Regulatory changes during the pandemic

Published on: 19th December 2021 | Updated on: 26th August 2022

This page is now archived and will not be updated

Community Pharmacy England worked with HM Government and NHS leaders to provide as much support for community pharmacy teams as possible during the COVID-19 pandemic.

This included amendments to some of the NHS regulations, which are detailed on this page.

Market entry applications

NHS England and NHS Improvement (NHSE&I) announced that, as part of its overall recovery plan to restore services paused during the lockdown, staff would return to their Market Entry roles and resume work to process applications and that full market entry function would be resumed from 1st June 2020.

Many of those with existing applications will have received letters from Primary Care Support England (PCSE) and it is understood that priority will be given to those with applications relating to – business or pharmacy service continuity – or where there are pressing reasons for the contractor.

Business or pharmacy service continuity could include consolidations, closures (for example, as part of a business merger), relocations and change of ownership applications. Pressing reasons for contractors might involve, for example, issues associated with leases and health and safety requirements (e.g. social distancing concerns).

Granted applications where deadlines have passed or where they are close to passing – for example, where there is a Notice of Commencement to be submitted – and other related issues should be raised urgently with NHSE&I.

NHSE&I are seeking to take a pragmatic and fair approach to resolving any issues, with national oversight, and are taking mitigating steps so that issues for contractors and other applicants are minimised.

For more information see our clarification announcement on 28th April 2020.

NHSE&I and Community Pharmacy England sought changes to the NHS regulations to assist the process for contractors as the practical difficulties of keeping to specified timescales during the COVID-19 outbreak may continue. These regulations were drafted some time ago but have been delayed while the whole Amendment Regulation was finalised. They provide that:

Where a six month opening period expires after the Amendment Regulations come into force, this automatically extends to 12 months (amendment to paragraph 34(4)(b)).
Where a three month discretionary extension expires after the Amendment Regulations come into force, this is automatically extended so that it ends 6 months after the Amendment Regulations come into force.
Where a three month discretionary extension expires in the six months before the Amendment Regulations came into force. This extension is revived and the period automatically extended to 6 months after the Amendment Regulations come into force.

Next publication date of Pharmaceutical Needs Assessment

The Department of Health and Social Care (DHSC) announced that due to ongoing COVID-19 pressures across all sectors, the requirement to publish renewed Pharmaceutical Needs Assessments (PNAs) would be suspended until October 2022 – an extra six months.

The announcement followed requests by Community Pharmacy England and Local Authorities and is welcomed by Community Pharmacy England.

In the meantime, before a renewed PNA is published, in most cases Local Health and Wellbeing Boards (HWBs) retain the ability to issue supplementary statements to respond to changes in the availability of pharmaceutical services, where those changes are relevant to the granting of applications.

DHSC has also announced that updated guidance on PNAs will be published this summer, which should assist HWBs and LPCs with the process of renewing PNAs.

Updated template PNA questionnaire 2021

Community Pharmacy England has updated its template questionnaire to help support the local development of PNAs. The template questionnaire is intended to be assist LPCs to support the process by gathering information on the services offered by their contractors. The use of this template pharmacy questionnaire is not mandatory but may prove to be a useful resource to inform any PNA development discussions with HWBs. The template is in line with the regulations and previous guidance issued by NHS Employers, covering all the questions relevant to development of the PNA.

Whilst this information should be known to the Clinical Commissioning Groups (CCGs), LPCs may wish to issue the questionnaire as a useful way to check that the data is as accurate as possible. The questionnaire can also be used to determine future willingness to provide services.

Template PNA pharmacy questionnaire (April 2021)

Supplying medicines to care homes

DHSC has published guidance on new regulations which make COVID-19 vaccination a requirement for people working or deployed in care homes; the regulations came into force on 11th November 2021.

The requirements will apply to community pharmacy contractors who are providing services to care homes, for example, providing a locally commissioned service or delivering medicines to care homes.

The guidance provides information on demonstrating evidence of vaccination, medical exemptions and guidance for visiting professionals, as well as requirements when making deliveries to care homes.

View the DHSC Vaccination of people working or deployed in care homes guidance

NHSE&I wrote to community pharmacy contractors to detail how this will be delivered operationally. Contractors who provide services to care homes will need to:

actively support staff to have their first COVID-19 vaccine by 16th September 2021 (as eight weeks is required between the two doses);
carry out proactive workforce planning to ensure:
only staff who are vaccinated, or exempt, are deployed to a care home from 11th November 2021;
service provision is not disrupted once this regulation comes into force; and
ensure that relevant staff can demonstrate to care home staff, via the NHS COVID Pass service, that they have either had two doses or are exempt.

NHSE&I has also published FAQs, which will be updated on a regular basis, to support implementation of the new regulations.

Read the NHSE&I letter and FAQs

Government's safety net indemnity

The Department of Health and Social Care (DHSC) has confirmed that community pharmacy is covered by the Government’s safety net indemnity provisions in the Coronavirus Act 2020. DHSC has confirmed that the Secretary of State for Health and Social Care has made arrangements with NHS Resolution for the safety net indemnity to apply to community pharmacy, confirming that:

….where COVID related activity on behalf of the NHS is not covered [by existing indemnity arrangements], lawyers have confirmed that the provisions of the Coronavirus Act 2020 (CVA) cover community pharmacy teams.

The Coronavirus Act does give the Secretary of State powers to provide or arrange for the provision of the indemnity described in the Act, but the question is whether those powers have been exercised – whether the Secretary of State has in fact provided or arranged for the provision of that safety net indemnity (see this Community Pharmacy England article for the background). DHSC has confirmed that it has been arranged and the relevant FAQs on NHS Resolution’s website have now been updated to confirm this.

Community Pharmacy England wanted to clarify the position to avoid confusion, particularly around the application of the Government’s safety net indemnity to volunteers delivering medicines to shielded, vulnerable and other patients. If volunteers are not covered by a pharmacy’s indemnity insurance arrangements, they should be covered by the Government’s safety net indemnity.

The answer to question 11 in the FAQs on NHS Resolution’s website, which asks about the indemnity arrangements for community pharmacists, now states:

“…we do not want any indemnity concerns to be a barrier or delay to the response to the coronavirus outbreak. The powers taken in the Coronavirus Act 2020 allow the Secretary of State to provide indemnity for clinical negligence liabilities arising from NHS activities carried out for the purposes of dealing with, or in consequence of, the coronavirus outbreak, where there is no existing indemnity arrangement in place. Under these powers we have made provision for organisations or individuals undertaking NHS activities to respond to the coronavirus to be covered for clinical negligence in these circumstances. This includes those working in community pharmacy delivering pharmaceutical services for the NHS.”

Details of the claim procedure for community pharmacy are expected to be announced in due course.


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