NHS (Pharmaceutical Services) Regulations
House of Lords

Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)

The Department of Health has today laid new NHS (Pharmaceutical Services) Regulations (SI 2012/1909) following consultation.

These regulations:

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; and make provision for managing the transition between the current legislative system and the new arrangements.

This new legislative system is part of our commitment, originally set out in our NHS White Paper Equity and excellence: Liberating the NHS, to ensure NHS pharmaceutical services respond to local needs for high quality and efficient services that support better health and better outcomes for all.

We are publishing on the department's website a final impact assessment to accompany these regulations. It is accessible at: http://transparency.dh.gov.uk/category/ transparency/ias/.

This assessment estimates a net benefit of introducing this new regime of £952 million over 10 years.

Alongside these regulations, we are publishing the department's response to the consultation we held on amending these regulations. That consultation ran from 31 October 2011 to 25 January 2012. The response provides a written overview and analysis of the responses received and a numerical analysis of responses to each question. It also sets out the department's comments on the views received and the action the department has taken where appropriate to address the points raised. The response has been placed in the Library and is available at: http://www.dh.gov.uk/health/2012/07/response-pharmaceutical-market/.

From April 2013, responsibility for making these determinations will pass from PCTs, on their abolition under the Health and Social Care Act 2012, to the NHS Commissioning Board. These regulations will therefore require amendment to reflect the new NHS structure and that responsibility for PNAs will transfer from PCTs to local authority Health and Wellbeing Boards. Work on this has already started with the help of an advisory group with representatives of the NHS, local authorities, contractors, patients and consumers.