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Drug switching

Pharmacy drug-switching protocols a ministerial 'power grab', says shadow health secretary

Jonathan Ashworth says ministers should have brought amendments to the Human Medicines Regulations 2012 to the House of Commons for “proper scrutiny”. 

Jonathan Ashworth, the shadow health and social care secretary

Source: Russell Hart / Alamy Stock Photo

Jonathan Ashworth, the shadow health and social care secretary, said the government was “effectively using Henry VIII powers to enable ministers to issue a protocol to pharmacies for them to follow”

Amendments to legislation allowing pharmacists to switch patients’ medicine without consulting their GP is “an extraordinary power grab” by health ministers, the shadow health secretary has said.

In a parliamentary debate on changes to legislation that would allow “serious shortage protocols” to be issued during medicines shortages, held on 18 March 2019, Jonathan Ashworth, the shadow health and social care secretary, said the draft legislation should have been put forward in Parliament “for proper scrutiny” before going out for “proper consultation”.

If a protocol was issued by the government, pharmacists could be asked to respond to a medicine shortage in one of four ways: dispensing a reduced quantity; a therapeutic equivalent; a generic equivalent; or an alternative dosage form of the drug.

In a House of Commons debate on the change to the Human Medicines Regulation 2012, which was implemented on 9 February 2019, Ashworth said: “Ministers should have brought them to the [House of Commons] for proper scrutiny and then, of course, they should have gone out for proper consultation with patients, patient groups and health stakeholder.”

He added that the government was “effectively using Henry VIII powers to enable ministers to issue a protocol to pharmacies for them to follow”.

So-called ‘Henry VIII powers’ are clauses in a bill that enable ministers to amend provisions in an act using secondary legislation without having to go through Parliament a second time.

Ashworth warned that a medicines would no longer “be prescribed by a doctor who knows the medical history of the patient but instead by a pharmacist acting in accordance with a protocol drawn up by the government”.

“That is why these emergency measures have, quite rightly, raised alarm among various patient groups — because these changes could cause real problems for people with long-term conditions,” he said.

Ashworth’s comments come despite a High Court ruling against progressing with a judicial review of the amendment, which was brought forward by the legal campaign group The Good Law Project.

The group contested the legislation on 19 February 2019 on grounds that included an “insufficient and unlawful” consultation process, which was open for one week in December 2018.

The Department of Health and Social Care argued in its response to the legal action that there was an “obviously pressing” need for the introduction of serious shortage protocols “both generally … and in the context of Brexit”.

However, on 15 March 2019, Mr Justice Swift of the High Court refused permission to apply for a judicial review on four grounds.

He said, in response to The Good Law Project’s claim that the consultation was sent to a “narrow” set of people and allowed for “insufficient time”, that neither point is arguable.

“In the absence of any statutory framework for the consultation, the secretary of state could, subject to the usual public law principles, decide whose views to seek,” he said. “The selection made by the secretary of state was not (even arguably) irrational.”

The judge added that while the response period was short, “having regard to the identity of the bodies consulted (all bodies with expertise) and the targeted nature of the questions posed, it is not arguable that it was unfair for the response period to be as short as it was”.

The Good Law Project has said on Twitter that the High Court’s “reasoning is very poor and we have asked the Court for an urgent oral permission hearing”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206311

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