Market Entry Regulations

Published on: 20th May 2024 | Updated on: 20th May 2024

Please note: Persons who are not already pharmacy contractors should seek their own legal advice since Community Pharmacy England and LPCs are unable to offer support. The following are links to the relevant regulations and guidance.


Delays with market entry applications 

Briefing

We have produced a briefing that expands upon the requirements of the regulations and highlights the most common reasons for delays in the determination of applications. It is not a substitute for the guidance available, for example from PCSE at https://pcse.england.nhs.uk/resources/pmas-resources but should be of assistance to pharmacy owners who are applicants and those who are not, for example, those who may be selling their pharmacies.

We have produced a guidance document with 10 key points to support applicants and their referees with their market entry applications.

To assist pharmacy contractors:

If applicants are struggling to resolve issues with PCSE and the delays with their application are lengthy, please contact the Regulations Team by email at regulations.team@cpe.org.uk.

We’ll need some basic information on your application, for example, the CAS reference number allocated by PCSE and where it has got to in the process. We will seek to liaise with PCSE and the ICB on your behalf to identify and, if possible, help to resolve the issue that is delaying determination. We may also involve your LPC.

Please note: that you must first follow up on your application with PCSE using its online enquiry form at https://pcse.england.nhs.uk/contact-us or telephone their customer support centre on 0333 014 2884 (who will arrange a call back to you from the market entry team) before we will be able to help you.

Background

Community Pharmacy England has been increasingly aware of delays in the market entry process, which includes change of ownership applications. The process is administered by Primary Care Support England (PCSE) with decisions being made by integrated care boards (ICBs).

The delays appear to be due to a number of factors and issues including:

  • increased pharmacy sales, for example, the sale of hundreds of pharmacies by Lloyds, which has substantially increased the volume of applications and notifications being submitted,
  • delays due to not all the required information being provided by applicants (particularly fitness information) or delays with referees responding to reference requests,
  • delays due to PCSE’s capacity to process the high number of applications, and
  • delays at the ICB decision-making stage of the process.

From 1 April 2013, pharmaceutical lists are maintained by NHS England and so applications for new, additional or relocated premises must be made to the local NHS England Area Team.

Most routine applications for a new pharmacy will be assessed against the Pharmaceutical Needs Assessment for the area, prepared by the Health and Wellbeing Board (HWB). Guidance has been issued to Health and Wellbeing Boards.

The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 set out the arrangements for pharmaceutical lists and the applications that may be made, and the Department of Health and Social Care has issued guidance on these.

 

Click on a heading below for more information.

Paper and Electronic Application forms for inclusion on the pharmaceutical list

The paper application forms for all types of market entry applications are available from Primary Care Support England (PCSE).

If you are ready to move online you can register with the PCSE online portal and submit your application electronically.

Fees for inclusion on the pharmaceutical list

Applications for inclusion in the pharmaceutical list must be accompanied by the relevant fee.  The fees are set out in the Secretary of State Directions of Fees for applications.

ODS Code changes

Electronic Prescription Service (EPS), IT changes, possible ODS code changes and related actions are set out on the Pharmacy change: IT/EPS checklist and guide. Community Pharmacy England recommends that pharmacy contractors planning such changes work through all of this guide and give the notice periods which are suggested within the guidance (ahead of the planned date for the expected change).

Closure of pharmacy premises

Community pharmacy contractors who no longer wish to provide NHS services from their NHS pharmacy premises must provide their local NHS England team with adequate notice.

Generally, contractors must give at least 3 months’ notice to the local NHS England team in advance of the date on which they intend to cease providing pharmaceutical services.

The exception is for contractors with 100 core hours in which case six months’ notice is required.

Community Pharmacy England recommend that contractors notify the local NHS England team by e-mail and/or by letter via recorded delivery. This is to provide an audit trail so that there is proof that notification was sent to the local NHS England team.

Closure of premises notification form NHS England.

There are other key considerations when deciding whether to close a NHS pharmacy or not and contractors should contact their trade association such as the NPA for further guidance and resources.

Primary Care Support England (PCSE)

On 1 September 2015, Capita assumed responsibility for the delivery of most of NHS England’s primary care support services. PCSE (formerly Primary Care Support Service – PCSS) provides administrative and support services to community pharmacies and other primary care providers on behalf of NHS England.

Not all PCS services were transferred as part of the contract with Capita, and some services will continue to be delivered by other organisations – including Commissioning Support Units, CCGs, NHS Shared Business Services and NHS Pensions.

For current services provided by PCSE including their online portal, please see here. If you are not ready to move online, paper forms can be accessed here.

If in doubt, pharmacy contractors should contact PCSE.

Market entry - timelines

From September 2015 the primary care support services functions of NHS England were transferred to Capita.  PCSE have an online portal for receipt of applications, and pharmacy contractors will be able to check progress using that online portal.  Determination of applications remain the responsibility of NHS England’s local offices. Please see FAQ below for further information.

NHS Pharmacy Manual

The Pharmacy Manual (updated in February 2023) outlines the procedures to be followed which are relevant to pharmacy contractors including market entry such as applications to join the pharmaceutical list, change of ownership and no significant change relocation.

There are also extensive appendices which accompany the Pharmacy Manual.

Please visit the NHS England website for guidance, policies and procedure documents.

One of the key aims of the Pharmacy Manual is to try to ensure that NHS England make fair, proportionate and consistent decisions.

Community Pharmacy England guidance

For more information on market entry requirements, please see the following pages:


FAQs

Q. I have made an application. How long does the market entry process take?

It depends on the type of application.

  • Notifiable applications – the determination of the application should be within 4 months of the receipt of all required information and documentation
  • Other applications – 30 days from the date of receipt of all required information and documentation.

