Market entry regulations
Market entry regulations
|Pharmacy Regulations 2013|
Please note: Existing pharmacy contractors (i.e. persons already on a pharmaceutical list) who have queries on the Market Entry system, can seek support from their Local Pharmaceutical Committee (LPC). Persons who are not already pharmacy contractors should seek their own legal advice, since PSNC and LPCs are unable to offer support. The following are links to the relevant regulations and guidance.
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 either by the Primary Care Trust, or the Health and Wellbeing Board (HWB). PNAs prepared by PCTs will continue to be valid until the HWB has published its own, who have until 1 April 2015 to do so. Guidance has been issued to Health and Wellbeing Boards and is available here.
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. For help navigating the 2013 regulations, contractors may find page 15 of the HSCIC’s (now NHS Digital) General Pharmaceutical Services report helpful.
Click on a heading below for more information.
Application forms and fees for inclusion on the pharmaceutical list
The application forms for all types of market entry applications are available from NHS England.
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.
Primary Care Support England (PCSE)
PCSE (formerly Primary Care Support Service – PCSS) provides administrative and payment services to community pharmacies amongst others. On 1 September 2015, Capita assumed responsibility for the delivery of most of NHS England’s primary care support services.
Not all PCS services are 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.
NHS England have produced FAQs on the services now provided by PCSE available here.
The summary of the services provided by PCSE document outlines the “out of scope” services and how these are now provided. Pharmacy contractors should review this and the PCSE – Description of Services guidance which indicates the services delivered by PCSE and other organisations to determine what PCSE does and does not provide. If in doubt, pharmacy contractors should contact PCSE.
Future changes to the services provided by PCSE include new arrangements in relation to pharmacy payments – delivering a simplified process for claiming payments via the online portal (anticipated October to December 2016) and pharmacy market entry – enabling straightforward online applications. Applications will automatically be checked for completeness before they are submitted (anticipated April to June 2017).
NHS stationery ordering portal
On 29 March 2016, Primary Care Support England (PCSE)’s online portal for ordering NHS stationery went live across England, and all community pharmacy contractors should have received registration letters. If any queries arise, the PCSE website has a number of helpful FAQs: pcse.england.nhs.uk/help
The online portal will replace the current contacts and channels pharmacy contractors previously used to order NHS stationary.
One query that has been raised a number of times is “Will I be charged for my order?” This question has arisen because the online ordering portal includes prices for many of the items. As stated in the relevant FAQ, contractors will not be charged for standard orders made using the portal. PCSE is committed to ensuring NHS England supplies are ordered responsibly and for this reason, prices for items are included to help contractors make an informed decision about what they need. (Note, there may be a charge for urgent supplies.)
PCSE user panel
Community pharmacies can join PCSE’s user panel to share their experiences and give their feedback on future services. The user panel aims to better understand what is needed from the services being delivered. Pharmacy teams can join now.
Market entry administration - timelines
From September 2015 the primary care support services functions of NHS England were transferred to Capita. It is anticipated that Capita will introduce 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
In April 2016, NHS England published the Pharmacy Manual which 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.
For more information on market entry requirements, please see the following pages:
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, Capita 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. Capita 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, Capita will notify the parties as per the regulations.
Until the online portal is introduced, there is no other way to check progress than to contact the office where the application was submitted. When sending applications, 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 Capita 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.
For assistance on the timescales etc. applicants who are already contractors may contact William Goh, Regulations Officer.
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 Appeals Unit 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 Unit 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 Unit 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 Unit considers would be desirable to hear about at the oral hearing; and
(d) the Appeals Unit 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 Family Health Services Appeals Unit (the Appeals Unit) 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 Appeal’s Unit 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’ Unit 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 Unit 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.