To ask Her Majesty's Government whether they will make provision for pharmacy contractors to appeal against pharmaceutical needs assessments carried out by primary care trusts as set out in the Health Bill; and, if so, what form such an appeal process will take. [HL1785]

To ask Her Majesty's Government whether provision will be made for an appeal process where (a) a primary care trust has failed to identify a service need in its pharmaceutical needs assessment (PNA), or (b) a primary care trust decides that a particular pharmacy application will not meet the need for services as set out in its PNA; and, if so, what form such an appeal process will take. [HL1786]

To ask Her Majesty's Government what assessment they have made of the future role of the NHS Litigation Authority with regard to provisions in the Health Bill relating to pharmaceutical needs assessments. [HL1787]

To ask Her Majesty's Government what mandatory parameters primary care trusts will be obliged to take into account when determining their pharmaceutical needs assessments as set out in the Health Bill. [HL1788]

We do not consider it appropriate to award specific appeal rights to specific parties in respect of the pharmaceutical needs assessments (PNAs) carried out by primary care trusts (PCTs). Instead, the Health Bill proposes that regulations will set out specific matters to which a PCT must adhere when formulating its assessment. Such matters must include the information to be contained in these assessments and may, in particular, make provision requiring consultation with specified persons about specified matters, the manner in which an assessment is to be made and matters to which a PCT must have regard when making an assessment. Consequently, we do not consider that PCTs will usually fail to identify service needs in their assessments since the Bill already contains powers to enable the regulations to make particular provision as to the pharmaceutical services to which their assessment must relate and to consult as required.

If a PCT subsequently failed to identify a service need, did not adequately address how such needs were already being met locally or otherwise did not comply with the requirements of the relevant regulations then we would expect the PCT or strategic health authority to identify this and for the PCT to take appropriate action to correct the failure.

The Health Bill contains provisions to enable the Secretary of State for Health to set out in regulations the circumstances in which a PCT must make a new assessment. It would also be open to an aggrieved person to challenge the adequacy of a PCT's assessment of pharmaceutical needs through the courts by means of a judicial review application.

We would expect the regulations to set out the rights for parties to appeal decisions of PCTs not to grant pharmaceutical applications using the existing powers in the National Health Service Act 2006 and to follow the procedures currently used in such cases. The NHS litigation authority is constituted to hear appeals of such decisions and its procedures are well established so we anticipate that it will continue to hear appeals when the new test is brought into effect. Where the NHS litigation authority considers that the PCT's assessment of local pharmaceutical needs did not comply with prescribed requirements and that, as a result of this, the PCT would have been unable to undertake a proper assessment of whether or not to grant the application, then it would be open to it to make such a finding. In such a circumstance, the PCT would need to review its PNA and reconsider the application accordingly.

Further information about the likely content of regulations relating to PNAs is given in the Explanatory Notes and supplementary information on secondary legislation accompanying the Health Bill. In summary, the regulations must set out the minimum information requirements which each assessment must contain and the procedures for publication and undertaking a new assessment. For example, the regulations might stipulate that a PNA 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. They might also stipulate, for example, that PCTs 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.

The regulations might also include the kinds of pharmaceutical services which the PNA must relate to, for example, the provision of certain services such as reviews of patient medication and clinical support for patients starting medication to treat a long-term condition.