Hormone Pregnancy Tests

Baroness May of Maidenhead Excerpts

Thursday 7th September 2023 Commons Chamber

[Mrs Theresa May (Maidenhead) (Con)]

I thank the Backbench Business Committee for agreeing to the debate, and most of all I congratulate the hon. Member for Bolton South East (Yasmin Qureshi) on securing it. She has been an intrepid campaigner on this issue over many years, as have other Members, including my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning), who has another important debate later this afternoon on fibrodysplasia ossificans progressive. I am afraid I will not be able to attend, but I recognise the significance of that issue.

I will focus on three issues in the time available to me. I echo the sentiments of the hon. Member for Bolton South East: it is a pity that we have to be here yet again, making these arguments to Government. Up until recently, the Government have been able to say in debates that they could not do or say anything because a legal case was going through the courts. Well, that case is no longer in the courts, as a result of the decision taken by Lady Justice Yip, so the Government’s position today should be rather different. We will wait and see in the Minister’s response.

The other thing that the Government have done is hide behind the expert working group report, which the hon. Lady referred to. Many issues have been related to the expert working group report, which of course found in its overall conclusion that

“the available scientific evidence, taking all aspects into consideration, does not support a causal association between the use of HPTs, such as Primodos, during early pregnancy and adverse outcomes, either with regard to miscarriage, stillbirth or congenital anomalies”

Given that conclusion, it might seem rather strange to the Minister and the House that it was that very report that led to my setting up the Cumberlege review. The reason I did so was that earlier in the report it says:

“The totality of the available evidence from pharmacology, non-clinical, epidemiological and adverse event reporting data was very limited and did not, on balance, support a causal association between the use of HPTs, such as Primodos, by the mother during early pregnancy and congenital anomalies in the child.”

To me, “on balance” means that there was an argument against a causal link and, on the other side, an argument for a causal link, so the strength of the absolute decision that the expert working group came out with was, I think, a misrepresentation of what they had put earlier in the report. It was that sense of a balanced argument that led me to call for the Cumberlege review.

[Ed Davey (Kingston and Surbiton) (LD)]

I thank the right hon. Lady for the work that she did as Prime Minister to set up the Cumberlege review. May I take her back to her first point? She said rightly that the Government have been refusing to take forward the recommendations of the review because of the legal case, and that that case has now come to an end. Is she aware that the defendants in that case, including the Government, have sent letters to some of the applicants saying that they must sign away their right to take forward any further legal cases or be faced with, and pressured by, millions of pounds in legal costs? Does she agree that for the Government solicitor to be part of that process, and threatening those families, is quite atrocious?

[Mrs May]

I was not aware of that. I am very concerned by the situation that the right hon. Gentleman sets out, and I hope that the Government will urgently consider the position that their solicitors have been taking on that issue.

The second issue I will raise is the very important matter of redress. Let me refer first to the timeline. The report that everybody looks at as, in a sense, the first report of a potential causal link between Primodos and birth defects was, of course, the report led by Isabel Gal in 1967. There had been earlier indications of potential problems, and there have continued to be indications up until most recently. But it is not just that the NHS, through its various regulatory regimes, did not act on the basis of the 1967 report; later, even when Primodos was being withdrawn in other countries, it continued to be available to women here in the UK. As my right hon. Friend the Member for Hemel Hempstead rightly said in his intervention, we are not talking about some private clinics and doctors; we are talking about GPs in the national health service. It is that issue of responsibility that the Government need to address; that is important in relation to redress.

The Cumberlege committee said that the independent redress agency

“should be created based on models operating effectively in other countries.”

There are other countries where this issue has been recognised and redress is available. A redress scheme is being worked on for sodium valproate and for pelvic mesh. Why not for Primodos? I sincerely hope, now that the constraints of the legal case have been removed, that the Minister will be able to give a positive indication at the end of the debate that the Government will indeed consider redress for those who took Primodos and those who have suffered as a result.

My final point is one that was made to me recently by Marie Lyon. Women who took Primodos, and who saw their children suffer, often feel guilty; they feel somehow that it was them and their fault. It was not. They have no reason to feel guilty at all. The drug was given to them by their GPs. I hope that the Minister will stand up and say very clearly that women who took Primodos and whose children suffered were not in any way at fault and should not feel guilty at all. The fault lay with the NHS.

