Northern Ireland (Executive Formation) Bill

Debate between Owen Smith and Jim Shannon

3rd reading: House of Commons & Committee: 1st sitting: House of Commons & Report stage: House of Commons
Tuesday 9th July 2019 Commons Chamber

[Jim Shannon]

I thank the hon. Gentleman for his intervention, and what he says is true—it is a fact. Those figures have not been refuted. Indeed, they have been endorsed. I thank him for reminding the House clearly of the 100,000 lives saved because of not having abortion on demand in Northern Ireland.

Last year, an abortion was carried out every two and a half minutes in England and Wales—that is of every hour, of every day of the week, with no holiday and no break. Was that the intention of the Abortion Act 1967? No, it was not, but it was the result. I heard the hon. Member for Walthamstow (Stella Creasy) say that she is speaking for women from Northern Ireland as no one is speaking for them. I seek gently to remind her that I am here, speaking on behalf of my constituents.

As of Monday evening, my office had received 443 emails on this issue, the majority of which were from women in my constituency, and 412 of the emails opposed any attempt by this place to change abortion laws in Northern Ireland through external interference, with some even labelling this as an attack on devolution and democracy. Just 31 asked me to support these amendments. That means that 92.5% of my constituents—the people I am paid to represent in this House—have asked me not to accede to this amendment. Their reasons replicate mine: some are opposed to what brings about abortion on demand, and some are incensed that Members of this House will not “interfere” to bring about a resolution on urgent health and education matters, but will step in over our heads on a matter that was one of the last to be discussed at Stormont and to be voted against.

Members of this House cannot have it both ways to boost their own profile. Clearly, I speak for the majority of my constituents—I am happy to say that—and indeed for the 60% of those in national polls who would not be in favour of abortion on demand. I hope that I have spoken with gentleness and concern but am yet clear. The people of Strangford have been clear to me and we must also be clear: what is being asked here is not the desire of the people.

I end where I started, ever conscious of the time that you have allowed me, Dame Rosie, by saying that both lives matter and both rights must be upheld. This proposal protects neither, so I will not support new clauses 1, 10, 11 or 12. They do not represent the viewpoints of the majority of people in Northern Ireland.

[Owen Smith]

It is a pleasure to follow the hon. Member for Strangford (Jim Shannon), who spoke, as he always does, with sincerity, conviction and gentleness. I will respect his request that we are respectful of the views of others in this place, even when we do not agree with them. I also respect the views of right hon. and hon. Members from Northern Ireland who today have expressed their frustration that we are not debating what I suppose many in Northern Ireland would feel is the primary political issue of the day: the restoration of the Executive and the political process that is ongoing there. I feel, as he doubtless does, that we spend too little time in this place debating issues that affect people in Northern Ireland. Arguably, we are becoming strangers in this place to many of the issues that affect people in Northern Ireland, Wales and Scotland, as this place becomes a rather more English-centred Parliament, often by accident.

I do not believe, however, that the clauses that have been brought forward today are an attempt to hijack this debate. They are in some respects—new clause 1 and amendments 9 and 5, and the issues they pertain to—a reflection of the fact that, as Ron Davies, a former denizen of this place observed, devolution is “a process” and “not an event”. As someone who served the most recent Labour Government as an adviser in both Wales and Northern Ireland and who as a parliamentarian has served as shadow Secretary of State for Wales and for Northern Ireland, I think our attitudes to devolution are changing. In some respects, although we cannot have a hierarchy of rights, this debate is about the sense that some rights must be seen as universal and must, indeed, supersede the right to devolution. Those rights are, in particular, the rights we are talking about today: reproductive rights for women and the right for the LGBT people of Northern Ireland to be treated equally to their brothers and sisters throughout the rest of the UK.

Licensing of Medical Devices

Debate between Owen Smith and Jim Shannon

Tuesday 12th February 2019 Commons Chamber

[Owen Smith]

I am grateful to my right hon. Friend for her kind words. She is completely right to say that there are devices on the market here and across the world that are still causing grave medical problems for patients. The question we have to ask is: how did these things get on to the market in the first place? How have we got so many of these devices that are causing such significant problems? The common problem that unites mesh with all the other device scandals in our country and across the globe is the weakness of the regulatory system in the UK, in the EU and, to a lesser extent, in America, where the pathway for testing approval, marketing and surveillance of such devices just is not good enough.

