Independent Medicines and Medical Devices Safety Review

Debate between Hannah Bardell and Baroness May of Maidenhead

Thursday 8th July 2021 Commons Chamber

[Mrs May]

The hon. Gentleman is absolutely right and I shall come to the issue of redress in relation to these particular aspects of pelvic mesh, sodium valproate and Primodos and other HPTs. I was making the general point that I see constituency cases of individuals where a mistake has been made by the NHS. They want an apology and to know that change is going to take place, but they come up against a brick wall and sometimes find themselves battling and ending up in court to try to get some redress—with all the problems that that creates—because the institution has defended itself, rather than taking the patient’s voice seriously.

Our NHS does amazing work day by day and it has done amazing work during the pandemic, but, sadly, when mistakes are made, it does not always respond in the right way. The report of the independent review made this very clear:

“There is an institutional and professional resistance to changing practice even in the face of mounting safety concerns. There can be a culture of dismissive and arrogant attitudes that only serve to intimidate and confuse. For women there is an added dimension—the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”

It went on:

“Mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of overall effective accountability.”

It was apt that the report was called “First Do No Harm”; as the noble Baroness Cumberlege said:

“It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not.”

Like the hon. Member for Kingston upon Hull West and Hessle, I am concerned that the Government have not responded to and accepted the recommendations of the review in full. The recommendations were not made lightly; they were made after listening to considerable evidence and hearing the voice of people who had suffered for years as a result of the use of these medicines or medical devices. The report identified where changes needed to be made. Of course responses take time and of course the Department has been dealing with the pandemic, but I hope that the Government are going to respond properly on all the issues raised.

The Government have agreed to set up an independent patient safety commissioner—partly, I have to say, because of the action in the House of Lords in relation to amendments to a Bill—and they are now consulting on the position, but we do not know when the commissioner is going to be in post. The commissioner is important, because it is the commissioner who will enable the user’s experience—the patient’s voice—to be heard. By hearing that voice, it will be possible to detect and stop the use of medicines and medical devices that lead to avoidable harms.

[Hannah Bardell]

The right hon. Lady has made the point about institutional cultures, defensiveness and the culture of litigation that it feels like we have now got into, particularly in respect of some aspects of the health service. Does she agree that the patient safety commissioner must have teeth and must be able to help us—I think there would be agreement across this House and in the other place on this—to try to move away from that culture so that we can learn from mistakes?

[Mrs May]

I absolutely agree about the importance of the patient safety commissioner; they have to be able to do the job that is intended and set out for them to do. I know that there will be those who will be concerned that their sponsoring Department is the Department of Health and Social Care. It is natural because this is a health issue, but I hope that the Department will make every effort to ensure that it cannot be accused of trying to water down the role of the independent safety commissioner, because, as we are saying, it is important for the user’s experience to be heard. This is not about trying to get at the Department of Health or the NHS or anything. It is about people who are suffering real-life experiences and impacts as a result of the use of medicines and medical devices; it is about identifying those situations and ensuring that action is taken to stop them happening so that others can be protected.

The issue of redress was mentioned by the hon. Member for Kingston upon Hull West and Hessle and the hon. Member for—I apologise, because the hon. Gentleman is in the House so frequently, but I have forgotten his constituency—[Interruption.]. Strangford, thank you. The issue was also mentioned by the hon. Member for Strangford (Jim Shannon). The Government have said that an agency is not needed, yet time and again the only redress for patients is through recourse to the courts. That is expensive and stressful. It is also expensive for the national health service; in 2018-19, the NHS paid £2.4 billion in clinical negligence claims. But redress is about far more than compensation. It is about relating to the real impact that the use of these medicines and medical devices has had on people, such as the need for special education for children who have been affected because their mothers have taken sodium valproate when pregnant. There are many other examples. I urge the Government to look again at that issue.

