A Court of Appeal decision could have major ramifications moving forwards.
The Court of Appeal has today (10 May 2019) confirmed the High Court’s decision to refuse permission for The Good Law Project (“the GLP”, a not for profit organisation fighting against all things Brexit-related) to seek judicial review of the Serious Shortage Protocol (“SSP”), which was introduced by the recent Human Medicines (Amendment) Regulations 2019 (“the Regulations”).
Under Regulation 9 of the Regulations, the SSP empowers pharmacists 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 GLP initially sought judicial review of the SSP on the basis 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, and argued that the consultation carried out on the SSP was “rushed and inadequate”, rendering the amendments unlawful. The GLP also claimed that the DHSC had failed to comply with section 149 of the Equality Act 2010 and the NHS Constitution when enacting the SSP.
However, the High Court disagreed with the GLP’s arguments and denied permission for judicial review at a hearing on 26 March 2019. The High Court found that the DHSC did have the power to make the SSP and that the DHSC had complied with all of its legal obligations in carrying out the consultation process. The High Court also made a costs order against GLP in favour of DHSC, but this seemingly did not deter the GLP.
The GLP subsequently applied to the Court of Appeal for an expedited appeal of the High Court’s decision. The case was heard earlier today and the GLP based its arguments on its view that the SSP is ultra vires under European Union law and the Medicines Act 1968.
Whilst the Court of Appeal’s judgment has not yet been released, it has been confirmed that it has also denied permission for judicial review of the SSP. The GLP has since released a statement confirming that it will not be pursuing this legal challenge any further.
So, with the GLP backing down from the fight, is the SSP here to stay? On the one hand, some MPs are calling for additional clarification on when the SSP would be implemented, claiming that a “serious” shortage should be defined before pharmacists are granted such discretionary powers. However, on the other hand, the Pharmacy Law and Ethics Association has commented that defining “serious” would “not be sensible”, and that the “ongoing resistance to granting pharmacists medicine shortages powers unnecessarily politicises an issue that should be about patients”. We continue to consider that the SSP is a sensible approach to mitigate against any adverse consequences for patients that could occur as a result of a prescription medication shortage.
Further details and analysis of the initial challenge to the High Court can be found here. For any advice in relation to the SSP, please contact Brabners pharmacy team.