How does the system work? It will shock people to hear that we do not have a central body that is responsible for checking out, authorising and licensing devices in the same way as for medicines. If a company in the UK wants to create a new prosthetic hip joint, it does so and then it shops around among a group of what are called notified bodies. These are effectively commercial organisations that are in turn licensed by the MHRA to be a body that checks safety and efficacy through the clinical data provided by the companies and then gives them their conformité Européenne—their EU kitemark. Once a company has received that mark, the device can be sold all across the EU.

Companies do not need clinical trial data in order to substantiate their claims that devices are efficacious and safe. Quite often—this is true of a remarkable proportion of the devices on the market—they do not even have to undertake first-hand clinical evaluations themselves and can rely on being follow-on products that go through a regulatory pathway that is termed as being “substantially equivalent” to the products that have gone before. For instance, there are examples of mesh on the market now that are the 61st iteration of an original licensed mesh that is no longer on the market because it was proven to be dangerous. There is no real mandatory post-marketing surveillance of these devices.

Given that the difficulty of randomised control trials versus placebo for a device—someone cannot put a wooden heart into one patient and a pacemaker into another in order to see which one works—means that there will be a degree of risk in testing such things in the real world, one would think that we would have a system that would test how devices are doing in the real world and get companies or the Government to monitor them, but we do not, which is in stark contrast to the regime for medicines. Changes are coming into effect, however. A new medical devices regulation was launched across the EU in 2017 and will come into effect in May 2020. It was introduced with the acknowledgement of many of the problems that I have highlighted.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Gentleman on securing this debate on an issue that is important to many of us. With the EU’s new medical device rules coming into place in May 2020, as he says, does he agree that the number of available notified bodies is already diminishing? The Government must be aware of that and must work to find a way to secure acceptance of UK notified bodies as part of any arrangement, allowing for the smooth transition of notified bodies and product certification.

[Owen Smith]

I agree in part with the hon. Gentleman. One thing that I did not say earlier is that there are 50 notified bodies across the EU, so if a company goes with its new artificial hip to one body and says, “Will you approve this for my CE mark, because I would like to sell it in the EU?” and the body says no, because it does not think the data is good enough, all the company has to do is go to the next notified body, and if it says no, the company can go to the one after that, and if the third body says no, the company can go to the fourth one. Neither any of the notified bodies nor the manufacturer are under any obligation to disclose that the device had been turned down earlier. I agree that fewer notified bodies would be a good thing, but there are big questions for us in the UK because we will have no notified bodies once we have left the EU.

There are other problems with the new directive, which is a strengthening of the regulations, but it is not strong enough. For example, it now says that companies should summarise their clinical trials data, that they should take clinical data that is, if possible, sourced from clinical investigations carried out under the responsibility of a sponsor—meaning something more akin to randomised control clinical trials—and that they should ordinarily have a quality management system and a post-market surveillance system that should be proportionate to the risk class of the device in question. However, the point is that none of those things is mandatory.



There is no mandatory requirement to conduct proper trials or to max out the tests that are done. There is no mandatory requirement to publish data. There is no mandatory requirement to publish all data, including negative data. There is nothing to stop the companies continuing to conceal data, or shopping around between different notified bodies, and there is nothing to stop the companies doing the bare minimum on surveying how their product is doing in the marketplace. The directive is a strengthening but, unfortunately, it is not the strengthening we need.

If we leave the EU, the directive will not necessarily apply in all regards in the UK. The Government have tried to respond to the concern voiced by others before me by saying that they will effectively apply the regulation in future, but that would bring difficulties in and of itself. As I said, we would effectively be accepting products that are kitemarked and approved elsewhere in Europe, and not by our own notified bodies, because we will not be part of that system any longer. I assume we will be using the European database on medical devices, which is designed to work right across Europe, but we will not be part of the expert panels that reflect on the findings reviewed through that database.

