As part of the Department of Health’s (DH) review of pharmaceutical services, the Health Act 2009 placed a duty on each primary care trust (PCT) to:

  • assess needs for pharmaceutical services in its area; and
  • publish a pharmaceutical needs assessment (PNA).

PNA’s will be used to determine market entry to NHS pharmaceutical services provision. The purpose of the draft National Health Service (Pharmaceutical Services) (Amendment) Regulations 2010 (regulations) is to make provision for these requirements.

The new obligations, stemming from the regulations, will apply to every PCT established on or before 1 April 2010 and are comprehensive. PCT’s will be required to:

  • assess the provision of pharmaceutical services in its commissioning area;
  • assess specific matters for consideration as listed in the regulations (these include for example the different needs of different members of different groups in the PCT’s area, the demography of the PCT’s area, the benefits of choice regarding pharmaceutical services)
  • consult broadly within its commissioning area including with specified bodies; and
  • each PNA will have to contain certain information listed in the regulations; importantly, this is a recurring obligation on PCTs and each PCT will have to publish a revised PNA within ten months of the PCT’s commissioning area being varied under section 18 of the NHS Act, or, within three years of its previous publication.

Consultation by the DH on the draft regulations and accompanying guidance is expected to close on 28 February 2010. Subject to the outcome of the DH’s consultation, the regulations are anticipated to be laid down in March 2010 and effective from April 2010 with PCT’s being required to publish their first PNA by 1 February 2011.

Further information on the DH consultation and a copy of the draft regulations can be accessed here.