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?