I also want to raise the issue of the patient’s voice, because this has all been about an unwillingness in the past to listen to the patient’s voice. Setting up the patient reference group was fine, but I understand that it is due to publish findings shortly, and nobody knows whether the patient’s voice is going to be taken into account or how it can be in the future. I urge the Government to ensure that patients are part of the implementation; it is their experience that we are talking about, so it is so important that they are included.

My final point relates to sodium valproate and it partly comes from constituency experience. This medicine has a one in two risk of causing harm to a baby if a woman is taking it while she is, or becomes, pregnant. What lies behind this issue is information and education, but it took a year for the Government to write to women to raise awareness of the risk. I hope that the Government do not think that that is job done, because this is an ongoing issue that has to be addressed. It is not just about providing information to women; it is also about ensuring that their clinicians are well informed when they are prescribing and dealing with their cases.

Women suffered considerably from the use of pelvic mesh, from hormone-based pregnancy tests, predominantly Primodos, and from sodium valproate, but they and their children are still suffering today. At the heart of this situation lay a health system that, in the words of the report, is

“not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that.”

The system did not listen. It saw real pain and debilitation as women’s problems. The service which at its heart has our safety and protection ignored concerns over safety for too many years. The independent report recommends steps for the system to change. I urge the Government to embrace the recommendations in full. That way, we will be on the way to ensuring that we have a system that genuinely first does no harm.

Leaving the EU

Debate between Hannah Bardell and Baroness May of Maidenhead

Tuesday 12th February 2019 Commons Chamber

[The Prime Minister]

We are committed to ensuring that our environmental standards do not fall. I believe that it is in the interests of this country—indeed, it is the desire of this House and this country—to enhance our environmental standards in the future. The Government have shown their commitment through the 25-year environmental strategy and the environment Bill that my right hon. Friend the Environment Secretary will bring forward. In a number of ways, we are showing our commitment to enhanced environmental standards.

[Hannah Bardell (Livingston) (SNP)]

A close member of my family suffers from ulcerative colitis and is a serving police officer. They have been told that they may not be able to access the medicine they need to keep them well on a day-to-day basis. What does the Prime Minister say to my family member and to the many thousands of people across the UK who have chronic illnesses, some of which are exacerbated by anxiety and uncertainty, as she recklessly goes towards no deal by threatening Members? She needs to think again. What impact assessment has she done for people like my family member who are suffering from chronic illnesses?

[The Prime Minister]

That point was raised earlier by the hon. Member for North Ayrshire and Arran (Patricia Gibson), to whom I responded by making clear the work we have been doing with suppliers of medicines to ensure that there will be continuity of supply and that patients will continue to receive the medicines they need in all scenarios, including a no-deal scenario. When we are able to bring a deal back that deals with the issues raised by this House, the hon. Lady and every Member will have the responsibility of determining whether they want to leave the European Union with or without a deal.

Exiting the European Union

Debate between Hannah Bardell and Baroness May of Maidenhead

Monday 10th December 2018 Commons Chamber

[The Prime Minister]

My hon. Friend asks “Why on earth would it not?” The fact is that the European Union has been making some of its own preparations for no deal. It has sent out certain notices in relation to certain matters. However, it has not been engaging with us on the aspect of determining, or mitigating, the impact of no deal on both sides of the border.

[Hannah Bardell (Livingston) (SNP)]

I ask this on behalf of the many Livingston constituents who have been in touch with me, and, I am sure, many people across the United Kingdom. What the heck is going on? This is a complete and utter clusterbùrach. Why is the Prime Minister more concerned with her own self-preservation, and with narrow party unity, than with the lives and livelihoods of my constituents? How dare she postpone this vote, just because she was going to lose? Downing Street and her team have spent the last few days saying that the vote was happening. How can anyone in the House, or indeed anyone in the countries of the United Kingdom, trust a single word that she or her Government speak ever again?

[The Prime Minister]

I will tell the hon. Lady what is going on. What is going on is that the Government are working to ensure that we can get over the line through this Parliament a deal that is good for the whole of the United Kingdom.

