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Consulting on NHS market entry

Dispensing GPs must engage with PCTs over pharmaceutical needs assessments.

The next stage of the PNA process may be the biggest challenge for dispensing doctors
The next stage of the PNA process may be the biggest challenge for dispensing doctors

Consultation on NHS market entry is due to start at the end of July. For dispensing doctors, this brings the hope that some much-needed stability will return to the contentious area of pharmacy openings.

For many doctors dispensing in rural areas, the rethink of the five-year-old market entry rules, which come into effect in April 2011, cannot come too soon.

NHS figures for pharmacy openings in controlled areas show that, during 2008/9, PCTs approved 77 per cent of applications for pharmacies exempt from the control of entry regulations (most, under the 100-hour opening rules).

This compares with the 45 per cent success rate seen by non-exempt category pharmacy applications in controlled areas.

New-look PNAs
The changes to pharmaceutical services market entry comes as part of a general overhaul of PCT commissioning, which started, in earnest, in July last year. Legislation formalising the role of Pharmaceutical Needs Assessment (PNA) as a commissioning tool comes into force on 24 May.

Dispensing doctors have gained important ground during this process: namely, that the contribution of dispensing doctors as providers of pharmaceutical services and the needs of population groups who live in rural or more isolated areas, are properly considered.

The Dispensing Doctors' Association considers this an important 'win', given the focus on extending pharmacy services in the pharmacy white paper, which first prompted the PNA rethink.

Dr Richard West, chairman of the DDA, and an invited guest on the NHS (Pharmaceutical Services) Regulations advisory group, says: 'We believe that the new approach to PNAs should lead to less conflict, due to the greater clarity of approach in application procedures.'

PCTs have until 1 February, 2011 to draft and implement their new-look PNAs, a challenging timescale for trusts that have not yet initiated their PNA overhaul and/or have poor engagement with local healthcare service providers.

Dispensing doctors see this PNA 'writing time' as an important opportunity, at local level, to stake their claim as bona fide local providers of pharmaceutical services, both as a group and as individuals.

Dr West says: 'PCTs have a statutory duty to consult with LMCs so it is important dispensing doctors use this channel to engage with PCTs early, and look at the draft PNA to ensure the practice's own circumstances will not be disadvantaged by the proposals.'

Market entry rules
Although the DoH's advisory group has now passed the PNA drafting baton to PCTs, work continues on redrafting the market entry rules into a new, PNA-centric process.

At this point, it is hard to know the fate of the much-criticised exempt pharmacy-opening categories, although the recently-published evaluation of the 2005 control of entry reforms suggests change will be on the cards.

Whatever the result, dispensing doctors have already ascertained that (apart from administrative improvements), the following shall pass unaltered into law: provisions and procedures for determining rural areas; applications and appeal rights from pharmacies to provide pharmaceutical services to a defined rural area; applications for outline consent and appeal rights for doctors to dispense to patients living in a defined rural area, premises approval, relocations and practice amalgamations, removal from lists; and the concept and application of 'reserved' locations within defined rural areas.

However, yet to be resolved as legislation reaches the early drafting stage are issues such as: the use of supplementary statements in application decisions, to reflect changes to pharmaceutical services since the publication of the PNA; policing condition-specific applications; new rights to legal representation; and the process for applications, for which there is an identified future, but no current, need.

For this reason, the DDA sees the next stage of the PNA process as, perhaps, the biggest challenge for dispensing doctors.

Dr West says: 'It is hard to know whether PNAs are an opportunity or a threat to dispensing doctors. What we do know is that entry will change; it is yet to become clear whether this will be for the better, the worse - or the same.'


  • Advisory Group on the NHS (Pharmaceutical Services) Regulations www.dh.gov.uk/en
What's going to be in a PNA?

When developing their PNAs, PCTs must consider:

  • The joint strategic needs assessment.
  • Different patient groups' needs.
  • Local demographics.
  • Desirability of choice.
  • Different needs in each locality.
  • Arrangements with neighbouring PCTs.
  • Dispensing/other NHS services provided in or outside its area.
  • Likely future needs.

Advice on getting involved:

  • Don't wait to be invited by your PCT to comment on the draft PNA, use your LMC to make a proactive approach.
  • Once the PNA is sent out for formal consultation, in practical terms it will be too late to make significant changes and there is no right of appeal against poorly-constructed PNAs.
  • There appears to be cross-party backing for PNAs: there was no substantial opposition to the PNA provisions as the Health Bill passed through parliament.
  • Once in place, PNAs may not be reviewed for three years.


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