High Court challenge to legality of serious shortage protocols
For David Reissner, one organisation’s legal challenge to allowing pharmacists to dispense an alternative in the case of a major medicine shortage was a surprise.
It’s only a been a few weeks since the Human Medicines (Amendment) Regulations 2019 order came into force, which allows pharmacists to supply an alternative if there is a serious shortage of the medicine prescribed, in accordance with a ‘serious shortage protocol’.
News that the Good Law Project – a non-profit organisation that says it fights cases to defend or change the law in the areas of Brexit, tax and workers’ rights – has applied to the High Court for permission to challenge the regulations comes as a surprise.
I wouldn’t have expected the shortage protocol to be on the Good Law Project’s hit list. This is partly because ministers’ new powers can be used in the case of any serious shortage – not just in the event of a Brexit-related shortage – and partly because, when patients need medicines, everyone wants them to be available without delay.
The Good Law Project says – among other things – the shortage protocol regulations are unlawful because:
- they contradict section 64 of the Medicines Act, which prohibits a supply of a medicine which is not of the nature or quality demanded
- they are inconsistent with the prohibition on supplying a prescription-only medicine (POM), except in accordance with a prescription
- there should have been a proper consultation before implementing a “complex, sensitive and life-endangering proposal”.
As far as section 64 of the Medicines Act is concerned, it only takes effect if what is supplied harms a patient. As for the prohibition on supplying a POM without a prescription, there are already a number of exceptions to this requirement, including emergency supplies and patient group directions.
The government normally consults for at least 12 weeks before implementing changes in the law. The Good Law Project complains that the Department of Health and Social Care (DH) only conducted an informal consultation with selected pharmacy stakeholders over a few days.
The DH said the shortage protocol will not extend to epilepsy medicines. However, the Good Law Project complains that other groups, such as those concerned with Parkinson’s or multiple sclerosis, were also not consulted.
I am not convinced about the legal argument. The impending Brexit may cause or exacerbate shortages, and there wasn’t time for the proper consultation good government usually requires. The DH has made it clear a shortage protocol for any medicine will involve clinical input; it is hardly likely that the clinicians who advise the DH will suggest alternative medicines if it would destabilise a patient’s regime.
Judicial review is a two-stage process. A judge will now consider the Good Law Project’s documents and the DH’s written response, possibly without a hearing. If the judge considers the organisation has an arguable case, a full hearing will be ordered. If the Good Law Project is successful at the full hearing, amendments to the regulations will have to be withdrawn, and a full consultation may have to be carried out.
If a serious shortage occurs in the meanwhile, I expect the DH will have to use its powers if the alternative would be damaging to the health of patients. I’d like to know what the Good Law Project would expect the DH to do.
Our thinking
Charlotte Healy
Charlotte Healy and Katie Bewick write for Pharmacy Business on expert determination
Charlotte Healy and Katie Bewick write for Pharmacy Business on expert determination
Pei Li Kew
Pei Li Kew writes for Pharmacy Business on the link between pharmacy and IP
Pei Li Kew writes for Pharmacy Business on the link between pharmacy and IP
Oliver Park
Oliver Park writes for P3 Pharmacy on the impact of the Building Safety Bill on pharmacy owners
A key requirement under the Order is the need for a fire risk assessment, which must be regularly reviewed.
Jonathan McDonald
Jonathan McDonald and Ilona Bateson write for P3 Pharmacy on data protection compliance for pharmacy business owners
Health organisations hold more sensitive personal health data than ever.
Becky Lawton
Becky Lawton and Francesca Charlton write for P3 Pharmacy on employment issues for pharmacies in light of the Omicron variant
What can owners and managers do if staff refuse to comply with latest restrictions?
Melania Constable
Melania Constable and Georgina O'Sullivan write for P3 Pharmacy on the easing of Covid winding up restrictions
Regulations mean that a creditor can once again rely on an unpaid statutory demand to apply to the court for a winding-up petition.
Amelia Goodwin and Georgina O'Sullivan write for P3 Pharmacy on the key to managing performance
Day-to-day management is time consuming enough, so if you have a workforce with no apparent issues, performance may not be on your radar.
Tim Jenkins
Pharmacy Brief - September 2021
The September edition of our Pharmacy Brief
Noel Wardle writes for P3 Pharmacy on whether pharmacies have to provide medicines in compliance aids
Do pharmacies have to provide medicines in compliance aids, and can they can charge for them?
Lauren Kelly
Jennifer Berritt and Lauren Kelly write for P3 Pharmacy on The Lease Code and looking for better lease terms
The Lease Code published by The Royal Institution of Chartered Surveyors took effect on 1 September 2020.
Noel Wardle wrote for Chemist & Druggist on the implications of the new Health and Care Bill mean for community pharmacy
The government has now published its proposed overhaul of health and care in England.
Tim Jenkins
Charles Russell Speechlys advises Avicenna Group on duo of pharmacy group acquisitions
The acquisition takes Avicenna to a total of 135 pharmacy branches.
Pharmacy Brief - June 2021
The June edition of our Pharmacy Brief
Samuel Milne
Sam Milne writes for Pharmacy Business on the process of selling a pharmacy
Sam Milne outlines the process in making that all important decision to sell a pharmacy.
Noel Wardle quoted by Chemist and Druggist on how to make hub-and-spoke work for all independent pharmacies
Noel considers whether patients would be for or against their prescription being assembled at a hub, rather than a pharmacy.
Noel Wardle writes for Pharmacy Business on the balancing act of medicine supply
Do community pharmacies have to provide medicines in compliance aids, and can they charge for the service?
Rachel Warren
Property Patter: Navigating the complexities of Pharmacy Property
Pharmacy property is a specialist area which contains many traps for the unwary.
Amelia Goodwin and Georgina O'Sullivan write for Pharmacy Business on managing employee performance
Why contractors should prioritise performance management of employees as a regular feature of their business strategy.
Pharmacy Brief - March 2021
The March edition of our Pharmacy Brief
Natalie Deuchar
Natalie Deuchar and Leonora Owens write for Pharmacy Business on the considerations to take into account when pharmacists look to obtain a new unit
Pharmacists should be aware of the law when considering obtaining a new unit.