Hormone Pregnancy Tests

Debate between David Mowat and Hannah Bardell

Thursday 13th October 2016 Commons Chamber

[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.