Medicines and Medical Devices Bill

Debate between Lord Lexden and Lord O'Shaughnessy

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Lord O’Shaughnessy (Con)]

I shall speak to the amendments in reverse order, starting with Amendment 123 in the name of my noble friend Lady Cumberlege. As she said, these amendments deal with the here and now and with the future, and it is important that we start with the here and now. The perspective I bring to this is again informed by my work with valproate charities through the all-party group and by reflecting on the evidence compiled by charities such as INFACT and others and presented in my noble friend’s report. Historically, some 20,000 babies were exposed to valproate in the UK and half suffered harm. The disorder recognising those harms, foetal valproate spectrum disorder, was fully recognised only in 2019, although the drug was known for decades to have effects of that kind.

It must now be the case that for those families and others we put in place a proper redress scheme. They have had to battle to be recognised. They have had to battle to change clinical behaviour. They have had to battle red tape and a lack of understanding in personal impact payment schemes and in the education and health assessments carried out for young children. This is not only a historical problem; it is true today. We need a solution in the here and now. We do not need to spend huge amounts of time creating a new agency or anything else—I will come to that in a moment—but we need to address that and their harms today. I hope my noble friend will be sympathetic to that spirit.

Amendment 122 is in the name of the noble Lord, Lord Hunt. He is quite right to want to look at this structurally, given all the scandals over the years, including thalidomide, contaminated blood, which I dealt with briefly when I was a Minister, breast implants and many others. It was quite right that my noble friend Lady Cumberlege talked in her report about creating an agency and a proper redress scheme for clinical negligence. Indeed, she has been promoting such an idea since her work on maternity safety, where, as we know, are the largest financial claims and some of the most heart-breaking. I do not think any of us can deny that the system is currently broken. The noble Lord, Lord Hunt, talked about some of the data points from NHS Resolution’s annual report. The annual cost is now nearly £2.5 billion and there are total liabilities of £84 billion because of clinical negligence. A lot of that is the cost of care for people who have been harmed, but a lot of it is the frictional cost—the legal and other costs of going through the process—let alone the uncounted cost to families, especially as the average number of days to settle claims has been increasing over the past decade. There is a very strong case for acting in a big structural way to do something about this.

Having said all that, and having been responsible for this policy area as a Minister, it is a very complex situation. There is undoubtedly a case for moving to a less confrontational and swifter approach. This is not a new idea, as the noble Lord, Lord Hunt, pointed out. We have been thinking about this and legislating for this purpose for at least the past 15 years. There are good examples of no-fault compensation schemes that work in New Zealand and across Scandinavia, which generally satisfy all the participants and, importantly, change clinical behaviour, which is so important in reducing the cost. However, the truth is that this is tied up in broader tort reform, which I am definitely not expert enough to discuss, and in considerations attached to other legislation. A good example is Section 2(4) of Law Reform (Personal Injuries) Act 1948, which has been discussed in this House before and concerns the entitlements of people who have suffered from clinical negligence, but inevitably affects other people who have been harmed.

It is also true that these kinds of schemes do not necessarily save money. Indeed, the modelling I saw when I was a Minister suggested that they could end up being more expensive. That is the challenge and we have to be realistic. It might be deserved, but it is a challenge in moving from one scheme to another.

I am definitely a supporter of action on this front, and I would very much like to hear from my noble friend that work is going on. I worked closely with my noble and learned friend Lord Keen, when he was at the Ministry of Justice, on this programme, and I hope it has continued. I am not sure that this can be dealt with in the way suggested, with a clause dropped into the Bill, because of all the consequential changes and the very difficult issues that it raises, but it is unbelievably important. The cost—that liability of £80 billion—is two-thirds of annual spending on the NHS and we simply cannot go on taking on these liabilities to future tax- payers, let alone to those people who have been harmed. We need to see a more robust policy response from the Government in general on this.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

The next speaker on the list, the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so I call the noble Lord, Lord Lansley.

Medicines and Medical Devices Bill

Debate between Lord Lexden and Lord O'Shaughnessy

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, unfortunately, a connection has not been made with the noble and learned Lord, Lord Woolf, who was due to contribute remotely.

[Lord O'Shaughnessy (Con) [V]]

My Lords, it is a pleasure to be able to follow the noble Lords, Lord Hunt and Lord Lansley, on these amendments. The issues that they raise could not be more important. Indeed, they have both been assiduous, particularly the noble Lord, Lord Hunt, when he was opposite me at the Dispatch Box, in raising this issue of the NHS’s attitude to medical innovation. His point about the methods review is very well made. He is also right to raise the fact that the voluntary pricing scheme for medicines is designed with a cap-to-cap growth of 2%. It is hard to explain how, with the cap in place, rationing attempts are still going on within the NHS, because the cap is precisely meant to give that protection. The problem is that, with the benefits of the cap, the rebates go to the Treasury, whereas the costs of paying for medicines bite locally. Until we get that imbalance sorted out, I fear that we will have strong imperatives on local trusts and CCGs to ration as he has talked about. I regret that, as the Minister responsible for negotiating that scheme, that was not something we were able to resolve—but I hope that my noble friend will be able to next time around.

The reason why I wanted to speak in this group was to offer my strong support for the amendment proposed by my noble friend Lord Lansley, Amendment 85 on medtech funding guidance. I declare another interest here in that this was one of mine, in its current incarnation, in the industrial strategy life sciences sector deal 2 from autumn 2018. It was hard won with the NHS, for obvious reasons, but the case for doing it was very powerful, and was brought home to me by a device—a diagnostic tool by Roche Diagnostics for pre-eclampsia. It had sailed through all the medtech evaluations and had gold star guidance next to it but had only something like 5% of the uptake that we would expect, despite the fact that it saved money and lives and did everything that we would want of it. In a way, that was a powerful emblem of why we could not go on as we were and needed some sort of medtech funding guidance.

It has been two years. My noble friend Lord Lansley is quite right in tabling his amendment to, I hope, elicit a response from my noble friends at the Dispatch Box on a commitment to when a full introduction of this will be done. As we are, I hope, in that kind of positive mood, perhaps I could entice my noble friend the Minister to commit also to exploring two things: to extending the eligibility criteria for the guidance, which were very strictly drawn and quite limiting; and, as is very germane to our Covid efforts, to consider how it could be used specifically to support the diagnostic industry.