Medicines and Medical Devices Bill

Lord Woolf Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord Woolf (CB) [V]]

I am most grateful to the noble Lord, Lord Lansley, for setting out the position we are in with such clarity. I will add just a few words to explain my involvement. It has already been pointed out that not many of my legal friends who I would expect to be concerned about this are present in Committee today. I am sure that the ones who one thinks of are busily engaged in the Chamber over a different piece of legislation which is causing them greater concern than the proposal here, although I believe that they would not disagree with my comments.

In this House, we naturally think as parliamentarians and are concerned about our process of scrutinising legislation, but bad legislation all too frequently ends up not being disputed in this House. That is not the end of the matter, however: the difficulties it creates then have subsequently to be sorted out, which is frequently done by judicial review in the courts. What the noble Lord, Lord Lansley, has said so well is very relevant to judicial review, and that is an area where I feel that, just as the doctors can comment about this Bill with a certain background of knowledge, I should refer to my entries in the register, which, at least with regard to judicial review, are quite important.

If the courts are to provide scrutiny at a later stage, they must know the purpose of the legislation. That is why what the noble Lord, Lord Lansley, has already said is so important. With blank cheques, the danger is that they can be used for all sorts of purposes. I have been trying, under the leadership of the noble Lord, to ensure that the blank cheques given by this legislation are as restricted as they can practically be, bearing in mind the situation in which we find ourselves.

I agree with what the noble Lord said about the amendments with regard to the present proposals. On the one hand, there is the proposal put forward by the Government; on the other is the proposal that the noble Lord, Lord Lansley, and I have suggested might be appropriate. My view, for the reason he indicated, is that our proposal is better, but, above all, I am attracted by the fact that what the Government are proposing is much better than what was there before. On that basis, with a degree of reluctance, I would be capable of being persuaded that we should accept what the Government offer, whereas I am quite satisfied that we should not have accepted what was there before.

Leaving the matter in that way, I hope that the further discussion which will no doubt take place will enable agreement to be reached on an amendment which achieves what is needed for the purposes I have indicated.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am glad that the Minister said that he was listening, and his amendments are important, particularly the one that makes the principle of the health and safety of the public the key consideration when making regulations under the parts of the Bill relating to human medicines and medical devices. He will be aware that concern was expressed by patient groups, in particular, about the Bill as originally drafted and the implication of the attractiveness provision. That concern takes us back to our first debate on “whither regulation in future”.

If we are not going to be aligned to the European Medicines Agency and are to plough it alone, the UK pharma industry will be at a huge disadvantage unless the Government offer an incentive. It may be a bung—the debate about state aid is very relevant to that—or much faster regulation. Otherwise, it is very difficult to see why the industry would continue to invest in R&D in this country. Its position could be as vulnerable as is the motor car industry as a result of the bumbling ineptitude of the Government in their Brexit so-called negotiation.

It is not far-fetched, it is a legitimate question to ask what on earth the Government really want from medicines and medical devices regulation. They may have issued all sorts of draft regulations, but we are clueless about what they are actually seeking to do. The MHRA is clearly not allowed to talk to anybody about this. I remember when the MHRA would talk to politicians and debate these things. It has clearly been given an instruction not to talk to anyone. We are absolutely clueless about the future direction of regulation. None the less, the amendments are clearly helpful, and no doubt we will consider them between Committee and Report.

I would, however, like to ask the Minister about Amendment 2 and its relevance to Northern Ireland. I understand that, exceptionally, it will be moved in Grand Committee because legislative consent takes three months to get through, which impacts on the Bill’s process. I understand that, but, as Parts 1 and 2 of the Bill affect Northern Ireland, does that similarly affect any amendment to Part 1 or 2 passed on Report? What is then the impact on Northern Ireland legislation?

Overall, however, most of the amendments are a constructive improvement, but we will obviously consider them further between now and Report.