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Supreme Court judgment in Lyrica/Pregabalin case
Posted: Wednesday, November 14th, 2018
The Supreme Court has handed down its judgment https://www.supremecourt.uk/cases/docs/uksc-2016-0197-judgment.pdf in a dispute that affects the potential liability for community pharmacies when a drug patent is infringed.
In Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56, the claimant alleged that the launch of generic pregabalin infringed its patent for Lyrica. The Lyrica patent was originally granted to protect the use of the drug in the treatment of seizure disorders, notably epilepsy. However, Warner-Lambert were later granted a second patent for the treatment of neuropathic pain. The latter patent remained current after the patent for treating seizure orders had expired. If Warner-Lambert was right in asserting that the latter patent was valid, it would mean amongst other things that any pharmacy or pharmacist who supplied generic pregabalin to a patient who had a seizure disorder would have breached the patent and be liable for substantial damages or loss of profits, even if the pharmacist did not know the condition for which pregabalin had been prescribed.
The Supreme Court dismissed Warner-Lambert's appeal against rulings of the High Court and Court of Appeal. Amongst other things:
- The Supreme Court was very much alive to the risk that, as argued by Warner-Lambert, pharmacists who acted in good faith could be sued for large sums of money for unintentionally breaching a patent (see, eg paragraphs 63 and 65). The court also recognised that this risk would stifle the generics market and pharmacists would not be willing to supply the generic version if there was a risk of being sued.
- The justices gave different reasons (summarised in paragraph 15) for dismissing the appeal. Lord Sumption and Lord Reed were of the view that if the outward appearance (including packaging, labelling and patient information leaflet – see paragraph 84) was presented as suitable for the patented use, a pharmacist who dispensed it for a non-patented use (such as epilepsy in this case) would not be liable for patent infringement. Lord Mance agreed except to the extent that there might be a rare case in which the context made it obvious that the outward appearance should not be taken at face value.
- The result means that pharmacists are now less at risk of being sued for patent infringement, but there is still some risk if the outward appearance of a patented product suggested a use that was not a patented use.
- It is worth bearing in mind that the case was about “second use” patents ie Warner-Lambert already had a patent for Lyrica for the original use, and were seeking to extend it for use in the treatment of neuropathic pain. If there was no second use and the original Lyrica patent was still current for the treatment of seizure disorders, a pharmacist who supplied a generic version could still be sued and the Supreme Court judgment would not remove the liability.
Civil liability of unqualified staff
Posted: Friday, October 19th, 2018
The Supreme Court has handed down its judgment in Darnley v Croydon Health Services NHS Trust [2018] UKSC 50. The claimant, Michael Darnley, had been struck on the head. A friend drove him to the A&E Department at Mayday Hospital in Croydon. The claimant told the receptionist that he thought he had had a head injury and was feeling very unwell. The receptionist said there was a wait of up to four or five hours. The claimant told the receptionist he was feeling too unwell to wait that long. After waiting 19 minutes, he left because he was feeling too unwell to remain, and went to his mother's home. The claimant's condition worsened, and he suffered severe and permanent brain damage because he had not been treated when he first attended the hospital.
The A&E receptionist had failed to inform the claimant that he would be seen by a triage nurse within 30 minutes of arrival. Had he been told this, he would not have left the hospital. At the trial and in the Court of Appeal, the claimant's claim was dismissed on the basis that the receptionist did not owe the claimant a duty of care, and also because there was no causal link between any breach of duty and the injury.
The Supreme Court allowed the claimant's appeal, holding amongst other things that where there a duty of care, it is not appropriate to distinguish between medical and non-medical staff because the Hospital Trust had given the A&E receptionist the role of being the first point of contact for persons seeking medical assistance and, as a result, the receptionist was responsible for providing accurate information about the availability of medical assistance.
The case may have implications reaching beyond the hospital sector because community pharmacies employ counter assistants who may be the first point of contact when patients enter a pharmacy.
Cannabis on prescription
Posted: Friday, October 19th, 2018
The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 will come into force on 1 November 2018.
Following a review prompted by the well-publicised cases of Alfie Dingley and Sophie Dixon in the Summer, the Misuse of Drugs Regulations will be amended so as to allow a medical practitioner who is on a specialist register to prescribe medicinal cannabis as a special.
MHRA consultation on FMD implementation
Posted: Friday, September 21st, 2018
The MHRA is conducting a consultation - open until 23 September 2019 - on implementing the Falsified Medicines Directive, which will come into force on 9 February next year.
PLEA has submitted a response to just one question in the consultation, which asks whether there should be a range of civil sanctions to deal with breaches. Regulations will include criiminal sanctions but these may be appropriate only for the most serious cases. In our response, drawing on an earlier Law Commission paper, we expressed agreement with the proposal to have a range of civil sanctions which are likely to be a more proportionate way to deal with breaches in most cases.
GPhC report on whistleblowing
Posted: Wednesday, September 12th, 2018
On April 1 2017 a new legal duty came into force which required healthcare regulators to publish an annual report on the whistleblowing disclosures made to them by workers. The report published jointly by the regulators has just been published and can be found here https://www.pharmacyregulation.org/sites/default/files/document/whistleblowing_report_2018.pdf .
