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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 articles

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

PPE litigation

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.

 

 

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:

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:

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.

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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.