The ‘notifiable applications’ are all the routine applications (e.g. current need, future need, improvement or better access, unforeseen benefit) together with no significant change relocations (formerly the minor relocation), applications to open a distance selling pharmacy and pharmacy consolidations.

On some occasions, the information submitted by applicants is incomplete and NHS England requests more information – if this happens, the clock stops and restarts when the requested information is produced.  Changes to the application after submission may be permitted, but if consultation is underway, the consultation may need to be restarted, causing delays.  It is therefore important to ensure all required information is included in the application and that the information is accurate.

On receipt of an application, PCSE will check that the documentation is complete, that the application is accompanied by the fee, and will notify interested parties if it is a notifiable application.  PCSE will also process some of the fitness to practise materials (for example requesting the references, where required). After receipt of comments from interested parties, the application, comments and any FtP information is sent to the local NHS England office for determination.  Some straightforward applications (e.g. change of ownership) may be dealt with by an official at NHS England, but most applications will be considered by a panel.  These panels may have set meetings each month, or may meet on an ad hoc basis where required.

Once the determination has been made by NHS England, PCSE will notify the parties as per the regulations.

PCSE have an online portal for receipt of applications, and pharmacy contractors will be able to check progress using that online portal. When sending applications by post, we recommend using recorded delivery, with a telephone follow up a few days later to ensure it has been received by the right person, and asking for confirmation that the documentation is accepted as complete.  This can avoid waiting several months only to find the original application was not received, or that a request to the applicant for further information has been lost in the post.

If timescales are exceeded and PCSE is unable to give a date by which the application will be determined, applicants should escalate to the Director of Commissioning at NHS England’s local office.

Q. I have been invited to make comments on an Appeal. Do I have to make written representations, or can I just make my representations at the oral hearing?

The Primary Care Appeals Service (the Appeals Service) will inform those who have ‘third party’ appeal rights when an appeal has been made.  This allows the third party to make further representations, but these must be made within 30 days of the notice being sent.  The Appeals Service has flexibility in how it will determine applications and whether or not to hold an oral hearing.  If an interested party has an key point to put across, it is important to make written representations, because  the Appeals Service may decide to proceed without an oral hearing.  If a contractor has been invited to make representations, he would be able to attend and make oral representations if:

(a) he was invited to make representations and did so within 30 days of the notice being sent;

(b) he indicated in his response that if an oral hearing is to be held, that he would wish to make oral representations;

(c) he has identified a matter which the Appeals Service considers would be desirable to hear about at the oral hearing; and

(d) the Appeals Service is satisfied that the person made a reasonable attempt to express his views on the appeal adequately in the written representations.

It is therefore vitally important for a contractor who is invited to make representations, that has salient points to be made in an appeal, to set out  those points adequately in writing, in case no oral hearing is called, and also to indicate whether or not he wishes to attend an oral hearing (if one is called).

Q. Do I have a right to attend an Oral Hearing if one is held?

An applicant or ‘additional presenter’ may attend an Oral Hearing (both at the stage when NHS England considers the application, and if there is a subsequent appeal).  A person is an ‘additional presenter’ only if they have made reasonable attempt to express views about the application which are relevant, and have indicated in their representations, that they would wish to make oral representations at an oral hearing if one is held.  There have been cases where interested parties have been unable to attend oral hearings because they have failed to indicate their desire to attend and speak, so do ensure this point is made in any response.

Q. NHS England have turned down my application. Can I appeal?

Generally, an appeal (except in respect of temporary arrangements e.g. emergencies or because of circumstances beyond your control) is possible provided you notify the Appeals Service with a valid notice of appeal within 30 days of the date on which you were notified of the decision. A notice of appeal is valid if it includes a concise and reasoned statement of the grounds of appeal.

Q. The Appeals Unit have refused my appeal. Can I challenge this?

There is no further appeal within the Regulations against the Appeals Service’s decision. One option to challenge the decision is judicial review. If you have reason to believe that there may be ground/s (for reasons of illegality, procedural unfairness, irrationality etc) for the courts to review the Appeals Service’s decision then you may wish to seek independent legal advice to explore this further.

Q. NHS England have granted an application. I did not make the application but can I appeal?

It depends. A person with “third party rights” may appeal against NHS England’s decision to grant a notifiable application, change of ownership application, temporary listing arising from suspension application or right of return to the pharmaceutical list application.

A person will have third party rights where they are a person NHS England is required to notify about the decision in that in the opinion of NHS England that person’s interest might be significantly affected by the decision. In terms of pharmacy contractors, this person must be:

  • An existing pharmacy contractor (include those entitled to be included in a pharmaceutical list) or;
  • An LPS contractor or;
  • An applicant whose market entry application was considered together with another one

If the potential appeal is regarding a notifiable application then a person with third party rights must have made representations in writing and NHS England is satisfied that those representations (along with any oral representations) make a reasonable attempt to express their grounds for opposing the application and has grounds for opposing the application (i.e. those which do not relate to the legality or reasonableness of the PNA) and are not frivolous or vexatious.

If the notification of the grant of the application is the first you have heard about the application (for example a change of ownership) then you will not have had prior opportunity to comment on the application.

In any event, NHS England is required to set out in the notification letter any rights of appeal that apply, but if you believe you should have a right of appeal and the letter is silent on that point (or if you do not receive notification), then you would need to contact the Appeals Unit and / or seek independent legal advice.

Please note: A person with third party rights must notify the Appeals Service with a valid notice of appeal within 30 days of the date on which they were notified of NHS England’s decision. A notice of appeal will not be valid unless it includes a concise and reasoned statement of the grounds of appeal.

QUICK LINKS

Pharmacy Regulations 2013

For more information on this topic please email comms.team@cpe.org.uk

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