Hormone Pregnancy Tests

– in the House of Commons at 1:09 pm on 7 September 2023.

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Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office) 1:09, 7 September 2023

I beg to move,

That this House
notes that children were born with serious deformities due to the hormone pregnancy test drug Primodos, which was taken by expectant mothers between 1953 and 1975; further notes that official warnings were not issued about Primodos until eight years after the first reports indicated possible dangers;
observes that the report by the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests in 2017 was inconsistent with other academic reports;
notes that the Independent Medicines and Medical Devices Safety Review, First do no harm, found that Primodos caused avoidable harm;
further notes that the Government has refused to acknowledge the recommendations by the Independent Medicines and Medical Devices Safety Review relating to Primodos families;
and calls on the Government to fully implement the recommendations in the Independent Medicines and Medica al Devices Safety Review and to set up a redress fund for families affected by Primodos.

I thank the Backbench Business Committee for granting this debate. This is now the fifth time we have had a debate trying to persuade the Government to grant justice to families affected by Primodos. I cannot even begin to count the number of times in the last 12 years that this issue has been raised on the Floor of this House during Prime Minister’s questions, Health questions, business questions and even Treasury questions. Time and again, this Government have insisted that there is no credible evidence to support an association between Primodos and deformities. Indeed, they have gone to great lengths to try to prove that there is no association at all.

I remind this House that Primodos was a tablet given to patients by their general practitioner as a pregnancy test. It was 40 times—I repeat, 40 times—the strength of an oral contraceptive today. It does not take a scientist to imagine what a dosage of that strength would do to a foetus. Babies were born with severe deformities, babies who are now adults in their 40s and 50s and have lived their whole lives with these disabilities.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

May I take the hon. Lady back a few moments to the tablets that were given by the patient’s GP in a national health surgery, paid for by the national health, and the doctor was paid by the national health? It was not private clinics, but the national health giving this drug.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office)

I thank the right hon. Gentleman for his intervention. It is important to stress that it was the state, the NHS, involved in this.

In July 2015, I stood in this House and urged the Government to disclose all the evidence they had and to set up an independent inquiry. The then Minister, George Freeman, heard those concerns and agreed to an independent review, which would be led by an expert working group.

However, first, the expert working group was not independent. In fact, many of the experts were found to have conflicts of interest with the industry. Secondly, the review of the evidence conveniently ignored several important studies and then later said, “Oh, well, there was insufficient evidence.” Thirdly, the terms of reference of the review had said that it would try to find a possible link. Yet the reports’ conclusion said it was unable to find a “causal link”. How exactly does the Government intend to find a causal link, short of testing the drug on pregnant women?

Photo of Peter Dowd Peter Dowd Labour, Bootle

On that point about evidence, so many medical records were destroyed. How is it possible to have an absolute evidential base for the reports, when the evidence seems to have been destroyed?

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office)

That is absolutely right; I thank my hon. Friend for that point.

I am pleased to see Mrs May in the Chamber. I know that, as Prime Minister at the time, she read this report. I note that in a recent Sky News interview she said

“I felt that it wasn’t the slam dunk answer that people said it was.”

I am truly grateful to her for commissioning Baroness Cumberlege to carry out a review that was both independent and credible.

Knowing what we now know, that the expert working group report was a whitewash, riddled with factual inaccuracies and conflicts of interest; knowing that studies from Oxford University have proven that the evidence in this report was deliberately manipulated to reach its conclusion; knowing that the Prime Minister of the day knew something was not right and then commissioned another review—how can it be right that any Government can continue to use this report to hide their sins?

Only a few weeks ago, lawyers used the report in court to defend their preposterous claims, and Ministers have used it as a basis to refuse and deny families redress. It is outrageous. I ask the Minister today: will she take a stand and do the right thing? Will she be courageous and read beyond the lines of the ministerial briefing she has been given? Only then will she agree with me that the expert working group report is not worth the paper it is written on.

The report stands in the way of justice for families affected by Primodos. I urge the Minister to work with us to set up an independent review of the scientific evidence, because I can assure her that only a truly independent review will find that there is an association between Primodos and malformation.

The scientific evidence is vast. Over several decades, numerous studies and animal experiments have found that the use of such tests can cause potential birth defects. In 2018, a team of academics at Oxford University conducted a systematic review of all previous human studies. They pooled together the data and found a “clear association” with several forms of malformation. At Aberdeen University, Professor Neil Vargesson has been working on this issue for years. He published research on zebrafish, which are genetically like humans, and found that the drug caused deformities in embryos. More recently, he has been working with human tissues and has again found the same association. There is another groundbreaking study take place in Sweden, which will be published soon. Again, that will continue to show how much evidence there is regarding this particular medication.

I have no doubt that later in the debate the Minister will stand at the Dispatch Box and tell the House that there is nothing she can do for the Primodos families because there is no proven association, because she has been convinced by the civil servants, the Medicines and Healthcare products Regulatory Agency and others. Would she like me to send her some of these studies—or perhaps I can hand them to her today? Is she willing to confront the truth, or is she going to be like her predecessors, burying her head in the sand? As long as she takes that position, she is standing in the way of truth and justice.

Photo of Lilian Greenwood Lilian Greenwood Shadow Minister (Culture, Media and Sport)

Does my hon. Friend share my concern that since the Cumberlege report there has not been progress on the vast majority of recommendations, and that for Primodos families time is running out? This issue needs to be addressed, and soon.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office)

I thank my hon. Friend for that; I will come on to the recommendations of the Cumberlege review.

The Minister will know that in May this year, families took the issue to the High Court. It was a David and Goliath moment. Government and Bayer lawyers used the expert working group report to argue that there was no basis for a case. The families did not have sufficient legal representation, as the firm representing them on a pro bono basis pulled out without any real explanation. It was not a fair hearing and was never going to achieve a fair outcome.

The action to strike out thus succeeded. Had that not happened, the families would have been given their day in court—an opportunity to present new scientific evidence, to argue about the misconceptions of not using epidemiological evidence to prove causation and to scrutinise the heavily flawed expert working group.

When the Cumberlege review came out, the then Health Secretary, Matt Hancock, went on the television and apologised, but nothing has happened since then. For the first time, the Cumberlege review, known as the “Independent Medicines and Medical Devices Safety Review” or IMMDS, looked at the historical evidence and the Government documents, which showed a cover-up, and concluded that Primodos had caused “avoidable harm” and it was preventable.

The UK regulator first received a warning about the drug in 1958. A definitive study was published in 1967, which linked birth defects to the synthetic hormones in Primodos. Baroness Cumberlege concluded that Primodos should have been removed from the market in 1967. The UK regulator failed in its duty of care to women: Primodos was eventually withdrawn in 1978, 20 years after the first warning.

Let me be clear by saying it one more time: an independent review found that Primodos caused preventable and avoidable harm—the Government cannot argue their way out of that—and recommended that the Primodos families should have redress. If the Minister wants to waste time by arguing that the Cumberlege review was not a scientific one, then we can have an independent review of all the scientific evidence, but let us not waste time; let us get on with it.

The families have already been through so much in their lives. Many of them have died, others are still very unwell. Why do the Government still insist on putting them through so much emotional and mental anguish? I ask the Minister to look at the Public Gallery, where some of those families sit, having travelled from across the country. Their campaign has been led by the amazing Marie Lyon, and they have been on a long and challenging journey, spanning almost five decades, to achieve justice. Their stories are at the heart of that justice. Those in the Gallery are just some of the families, but there are many hundreds more.

Justice delayed is justice denied. The legal system has failed those families, and so far the Government have failed them as well. I ask the Government to include Primodos families in the redress scheme being delivered to the victims of mesh and valproate as a result of the recommendation in the IMMDS/Cumberlege review. This was once referred to as the worst medical fraud of the 20th century, and I believe that to be true. The families are entitled to seek reparation and redress, as the Cumberlege review made clear. The Minister has an opportunity. She has it in her power to dispense justice and grant the affected families the redress that they rightly deserve. The ball is in her court.

Several hon. Members:

rose—

Photo of Rosie Winterton Rosie Winterton Deputy Speaker (First Deputy Chairman of Ways and Means)

Order. This debate is well subscribed, so my advice to colleagues is to keep speeches to around seven minutes so that we can get the next debate in as well.

Photo of Theresa May Theresa May Conservative, Maidenhead 1:22, 7 September 2023

I thank the Backbench Business Committee for agreeing to the debate, and most of all I congratulate 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 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.

Photo of Edward Davey Edward Davey Leader of the Liberal Democrats

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?

Photo of Theresa May Theresa May Conservative, Maidenhead

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.

Photo of Angela Eagle Angela Eagle Labour, Wallasey 1:28, 7 September 2023

It is an honour to follow Mrs May. I pay tribute to the work she has done and place on record my thanks to the all-party parliamentary group on hormone pregnancy tests, which is very ably led by my hon. Friend Yasmin Qureshi, who secured the debate. She demonstrated her passionate support for those affected by this great injustice that it has taken far too long to put right.

I would also like to mention the Association for Children Damaged by Hormone Pregnancy Tests, led by the redoubtable Marie Lyon, whom we all know and have met, as well as our constituents who have been subject to the terrible effects of taking Primodos in their pregnancies. Both the APPG and the Association for Children Damaged by Hormone Pregnancy Tests have campaigned tirelessly—this year marks a decade of the APPG—for countless families who have had their lives irrevocably changed by the impact of Primodos.

Locally, my constituent Marjorie Lancaster-Smith has long been an active campaigner within these groups and has shared with me at length the impact that Primodos has had on her family. Following the use of Primodos during Marjorie’s pregnancy, her daughter Tania has complex heart and intestinal problems, which she has had to live with her entire life. These have impacted both Tania and the family as a whole, and she has had several periods of severe ill health, operations and complications that have been life-threatening on several occasions. Both Marjorie and Tania are missing vital medical records—in fact, there are none at all for the first few years of Tania’s life or for Marjorie’s pregnancy. It is therefore very difficult to have definitive proof of exactly what happened to them. This is a convenient omission—that is all I am going to say.

This campaign has been incredibly trying for many families, as they have often felt sidelined and stonewalled at every turn as they pursue justice for their now grown-up children. However, as this debate and those attending it today demonstrate, they remain determined to win their campaign for answers and redress. As Marjorie movingly put it in one of our recent communications,

“Nevertheless while there is breath in my body, I will continue to support my daughter and all our members who struggle every day because of the damage caused by Primodos. It is an absolute disgrace that they have not received justice and that Bayer”— the pharmaceutical company that manufactured this drug—

“and the Government think they can just walk away scot-free.”

