*This article has been corrected since first being posted

A campaigning group has threatened to issue judicial proceedings on Tuesday February 26 unless the Department of Health and Social Care repeals the Serious Shortage Protocol regulations that came into law on February 9 and holds a full 12-week consultation.

The Good Law Project, which says it uses the law to advance progressive issues and has campaigned vocally against Brexit, said in a February 19 letter to health secretary Matt Hancock that it would bring judicial review proceedings should he fail to confirm by 4pm on Monday February 25 “that the Regulations will be withdrawn pending compliance with the Defendant’s statutory obligations”.

The group says there is no provision in law entitling Mr Hancock to amend aspects of the Human Medicines Regulation requiring “medicinal products to be sold of the nature or quality specified in any prescription”.

"Truncated" consultation

A short, ‘informal’ consultation of “relevant stakeholder representative bodies” was held from 5-12 December 2019 on the proposed amendments to the Human Medicines Regulation 2012. The Good Law Project has expressed concerns that patients' organisations such as the National Aids Trust were not consulted.

The ‘informal consultation’ document issued by the DHSC said: “Normally, we would consult publicly for 12 weeks before making any changes to the Human Medicines Regulation 2012. However, you will understand that any legislative changes in relation to the UK’s exit from the EU need to be progressed quickly so that they are in force the day that the UK leaves the EU.”

This swift process was aimed at ensuring the protocols could be implemented in the event that the UK leaves the European Union without a deal on March 29, in order that the impact of any medicines shortages on patients could be limited, though the Good Law Project says the “truncated” nature of the consultation renders it “unlawful”.

However, it does appear that plans to introduce the protocols had been discussed for some time prior to the consultation.

When Pharmacy Magazine asked PSNC in December about the processes involved in passing the amendment, a spokesperson said that “in terms of the [protocols] and the consultation on them, many of the issues were raised and discussed at the Community Pharmacy Brexit Forum meeting in September at which DHSC was also present”.

“Our objective in all of this is to ensure that patients can still access the medicines they need after Brexit; this is clearly important work and it also very time sensitive,” they said.

Pharmacy bodies back the protocols

The community pharmacy bodies appear to be largely in favour of the SSPs (the RPS has said pharmacists are medicines experts and “we support pharmacists using their professional judgement”), though the Pharmacists’ Defence Association has warned of wider legal implications apparently overlooked by the DHSC that could leave pharmacists exposed if not addressed.

The British Medical Association has told Pharmacy Magazine it is “broadly supportive” of the SSPs but disagrees with pharmacists dispensing “therapeutic equivalents” to prescribed medicines without contacting a prescriber.

In addition to therapeutic equivalents, the SSPs give pharmacists powers to dispense a ‘reduced quantity’, ‘alternative dosage form’ or ‘generic equivalent’ to that stated on the prescription.

An explanatory note issued by the DHSC says protocols for therapeutic or generic equivalent “would only be used in very exceptional circumstances” and would not apply to certain drugs including epilepsy medications and treatments requiring biological products "where the medicines that are prescribed need to be prescribed by brand for clinical reasons".

Commenting on the possible legal action against the Government, Jolyon Maugham QC, director of the Good Law Project, said: “Both doctors and patients have proper concerns about their safety in the event of medicine shortages. We want the Government to withdraw the prospect of SSPs until it has complied with its legal duties and consulted properly on their use. If the Government does not take this step, the Good Law Project will launch judicial review proceedings in the High Court.”

National Aids Trust chief executive Deborah Gold said the charity was “deeply concerned that these changes were made without proper consultation” and that the “only person qualified to safely alter the medication prescribed to a person living with HIV is that person’s HIV consultant”.