Crucially, I assume that the MHRA will be filling some of those gaps. It will already have an almighty job on its hands in trying to fill the gap on medicines once we are outwith the purview of the European Medicines Agency. I fear that devices will once again be the Cinderella of the medical game. We did not have regulations for devices at all before 1990, and we may find that we are playing catch up with the European Union in future.

Whichever way Brexit turns out, and in reflecting on the flaws in the regulatory system I have highlighted, I ask the Minister, first, to try to get the MHRA, or whatever replaces our current regulatory pathway, to go back to the first principles of protecting patient safety at all times. There is too much talk in Europe of maintaining our advantage over other markets as an early adopter of innovation. Well, early adoption can go wrong if the innovation has not been adequately tested, and mesh is a great example.

Secondly, will the Minister do what the Royal College of Surgeons has asked her and the Government to do and set up a national registry of all “first implanted into a man or woman” devices—the innovations—so that we can track what happens with those devices, as we should have been able to do with mesh? Thirdly, will the Minister make sure that whatever system we have imposes much more stringent obligations on companies to undertake the most rigorous tests in respect of such medicines? In any new system, we should rule out anything like the substantial equivalence model that has been deployed in Europe for so long. It seems crackers to have a system that is basically a paper-based exercise without any real-world tests.

Lastly, I would like our Government to follow the example of the Australian Government, where the Minister’s counterpart, Greg Hunt, issued a national apology to the many women whose lives have been ruined by the debilitating effect of pelvic mesh implants:

“On behalf of the Australian government I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes”.

Our Government should similarly apologise to women damaged by surgical mesh. Irrespective of how Brexit turns out, they should pledge to radically reform the regulatory pathway for this class of medicines in order to make sure that no patients, men or women, suffer, as patients have in the past, as a result of medical devices.

Northern Ireland Budget (Anticipation and Adjustments) Bill

Debate between Owen Smith and Jim Shannon

2nd reading: House of Commons & 3rd reading: House of Commons
Tuesday 20th March 2018 Commons Chamber

[Owen Smith]

I know from the hon. Gentleman’s time on the Select Committee that he is very familiar with this issue. He is absolutely right. I referred to the 500 seriously physically injured victims and survivors, and the £2 million to £3 million quantum that is the annual sum associated with their receiving some form of pension. He is also right that a further significant issue to be considered is the people who have been injured permanently and psychologically as a result of the troubles. No, I do not have an absolute idea about how this would be achieved. I have of course read the commission’s report on how it might be achieved, and other pieces of work have been done. That would need to be taken into account. I repeat, however, that time is passing for all the victims of the troubles, and time is the one thing they cannot afford. I therefore urge us all in this House to get past these difficulties and see a way clear to providing the resources that are needed.

[Jim Shannon (Strangford) (DUP)]

When we had the debate here on the Northern Ireland covenant, the hon. Gentleman said in response to many of the questions that he would go back to Sinn Féin to see how we could move the thing forward. In the period between that debate and now, has he had the opportunity to talk to Sinn Féin to see what its position on the Northern Ireland covenant would be, and is he going to give us good news that it will agree to it?

[Owen Smith]

No, I have not.

I know that the Secretary of State agrees that this should be the last year that we are passing a budget in this place instead of at Stormont. Will she outline a little further what she is doing now to ensure that that is the case?

For our part, notwithstanding the slightly less than successful intervention by the Prime Minister in February, we continue to believe that there is an important role for the Prime Minister in galvanising parties in Northern Ireland and acting as a rallying point to try to bring people together, ideally in some sort of prime ministerial and Taoiseach-led summit of all the parties. These things have worked in the past and we cannot understand why there has been so much refusal to consider it in the past 14 months. We also believe that the Secretary of State should be thinking about asking an independent chair to come in to try to take those talks to fruition.

If we simply continue with the cycle of failure that we have seen in the past year—if we do not try to shake things up somehow and inject new energy and dynamism into this process—we can all see the danger that we do drift towards direct rule. I know that she feels that that would be a grossly retrograde step for Northern Ireland, so I urge her to tell the House today, and in the coming days, what she is doing to make sure that it is not where we end up.

