Draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) (EU Exit) Order 2018

Debate between Justin Madders and Steve Brine

Thursday 11th October 2018 General Committees

[Steve Brine]

I am not giving the hon. Lady that guarantee. I am saying that it is a live consultation and it would not be appropriate for me to pre-empt it. I do not share the hon. Lady’s half-full view of our ambition for the future, which the Prime Minister set out in terms of our relationship with the EMA. The EU does not have a relationship with the UK as a third country at the moment. That is why we have set out an ambitious proposal for our new relationship with the EU and its agencies, including the EMA. I am hopeful, as are the Prime Minister and the Government whom I speak on behalf of, that we will secure a good deal. We still think that that is the most likely outcome. That includes a new relationship with the EMA. We should remember that the expertise that we have in this country, and the work we do with the EMA, will not suddenly change because it is based in Amsterdam. It will still need that expertise and that relationship. I am ambitious about the future, which is why I say what I say.

The matter before the Committee today is technical, to make changes to enable the agency to function after exit day.

[Justin Madders]

The Minister is speaking with great confidence, without any basis in fact, in saying that the MHRA will not need any state handouts in the future. Will he commit to report back to Parliament, if it turns out that it is not, in future, self-financing?

[Steve Brine]

Of course, if there is any change to any arm’s length agency that the Department works with, we will come back to Parliament for that discussion. That is partly what the consultation is about at the moment. So if the hon. Gentleman wants a blank cheque to say that we would come back to the House to have discussions around any future changes, the answer is self-evidently yes.

Question put and agreed to.

Medicines Regulation

Debate between Justin Madders and Steve Brine

Tuesday 21st November 2017 Westminster Hall

[Steve Brine]

I share the hon. Lady’s concern. As I said, so much about this is still subject to negotiation. I cannot give her the exact assurance that she wants at this time.

The hon. Lady also asked about the EU exit transition. The Government are clear that we want to continue collaborating with the EU in the interest of protecting patient safety. The detail of any future relationship is, of course, subject to that negotiation. That is nothing new. We recognise completely that new arrangements can take time to implement, and we will work closely with the industry and key health system partners to ensure smooth implementation. The European Union (Withdrawal) Bill, which is going through the House at the moment, will ensure that a known legal framework is in place immediately after we leave the EU.

The hon. Lady talked about the Secretary of State “flirting” with leaving the EMA for the FDA. Earlier this year, the Secretaries of State for Health and for BEIS published a letter in the Financial Times setting out our aim to retain a close relationship in respect of medicines regulation. The FDA has been clear that it would not let another country “join” FDA processes even if we wanted to, but if we are outside EU processes, we will certainly look at how we can co-operate more closely with other global regulators.

The hon. Member for Lewisham East (Heidi Alexander) asked whether we had had contact with Australia and New Zealand. The chief executive of the MHRA chairs the International Coalition of Medicines Regulatory Authorities, and we of course have had discussions through that group on a contingency basis with Canada, Australia and others about the potential for greater collaboration once we have left the EU.

The hon. Lady asked whether I can guarantee that the adverse effects of drugs will be detected quickly. She also asked about orphan drugs and clinical trials. Increasingly, information about the adverse effects of drugs is shared at a global level. The EMA collaborates with many third countries. There is no need for a broad deal to agree to share safety information. We want to continue collaboration with the EU on orphan drugs for rare diseases, which she rightly pointed out are a subset of the wider issue. If we are outside EU processes, we will need to consider incentives for orphan drug development, and we are doing that. Clinical trials all receive national approval today, and they will receive approval under the EU clinical trials regulation, which is due to come into force in late 2019. The UK will remain a leading centre for clinical trials. There is no reason why multi-country trials cannot include the UK after Brexit.

Several Members, including the shadow Minister, the hon. Member for Ellesmere Port and Neston (Justin Madders), asked about MHRA resources. Some 90% of medicines on the UK market already have a national licence from the MHRA; fewer than 10% come via work that we do for the EMA. We have world-renowned scientific assessors at the MHRA. Some work and workloads may change post-Brexit, but I do not think that claims of fundamental change are correct. MHRA has full contingency planning in place.

