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  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.
Consultation on implementing Falsified Medicines Directive
Posted: Tuesday, August 7th, 2018
The MHRA is consulting on proposed steps to implement the Falsified Medicines Directive (FMD) which comes into force on 9th February 2019. The Government has made clear that whatever the outcome of Brexit, this Directive will be implemented in the UK. The "safety features" are
a unique identifier (a 2D data matrix code and human readable information) that must be scanned at fixed points along the supply chain
an anti-tampering device allowing verification of whether the packaging of a medicinal product has been tampered with
Consultation closes on 23rd September
New law to protect vulnerable people in care
Posted: Friday, August 3rd, 2018
The Mental Capacity (Amendment) Bill was introduced to the House of Lords on Tuesday 3 July and seeks to replace the current system known as ‘Deprivation of Liberty Safeguards’ (DoLs).
DoLs is an assessment currently carried out on people who do not have the mental capacity to make their own decisions about their care, for example because they are living with dementia. It was criticised by a 2017 Law Commission review for being too complex and bureaucratic.
The government has now developed a new system, known as ‘Liberty Protection Safeguards’, which will become law through the bill.
Two consultations on rebalancing law
Posted: Friday, August 3rd, 2018
Two draft orders which would amend pharmacy legislation are now out for consultation until 10th September 2018
The 2 draft orders are:
The Pharmacy (Preparation and Dispensing Errors – Hospitals and Other Pharmacy Services) Order 2018
The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc) Order 2018
The first draft order seeks to extend defences that already exist for pharmacy professionals working at or from registered pharmacies in the case of accidental preparation and dispensing errors. It would cover pharmacy professionals working in hospitals and other relevant pharmacy services.
The second draft order seeks to clarify and strengthen the arrangements of registered pharmacies concerning how they are governed. Specifically, it makes the roles of responsible pharmacists and superintendent pharmacists clear in primary legislation.
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.