In the three years since Baroness Cumberlege’s independent medicines and medical devices safety review reported, we have seen long overdue work undertaken to support those impacted by pelvic mesh and sodium valproate, including the development of redress schemes, but Primodos victims have had no action whatsoever—indeed, there has been total silence and avoidance. I echo the point made by the right hon. Member for Maidenhead that as the legal process has now ended, what ended with it was the Government’s latest excuse for not pursuing some form of redress. I hope that the Minister is able to reassure us that that position has now changed.

As other Members have highlighted, the all-party parliamentary group has three clear asks of the Government, which I hope the Minister will address when she responds: first, that the sensible and necessary recommendations made in the independent medicines and medical devices safety review relating to Primodos be implemented, including the creation of a redress fund for the families affected; secondly, that there is an acknowledgment of and explanation for the present lack of implementation of those recommendations, because it has now been a long time—three years; and finally, the withdrawal of the highly disputed findings of the expert working group, which my hon. Friend the Member for Bolton South East talked about. The right hon. Member for Maidenhead has called those findings into question, and she explained in her contribution why she did that.

Families such as Marjorie’s are long overdue answers for this miscarriage of justice, and they are all desperate to ensure that no further families suffer the adverse consequences of medicines they take or medical devices they have been given by the NHS without having access to redress much more quickly. They have endured great suffering, and they will continue to experience that suffering as a product of the use of Primodos during pregnancy. That suffering cannot be diminished, and it is a tragedy that they have had to wait so long and been so neglected, and that they are now being stalled just when they thought that finally, after years of campaigning, their suffering and the adverse effects had been recognised. I call on the Government to build on the statements of previous Ministers and finally take action to implement the recommendations of the review in full—critically, including the consideration of a redress scheme specifically for Primodos-affected families.

Photo of Suzanne Webb Suzanne Webb Conservative, Stourbridge 1:35, 7 September 2023

I thank the hon. Members for Bolton South East (Yasmin Qureshi) and for Livingston (Hannah Bardell) and pay tribute to all the work they have done. I also thank Beccy’s family, who I am going to talk about today and who I met recently, and Beccy. Beccy’s family are sitting in the Gallery today.

This is Beccy and her mum Helen’s story. In 1970, when Helen thought she was pregnant, she went to her doctor in Wrexham, north Wales, to confirm the pregnancy. At the time, Helen, aged 24, was a mature student at a teacher training college. Her husband had just got a job in Stourbridge, and she was living with her parents while completing her college course and needed to be sure about the pregnancy as soon as possible. At the time, there was no reliable simple pregnancy test available. The GP said that there was a new product available, which would be the quickest way to confirm the pregnancy. He produced two pills from his desk, for which there was no prescription. The drug was Primodos. These were to be taken on consecutive days. If she was not pregnant, she would have a period within a few days. If she was pregnant, there would be no period. Helen’s medical record confirms that she took Primodos in March 1970.

By way of an explainer about Primodos, the same components that are in Primodos are contained in oral contraceptives, but at 40 times the strength of a contraceptive—40 times. That puts it in context. At the time, the doctor explained that the tablets came with a warning that they should not be used for pregnancy testing if the woman was not young and healthy. For example, they should not be used if the woman was older or suffering with conditions such as diabetes or heart problems. None of this applied to Helen—she was only 24—so he decided that this would be the best way to confirm whether she was pregnant.

Beccy was born on 7 November 1970. Her mum had a normal pregnancy and a normal birth. Beccy weighed in at 8 lb 4 oz and appeared a bonny, normal baby. At first, Beccy appeared to develop normally, though she did have many screaming sessions. As first-time parents, they did not think this unusual. Beccy seemed generally fit and healthy, though it seemed that she was not developing as other babies were. When she did not sit up, roll over or crawl at the expected times, her mum was told that she was just being a fussy young mother, but as Beccy got older, it became apparent that she was severely handicapped.

Beccy has never walked and has always been wheelchair dependent. She has curvature of the spine and some deformation of her hands and feet. She had an operation to try to straighten one of her feet when she was six. These problems are worsening as she gets older. Her mental impairments are very severe. She has had many diagnoses including cerebral palsy and autism, and this leads to very complex and challenging behaviours. She will often go days without food and refuse to co-operate with her carers. She has very limited speech, though it is believed she understands much more than she is capable of expressing. This can be very frustrating, and she is often reduced to very distressing screaming sessions. Beccy has been subjected to innumerable tests and procedures, including full genetic screening. There has been no explanation or cause for her impairments. Primodos is the only common denominator.

Beccy lives in a residential home with 24-hour care. She can do virtually nothing without help. She does stay at home with her family regularly, which is very important to her and her family; when she is at home, she relies on her family for all her needs, but that is becoming more and more difficult with age. It is also very distressing for her mum, who is terrified about what will happen to Beccy when she is not around. I have nothing but admiration for Beccy’s family, and it was a no-brainer that I would want to speak in today’s debate, especially as I am not sure that anyone is giving the families a fair hearing.

The history of Primodos has been well described, so I just want to highlight the issues that are pressing for this family. The first is the report of the expert working group in 2017. The working procedures of the EWG and the conclusions of its report have been widely criticised, and the family are now seeking a properly independent review of them. They believe that such a review is necessary for acknowledgement and justice for their daughter. They want to be listened to, and I want them to be listened to. My right hon. Friend Mrs May and others have talked about the fact that these were not private clinics: it was the NHS that issued Primodos, so I think we are all looking for that redress.

I therefore want to raise with the Minister the necessity of a fully independent review of the expert working group report, so that all these families and individuals can be heard. After all, the first warning signs of harm were in 1958, when a Dr Edwards said that Primodos can cause damage to the foetus in the early stages of pregnancy. It is not something that has just come to light; it is something that has continually been raised as an issue. Many more warnings were forwarded to the Committee on Safety of Medicines, the UK regulator, from 1958 to 1967. All of those warnings were suppressed by the committee and Primodos remained on the market until 1978—20 years after the first warning was received by the UK regulator. These families want a fair hearing, and I believe they deserve one. I support the family 100% in their call for the UK regulator to stop protecting the drug companies and start protecting women and children.

So that is Beccy’s story. It tugs at the heartstrings. Not only has Beccy been robbed of a normal life; the effect on the family has been all-consuming. However, her story is not a one-off. The context to Beccy’s story is simple: her mum took Primodos at the age of 24 to establish whether she was pregnant, because she was advised to do so. Primodos contains the same components as oral contraceptives, as I mentioned, but at 40 times the strength. We do not have to be medical experts to work that one out.

Photo of Edward Davey Edward Davey Leader of the Liberal Democrats 1:42, 7 September 2023

It is always a privilege to follow 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 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 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.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Foreign Affairs Team Member), Shadow SNP Spokesperson (International Development Team Member)

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?

Photo of Edward Davey Edward Davey Leader of the Liberal Democrats

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.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

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.

Photo of Edward Davey Edward Davey Leader of the Liberal Democrats

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.

Photo of Edward Davey Edward Davey Leader of the Liberal Democrats

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 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.

Photo of Esther McVey Esther McVey Conservative, Tatton 1:52, 7 September 2023

I, too, thank Yasmin Qureshi for bringing this debate to the House. Listening to all the powerful speeches really makes me proud of the Chamber. This is the Chamber at its best, with the powerful speeches of my right hon. Friend Mrs May and Ed Davey.

How distressing it must be for the women and families harmed by Primodos that they are still having to fight nearly five decades on. Their road to justice has been long and cruel, and it is shameful that we find it necessary to debate this again. How can it be that the Primodos families are still not being properly supported and compensated after all the evidence that has been presented?

Sadly, Primodos is not an isolated case, and we have seen many examples over the years of our regulatory bodies failing to keep patients safe from new medicines and medical devices. In 2013, the Medicines and Healthcare products Regulatory Agency listed 27 medicines that had been withdrawn on safety grounds. The average time they were on the market was 11 years. I wonder how many times we will allow history to repeat itself. There have been reports and reviews calling for reform, and back in 2004 the Health Committee undertook an inquiry into the influence of the pharmaceutical industry. It noted, of drug companies, the

“closeness that has developed between regulators and companies”, which had

“deprived the industry of rigorous quality control and audit.”

It also highlighted

“the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust.”

In 2020, Dame June Raine, the chief executive officer of the MHRA, stated that her agency had transformed itself from watchdog to enabler, so I ask: has anything improved in the intervening 20 years since the Health Committee inquiry? I fear not, and I think the time has come for another inquiry of similar scope and depth, only with more robust outcomes. That is what we want—robust outcomes.

In 2020, the independent medicines and medical devices safety review, “First Do No Harm”, found that Primodos, sodium valproate and pelvic mesh had all caused “avoidable harm”. The review showed that patients had been let down, and it called for significant reforms of the MHRA, due to its mishandling of safety concerns. The review was clear that there is “gross under-reporting” of suspected adverse reactions and that

“systems are both too complex and too diffuse to allow early signal detection.”

That theme keeps coming up, and in a recent meeting of the APPG on pandemic response and recovery we heard from Professor Carl Heneghan, who described widespread problems with the reporting of adverse drugs and device reactions, which continue to be a major cause of hospital admissions. As many as 98 out of 100 adverse drug reactions go unreported.

The APPG, of which I am a co-chair, was told that the MHRA is running a system that is too slow to act and is beset by conflicts. Failure to act now will only lead to more harm. We also heard from the solicitor Peter Todd who was acting for 43 individuals who suffered blood clots as a result of the AstraZeneca vaccination. He described how the Government’s vaccine damage payment scheme is operating poorly and failing to help those who have been injured. Not only is the current system unable to protect patients from harm, but it is failing to look after those who have already been harmed.

Three years on from Baroness Cumberlege’s landmark review, the Government have not fully implemented its recommendations. In particular, we are still waiting for redress schemes to be set up to meet the costs of additional care and support for those who were harmed by Primodos, sodium valproate and pelvic mesh. Why has that not been done?

