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

Relocations

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.

Appeals

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.

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