New regulations on entry to NHS pharmaceutical market published

The Department of Health has published new Regulations on NHS pharmaceutical services, following consultation.

Laid before parliament, today, the Regulations, NHS (Pharmaceutical Services) Regulations Statutory Instrument SI 2012/1909, which come into force on 1 September 2012:

• replace the current legislative system known as “control of entry”, where decisions, with certain exceptions, are based on whether it is “necessary or expedient” for a Primary Care Trust (PCT) to grant applications for entry to its NHS pharmaceutical services list, with a new regime where PCTs’ determinations are based on needs or improvements identified in the relevant PCT’s local Pharmaceutical Needs Assessment (PNA)
• introduce the concept of “unforeseen benefits” to the overall provision of services allowing applicants to demonstrate innovative ways of providing services or of delivering better health outcomes not anticipated in the PNA
• remove three of the four current exemptions to the “necessary or expedient” test – for pharmacies opening at least 100 hours per week, in designated large out-of-town shopping centres and in large one-stop primary care centres
• introduce a new performance regime for under-performing chemists, which involves a series of graduated actions that PCTs will be able to apply, with removal from the PCT’s pharmaceutical list as an ultimate sanction
• make provision for managing the transition between the current legislative system and the new arrangements.

A summary of consultation responses on these Regulations is also published.

Regulations :

• The National Health Service (Pharmaceutical Services) Regulations 2012
• Schedule 7 to the NHS (Pharmaceutical Services) Regulations 2012 containing transitional provisions
• The NHS (pharmaceutical services) regulations 2012 – transitional provisions guidance: addendum – 31 July 2012

Determinations, Designations and Directions:

• The Schedule 14 Determination and Designation (No.2) 2012
• The Payments to Suspended NHS Chemists (England) Determination 2012
• Pharmaceutical Services (Fees for Applications) Directions 2012
• NHS Litigation Authority (Functions Relating to Pharmaceutical Services and Local Pharmaceutical Services) (England) Directions 2012
• Local Pharmaceutical Services (Essential Small Pharmacies) (Amendment) Directions 2012
• Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2012