Leaving the EU

Debate between Hannah Bardell and Baroness May of Maidenhead

Monday 26th November 2018 Commons Chamber

[The Prime Minister]

I believe that the deal we have negotiated does enable us to do the things I am sure my hon. Friend would wish us to do—crucially, to bring an end to the jurisdiction of the ECJ in the UK; crucially, to bring an end to free movement once and for all; and to come out of those aspects of the European Union that have not provided for certain sectors of our economy, such as the common agricultural policy and the common fisheries policy. We are negotiating a deal with a free trade area at its heart, and it goes beyond any other free trade agreement that the European Union has negotiated with other countries. It is an agreement of unprecedented ambition and depth that is being proposed for the United Kingdom.

[Hannah Bardell (Livingston) (SNP)]

Even if the Prime Minister gets her blind Brexit deal through Parliament—and it is a big “if”—we all know it will be only the beginning of detailed negotiations on our relationship with the rest of the EU. Given her deeply offensive comments about EU nationals and the cack-handed way she has negotiated this deal, is she not a little worried that she might be at the back of the queue when it comes to negotiating her priorities?

[The Prime Minister]

No. The commitment from both sides on negotiating the future economic partnership and future security partnership is clear in these documents.

Oral Answers to Questions

Debate between Hannah Bardell and Baroness May of Maidenhead

Wednesday 5th September 2018 Commons Chamber

[The Prime Minister]

This is an important piece of legislation and, as the hon. Gentleman says, it will make a difference to people’s lives. We have, as he says, given this legislation our backing, and we will continue to give it our backing precisely because of its importance and the impact it will have on people.

[Hannah Bardell (Livingston) (SNP)]

On a point of order, Mr Speaker.

Oral Answers to Questions

Debate between Hannah Bardell and Baroness May of Maidenhead

Wednesday 9th May 2018 Commons Chamber

[Hannah Bardell (Livingston) (SNP)]

Q3. The Life Sciences Scotland firm Tepnel Pharma Services employs 50 people in my Livingston constituency, who test the safety standards of everyday drugs to ensure that our citizens are kept safe. In its Trade Bill evidence, it expresses grave concerns about the lack of information and the plans for Brexit. I met it last week, and it is fair to say that its concerns have gone from amber to red. The life sciences in Scotland and across the UK rely on a harmonised regulatory environment. Patient safety is on the line and businesses need answers from the Prime Minister. When will they get them?

[The Prime Minister]

As I made clear in my Mansion House speech, the European Medicines Agency is one of those that we wish to discuss with the European Union the possibility of having associate membership of. I and the Business Secretary, as well as others, spend time with the life sciences industry and with other industries to understand their concerns. We will be looking to ensure that we can provide the same level of interaction in the future to enable our life sciences industry not just to continue at the current level, but actually to be enhanced and to grow.

European Council

Debate between Hannah Bardell and Baroness May of Maidenhead

Monday 26th March 2018 Commons Chamber

[The Prime Minister]

As I said in response to my hon. Friend the Member for Dumfries and Galloway (Mr Jack), I am aware of how the fishing industry felt it was treated when the UK entered the then Common Market. I am also very clear that as we leave the EU, we need not only to uphold the interests of the fishing industry but, as I have said to other hon. Friends, to give it an opportunity to rebuild and be enhanced.

[Hannah Bardell (Livingston) (SNP)]

Given that the Prime Minister’s Government and, unfortunately, the official Opposition have had more positions on Brexit than the Kama Sutra, is it not time that the “I had this idea first” nonsense stopped, and that she and her Government spelled out how our constituents will be protected from the disastrous economic impacts of Brexit?

[The Prime Minister]

The picture that the hon. Lady paints is not one that I recognise—[Laughter.] Indeed, in relation to anything that she said in her question.

