Hormone Pregnancy Tests

David Mowat Excerpts

Thursday 13th October 2016 Commons Chamber

[The Parliamentary Under-Secretary of State for Health (David Mowat)]

May I just say at the outset that nobody in the Government has any interest other than in getting to the truth in this matter? We are as keen as the people who have spoken today, and indeed the families that are watching us, to make sure that we do that, and there is a process that is to be followed to make that happen. We have heard some strong words today: “establishment whitewash”, “sham inquiry” and “a blanket over the issues”. I say again: nobody on the Government side of the House has any interest in anything other than getting to the truth, and the process that was put in place two years ago had that at its heart.

Let me join others in congratulating the hon. Members for Bolton South East (Yasmin Qureshi) and for Livingston (Hannah Bardell) on leading the charge on this, not just today, but in terms of the APPG and making sure that this issue is very high on the Government’s agenda. It is massively important that those who feel their lives have been adversely affected by drugs, albeit 40 or 50 years ago, see that processes are in place to make sure that we do what we can.

I would also like to pay tribute from the Government side to the Association for Children Damaged by Hormone Pregnancy Tests, and particularly to Marie Lyon for the work that she has done and continues to do—and should continue to do until we get to the truth of this matter.

I am going to talk in some detail about the progress on the inquiry, but it was very clear, as I listened to the debate, that, at the very least, the association does not have confidence in the work of the inquiry, and that is unsatisfactory. I have heard people talking about letters being unanswered and all that goes with that, and that is unacceptable. I make a commitment at the start to the association, or the APPG, that one of the things that should come right out of what we are talking about today is a letter from them, in as much detail as they want it to be, raising as many concerns as they feel they have about the details of the inquiry—a lot of detailed points have been made, which I will not be able to answer today. That letter will be answered in detail, and after that we should have a meeting to make sure that everyone is content with the direction in which we are going.

[Mr George Howarth]

I am grateful to the Minister for his offer. Does he accept that part of the problem is that if people do not have confidence in the process and do not feel that it is being conducted in a transparent way— there is evidence that that is the case—they will say that the inquiry is likely to be a whitewash? He needs to reassure not just the families and my hon. Friends, but everybody concerned with the inquiry that the process will be transparent and open. In those circumstances, people would have more confidence in it.

[David Mowat]

I accept that, which is why I have made the offer. I guess the caveat is that, in the end, science will play a big part in getting to where we need to be. The science will find its own path, and I want to talk a little about how we are trying to achieve that.

As hon. Members have said, two years ago my hon. Friend the Member for Mid Norfolk (George Freeman), who was then the Minister for Life Sciences, established an inquiry that, at the time, was committed to having an independent review of the evidence and to attempting to find a scientific link between the hormone pregnancy test—in particular, Primodos—and the adverse effects on pregnancy and all that goes with it. It is worth saying at this point that, as hon. Members have said, this is an international issue that has been around for 40 to 50 years. We are the only country to have set up such an inquiry, and the only one to have attempted to find a scientific route to the truth in this way.

[Hannah Bardell]

Will the Minister give way?

[David Mowat]

I will continue to make progress, but will come back to the hon. Lady.

Two years ago, the MHRA was charged with putting the inquiry in place. It worked with the Commission on Human Medicines to set up an expert group, whose job was to establish whether there was a scientific link between the drugs prescribed and the adverse effects. The first meeting was a year after that, which was a long time. I apologise for that on behalf of the Government; I think it was too long. I have inquired why that was, and I have been told that there was the election and the purdah period, but it was too long. The group has met four times, and its next meeting is on Tuesday next week. I think we can all conclude that the members of the inquiry will be watching our proceedings and listening to the points that have been made. At that time, the review’s focus was on the science to establish whether it could be shown that there was a link between the drugs prescribed and the adverse effects. The terms of reference were subsequently altered to cover going into the lessons learned.

[Hannah Bardell]

I absolutely take on board what the Minister is saying—he is being very positive, and has clearly listened to the concerns we have raised—but I have a couple of comments. First, the fact that we are the only such country is surely a good thing given how far behind we lagged. We have an opportunity to lead the world on this and to show how this can be done positively. Secondly, as he says, no Government members want the inquiry to fall down. Is it not therefore his duty to intervene to make sure that it has the right resources, the right expertise and the right processes?

[David Mowat]

There is nothing in that intervention with which I disagree. We all want the inquiry to work. The Government have not established an inquiry in order for it to fail. We have not established an inquiry for it not to have the confidence of the association. We need to get to the truth, but that is a scientific process, and because it is a scientific process, it can be frustrating and long-winded; it can take a long time.

