Access to Medical Treatments (Innovation) Bill

Debate between Natascha Engel and Heidi Alexander

Friday 29th January 2016 Commons Chamber

[Heidi Alexander]

I have listened carefully to the debate on this group of amendments. Although I know that the hon. Members for Bury St Edmunds (Jo Churchill) and for Newton Abbot (Anne Marie Morris) have concerns about creating excessive bureaucracy, I think those concerns are somewhat overstated. The Bill already requires consultation before regulations are made. I am seeking to ensure that the appropriate organisations are able to have their input into the process. However, in the spirit of cross-party working for which the Minister has developed a fondness this morning, I beg to ask leave to withdraw my amendment 8 and not to press amendment 9.

Amendment, by leave, withdrawn.

Clause 3

Responsible Innovation

Amendment made: 2, page 2, line 26, leave out clause 3 —(Chris Heaton-Harris.)

Clause 4

Effect on Existing Law

Amendment made: 3, page 3, line 19, leave out clause 4 —(Chris Heaton-Harris.)

Clause 5

Interpretation

Amendments made: 4, page 3, line 40, leave out “this Act” and insert “section 2”.

Amendment 12, page 3, line 42, leave out paragraph (b).

Amendment 13, page 3, line 44, at end insert—

‘(1A) 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 marketing authorisation is in force.

(1B) In subsection (1A)(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.

(1C) In this section—

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

(b) “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 marketing authorisation.”’—(Chris Heaton-Harris.)

Amendment 15, page 4, line 1, leave out subsection (2) and insert—

‘( ) 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).”—(George Freeman.)

This amendment makes it clear that the database for which clause 2 provides may contain information about treatments carried out for the purposes of medical research (including, for example, in the context of a clinical trial).

[Madam Deputy Speaker (Natascha Engel)]

We now come to amendment 5. With the leave of the House I will put the questions on amendment 5, 6 and 14 together.