In the case of the GPhC, it reports that in the 12 months from April 2017, it took action in 5 whistleblowing cases with one more still under review. Of the concluded cases, three of them had been through a fitness to practise process, and concluded with no further action. The two others were investigated by a GPhC inspector and were concluded with guidance being given by the inspector to the employer.
GPhC consultation on publication and disclosure
Posted: Sunday, September 9th, 2018
We have responded to a consultation by the GPhC on its new publication and disclosure policy. This policy deals with how its register is annotated when a registrant is the subject of an interim suspension, suspension or removal from the register; and how long the annotations last for.
You can see a link to our response on Twitter by going to @PLEA_UK . Amongst other things, we say it is unfair to registants concerned (and misleading for the public) that the same annotation on the register is used for someone who is the subject to an interim suspension order (whose full fitness to practise hearing has not yet taken place), and a registrant who has been suspended after a full fitness to practise heairng at which their fitness to practise has been held to be impaired.
The consultation period will end on 14 September 2018.
Commentary on the remuneration appeal judgment
Posted: Wednesday, August 29th, 2018
Chemist & Druggist has published David Reissner's blog on the the Court of Appeal's judgment dismissing the appeals by the PSNC and NPA against the refusal of their applications for judicial review of the Secretary of State's decision to impose pharmacy funding cuts.
You can read the blog here: https://www.chemistanddruggist.co.uk/opinion/funding-cuts-appeal-was-rejected-over-profit-and-closure-confusion
Court of Appeal rejects appeals against dismissal of challenge to NHS remuneration determination
Posted: Monday, August 27th, 2018
In The Queen (on the application of The Pharmaceutical Services Negotiating Committee and others) v The Secretary of State for Health [2018] EWCA Civ 1925, the Court of Appeal has dismissed the appeals by the PSNC and the NPA against the decision of Mr Justice Collins to refuse their applications for judicial review of the Secretary of State’s decision to cut NHS pharmacy remuneration. The judgment can be found here https://www.bailii.org/ew/cases/EWCA/Civ/2018/1925.html.
Giving a single judgment, Lord Justice Irwin, Lord Justice Hickinbottom and Sir Jack Beatson set out at length what internal Department of Health documents disclosed about how the Secretary of State’s decision to slash pharmacy remuneration came to be made and these findings, rather than any specific legal ruling, were the key to the outcome.
The size of the remuneration cut (which the Court of Appeal described as “unprecedented”) was not itself in dispute, but the PSNC argued that correct processes had not be followed in reaching the decision. The Department realised from the start that the cuts would result in pharmacy closures but could not assess reliably how many would shut. The Court accepted the Department’s evidence that closures were not the objective of the cuts, even though they would be a by-product. The PSNC criticised the financial information the Department took into account, including a reference in its Impact Assessment that pharmacies were achieving a 15% profit margin, and information from an anonymous “industry insider”. However, the Court held that the Department had recognised the limitations of such information and accepted that it had not actually been relied on when the cuts were determined. Although the PSNC argued that the Secretary of State's decision was unlawful because he lacked sufficient reliable information on which to base his decision, the Court held that it was not practicable to obtain more reliabe information about the effect of the cuts.
The NPA raised an additional argument based on the Secretary of State’s duty in section 1C of the National Health Service Act 2006 in exercising his functions to have regard to the need to reduce inequalities between the people of England with respect to the benefits that they can obtain from the health service. However, the Court said the “Secretary of State has a substantial degree of flexibility as to how he goes about his task…[which] will inevitably involve the allocation of limited resources between competing needs”. Departmental papers showed that officials had presented Mr Hunt with a briefing paper reminding him of his legal obligations. This was enough to satisfy the Court that he had had regard to his duties. The documents also satisfied the court that the need to maintain reasonable access to pharmacies, notably in rural areas, was given considerable weight. As for areas of deprivation where there were larger numbers of pharmacies, the evidence showed that overall funding had not fallen when the new Pharmacy Access Scheme is taken into account.
Response to GPhC discussion paper on online pharmacy services
Posted: Sunday, August 19th, 2018
We have responded to the GPhC's discussion paper regarding online pharmacy services.
Amongst other things
- athough the GPhC's aims may be laudable, its proposals stray into areas that are more appropriately within the remit of other regulators, including the MHRA and bodies that regulate prescribers in the UK and elsewhere; and
- the proposals assume that websites which patients use to obtain prescription medicines are owned by the pharmacy that supplies what is prescribed, but this is not always the case.
Our response will be posted to our website shortly and is accessible via Twitter @PLEA_UK.
Regulating online pharmacy services
Posted: Friday, August 17th, 2018
The GPhC is consulting on proposals to regulate online pharmacy services. The proposals include a requirement to publish details of prescribers who are not in Britain, even though they may be registered with the GMC.
PLEA will be responding to the consultation (which can be found here https://www.pharmacyregulation.org/online-pharmacy) before the consultation ends on 21 August 2018.
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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.
