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A new approach to pharmacy regulation

Pharmacy practice in Great Britain will change in the next decade, with pharmacists and pharmacy technicians delivering new services across all sectors and settings.

The functions and powers of the GPhC are designed to sustain these developments and to support innovation.

The GPhC will be operating a risk-based system of regulation that allows it to focus its resources where they are most needed, while still encouraging innovation and maintaining thoroughness and high-quality practice.

A key focus will be to improve standards and the quality of care and services for all, rather than simply addressing poor practice and using regulation as a means of discipline.

What is risk-based regulation?

Risk-based regulation involves setting standards on the basis of assessments of the risk that activities pose to the health, safety and wellbeing of the public, and assessing the risks posed by pharmacists, pharmacy owners/employers and pharmacy technicians.

Once risks have been assessed, the regulator prioritises resources in areas such as enforcement and inspection, but without stifling innovation or new developments.

The overall goal is proportionate regulation; the main focus will be on patient safety and delivering improvements, but at a reasonable cost and without creating regulation that feels like a burden. The Government has said that regulation should be proportionate to the risks it addresses and the benefits it brings.

How will it work in practice?

The draft Pharmacy Order 2010, which is the legislation that establishes the role, function and powers of the GPhC, is written with broad provisions so as to provide the flexibility needed to enable the organisation to respond to variations or changes in practice or context without needing to seek changes to the legislation.

For example, in relation to the regulation of premises, the GPhC has the power to set different fees, depending on factors such as size of premises and complexity of services or activities, and for different periods of time, such as annually or three-monthly.

This will allow the GPhC to decide how to make the detailed standards and rules for premises' fees proportionate and risk-based, in consultation with the professions and other stakeholders.

Whatever approach the GPhC decides to take, it is under a duty to 'have proper regard to' and to 'co-operate with' a large range of stakeholders, including pharmacy owners/employers, registrants, prospective registrants and the public.