2017 No. 212

National Health Service, England

F1NHS England (Additional Functions) Regulations 2017

Made27th February 2017

Coming into force1st April 2017

The Secretary of State, in exercise of the powers conferred by sections 13Z1 and 272(8)(a) of the National Health Service Act 20061, makes the following Regulations.

In accordance with section 272(6)(zb) of that Act2, a draft of this instrument was laid before and approved by a resolution of each House of Parliament.

Citation and commencement1.

These Regulations may be cited as F1NHS England (Additional Functions) Regulations 2017 and come into force on 1st April 2017.

Interpretation2.

In these Regulations—

“2006 Act” means the National Health Service Act 2006;

“health service” means the health service continued under section 1(1) of the 2006 Act3; and

“regulation 4(1) function” means the function specified in regulation 4(1).

Additional functions of F1NHS England 3.

F1NHS England is to have the functions specified in regulations 4 to 6.

Power to conclude and manage framework agreements4.

(1)

F1NHS England may conclude and manage framework agreements to facilitate the purchase and supply of a service, drug, medicine or other substance or product to which paragraph (2) applies.

(2)

This paragraph applies to a service, drug, medicine or other substance or product that is to be provided as part of the health service for—

(a)

the purposes of preventing, diagnosing, monitoring or treating a physical or mental illness;

(b)

the purposes of providing care to an individual; or

(c)

a purpose related to any matter mentioned in sub-paragraph (a) or (b).

(3)

In this regulation—

(a)

“framework agreement” means an agreement between F1NHS England and one (or more than one) F2supplier, the purpose of which is to establish the terms governing contracts to be entered into during a given period, in particular with regard to price and, where appropriate, the quantity envisaged; and

(b)

“other substance or product” includes—

(i)

medical supplies within the meaning of section 260(5) of the 2006 Act6;

(ii)

a medical device within the meaning of regulation 2 (interpretation) of the Medical Devices Regulations 20027; and

(iii)

a human blood component.

Duty to provide assistance5.

In relation to the exercise of the regulation 4(1) function, F1NHS England must comply with a request made by the Secretary of State for any assistance the Secretary of State considers necessary or expedient for the purposes of the functions of the Secretary of State relating to the health service.

Duty to consult and collaborate6.

(1)

For the purposes of exercising the regulation 4(1) function, F1NHS England must consult and collaborate with the registered pharmacist, or a person representing the registered pharmacist, of every trust.

(2)

In this regulation—

(a)

“the registered pharmacist” means a person falling within the definition of “registered pharmacist” in section 275 (interpretation) of the 2006 Act who has been nominated by a trust for the purposes of paragraph (1); and

(b)

“trust” means—

(i)

a body in England established by an order made under section 25(1) of the 2006 Act as a National Health Service trust8; or

(ii)

a body included in the register referred to in section 39(1) of the 2006 Act9 (register of NHS foundation trusts).

Signed by authority of the Secretary of State for Health.

O’Shaughnessy

Parliamentary Under-Secretary of State,

Department of Health

27th February 2017

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 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.