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

The claimant sought permission to challenge regulation 9 of the Human Medicines (Amendment) Regulations 2019, which inserted regulation 226A into the Human Medicines Regulations 2012 permitting the Secretary of State to issue Serious Shortage Protocols (SSPs) in the event of, or risk of, serious shortages of prescription-only medicines. The claimant advanced four grounds: (1) that regulation 9 was ultra vires because it was not authorised by the European Communities Act 1972 and conflicted with ss.58A and 64 of the Medicines Act 1968 and regulation 214(1) of the 2012 Regulations; (2) breach of the public sector equality duty under s.149(1) of the Equality Act 2010; (3) failure to have regard to the NHS Constitution under s.1B(1) of the National Health Service Act 2006; and (4) failure to consult in accordance with statutory and public law expectations.

The court held that the power in s.2(2)(b) of the European Communities Act 1972 authorised the making of regulation 9 as a measure dealing with matters arising out of or related to EU obligations under Directive 2001/83/EC (Articles 70–71) on prescription-only medicines. Regulation 226A was a parallel supply mechanism for use in shortage circumstances and did not change the classification of medicines as prescription-only nor improperly exempt medicines within s.58A(2) of the Medicines Act. On equality, the court found that the Department had given due regard to s.149(1) of the Equality Act 2010 by the analysis in Annex C and related materials and that further equality analysis would follow at the SSP implementation stage. On consultation, the court found the targeted and expedited consultation exercise, given the exigencies described, to be fair and adequate and that staged consultation on principle followed by operational detail was permissible. The application for permission was refused.

This is a renewed application for permission to bring judicial review proceedings challenging regulation 9 of the Human Medicines (Amendment) Regulations 2019 which inserted regulation 226A into the Human Medicines Regulations 2012 to permit Serious Shortage Protocols. Permission had previously been refused on the papers by Swift J and the renewed application was heard by Mr Justice Supperstone on 26 March 2019.

Parties and relief sought: The claimant, Good Law Project Limited, sought permission to challenge the lawfulness of regulation 9 and to argue that the Secretary of State lacked vires to make that regulation, and in any event acted unlawfully by failing to comply with the public sector equality duty and statutory duties to consult and to have regard to the NHS constitution. The defendant was the Secretary of State for Health and Social Care.

Issues framed:

• Whether regulation 9 was ultra vires the enabling power relied upon in the amendment instrument (ss.2(2) and (5) of the European Communities Act 1972) and/or inconsistent with ss.58A and 64 of the Medicines Act 1968 and regulation 214(1) of the Human Medicines Regulations 2012;
• Whether the decision to make the 2019 Regulations breached the public sector equality duty (s.149(1) Equality Act 2010);
• Whether the Secretary of State failed to have regard to the NHS Constitution under s.1B(1) of the NHS Act 2006 (no submissions were made on this ground); and
• Whether the consultation that took place was inadequate in scope and length and therefore unlawful.

Court’s reasoning: On vires the court concluded that the relevant EU obligations under Directive 2001/83/EC, and in particular the regime for classifying and controlling prescription-only medicines (Articles 70 and 71), meant that a power to deal with shortages was plainly a matter "arising out of or related to" those obligations and therefore within the scope of s.2(2)(b) of the European Communities Act 1972. Regulation 226A was treated as creating a contingent, parallel mechanism to prescriptions for specified shortage circumstances and did not purport to reclassify medicines or to remove from the prescription-only classification medicines falling within s.58A(2). On the public sector equality duty the court accepted that a formal equality impact assessment was not required; it considered the analysis in Annex C to the December Submission, the economic and social impact assessment and the targeted stakeholder engagement sufficient to demonstrate that the Secretary of State had had due regard to equality obligations, with further work to be done at the operational stage of SSPs. On consultation the court examined the sequence and content of meetings, written invitations, 47 responses and the Consultation Response document, and concluded that in the exigent circumstances the focused and expedited consultation on principle followed by staged operational engagement was fair and adequate. The court also noted that the claimant had not pursued the NHS constitution ground in submissions. The judge declined to decide standing in the absence of fuller argument.

Disposition: Permission to proceed was refused because the claim was not arguable; regulation 9 was held to have been lawfully made.

The application for permission to judicially review regulation 9 of the Human Medicines (Amendment) Regulations 2019 is refused. The court held that the power in s.2(2)(b) of the European Communities Act 1972 validly authorised regulation 9 as a measure dealing with matters arising out of EU obligations under Directive 2001/83/EC; regulation 226A constituted a lawful, exceptional, parallel supply mechanism and did not unlawfully contravene ss.58A or 64 of the Medicines Act 1968. The Secretary of State complied with the public sector equality duty and conducted a fair and adequate consultation in the expedited circumstances.

Permission was initially refused on the papers by Swift J. The claimant renewed the application; the renewed application was heard by Mr Justice Supperstone on 26 March 2019 and determined by judgment dated 29 March 2019 ([2019] EWHC 800 (Admin)).