Armed Forces Covenant: Northern Ireland

Debate between Owen Smith and Jim Shannon

Wednesday 7th March 2018 Commons Chamber

[Owen Smith]

The point is that this is clearly a politicised and, at some level, a political issue. Clearly, points are being scored on both sides of the divide in Northern Ireland. The key point I want to make is that the Government’s view, which we share, is that—

[Jim Shannon (Strangford) (DUP)]

rose—

[Owen Smith]

I am going to draw my remarks to a conclusion. The point is that 90% or so of the covenant is being applied properly in Northern Ireland, but there are some gaps. I have raised some with the Minister, and the right hon. Member for Lagan Valley has raised others. Mental health needs to be considered in particular.

In practical terms, the view expressed repeatedly to the Northern Ireland Affairs Committee when it assessed the situation is that the reality is that no material disadvantage is being suffered by veterans in Northern Ireland. In support of that conclusion, Colonel Richard Gordon of SSAFA said to the Committee that he did not think that there any disadvantages to the armed forces community in Northern Ireland in respect of the covenant, and Brian Maguire of the Royal British Legion said:

“I cannot point to a single case, in all the cases we have dealt with in our time, where I can say for sure that the individual would have been better treated had they been living elsewhere in the United Kingdom.”

The right hon. Member for Lagan Valley mentioned what an important institution the Royal British Legion is in Northern Ireland and elsewhere, and I completely support him. Alongside SSAFA, it is one of the most important organisations providing support to veterans, and it does not support the conclusions that he drew in his remarks. The Royal British Legion supports the conclusions that I draw, and we need the covenant to be implemented properly. I therefore support the Government in not changing section 75, because it is entirely consistent with the application of the covenant to Northern Ireland.

--- Later in debate ---

[Jim Shannon (Strangford) (DUP)]

It is a pleasure to do the winding-up speech in this debate. I congratulate my right hon. Friend the Member for Lagan Valley (Sir Jeffrey M. Donaldson) on setting the scene so well and on reminding us of the 300,000 people who have served in uniform since 1969. He also reminded us—we need reminding sometimes—that those people from Northern Ireland have served in Iraq, Afghanistan and across the world, so it is not just in Northern Ireland. He also mentioned post-traumatic stress disorder and the fact that the very high levels are much due to the 30 years of the troubles. He spoke about the need for veterans’ mental health and psychological problems to be addressed. The Royal Irish Regiment aftercare service also needs to be extended. He referred to the opportunities—equal opportunities and better opportunities —in housing, for victims and in education, health and employment, and he asked the Minister about the Government’s report and the appointment of a champion for Northern Ireland. We look forward to his answer.

The Minister for the Armed Forces, the right hon. and gallant Member for Milton Keynes North (Mark Lancaster), is still a reservist and is still serving in uniform. He is still fit enough to do so—I am afraid I am not, by the way—and it is good to know that he is totally committed to the armed forces. I gently remind him of my question from November 2016, when I referred to the armed forces covenant. He replied that 93% of the covenant was in place in Northern Ireland, but we need to see 100%. He also referred to the LIBOR funding and the good projects that come from that.

The hon. Member for Pontypridd (Owen Smith)—I am pleased that he is in his place—referred to the armed forces covenant and the support that he said he was giving for the military covenant. I remind him—I say this very gently and kindly to him—that we are not terribly happy about the comments that he made in our debate. I remind him that the former shadow Secretary of State certainly understood the issues relating to our commitment to the armed forces in Northern Ireland and the need for a full commitment. The next time he meets Sinn Féin, perhaps he will report back to the House and tell us exactly their thoughts on the need to have the armed forces covenant in place and fully part of what we are about. If he has time, he might also like to come and hear our point of view—I am not aware he has met the DUP parliamentary team in Westminster—and the quicker the better.

[Owen Smith]

I have, of course, met DUP Members, and I would be happy to do so again on any occasion the hon. Gentleman chooses. On the implementation issue, the reality is that the armed forces covenant does apply in Northern Ireland. As I said, there are some issues with implementation, but the semantic point that I think his colleagues were trying to make was that it was not fully endorsed by the Executive, for obvious reasons.

[Jim Shannon]

It is not about endorsement; it is about adoption and putting it 100% in place. That is what we want. I say gently to the hon. Gentleman that perhaps someday he will appreciate and understand what we are about.