I want to talk about some of the concerns that have been raised. There were three types of concerns. The first was that the independent group of experts is not reviewing the regulatory concerns or the delays that took place at the time, in particular the failures of the then Committee on Safety of Medicines and the five or eight-year delay, which we have heard about. The UK was not the first country to ban the drug, but it was not the last either. The second concern, which I will talk about at some length, was that members of the expert group might not be independent and might not have fully declared their conflicts of interest. We have heard words like “colluding” and “cover-up” from some Members. The third concern was that not all the available evidence is being considered by the group, and we heard about the German material not being translated. I will address all three points.

On the first issue, we have heard that there was a regulatory failure and that the inquiry should look at it. I say to the House that if, when the expert group reports next spring, it finds a clear causal link, that will be the time to take further action on issues such as regulation and liability, and everything that goes with that. The first step we are taking is to establish the science. The group that has been set up is an expert group. It is science-led. It is important to make it clear in the House that we are not criticising individual members, because they are striving to get to the truth. It is a group of eminent people.

It would be quite wrong if we conflated the possible eventual need to look at the regulatory actions that were taken, the legal liabilities and everything that goes with that, with the first step of the process, which is to establish whether the science leads us to that link. In spite of some of the comments that have been made today, that has not been done yet in any country. The first serious attempt to do it is the one that is going on now.

The second concern is that the expert working group is not impartial. The MHRA has taken a vigorous approach to evaluating and handling potential conflicts of interest. No member of the expert working group can have any interest in any of the companies that were involved or their predecessors. Members should not have publicly expressed a strong opinion, favourable or unfavourable, about the possibility of birth defects arising from these drugs. We heard that one of the members had tweeted. If there is evidence of that, we will follow it up. It is true that one member not of the expert group, but of the advisory group was removed because it was felt that he had a conflict of interest that was not properly declared. Action was taken very quickly in respect of that.

The inquiry is chaired by a consultant gynaecologist from the Chalmers centre in Edinburgh. The group has 14 scientists drawn from some of the best universities in the UK. We have no reason to believe that any of them have any more reason not to want to get to the truth than Members on both sides of this House.

[Maria Eagle]

Does the Minister not realise how important it is that, whatever the rights and wrongs of this and whatever the qualities of the members of the panel, the families need to have confidence in it? There is no point in saying that they are all wonderful people. The families have concerns and if they are not assuaged, in one way or another, the outcome will not have their confidence.

[David Mowat]

I said at the start of my remarks that the learning point I have taken from this debate is that, whatever we think about the truth, the science and whether we are doing the right thing, the families are not happy. I also said that we will do what we can to amend that.

As well as that, Members on both sides of the House need to accept that we need to get to the scientific truth. In order to do that, there needs to be a scientific process. That has to happen and that is why some of this is time-consuming and difficult, even though we wish that it was not.

[Mr George Howarth]

The Minister is being generous in giving way. I am not sure that the terminology he is using is necessarily suitable. I do not understand this to be a scientific process per se. I understand it to be an informed judgment about the available evidence and, understandably, that is best conducted by scientists. I think he was a lawyer in a previous existence, so he will understand the difference between the two approaches.

[David Mowat]

I am guilty of many things, but I have never been a lawyer. However, in case I was not clear, I understand the difference between the two processes and accept the distinction that the right hon. Gentleman makes. The point I would make again, however, is that the panel has 14 members who have been chosen for particular skills in the issues involved, plus lay members who are not scientists.

[Yvonne Fovargue]

Will the Minister give way?

[David Mowat]

I will not, as there are only a couple of minutes left and the hon. Member for Bolton South East needs to sum up.

I will now address the third point that arose in the debate, namely whether all the available evidence will be reviewed by the expert group. The answer is yes. That is one reason why the process is taking so long. A specific question was raised about a great deal of evidence that has recently come to light which is in German. All that evidence will be translated, and all the translations will be put before the group. The chairman will be responsible for ensuring that that evidence is looked at and reviewed properly. There is absolutely no intention that the inquiry be anything other than a properly resourced attempt to get to the truth. That is difficult for something that happened 40 or 50 years ago. We all need to accept that point.

I finish by making the same point that I made at the start of my remarks. The Government are responsible for the efficacy of this inquiry, and we need to get to the right answer. It is important, and I accept, that the inquiry clearly does not have the confidence of some of the stakeholders. That is not acceptable or satisfactory. I will make the same undertaking as was made by the then Minister for Life Sciences two years ago when putting the inquiry in place, namely that we will try to put things right. I make the offer again: if there is a letter giving the detail of the points that have been made, that letter will be answered and we will hold a meeting to discuss it subsequently.