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...