Licensing of Medical Devices

Debate between Owen Smith and Mark Tami

Tuesday 12th February 2019 Commons Chamber

[Owen Smith (Pontypridd) (Lab)]

I rise to talk this evening about medical devices and the way in which they are licensed and regulated. They are a very important and growing part of medicine, and they can save and transform lives—indeed they have done for millions of patients over many generations. However, when faulty or poorly designed or poorly looked into and proven, they have also damaged, and indeed ended, the lives of many thousands of patients around the world. My principal point is that the regulatory system for medical devices in our country, and across Europe and arguably the wider world, is simply not fit for purpose and must be properly reformed.

The term “medical devices” is rather vague. It refers to everything from bandages to syringes through to heart pacemakers and artificial joints, and I want to be clear that what I am talking about is the more complex end of the spectrum: the more high-risk, class III as they are called, implantable devices.

[Mark Tami (Alyn and Deeside) (Lab)]

I want to put on record my thanks for all the work my hon. Friend has done on mesh. Does he agree that we must be careful that what might appear to be a relatively cheap quick fix can turn out to be a massive problem for a lot of patients?

[Owen Smith]

I thank my hon. Friend for his thanks, and I will talk about mesh shortly as it is illustrative of the wider problem.

The problem is best summed up not in my words but those of the Royal College of Surgeons, which said at the tail end of last year, in response to a big journalistic investigation, that we need to see in our country urgent and drastic regulatory reform and in particular that we need to start with the creation of a compulsory register for all new devices and implants that go into patients in the UK. Will the Minister commit to that?

Let me give a couple of examples of what I am talking about. Last year alone in the UK surgeons operated on patients for 80,000 knee joints, 60,000 hip replacements, 50,000 pacemakers and 7,000 usages of surgical vaginal mesh, down from its height in 2008 when there were 14,000 instances of surgical vaginal mesh inserted into women. Let me pause for a moment to talk about that example of vaginal mesh and why its use has declined so precipitously. The answer lies in what I am talking about—in the development and marketing, and the fact that, as with so many of these devices, their true safety and efficacy is only revealed in the real world once they have been implanted into patients, and sometimes after many years. Many of the variants of vaginal mesh, like most of the other devices now on the market, are developed without any real clinical trials, and certainly without the randomised controlled clinical trials we are familiar with in respect of medicines; that is an extraordinary fact. We understand why that is the case, but there are other ways in which the device manufacturers could ensure their devices were safer and definitely not going to harm patients.

Surgical Mesh

Debate between Owen Smith and Mark Tami

Thursday 19th April 2018 Commons Chamber

[Owen Smith]

Yes. The long and the short of it is that this has become such a widespread problem because younger women, in particular, were told by their doctor that there was a quick and easy way in which a minor inconvenience for many women—although a major inconvenience for some—could be dealt with.

Clearly, the scale of the side-effects was not apparent, for all the reasons my hon. Friend the Member for Kingston upon Hull West and Hessle listed, but notably because there is no long-term trials data in respect of devices. The sorts of complications that we now see emerge over a long period. That is why, in our country and across the world, such widespread concern about mesh has been emerging in every health market.

[Mark Tami]

My hon. Friend mentioned removal of mesh. Does he agree that there should have been a lot more research about how easy it is to remove, because it is actually very difficult and only a few surgeons will undertake that work?

[Owen Smith]

My hon. Friend is right. The whole point of mesh is that it is designed to induce scar tissue in order to fuse the mesh with the muscle, and therefore trying to excise the mesh is incredibly difficult. That is why there are partial removals and some women are left with pieces of mesh inside them, even after surgery. Those sorts of complications are clearly very worrying. They ought to have been explained properly to women, but obviously were not, in very many cases.

Government Policies (Wales)

Debate between Owen Smith and Mark Tami

Wednesday 26th November 2014 Commons Chamber

[Owen Smith]

I think that the evidence for Jobs Growth Wales is absolutely clear to us all. It has proven to be the most effective youth employment programme anywhere in Europe. It is succeeding in creating 16,000 opportunities for young people, and it is succeeding in keeping those young people in work beyond the six months. It is widely supported by the business community right across Wales. I cannot imagine for a minute that the Secretary of State should wish to undermine it, especially when it stands in such stark and promising contrast to his Government’s Work programme.

[Mark Tami (Alyn and Deeside) (Lab)]

Is my hon. Friend as amazed as I am by what the Secretary of State has just said? He has effectively said, “Well, we shouldn’t do anything for young people, because most of them will probably get jobs anyway.”

[Owen Smith]

Around 750,000 young people in Britain are still unemployed. Although that is fewer than the 1 million who were unemployed just a couple of years into this Government’s time in office, and we welcome that fall, I suggest that 750,000 is an enormous number of people to be left languishing on the dole, but that is what we have come to expect from a Tory Government.

