UK: Pharmacy Brief - December 2011

Last Updated: 1 December 2011
Article by David Reissner

Market Entry 2012

The Department of Health has finally published draft regulations that are intended to govern the grant or refusal of applications for NHS pharmacy contracts from an unspecified date in 2012. The expression "control of entry" will be replaced by "market entry", and there will also be rules for market exit.

The draft Regulations are extremely complicated, although the Department has also published guidance.

Here is our simplified guide to some of the key features:

Legal Advice and Representation

The new application procedures will be much more complex, justifying the decision to allow legal representation at PCT hearings – so good news for lawyers!

Routine or Exempt

  • There will be routine applications and exempt applications
  • There will be no more exemptions for 100-hour pharmacies or pharmacies at one-stop primary care centres or large retail parks.
  • 100-hour pharmacies will have to continue to provide services for 100 hours a week and PCTs will not be permitted to change this.

In the PNA or Not? Present or Future?

  • Routine applications will have to spell out whether they are intended to
    • meet a present or future need or fill a gap in services referred to in the local Pharmaceutical Needs Assessment
    • or secure improvements or better access to services listed in the PNA
    • or secure improvements or better access to services that were not foreseen when the PNA was drawn up
  • Applications that would meet a present or future need may not be granted, because the PCT must have regard to various other factors such as:
    • Whether to consider or invite other applications
    • Changes since the PNA was published
  • In the case of future needs, the PCT may make a grant conditional on the occurrence of a future event

If not in the PNA...

  • Applications intended to provide improvements or better access to services that were not foreseen in a PNA will also have to confer a significant benefits on people in the area.
  • But if an application is intended to provide improvements or better access to services not mentioned in the PNA, the PCT must take into account factors such as
    • Whether granting the application would cause significant detriment to proper planning of pharmaceutical provision (in which case the application must be refused)
    • Whether there would be significant detriment to existing arrangements (in which case, the application must be refused)
    • The desirability of reasonable choice
    • The desirability of innovative approaches regarding the delivery of services.

English Language and European Pharmacists

  • All applications by pharmacists who have qualified in Switzerland or elsewhere in the EEA must be refused unless the applicant satisfies the PCT that he or she has a "level of knowledge of English ...necessary for the provision of services".
  • Ironically, the language requirement is proposed just as the Department of Health has changed the Medicines Act to lift the ban on European-qualified pharmacists acting as responsible pharmacists in pharmacies that have been registered for fewer than 3 years.

Preliminary Consent and Conditional Grant

  • There is no longer a right to apply for preliminary consent. Applicants may apply for a conditional grant if they are only able to provide a best estimate of where proposed premises would be. If granted, the applicant must notify the PCT of the address within 6 months of the date on which the decision was sent or, within 6 months of an appeal decision.
  • The 6-month period cannot be extended, and a grant will lapse if the condition is not satisfied.
  • The PCT must notify the applicant within 14 days whether it is satisfied that the notification is valid


The concept of minor relocation will disappear. Relocations will be granted if:

  • The new location would not be significantly less accessible
  • There would not be significant change to existing arrangements;
  • Granting would not cause significant detriment to proper planning of pharmaceutical services;
  • The same services (including enhanced and advanced) will be provided without interruption

Distance Selling Exemption

Internet/mail order pharmacies will remain exempt from the market entry test, but:

  • Applications must be refused unless there is uninterrupted provision during opening hours (so the responsible pharmacist may have to be present the whole time)
  • Applications must be refused unless the PCT is satisfied there will be "safe and effective provision of essential services without face to face contact between any person receiving the services and the applicant or the applicant's staff".

Change of Ownership

Changes of ownership should be simpler, and it will be possible to apply for combined change of ownership and relocation.

Refusal – Adjacent Premises

  • Applications must be refused if the premises are the same or adjacent to premises where services are already being provided and the proposed services are part of the existing business.
  • If premises are adjacent to or "in close proximity to" an existing pharmacy, applications must include an explanation why the application should not be refused.

Processing Applications

  • PCTs will have express power to ask for information or documents.
  • Applicants can ask for a review of the request and can ask for more time to comply
  • If the applicant does not comply, the application is to be treated as withdrawn
  • Because of the restricted rights of appeal for objectors (see below), legal advice should be sought before making written representations to the PCT

PCT Oral Hearings

In view of the complexity of the Regulations, legal representation will be permitted at PCT hearings.


Applicants will have an unfettered right of appeal against the refusal of applications, but objectors will only have a right of appeal against a grant if the PCT decides objectors satisfy a complex criteria. Legal advice will be essential.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

David Reissner
In association with
Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions