Not much glory, but thank you very much.
Before I talk about the amendments I intended to speak to, I want to comment on the amendment tabled by the noble Lord, Lord Lansley, and the comments that the noble Lord, Lord Hunt of Kings Heath, just made, which I absolutely agree with.
The noble Lord, Lord Lansley, is right about innovation. It should be part of the Bill, together with clinical trials. As he rightly said, we are a nation that excels, and has done for more than 20 years, in discovery science, particularly in biology and molecular biology. He mentioned Nobel prizes: the United Kingdom has won 29 Nobel prizes in medicine and physiology, and 29 in chemistry, two subjects often linked with discoveries in biology.
However, as the noble Lord, Lord Hunt, said, we are poor at taking the biology forward into innovations and drug development. We have some fantastic universities for drug development, but for that they require a strong allegiance with the NHS. The science base needs to be integrated with our NHS and its data, including patient data, to develop drugs. That is what we lack. He is absolutely right. I hope that we will have another opportunity to address this matter. Are our policies on how drugs are procured and assessed holding us back? That is a good debate to have, and it is a pity we are not having it today.
I have already said that I support Amendment 16, in the name of the noble Lord, Lord Lansley; I also support Amendment 20, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to my own amendments—Amendments 21, 61 and 82—which are supported by the noble and learned Lord, Lord Mackay of Clashfern, who could not be with us because he is in the Chamber.
With regard to government Amendment 14, I have said before, and I repeat now, that the construction is open to the interpretation that the attractiveness of the UK is to be treated as part of what promotes public safety. If so, the amendment would not address—indeed, it would appear to prevent—the argument being made that attractiveness and the safety of medicines and medical devices can sometimes be in conflict. The consideration of attractiveness can undermine the consideration of safety. This is in line with the Government’s repeated assertion that attractiveness is never in conflict with safety.
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In essence then, the amendment appears to make little substantive change. The third point raised under this head also relates to the arguments on the promotion of public safety. The very slight amendment to the attractiveness paragraphs in Clauses 1, 8 and 12 means that the appropriate authority must consider
“the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”
The change relates to the insertion of the words “likelihood” and “being seen”. That does nothing to address the concern that the original clause lacked a definition of attractiveness—the implication being that that is subjective. The amendment retains, and indeed makes explicit, the idea that attractiveness will be judged by discretionary judgment, with no statutory guide as to the perception of the UK as being attractive.
The explanation of the amendment in the letter from the noble Lord, Lord Bethell, is brief, simply stating:
“This is a clarification of the definition of attractiveness”.
However, attractiveness is not defined, except in relation to its subjectivity. In my view, that achieves little of any substance, so I am not too sure what the government amendment is trying to convey.
I shall now move on to my amendments. The Bill in its current form says that the appropriate authority must have regard to three considerations—the safety of medicines, their availability, and
“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines.”
As I have already said, there is no definition of attractiveness in the Bill; neither is there an explicit prioritisation of patient safety, as we have already discussed several times. This leaves it open to the Government to use the attractiveness provision as a vague and ambiguous term to serve whatever ends they see fit, with no appropriate legislative constraint in place. That is repeated in Clause 8, with regard to “Power to make regulations about veterinary medicines”, and Clause 12, with regard to medical devices. So the
points made here, in connection with this amendment, apply equally to similar amendments tabled to those clauses.
In principle, the attractiveness of the UK as a place to conduct clinical trials and supply medicines, veterinary medicines and medical devices is desirable, to ensure the success of our life sciences industries, and access to improved treatments and innovations. But it must not come at the cost of patient safety.
The Cumberlege review highlighted concerns that the previous regulatory framework—for medical devices, for example—relies heavily on industry self-regulation, and recommended overhauling the regulatory framework to ensure that patient perspectives and public interests take priority over industry interests.
In my view, the attractiveness clause gives rise to a number of unanswered questions. How is the UK to be made more attractive as a place to conduct clinical trials, set up businesses and market medicines and medical devices? What measures might the Government justify in future, using attractiveness under these broad powers, requiring a lesser degree of scrutiny than would otherwise be the case? Is this going to lead to safety being traded off against attractiveness post Brexit, as the UK outside the EU loses some of its competitiveness in the life sciences sector? Will the interpretation of attractiveness further enhance the interests and voices of industry?
New legislation, in my view, must not leave room for the UK to become a wild west of medicines and medical devices, in a bid to remain an attractive place to do business. Our amendment provides a more specific definition of attractiveness to mitigate some of these concerns. It narrows the definition to that of facilitating supply and demand of medicines, veterinary medicines and medical devices under the respective clauses, and as being favourable to the establishment of research, design and manufacture. There is currently no commitment in the Bill to prioritise patient safety over other considerations of liberty and attractiveness. The Government have stated their commitment to safety at all stages of the Bill so far, yet that is not backed up in the Bill by any concrete provisions. The amendment addresses that by prioritising safety over those other considerations.