Home Control of Entry
The Control of Entry system, introduced in 1986 and reformed in 2005 is again subject to review. In the White Paper: Building on Strengths - Delivering the future, it was proposed that the current test would be replaced by one based on the Pharmaceutical Needs Assessments prepared locally by PCTs. The Health Act 2009 introduced the legislative framework for Pharmaceutical Needs Assessments and these were required to be published by 1 February 2011.
UPDATE JANUARY 2012
The consultation period has now come to an end (as of 25th January 2012) and the findings will be analysed and discussed. As soon as an announcement about any decisions reached is made, the information will appear both on this page and as a main news story on the PSNC home page.
UPDATE OCTOBER 2011
PSNC has welcomed the publication of a consultation on the NHS (Pharmaceutical Services) Regulations 2012, which will introduce the Pharmaceutical Needs Assessment (PNA) as the basis for decisions on market entry.
The regulations, published for consultation today by the Department of Health, will see the PNA based test replace the current 'necessary or expedient test' and remove the need for three of the exemptions from the control of entry test, including the 100 hours exemption.
More information, including the consultation document itself, can be found here.
UPDATE JULY 2011
Since the decision taken in April not to proceed to consultation on revised market entry regulations, PSNC has received many requests for further information. This is the information we have at present:
Q. When will an announcement be made?
A. The Minister has still to decide whether and if so when to consult on changing to a PNA based market entry test. When that decision is made, then there will be further update to this website.
Q. As the announcement states 'the question of whether, and when, we should move to a system of [PNA based market entry test]' - does this mean that the Minister might decide not to make any changes?
A. In theory, Yes. The Minister may decide that the proposals for a PNA based test (which were introduced by the previous government) should not proceed. Of course the Minister could also decide to continue, or could decide to make other arrangements for market entry. But, the PNA based test was a feature of amendments made to the National Health Service Act 2006, and whilst the Health and Social Care Bill, which is currently going through Parliament has proposed modifications to the PNA based test, the current government has given no indication that it intends to remove that test from the Act. Until the Minister has made a decision, it is impossible to speculate as to what decision might be taken.
Q. Has the control of entry test changed?
A. No. Pending any decision as above, the current control of entry provisions continue in operation - ie, a necessary or expedient test, with four exemptions (100 hours, large retail developments, one stop primary care centres and distance selling pharmacies.
Q. Can the PNAs be used in support of new applications without new Regulations?
A. Yes. The PNAs that have been published by PCTs can be taken into account by PCTs when determining applications under the necessary or expedient test.
Q. Is the exemption for 100 hour pharmacies going to continue?
A. Unless and until regulations are changed, the 100 hour exemption (as well as the three other exemptions) continues to be available.
Q. The growth in the number of 100 hour pharmacy applications is causing lack of confidence for pharmacy contractors. Is PSNC doing anything to address this?
A. PSNC has been pressing for a moratorium on the further use of the exemption, pending the introduction of a PNA based market entry test. The Department of Health's position is that it would need secondary legislation to enable it to introduce a moratorium and before government could bring in such legislation, it would be required to consult. It is thought that consulting on a proposal to introduce legislation to effect a moratorium would prompt a substantial number of applications seeking to beat any deadlines. There were many applications during the first three months of 2011 when many people expected the exemption to be removed from April - so it is likely that consulting on a moratorium would also result in a large number of applications.
UPDATE APRIL 2011
The second stage of the reform was widely expected to be introduced during 2011. This involves revising the control of entry regulations, to require the PCT to assess applications against the needs identified in the PNA. The Department of Health announced on 4 April 2011 that revised market entry regulations would not be introduced in April, saying
We are considering carefully, the question of whether, and when, we should move to a system of NHS market entry aligned to local assessments of pharmaceutical need.There are a number of inter-related developments, not least of which is the outcome of the pharmacy Cost of Service Inquiry, which is nearing completion. We need to take these fully into account. We therefore expect to reach a decision on these new provisions once we have considered all relevant factors.
PSNC is disappointed that the Department of Health has chosen to delay its consultation on implementing new proposals for market entry based on Pharmaceutical Needs Assessments (PNAs). Market entry arrangements for pharmacies must strike a delicate balance: preserving patients’ ability to access to high quality NHS services, avoiding undesirable gaps in provision, and maintaining pharmacy’s ability to deliver the kind of cost effective, community based services that this Government has so strongly endorsed. Arrangements that do not achieve these objectives could seriously hinder the development of the NHS pharmacy service, and PSNC will continue its work to ensure this is understood by the government.
The 'Control of Entry' test has been a feature of the NHS (Pharmaceutical Services) Regulations since the late 1980s. Under this test, an application for inclusion in a pharmaceutical list will be granted only if it is necessary or desirable to grant the application in order to secure, in the neighbourhood in which the premises from which the applicant intends to provide the services are located, the adequate provision, by persons included in a pharmaceutical list, of the services, or some of the services, specified in the application.
There are four exemptions from this test:
1) New One Stop Primary Care Centres;
2) Large retail developments;
3) Pharmacies undertaking to provide pharmaceutical services for at least 100 hours per week;
4) Pharmacies providing pharmaceutical services wholly by mail order or internet.
Click on the link below to view the regulations in which the control of entry provisions and the exemptions are set out.
NHS (Pharmaceutical Services) Regulations 2005
The Department of Health has also issued a number of resources to guide pharmacy contractors and PCTs about the control of entry provisions (and includes a link to the updated list of approved retail areas for retail shopping areas greater than 15000 square metres). You can access this information by clicking the link below:
DH guidance, including updated list of approved 15000 sq m developments
Guidance on Control of Entry
The Department of Health has issued guidance to Primary Care Trusts on the control of entry provisions. Click on the link below to access this guidance (last updated September 2009)
DH guidance to PCTs on Control of Entry
For guidance on the Control of Entry Regulations, existing contractors should contact PSNC's Aylesbury Office. Persons who are not already on a pharmaceutical list should contact the relevant Primary Care Trust
Application for Inclusion in a Pharmaceutical List
The Department of Health has produced a standard template application form, for use by applicants seeking to have their premises included in a pharmaceutical list. Please note, however, that the use of this form is not mandatory. Click on the link below to view the standard template.
Note: applicants should also read the guidance on control of entry (see above).
DH application form for inclusion in a pharmaceutical list (PDF Format)
DH application form for inclusion in a pharmaceutical list (MS Word Format)
Fees for applications forinclusion on the pharmaceutical list
Applications for inclusion in the pharmaceutical list must be accompanied by the relevant fee. The fees are set out in Directions issued by the Secretary of State.
Secretary of State Directions of Fees for applications
Further Advice
Pharmacy Contractors (i.e. persons already on a pharmaceutical list) who have queries on the Control of Entry system, can contact Steve Lutener, at PSNC 0207 2422 956 for advice.
Note: Persons who are not already pharmacy contractors should seek their own legal advice, since PSNC is unable to offer support.
DOWNLOADS: Some documents are available in PDF format, you will require Adobe Acrobat Reader 5.0 or later for viewing which can be downloaded from the Adobe Website
DOWNLOADS: Some documents are available in ‘Microsoft Word’ format. If you do not have Microsoft Word, you can read these forms by downloading the free 'Word Viewer'. This program can be downloaded at the Microsoft website