Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Debate between Lord Warner and Baroness Manzoor

Thursday 7th March 2019 Lords Chamber

[Lord Warner]

The Minister does not need to convince me; she needs to convince the industry. It is simply not convinced by the changes that have been introduced. These are the companies earning their living in this sector day to day. The Government have a lot of work to do to try to convince the industry that they have not damaged the exclusivity period for many of these biotech companies. They are the people who have done the briefing on this and the Government—not the Minister personally—have failed to convince them, just as they have failed to convince them by going back on the kind of assurances about no more bureaucracy that the noble Lord, Lord O’Shaughnessy, gave to the industry in July 2017.

[Baroness Manzoor]

My Lords, I would like to think that I am trying to convince the noble Lord as well as the industry. I reassure him that we work closely with industry and take its views seriously. As I was saying, maintaining the start of data exclusivity as the date of first authorisation in the UK or EU should incentivise parallel applications to the EU and UK and thus help to mitigate any risk of delays in innovative products being brought to the UK for licensing. This is an appropriate way to address, through the powers in the EU withdrawal Act, something that would otherwise present a risk to public health in the UK. However, we have committed to reviewing this position and of course we will continue to work with industry on this issue.

There were a number of other questions; I will go through those very quickly to ensure that I have not missed anything. The noble Lord, Lord Warner, and the noble Baroness, Lady Wheeler, asked what assessment of impact on EU researchers and clinical trials there will be. The Government recognise the need for accessing highly skilled researchers and the clinical trials research delivery workforce. The Government have published our immigration White Paper and are working with stakeholders to ensure that, after exit, the system will support researchers and clinical trials. Of course we recognise that the clinical trials research delivery workforce is important.

I have a brief note on the comments from the noble Lord regarding industry. As I said in my opening comments, it is a priority for the Government to ensure that the UK continues to be a competitive destination for life sciences companies from around the world, in any Brexit scenario. The Government are committed to maintaining our world-renowned strength in science and research and plan to increase R&D expenditure to 2.4% of GDP by 2024. Since the referendum, we have seen many signs of industry’s continued confidence in the UK. In 2017, we received the highest level of life sciences investment in Europe, and worldwide were second only to the US. In the same year, UK biotech initial public offerings raised twice as much money as in 2016. That is a strong vote of confidence.

I end by stating very clearly that the effect of these three sets of regulations is to ensure continuity in the area of medicines, medical devices and clinical trials in a no-deal EU exit. The department has sought to minimise any disruption to patients and industry; to make sure that UK regulators can still protect public health; and to ensure that the UK’s life sciences sector contributes, and continues to be a world leader in clinical research and the pharmaceutical sector. This legislation does not prevent future changes we may wish to make to ensure that the UK maintains a competitive regulatory environment and remains one of the best places in the world for science and innovation. With the assurances I have given, I hope that the House will approve these important SIs. I commend them to the House.

NHS: Accident and Emergency Departments

Debate between Lord Warner and Baroness Manzoor

Tuesday 5th February 2019 Lords Chamber

[Baroness Manzoor]

My Lords, the noble Lord is absolutely right: performance targets are important. However, we must ensure that the NHS is focusing on clinically appropriate targets. The clinical review of standards is considering standards for both physical and mental health. Following its interim findings, any recommended changes will be carefully field-tested across the NHS before they are implemented. An impact assessment will be published and changes to the NHS constitution will be consulted on, as is legally required.

[Lord Warner (CB)]

My Lords, I remind the Minister that 12 years ago, when I was the ministerial enforcer of the four-hour A&E target, the royal college came to plead with me not to abandon it. Its arguments were not only the ones made by the noble Lord, Lord Hunt, but that this target had caused acute hospitals to reorganise their affairs much more efficiently. How will getting rid of the four-hour target impact on the Government’s drive to improve the efficiency of the NHS?

[Baroness Manzoor]

My Lords, I have already said that performance targets are important. The Academy of Medical Royal Colleges released a statement on 30 January, which said:

“Reviewing, updating and improving the clinical standards to ensure that they remain relevant and appropriate is sensible and overdue. We support an evidence based review that is driven by clinical considerations as to what is appropriate, that informs and promotes changes in service delivery where needed and involves wide input from all relevant parties … any review may suggest change or reinforce current measures”.


I could not have put it better myself.

Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019

Debate between Lord Warner and Baroness Manzoor

Wednesday 9th January 2019 Grand Committee

[Lord Warner (CB)]

Before the Minister responds, I have a relevant point. I have sat here listening interestedly to this debate over the last 40 minutes or so; I am waiting to speak on some later regulations. If the Minister could say that she was willing to take matters away in the light of the comments made in Committee for further consideration by the Government, or to withdraw the regulations while that was happening, it would speed up the consideration of these regulations. I think the Minister might take advice very quickly on that issue because we are going to go through the same issues on regulation after regulation. Unless there is some capacity for the Government to respond to the concerns that are being expressed, not just about this set of regulations but on the others as well, we are going to be here for a very long time.

