Introduction

In the landmark case of Community Pharmacy Scotland v Fife Health Board and Lothian Health Board ([2023] ScotCS CSOH_65), the Scottish Court of Session addressed pivotal questions concerning the regulation of prescription collection lockers operated by pharmacy contractors. The petitioner, Community Pharmacy Scotland, challenged the decisions of Fife Health Board and Lothian Health Board, asserting that the installation and operation of automated prescription collection points (lockers) outside the pharmaceutical lists maintained by health boards were unlawful under the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009.

The core issues revolved around whether the 2009 regulations mandated the inclusion of premises housing prescription collection lockers in the pharmaceutical lists and whether such regulatory requirements fell within the legislative competence of the Scottish Ministers under the Medicines Act 1968.

Summary of the Judgment

Lord Harrower delivered the opinion of the Outer House, dismissing the petitioner's claims. The court interpreted the relevant sections of the 2009 regulations, particularly focusing on paragraph 6(1) of Schedule 1. It concluded that this regulation does not prohibit pharmacy contractors from providing services outside their listed premises but requires them to at least maintain their listed premises operation. Furthermore, the court held that the 2009 regulations, as amended in 2021, are within the legislative competence of the Scottish Ministers, thereby rejecting the argument that they overstepped into areas reserved by the Medicines Act 1968.

The court rejected the petitioner's interpretation that the regulation required all pharmaceutical services, including those provided via collection lockers, to be listed premises. It clarified that collection and delivery arrangements are permitted as defined, provided the core services continue to operate from the listed premises. Consequently, the decisions of Fife Health Board and Lothian Health Board were upheld, allowing the continued use of unlisted prescription collection lockers.

Analysis

Precedents Cited

The judgment referenced several key precedents to support its interpretation of the regulations:

• R (Quintavalle) v Secretary of State for Health [2003] 2 AC 687: This case emphasized the importance of interpreting legislation within its broader context and purpose.
• R (on the application of Spath Holme Limited) v Secretary of State for the Environment, Transport and the Regions [2001] 2 AC 349: Highlighted the necessity of considering the legislative intent and surrounding circumstances in statutory interpretation.
• Martin v Most, 2010 SC (UKSC) 40: Discussed the scope of regulatory competence.
• Imperial Tobacco Ltd v Lord Advocate, 2013 SC (UKSC) 153: Reinforced principles related to legislative competence and regulatory scope.
• In re UK Withdrawal from the European Union (Legal Continuity) (Scotland) Bill [2019] AC 1022: Addressed issues of legislative competence post-Brexit.
• Reference by the Lord Advocate of Devolution Issues under paragraph 34 of Schedule 6 to the Scotland Act 1998 2022 SLT 1325, para 75: Provided authoritative guidance on the devolution powers related to the case.

Legal Reasoning

The court's legal reasoning centered on a meticulous interpretation of the 2009 regulations in conjunction with the 2021 amendments. Lord Harrower clarified that paragraph 6(1) of Schedule 1 requires pharmacy contractors to provide pharmaceutical services from their listed premises but does not restrict them from offering additional services via unlisted premises, such as prescription collection lockers.

The petitioner contended that the regulations implicitly required all premises facilitating pharmaceutical services to be listed, thereby excluding adequately licensed prescription lockers. However, the court found this interpretation flawed, emphasizing that the regulations explicitly permit "collection and delivery arrangements" to operate from premises not listed, provided they adhere to the defined conditions, including being capable of being closed to the public.

Additionally, the court addressed the devolution argument presented by the respondents, affirming that the 2009 regulations fell within the devolved competencies of the Scottish Ministers. Even if one were to accept the petitioner's broader interpretation of the regulations, the connection to the Medicines Act 1968 was deemed too tenuous to render the regulations ultra vires.

Impact

This judgment reinforces the legality of prescription collection lockers operating outside the health boards' pharmaceutical lists, provided they meet the specified regulatory criteria. Consequently, pharmacy contractors can continue to utilize such automated systems to enhance accessibility and convenience for patients without the burden of listing every collection point formally.

Moreover, the decision delineates the boundaries of the Scottish Ministers' legislative competence, affirming their authority to regulate pharmaceutical services under the devolved powers. This clarity prevents future disputes regarding the scope of pharmaceutical regulations and supports the integration of modern service delivery methods within the existing legal framework.

Complex Concepts Simplified

Pharmaceutical List

The pharmaceutical list is a register maintained by each Scottish health board containing the names of individuals or entities authorized to provide pharmaceutical services within that board's jurisdiction. It includes details of their premises and the nature of services offered.

Collection and Delivery Arrangements

Collection and delivery arrangements refer to systems where patients can deposit prescriptions and collect their medications via automated lockers outside the traditional pharmacy premises. These arrangements offer 24/7 accessibility, enhancing convenience for patients.

Legislative Competence

Legislative competence pertains to the authority granted to a legislative body to enact laws within specific domains. In this case, it relates to whether the Scottish Ministers had the authority to regulate certain aspects of pharmaceutical services under the devolved powers.

Impact

The court's decision has significant implications for the pharmaceutical sector in Scotland:

• Operational Flexibility: Pharmacy contractors gain greater flexibility in service delivery, allowing the expansion of prescription collection options without the need for exhaustive listing procedures.
• Patient Accessibility: Patients benefit from increased accessibility to their medications through automated lockers, which are available beyond standard pharmacy operating hours.
• Regulatory Clarity: The affirmation of the Scottish Ministers' legislative competence provides clear boundaries for future regulatory developments, preventing overreach and ensuring that regulations remain within the intended scope.
• Market Dynamics: The decision may influence the viability and competitive landscape of high street pharmacies by endorsing alternative service delivery models.
• Future Litigation: The judgment sets a precedent that can guide future legal disputes related to pharmaceutical service regulations and devolution powers.

Conclusion

The ruling in Community Pharmacy Scotland v Fife Health Board and Lothian Health Board underscores the Scottish judiciary's commitment to interpreting pharmaceutical regulations in a manner that accommodates modern service delivery innovations. By affirming the legality of unlisted prescription collection lockers under the 2009 regulations and upholding the Scottish Ministers' legislative authority, the court has provided a robust framework that balances regulatory oversight with operational flexibility. This decision not only enhances patient access to pharmaceutical services but also ensures that the regulatory environment remains conducive to adapting to evolving healthcare needs.