EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made under section 13Z1 of the National Health Service Act 2006 (“the 2006 Act”). They confer additional functions on the National Health Service Commissioning Board (“the Board”) in relation to the National Health Service (NHS) in England. The Board is also known as NHS England.

Regulation 4 confers a new power (“the regulation 4(1) function”) on the Board to conclude and manage framework agreements with suppliers and manufacturers of services, drugs, medicines and other substances and products. The services, drugs, medicines, etc. in question are those that are intended to be provided under the NHS for the purposes of preventing, diagnosing, monitoring or treating a physical or mental illness, to provide care to a person or for a purpose related to any of these matters.

The framework agreements will be used mainly by NHS trusts and NHS foundation trusts to enter into contracts with suppliers and manufacturers who are parties to the framework agreements for the purchase of services, drugs, medicines, etc. on the terms and conditions (including price) stipulated in the framework agreements.

Regulation 5 imposes a duty on the Board to provide assistance requested by the Secretary of State for the purposes of the Secretary State’s functions relating to the NHS. This duty applies in the context of the regulation 4(1) function, for example, in how the function is to be exercised or in providing assistance that the Board is able to provide as a consequence of exercising the function.

Under regulation 6, for the purposes of exercising the regulation 4(1) function, the Board must consult and collaborate with every NHS trust and NHS foundation trust through a registered pharmacist nominated by each trust (usually the chief pharmacist) or with the representative of any such registered pharmacist. The consultation and collaboration envisaged includes, in particular, considering the drugs, medicines, services, etc. that are to be the subject of framework agreements to be concluded under regulation 4(1).

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sectors is foreseen.