Independent Medicines and Medical Devices Safety Review

Cat Smith Excerpts

Thursday 8th July 2021 Commons Chamber

[Cat Smith (Lancaster and Fleetwood) (Lab) [V]]

As I am chair of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy, my comments are on that issue. However, I just want to note the harm done, the hurt caused and the justice needed for victims of surgical mesh and Primodos, who are in a similar position to those who have been harmed by sodium valproate.

One of the common threads that runs through all three campaigns is the way in which, more often than not, it is women who are the victims and it is women’s concerns that have been dismissed. Justice, frustratingly, always seems just out of reach.

One year on from the report’s publication, we really are not much further forward when it comes to sodium valproate. NHS England wrote recently to all women and girls aged 12 to 55 who are currently prescribed sodium valproate, reminding them of the risks of taking it while pregnant. That is a step in the right direction, but it has taken a year. One letter is not going to resolve the issue. The Government really must explain what further action will be taken and over what timescale.

Baroness Cumberlege’s report included nine general recommendations, in addition to a number of specific recommendations on sodium valproate. In January, the Minister provided the Government’s initial response to the recommendations. However, she only responded to the general recommendations and not the specific recommendations on sodium valproate. The Government have since stated on a number of occasions that they will respond in full later this year. Do the Government still plan to make a full response this year and will they address the report’s specific recommendations on sodium valproate?

I have a few brief comments about recommendations 3, 4, 5 and 9 of the report, before turning to the specific recommendations on sodium valproate. I would appreciate an update from the Minister.

Recommendation 3, which is for a new independent redress agency for those harmed by medicines and medical devices, has not been implemented, and it appears that the Government are unwilling to do so. May I express how hugely disappointing that is, given the avoidable harm that so many families have experienced? The case for an independent redress agency remains strong. Other countries have successfully set up an agency without such a mechanism, and people who have suffered avoidable harm following healthcare treatment have no option but to go to court, which is such a lengthy, expensive, confrontational and stressful process.

On recommendation 4, although the Government have stated that they are carefully considering a redress scheme for those harmed by sodium valproate, no further progress has been made. Again, I feel so disappointed, and I know that the families affected share that feeling. Patients who have suffered avoidable harm need help and support now, and actually we owe it to them. That may take the form of additional financial support, above and beyond that to which they are already entitled via welfare benefits and respite care. The frustrating thing is that many have already waited decades for help. What progress is being made to establish a redress scheme for those affected by sodium valproate?

On recommendation 5, again there has been no progress on establishing any specialist centres for those adversely affected by medicines taken during pregnancy. The Department of Health and Social Care appears to take the view that such centres are not needed. I therefore call on the Government to commit to introducing a network of such specialist centres, in recognition of the additional support and care that those affected require.

Recommendation 9 is that the Government should immediately set up a taskforce to implement the review’s recommendations. The Government have been quite clear that they have no plans to establish such a taskforce. The 14-person patient reference group that has been established had a series of meetings this year and will publish its findings shortly. I look forward to reading them, but the group is only able to provide feedback on proposals, whereas a taskforce would have been able to implement the recommendations. The Government really need to explain how they intend to keep patients fully involved as they move forward with full implementation of the report.

On the sodium valproate recommendations, the Government have not responded directly to any of these recommendations, and quite frankly they need to. More importantly, they need to implement them. On the recommendation that a clear process should be agreed to ensure that women can receive counselling related to their epilepsy treatment and contraception choices, at the moment it is a postcode lottery, so what progress is being made to ensure that women and girls with epilepsy have access to pre-conception counselling on epilepsy medicines and contraception?

On the recommendation that information should be collected to identify those already affected by exposure to valproate to ensure that they have access to diagnosis and support and plan their service provision, it is still not sufficient, especially without the redress scheme in place. May we have a response to that recommendation, please?

On the recommendation that a prospective registry should be established for all women on anti-epileptic drugs who become pregnant, and to include them in mandatory reporting of data relating to them and their children, such a registry could be expanded to collect data on paternal effects as well, but at the moment we are just looking at valproate. The valproate registry has been established, and it has been confirmed that other epilepsy medicines will be included, but that has not happened yet. It needs to be expanded to include those other epilepsy medicines as a matter of urgency, because we already know that anti-seizure medication is causing problems during pregnancy.

On the recommendation about stakeholders continuing to work with the patient groups to monitor and improve the pregnancy prevention plans and look at the next steps, all women and girls of childbearing potential have been written to, as I said at the start of my contribution, but we really need to do so much more to improve the PPP. It is important that a balance be found that allows women to make a choice about their treatment and care, while limiting the number of pregnancies exposed to sodium valproate and other harmful epilepsy medicines. May I ask the Minister what progress has been made in making improvements to the PPP?

