Pharmaceutical Services in England
283.Sections 25 to 29 introduce changes to the way in which PCTs determine applications by contractors to provide NHS pharmaceutical services [DN: Does this term need to be defined in the Glossary of Terms and Abbreviations?] and also introduce new provisions enabling PCTs to take action against contractors for breaches of the arrangements for providing those services.
284.In addition, the sections amend current legislation concerning the provision of local pharmaceutical services (LPS) contracts enabling PCTs to provide services under LPS schemes in prescribed circumstances. Under existing legislation, PCTs can only commission such services.
285.These measures follow a Department of Health consultation in the autumn of 2008 on a series of proposals to amend the structure and legislation of NHS pharmaceutical services, following publication of the Government’s White Paper Pharmacy in England: Building on strengths – delivering the future published in April 2008. A report of the outcome of that consultation, which concerned the measures contained within this Act, was published on 16th January 2009 and is available on the Department of Health website.
Section 25: Pharmaceutical needs assessments
286.Section 25 inserts section 128A in the NHS Act which creates a new duty for all PCTs in England in respect of their assessments of pharmaceutical needs, commonly known as pharmaceutical needs assessments.
287.Section 128A(1) requires PCTs, in accordance with regulations, to undertake assessments of needs for pharmaceutical services in their respective areas and to publish a statement of their first assessment of those needs and any subsequent revised assessment.
288.Section 128A(2) requires regulations to make provision for certain matters relating to the procedures which PCTs must follow when undertaking their pharmaceutical needs assessments. Regulations must stipulate—
the minimum information requirements which each pharmaceutical needs statement must contain;
the extent to which the pharmaceutical needs assessment is to take account of likely future needs for pharmaceutical services;
the date by which each PCT must publish their first assessment; and
the circumstances in which a PCT must undertake a new assessment.
289.For example, the regulations might stipulate that a pharmaceutical needs statement must contain information on the demography of the people in its area and any seasonal trends or variations as well as longer-term population projections and age profiles. It might also, for example, stipulate that PCTs must publish their first statement within six months of the regulations coming into force and that they must undertake a new assessment where important new health data, trends in disease or evidence of the effectiveness or ineffectiveness of certain types of service emerge.
290.Section 128A(3) enables regulations to provide for additional matters or make provision relating to pharmaceutical needs assessments. The additional matters may include the kinds of pharmaceutical services which the pharmaceutical needs assessment must relate to, for example, the provision of certain services such as reviews of patient medication, clinical support for patients starting medication to treat a long-term condition, advice and information to patients or other healthcare professionals. The regulations may also impose requirements on PCTs to consult specified persons about specified matters when undertaking their pharmaceutical needs assessment. The PCT may for example, be required by the regulations to consult local authorities, patient and community groups and local professional representative committees. The regulations may also prescribe the manner in which an assessment is to be made. The regulations may require the PCT to show, when publishing its pharmaceutical needs statement, how it has consulted interested parties. The regulations may also include a range of matters which a PCT must have regard to when making an assessment of pharmaceutical needs. Such matters may include for example—
data on future disease trends;
population forecasts;
information on health concerns which may be specific to the PCT (such as asbestosis in mining areas); and
how the PCT has taken into account the views and comments received as a result of consultation, whether it has accepted or rejected those views and, if rejected, the reasons why.
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.
Section 27: Pharmaceutical lists: minor amendment
303.Section 27 corrects an apparent anomaly in section 129(6)(d) of the NHS Act. Section 129(6)(c) refers to a particular kind of application for inclusion in a pharmaceutical list and was not intended to affect the meaning of “such an application” in section 129(6)(d). The amendment makes clear that the provision in section 129(6)(d) for the inclusion of an applicant on a PCT’s list for a fixed period may apply to any application made under section 129.
Section 28: Breach of terms of arrangements: notices and penalties
304.Section 28 inserts in Part 7 of the NHS Act a new Chapter 5A, consisting of new section 150A, that concerns the issuing by PCTs of notices to contractors and the withholding of payments to contractors by PCTs.
305.New section 150A enables regulations to provide that where a contractor breaches a term of arrangements for providing NHS pharmaceutical services (for example, of a term of service, such as agreed quality standards or of performance in the provision of services) then PCTs will have the power to issue remedial notices, requiring corrective action to be taken or requiring the contractor to refrain from continuing with actions which have led to the breach, within a specified period. The regulations may also enable PCTs to withhold all or part of any payments due to the contractor for a prescribed period in view of such a breach. Powers to withhold payments could be used on their own or in conjunction with the issue of remedial notices.
306.Section 150A(2) requires that any regulations under this section must include prescribed rights of appeal for the contractor against decisions made by the PCT under this section.
307.Section 150A(3) provides definitions for this section.
Section 29: LPS schemes: powers of Primary Care Trusts and Strategic Health Authorities
308.Section 29 introduces changes to section 144 of, and Schedule 12 to, the NHS Act that remove the restrictions in NHS legislation on PCTs providing LPS or to other PCTs, in certain circumstances, for example, in the event of any emergency such as a flu pandemic or where there was no alternative provider. Where a PCT is a provider of LPS within its own area it is intended that the LPS commissioner would be the Strategic Health Authority.