Oral Answers to Questions

Debate between Hannah Bardell and Baroness May of Maidenhead

Wednesday 13th September 2017 Commons Chamber

[The Prime Minister]

Once again, my hon. Friend is campaigning tirelessly for his constituency. I welcome his efforts across a number of issues which he referred to. We do need affordable, clean energy to keep the lights on in the decades ahead, and he is absolutely right that nuclear energy is an important part of our energy mix. In regard to the particular site, I believe there is land next to the existing Heysham nuclear power station, which is one of the eight sites in the UK that has been designated for new nuclear build.

[Hannah Bardell (Livingston) (SNP)]

Q7. The House and the Prime Minister will remember the case of my constituent, Lola Ilesamni, whose daughter is under threat of female genital mutilation from Lola’s abusive ex-partner. I want to thank “Channel 4 News” and Cathy Newman for breaking the story, and the Prime Minister for intervening and granting an 18-month reprieve. Lola now has a temporary right to work, but no recourse to public funds if she cannot find a job. That wee girl and her family need long-term certainty. Will the Prime Minister look again at that case and allow Lola and her family to stay in Livingston in the long term?

[The Prime Minister]

The hon. Lady is right. She has raised that case before, and I understand that the Immigration Minister was in touch with her. I can confirm that, following a comprehensive and rigorous review, Ms Ilesamni has now been granted leave to remain in the United Kingdom, as the hon. Lady set out.

I want to say something about the issue of female genital mutilation, which the hon. Lady raised. She talked about her concern about the threat that Lola’s daughter might be facing. FGM is an absolutely abhorrent crime. The Government have done a lot to deal with it, but we cannot tolerate that practice. Our work to tackle FGM is an integral part of our strategy on violence against women and girls, which we published in March last year. We all accept that we need to do more to ensure that young girls are not subject to this horrific abuse.

Oral Answers to Questions

Debate between Hannah Bardell and Baroness May of Maidenhead

Wednesday 5th July 2017 Commons Chamber

[Hannah Bardell (Livingston) (SNP)]

Q1. If she will list her official engagements for Wednesday 5 July.

[The Prime Minister (Mrs Theresa May)]

Today marks the 69th anniversary of the NHS, and last week saw the 80th anniversary of the 999 service. I know that Members on both sides of the House will join me in paying tribute to the incredibly dedicated men and women who work tirelessly to save and improve lives day in, day out.

This morning I had meetings with ministerial colleagues and others. In addition to my duties in the House, I shall have further such meetings later today. Later this week I will attend a meeting of the G20, where I will discuss the global economy, counter-terrorism and sustainable development with my fellow leaders.

[Hannah Bardell]

Her face smashed with an iPad, her body beaten, and forced to abort a baby girl: that is only some of the domestic abuse that my constituent Lola Ilesanmi has suffered from her estranged husband because she has refused to allow the genital mutilation of her daughter. Lola is educated, has a mortgage, and had a good job with Royal Bank of Scotland until the Home Office revoked her right to work. I have been writing to the Home Office since March, and have got nowhere. Will the Prime Minister now intervene to prevent the family from being deported, and to prevent that three-year-old girl from being subjected to genital mutilation?

[The Prime Minister]

The Home Secretary has obviously heard the case that the hon. Lady describes. The issue of female genital mutilation is one on which I think all of us, throughout the House, are agreed. It is an abhorrent activity; it should not be taking place. Great efforts have been made in recent years in strengthening the law on female genital mutilation, getting information out about the issue, and trying to support people in communities where FGM is practised. The message must go out from the House today that we will not accept FGM in this country.

London Attack

Debate between Hannah Bardell and Baroness May of Maidenhead

Thursday 23rd March 2017 Commons Chamber

[Hannah Bardell (Livingston) (SNP)]

I very much associate myself with the Prime Minister’s statement and everyone’s comments, and I pay tribute to all those involved. We are thinking of the victims and their families. I am the sister of a police officer in uniform, and when police officers go out of the front door in the morning, none of us really knows what they will face. Yesterday hit all of us and was particularly hard for those of us who have family in uniform. I am pleased to hear that the Prime Minister will give all the support she can to the victims, their families and all those who were affected.

