Access to Medical Treatments (Innovation) Act 2016

Year2016


Access to Medical Treatments (Innovation) Act 2016

2016 CHAPTER 9

An Act to make provision for access to innovative medical treatments; and for connected purposes.

[23rd March 2016]

Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—

Introductory

Introductory

S-1 Access to innovative medical treatments

1 Access to innovative medical treatments

The purpose of this Act is to promote access to innovative medical treatments (including treatments consisting in the off-label use of medicines or the use of unlicensed medicines) by providing for—

(a) the establishment of a database of innovative medical treatments, and

(b) access to information contained in the database.

Database of innovative medical treatments

Database of innovative medical treatments

S-2 Database of innovative treatments

2 Database of innovative treatments

(1) The Secretary of State may by regulations make provision conferring functions on the Health and Social Care Information Centre (“the HSCIC”) in connection with the establishment, maintenance and operation of a database containing information about—

(a) innovative medical treatments carried out by doctors in England, and

(b) the results of such treatments.

(2) In this section, “innovative medical treatment” means medical treatment for a condition that involves a departure from the existing range of accepted medical treatments for the condition.

(3) Regulations under subsection (1) may in particular—

(a) confer power on the HSCIC to make provision about—

(i) the information to be recorded in the database, and

(ii) procedures relating to the recording of information in the database;

(b) make provision for and in connection with access to information recorded in the database.

(4) The provision that may be made by virtue of subsection (3)(b) includes, in particular—

(a) provision requiring or authorising the HSCIC to disclose information—

(i) to specified persons or descriptions of person, or

(ii) for use for specified purposes;

(b) provision requiring or authorising the HSCIC to impose conditions to be complied with by persons to whom information is disclosed by virtue of paragraph (a) (which may include conditions restricting the use or further disclosure of information).

(5) Regulations under subsection (1) may be made in relation to...

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