[Baroness Manzoor]

My Lords, it will be a matter for the Grand Committee in terms of how it wishes to proceed. My role today is to enable the scrutiny of the statutory instruments and give the reasons and the arguments as to why they have been put before the Committee for its consideration. It is above my pay grade to take them away and come back. We are here to deal with these three regulations, and I intend to do so.

I wanted to close off the wider debate because much of the debate has not really been about the content of the regulations but about the impact of SIs generally. As the noble Lord, Lord Tyler, said, he has used this Sitting because he felt that no opportunity had been given to him and others to have the debate on the Floor of the House. Again, that is of course not within my remit, but I have listened to what the noble Lord has said and I am sure the Chief Whip and others will hear it. It is open to him and other noble Lords to talk to the usual channels if they have issues regarding what debates take place and which SIs come forward.

Moving sharply on, a number of noble Lords but particularly the noble Lord, Lord Adonis, asked about cost in relation to this particular regulation, although this applies to all three. We expect the cost to be minimal because clinics that need import licences already have them. We estimate that fertility clinics will need to put 60 to 100 new agreements in place, and they will be able to use their existing agreements as templates for the new ones. We are not expecting any additional transportation costs, to which the noble Lord also alluded, because the clinics already meet transport costs for importing from the EU.

Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019

Debate between Lord Warner and Baroness Manzoor

Wednesday 9th January 2019 Grand Committee

[Baroness Manzoor]

My Lords, of course, if we have a deal, these SIs will not be necessary. Perhaps I may rephrase that. If there is a deal, we do not need these SIs as they relate only to a no-deal scenario. Therefore, it is contingency planning, as I have repeatedly said throughout. Of course, if a deal is reached, new SIs will need to be laid.

[Lord Warner]

I am trying to understand this. If these deals are revoked at the end of six months, does that not assume that a new set of arrangements, in light of a deal, have been made? Is that what it means, or do they hang around in Whitehall departments for the end of the transition period if there has been no agreement, and they then get brought forward as having passed through Parliament? Excuse my suspicious mind, but I have been a senior civil servant and I have seen things taken out of the cupboard from one Government to another. Is my interpretation correct?

[Baroness Manzoor]

My Lords, the noble Lord does have a suspicious mind, and perhaps I was not clear. This is contingency planning and the agreements that will be put in place within the six months can continue after the six months. They are not just for six months. If there is a deal, then that is an entirely different matter.

Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

Debate between Lord Warner and Baroness Manzoor

Wednesday 9th January 2019 Grand Committee

[Lord Warner (CB)]

My Lords, I want to comment on this set of regulations but will relate my remarks to all 10. I address my remarks to the three Ministers here, bearing in mind the three hours that we have spent on these regulations so far, as the noble Baroness, Lady Barker, has said. It can be taken as given that most of what I, the noble Lord, Lord Winston, and others said on the previous set of regulations is what we would say on this set of regulations, but I am not going to repeat it. The same considerations apply.

We are not going to get to number nine on the list, and I want to question what the Minister has been saying, and what the Government have been asserting, all the way along, which is that these regulations do not change policy. The Minister has said this a number of times. I know from the speech I am going to make on number nine that it has changed policy, and I shall deploy the arguments to demonstrate that. Unfortunately, the noble Lord, Lord Henley, is not here to hear them, but if I ever get the chance, he will hear them.

I have a terrible feeling that my concerns about item nine apply all the way through this set of regulations. They do change policy and, although this is not the Minister’s fault, the Government have been asserting for month after month that they do not. They do, and they change policy that is set out in primary legislation in some cases. We do not have any alternative, if I may say to the Grand Committee, to continuing to negative—or whatever the verb is—all these sets of regulations. We can go through this process all the way down to item 10 if the Government want us to do that. I am quite prepared to do that to make the point to the Government. I am doing that not as a member of any party—I am the only Cross-Bench Peer in the Room—but because we are discrediting this House by giving an authenticity to these regulations, which I fear would then get tucked away in the cupboards of Whitehall to be produced again when the need arises. I do not want to be associated with giving authenticity to this set of regulations, and would hope that other Members, of different political parties, feel the same way. I want these three Ministers, who have heard this and sat through this very patiently, to go to the Chief Whip and the powers that be in the government party with feedback about the farce being created.

[Baroness Manzoor]

My Lords, for two years, the Government have been implementing a significant programme of work to ensure that the UK will be ready, from day one, in all Brexit scenarios, and I have tried to make that clear throughout the three SIs. For organs, tissues and cells, our priority is to ensure the continuity of supply and to maintain the existing high standards of safety and quality. Organs for transplant and stem cells need to be transported urgently, as has been made clear today, and we are working across government with the health sector to prepare for, and mitigate, any possible disruption which may affect the organs or stem cells imported from the EU. For other less time-sensitive tissues and cells, we are also preparing for possible disruption, and information for tissue establishments will be available through the regulator.

This has been an interesting debate. I for one take very seriously the comments that have been made by noble Lords. I will endeavour to ensure that the Chief Whip is made entirely aware of the comments regarding SI processes and the future. I have already undertaken to do that but it is important to restate the point.