The final recommendation on sodium valproate is:

“Clinicians should continue to follow guidance regarding prescribing of valproate and alternatives”.

Although further measures have been introduced to communicate the need for that, it is unclear—perhaps the Minister can shed some light—whether or not it is happening in practice, particularly given past concerns about the lack of communication with women and girls. That is a huge concern for me, as I know it is for many of the campaigners involved.

This is not the first time that I have raised the issue in the House. I put on record my thanks to my constituent Janet Williams and her fellow campaigner Emma Murphy for bringing the scandal to my attention in my first few weeks as an MP. Since then, I have learned so much about sodium valproate and epilepsy. I also put on record my thanks to Daniel Jennings from Epilepsy Action for his support in keeping me abreast of this and other issues that people with epilepsy face.

The challenges that women seeking pregnancy face while managing their epilepsy are not just about sodium valproate. Evidence shows that there are a number of other anti-epilepsy drugs that can cause preventable disabilities in babies when taken by their mothers. We must not forget the women impacted by other anti-epilepsy drugs. We cannot go on seeing history repeat itself. Anyone watching this debate who is in that situation might want to seek out the Epilepsy Society’s “Safe Mum, Safe Baby” campaign.

The Government need to consider funding research into safer epilepsy medicines so that babies will not be born with preventable disabilities caused by their mothers’ life-saving drugs. Some important progress has been made, but there are far too many areas in which we are still waiting for action and further response from the Government. It is deeply concerning that the Government have so far chosen not to respond to the specific recommendations on sodium valproate, because it took six months before they produced their initial response to the Cumberlege report, and after a further six months we are still waiting for their full reply.

[Madam Deputy Speaker (Dame Eleanor Laing)]

Before we go any further, may I make an appeal to hon. Members who are speaking from home to remember that those who are here in the Chamber still have to get back to their constituencies this evening—and that usually that which can be said in 10 minutes can be said more effectively in five or six?

Women’s Health Strategy

Cat Smith Excerpts

Monday 8th March 2021 Commons Chamber

[Ms Dorries]

This call for evidence is going to last for 12 weeks, we are going to keep up the drumbeat consistently and it will be cross-departmental. I hope that other Ministers in other Departments will pick up part of the load along the way and use their contacts and access to charities and organisations. We are working strongly with journalists and other outlets to try to get the news over about what we are trying to achieve, our aims and objectives. My hon. Friend is absolutely right that working with charities, organisations, the third sector and all women, and their families and friends, across the UK is really important.[Official Report, 12 March 2021, Vol. 690, c. 6MC.] I ask her, as I have asked everybody else: if she knows of any particular organisations or charities that feel that they can contribute, she should encourage them to do so.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

For decades, women with epilepsy were prescribed sodium valproate and were told it was safe to take during pregnancy. It was not. Their babies were harmed, and women continued to be prescribed sodium valproate and babies continue to be harmed right to this day. The Minister in her statement paid lip service to the Cumberlege review, but this statement comes on the same day she has given me a written answer that I have here, where she said that she is not going to implement recommendation 3, which is about a redress agency for victims of sodium valproate. If this statement is meant to mean anything on International Women’s Day, can the Minister remember those women with epilepsy whose babies were harmed in the womb? Can we get a redress agency for the victims of sodium valproate?

[Ms Dorries]

Ever since sodium valproate was first licensed, the Medicines and Healthcare Products Regulatory Agency’s position has been clear: valproate should only be used in women of childbearing potential if no other medicine is effective or tolerated. The MHRA has kept sodium valproate under constant review. The national director for patient safety has recently set up a clinically led valproate safety implementation group to consider the range of issues relating to valproate and prescribing and to explore options to review and reduce prescribing. In terms of the redress agency, we have looked at that across the board as a result of the Cumberlege recommendations. A number of redress processes are available already, and we did not want to complicate the landscape any further. We feel that, with the MHRA and the national director for patient safety, we have a response to sodium valproate.

Covid-19: Vaccinations

Cat Smith Excerpts

Monday 11th January 2021 Commons Chamber

[Nadhim Zahawi]

My hon. Friend raises an important point. I commit to looking specifically at the point she raises. The NHS in England has done an incredible job, but of course some teams have outperformed others. We have to learn from the best and make sure we share that knowledge. If some teams need additional resource and help, we will do that. That is why we have the additional 80,000 people in the programme who are ready to help and ready to make sure we get the jabs into the arms of the most vulnerable people.

[Cat Smith (Lancaster and Fleetwood) (Lab) [V]]

For parts of Lancashire, the closest mass vaccination centre is more than 60 miles away in Manchester. The Minister has said that there will be more mass vaccination centres, so can he reassure my constituents that we will get a centre on the Fylde coast and in north Lancashire?