This is a bleak and worrying situation, so I will try to end on a more positive note by commending the important work of the hon. Member for Bolton South East as chair of the APPG on hormone pregnancy tests. My final tribute must go to Marie Lyon, whose tireless campaigning on Primodos over the decades has been inspirational. She deserves the full support and respect of this House, and I hope she and others harmed by this drug can finally get justice.

Photo of Jeff Smith Jeff Smith Shadow Minister (Clean Power and Consumers) 1:57, 7 September 2023

It is a pleasure to follow my near constituency neighbour, Esther McVey, and I join her and others in paying tribute to my hon. Friend Yasmin Qureshi for her campaigns over the years, and of course to Marie Lyon for her many years of campaigning for justice for the families affected, including in my constituency.

When Baroness Cumberlege’s report “First Do No Harm” was published in 2020, it finally offered those families hope of justice. It was unequivocal in finding that those affected by Primodos had “suffered avoidable harm” and should be entitled to support and financial redress. That should have been a landmark moment. The then Health Secretary apologised, appearing to take responsibility and accept the report’s verdict, so it is really so disappointing that, as I stand here today, no Primodos-affected families have received any compensation payment to address what they have been through.

I want to emphasise the impact on individual lives by looking at two families in my constituency. Patricia McClellan had two children, giving birth to a daughter in 1969 and to her son, John, in 1971. She did not take any hormone pregnancy tests before giving birth to her daughter, who was born healthy, but she was prescribed Primodos when pregnant with John, who was born effectively missing an arm. When doctors came to assess him a couple of days after his birth, Patricia described being asked if she had taken any medication during her pregnancy, to which she replied that she had been given Primodos. She said:

“I will never forget the professor and the Doctors took themselves into my bathroom for a private conversation. I felt powerless as events happened around me.”

She had a succession of other disempowering, worrying and disappointing experiences with medical professionals while caring for John of the type that were highlighted in Baroness Cumberlege’s review.

She said:

“I have felt as though I have been kept in the dark for over 40 years. I just want answers and justice for my son and hopefully some closure to the trauma, guilt and stress that has affected almost my entire life.”

Sadly, Patricia died in 2019, never having received the closure and justice that she needed.

John has lived his whole life with the impact of his disability, and struggles with red tape and constantly having to go through the processes to get recognition of his disability from the Department for Work and Pensions. He and his daughter Leah, Patricia’s granddaughter, continue to fight for justice alongside other Primodos-affected families. Leah said to me:

“Being the daughter of a Primodos victim has also had its effects on me. I’ve lost trust in our health officials, I’ve witnessed the lies that have been told time and time again. Seeing my father deteriorate mentally and physically because of this is worrying for me.”

In Leah’s words, too many people affected by Primodos

“have sadly died since all this began. It truly feels like the Government is just waiting for them to pass on so this can be brushed under the carpet.”

Photo of Peter Dowd Peter Dowd Labour, Bootle

The mother of one of my constituents was given Primodos in August 1972, two years after the standing joint committee for propriety in medicine said that it should have been withdrawn. Warnings were there for years. Why did that happen? Does my hon. Friend agree that my constituent, and his mother and father, who are up in the Gallery today, require justice to be done, and to be seen to be done by way of redress?

Photo of Jeff Smith Jeff Smith Shadow Minister (Clean Power and Consumers)

I could not agree more, and families across the country have been affected in such a way.

The Pierce family are another family in my constituency whose whole lives have been shaped by Primodos. Edward and Janet Pierce’s daughter, Louise, is now 54 years old. She was born with several different disabilities, which the families are convinced were caused by her mother having been prescribed Primodos. Louise has a severe mental disability, profound hearing loss, and difficulty walking. She has always required full-time care, which has been provided by her parents for most of her life. She lived at home with Edward and Janet until she was 50. Edward said:

“We didn’t realise the physical and mental effect this was having on our lives, it just creeps up on you.”

In 2018, Janet had a serious stress-related breakdown, leaving her with short-term memory loss and lack of awareness, and Edward now acts as her full-time carer. Louise went into full-time residential accommodation at the time of Janet’s illness. Edward said:

“I’m sure you can imagine the devastating effect this is still having on all our lives.”

It is so disappointing that the Government rejected the report’s recommendation for a new independent redress agency, and instead again highlighted the existing legal routes for redress. The Government apologised to people affected by the Primodos scandal, but are offering them no support. Those families lack the funding to be able properly to challenge the Government in court and get redress from existing legal routes, and they are being offered nothing else by the Government.

One of the specific recommendations in the Cumberlege review was the establishment of an ex gratia scheme for the victims of hormone pregnancy tests, and discretionary payments to provide redress for the stress, anxiety, psychological harm and toll of fighting for recognition experienced by those affected. That is what these families deserve.

Haven’t these families suffered enough? The mothers who were given Primodos are in their 70s and 80s now, and some have sadly died. Their children are mostly in their 50s. Time is running out to give them the redress they deserve. The Cumberlege report stated that

“while there is disagreement between experts about whether Primodos caused birth defects, the fact remains that thousands of women and unborn children were exposed to a risk that was acknowledged at the time.”

Primodos was deemed dangerous enough to pregnant women to be pulled off the shelves, and Baroness Cumberlege found that those families had suffered avoidable harm. In such circumstances, and having commissioned the report, surely it is the Government’s moral duty to implement that report’s recommendations in full or, failing that, to explain how those families will get the financial redress they deserve.

In July 2021, the then co-chairs of the all-party parliament group first do no harm responded to the Government’s response, welcoming their acceptance of four of the review’s nine recommendations, and a further one in principle. It also said:

“But we are deeply disappointed the Government has rejected calls for an independent redress agency or any redress for families whose lives have been devastated by medicines or medical devices. For those families justice has not been done today.”

One of those co-chairs, Jeremy Hunt, is now Chancellor of the Exchequer. He has the purse strings and he could make those ex gratia payments happen.

We have heard today from the former Prime Minister, Mrs May. She knows this issue so well and her remarks were powerful. I completely agree with Ed Davey that the drug companies must be held responsible. Ultimately, they should be the ones who pay, but in the meantime it is time for the Government to stop hiding and avoiding their responsibilities. It is time to act, and time to give these families the justice they deserve.

Photo of Theresa Villiers Theresa Villiers Conservative, Chipping Barnet 2:05, 7 September 2023

I was moved and saddened to read of the lifelong health difficulties experienced by one of my constituents, whose mother was given the Primodos hormone pregnancy test. It is a story of school, work and family life disrupted over a period of decades, with frequent hospital visits, multiple operations, organ transplants, and a lifetime requirement to take a powerful concoction of immunosuppressants and other medication. I was hugely impressed and inspired to hear of this brave individual’s determination to succeed in life despite that adversity, and I believe it is time that he, and other Primodos victims, are finally given justice. I pay tribute to all the campaigners who have continued their fight for redress over all these years, despite so many setbacks.

The first warning of harm caused by hormone pregnancy tests came as early as 1958. Over the following period, many further problems were highlighted to the regulator of the time, the Committee on Safety of Medicines. As we have heard, the 1967 study by Dr Isabel Gal provided a clear warning of the serious damage being done by those tests, yet the sale of the product was not formally halted until 1978, 20 years after the first safety alerts, and 11 years after Dr Gal’s ground-breaking study. Since then, research has repeatedly indicated that taking the test increased the risk of children being born with debilitating and life-shortening birth defects such as damaged limbs, brain damage and heart problems.

A major review was conducted at the University of Oxford in 2018, led by the distinguished scientist Professor Carl Heneghan, director of the Centre for Evidence-Based Medicine. That study looked at 26 hormone pregnancy test studies involving over 76,000 women. The researchers concluded that taking drugs such as Primodos increased the risk of birth defects by 40%. They found “a clear association” between Primodos and several forms of malformation.

Photo of Olivia Blake Olivia Blake Labour, Sheffield, Hallam

I am a biomedical scientist by background, and having read that review, what I find important is the way the researchers interrogated all the subsequent research that had been done, to ensure that there was no bias in any of the studies they included, and they excluded any studies that they felt were biased, using stringent statistical analysis. That makes the review all the more important to listen to.

Photo of Theresa Villiers Theresa Villiers Conservative, Chipping Barnet

I agree with the hon. Lady. It was a rigorous study, and it is a concern that in 2019 MHRA experts rejected that report, arguing that the quality of the studies examined was poor and the methods used to analyse them were

“not in line with best practice.”

As the hon. Lady pointed out, I do not think that is justified, and the Oxford team behind the research strongly refuted the claim made by the MHRA.

Despite all the scientific studies and research, campaigners have so far failed in their attempts to get compensation through the courts, and they have not been able to establish clear enough evidence of causation. That has been a massive hurdle in many cases over the years, not least in relation to tobacco, where it took decades of legal battles finally to show beyond doubt the causative link between smoking and cancer.

One of the problems faced by the families campaigning for compensation in this case is that many of the scientific studies of the ’70s and ’80s just do not meet the standards we necessarily expect in the 2020s. Many times in this House the call has come from Back Benchers loud and clear to support the families, to listen to their stories and to secure a fair outcome at last. The pressure that has come from this Chamber in so many debates helped to secure the welcome decision by the then Prime Minister, my right hon. Friend Mrs May to include Primodos in the independent medicines and medical devices safety review, led by Baroness Cumberlege.

Baroness Cumberlege concluded that Primodos was responsible for avoidable harm, that it continued to be used for years longer than it should have been, and that a fund should be set up to support families with the cost of care. She was very clear that, in the face of growing concerns, it should have been withdrawn from 1967. Her report acknowledges the disagreement between experts on whether Primodos caused birth defects, but she stated

“the fact remains that thousands of women and unborn children were exposed to a risk that was acknowledged at the time. That should not have happened. This is not a case of us judging the actions of the past by the standards of today. This was discussed at the time, but not acted upon. The system failed.”

Those conclusions from Baroness Cumberlege are truly damning. We have a Government-sponsored independent review concluding that the system failed the victims and survivors of the Primodos tragedy. We must find a way to put that right and ensure that the families get the recognition and financial redress they deserve. I urge Ministers to listen to the House today and take action at last. We cannot let this injustice continue.