[Justin Madders]

On that point, can the Minister confirm that Department of Health budgets will not be used to fund any additional MHRA costs?

Hormone Pregnancy Tests

Debate between Justin Madders and Steve Brine

Thursday 16th November 2017 Commons Chamber

[Steve Brine]

I thank my right hon. Friend—one of my predecessors in this role—for her question. I appreciate that she will have met constituents who have been affected by this in her surgeries and that that must have been very difficult. The report’s conclusions do not detract from the suffering experienced by the families, and we recognise that the families may find those conclusions hard to accept. Birth defects occur naturally in up to four in every 100 babies, and the existence of a birth defect in a baby exposed to a medicine during pregnancy does not necessarily mean that it was caused by the medicine.

As for the question of any future parliamentary discussion of this subject, I suspect—in fact, I know—that my right hon. Friend is more than capable of seeking such opportunities.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

This decision has rightly been met with disbelief by campaign groups. It has been called a whitewash, an injustice and a betrayal. It is clear from the reaction to yesterday’s report that real anger remains about the way in which the affected families have been treated. Have we learnt nothing from previous scandals and cover-ups? The chair of the campaign group, Marie Lyon, has said:

“I could go to prison if I divulge what was discussed.”

Does the Minister not agree that that is as far away as possible from transparency? How can Marie Lyon or any of the other campaigners say that their views have been properly taken into account? Will the Minister tell us what conversations he has had with the affected families about the results of the report and what further action they want to take?

A draft of the report, which was published in October, stated

“Limitations of the methodology of the time and the relative scarcity of the evidence means it is not possible to reach a definitive conclusion.”

However, that sentence was removed from the final version. It is critical that the Minister answers these questions: why was the sentence removed; why was there a delay of a month; and did he speak to the authors of the report about the sentence before its removal? The inquiry has answered a question that it was not asked to answer, and it has reached a conclusion not supported by the evidence. What is the Minister’s view of the various studies that have been referred to that show a causal connection?

When he set up the inquiry, the previous Minister for life sciences, the hon. Member for Mid Norfolk (George Freeman), said that he wanted to

“shed light on the issue and bring the all-important closure in an era of transparency”. —[Official Report, 23 October 2014; Vol. 586, c. 1143.]

The reaction that we have seen will demonstrate to the current Minister that on that measure the inquiry has failed. Will he look again at holding a full, independent review, so that families can feel they have seen justice done and we can be sure that this will never happen again?

[Steve Brine]

The hon. Gentleman referred to a “whitewash”. As I have said, this was a comprehensive, independent, scientific review of all available evidence by experts on a broad range of specialisms who, with respect, are far more qualified to consider the subject than either him or me. It was a rigorous, important and impartial review conducted over the best part of two years, and the experts were given access to all the available documents.

As for the families and issues relating to disclosure, yes, Mrs Lyon was on the panel. However, it is standard procedure for expert working groups to sign such an agreement, as all members of the panel did, in order to keep the process free from external influence and to prevent it from being constantly discussed in the media. The companies did meet the group and gave evidence to it. Having discussed the matter briefly with members of the Medicines and Healthcare Products Regulatory Agency this morning, I have to say that I think the families could have been treated a great deal better when they met the group. I thought that the layout of the room was intimidating. Not everyone is like a Minister or a Member of Parliament who can sit in front of a Select Committee and know how to handle it. I think that the process could have been handled better, and I made that very clear.

As for Ministers and meetings, my noble Friend Lord O'Shaughnessy, who ultimately has responsibility for the MHRA and whom I “shadow” in the House of Commons, has met the all-party group and the families group. He will meet them again on 6 December, now that the report has been published. The APPG is also meeting the chair of the expert working group.

The hon. Gentleman mentioned other research. He might have been referring to Dr Vargesson, an Aberdeen-based researcher who is, I believe, working on the components of Primodos in fish. He was invited to give evidence to the group, and he did so, but he did not want to leave his work and the evidence, which he said would shortly be published, with the expert working group. As far I am aware, that work has still not been published, but I know that the MHRA will be keen to look at any new work that is published.