Only a few days to go: We’re raising £25,000 to keep TheyWorkForYou running and make sure people across the UK can hold their elected representatives to account.Donate to our crowdfunder
In Amendment No. 106, I take a slightly different tack from that adopted by my noble friend. As I said earlier, I think that the words "have the potential to" are the only appropriate words in the context of research, which is, by definition, exploratory. I agree fully with what the noble Lords, Lord Hunt and Lord Turnberg, said in that connection.
Having said that, I am sympathetic to my noble friend's wish to insert the word "directly" here. Surely, we are talking about two distinct types of research in paragraphs (a) and (b). Paragraph (a) is research where there is a possible benefit to P; and paragraph (b) is research where there will be no benefit to P, but potential benefits to other people.
That is a perfectly valid distinction; it is undesirable to blur the line between the two. I am not happy that, as the clause is now worded, the first category could include research where the potential benefits to P are not direct therapeutic benefits at all, but benefits that are, at best, indirect and certainly nothing to do with the patient's actual condition. For example, the patient may be suffering from an irreversible genetic condition. The research conducted on him may be designed primarily to benefit a family member with the same genetic profile. In the loosest sense, the research could be taken as benefiting P, but it would not be of direct benefit to P. That sort of research should rightly fall under paragraph (b), but it would get in under the wire of paragraph (a).
What is the merit in not being absolutely clear cut about the distinction? It is a distinction that matters because the wording of Article 17 of the European convention makes a particular point of distinguishing research that has,
"the potential to produce real and direct benefit to [the person's] health", and research that,
"has not the potential to produce results of direct benefit to the health of the person".
The second sort of research may be authorised only under exceptional circumstances. I have resisted the idea of introducing the word "real" here—as I said, the convention talks about "real and direct benefit"—because I am not at all sure what the word "real" means or what force it carries. But the word "direct" has a very clear meaning and reduces the potential for lines to be blurred. If the European convention contains it, why have the Government not included it?