Wales Bill

Debate between Owen Smith and Mark Tami

Tuesday 24th June 2014 Commons Chamber

[Owen Smith]

If I understand the hon. Gentleman’s question correctly, the answer is borrowing powers for Wales, because we have seen £1.6 billion cut from the budget for Wales, which is money that could usefully be made up by borrowing. Of course, all the tax powers set out in the Bill—income tax and, more immediately, stamp duty and landfill tax and other minor taxes—are directly associated with those borrowing powers. We are keen to see those borrowing powers afforded to Wales, and therefore to see the Bill passed.

However, we have never said that income tax-varying powers are a Labour priority for Wales. We remain sceptical about the benefits they would afford to Wales. Our scepticism is entirely factually based. The Silk commission’s report looks extensively at the revenues Wales receives from taxes and compares them with expenditure in Wales. It determines, to put it in blunt terms, that Wales currently spends around £35 billion in public moneys and nets in revenues from tax receipts of around £17 billion. That leaves a significant deficit that would need to be made up by a Welsh Government, were they to be reliant to a greater extent on their own tax receipts.

The Minister explained a moment ago that, under the terms of the formula outlined in the Bill and in some of the explanatory material, Wales would of course benefit if the growth of GDP in Wales outstripped that of England, but he also said that it

“would be adversely affected if growth in Wales was slower.”

Although in recent years the rate of GDP growth has been faster in Wales than in England, he will know that historically—if we look at the past 20 years, for example, and certainly over any longer period—the rate has been lower in Wales than in England, for all the obvious demographic and industrial reasons. We need to be certain that Wales would not be worse off, in both the short and the long term. We remain suspicious that tax competition, which seems to be the Government’s driving ideological imperative on the matter, will not benefit Wales, for the reasons I have given.

[Mark Tami (Alyn and Deeside) (Lab)]

As someone who represents a border constituency, I think that my hon. Friend touches on a very important area. Tax competition, which might mean people moving their office across the border to take advantage of where the rate was better, will not do the overall economy in England or Wales any good.

[Owen Smith]

Absolutely. On previous occasions in the House I have outlined the difference between Wales and Scotland, in terms of the populous nature of our border, as well as the far greater problems that we will experience in Wales. I will touch on that later.

Wales Bill

Debate between Owen Smith and Mark Tami

Monday 31st March 2014 Commons Chamber

[Owen Smith]

I will have to look carefully at my hon. Friend’s proposal and take it into consideration. I would not want to discourage Members from moving back and forth between the Assembly and Westminster, which I think is a positive state of affairs that should be encouraged, but I note the point he makes so eloquently.

[Mark Tami]

Further to that point, the offices the candidates opened are also funded by the taxpayer. Does my hon. Friend think that is right?

[Owen Smith]

That is a very good point that we ought to consider. I would, of course, not support parliamentary or Assembly expenses being deployed for party political reasons.

I will move on to the minor taxes, particularly stamp duty land tax and landfill tax. We heard very little detail from the Secretary of Sport—[Interruption.] Well, there was very little sport there for anyone to have, to be perfectly honest. Hopefully we will have a bit more sport with the Secretary of State now. We will support the devolution of stamp duty land tax and landfill tax to Wales. However, there are many questions about how that will be implemented, so we will seek clarification during the passage of the Bill. Perhaps he will take note of some of these points now so that his Minister can respond to some of them later.

The first point concerns the suggestion that properties on the border between Wales and England would somehow be split, with stamp duty land tax being charged on the English portion and whatever its successor tax is being charged on the Welsh portion. It is an interesting concept. Will the Secretary of State tell us at some point during the passage of the Bill how many such properties there are on the border, given how populous it is? Will he tell us how the Government propose splitting those properties, as in many instances they are houses straddling the border? Will there be a number of bedrooms in England and a number in Wales? We know that the Government are keen on taxing bedrooms.

The second point relates to the cost of devolving that to Wales. We understand from the Bill that the Welsh Government will be asked to pay for the administration of any new tax, which is fair and just, and that that will be offset by any reduction in the cost to Her Majesty’s Government of administering the taxes as they had previously done in Wales. Given that the Secretary of State and the Treasury—this was confirmed by the Exchequer Secretary—have conducted little or no analysis of the impact of those various schemes in Wales, will he tell us how much he thinks it will cost the Welsh Government to administer and how much the offset will be?

On the even more important question of the reduction in the block grant that will come about as a result of the changes—it will be reduced by around £200 million and reviewed periodically—will the Secretary of State comment at some point during the Bill’s passage on the volatility associated with stamp duty land tax, because that figure of £200 million varies radically over time? Will he also tell us how he will calculate any differential in the rise and fall of house prices in England and Wales? By way of illustration, stamp duty land tax revenues in Wales have varied wildly over the past 20 years. They were £20 million in 1997, up to £95 million in 2003 and £130 million in 2005, and then down to £55 million in 2008-09 and £65 million last year. It is an extremely volatile tax, so I would be intrigued to know how the Treasury will account for it in any indexed reduction in the block grant, because that will have a significant impact on both the borrowing powers and, potentially, the revenues of the Welsh Assembly Government.