[The Prime Minister]

The hon. Lady speaks well on this. When I was Home Secretary, two events always brought home to me the commitment, bravery and dedication of police officers. One was the National Police Memorial Day service, when the police recognise those who have fallen, and the other was the police bravery awards, where groups of police officers are recognised for brave acts that they have undertaken. What always struck me—and, I am sure, other hon. Members who have been at that ceremony—was the matter-of-fact way in which our police officers, whatever they had done, whomever they had dealt with and whatever injuries they had suffered, would say that they were just doing their job. We owe them a great deal.

Oral Answers to Questions

Debate between Hannah Bardell and Baroness May of Maidenhead

Wednesday 15th March 2017 Commons Chamber

[The Prime Minister]

My hon. Friend is absolutely right. Small businesses and entrepreneurs are essential to an economy that is working for everyone. The opportunity that comes from Brexit is to see those firms go out and export across the world, and to do those trade deals that will be of benefit to them, to their communities and to our economy. We want to encourage more businesses to go out there and export. That is exactly what my right hon. Friend the Secretary of State for International Trade is doing. This is an important part of building a stronger, fairer Britain for the future.

[Hannah Bardell (Livingston) (SNP)]

Q14. Her Majesty’s Revenue and Customs employs more than 1,000 vital staff in my Livingston constituency. Despite widespread criticism from the National Audit Office and the Public Accounts Committee, and despite Livingston having the most engaged and productive staff, the Prime Minister’s Government are determined to move jobs from Livingston to Edinburgh. Staff do not want to move there and rental costs will be higher. To compound that, last week Ethicon announced that 400 jobs are set to go at its Livingston site. Will the Prime Minister therefore change her mind on HMRC jobs in Livingston, and meet me to ensure that public sector jobs that are vital to Livingston stay in Livingston?

[The Prime Minister]

HMRC is indeed relocating from 170 outdated offices to 13 large, modern regional centres. The new centres will be equipped with the digital infrastructure and facilities that are needed to build a more highly skilled and flexible workforce, to enable the modernisation of ways of working, make tax collection more efficient and effective, and bring significant improvements to HMRC’s customer services.

Oral Answers to Questions

Debate between Hannah Bardell and Baroness May of Maidenhead

Wednesday 30th November 2016 Commons Chamber

[The Prime Minister]

I recognise the concerns of my hon. Friend and other Members on the particular issue of the rights of EU citizens and UK citizens variously living here in the UK and in the other member states of the European Union. I hope it is something that we will be able to address at an early stage. We have not yet triggered article 50 and the negotiations will have up to two years to run, as set out in the Lisbon treaty. As I say, I hope we will be able to address this at an early stage to give people the reassurance they need.

[Hannah Bardell (Livingston) (SNP)]

A year ago this week, my constituent Deborah Pearson lost her niece Julie, who is believed to have been unlawfully killed in Eilat, Israel. A year ago, the Prime Minister’s predecessor was good enough to give me support, as was the Foreign and Commonwealth Office, but after a year of writing letters, having meetings and putting pressure on the Israeli authorities, the family is no closer to having justice for Julie. Will the Prime Minister meet me and my constituent to understand what further pressure can be brought to bear so that the family can get answers and understand who brought this terrible crime against their family member?

[The Prime Minister]

I understand the concern that the hon. Lady rightly shows for her constituent, and obviously her constituent’s deep concern to find out what happened in this terrible tragedy. I understand that the appropriate Minister in the Foreign Office is actively working on this question. I will ask him to respond to the hon. Lady and to meet her to discuss what more can be done and to set out exactly what the Foreign Office is doing on this issue.



Bill Presented

Withdrawal from the European Union (Article 50) Bill

Presentation and First Reading (Standing Order No. 57)

Mr Peter Bone presented a Bill to require Her Majesty’s Government to notify the European Council by 31 March 2017 of the United Kingdom’s intention to withdraw from the European Union.

Bill read the First time; to be read a Second time on Friday 16 December, and to be printed (Bill 104).