Health Bill [HL]

My Lords, the noble Earl, Lord Howe, seeks to put a requirement in the Bill for primary care trusts to refuse a new application under the proposed new entry test if that application has an adverse affect on existing primary care services. For the last 20 years, as noble Lords may be aware, whether a pharmacy contractor provides NHS services has been largely determined by the regulatory system known as "control of entry". An application will succeed only if a PCT considers it necessary or expedient to grant it in order to secure adequate provision of NHS pharmaceutical services locally. Over the years, this test has been subject to considerable review by the courts. The test is set out in Section 129 of the National Health Service Act 2006. Clause 24 amends that section to replace the test so that PCTs will in future determine whether a new prospective provider will be admitted to a PCT’s pharmaceutical list—or whether an existing listing can be amended—by reference to, and determined against, its pharmaceutical needs assessment. Regulations will set out the detailed requirements of what must be contained in those assessments and may prescribe matters that a PCT must consider when making a decision on an application. One of our key concerns in proposing this new regime is that it should not be used in such a way that PCTs can simply refuse applications without sound and objective grounds, but I fear that that could well be a consequence of the amendment. It would unduly restrict new entry if it enjoyed special status above all other considerations. I understand that the noble Earl is probing how the regulations will work, how they will be applied and, indeed, the competence of PCTs to ensure that this is done in a proper and appropriate fashion. We must strive to achieve the right balance between appropriate PCT controls and contractor freedoms without imposing undue restrictions or burdens and without severely restricting choice and competition, ensuring that the right considerations are taken into account in terms of rural matters, the elderly and the other issues that the noble Earl identified. Nevertheless, we recognise those concerns, which revolve around the detail of the new regime. That is why we proposed, when we consulted on these measures last autumn, to carry forward a number of factors introduced in the 2005 regulations that help PCTs to reach their decisions. These factors are: the level of access; the choice and diversity of providers or of services; innovation; the services available to specific populations or to meet specific health conditions or disease needs; and the overall long-term impact of approving new applications. We are in fact already addressing the concerns raised by the amendment in the new regulatory framework. Nevertheless, we cannot accept the amendment. There is another reason why we find it difficult to accept. Each application will need close evaluation and the evidence to be weighed. As I have said, the amendment appears to give pre-eminence to one specific factor over all others. The noble Earl also talked about rural areas and asked how those should be taken into consideration. I stress that the safeguards that exist will also continue under the new regime. He asked about PCT capacity. Subject to parliamentary approval, new regulations to be derived from the powers of the Bill will set out the requirements for how and when the assessment should be made, including a time period by which a PNA should be produced and requirements for consultation. Guidance on commissioning pharmaceutical services and more detailed advice and information on the needs assessments and what they should contain were published on 31 March. They are designed to provide a comprehensive support programme for primary care trusts to achieve the necessary capability to be commissioners of high-quality pharmaceutical services. The toolkit on pharmaceutical needs assessment will be published shortly. It is important to give the right kind of support in this area. We believe that our proposals are the right path for pharmacy to follow—otherwise it will remain rooted in the last century. Equally, we recognise that all parties should be given the opportunity to be involved in the technical details of the regulations to come and their implementation. We therefore expect to work closely with interested parties, including NHS and contractor representatives. I hope that I have given the noble Earl sufficient assurance that, as we move forward to a new system such as this, safeguards will be built in and that there is no need to add the specific matters in the amendment. I therefore ask the noble Earl to withdraw his amendment.