All 2 Baroness Hollins contributions to the Medicines and Medical Devices Act 2021

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Wed 2nd Sep 2020
Medicines and Medical Devices Bill
Lords Chamber

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Mon 26th Oct 2020
Medicines and Medical Devices Bill
Grand Committee

Committee stage:Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords

Medicines and Medical Devices Bill Debate

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Department: Department of Health and Social Care

Medicines and Medical Devices Bill

Baroness Hollins Excerpts
2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020

(3 years, 6 months ago)

Lords Chamber
Read Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Consideration of Bill Amendments as at 23 June 2020 - (23 Jun 2020)
Baroness Hollins Portrait Baroness Hollins (CB) [V]
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My Lords, I refer to my interests in the register and congratulate the noble Baroness, Lady Cumberlege, on her review, which, as we have heard, was asked to look at three interventions in particular detail: hormone pregnancy tests, the use of sodium valproate in pregnancy, and pelvic mesh implants. The connection between these was not lost on the review, which noted that each of them are

“taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy.”

The review found a litany of failures in the system to monitor harmful effects and heard about: patients not being provided enough information to make informed choices; a lack of awareness as to how to raise complaints; struggles to be heard; not being believed; dismissive attitudes by clinicians; and life-changing consequences due to the harms that ensued.

For women, there seemed to be a confounding factor, which the report described as

“the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”

In my field, we call this diagnostic overshadowing. The review described the stories of adversity and harm it heard as being “harrowing”. This is what happens when a group is not believed and when systematic prejudices diminishes a speaker’s credibility. This stark example of epistemic injustice should serve as a reminder to all of us of the harms of ignoring the voices of the disfranchised. Of course, there are many groups whose voices are not heard and have, for too long, proved to be too easy to ignore. These include, for example, the voices of some patients detained under mental health legislation.

As we have heard, the Bill we are debating today grants wide-ranging powers to the Government—and, indeed, the Minister—in relation to medicines and medical devices, with a large number of putative regulations subject only to the negative procedure. Will Her Majesty’s Government commit to using this timely opportunity to implement the recommendations of the noble Baroness, Lady Cumberlege, in the framework of the present Bill?

There were nine recommendations, which included appointing a “patient safety commissioner” and the formation of an independent “redress agency”. Another was, quite simply, for the Government to apologise to all the women who have suffered lasting harm. I hope the Minister will inform the House of Her Majesty’s Government’s specific intentions with respect to patient safety.

The report suggests that the MHRA’s yellow card safety-monitoring scheme is poorly sensitive to adverse treatment outcomes and that the MHRA needs “substantial revision”. Will the Government commit, in this Bill, to a far greater emphasis on post-market surveillance of medicines and medical devices? In Clause 1(2), the Bill places market considerations on an equal footing with patient safety and distributive justice—namely, the availability of human medicines.

While the economic implications of the pharmaceutical and medical devices market are, of course, important, there is no implicit or explicit hierarchy in the current drafting of the Bill that would enable defence of the appropriate authority’s decision-making being based primarily on safety, or safety and availability. Will Her Majesty’s Government amend the Bill to ensure that the hierarchy of these principles is recognised in statute? I am considering such an amendment myself.

The Bill gives the Government power to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so. Can Her Majesty’s Government comment as to which professional groups they propose to extend prescribing responsibilities to and, if they do not intend to do so at the present time, when they would consider addressing this issue? What safeguards would they consider to be necessary?

Medicines and Medical Devices Bill Debate

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Department: Department of Health and Social Care

Medicines and Medical Devices Bill

Baroness Hollins Excerpts
Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020

(3 years, 5 months ago)

Grand Committee
Read Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Lord Patel Portrait Lord Patel (CB) [V]
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My Lords, as I was not able to get in following the comments made by the noble Earl, Lord Howe, I say that, as a Cross-Bencher, I was irritated that we were not involved in the communication, I am glad that the statement has been made and I concur with most of the comments of the noble Baroness, Lady Thornton. I hope that from now on the procedure will be better. I had threatened to negative the amendments, but I will not do so now.

I speak in strong support of Amendments 10, 12, 74 and 75 tabled by the noble Baroness, Lady Cumberlege, to which I have added my name. I concur with all that she and other speakers have said. So far as her findings were concerned, I will repeat what I said when we debated her report. The profession needs to hide its head in shame that such trauma was inflicted on women and that such harm to unborn children was caused by disregard for guidance. As an obstetrician, I have never used mesh; I am one of those old-fashioned surgeons who did not use any artificial devices, but then I was not regarded as an avant-garde or fancy surgeon in that respect. Her report is a salutary lesson about the importance of patient safety. I will confine my remarks to medicines and medical devices, and the importance of embedding patient safety.

