Access to Medical Treatments (Innovation) Act 2016 (c. 9)

Prospective

Database of innovative medical treatments E+W

3 Section 2: supplementary E+W

(1) In section 2, “doctor” means a registered medical practitioner.

(2) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—

(a) the off-label use of an authorised medicinal product, and

(b) the use of a medicinal product in respect of which no [F1 UK ] marketing authorisation is in force.

(3) In subsection (2)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—

(a) for a purpose other than one for which its use is specified,

(b) in relation to a person who is not within a description of persons for whom its use is specified, or

(c) in any other way in which its use is not specified.

(4) In this section—

(a) “authorised medicinal product” means a medicinal product in respect of which a [F2 UK ] marketing authorisation is in force;

(b) “ [F3 UK ] marketing authorisation” and “medicinal product” have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);

(c) “specified”, in relation to a medicinal product, means specified in its [F4 UK ] marketing authorisation.

(5) References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research).

(6) Nothing in section 2 applies in relation to treatment which is carried out solely for cosmetic purposes.

Textual Amendments

F1 Word in s. 3(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in s. 3(4)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in s. 3(4)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in s. 3(4)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)