Clause 29 - Prohibition of commercial dealings in human material
Human Tissue Bill
5:00 pm
Mr Andrew Lansley (South Cambridgeshire, Conservative)
I beg to move amendment No. 155, in
clause 29, page 20, line 10, at end insert—
'(e) material necessary for the conduct of clinical trials of pharmaceutical preparations or products (including diagnostics and medical devices).'.
The amendment relates to another part of the clause on which we seek the Under-Secretary's help, either in explaining or considering it. The point has to do with the conduct of clinical trials. If one were simply consenting patients for the trial itself, the immediate response of the patient to treatment would not really be affected. If we are talking about the sort of clinical trial that involves the collection of tissue samples and subsequent examination, that might involve the tissues being transferred from a number of centres to some kind of co-ordinating centre that provides a service in relation to the clinical trial, perhaps on a commercial basis. It might involve research companies, charities and the NHS itself. The Under-Secretary is only too familiar with how that works.
The question is how that is to be dealt with. Does it follow that that will be illegal, because the taking of the tissue samples must be covered by the consents making it lawful under the legislation, and therefore must be regulated by the authority and licensed? Do we need to
be concerned that clinical trials of that kind will not necessarily fall within such definitions, and therefore need to be excepted from the Bill? I suppose there are one or two aspects of clinical trials themselves, such as advertising for people to participate in them or the process of payment for the transfer of tissues between those in them, that raise exactly the kind of issues that we have debated under amendment No. 152. They are not within the regulatory structure of the authority for giving licensing premises, licensing individuals and regulating consent for the activities themselves, but go beyond that into commercial dealing. As I understand it, the authority cannot make commercial dealing legal; it has to regulate what it regulates, and commercial dealing, outwith what it regulates, is illegal. There may be a risk, particularly where advertising is concerned, of it being rendered illegal but perhaps the Under-Secretary will help us on that matter, too.