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

The classification provisions in Directive 2001/83/EC do not expressly or impliedly require every supply of a prescription only medicine to be made pursuant to a prescription. Member States may establish carefully defined exemptions, including supply under a serious shortage protocol.

Such an exemption falls within section 2(2)(b) of the European Communities Act 1972 where it has an objective close link with EU obligations. Supply in accordance with a serious shortage protocol is not supply in pursuance of a prescription for the purposes of section 64 of the Medicines Act 1968. The challenge was unarguable and permission to appeal was refused.

The applicant sought permission to appeal an order of Supperstone J dated 29 March 2019, refusing permission to apply for judicial review of regulation 9 of the Human Medicines (Amendment) Regulations 2019.

Regulation 9 inserted regulation 226A into the Human Medicines Regulations 2012, permitting retail pharmacists, subject to specified conditions, to supply alternative prescription only medicines or different strengths, quantities or pharmaceutical forms under serious shortage protocols.

The remaining ground alleged that regulation 9 was ultra vires Directive 2001/83/EC, section 2(2) of the European Communities Act 1972, and section 64 of the Medicines Act 1968. The central question was whether the challenge had any arguable prospect of success.

Application refused. Sir Stephen Richards, giving the judgment of the court, held that the proposed appeal had no real prospect of success. Hickinbottom LJ agreed.

1. Compatibility with the Directive. Articles 70 and 71 of Directive 2001/83/EC establish requirements for classifying medicinal products as subject to medical prescription. They do not impose an express or implied obligation to prohibit every supply of such products otherwise than pursuant to a prescription. Article 71(4) itself indicates a degree of discretion in relation to classification. The Directive must be understood in the context of the wider harmonised regulatory scheme. The basic prohibition in regulation 214(1) of the Human Medicines Regulations 2012, together with carefully defined exemptions, provides a balanced and effective scheme. Regulation 9 was therefore not contrary to the Directive.
2. Section 2(2)(b) of the 1972 Act. The court applied the close-link approach described by Lord Mance in United States of America v Nolan [2015] UKSC 63; [2016] AC 463. The power extends to matters arising out of or objectively closely related to EU obligations or rights, but not to a merely domestic policy scheme outside that field. The conditions governing supply during serious shortages were within the field covered by the Directive and closely related to its obligations. Regulation 9 was therefore within the statutory power.
3. Section 64 of the 1968 Act. Although the process begins with a prescription, a sale or supply satisfying regulation 226A and made in accordance with a serious shortage protocol is not a sale or supply in pursuance of that prescription. The protocol is the instrument governing the supply in that situation. Section 64 was directed at a different mischief and did not prohibit regulation 9.

The application for permission to appeal was accordingly refused.

1. Court of Appeal (Civil Division) On 10 May 2019, the court refused permission to appeal, holding that the proposed appeal had no real prospect of success: [2019] EWCA Civ 1211.
2. Administrative Court Supperstone J refused permission to apply for judicial review on 29 March 2019.