[Nadhim Zahawi]

The hon. Lady is right to highlight the issue of distance. No one in her constituency or anywhere else in England will be more than 10 miles away from a vaccination site.

DHSC Answers to Written Questions

Cat Smith Excerpts

Thursday 19th November 2020 Commons Chamber

[Edward Argar]

I am grateful to my hon. Friend, and I pay tribute to the officials in the Department, who are working hard to clear the backlog and do take this very seriously. As I say, we are trying to clear the older PQs first, and then get back up to the performance we had before. She is absolutely right to highlight the other methods of communication. I may not be the most technological Minister in this House, but we have been seeking to use every means we can to try to answer colleagues’ questions and to give them the information they need.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

In my time in this House, I have campaigned alongside women and families affected by sodium valproate. Many of the victims of this scandal have felt for decades that Governments have tried to push it under the carpet, so can the Minister understand the frustration and suspicion that these victims feel when written parliamentary questions about the Cumberlege review, which was published on 8 July, continue to take a long time to answer—and when those answers come, they are very poor—and their frustration that since July there has been no progress, beyond the apology in this House, in implementing that review? Can the Minister update the tens of thousands of victims of the Primodos, surgical mesh and sodium valproate scandals and assure them that their campaigns for justice remain high on his Department’s agenda?

[Edward Argar]

Again, I am grateful to the hon. Lady for the tone she adopts on what is actually a very sensitive and very important issue. I can reassure her that that issue does remain very high on the Department’s agenda. At risk of tempting fate, if she wishes either to write to me or to table a question to me, I will endeavour to get it answered very quickly so she has something on the record on that.

Covid-19 Update

Cat Smith Excerpts

Tuesday 10th November 2020 Commons Chamber

[Matt Hancock]

I understand the question that the hon. Lady asks on behalf of her constituents. I pay tribute to my opposite number in Northern Ireland, Robin Swann, and because this is a devolved matter, I hope that she will understand if I allow him the discretion to provide an answer to that question, rather than to answer on his behalf.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

Students and their families across the country will be very pleased with the news that students are to be offered covid tests as early as 30 November to ensure that they can go back for Christmas. Subsequent to the Secretary of State’s answer to my right hon. Friend the Member for Leeds Central (Hilary Benn), may I ask whether similar arrangements will be put in place in January, so that students can then return to study in the new year?

[Matt Hancock]

One step at a time.

Covid-19 Update

Cat Smith Excerpts

Programme motion
Monday 19th October 2020 Commons Chamber

[Matt Hancock]

Yes, I hope I can reassure my hon Friend on both points. First, we have largely resolved the problem of the supply of Roche kit for non-covid tests—mostly blood tests. There has been a huge amount of work on that and I thank my team and the Roche team for solving the problem with the warehouse in Kent. Secondly, I absolutely reassure my hon. Friend that the situation does not affect covid tests: although Roche supplies around 5,000 covid tests a day, they were protected throughout.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

At the beginning of last week, my constituents in Lancashire were already bound by local restrictions. Last week, the Secretary of State made it clear that Lancashire was being put into tier 2 restrictions, which was a relaxing of the restrictions that my constituents had been under at the beginning of the week; by Friday, my constituents were told that we were going into tier 3. This hokey-cokey of restrictions has left my constituents, who want to play by the rules, really confused as to what the rules are, even though they want to abide by them. I level with the Secretary of State: the communications that come from his Department need to be clearer.

I wish to ask the Secretary of State about support for businesses. Viable businesses in Lancashire are now knocking on the doors of our district councils to ask for financial support, but those district councils have not been told under what criteria they will be able to distribute that support and have not had the cash released from Government. When will the Secretary of State get a grip on this situation?

[Matt Hancock]

Again, I will defend the honour of my right hon. Friend the Chancellor, who has put in huge amounts of economic support. On the first point, one of the reasons to go to the tier system and one of the reasons I think it was, at the time, widely welcomed across the House, was to have a system where people can much more straightforwardly understand the rules. I say to everybody living across Lancashire that the very high alert level in Lancashire is because we urgently need to get the case rate down. The thing everybody should do is follow the rules and restrictions that are in place. They are there for good reason and they are agreed across Lancashire. What we can all best do together is work together to get those rates down.

