Hormone Pregnancy Tests

Ed Davey 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.

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

It is always a privilege to follow the hon. Member for Stourbridge (Suzanne Webb). I think the whole House is grateful to her for telling the story of her constituents and their daughter Beccy. It is so important that the Minister and colleagues hear the impact that Primodos has had on ordinary families, and why we need justice.

I have been involved in this campaign for nearly a decade, but there are three women who have been critical in leading it. The first is the hon. Member for Bolton South East (Yasmin Qureshi), who has chaired the APPG, but who has also done many more things: she has had more meetings, asked more questions and sent more letters, and we are all grateful to her. She is one of the greatest campaigners this House has seen in recent times. Like others, I also pay tribute to Marie Lyon and her husband, who have campaigned with more courage and bravery than I have seen from anyone outside this House in my time here. They are relentless, representing the interests of thousands of women and their families. They are not going to give up until they get that justice, and neither should we.

The third woman I want to mention is a lady called Sue Ilsley, the constituent who brought this issue to my attention. Sadly, Sue died earlier this year. I actually got to know her before this, because she was a campaigner on mental health issues in my constituency; as far as I was concerned, she was the best campaigner. I think that was partly because her mental health had been impacted by her experience of having taken Primodos as a teenager and then giving birth to a daughter—a wonderful daughter, but a daughter who had serious deformities as a result of Primodos. She campaigned on mental health, and later she brought the Primodos issue to me. When I used to speak to her, I could obviously feel her hurt and her anger, but just as the right hon. Member for Maidenhead (Mrs May) said, I could also feel her guilt. She should not have had any.

There are guilty people. The right hon. Lady mentioned the NHS, but I want to take it back: Schering, the original drug company that has now been bought by Bayer, bears a lot of the guilt. All the professionals and the various medical regulators who have looked at this issue over the years bear the guilt. We should not finish campaigning until those guilty people are brought to justice. Experts and judges have looked at this recently and said, “They are not guilty”—well, they are. Look at the evidence. The expert working group was shocking, and when the right hon. Lady was Prime Minister, she was quite right not to accept its report and to go for the review. We had a debate in 2019 in which that report was pulled apart, and we have seen the work of Carl Heneghan, Neil Vargesson and others, who have proved as scientists and statistical experts that the evidence is overwhelming.

I am not a scientist or a medic, but I can sort of understand legal notes, and when I spoke in this House in December 2017, I read extensive extracts from the minutes of meetings held on 20 and 21 December 1977 at the Goldsmith Building, Temple, London. Schering, the original pharmaceutical company, was getting legal advice from a Mr Clothier QC. I will not repeat that speech today, but I will repeat a few of the things that I mentioned:

“Mr Clothier felt, if the case were tried to the end by a judge, the chances were that the company would be found to be in neglect of its duty.”

This was in 1977.

“Clothier stated that there seemed to be a 5:1 chance that, if there were a malformation in a child and the mother took Primodos while pregnant, it was the fault of the drug”,—[Official Report, 14 December 2017; Vol. 633, c. 707.]

so Schering knew that. That was its legal advice decades ago. Page 7 of the memo from the Berlin archives, which this note came from, states that Mr Clothier told Schering that

“there were 2 alternatives open to us—one is to establish a voluntary scheme of compensation in which a justifiable claim will be given compensation without proof of liability but simply accepting moral responsibility.”

The company’s review came to that conclusion. Decades later, why has it not happened?

The other alternative was to take the claims to court. What I found really interesting, and what I want to focus colleagues’ attention on, is that according to the memo, the Schering representative, Dr Detering, said that he was

“hesitant in establishing a scheme as the product is marketed world-wide. If we introduce this scheme in one country, we should introduce it in other countries.”

This product was marketed in 81 countries. That is the issue here; that is why there has been a cover-up for decades. That is why the medical regulators have stood behind the pharmaceutical company in question, because they know this would cost the company a fortune. Its shareholders would have to cough up—possibly cough up billions. In my view, this is potentially one of the biggest cover-ups of a pharmaceutical outrage that the world has ever seen.