--- Later in debate ---

[Maria Caulfield]

I take the hon. Lady’s point that causality is a high bar. I am just going through the fact that there have been a number of reviews of the evidence so far. Baroness Cumberlege, when she set out the remit for her review, also stated from the outset that she would not be able to touch on causality for many of those reasons. There have been a number of reviews of the evidence, but I hear from right hon. and hon. Members some concerns that those reviews still have not got to the bottom of the issues that the families and those affected by Primodos feel that they have faced.

On the next steps, I have heard hon. Members. I heard my right hon. Friend the Member for Chipping Barnet (Theresa Villiers), who was clear about the drug being taken even after evidence had emerged. I heard from my hon. Friend the Member for Stourbridge (Suzanne Webb) about the effect on her constituent Helen and her family. I heard from my right hon. Friend the Member for North East Somerset (Sir Jacob Rees-Mogg) about his experience in Government and why these things often take so long. And, of course, I heard my right hon. Friend the Member for Maidenhead (Mrs May), who set up the Cumberlege review in the first place. My hon. Friend the Member for Leigh (James Grundy) has lobbied me hard outside this place on behalf of his constituent Marie Lyon and the many others who have been affected.

Now that we are in between the first and—potentially—second court cases, I am keen to meet and get to the bottom of right hon. and hon. Members’ concerns.

[Mrs May]

I wonder whether the Minister might clarify one point about the second court case. The Government were a party to the first court case; that was the argument that they used for being unable to come to a decision. Are the Government a party to the second court case? If not, the second court case seems to me irrelevant.

[Maria Caulfield]

I will come to that in a minute. We are in between cases, and I want to make progress while we do not have a live case. Discussions are ongoing at the moment.

I am the Minister with responsibility for patient safety, and on this matter, I, rather than officials, wrote my speech. We all know that tragic events and accidents can happen, but I am weary of meeting families up and down the country who are victims of the injustice in the health service at the moment. I and the Secretary of State met the families at the Countess of Chester Hospital only last week. I met the families from Tees, Esk and Wear valleys, whose young children died by suicide. I met, as you will know, Mr Deputy Speaker, the families whose children died in east Kent, where there was an inquiry. I met Janet and Emma, the sodium valproate campaigners from In-FACT—the Independent Fetal Anti-convulsant Trust—and the women who lead the mesh campaign. I hear day in, day out about the injustice that many have to face, and about the fight to get answers to basic questions when things go wrong.

I am very happy to say from the Dispatch Box that I will meet the all-party parliamentary group, the hon. Member for Bolton South East, and other hon. Members who have taken part in the debate. I am very happy to commit to a meeting with my hon. Friend the Member for Leigh and with Marie Lyon, as well as with any other families who wish to meet, to discuss the Primodos case. If there are concerns that evidence was left out or not scrutinised, or that evidence in previous reviews is disputed, I am very happy to look again at that evidence and to leave no stone unturned until we absolutely get to the facts of the matter.

The right hon. Member for Kingston and Surbiton (Ed Davey) mentioned the letter that has gone out to those taking part in court cases. I do not want people to be in a position where they feel that they cannot get justice simply because they cannot afford to, so I commit to looking at that matter and addressing the points that he made as soon as I get to the Department.

I do not want to come back to the Dispatch Box to discuss the issues around Primodos on an ongoing basis. If patients feel that there has been an injustice, and that there is evidence to support that, I am very happy to look at it again. There may be future court cases, as my right hon. Friend the Member for Maidenhead said, but we are at a point where we can look at that now.

[Mrs May]

I am sorry; I did not say that there may be future court cases. The Minister herself referred to a second court case, and I asked a simple question about whether the Government would be a party to that case. I am grateful, and I am sure that the families will be grateful, that the Minister has opened the door to sitting down with and hearing directly from the families and campaigners. She says that she is prepared to look at any evidence that comes forward. The Cumberlege review is the evidence; it sets it out very clearly. That is all the Government need.

[Maria Caulfield]

To be specific on that point, the Government are involved in a second claim. We are not sure whether that claim will go forward—discussions about that are ongoing. As the appeal timed out on 11 August, I am happy to commit today to looking at the evidence and the Cumberlege review. Baroness Cumberlege is my constituent, and I am sure she will be pushing me for that.