Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I understand that the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so the next speaker will be the noble Lord, Lord O’Shaughnessy.

[Lord O'Shaughnessy (Con)]

My Lords, I will speak to Amendment 108. In doing so, I remind noble Lords of my interests as listed on the register and my membership of the First Do No Harm All-Party Group, set up by my noble friend Lady Cumberlege. It seems that the debate and discussion on this issue revolve around the use of “may” or “must”, as is often the case in legislation —we are all familiar with this. I fully understand why the Bill uses the word “may” in relation to concerns as set out currently in the clause because, as described, they involve ambiguity. That is implicit in the way the clause is framed. It therefore requires judgment about the balance of risks, which is difficult to prejudge.

It seems that Amendment 108 is a build, as they say, on this and an elegant solution to the existence of a higher-risk category of the kind that the noble Lord, Lord Patel, my noble and learned friend Lord Mackay and my noble friend Lady Cumberlege have talked about. It would leave “may” in place for when ambiguity exists, but would introduce “must” when, in their words,

“there is a clear threat to public safety”,

which is the highest category of risk. It seems unconscionable to think that, when there is knowledge of such risks, they should not be communicated; indeed, there should be, if there is not already, an obligation to do so. Consequently, I feel that this amendment improves on the Bill. It seems perfectly logical and rational to me, and I hope my noble friend the Minister will be sympathetic.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I next call the noble Baroness, Lady Jolly, and I dare say that there will be a little pause before she speaks.

--- Later in debate ---

[Lord O’Shaughnessy (Con)]

My Lords, it is a pleasure to follow my noble and learned friend Lord Mackay of Clashfern in talking to my noble friend Lady Cumberlege’s important amendment. It is impossible to match the passion and forensic skill with which she introduced her amendment—no one can make the case better and I will not try—but I offer her my deepest support for what she is trying to achieve through it.

The review that my noble friend carried out is quite simply one of the most remarkable of its kind, detailing as it does the extraordinary harm done to patients, mostly women, because of an inadequate safety regime that was too lax on products coming into the market, not capable of fully monitoring the adverse effects of products while they were used in the health system, and unwilling to heed the voices of those crying out in agony because of the harm being done to them and their families.

The First Do No Harm report is full of arresting facts: the 11-year delay between the first statistically significant evidence of the links between hormone pregnancy tests and malformations in babies; the lack of clinical evaluation of the use of mesh—a supposedly inert and harmless device—in the treatment of pelvic organ prolapse in tens of thousands of people; and the 20,000 people exposed in utero to sodium valproate in the UK, around half of whom have been affected physically or mentally, often very severely. But its true power comes from the testimony of those women whose lives were turned upside down by the adverse effects of these tests, pelvic mesh, sodium valproate and other medical scandals.

It was a privilege to hear this testimony at first hand when I was a Minister in the department, and I pay tribute to those brave women who led delegations to bring their message of pain and sorrow, and of being patronised by those who claimed to care for them, to us. Marie Lyon, Kath Sansom, Emma Murphy, Janet Williams—women like them are the reason why Ministers, and ultimately the then Prime Minister, asked my noble friend to carry out her review. It is to tens of thousands of women like them and their families that we owe a duty to implement the findings of that review.

There are many excellent proposals in the report, and it is my sincere wish that my noble friend Lord Bethell and his colleagues at the department will implement its recommendations as soon as possible. However, one recommendation stands out: the proposal for a patient safety commissioner, which is the subject of the amendment. Having served in government, I know that there is often internal resistance when a review proposes a new arm’s-length body or something of that kind, so I will explain why I believe that this one is so important and why there is a strong precedent for a Conservative Government introducing one.

As my right honourable friend Jeremy Hunt said when he first launched the medicine and medical device safety review in February 2018, it is the responsibility of the Government to listen, hear and act with compassion, speed and proportionality when things are going wrong. As the exhaustive findings of my noble friend’s review show, this did not happen, time and again, over many decades—and it must.