[Hannah Bardell (Livingston) (SNP)]

The right hon. Gentleman is making an incredibly powerful contribution. Does he agree that the recent drama documentary on Netflix, “Painkiller”, highlights just how this kind of issue happens and keeps on happening, and that if we do not get to the heart of it—if we do not stop pharmaceutical companies flooding the markets unregulated and drugs getting to patients, including our constituents, and doing them damage—it is just going to continue?

[Ed Davey]

I am grateful to the hon. Lady for her intervention. I did not see that particular programme, but I am sure she is right. The key thing is that we need to make sure that those large organisations are held to account. That is our job, and we have been failing, because we have not held them to account—we are still here, many years and many debates later. We have had a Prime Minister on our side, and these people still have not been held to account.

[Sir Mike Penning]

Actually, the records show that this issue did get to court in America, and the drug company did a deal—as happens in American courts—on a non-disclosure. Why would a drug company do that unless it was trying to cover up? It settled in the American courts, as I understand it, but on the basis that all the information was destroyed and would never be disclosed. Those are the sorts of things we are dealing with.

[Ed Davey]

The right hon. Gentleman is right to remind me and the House of that particular case. Interestingly, an American law firm was helping the campaign and was going to take the issue to court because of what had happened in America. For some reason, it pulled out.

[Sir Mike Penning]

What a surprise!

[Ed Davey]

Yes, what a surprise. All these examples add up to show that a lot of powerful people are trying to stop justice being done in this country and around the world, so I am so pleased to see cross-party support here today, in a very powerful way, to make sure that is put right.

Justice should come before the interests of the shareholders and justice should come before the professional reputations of the medical people on the regulatory bodies, and that is why the Minister should listen to the House today. Absolutely we should see the recommendations of the review come forward and absolutely there should be the compensation fund. She should get up at the Dispatch Box today and announce that. The offer that was made, I am told—I have not seen it in writing, but I am told an offer was made—was a £1 million total pot for all the families, which would have been a few thousand pounds per family. I hope the Minister does not suggest that that will be good enough. We need a proper compensation fund, and we will not stop fighting until that the Government provide for that. I hope she will respond to the answer from the right hon. Member for Maidenhead to my intervention about why Government solicitors are threatening the families and telling them they have to sign agreements that they will not continue any legal action, which goes exactly to the point that the right hon. Member for Hemel Hempstead (Sir Mike Penning) made.

I want to see that action and I want the recommendations of the review to be implemented, but I want to put on the record that I am a bit suspicious. I think those involved are going to try to wriggle out of this in some way. They are going to make sure that no liability is mentioned, but they were liable. They knew it in the 1960s and they knew it in the 1970s: they are liable, and everyone who has been looking at this case knows it. I want the review to be implemented because the families need the money now. Individuals are dying, such as my constituent, and people are worried about their adult children and need their adult children to have the money now. I want the Government to go ahead and do that now. But I will tell the House what I really want: I want a public inquiry. I am fed up with these reviews. The review was great, but because this is such a scandal—a global pharmaceutical scandal—we want more. All this will come out only if the lawyers cannot threaten people and have non-disclosure agreements, so I want an inquiry in public—a public inquiry so that these people can be properly held to account once and for all.

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[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.

[Ed Davey]

To follow on from the point made by the right hon. Member for Maidenhead (Mrs May), the Cumberlege review has concluded. There are recommendations. Is the Minister saying from the Dispatch Box that the Government are not accepting those recommendations? We want to hear that they are going to implement those recommendations, not hear more evidence—implement them!

[Maria Caulfield]

Finger pointing is not exactly effective. As I set out at the beginning of my remarks, we have accepted the majority of those recommendations. We could not accept the Primodos ones while there was an ongoing court case. I have given my commitment from the Dispatch Box to review the outstanding recommendations in relation to Primodos, because I want to get to the bottom of this once and for all and provide justice for the families. I have heard from Members across the House about their concerns and the outstanding recommendations of the Cumberlege review, and my commitment is to look at those now.