NHS staff and care workers caused by COVID-19. The letter says that “the Secretary of State and other public bodies (notably Public Health England and relevant NHS bodies) owe a positive duty to have adequate systems in place to protect the lives of NHS staff and other care workers”. Specifically, they say that Article 2 “requires relevant public authorities to procure and supply adequate equipment – including PPE – for hospital, NHS and other care staff in advance of any relevant incident, in so far as the need for such equipment can reasonably be anticipated.”
The letter seeks a response from the Secretary of State by 25 May 2020.
Confidential patient information to be disclosed
The Health Service (Control of Patient Information) Regulations 2002 gave the Secretary of State for Health power to give notice to any body or person, requiring that body or person to disclose confidential patient information with a view to controlling, preventing monitoring and managing the spread of communicable disease. The Secretary of State has now written to organisations providing health services, General Practices, Local Authorities and Arm’s Length Bodies of the Department of Health and Social Care https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/874509/Coronavirus__COVID-19____notice_under_regulation_3_4__of_the_Health_Service_Control_of_Patient_Information_Regulations_2002.pdf saying that they must disclose confidential patient information.
Re-use of medicines
Our member, Susan Hunneyball, has written an article in P3 on government guidance on the reuse of medicines during the pandemic https://www.p3pharmacy.co.uk/applying-reuse-guidance
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.
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.