Good Law Project Ltd, R (On the Application Of) v Secretary of State for Health And Social Care

The power to create serious shortage protocols for prescription-only medicines may be made under section 2(2)(b) of the European Communities Act 1972 where it deals with matters arising out of or related to EU obligations concerning the classification and supply of medicines. Such protocols do not remove a medicine’s prescription-only classification or unlawfully amend the Medicines Act 1968.

Compliance with the public sector equality duty does not require a formal equality impact assessment. The question is whether the decision-maker had sufficient evidence of a proper and conscientious focus on the statutory criteria. Consultation may lawfully occur in stages, and its fairness depends on the circumstances, including the subject matter, consultees and time available.

This was a renewed application for permission to bring judicial review proceedings challenging regulation 9 of the Human Medicines (Amendment) Regulations 2019. Regulation 9 inserted regulation 226A into the Human Medicines Regulations 2012, enabling Ministers to issue serious shortage protocols for prescription-only medicines.

The claimant argued that the Secretary of State lacked vires, breached the public sector equality duty, failed to have regard to the NHS Constitution, and failed to consult fairly. Permission had previously been refused on the papers. The central issues were whether regulation 9 was lawfully made and whether the preparatory process was unlawful.

1. Permission refused. The claim was not arguable and regulation 9 was lawfully made.
2. The power in section 2(2)(b) of the European Communities Act 1972 extends to provision dealing with matters arising out of or related to EU obligations. Managing shortages of prescription-only medicines was sufficiently connected with the obligations under Directive 2001/83/EC concerning the classification and supply of medicines.
3. Serious shortage protocols were a parallel mechanism to prescriptions. They did not exempt medicines from the prescription-only categories in section 58A of the Medicines Act 1968, nor did they constitute an unlawful exemption from section 64. They changed the instrument of supply in specified shortage circumstances from a prescription to a protocol.
4. The public sector equality duty in section 149(1) of the Equality Act 2010 did not require a formal equality impact assessment. The equality analysis in the ministerial material, together with stakeholder engagement, was sufficient to show due regard. Further analysis could properly occur when the operational scheme and individual protocols were developed.
5. No statutory duty to undertake a formal consultation arose under section 1B(1) of the National Health Service Act 2006 or section 129(6) of the Medicines Act 1968. The consultation nevertheless had to be fair and adequate. In context, the bodies consulted, the extensive engagement undertaken and the need for speed made the shortened consultation lawful. Consultation in stages was permissible, consistently with R (Breckland District Council) v Boundary Committee for England [2009] EWCA Civ 239.
6. The court declined to refuse permission for lack of standing without full argument. That issue therefore did not determine the application.

This was a first-instance renewed application for permission to seek judicial review. Permission had previously been refused on the papers by Swift J. The Administrative Court refused permission.