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I wish to speak to Amendments Nos. 101 and 116, which are grouped with Amendment No. 100. Amendment No. 101 seeks to substitute the words,
"lawful if and only if", for "unlawful unless" in Clause 30(1). This may seem rather odd, as it might be thought that the phrases are identical in meaning and effect. However, perhaps I may briefly explain the thinking behind it.
There is a concern in the scientific community that the use of the words "lawful unless" implies that Clauses 30 to 33 are not enabling provisions in the fullest sense; that is to say, it cannot be said that it is lawful to include incapacitated adults in intrusive research if all of the requirements of those clauses are met. The interpretation that might be put on the current wording is that Clauses 30 to 33 are not exhaustive but instead impose requirements additional to any that may already exist at law, either under the Bill itself or under the existing common law of necessity.
The current law is in fact unclear and difficult to apply in a research context. The law of necessity requires that the research is in the best interests of the patient, which as we know is one of the overarching themes of this Bill. But research is rather different from other sorts of activity done for or on behalf of a patient. The nature of research is such that it is very difficult to say at the outset that its outcomes will benefit those patients participating in it, or, indeed, anyone else. In fact it is that very uncertainty that tends to make the research necessary. Research is really about exploring potential opportunities to benefit patients, present and future. So it is sometimes quite difficult to argue that this kind of activity is in an individual patient's best interests, unless one extends best interests to include the opportunity to fulfil the patient's belief in being altruistic.
I therefore share the misgivings of the scientific community about the appropriateness of the best interests test in a research context. If we insisted upon it, it could jeopardise much valuable research work that could be of great value to those suffering from mental illness or impairment, or at risk of suffering from them. If Clauses 30 to 33 are not enabling provisions and the best interests test under common law will continue to apply in addition to them, very considerable problems will persist as researchers attempt to apply the law. We want the law to be clear, but many fear that these provisions are not as clear as they might be.
I turn briefly to Amendment No. 116, which is in this group. There is a concern that the requirements in Clause 31 have been drawn up on the basis of our current understanding of how medical research works and how it benefits individuals. I am not a great one for giving Ministers more order-making powers, and perhaps the terms of the amendment are rather broader than on reflection I would wish, but this may be one case where a power of some kind is desirable to ensure that if there are scientific developments in the future that we cannot anticipate at present, the law can adapt to those without the need for passing primary legislation.
In passing, and in her absence, perhaps I may refer to Amendment No. 102, standing in the name of the noble Baroness, Lady Finlay. I think that it is appropriate for me to speak briefly to this amendment as it chimes in with an amendment that the noble Lord, Lord Turnberg, moved, I think, on the first day of our Committee proceedings. I believe that we have covered the material point in question that the noble Baroness raises in Amendment No. 102, but perhaps the Minister when replying could respond so that there is a reply on the record.