Photo of Allan Dorans Allan Dorans Scottish National Party, Ayr, Carrick and Cumnock 2:11, 7 September 2023

There is considerable evidence indicating that those women who took the drug Primodos—prescribed by their general practitioner—and who were pregnant at that time gave birth to babies with serious birth defects, including deformities and disabilities, missing limbs, cleft palates, brain damage and damage to internal organs. In some cases, those women miscarried or had stillbirths.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

This is a really important point: Primodos was not prescribed; no prescription was written. No pharmacist could look at the patient and say, “Is this the right drug for that person?” It was a drawer opened, tablets taken out and pushed across. I know it is not intentional, but the word “prescription” is slightly misleading.

Photo of Allan Dorans Allan Dorans Scottish National Party, Ayr, Carrick and Cumnock

I thank the right hon. Member for his intervention; he is absolutely correct. The surviving victims are now mainly in their 40s and 50s. Many face a host of new medical problems and their bodies continue to suffer. Many have died prematurely.

Photo of Peter Dowd Peter Dowd Labour, Bootle

The Public Authorities (Accountability) Bill—the Hillsborough law—would require public authorities to admit responsibility following adverse and mass casualty incidents. 97 people died as a result of Hillsborough, and a scandalous cover-up went on for decades. Would the hon. Gentleman agree with me, my constituents in the Gallery and other constituents in the Gallery, that it is time to end the cover-up and to establish how many people have died prematurely as a result of Primodos?

Photo of Allan Dorans Allan Dorans Scottish National Party, Ayr, Carrick and Cumnock

I would welcome that type of inquiry and the opportunity to view the outcome.

Despite serious concerns being expressed by the eminent paediatrician, Dr Isabel Gal, in 1967 indicating the possible dangers of Primodos, no official warnings were issued about these drugs until eight years later. There is strong and compelling evidence of systematic regulatory failures, demonstrating that the committees tasked with safeguarding the health of pregnant women failed in their duty of care.

When I was elected in 2019, I had never heard of the drug Primodos, and I suspect that is the case for many Members. I had heard of thalidomide, as it received far greater coverage in the media at the time. However, since then I have learned much about the horrors caused by Primodos—the devastating effect it had on unborn babies and on the babies born with horrendous birth defects, and the continuing, unimaginable tragic consequences for the mothers and families whose lives have been so cruelly affected by the drug. It is an absolute disgrace and shameful that those families have not only been utterly abandoned and ignored by the drugs companies responsible, but also by successive Governments, who actively put up barriers to avoid accepting the consequences of the manufacture, approval, prescribing and giving out of Primodos.

The drugs companies involved in the production of Primodos, the medical authorities at the time who failed to protect people and successive Governments are all liable for the suffering caused to the victims of Primodos. They are all culpable and guilty of negligence, for failing to put right this horrendous wrong put upon innocent people. It cannot be right that the fight for justice in these circumstances has been left in the hands of a few determined individuals battling against a huge global pharmaceutical conglomerate with millions of pounds of resources and our own Government.

I highlight the case of my constituent, Nan. I have her permission to share her experience and the effect that Primodos had on her and her daughter, Michelle. In January 1975, Nan was a recently married, healthy young woman. Feeling sick and suspecting she may be pregnant, she went to her GP for a pregnancy test, expecting—as was normal at that time—a urine test. Instead, her doctor gave her two Primodos tablets. By 1975, Primodos had already been banned for use as a pregnancy test for five years in Norway and Sweden. Nan put her utmost trust in the knowledge, experience and expertise of her GP. It was subsequently confirmed that she was about seven or eight weeks pregnant. She had a very uneventful pregnancy during which she neither smoked nor drank alcohol.

On 28 August 1975, Nan’s daughter, Michelle, was born. It was immediately discovered that Michelle was born with a hole in her diaphragm, which had allowed her bowel and spleen and part of her liver and kidney to be forced in to her chest cavity, crushing her lung. She was not expected to live, but through the exceptional skills of our national health service she survived and is now 48 years of age. Throughout her life, she has endured numerous operations and surgeries and long periods of hospitalisation. She has suffered severe health issues, including breathing difficulties, a weakened immune system, numerous bowel obstructions and inflammatory bowel infections, and she has been unable to conceive children. The horrendous effects of the debilitating physical, psychological and medical conditions and the extremely challenging health conditions suffered by Michelle and her parents for the past 48 years just cannot be adequately described by me with words.

When Michelle was born in 1975, Nan was unaware that the drug that she had been given to test for pregnancy had been associated with birth defects for the previous eight years. It was not until some two and a half years later that she read an article in the press that reported on a number of cases linking birth defects to Primodos, including internal organ damage similar to that suffered by Michelle. Since that time, Nan, along with many other women, has been fighting the injustice, where no one has ever been held responsible for the damage caused to so many lives through prescribing Primodos, which had been approved by the Government.

In February 2018, the then Prime Minister, Mrs May, announced that Baroness Cumberlege would oversee an independent medicines and medical devices safety review. This review was, among other things, instructed to consider the consequences of Primodos. One of the conclusions in the report by Baroness Cumberlege is that Primodos should have been withdrawn from the market in 1967, after the first report by Dr Gal. However, the Government refused to accept responsibility for the effects of Primodos without a proven causal association, but admitted later, in a Sky TV interview, that there was a possible association. There was a moral duty for Government representatives on the Committee on Safety of Medicines to protect patients, but they failed in their duty of care by suppressing the evidence of harm caused by the drug. Even today, the Government continue to deny that they suppressed evidence, while supporting the flawed conclusions of the 2017 expert working group.

The damage to individuals, lives and families caused by Primodos, successive Governments’ lack of action and the failure to prevent, is immeasurable. This could be a far greater tragedy than thalidomide. Apart from frustration at the pharmaceutical companies and the glacial pace of Government in righting this tragic, historical wrong, the most chilling words we hear, increasingly regularly, are: “We have recently lost another of our Primodos family.” The tragedy is that we all know that those people died without receiving the justice they deserved. Even if compensation were paid, it would never fully compensate the families who were so tragically affected, or take away the immense guilt experienced by mothers who feel that they were in some way to blame for the defects that their children suffered.

It is well past the time for the current Government to put right this historical wrong, end the scandal and give some security to those who have suffered so much, thus allowing the mothers, fathers and the children who have survived some dignity and compensation for the tragedy that was caused through no fault of their own. The very least the Government can do is accept responsibility for the tragic circumstances, immediately issue a full apology to everyone affected by Primodos and compensate the victims. I and my party urge the Government to accept and commit to implementing the full recommendations of the Independent Medicines and Medical Devices Safety review and to set up a redress fund for families affected by Primodos.

Photo of Nigel Evans Nigel Evans Deputy Speaker (Second Deputy Chairman of Ways and Means), Chair, Restoration and Renewal Programme Board Committee, Chair, Restoration and Renewal Programme Board Committee

When we get to the winding-up speeches, it will be six minutes, eight minutes, eight minutes and then we will leave two minutes for the proposer of the motion.

Photo of Selaine Saxby Selaine Saxby Conservative, North Devon 2:21, 7 September 2023

I thank Yasmin Qureshi for securing this important debate and for her outstanding and ongoing work on the issue.

I am here today on behalf of my constituent Helen Barham, who since her birth has suffered from the brain disorder agenesis of the corpus callosum, hydrocephalus, damage to her skeletal system, and a brain haemorrhage at only 12 weeks, leading to epilepsy. She wears callipers and boots due to her feet deformities. She has had to have a number of major surgeries throughout her lifetime, including spinal surgery and a total hysterectomy. Despite all that, she still awaits compensation, which would allow her a personal carer and more comfort than she currently lives in.

Following Helen’s brain haemorrhage at 12 weeks in 1975, her mother Diane was told, in Diane’s words, that Helen would be spastic, mentally retarded, partially sighted and that, if the doctor was her, they would go home and forget about Helen, as she would be nothing but a cabbage. Diane and Helen have defied that awful prognosis. Helen has an active social life, with swimming, discos and holidays to Butlins.

Over the last almost 50 years, Diane has tirelessly kept fighting for Helen to have the best quality of life possible. However, ultimately the opportunity for a normal and healthy life was taken from Helen while she was still in the womb, because in 1974, Diane was given two pills following a missed period. It was only when Helen was three years old that a doctor from Great Ormond Street Hospital informed Diane that it was likely that those two Primodos pills were the cause of Helen’s disabilities.

Although Diane has dedicated much of her life to Helen’s care, as she has said, it has often come at a cost to her other children, her marriage, and her relationship with her parents. She is getting older and less able to look after Helen. All Diane asks is for Helen to receive compensation so that she can have someone to care for her all the time. Helen is currently in hospital after experiencing yet another complication following recent surgery to remove her gall bladder. Doctors were unable to remove Helen’s gall bladder fully and she is still struggling on the ward.

I welcome the Government’s apology to families by the former Health Secretary on behalf of the healthcare system, but it is financial assistance that families like Diane and Helen’s need. As has already been said, the Independent Medicines and Medical Devices Safety review led by Baroness Cumberlege found that the drug should have been removed from the market in 1967, and that both the state and the manufacturer had an ethical responsibility to fund a financial scheme for those harmed to help them with their care costs. Having been born in 1974, Helen certainly falls into that camp.

The Government are already working towards redress systems for valproate and vaginal mesh, as advised by the Independent Medicines and Medical Devices Safety review, but there has been no progress on a scheme for Primodos families. The 2018 systematic review of historical human studies by Professor Carl Heneghan clearly demonstrated that Primodos had a clear association with different forms of malformations, including musculo- skeletal, neurological and neurogenetical forms, all of which have affected Helen.

Modern science is also paving the way. Previously it was impossible to prove a direct link with human studies, as that would require testing the drug on pregnant women, but Professor Neil Vargesson has found similar outcomes to those for children born following their mothers being prescribed Primodos when testing the drug on zebrafish, chosen for their genetic similarity to humans. A new study has used chicken embryos and human cell lines, and even low doses produce developmental abnormalities. The full results are due later this year. Baroness Cumberlege felt that there was enough evidence of a link between Primodos and complications from birth for financial support in February 2018. Since then, the evidence has only grown.

I would like to reiterate to the Minister today how much difference the financial redress recommended by the IMMDS would make to Helen and Diane’s quality of life. Diane trusted her NHS doctor and our medical system, and now we need to support her and her family as they continue to face Helen’s complications together.

Photo of Margaret Greenwood Margaret Greenwood Labour, Wirral West 2:26, 7 September 2023

I congratulate my hon. Friend Yasmin Qureshi on securing this debate, and thank her for her outstanding work in leading this campaign in Parliament. I also pay tribute to all the families of children who were born with birth defects after their pregnant mothers took Primodos for the courage that they have shown. In particular, I pay tribute to Marie Lyon—who, I am pleased to see, is here with us today—for her tireless work.