Whose responsibility, then, should it be? I, like other noble Lords, have great confidence in the NHS, the MHRA, the DHSC and other bodies, but we must be honest that none of them has consistently lived up to the maxim propounded by the former Secretary of State. More importantly, too many patients have had negative experiences interacting with these organisations when they were seeking help, so confidence in their ability to act in patients’ interests is not robust.

As the review continued, it became clear to me, as it did to my noble friend Lady Cumberlege, that there was a need for an entirely independent body that could act as the patient’s friend on safety in the system, a gateway and a support mechanism where those who were not being listened to could go—if you like, a conscience for the system. This would benefit the health system too, providing aggregated access to new information on safety issues and a potential to spot emerging concerns. Nothing that currently exists could perform both these essential functions in a way that carries the support of patients.

These are precisely the roles that the patient safety commissioner is proposed to play. There are different ways it could be implemented, of course, but it must be independent of the department and the NHS, as other noble Lords have said, and it must be patient-facing in all it does. We already have examples of how this could and should work. Many noble Lords have referred to the excellent work of the Children’s Commissioner. I also point to the Victims’ Commissioner, a role fulfilled until recently with great expertise by my noble friend Lady Newlove, and the new independent office of the Domestic Abuse Commissioner. It is absolutely right that these new positions have come into being, and I am proud that it was a Conservative Government who created them.

So once again I throw my weight behind the proposals of my noble friend Lady Cumberlege. I am sure that my noble friend the Minister is highly sympathetic to this cause. For the sake of all those women—and the men and children who have also been harmed—I hope that we can work together to make it happen.

[Lord Blunkett (Lab)]

First, I declare a tangential interest in the sense that I am patron of the Society of Occupational Medicine and, together with the faculty, it obviously has a real interest in this area, as well as its broader remit. I apologise to the noble Baroness, Lady Cumberlege, and the Committee for not being in my place at the beginning of her incredibly powerful speech, and I endorse what people have said already about not only the speech but the incredible work and reflections in the report.

The history that the noble Lord, Lord Patel, gave us, indicates very clearly the challenges that have been faced in this area. I am the first Member to speak who, as a former Member of Parliament, had people at my surgery bewildered, frustrated and not in a position, as they were in America, to go down the litigious route to get any satisfaction. But, of course, down the road and down the line is, as the report of the noble Baroness, Lady Cumberlege, indicates, is too late. Having someone who can intervene to prevent misery, hurt and, for many, terrible trauma for life is really important.

When you have the noble and learned Lord, Lord Mackay, and a former Health Minister, the noble Lord, Lord O’Shaughnessy, on your side, you are on a winner, and I hope that the noble Lord, Lord Bethell, will be able to indicate that he is prepared to go back to what we used to call the Legislative Committee—difficult as that is, because there is enormous resistance in government, as the noble Lord, Lord O’Shaughnessy, will remember and my noble friend Lord Hunt will be painfully aware, to having substantial amendments to Bills and to conceding that measures were not thought of first within the department. But I hope that on this occasion it will be possible to do so.

Reference has been made to other commissioners, and I endorse what the noble Lord, Lord O’Shaughnessy, said about the noble Baroness, Lady Newlove, and the powerful work that she did. I respect her greatly, as I do Anne Longfield, the Children’s Commissioner. I say to my good friend and noble friend Lord Hunt that I like to think that some of us in the political arena played a bit of a part in getting the schools reopened as well as the commissioner, but she did a phenomenal independent job in that area. I hope that the commissioner recommended by the noble Baroness, Lady Cumberlege, would be able to do the same in this sometimes forgotten area.

I am not sure that she will thank me for this, but perhaps the noble Baroness will accept that there may be a connection with the Health and Safety Executive, because the research and testing facilities it has may have a relevance here, and some connection with the commissioner that she has recommended may be sensible. My noble friend Lord Hunt and I shared an interest in this when we were both at the Department for Work and Pensions and the HSE reported to us. We had a number of ideas which, because we had both moved on, did not come to fruition—but here we are, all those years later, with an opportunity to do something that would be of great benefit to many people—mainly, as the noble Lord, Lord O’Shaughnessy, said, women—who have suffered so grievously and did not need to.