Closing the “loophole”
Pharmacy applications in rural (controlled) areas – from April 2005  

The first thing to emphasise is that all those so-called market town doctors who were thinking of applying to dispense to their rural patients have had their hopes torpedoed.  They are too late!!!

Readers should obtain a copy (perhaps download one) of NHS (Pharmaceutical Services) Regulations 2005 – Information for PCTs (Control of Entry).   This gives excellent guidance for applicants although their solicitors will need the full Regulations if an application is to be made..

Both The Complete Dispenser and Your own Pharmacy go into some detail about pharmacy applications in rural areas but both were written before the recent changes were announced.   Regrettably, neither GPC nor the DDA would give any advance notice of the changes to be instituted following their negotiations to close the “loophole”, so the description in the books has now become partially inaccurate.

The “loophole” allowed chemists who already had premises within their FHSA area to avoid applying through the Clothier Regulations, thus denying dispensing practices any right to defend their businesses.

This was plainly against the spirit of Clothier yet chemists were incited in 1994 by Mr King, PSNC Assistant Secretary, to take advantage of the provision “quickly” lest the Department amend the regulations.       And, by George, they did and continued to do so until April 1^st this year, 11 years later..

The new regulations are basically the old CLothier which we know and love, with the following additions and alterations. 

The main changes to the Clothier regulations

• Doctors and pharmacists must be notified of applications.   [Not just LPCs and LMCs]

• Pharmacists already on the PCT pharmaceutical list must satisfy the “prejudice” test in future.     [This closes the “loophole”]

• New “reserved” locations with medical lists of less than 2,750 to be designated.    Pharmacies opening here would not have the 1.6km protection and patients will be permitted to remain on the dispensing doctors dispensing list if they wished.   [This removes the automatic loss of dispensing rights of some dispensing practices and allows patients a free choice]

• GPs within 1.6km of a pharmacy will have their application to dispense refused.   [This mostly denies “market town” practices from applying to dispense to their rural patients].

• Dispensing doctors “relocating” will have to satisfy “prejudice” unless the move is “minor” or under “exceptional circumstances.”

• “Minor relocation” is introduced for doctors.

• If a doctor moves to premises more than 1.6km from a chemist, the chemist will have 12 months to decide to follow him.   [This effectively prevents a new dispensing application by a doctor consequent upon the move]

• The amalgamation of a non-dispensing with a dispensing practice will have to satisfy “prejudice” in a new application.   The original dispensing practice may be allowed to continue dispensing to their original patients.   [It is advisable that the dispensing application by the non-dispensing practice be made before the amalgamation to allow for a change of mind if the application is turned down]

• PCTs must notify any patients’ forum or any other patient, community or consumer group serving the PCTs area and which has an interest in the outcome of any application.

• Other patient groups or persons who may not have been notified and who may be affected ma, within a reasonable period, send written representations.

• Pharmacies applying through the “OFT changes” will still have to pass the “prejudice” clause

• “Gradualisation” has been reduced to a suggested 3 months.  The PCT must explain the reasons for its decision the all parties.

• Doctors’ dispensing premises must be registered with the PCT from April 1^st 2005  
  
  
  
• Dispensing doctor premises are now open to inspection by the PCT

The application process for a pharmacy

All pharmacists or “bodies corporate” (including those owned by doctors) applying for entry to the PCT pharmaceutical list must satisfy three provisions:

            Rurality – that the area is not “controlled”

            Prejudice – that the proper provision of GMS or GPS will not be prejudiced

            Necessary or desirable – that pharmaceutical services are needed.

  Rurality – a “controlled area”
PCTs should have very detailed maps which clearly show which parts of their area are rural.   Areas not marked rural are to be taken to be “non-rural” until a decision has been made.   The map should be freely obtainable from the PCT.

Building in a rural area may change its status and reconsideration of an area may be carried out at any time by request of the LPC or LMC.

[Once again, any doctors’ pharmacy company should check that their application to open a pharmacy will not disadvantage a nearby dispensing practice].

Definition of rurality
Rurality has been included here because the Guidance to PCTs gives some indication of a definition where there wasn’t one previously.

There is still no set, hard and fast definition, nor can there be, but the whole matter is discussed on the down-loaded document, NHS Pharmaceutical Services, Regulations 2005 – Information for PCTs,  pp 80-84

Dispensing doctors wishing to open their own pharmacies will not have a problem, even with the new “reserved locality” regulation (above) which appears to give them the edge over an incoming pharmacist.

Factors considered include: environmental, size, employment pattern, transport and other facilities.

Once a decision is made it cannot be changed for five years unless there is a substantial change of circumstances.

Before making a decision the PCT must notify the LPC and the LMC and any affected chemist or GP practice and these bodies have right of appeal to the Appeal Unit in Harrogate (as above).  There may or may not be an oral hearing and the usual conditions, as mentioned earlier, apply.

The “prejudice” and the “necessary or desirable” tests and other matters
One important and vital failure of the GP negotiating teams relates to “pharmaceutical services”.    The regulations still state that dispensing doctors do not provide pharmaceutical services to their patients.  This has always been a disadvantage when a practice has been attempting to defend itself against a predatory chemist.

This means that an applicant chemist does not have to prove that the adverse effect of his new shop on the dispensing doctor service will prejudice pharmaceutical services to the area since, by definition, where there is no chemist there are no pharmaceutical services.

It also means, as there are no pharmaceutical services even though the doctors provide all drugs etc, that a pharmacy is almost certainly “necessary or desirable” to provide those “absent” services.

That is somewhat offset for the smaller dispensing practices in reserved areas, serving a population of less than 2750 patients, because their patients will still be allowed to use the doctors’ services.

However, there is still no protection to the larger rural practices other than that the “loophole” has closed.    They can expect just as many applications through Clothier as before.   It would be as well, therefore, if they were to continue to pre-empt a pharmacy application by forming their own body corporate.

On the other hand, the previous right of so-called market town practices to apply to dispense to their outlying patients has been summarily removed.   Even if they move to a site more than 1.6km from the chemist, the chemist has a year to catch up with them.

Dispensing doctors, therefore, remain more vulnerable than pharmacies although not as vulnerable as previously.

Conclusion
The "loophole" has been closed and, in addition, the LMC/DDA Ltd team have achieved one or two important advantages for dispensing practices.  However, it would not be true to say that every dispensing practice is now secure from further pharmacy attack.  Far from it.

Despite all the claims and earlier boasts of the DDA Ltd, only the small practices seem to be safe and then only until they grow to have a patient population of greater than 2750.  After that Clothier-style regulations come back into play.

Another significant and vital failure of the DDA Ltd team was that dispensing doctors, against all logic, still do not provide "pharmaceutical services" and, therefore remain unable to put up an effective defence to the "necessary or desirable" and, possibly, to the "prejudice" tests.   Presumably the medicines dispensed to dispensing patients are nothing more than sugar pills?

Another important loss to general practice, again illogically, is that so-called market town practices will no longer be able to apply to dispense to their rural patients.  Whereas an equally town-based pharmacy will be able to dispense to those same patients.   To be fair to the DDA Ltd/GPC, it was their intention all the time to donate this important benefit to pharmacy.

David Roberts

(26/4/05)