Medicines and Medical Devices Bill

Baroness Burt of Solihull Excerpts

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

[Baroness Burt of Solihull (LD) [V]]

My Lords, I speak to Amendments 10, 12 and 74, to which I have added my name. Although I support all the amendments in this group, they pretty much do the same or a similar kind of job, but I added my name to those amendments specifically because they speak to safety being paramount for new drugs and devices. I say that because the excellent Cumberlege report tells the graphic and heart-rending story of what happens when it is not.

We have heard about the effects of the drugs Primodos and sodium valproate from the noble Baroness, and other noble Lords will cover those areas. My interest relates to mesh and what happens when insufficient care is taken in the implementation and tracking of the well-being of women who have had it inserted. When it goes wrong, it really can ruin the life of the woman affected. Noble Lords may recall the case that I mentioned on Second Reading of how Jane’s life has been ruined by mesh—not just physically but emotionally and economically. The noble Baroness described such things as well. Yet the surgeons who did this to her seem to exhibit no remorse and have closed ranks, denying the very existence of some of the pieces of mesh inside her.

It makes my blood boil to hear those harrowing stories, and the noble Baroness had to listen to such testimony from victims for two years. As she says in her report, this took its toll on her and the other members of the panel, but how much worse must it have been for the victims themselves? Yet we see phrases in the Bill such as,

“the appropriate authority must have due regard to ... the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.

Attractiveness? What does that even mean? My noble friend Lady Jolly spoke on the third group of amendments about the multiple interpretations that the term could have. Are we trialling drugs and devices on human beings so that we can subsequently flog them abroad? I am sure that the Minister will deny that and give us a proper definition of the word.

Attractiveness and availability must be a low priority compared with safety and that is why I strongly commend the amendments. If the Minister believes that safety must be the overriding consideration, I trust that he will have no difficulty in accepting them.

[Lord Patel (CB) [V]]

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.