Those affected should not have to fight for justice. I join colleagues in the debate in calling on the Government to acknowledge the fact that the recommendations in the Independent Medicines and Medical Devices Safety review relating to Primodos-affected families have not been implemented, and to explain why; to implement those recommendations and to set up a redress fund for families affected by Primodos; and to withdraw the 2017 expert working group report on hormone pregnancy tests, which has been disputed by academics and is inconsistent with other more independent studies.

In their fight for justice, the families have suffered setback after setback. The latest came a few months ago when claims for damages against Bayer Pharma, Schering Health Care Ltd, Aventis Pharma Ltd and the Government were struck out in the High Court, partly owing to lack of funding for legal representation. That was a bitterly disappointing blow.

The Government have a moral duty to set up the redress fund for those affected. As far back as the late 1950s, concerns were raised that hormone pregnancy tests, the most commonly used of which was Primodos, could cause abnormalities in a developing baby. Further studies in the UK and elsewhere from the late 1960s to the early 1970s suggested a link between the use of hormone pregnancy tests and a wide range of serious birth defects.

It took until 1975 for the Committee on Safety of Medicines to recommend that hormone pregnancy tests should no longer be used. The committee said that there was “little justification” for them, as alternatives were available. It then sent an alert letter to all doctors in the UK, advising them of a possible association between hormone pregnancy tests and an increased incidence of congenital abnormalities. The letter recommended that doctors “should not normally prescribe” those products as pregnancy tests.

However, it has been reported that Primodos sometimes continued to be used as a pregnancy test within the NHS until it was withdrawn from the market by the manufacturer, Schering Chemicals Ltd, in 1978. By that stage, the damage had been done. Legal proceedings by the affected families began, but were discontinued in the early 1980s. It was not until early 2014, and the discovery of documents from the 1960s that reportedly showed that studies suggested that hormone pregnancy tests caused miscarriages and congenital abnormalities, that a new campaign called for an independent public inquiry into them.

Criticisms of the 2017 independent expert working group report on hormone pregnancy tests included the fact that it did not examine regulatory issues and that a number of documents had not been included in the review. Additionally, the methodology and findings in the report have been disputed by academics and are inconsistent with other academic reviews, as today’s motion highlights. One of those reviews was by a group of researchers at the University of Oxford, led by Professor Carl Heneghan. The researchers concluded:

“The evidence of an association”— by which they mean between hormone pregnancy tests and birth defects— “has previously been deemed weak, and previous litigation and reviews have been inconclusive. However, we believe that this systematic review shows an association of oral HPTs with congenital malformations.”

Despite that, the Government say that they currently have no plans to reassess the findings of the expert working group review. I hope that, today, we hear a different response from the Minister.

In 2018, the independent medicines and medical devices safety review was announced by the Government, led by Baroness Cumberlege. Despite the Cumberlege review’s finding that Primodos caused avoidable harm, and the clear recommendation for redress for those affected, the Government have refused to even acknowledge it. That is a grave injustice and an insult to those who have suffered. Let us remind ourselves of some of the adverse impacts that affected individuals and families have attributed to hormone pregnancy test use: congenital heart defects, dysmorphic facial features such as cleft palate and lip, digestive system and bowel issues, intellectual disability, limb defects and, tragically, death.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

Could I add to that those who were told to have an abortion, and those who had a miscarriage or a stillbirth? Their families have been damaged almost as much, and the guilt is still with them.

Photo of Margaret Greenwood Margaret Greenwood Labour, Wirral West

The right hon. Gentleman makes an excellent point and I agree. The Minister must recognise the clear moral case to support those affected. Back in 2017, the then Health Secretary apologised

“on behalf of the NHS and the whole healthcare system...to those who’ve suffered and their families, for their frustration, for the time it’s taken to get their voices heard.”

However, in the years since, the Government have failed to provide the recognition and redress that those affected by Primodos deserve. The Government must fully implement the recommendations in the independent medicines and medical devices safety review and set up a redress fund for those affected by Primodos as a matter of urgency. Those affected by Primodos have suffered enough, and they deserve justice.

Photo of Jacob Rees-Mogg Jacob Rees-Mogg Conservative, North East Somerset 2:31, 7 September 2023

May I join others in paying tribute to Yasmin Qureshi, who has done such terrific work campaigning on this issue? She commandeered me as we were neighbours on Upper Committee Corridor South, when I was relatively new in Parliament. Those campaigning efforts have been so important on a fundamental issue for so many of our constituents. One of my own constituents is here today, following our proceedings closely.

The case before us seems so remarkably straightforward that it is impossible to see why there is such a stick-in-the-mud attitude from the Government, though perhaps less so from the pharmaceutical companies, because they know that they are culpable and, ultimately, deserve a financial liability. Why can I be so confident of that link? There seems to be one very striking fact, which was revealed by Jason Farrell in the important work he did for Sky News: the drug was used in South Korea and Germany as an abortifacient. It was used to procure abortions. What is a drug that will do that doing to a baby? It is causing harm. That is so straightforward. We have heard already that Primodos contained 40 times the amount of hormone in a contraceptive pill. It also contained 13 times the amount of the morning-after pill. It is so clear and self-evident that harm has been caused, and therefore responsibility must be laid at someone’s door. We know from today’s debate where those doors are.

I have great sympathy for the Minister who is to respond, because there is an extraordinary, peculiar tendency of Government—one I do not understand as a Back Bencher and did not understand in government—to cover up the mistakes of long-since-passed Administrations. We have seen it with Hillsborough, the infected blood scandal and even with thalidomide. There is no doubt an almost endless list. I do not understand it—it is not the current Administration at fault. They have done nothing wrong; some were not even born—the Prime Minister was not—when the scandal started. Yet again and again, Governments and the bureaucracy will not open up, allow the real truth to come out and follow the evidence that was so brilliantly and clearly put by Baroness Cumberlege in her report.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Human Rights), Shadow DUP Spokesperson (Health) 2:35, 7 September 2023

I congratulate Yasmin Qureshi on raising this issue, and I thank her for bringing this important debate to the Chamber and enabling us all to participate and add our contributions. I have spoken on this issue in the Chamber before, as have others, but today is important. Sir Jacob Rees-Mogg said succinctly in his introduction that for the life of him he could not understand why the Government have not accepted the key issue. To him, it is an open and shut case; it is to me, too. The Government really should grasp that and come back with the answer that we all seek.

I want to speak up for all those mothers and families impacted across Northern Ireland. As the only Northern Ireland MP here in the debate, I wanted to contribute and assure those families across Northern Ireland that I am here to represent them and be their voice. The issues regarding Primodos have been ongoing for many years. We still have families fighting daily for justice, or simply for an explanation of what went wrong. The independent medicines and medical devices safety review has stated its view that from 1967, hormone pregnancy tests should no longer have been available. However, the facts show, as right hon. and hon. Members have illustrated on behalf of the families, that it was still used until 1978. I stand with right hon. and hon. Members to speak up for those who have no justice, no answers and no compensation to this day. Like Ed Davey, I wish to see compensation that reflects the loss and impact on those mothers and children and all the families.

Varying combinations of pills are used to this day by millions of women for contraception. Primodos tablets were 40 times the strength of the pill. My goodness, if we grasp that, it leads us straightaway to what happened, but nobody knew it. Campaigners have claimed that the use of the medicine in early pregnancy caused a range of devastating and lifelong impacts such as limb defects, spina bifida, congenital heart defects and developmental and learning problems, to name just a few. Furthermore, it has been claimed that the use of the drug led to miscarriage or stillbirths. Sir Mike Penning made that clear in his intervention, for which I thank him as it was a good reminder of the impacts.

I am pleased that it has now been decided that an apology is due. Words are great, and it is good to have the apology on the record, but as elected representatives we want support and compensation for the families who have suffered avoidable harm. I am not convinced that an apology goes far enough. I speak for those who have suffered miscarriages and stillbirths, and I have raised this issue before. In so many cases, we are unable to carry out genetic testing due to babies dying and their remains being gone, as the right hon. Gentleman rightly said in his intervention. I have no doubt that so many families out there are still traumatised by the prospect that their baby did not survive because of this drug. There must be support for those parents too. I look to the Minister to consider them for any form of compensation or support that may be forthcoming. There is sufficient evidence to prove that the drug was harmful for a period of time. We had a duty of care then and we have one now to those families. The Government must not fail again.

To conclude, I believe there is scope to do more, both now and in the future, to support the families who have been suffering these traumas for decades and to ensure that such mistakes are not made in the future and lessons are learned to protect life. Let us do something for all those families who this day want help which, at the moment, does not seem to be forthcoming. That is why I look to the Minister, who is very understanding. She understands the issue very well. She has the heart for it. On behalf of my constituents and others, I hope that today we get the answers and the full compensation we want for them.

Photo of James Grundy James Grundy Conservative, Leigh 2:40, 7 September 2023

First, I pay tribute to my parliamentary neighbour, Yasmin Qureshi, who has been so diligent over so many years in bringing this issue to the fore. Secondly, I pay tribute to local campaigner Marie Lyon, who lives in my borough and who has done so much to raise the issue of the Primodos scandal over a considerable period of time.

The Primodos pregnancy test was—I understand there has been some dispute about this description—prescribed to Marie over 50 years ago. She spoke about this very eloquently on Sky during its investigation. It was prescribed to her over 50 years ago. As other Members have said, the concentration of female hormones in the pill—she was told to take two pills, 12 hours apart—was the equivalent of taking 80 modern oral contraceptive pills in a single day, or, as my right hon. Friend Sir Jacob Rees-Mogg mentioned, the equivalent of 26 morning-after pills during a single day. The facts are beyond doubt. Is there anyone in this Chamber or on this earth who believes that that would not cause significant damage to unborn children?

This issue has festered for too long. I understand, from speaking to my hon. Friend the Minister on the many occasions I have buttonholed her to ask her about what progress we can make, that the cases in the court have delayed progress. I take her word on that, but as others have said, including my right hon. Friend Mrs May, I believe that this issue has progressed out of the court and it is now long beyond time that we put it to a permanent resolution. I hope that when my hon. Friend the Minister speaks from the Dispatch Box she can give the House the reassurance that that will indeed be the case, and that we move forward to a scheme of redress and compensation, and get justice for the families affected. I hope that as an early part of that process, she will make haste to contact Marie and other members of the families affected, and meet them to discuss how we can move the issue forward.