Covid-19 Update

Cat Smith Excerpts

Monday 5th October 2020 Commons Chamber

[Matt Hancock]

Mr Deputy Speaker, we have had three voices of Wales in a row, including yours, Sir. I could not agree more with the hon. Gentleman from Plaid Cymru. The impact of long covid can be very debilitating for many months, and some people who caught covid in the initial peak still suffer from long-covid symptoms. We have instituted more research, and we have started—in England at least—a long covid service in the NHS. Just today, the National Institute for Health and Care Excellence has published an approach to assessing long covid, which I would recommend to the hon. Gentleman. That approach will clearly need continued effort so that we can make sure that people who suffer from long covid get the support they need.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

On Friday, I and my constituents learned via local media and press reports that there are Government plans to close the hospitals in Lancaster and Preston, with plans to replace them with a super-hospital, which would have obvious implications for other Lancashire hospitals, such as Chorley and Blackpool Victoria. Closing two hospitals in Lancashire to build one super-hospital does not make it easier for my constituents or the people of Lancashire to access vital medical care. Does the Secretary of State believe, as I do, that the next time we hear a Minister talk about building 40 new hospitals, it should come with a health warning that that also means closing 80 hospitals?

[Mr Deputy Speaker]

Order. Before I invite the Secretary of State to answer that—I will give some flexibility—please make sure that your questions relate to the statement that has just been given.

Independent Medicines and Medical Devices Safety Review

Cat Smith Excerpts

Thursday 9th July 2020 Commons Chamber

[Ms Dorries]

I thank my hon. Friend for his comments and for his campaigning. It is the campaigning of Members of this House on behalf of their constituents that has got us to the position where we are today. It demonstrates how this place works at its best when MPs represent their constituents in campaigning on issues such as this. On his specific question, I would like him to write to me, because I am not quite sure why, if the operation was undertaken by the NHS, his constituent had to pay tens of thousands of pounds. If he would like to write to me and let me know the details, I will give him a more detailed response.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

As chair of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy, I would like to put on the record my and the group’s thanks to Baroness Cumberlege for her work on this. We welcome the report. I believe that its recommendations should be implemented in full as quickly as possible, because it is 268 pages about four decades of women being let down and lied to. When those women have campaigned for justice, Members of this House have told them that they are bored housewives and they are being hysterical. We cannot allow these women to be denied justice any longer. I would like to invite the Minister to join a meeting of our all-party group so that we can talk about the recommendations in more detail in a way that we cannot do on the Floor of the House.

[Ms Dorries]

I could not agree with the hon. Lady more. As I said earlier, whether it is Shipman, Paterson, Cumberlege or a maternity incident, women so often struggle to get their voices heard when they are at the heart of issues like this. I would be happy to talk to the all-party group, particularly on sodium valproate, where a huge amount of work is being done. We are seeing the number of users of sodium valproate in pregnancy declining, but there is more work to be done. I would be particularly interested in talking to the hon. Lady about how we get the message out about the dangers of sodium valproate, because there are women who suffer from epilepsy for whom sodium valproate is the only treatment that works effectively. That is the heart of the problem that we need to keep discussing and work through further. I am happy to meet and talk to her.

Covid-19

Cat Smith Excerpts

Monday 16th March 2020 Commons Chamber

[Matt Hancock]

We are of course reviewing all those points, and there are some measures in the Bill tomorrow to enable them to be addressed directly.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

The week before last it was “shortly”, last week it was “imminently”. Does the Secretary of State know when the public health budgets will be announced, and if he does, can he shed some light on that?

[Matt Hancock]

It is as soon as possible. There are so many things that we need to get on with, and this is one of them.

Oral Answers to Questions

Cat Smith Excerpts

Tuesday 10th March 2020 Commons Chamber

[Edward Argar]

My hon. Friend is right to highlight that his constituency has the highest average age in this country. As an assiduous reader of the Eastern Daily Press I recently saw the story outlining the trust’s plans for a UTC. I look forward to seeing those proposals develop further. The key to delivering them, or their making progress, will be partnership. I look forward to the hospital trust, my hon. Friend and the CCG working in partnership to deliver an outcome.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

19. What recent assessment he has made of trends in life expectancy.

[The Secretary of State for Health and Social Care (Matt Hancock)]

Life expectancy at birth is the highest it has ever been. Figures this week showed that last year mortality was the lowest since 2001, but we are not complacent. Already we have made clear our bold commitment to level up left-behind areas.

[Cat Smith]

The truth is that if you live in poverty you will get ill quicker and die sooner. For my constituents in Pharos ward in Fleetwood, life expectancy is 10 years shorter than just five miles down the road in Carleton, and following the report that came out last week we know that life expectancy has stalled and for the poorest women it is now declining. What kind of damning verdict does the Secretary of State think that is on his Government’s 10 years of Tory cuts and austerity?

[Matt Hancock]

I agree with most of what the hon. Member said and the starting point in particular—that the gaps in healthy life expectancy are far too big. She will have heard me articulate from this Dispatch Box how important it is that we close those gaps. The news out this week of lower mortality in 2019 was good news that she ought to welcome, but it certainly does not mean that the campaign to close the gap in healthy life expectancy is over. There is far more to come.