The High Court challenge by the Good Law Project to quash the serious shortage protocol (SSP) regulations allowing pharmacists to supply alternatives to prescribed medicines in the event of serious shortages has itself been quashed.
The Good Law Project links SSPs to Brexit, which it thinks is a “terrible idea”. Although SSPs can be used regardless of leaving the EU, the Department of Health and Social Care's consultation period before making the regulations was reduced to five days as part of no-deal Brexit planning. The Good Law Project calls this limited consultation “staggeringly negligent”.
To prevent the courts and public bodies being swamped with cases that lack merit, an application for judicial review can only be brought if a High Court judge gives permission. A judge will only give permission if there is an arguable case. Typically, cases are considered in private on the strength of the submitted paperwork. If permission is then refused, the applicant can ask for an oral hearing.
In this case, Mr Justice Swift refused permission after considering the papers. The Good Law Project asked for an oral hearing, which was heard by Mr Justice Supperstone. He went through each of the Good Law Project’s arguments and refused permission to apply for judicial review.
“Parallel system to prescriptions”
The Good Law Project argued that supplying under a SSP would conflict with the duty of pharmacists under section 64 of the Medicines Act to supply a product that is of the nature or quality prescribed. The judge described serious shortage protocols as "a parallel system to prescriptions".
It is implicit in this conclusion that a pharmacist who made a supply in accordance with a serious shortage protocol could not be prosecuted under section 64 of the Medicines Act if a patient was harmed through receiving an alternative medicine to the one prescribed. This has been a serious concern for pharmacists.
Rulings on applications for permission to apply for judicial review are not precedents that are binding on judges in future cases. Nevertheless, Mr Justice Supperstone's ruling may deter future prosecutions. The Good Law Project says it wants to appeal, so watch this space.
David Reissner is a consultant with law firm Charles Russell Speechlys LLP