On 14 September 2008, the Secretary of State for Health made the National Health Service (Directions by Strategic Health Authorities to Primary Care Trusts Regarding Arrangements for Involvement) Regulations 2008 (the Regulations).

The Regulations are made under the provisions of the Local Government and Public Involvement in Health Act 2007 (the 2007 Act). The 2007 Act, among other things, amends the legal duty on NHS bodies in section 242 of the National Health Service Act 2006 (the NHS Act) so that they are obliged to "involve" patients and the public in the planning and development of health services for which they are responsible (unless implementation of the relevant proposal will not have an impact on the manner in which services are delivered to users or the range of health services available). NHS bodies are defined for these purposes as Strategic Health Authorities (SHAs), Primary Care Trusts (PCTs), NHS Trusts and NHS Foundation Trusts.

In essence, the Regulations make provision for a SHA to direct a PCT not to involve patients and the public in relation to a particular proposal on the basis that such involvement has been or will be arranged by the SHA itself. Such a direction may only be given if (a) the SHA considers that its arrangements are more appropriate for securing efficient and effective involvement than those of the PCT, and (b) the SHA's arrangements would, if made by the PCT, satisfy the PCT's legal duty under section 242 of the NHS Act.

The Regulations also make provision for a SHA to direct that a PCT must act jointly with it to involve patients and the public in relation to a particular proposal, and for the exchange of relevant information between a SHA and a PCT where a direction has been made.

Finally, the Regulations provide that a PCT will not be regarded as being in breach of its legal duty under section 242 of the NHS Act where it is acting in compliance with a SHA direction.