Medicines and Medical Devices Bill

Debate between Baroness Cumberlege and Lord Sharkey

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

[Lord Sharkey (LD) [V]]

I shall speak briefly to Amendments 9 and 13. I should start by saying that I enthusiastically support Amendment 8, moved by the noble Baroness, Lady Thornton. We all know that the phrase “have regard to” lacks any real force. Like her amendment, our Amendments 9 and 13 are intended to strengthen Clause 1(2), whose opening words read

“In making regulations under subsection (1), the appropriate authority must have regard to”,


followed by a list of the things to which it must have regard. Amendment 9 would change those opening words to read, “In making regulations under subsection (1), the appropriate authority must have regard to, and in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,” and then the list of things to which regard must be had.

Clause 42(6), (7) and (8) are excluded because they contain urgency provisions and may now anyway make use of the “made affirmative” procedure. The purpose of the amendment is to ensure that there must be a full assessment of the impact of any regulation on the three specified areas. This applies to all three of the areas and is of particular importance in the assessment of safety and how it is to be prioritised, in subsection (2)(a).

Amendment 13 addresses the issue of assigning priority to the safety of human medicines, as do other amendments in this group. It would rewrite subsection (2)(a), so that instead of reading,

“the safety of human medicines”,

it would read “the priority of ensuring the safety of human medicines”. Other noble Lords have tabled amendments suggesting different ways of ensuring this priority and I look forward to hearing their contributions. But whatever the variations in approach, it is obvious that a strong, clear and unambiguous statement of the priority of the safety of human medicines needs to be inserted in the Bill.

[Baroness Cumberlege (Con)]

I shall speak to Amendments 10, 12, 74 and 75 on the second Marshalled List, and I thank the noble Lords who have supported these amendments—the noble Baronesses, Lady Burt of Solihull and Lady Hollins, and the noble Lords, Lord Patel and Lord Hunt of Kings Heath.

This Bill chimes perfectly with the review that I led into two medications and a device. The review culminated in the report First Do No Harm, which states:

“Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous.”


In conducting the review over two and a half years, my team and I listened to hundreds of women and their families, with their stories of anguish, acute suffering, destroyed relationships and parents whose children have been harmed, deformed and had their potential lives ruined.

I have been told that this Bill is not a safety Bill. If it is not, what is it, for goodness’ sake? How can safety not be the overriding purpose of the Bill? My modest amendments, and those of other noble Lords, seek to make it so.

In paragraphs (a) to (c) of Clause 1(2), safety is not the primary consideration but is on an equal footing with the availability of medicines and the UK as an attractive place in which to conduct clinical trials and the supply of medicines. These aspirations are of course important but in the way in which the Bill is drafted safety is simply an “also ran”. It should not be; it should be of overriding importance. As the noble Lord, Lord Patel, said in his amendment on the first day of Committee, the construction of this clause needs improvement.

My review found safety seriously wanting. We were commissioned to review two medications given to women. The first was Primodos. Between the 1950s and the 1970s, two little pills were given to women to test whether they were pregnant. From the late 1950s, concerns were raised that these tests could harm and cause abnormalities in a developing baby. Although disputed, there is a body of opinion that has linked these hormone pregnancy tests to a wide range of various malformations. We discovered opportunities where action should have been taken and was not.

These pregnancy tests were taken off the market in 1978 following concerns over their safety—more than a decade after safety concerns were first raised. No one listened. The risk to patient safety was not prioritised, one result of which has been a 40-year battle to get an independent review of the regulations that were found wanting. I accept that regulation was in its infancy in the 1960s and 1970s, but patient safety should have been the overriding consideration then, as it must be now.

In the course of our review, we met the children—now adults—who suffered so much and their families. Many dreadful impacts have been associated with these pregnancy tests, such as loss or shortening of limbs—we have seen other examples of this happening in the past—heart defects, spinal issues, seizures, dysmorphic facial features, digestive and bowel issues, and so on. We were struck by the unremitting guilt felt by the women who took the pills. They feel to blame for their children’s disabilities. They suffer enduring psychological harm, and although we told them, “It wasn’t your fault; you weren’t told; how can you be blamed?”, I fear that we did not convince them.

The second medication reviewed was sodium valproate. It is a very effective drug for controlling epilepsy but it has a history that should never be repeated. When first licensed in 1972, it was known to be teratogenic in animals. Prescribing doctors were warned that it should be used only in severe and resistant cases of epilepsy in pregnant women. In the 1980s, academic literature drew attention to the risks. In the 1990s, the risks of neural tube defects and other congenital malformations were known. Even then, women were saying that exposure to sodium valproate had caused damage to their offspring.

In early 2000, doctors were again warned of an association with delayed development in children, with delayed speech, IQ affected and reports of autism. Throughout this tragic history, clinicians have been warned and women and their families have not been listened to; they have been dismissed and had their knowledge denied. It took 40 years after sodium valproate was introduced to the market to produce a toolkit, the purpose of which was to provide information to women of childbearing age and healthcare professionals about the harm that could be caused. Two years later, in 2018, a pregnancy prevention programme was introduced; it stipulated three measures that were designed to prevent further harm.

You would suppose that this is the end of a tragic story—problem solved—but that is not so. It is truly shocking that, today, epileptic pregnant women on sodium valproate have a one in two chance of having a disabled child. They are still exposed to huge risks because they are not told what those risks are. Babies continue to be been born with lifelong disabilities due to exposure to this drug. We know that the results are catastrophic.

The third and final area that we were asked to review was surgical mesh, a device inserted to support pelvic organ prolapse and to treat stress urinary incontinence. For many women, mesh surgery is trouble-free and leads to improvements in their condition, but that is not the case for all. A BMJ article published on 10 October 2018 had the arresting headline “How mesh became a four letter word”. In the article, Jonathan Gornall charts the rapid rise and fall of vaginal mesh; it is, as he says,

“a story that offers lessons for the entire medical community, and for manufacturers and regulators”.

Unlike many other devices, polypropylene mesh is intended to remain in situ for life. We heard from countless women who sought to have it removed but were unsuccessful; sometimes attempts even caused further serious damage.

Why would they want it removed? Because mesh ruins their lives. We were told by hundreds of women that they suffer excruciating pain, recurrent infections and haemorrhages, bowel issues, recurring or new incontinence, and nerve damage that restricted their mobility. Fit young women were confined to a wheelchair for the rest of their lives. I will always remember one little boy telling us, “I just want my old mum back.”

We heard about sexual difficulties leading to the loss of a sex life and broken marriages. We heard from women how the constant pain resulted in the loss of employment—that is, their job—so they lost their income. Because of that, they could not afford the mortgage or rent so they lost their homes, and because they were homeless, they were fearful that their children would be taken into care. One woman told us:

“This is not a life. It is an existence.”


We were so shaken by what we heard that, in July 2018, we recommended that vaginal mesh should be paused. Our recommendation was immediately accepted by NHS England and the Department of Health and Social Care. The scandal is that our recommendations were not new; all had been suggested before, but no action had been taken. It should not have been for us to recommend this. If safety was of paramount importance, the healthcare system should have picked this up decades before. After all, mesh was first used in the 1960s. It gathered pace in the 1990s; by 2001, it was the most common operation used for ameliorating stress urinary incontinence—a very unpleasant condition, but not life-threatening.