As my right hon. Friend the Member for North East Somerset said, for many years Governments of all colours have failed to address these issues and have perhaps put a carpet over the sins of the fathers, as it were. It is long past time that this was dealt with. Sunlight is the best disinfectant. Justice delayed any further is certainly justice denied.

Photo of Jane Stevenson Jane Stevenson Conservative, Wolverhampton North East 2:43, 7 September 2023

I start by thanking Yasmin Qureshi for all her work in raising the issue of Primodos, and Marie Lyon. Like Allan Dorans, I knew nothing of Primodos when I was first elected in 2019. Shortly after my election, I met Marie with Charlotte Fensome, who joins us today in the Gallery. Charlotte’s brother Steven was a victim of Primodos and Charlotte’s family have been one of the affected families. Many of the words I am going to use today are Charlotte’s words, speaking of what her family has endured because of the advice of a GP to take Primodos. Not long after our meeting in Parliament, I met the Bagley family. Ted Bagley, Steven’s father, is here in the Gallery today and I welcome him to Parliament. This debate is long overdue. It is extremely important that, now legal proceedings are not ongoing, we can discuss what the Government can do for Primodos families.

The afternoon I spent in Wolverhampton North East with Ted and Pat Bagley, Charlotte, and Steven Bagley was a really enjoyable afternoon. I greatly valued the chance of meeting Steven and the Bagley family. It was a home filled with love. I have absolutely no doubt that Steven was aware that he was cherished and loved by his family every day of his life, but I left that home in absolute awe of the efforts to care for Steven made by the two parents in their 80s who were still entirely responsible for him. Let me read Charlotte’s summary of her family life:

“Mum was given Primodos by her GP in Wolverhampton in the early weeks of her pregnancy with my brother Steven…he was born in 1967 with severe brain damage. In many ways he had a difficult life. He had profound learning disabilities and was unable to speak, feed or wash himself. He was incontinent and wheelchair bound. He suffered violent seizures on a daily basis, due to a form of epilepsy that medicine was unable to control and that kept him awake at night. He needed twenty four hour care and my incredible parents cared for him with great difficulty, but with absolute devotion, at home full-time, from the day he was born until the day he died aged 53 years.

We are a close family and we all adored Steven. I know that despite his disabilities, he was happy in life and he felt loved. Seizures aside, he was always smiling and he had the most beautiful, expressive eyes that could tell you exactly how he was feeling. I’m sure that he understood far more than any professional gave him credit. He was a gentle man with a big personality and a devilish sense of humour, who loved being the centre of attention and enjoyed socialising. And although he may not have been able to talk, he was full of fun and made plenty of loud noises to compensate!

My parents were determined to give him a ‘normal life’ from day one, even though society was less accepting of disability…Steven went wherever we went as a family…on the dance floor…at parties…in restaurants…he travelled through Europe by car, flew on aeroplanes and sailed on ships. He loved listening to opera for hours with dad and was very partial to a McDonalds! He appreciated…life and did more in life than many people without his disadvantages.

The hardship has made my parents stronger despite the odds and this year they celebrated 62 years of marriage. To their credit, my own childhood was full of love, enjoyment and opportunity despite their difficult life. My sister Nikki and I were always incredibly proud to have Steven as our brother”.

I am in no doubt of that love for Steven, but the daily grind of looking after someone with such profound disabilities was awful to witness. Charlotte told me during my visit that because Steven’s epilepsy kept him awake at night, his parents had a round-the-clock watch. His mum Pat, in her 80s, sat up overnight with Steven, only sleeping when Steven’s father woke up in the early morning to take over the watch. The Cumberlege report gave Steven’s family some hope that finally help was on the way to support them in caring for Steven. That redress is what I want to speak about today.

Baroness Cumberlege says in her report that hormone pregnancy tests

“are not just a historic issue. We do not doubt the continuing psychological suffering caused by their use - indeed we have witnessed it on the faces and in the words of the families we have met;
the sorrow and anger arising from a conviction that lives had been needlessly, and often irreparably, damaged, both physically and mentally;
the impact of carrying a relentless sense of burning injustice for decades without resolution;
parents of the affected children, deeply anxious about what will happen to their adult child when they are no longer there for them;
mothers burdened by guilt at having taken the tablets. The extent of the suffering, endured over decades, must not be underestimated.”

The report calls for help for families to access support, and also for redress. Both are greatly needed, and I hope that the Government will respond positively to this debate. We have heard Members on both sides of the House speak of the impact that Primodos has had on families, and I am especially pleased that several have mentioned that no mother should feel any guilt about having taken it. It is crucial for every mother to know that she—like all of us when we see a GP—took the advice of medical professionals, whom we trust to know better than us and to be acting in our interests.

That redress would not cost a great deal in the overall scheme of Government spending. The Primodos families remaining are now in the low hundreds, not the many thousands. A discretionary award based on need would really help those families. When I asked Charlotte Fensome what the compensation and redress money would have allowed, she came back with several very manageable asks. The first was night sits to relieve her parents, who were in their 80s, of having to sit all night with Steven. The second was a choice of incontinence pads which were not available on the NHS. The third was continuity of domiciliary carers who could get to know Steven and understand his needs. The fourth was more suitable wheelchairs. The fifth was adult centre training to provide ways of occupying Steven, and the sixth was future care. That is the worry that families have. Primodos parents are getting older and older, and many of them worry about leaving behind a child who will be at the mercy of the state; we must give them reassurance. Finally, there was the difficulty in accessing help. The Government could accept that Cumberlege recommendation to give the families a contact point to help them to access the services that they so desperately need.

We have heard from many Members about the drugs fight in the courts, so I will not go over that ground. It was always a David-Goliath fight for the Primodos families, and I know that they feel exhausted. They have waited so long for redress; they have waited so long for help.

Steven sadly died on Boxing Day in 2020. He had been taken into hospital, having contracted covid from a visiting carer. His sister Charlotte, with typical determination, fought her way into the intensive care unit to be with her brother. It is too late for the Bagley family, but their greatest wish is for other families to have the support that they so severely and desperately needed.

Photo of Anna Firth Anna Firth Conservative, Southend West 2:52, 7 September 2023

I thank Yasmin Qureshi for securing the debate, and it is a pleasure to follow the incredibly moving and powerful speech of my hon. Friend Jane Stevenson. I also thank my right hon. Friend Mrs May for her very powerful speech, and for the vital work that she has done in this area. Finally, I pay tribute to the all-party parliamentary group on hormone pregnancy tests and Baroness Cumberlege for all that they have been doing to support the hundreds of women and children whose lives have been turned upside down by the use of Primodos from the late 1950s until the 1970s.

This is an extremely important issue for my constituents Sheila and Stuart Harvey, and Sheila’s son Raymond Hyman. I am delighted that they have been able to join us, and are watching and listening to this important debate from the Public Gallery. Sheila was given a Primodos pregnancy test in the late 1960s, completely unaware of the risks. Her son Raymond was born apparently healthy and happy, but Sheila soon became worried when he failed to put on weight. Three months into his life, and after numerous visits to different doctors and hospitals, a team of surgeons at Great Ormond Street Hospital discovered that his heart had failed to develop properly in the womb. Only one ventricle had formed, and the main arteries to his heart were the wrong way round. Raymond underwent six surgical procedures during his childhood, and there were many points at which his parents were worried that he would not survive.

Fortunately, Raymond has survived, but there has of course been an impact on his whole life. His growth and education were affected, and he continues to struggle with his mental health, as well as having to take a huge number of pills every day. I understand that he receives no financial assistance whatsoever, not even to help pay for the prescriptions that he needs to deal with the effects of the drug.

As many Members have said, families and victims such as Raymond deserve justice. The women who used Primodos did nothing wrong. The NHS failed them, and we should not turn our back on them now. The Government have apologised to the families for what they have been through, and I very much welcome that apology, but I understand that the Government have no plans at the moment to offer financial redress to the victims. The principle of providing redress is nothing new and has been applied before in this country. It happened in the case of thalidomide, for which the Department paid around £80 million over 10 years. It happened again with variant CJD, for which the Government allocated a fund of more than £67 million for the victims.

Just like thalidomide victims and those diagnosed with variant CJD, the victims of Primodos need and deserve our support, and not just in financial terms but with practical and non-financial help, too. The Government have so far refused to help, saying their focus is on preventing future harm. It should not be a choice between reducing the risk of future harm, on the one hand, and helping those who have already suffered, on the other. This is not an either/or but an and. We should be doing both.

I know that those watching our proceedings, both from the Gallery and at home, will very much hope for some assurance from the Minister today that a scheme to address this terrible injustice will finally be established. It is trite and has already been said, but the words of William Gladstone are so appropriate today: justice delayed is justice denied.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead 2:56, 7 September 2023

It has been an honour and a privilege to sit through this debate. As usual, I will be speaking with no notes, because a lot of what has been said today I would have said myself. I pay tribute to the chair of the all-party parliamentary group, Yasmin Qureshi. We have done much work together over the years.

I pay tribute to Marie Lyon and all the other campaigners, but there is something about this debate. Every time we have it there is unity, conformity, passion and love in the Chamber but, as my right hon. Friend Sir Jacob Rees-Mogg said, it disappears into Government and does not come back out. Governments of all descriptions have known about this for years and could have done something about it, but, for some unknown reason, they did not. When I was a Home Office Minister under my right hon. Friend Mrs May we did other inquiries together, but we had to battle to get them.

I do not understand why Governments, of all descriptions, do not come to the House to make statements, so we have to UQ them. It is plainly obvious that we will get a statement. We had three statements today, and quite rightly, but the Government would have been UQ-ed if they had not come to the House. Perhaps common sense is prevailing.

When it comes to really serious issues, like Primodos, for some unknown reason the Government, the Department and the Treasury pull down the shutters. It is not one Department, and I fear for the Minister when she stands at the Dispatch Box, because this is way outside the remit of just the Department of Health and Social Care.

