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Health Act 2009

Section 26: New arrangements for entry to pharmaceutical list

291.Section 129 of the NHS Act sets out various requirements under which regulations govern the provision of pharmaceutical services. Section 26 amends section 129 of the NHS Act.

292.Section 129(2)(c) sets out the legislative criteria which a PCT must apply when considering applications from pharmaceutical contractors to be included on a PCT’s pharmaceutical list for the provision of NHS pharmaceutical services or for changes to a contractor’s listing following admittance. These criteria are often referred to as the “control of entry” test. The section inserts new provisions regarding those criteria.

293.Subsection (2) of section 26 amends the criteria in section 129(2)(c) to provide for circumstances where an application must be granted by a PCT and circumstances where an application may be granted by a PCT.

294.Subsection (3) then sets out the circumstances—

  • in which a PCT must grant an application; and

  • in which a PCT may grant an application.

295.Under new subsection (2A), a PCT must grant an application where it is satisfied, having first taken account of what is set out in the statement of its assessment of pharmaceutical needs, and any matters which are prescribed in regulations, that the need for the services or some of the services in the application is established and will be met through grant of the application.

296.Under new subsection (2B), a PCT may grant an application where it is satisfied, having first taken account of what is set out in the statement of its assessment of pharmaceutical needs, and any matters which are prescribed in regulations, that it would secure improvements or better access to pharmaceutical services in its area. The matters prescribed in regulations might include additional criteria such as improvements in access (for example through extended hours), in the choice and diversity of providers or of services in its area (for example, dedicated clinics at evenings or weekends to stop smoking or to review patients’ medications), in innovation in the delivery of services or of services which meet the needs of specific groups of people in the PCT’s area or local health conditions or diseases.

297.New subsection (2C) makes additional provision in cases where a PCT is satisfied that an application meets the criteria for grant of the application required under subsection (2B). First, new subsection (2C) provides that the regulations may set out the manner in which the PCT is to determine whether to grant the application. For example, a PCT might first seek views from local patient representative bodies and other key interested parties where it is minded to grant an application under new subsection (2B). Second, new subsection (2C) provides that the regulations may stipulate certain matters which a PCT must or must not take into account when deciding whether or not to grant an application under new subsection (2B). For example, the regulations might make provision that a PCT must take account of the views of local patient representative bodies concerning the application in reaching its determination. Conversely, the regulations might make provision that a PCT must not take account of other matters in reaching its determination where such matters lead to the refusal of all applications (for example, on grounds of costs alone or of additional monitoring burdens for the PCT) where the criteria in new subsection (2B) are otherwise met.

298.Subsections (4), (5) and (6) of Section 26 modify the existing provisions which enable regulations to specify the circumstances in which two or more applications are considered together by the PCT.

299.Subsection (4) inserts a new subsection (3A) to provide that the regulations may prescribe the circumstances in which two or more such applications may be considered together by a PCT. Subsection (5) amends section 129(4) creating a general power to make provision for the case where two or more applications, taken individually, meet the test under new subsection (2A) or (2B), but taken together, do not.

300.Subsection (6) of section 26 inserts a new subsection (4A) which allows regulations under subsection (4) to include, in particular, the provision mentioned in subsection (5), with or without modification. This new subsection ensures the wording in subsection (5) can be tailored to apply to both parts of the two part test under subsection (2A) and (2B).

301.Subsection (7) introduces a new provision which enables regulations to specify the circumstances in which, and the manner in which, a PCT can invite applications to be included in its pharmaceutical list. For example, this might be appropriate where a PCT has identified, in its first or subsequent statement of needs, areas where there are gaps in provision or where the PCT wishes to secure improvements in access to, or in the choice or quality of, services provided and wishes to invite applications from pharmaceutical contractors.

302.Subsection (8) inserts a new provision which requires PCTs to give reasons for decisions made in relation to all applications received under section 129 and provides that references to a “needs statement” in the section are to the most recently published statement, which will be the statement in force at the time the application is decided.

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