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The government has argued that “there was no statutory obligation” to formally consult on changes to the law allowing pharmacists to switch patients’ drugs during a medicines shortage under a government-issued protocol.
The Department of Health and Social Care (DHSC) made the argument in response to legal campaigners at the not-for-profit group The Good Law Project, which is seeking a judicial review over the legislation that came into effect on 9 February 2019.
In a legal document sent to the DHSC on 19 February 2019, the group said that the “serious shortage protocols” consultation, which was open for one week in December 2018, was “insufficient and unlawful”.
But the government has now said that none of the challenges made by The Good Law Project were arguable owing to the “clear and pressing need” for the change to the Human Medicines Regulation 2012.
It said that while the secretary of state would normally consult publicly for 12 weeks before making changes to the Regulation 2012, it was not an “immutable” position, and this was “plainly not a normal situation”.
“The need for the power created by Regulation 9 was obviously important and obviously pressing — both generally … and in the context of Brexit (and the particular risks of shortages to which that might give rise),” the papers said.
Therefore, it argued that “there was no statutory obligation to hold a formal consultation in relation to Regulation 9” — the regulation enabling the government to issue protocols that would allow drug-switching.
The government noted that its invitations for responses to the consultation “stressed the need to move quickly, not least because of the potential need to have legislation in place before 29 March 2019”.
It also said that without the protocols, the consequences would be “highly unfortunate”, as the UK would be “left without an important tool by which the secretary of state can address any serious drug shortages arising, including post-Brexit”.
However, The Good Law Project responded to the government’s claims saying that there was not “any” need, especially not a “pressing” need, for the change in regulation.
“It was expressly not linked to Brexit and, in any event, Brexit day has been known for the last two years,” the response said.
The government has previously said on 14 January 2019 that the use of serious shortage protocols “was prompted” by Brexit, but was not linked to leaving the EU without a deal.
Jolyon Maugham, barrister and director of The Good Law Project, said he had not read anything in the government’s response that caused him to think it was a bad idea to continue to pursue a judicial review.
“There was a breach in the way that the government conducted the consultation — a lot of organisations did not know that there was a consultation — we think that that evidence is there that the consultation was not conducted properly.”
He also said that it was “a remarkable state of affairs” that the government had admitted that there was a risk of serious shortages in the event of a no-deal Brexit.
“That’s something that ought to trouble any MP — there’s no suggestion that the government plans to delay to avoid the risk to patient health of a no-deal [Brexit], but it admits the risk exists.”
He added: “The principle of the serious shortage protocol is not that it means that more medicines are magicked out of thin air, it’s just that patients don’t need to go back to clinicians to have those drugs prescribed.
“If the protocols are struck down — it remains open to patients to go back to GPs, who understand their medical history best of all, to prescribe their medicine. I don’t accept that striking down the measure will affect patients.”
The High Court will now decide whether the judicial review will go ahead.
