In Legal

Follow this topic

Bookmark

Record learning outcomes

The pharmacy landscape in England is undergoing one of its most significant regulatory shifts in two decades. Legal experts Richard Hough and Thorrun Govind explore what the changes mean for the sector…

From June 2025, the Department of Health and Social Care (DHSC), in agreement with NHS England and Community Pharmacy England (CPE), introduced a suite of reforms aimed at rebalancing the sector, enhancing patient access and ensuring long-term sustainability.

No new distance-selling premises pharmacies

A key change is the removal of the Regulation 25(1)(a) exemption in the NHS (Pharmaceutical and Local Pharmaceutical Services ‘PLPS’) Regulations 2013, which allowed applications to be submitted and granted for new distance-selling premises pharmacies (DSPs) to open without demonstrating local pharmaceutical services need.

Since June 23, 2025, no new DSP applications may be submitted in a move which ends a policy that had enabled online pharmacies to bypass the traditional “control of entry” system, which requires proof of local demand. 

Many DSPs were found to be operating primarily in their immediate vicinity, despite being contractually obligated to serve patients across England.

This legislative change is widely seen as a response to concerns that the rapid increase in the number of DSPs has contributed to the decline of traditional bricks-and-mortar community pharmacies.

While DSPs have offered convenience and efficiency, particularly during the pandemic, their growth has raised questions about sustainability, patient access to face-to-face care, and the creation of an uneven regulatory playing field.

By closing the DSP entry route, the government aims to stabilise the sector and protect the viability of bricks-and-mortar pharmacies, which continue to play a vital role in local healthcare delivery.

The government clearly believes that the existing network of around 400 DSPs is sufficient to meet national demand. This restriction is likely to drive up the value of existing DSPs, particularly those already providing NHS services and possessing established operational infrastructure, regulatory compliance, and patient trust.

Their ability to deliver prescriptions nationwide, support NHS initiatives, and offer convenience to patients cements their position as fundamental players in the future of integrated healthcare delivery.

Redefining the role of DSPs

From 1 October 2025, DSPs will no longer be allowed to provide certain NHS-funded services in person at their premises.

These directed services include flu vaccinations, blood pressure checks, and other clinical interventions that patients have previously been permitted to receive on a face-to-face basis at the pharmacy premises.

From this date, such services must instead be provided remotely or off-site, with approval from the local Integrated Care Board (ICB). A temporary exception allows in-person flu and COVID-19 vaccinations until March 31, 2026 to support winter pressures.

Flexibility for pharmacy opening hours

The reforms also introduce a new, streamlined process for pharmacies wishing to adjust their core opening hours.

While significant reductions in hours still require a full assessment of local service needs, minor adjustments that maintain the same total hours can now be approved based on whether they better meet patient demand.

The existing application route pursuant to paragraph 24(1) of Schedule 4 of the PLPS regulations remains, and a new route, paragraph 26(2ZB) of Schedule 4, will be introduced.

The existing route uses a two-part regulatory test:

• Firstly, whether the proposed changes to core opening hours maintain, as necessary, the existing level of service provision; and if not…

• Secondly, whether they will maintain a sustainable level of adequate provision in circumstances where this is unnecessary or unrealistically achievable.

The new route gives pharmacy owners more scope to apply to change the dates and times of their core opening hours. For an application to be granted, the proposed new hours must better meet the needs of patients and pharmacy users.

This will no doubt be a welcome development for many community pharmacies, which have struggled to maintain extended hours amid staffing shortages and financial pressures.

Implications for the sector

These reforms mark the end of the last of the four pharmacy-control-of-entry exemptions that were introduced in 2005 (100-hour, large retail parks, one-stop centres, and DSPs), none of which arguably fully delivered on their intended outcomes.

For DSPs, the focus now shifts to delivering high-quality remote services within a more clearly defined regulatory framework. For community pharmacies, the changes offer a more level playing field and greater operational flexibility.

Looking ahead

While the government has not signalled any new exemptions on the horizon, the broader debate continues: should the NHS maintain a control of entry system at all? Some argue for a more open model, with targeted support for rural areas.

For now, however, the emphasis remains on stability, equity and sustainability.

Richard Hough is a partner and head of healthcare at Brabners LLP and a former pharmacist. Thorrun Govind is a solicitor at Brabners, a pharmacist and TV health expert.