We heard earlier that Government lawyers are threatening activists who are trying to get justice for their families, loved ones and others. Many of these campaigners have lost their loved ones, and some of them were victims themselves when they were told to have an abortion or when they had a miscarriage or stillbirth. A lot has changed in society but, in the 1960s and 1970s, it was a really difficult thing for a woman to go to her GP because she thought she was pregnant, especially if she might be a single mum. These couples and single mums were passionately waiting for this pregnancy to make their life fulfilled, and then, a short time later, they were told that perhaps the best thing to do was to abort the child because they would have terrible deformities, or they might go through childbirth. I am lucky enough to have just become a grandfather. I remember being there 33 years ago when my wife punched me on the nose halfway through childbirth. She did not intend to do it; she had no idea what was happening. She was just in a lot of pain and doing that made her feel better. These women were there and then all of a sudden they realised that the disfigurements and abnormalities were there to be seen—or, as we have heard in this debate, not seen until a little later.

We will be having a debate later, which I will be leading, about a situation where babies are born exactly like that and people are being told, “Oh, they’ve got bunions.” They do not have bunions; they have a genetic deformity. But because that deformity is so rare, no one understands it. On this issue, however, the Government, the NHS, the GPs and the drug company knew what they were doing. If the drug company had withdrawn Primodos after a year, when it first started to see this, most of us would have understood that these sorts of situations occur and it should, rightly, have compensated. However, that is not what happened. This went on year after year, with it knowing about this drug.

My point about the word “prescribed” is not just semantics; this drug was not prescribed. A prescription is a prescription. Opening a drawer and giving out a couple of tablets to the lady in front of you is not a prescription; it is a handout. This was done with no information given as to the dangers that we all see today. We have only to buy a packet of paracetamol to see written across the back of it what could happen. These ladies were not given that opportunity. They needed to know whether or not they were pregnant, for whatever situation they were personally in, and the GP then opened the drawer. This was in an NHS surgery, with a GP who was self-employed, as they mostly are, but paid for by the NHS. Those drugs were given not through a pharmacist, but directly from the drug company to the GP to hand out.

Let me conclude on an area that we have not really touched on, and it is something that Governments need to understand. I was a shadow health Minister for four years and I was passionate about this. The damage to our NHS of public understanding of this is so, so bad. The public need to trust the NHS. When they go to their GP, they need to be able to trust that if something needs to be done, it will be done for them and not for the system. Our NHS is being damaged by the way this cover-up continues. Government lawyers have accepted bits of Baroness Cumberlege’s report, but the fundamentals of it, which my right hon. Friend the Member for Maidenhead made sure happened, have been completely ignored. We can run around the head of a pin and say, “It is because there was legal action here and legal action there,” but we should say, “Let’s just do what is right. We have made a mistake, in the Department or in the drug company, and we are going to put it right and put it right today, for those families who are still there and for those families we have lost.” That is the decent thing that this House should do.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Foreign Affairs Team Member), Shadow SNP Spokesperson (International Development Team Member) 3:03, 7 September 2023

It is a massive privilege to speak on behalf of my constituent Wilma Ord and those other victims. I declare an interest, as a vice-chair of the all-party parliamentary group on hormone pregnancy tests, where I work alongside an incredible campaigner, Yasmin Qureshi. She has done the most wonderful job and we have stood side by side.

One of the first cases I ever dealt with as a constituency Member began back in 2015, when Wilma Ord and her daughter Kirsteen came to my constituency surgery. As happened to so many of the victims—our constituents who have been mentioned today—Wilma’s doctor had taken out a pill from his top drawer when she was pregnant and handed it over to her, and she had trusted him. Ultimately, that is what this debate is about. It is about that social contract that our constituents have with us as parliamentarians and with Government, with their doctors and the institutions of the NHS, and with those private companies that are allowed into that space by us and by Government. It is also about the lack of regulation. If the Government continue to refuse to do anything about that, we can only conclude that these have been acts of state-sanctioned harm, because those companies were allowed to operate within the framework of our society and harm was done to our constituents.

Another issue, which has not been touched on an awful lot, is the flawed and failed legal process. I will touch on that, but first I pay tribute to Marie Lyon, who is a remarkable campaigner; to Jason Farrell of Sky News, who has done an incredible job and produced the documentary, “Primodos: The Secret Drug Scandal”, which I encourage Members to watch; to Baroness Cumberlege, for her remarkable work; and of course to Mrs May. In my opinion, her campaign on this subject is one of the right hon. Lady’s greatest achievements of her time in office. There may be many things on which we disagree, but we will continue to stand shoulder to shoulder on the issue. The Minister should be aware that we are not going anywhere. Whatever happens at the next election, parliamentarians from every party in this place will continue to hold the Government to account on the issue. The scientists Carl Heneghan and Neil Vargesson have been mentioned numerous times; their work has also been crucial.

In 2020 the right hon. Member for Maidenhead was right when she said:

“I almost felt it was sort of women being patted on the head and being told ‘there, there, dear. Don’t worry. You’re imagining it. You don’t know. We know better than you do.’”

I agree wholeheartedly with her, as that is exactly how my constituent was made to feel—she was gaslighted. I have sat with my constituent many times and I sat with her again recently. She lost her husband, George, a year ago. He died not knowing the truth and not seeing justice. It feels very much as if this Government are waiting for people to die rather than taking action, and that is for shame. When I met with Wilma recently we talked a little bit about what the future holds. As other hon. Members have said, our constituents are scared about what will happen next and about what the process and the future will hold.

I want to talk a little about that process. When some of our constituents took their legal action to court, the litigation was cumbersome and expensive and, after the judicial decision this year, the campaigners felt that they had really been done over. I will use my parliamentary privilege, Mr Deputy Speaker, to say that they were done over by a company called Pogust Goodhead, which approached the Primodos campaigners to take over the case. It then got cold feet and decided to drop the claimants and the victims when it did not fancy its chances of winning. To compound that, the company went on to withhold the documents that constituents such as Wilma Ord had presented to the company to pursue the case. That prevented the campaign from being able to find other legal representation and fundamentally meant that the campaign was unsuccessful in court. In my view, that is a hostile and odious movement by any legal firm.

The court citation states:

“Shortly after the service of the defendants’ evidence, PGMBM”—

Pogust Goodhead—

“informed the claimants that they could no longer act for them. They then applied to come off the record… The material placed…in support of the solicitors’ application to come off the record is privileged and has been withheld from me and from the defendants.”

Those are the words of Mrs Justice Yip. She goes on to say that

“some claimants discontinued their claims”, and talks about the issues around managing a case that has “so many unrepresented litigants”.

In its mission statement, Pogust Goodhead says it is a

“global partnership…working to help individuals, groups, and businesses access fair and tangible justice.”

What a load of absolute nonsense. I appeal to the company directly today, as I am pretty sure the lawyers who worked on the case will be watching: give our constituents their documents back and come clean on exactly how you pulled out of that litigation. And for shame on the Government for going into cahoots with that crowd and leaving our constituents and those victims in that situation. That is state-sponsored and funded action against our constituents and our citizens.

As many people have said, this injustice has gone on for decades, like contaminated blood, Hillsborough and the thalidomide case. It seems to be the order of the day and the order of Government to make people wait for decades, to traumatise and retraumatise them. Baroness Cumberlege’s review clearly took a different view from that of the expert working group and concluded that the manufacturer and the state had an ethical responsibility to find a financial scheme for those harmed.

Finally on my hit list is Bayer, formerly Schering, which said that financial recompense was not appropriate. Last year, its profits were $4.4 billion. It made millions off the back of Primodos and off the back of the damage that was done to our constituents. I am sorry, but this is not good enough for our citizens. It is not good enough from the Minister and it is not good enough from the Government. They need to get off their backsides and do something about this, because we, as parliamentarians, as campaigners and as constituents, are not going away.

Photo of Andrew Gwynne Andrew Gwynne Shadow Minister (Social Care) 3:10, 7 September 2023

I thank the Backbench Business Committee for granting this important debate and, as others have done, pay tribute to my hon. Friend Yasmin Qureshi for her tireless work on this issue. She not only secured today’s debate, but has been a powerful voice in this campaign for many years. I also wish to put on record my thanks to Marie and all the other campaigners.

Esther McVey, who is no longer in her place, rightly said that debates such as this show Parliament at its best. I commend the contributions from my hon. Friends the Members for Wallasey (Dame Angela Eagle), for Manchester, Withington (Jeff Smith), and for Wirral West (Margaret Greenwood). I also commend the speeches and contributions from Mrs May, who did some good work in this area as Prime Minister and carries on campaigning for justice, Suzanne Webb, the right hon. Members for Kingston and Surbiton (Ed Davey), for Tatton, and for Chipping Barnet (Theresa Villiers), Allan Dorans, who is also not in his place, Selaine Saxby, Sir Jacob Rees-Mogg, the hon. Members for Strangford (Jim Shannon), for Leigh (James Grundy), for Wolverhampton North East (Jane Stevenson), for Southend West (Anna Firth), Sir Mike Penning and, last but not least, Hannah Bardell, who leads for the SNP. Parliament has spoken with one voice and Parliament has spoken incredibly strongly. We know, as we have heard today, that it has taken decades for those affected by the hormone-based pregnancy test Primodos to be heard let alone be given justice.

Around 1.5 million women in Britain took Primodos in the ’50s, ’60s and ’70s before it was finally withdrawn in the late 1970s. Since then, countless women have come forward to tell their stories, alleging impacts on their children ranging from congenital malformations, birth defects to miscarriage and stillbirth. The voices of these women and their families were not heard for decades.

The Cumberlege report, published in 2020 after being commissioned by the then Prime Minister, the right hon. Member for Maidenhead, and the Secretary of State for Health, was a watershed moment in this decades-long struggle. It investigated not only Primodos and other hormone pregnancy tests, but sodium valproate and pelvic mesh.

What the Cumberlege report found was damning. It concluded that Primodos caused “avoidable harm” and that the handling of this issue spoke to an institutional failure to take the voices of women seriously. The report made several recommendations relating to Primodos, including but not limited to: a full apology to those affected by Primodos, a patient safety commissioner, a redress agency for those harmed and a taskforce to implement these wide-ranging recommendations.

It is important to welcome the apology that the then Secretary of State for Health and Social Care made in 2020 following the publication of the Cumberlege review. But, as has been made clear today, this apology was supposed to be the beginning. I am concerned that the Government have so far fully completed only two of the nine recommendations in the Cumberlege review. Four are classed as ongoing and three have been outright rejected.

