An application for judicial review of the Human Medicines (Amendment) Regulations 2019 (the “Regulations”), which recently came into force, has been refused by the High Court (the “Court”).
The Regulations were contested because, under the Serious Shortage Protocol in Regulation 9 (“SSP”), pharmacists will have the power to dispense amended or alternative prescriptions without having to consult the prescriber in the event of a serious shortage of a relevant prescribed medication.
The Good Law Project (“GLP”), a not-for-profit organisation which fights cases to “defend, define or change the law” to do with Brexit, tax and workers’ rights, recently applied to the Court for permission to challenge the Regulations, in particular the SSP provisions.
The challenge was surprising for a variety of reasons, including that it was unclear why the GLP was interested in the SSP as it does not appear to fall within the GLP’s public remit stated above. The new SSP powers can be used during any serious shortage and not only as a potential consequence of Brexit. This makes it a non-Brexit matter, and the Regulations do not relate to tax or workers’ rights, which begs the question why has GLP brought the case?
In addition, the SSP appears to offer a sensible approach to mitigate any adverse consequences that could occur as a result of medicines shortages in the future. Surely, it is in the patient’s best interests to receive an amended or alternative medicine using the professional judgement of a highly skilled and qualified pharmacist within strictly controlled parameters rather than for the patient to receive no medicine at all?
The GLP based its application for judicial review on the following arguments:
- The SSP provisions contradict section 64 of the Medicines Act 1968, which states that it is a criminal offence for any person to sell any medicinal product which is not of the nature or quality demanded by the purchaser, which (according to GLP) meant that the Department of Health and Social Care (“DHSC”, the defendant in the judicial review challenge) did not have the power to make the SSP.
- DHSC failed to comply with section 149 of the Equality Act 2010 when making the SSP by not carrying out a formal equality impact assessment.
- DHSC failed to act in accordance with the NHS Constitution when making the SSP.
- DHSC carried out a “rushed and inadequate” consultation for the SSP and therefore the amendments were unlawful.
At the hearing earlier this week, the Court considered GLP’s application and it was (unsurprisingly) refused. The Court found that GLP’s first argument was not arguable because the DHSC did have the power to make the SSP, as set out in the Explanatory Memorandum to the Regulations. Also, there was sufficient evidence to show that the DHSC had complied with its obligations under the Equality Act 2010. The Court found that the SSP was not inconsistent with the NHS Constitution and so that ground also failed.
Finally, in relation to the ground for challenge that the consultation was unlawful, the Court held that the consultation process had been fair in light of the expert bodies which had been consulted and the targeted nature of the questions. It was neither “rushed nor inadequate”.
Not only was the application for judicial review refused, but the Court also made an award for costs against GLP in favour of DHSC. It is our understanding that GLP has asked the Court for an urgent oral permission hearing in light of the refusal, but it seems unlikely that the GLP will be able to fight the SSP.
So are the SSP provisions safe from challenge? It appears not. The Regulations and SSP were debated in the House of Commons earlier this week and a motion to revoke the Regulations was narrowly defeated. Concerns are being raised over the level of power and discretion that the provisions will provide to pharmacists along with different types of medicines that may be at risk under the SSP. For now, however, the SSP provisions within Regulations stand.
For more information on the topic, please contact Richard Hough.
