Pharmaceutical Services – Market entry and market exit


The Department of Health has launched a consultation on market entry and market exit.  PCTs should consider the proposals and respond before the consultation closes on 25 January 2012

Department of Health Consultation:

The Health Act 2009 introduced proposals from the White Paper of 3 April 2008 into the NHS Act 2006.  Amongst other matters, this included three provisions:

  • Primary Care Trusts to develop and publish local pharmaceutical needs assessments (PNA);
  • Primary Care Trusts to use PNA as the basis for determining market entry to NHS pharmaceutical services provision; and
  • Primary Care Trusts ability to take action against chemists with regard to Quality and Performance, which may result in market exit.
The first provision:

The first provision was enacted in the NHS (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010 (S.I. 2010/914) and came into force on 24 May 2010. PCTs will have published their first PNA by 1 February 2011.

The current consultation:

The second and third provisions relating to market entry based on PNA and Quality and Performance measures including remedial actions and market exit provisions form the basis of the current consultation, which commenced on 31 October 2011 and concludes on 25 January 2012.  The relevant sections of the NHS Act 2006 are 129(2A), (2B) and 150A.

It is proposed that the current regulations are replaced by The National Health Service (Pharmaceutical Services) Regulations 2012 (“the 2012 Regulations”) with the current ‘control of entry’ test replaced by the ‘market entry’ provisions and local ‘Discipline Committee’ requirements replaced with ‘market exit’ provisions similar to those for other primary care contracting professions.

The current consultation can be accessed at:

Action for the PCT:

In addition to the draft 2012 Regulations, the Department of Health has published comprehensive draft guidance documents that the PCT may wish to consider.  It will be a matter for each PCT whether to respond to the consultation but we would urge all those involved in pharmaceutical decision making to review the proposed changes and consider how these would impact on your processes and procedures.

Hempsons will be providing training sessions once the consultation has closed and the legislation finalised but are happy to assist in advising on the current proposed changes and their impact.


© Hempsons 2014