That glacial progress is just not acceptable, so I will press the Minister on some key points that stood out to me in the Government’s implementation update report of last December, and other developments since. First, in relation to the recommendation for specialist centres for those adversely affected by medications taken during pregnancy, the Department of Health and Social Care has reiterated its view that specialist centres are

“not the most effective way forward.”

Instead, the Government point to NHS England committing to improve care pathways for the children and families affected. The Government’s report states:

“The Teratogen Clinical Development Group has recommended a proposal for regional multidisciplinary and interdisciplinary ‘hub and spoke’ services to sit within specialised neurodisability teams”.

Those services would support the treatment of children and young people exposed to harmful substances such as Primodos. However, the update report simply states that NHSE

“will explore this recommendation further”.

Can the Minister update the House on where that work has got to?

Secondly, as has been highlighted today, there are concerns about the Government’s approach to this issue. There has been a refusal to discuss the redress scheme, in contradiction to the Cumberlege review. There have been reports of refusals to meet with campaigners and parliamentarians, and news of lawyers representing the Government backing efforts to strike out legal action. The list goes on and is becoming more and more concerning. Given the High Court ruling in May, which I know many campaigners were exceptionally disappointed by, what steps are the Government taking to better engage with parliamentarians and campaigners on this issue, and do they have any plans to reconsider their position on redress and implementation?

Photo of Theresa Villiers Theresa Villiers Conservative, Chipping Barnet

I am really interested to know what Labour would do if it won the next general election. Would it set up a fund for financial redress?

Photo of Andrew Gwynne Andrew Gwynne Shadow Minister (Social Care)

There seems to be a bit of a trend for the current Government, and Ministers supporting the current Government, to be looking to Labour to fix some of these problems. We will look very seriously at these issues and the situation that we inherit after the next general election, but I want today’s Minister and her Government to do what they need to do now, not wait until the next general election, which could be 12 months or more away. We need justice and redress now.

This is not a party political issue; it is an issue for each and every one of us in this House—those who have contributed to today’s debate, and the many Members who have not. On both sides of the House, we have to ensure that this historic scandal is comprehensively addressed, and the sooner the better for the victims and families. I sincerely hope that in her response the Minister will agree with all that has been said today, and that we can secure some very long overdue justice for these women and their families.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women) 3:18, 7 September 2023

I thank Yasmin Qureshi for securing the debate and all right hon. and hon. Members who have taken part in it. We cannot help but be moved by the many cases that have been brought forward this afternoon. This is the first time I have been able to speak either in this Chamber or in Westminster Hall on Primodos because, as many Members have said, there were legal proceedings that ended in May. The claimants had until 11 August to make an application for permission to appeal, which they did not do in that time, so today is my first opportunity since that legal action to speak on it. A second claim is being issued by those who believe that they were harmed by hormone pregnancy tests, against Bayer/Schering. That claim was stayed pending the outcome of the first case and, given that the first claim was struck out by the court, there are now discussions regarding the next steps with that claim. However, I am free to speak today on the issues that we have discussed in the debate.

I want to be clear, as a Minister who is responsible for patient safety, that the patient safety element is the most pressing and important part of my role. Baroness Cumberlege is also a constituent of mine, so hon. Members can be assured that she lobbies outside Parliament as well as inside.

Baroness Cumberlege conducted a review, and the Government have accepted and made progress on most of those recommendations. As has been said, an apology was issued by Government Ministers at the time when they responded to that report. We have appointed an independent Patient Safety Commissioner, and Henrietta Hughes is doing an outstanding job holding the Government to account.

I will touch on the issues around redress in just a moment. We have set up the mesh centres for those affected by pelvic mesh; I meet regularly with those female campaigners to hear their feedback on the effectiveness of those centres, and there is work going on to review that. The MHRA itself is revising its practice as a result of Baroness Cumberlege’s report.

Photo of Angela Eagle Angela Eagle Labour, Wallasey

I think the Minister for her generosity in giving way, but this sounds like a typical civil service-drafted speech, if I may say so, mentioning everything but the issue we are talking about. We are not talking about mesh; we are talking about Primodos, and we want to hear about redress. Can she now please address those points?

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

I can show the hon. Lady my remarks—they are on the back of this paper, and I have been writing them down during this debate. I am only two minutes into my speech and I am addressing some of the points that were made. I will of course come on to Primodos as well.

It is important to recognise that we did take those issues in Baroness Cumberlege’s review seriously. We could not look at the issue around Primodos at that time because of the legal case, which I have touched on, but there have been some reviews. My hon. Friend George Freeman was here just before this debate. In his time as Minister for Life Sciences, he took the campaigns and the evidence around Primodos so seriously that he set up the expert review in 2014 to look at the evidence that was in place. I hear very loudly this afternoon some concerns about that expert working group and that maybe evidence was either misinterpreted or not looked at, but that expert working group did look at the evidence at that time and also issued a public call for evidence.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

The so-called expert group changed the remit that it was given, with no recourse, as I understand it, to any Minister for permission to do so. It changed the terms of what it was supposed to look at, which is not what it was asked to do in the first place.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

I hear my right hon. Friend and, as I said, I will come on to that specifically towards the end of my remarks.

There were further evidence reviews. Hon. Members have touched on the evidence from Heneghan et al., and from Brown et al. in 2018. Those were looked at, and again there was no evidence of causality found in those reviews.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Foreign Affairs Team Member), Shadow SNP Spokesperson (International Development Team Member)

Causality is one of the key issues here, because it is very difficult to prove. The only way it can be proven is if those tests were done on pregnant women, and we all know that would be utterly ridiculous and absurd. However, we do know that there was association, and the bar has been set so high that it has become impossible for people to get justice. That responsibility lies at the door of the Government. Thalidomide campaigners were able to settle with the company. We need to look at how we can make that happen for Primodos campaigners, but the Government also need to look at lowering the bar.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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 Theresa Villiers, who was clear about the drug being taken even after evidence had emerged. I heard from my hon. Friend Suzanne Webb about the effect on her constituent Helen and her family. I heard from my right hon. Friend 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 Mrs May, who set up the Cumberlege review in the first place. My hon. Friend 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.

Photo of Theresa May Theresa May Conservative, Maidenhead

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.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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.

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.

Photo of Theresa May Theresa May Conservative, Maidenhead

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.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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.

Photo of Edward Davey Edward Davey Leader of the Liberal Democrats

To follow on from the point made by 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!

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Foreign Affairs Team Member), Shadow SNP Spokesperson (International Development Team Member)

It seems to me that we are caught up in a quagmire of bureaucracy. We have had the Cumberlege review. We know what the results are. The Government said incessantly that they would not address the Primodos matter because of the court case. We now know that the court case was, in some respects, flawed, because the complainants and victims were not able to take their case forward as their information was withheld by the legal firm. As Ed Davey said, they are now being treated in a hostile manner by the Government by being told that they will be sued for over £10 million if they take another case forward. That is an utterly preposterous situation. If the Minister really wants to get to the bottom of it, she needs to implement fully the Cumberlege review and ignore the nonsense that has gone on in the courts.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

I do not want to test your patience, Mr Deputy Speaker, because I know that I am over time, but I have made the commitment to review the Cumberlege recommendations for Primodos patients. For those who have been affected by sodium valproate and mesh, we are making huge progress. Only this week, we introduced a statutory instrument so that sodium valproate can only be dispensed in the manufacturer’s original packaging. We have the pregnancy prevention programme, which is drastically reducing the number of babies born to those taking sodium valproate. We are installing the registry, so that women on sodium valproate are better cared for and not taking that medication. Now that 11 August has passed and the claim was not followed up, I am looking at the Primodos recommendations as well. My commitment is to come back to the House and update Members on the progress on those matters.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office) 3:32, 7 September 2023

First, I thank all Members who have spoken in the debate. In particular, I pay tribute to the vice-chair of the APPG on hormone pregnancy tests, Hannah Bardell.

The many interventions on the Minister from my colleagues show that we are very unhappy about what she proposes and what the Government seem to want to do about this. We want to meet the Minister, but not in six months or three months; we would like to have a meeting in the next week or so.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office)

We want to sit down with the Minister, and we want her to say to us, “This is what we are going to do about the Primodos case.” We do not want the Minister to tell us the problems. We want a system of redress right now—that is what we want from the Minister—and I hope that when we have that meeting, she and her officials will present to us the practical action they are going to take so that all the people who have been suffering for decades and decades actually get justice. We want her to tell us not about what has happened before or about the court cases, but about the actions she will take based on what the Cumberlege review said. [Interruption.] The Minister is muttering, but in the past it has sometimes taken us months and months to get a meeting with Ministers. I am glad that she has reassured us, and I hope that we will get a meeting in the next couple of weeks and that her and her officials will present a concrete plan for how to get redress for the victims. [Interruption.]

Photo of Roger Gale Roger Gale Deputy Speaker and Chairman of Ways and Means, Deputy Speaker

Order. I know that, strictly speaking, the hon. Lady has only two minutes, but these are important issues. If she wishes to give way to the Minister, she may.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office)

I am sorry; I did not realise the Minister was asking to intervene. I give way.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

I just wanted to reiterate that I have pledged to meet the APPG and all its members. I have also pledged to look at the recommendations specifically in relation to Primodos. I think it is important to meet the families and the APPG, so that we can make progress on this issue.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Equalities Office)

I thank the Minister for that intervention. I look forward to meeting her and her officials, and to a great scheme that will help the victims of Primodos. I remind her that if we do not get our meeting, or if we do not get a satisfactory result, we will be back again—all of us. We have been fighting for the past 10 or 12 years, and we will continue to fight this campaign, because the whole House is united behind it. I hope we will get positive news at our next meeting.

Question put and agreed to.

Resolved,

That this House
notes that children were born with serious deformities due to the hormone pregnancy test drug Primodos, which was taken by expectant mothers between 1953 and 1975; further notes that official warnings were not issued about Primodos until eight years after the first reports indicated possible dangers;
observes that the report by the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests in 2017 was inconsistent with other academic reports;
notes that the Independent Medicines and Medical Devices Safety Review, First do no harm, found that Primodos caused avoidable harm;
further notes that the Government has refused to acknowledge the recommendations by the Independent Medicines and Medical Devices Safety Review relating to Primodos families;
and calls on the Government to fully implement the recommendations in the Independent Medicines and Medica al Devices Safety Review and to set up a redress fund for families affected by Primodos.