The noble Baroness’s report is entitled First Do No Harm. I say with humility that the motto on my coat of arms is “Primum non nocere”. I am privileged that the shield that bears it will hang for ever in the chapel of St Giles’ Cathedral in Edinburgh. I took that motto not because of the medical oath, which of course is correct, but because I was at the time chairman of the National Patient Safety Agency of England, an organisation that the noble Lord, Lord Hunt of Kings Heath, had chaired before me. It no longer exists, but its aim was to establish the whole concept and methodology of patient safety in the NHS in England. The NPSA, as it was then known, had developed a confidential reporting system for incidents relating to patient safety for healthcare staff and patients. Nearly 40% of the large number of reports—we used to get as many as 200 confidential reports a day—were related to medicines, medicines delivery and devices.

The concept of the safety of medicines is not new, and the experience of over a century has framed laws, regulations and amendments to make medicines safe and effective. In 1937, more than 100 deaths were reported in relation to sulfanilamide. They were due not to the medicine itself but to the solvent, diethylene glycol, which was added to the active ingredient. This led to regulations requiring testing of medicines in non-clinical and clinical settings prior to their being licensed for therapeutic purposes. Is it not ironic, especially in the context of the report of the noble Baroness, Lady Cumberlege, on Primodos, that the drug thalidomide, used as an antiemetic in early pregnancy, was not licensed in the USA due to animal studies that had shown some deformities in animal embryos? The USA therefore avoided the harm that the medicine caused to unborn children and a condition called phocomelia. It was accepted in a large part of the world, including the United Kingdom, and resulted in tens of thousands of children being born with such deformity.

There are patient groups to whom regulators need to pay special attention when approving medications, such as pregnant women, children and older people. We will come to amendments later on alluding to this. There are many examples of medications that are withdrawn from the market because of patient harm, emphasising the importance of a secure system of post-licensing surveillance. Some 1.1 billion prescriptions are supplied every year in primary care. Furthermore, a mid-sized hospital supplies about 50,000 doses a day. A study in 2018 showed that 237 million medication errors occurred every year in England, of which 68 million caused some degree of harm. While the harm may appear in one part of the system, the solution often lies across it. Much can be learned from a well-run and monitored national reporting and learning system, particularly as to which medicines are commonly involved in errors and hence patient harm. A single change that would make a big difference is a system that recognises and establishes the greater involvement of patients in their own care.

A healthcare system that wants to achieve a significant reduction in patient harm from medications will need a national programme in which different parts of the system work together. The amendment in the name of the noble Baroness, Lady Cumberlege, may be a start to that, and I commend her for it.

Unlike with medicines and the EMA, even at EU level, there is no agency for the safety of medical devices. Regulation relating to medical devices or standards is often a voluntary process and is not governed by national or international standards unless recognised by a regulator as mandatory. The list of what constitutes a medical device is long and ranges from machines and in vitro reagents to software. As the UK leaves the EU, it has an opportunity to devise a system of regulation focused on safety. In 2017, there were more than 16,000 device-related reports of harm. Following the publication by investigative journalists of a series of reports on medical devices known as “The Implant Files”, there has been a demand from doctors and others for greater transparency from manufacturers of devices, particularly regarding safety. The same stringent regulatory process, including disclosure of data related to adverse events, should be part of a market approval process.

I know that several amendments coming up are related to safety and licensing, which currently does not exist in the UK for medical devices. The amendment in the name of the noble Baroness, Lady Cumberlege, in relation to patient safety, including medical devices, will go further than current requirements for market approval. Information and data related to safety, both short-term and long-term, may well be a requirement for market approval. Why is it necessary to have full safety data to license a cardiac drug but not for an implanted pacemaker? As an example, a device called Nanostim was withdrawn from the market three years after safety approval due to the alarming number of patients to whom it was causing harm, by which time 1,400 patients had had it implanted. The noble Baroness is right to highlight the need for more effective regulation for safety of medical devices and medication overall. I am pleased to support her amendment.

Baroness Hollins Portrait Baroness Hollins (CB) [V]
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My Lords, it is a pleasure to follow my noble friend Lord Patel. I commend his work on patient safety over many years. I strongly support the amendments in this group, which are intended to improve patient safety—in particular, Amendments 10 and 12 tabled by the noble Baroness, Lady Cumberlege. I withdrew my own, very similar amendment and added my name to that of the noble Baroness.

In the present drafting, as the noble Baroness has explained, there is no explicit hierarchy of the three stated principles: safety, availability and attractiveness of parts of the UK as a place to conduct clinical trials or supply medicines, yet this Bill could be so much more effective if it was more explicitly about patient safety. These amendments put patient safety first, as so clearly called for in the noble Baroness’s shocking recent report First Do No Harm. I quote from that report’s foreword:

“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.”


I simply stress that safety must apply across all aspects of the development and provision of human medicines with respect to both mental and physical illness. Noble Lords may be unfamiliar with the national STOMP programme, launched in 2016—STOMP stands for stopping over-medication of people with a learning disability, autism or both. Public Health England says that, every day, between 30,000 and 35,000 adults with a learning disability take psychotropic medications when they do not have the health conditions the medicines are for—they are also prescribed to children and young people—yet such medicines may have serious side effects, including adverse effects on their mental and physical health.

I do not wish to speak at length about this or other aspects of these amendments other than to stress that patient safety must be the foremost consideration in this Bill.