The Parliamentary Under-Secretary of State for Health (Steve Brine)
Let me start by saying that this debate has been carried out with a tone and style that do great credit to this House and to the families who have campaigned so hard for so long. The shadow Minister, the hon. Member for Washington and Sunderland West (Mrs Hodgson), and I are becoming known for the non-partisan way in which we approach some of the issues in our portfolio, and long may that continue.
Let me congratulate my right hon. Friend—I also congratulate him on his elevation last week—the Member for Hemel Hempstead (Sir Mike Penning) on securing a further debate on this important issue. I pay tribute to the Members who continue to campaign tirelessly on behalf of those who were given hormone pregnancy tests. I was struck by what the hon. Member for Liverpool, Riverside (Mrs Ellman) said—she mentioned that this was first raised in the House in 1978, when I was four. I hope that we can achieve closure before it is that long again.
Let me be crystal clear from the very start. The Government’s utmost priority is and always will be—my right hon. Friend the Secretary of State has done more than most—the safety of NHS patients. We have listened to the concerns of patients and their families. We have certainly listened to parliamentarians on the matter of hormone pregnancy tests over many years, and we will continue to do so over the coming weeks and months.
Time and again during today’s debate we have heard that there is a lack of trust and a lack of faith in this process—the hon. Member for Manchester, Withington (Jeff Smith) said this clearly; I thought he made a very good speech—contrary to the words of my hon. Friend the Member for Mid Norfolk (George Freeman) that the shadow Minister quoted. That troubles me, so let me be clear. We have ruled out no options at this time.
The report of the group published on 15 November represents the culmination of a rigorous piece of scientific work by a group of experts all well respected in their field. It is the most exhaustive investigation of the issue undertaken to date. However, it is clear to me that many Members and the families for whom they speak have concerns about this issue. We are committed to listening to them and acting on them. Although we differ on many points, there are surely a couple of things on which we can agree at the outset. The first is that the safety of mothers and their unborn children has to be paramount. The second is that standards in medicine, science and regulation have changed beyond all recognition in the last 50 years.
My hon. Friend the Member for Ayr, Carrick and Cumnock (Bill Grant) and the hon. Member for Liverpool, Riverside said that drugs were handed out from the GP’s desk drawer, and indeed it says that on page xii of the report. The footnote says:
“Today, there are strict requirements for the supply of free samples of medicines to prescribers, as set out in section 6.12 of the MHRA Blue Guide”.
That is why I say that medicine, science and regulation of prescribing have changed hugely in the past 50 years. It is imperative for me that we continue to seek improvement in this area. That is why we have tasked the Medicines and Healthcare Products Regulatory Agency with implementing the recommendations of the expert group. They are quite wide. They are not just nice to haves; they are valuable initiatives that should permanently benefit the millions of women who use medicines in pregnancy.
Several themes came up in the debate. My right hon. Friend the Member for Hemel Hempstead mentioned Mr Dobrik. I apologise if Mr Dobrik feels that his name has been used inappropriately; I think that is the right thing to do. He was invited, as an advocate for families facing these issues, and made a strong contribution throughout. Let me be clear as the Minister. We thank him for his contribution. He is a campaigner who rightly has wide respect across our country and the world, and I know that that will continue to be the case.
My right hon. Friend spoke about the name of the inquiry. I am told that the group was reminded from the start that it had been set up not as a statutory inquiry but as an expert group of the Commission on Human Medicines. It was important to be clear on that at the start because formal inquiries have a very different structure and statutory powers. I do not think that there was an inconsistency there, but we can continue that debate. Almost all those who spoke mentioned the terms of reference—“causal” versus “possible”. The terms of reference set out the scope of the review, and I do not believe that they changed. They were endorsed by the CHM in December 2014 a few weeks after the previous debate, and confirmed by the then Minister, my hon. Friend the Member for Mid Norfolk, in a letter to the all-party group in September 2015. In the same letter, the all-party group was informed:
“it is important to review the scientific evidence to establish whether there is any causal association between use of HPTs and subsequent birth defects in the child.”
It is implicit and integral to any scientific assessment of evidence on medicines and associated harms to see whether the medicine is actually responsible for causing the harm rather than simply being associated with it.
The hon. Member for Manchester, Withington and others mentioned changes to the expert group report. I know that many Members are concerned about differences in the draft and final reports, and especially over the removal of the sentence that said:
“limitations of the methodology of the time and the relative scarcity of the evidence means it is not possible to reach a definitive conclusion.”
That sentence in the draft report was followed immediately by the group’s overall finding
“that the available scientific evidence does not support a causal association between the use of HPTs such as Primodos, during early pregnancy and adverse outcomes.”
The CHM quite rightly considered the two sentences together to be misleading, and advised that the report should be revised to better reflect the scientific—I stress, scientific—conclusion of the group, and that is set out on page 100 of the final report.
The hon. Members for Bolton South East, (Yasmin Qureshi), for Manchester, Withington and for Makerfield (Yvonne Fovargue) and others spoke about historic actions. Ministers have always been clear that issues of historic regulatory process were outside the scope of this review because there first needed to be clarity on whether there might be a link between HPTs and birth defects. That point was made by the much-mentioned former Minister for Life Sciences—my hon. Friend the Member for Mid Norfolk—in his letter to the all-party group in September 2015, when he said:
“the review will include a chronology of events, but the EWG”—
the expert working group—
“will not be asked for its advice on systemic or regulatory failures”.
The hon. Member for Washington and Sunderland West and a number of other Members said that that should have been different. As I said to the hon. Member for Bolton South East, I am listening, but the report that I inherited on my desk this summer had that as its guidance. The group was not set up to look at those historic actions. Whether or not it should have is a matter of debate.
The hon. Member for Bolton South East—while we are talking about her—and the hon. Member for Makerfield mentioned the transparency issue and the “gagging order”. As I said during the urgent question, I can assure the House that, in being asked to sign a confidentiality undertaking, Mrs Lyon, who is here today—and I pay great tribute to her for her work—was not in any way treated differently from other panel members. This is standard procedure so that discussions can be held freely and openly in the group without external interference or a running commentary in, God forbid, the media. Despite being an observer throughout the review, Mrs Lyon was invited to speak after every agenda item and asked to give a presentation to the group on the evidence she had provided for the review.
The hon. Member for Bolton South East mentioned the evidence from Dr Dean and the Royal College of General Practitioners that was ignored. The interactions between Dr Dean and the RCGP are fully described in the annexes to the report, and I will come back to that in just a second before I close.
My hon. Friend the Member for Eastleigh (Mims Davies) and the hon. Members for Livingston (Hannah Bardell) and for Bolton South East mentioned the interactions with the families. I was clear the last time I was at the Dispatch Box on this subject that the families were not treated with the respect and the dignity that I would expect as the Minister from a body that I am responsible for. I have made that very clear to the members of the group, and I have asked them to report back to me as to how they will do things better next time. I look forward to seeing that, and they know that I mean it when I say that.
I mentioned the transparency issue. Minutes of the meetings and declarations of interest were published last week. I can update the House that annexes to the report, all documents from the national archive and studies conducted by Schering have been published today. The remaining documents, including those from the German archive, will be published sooner than originally agreed, once they have been checked for any personal data that needs to be removed due to confidentiality owed.
I am going to close there and give the sponsor of the debate a chance to close. I thank Members for their contributions. Nothing is off the table, and I am listening.