High Court challenge to legality of serious shortage protocols

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.