Safety of Medicines and Medical Devices

Baroness Jolly Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Jolly (LD)]

My Lords, the safety of medicines and medical devices is a cause in which we are all invested. I join others in thanking the noble Lord, Lord O’Shaughnessy, for instigating this debate and for his excellent opening speech. I was particularly interested in his account of treatment of cancer in the brain in Birmingham—my brother-in-law is an in-patient there as we speak.

In a context where important pharmaceutical and technical advances are being made, ongoing work must be undertaken to ensure that patient safety is never compromised. I am encouraged by some steps that the Government are taking, such as the independent medicines and medical devices safety review.

There are two key ways to keep people safe. The Government must improve regulatory oversight, and must advocate listening to and responding promptly to patients experiencing adverse effects from unsafe medication or devices. Many noble Lords will have received correspondence about the devastation caused by sodium valproate and the awful effect it has had on babies, now disabled adults. Their mothers took the drug while pregnant. Will the Minister hold a briefing session for interested Peers to update us on progress with that—perhaps when we have finished all the health legislation currently coming down the track? That would be hugely helpful.

The impact of Brexit on medicines and medical device safety has already been covered well by other noble Lords, so I will not spend too much time on the topic. I am worried, however, by the expertise we have lost through the relocation of hundreds of staff of the European Medicines Agency to its new headquarters in Amsterdam.

I note that numerous drug safety reports, and reports of suspected adverse reactions to drugs, previously submitted at the EU level will instead be submitted to the MHRA. I echo the concern of the BMA, which has warned about skills gaps in pharmacovigilance. Can the Minister confirm that there is a recruitment drive to ensure that the MHRA is sufficiently staffed to consider the broad range of medicines and medical devices that require scrutiny in the UK? Moreover, what are the Government doing to ensure that the relationship between the EMA and the MHRA remains strong and convergent post Brexit? Will the Government make stronger assurances than the text of the political declaration that accompanied the withdrawal agreement, which states only that the UK and the EU will,

“explore the possibility of cooperation”,

after the transition period? That is simply not good enough. A weak relationship could harm patients and stifle progress. I look to the Minister for assurance that she is aware of this and taking action.

I am pleased to note the work of the independent medicines and medical devices safety review currently under way, looking into how concerns about surgical mesh were handled, and the devastating effects of Primodos and sodium valproate. A lot of insightful evidence has been submitted so far. The noble Baroness, Lady Cumberlege, is investigating whether the NHS harbours enough of a listening culture. The Epilepsy Society raised this issue in its evidence. In the case of surgical mesh, it seems that there was a degree of gender bias, meaning that women’s pain was not taken seriously. My right honourable friend Norman Lamb MP was vocal on the subject of mesh implants, highlighting the years of life-altering pain experienced by affected women, compounded by the emotional trauma of not being listened to and believed. On the back of all that, he set up the APPG. With the review now one year old, does the Minister know whether affected patients finally feel listened to? The review’s impact must be wide-ranging; it should complement work happening upstream to improve review processes.

Several organisations, including the Royal College of Surgeons, have called for tighter regulation and oversight of devices. Looking forward, new devices may be more complex than those of old but, contrarily, some devices may become simpler. Both require vigorous testing. More importantly, we must build ever more comprehensive mechanisms for both regulation and patient feedback. These systems must speak to each other to ensure that every new medicine and medical device is safe for patients. Technology has a role to play in linking patient experiences with unsafe medicines and medical devices in a clear pattern. Just as John Snow—not that Jon Snow—related the spread of cholera to a single water pump, so we see now, through work to analyse multiple databases on patient and drug experiences, that symptoms can be traced to an inappropriate medicine or a faulty medical device. This is an expanding area of work that must be monitored.

The noble Baroness, Lady Masham, mentioned sepsis. A few weeks ago, the noble Lord, Lord Grade of Yarmouth, told the House about the benefits of a national sepsis register. For medicine safety, the Royal College of General Practitioners has recommended a single system, with some similarities for reporting drug safety issues, which would be linked to GP notes. Will the Government consider this, while being mindful of data privacy? Perhaps it could be cross-referenced with the yellow card scheme, providing a stronger pool of data from which to draw conclusions. Multiple health sector experts, including pharmaceutical companies and health professionals, advocate strengthening knowledge of and access to the yellow card scheme.

Training health workers is a key way to keep patients safe—if the Government will provide funding. This could include broader “driving licence” training for the safe use of particular pieces of medical equipment, as well as the training of other health professionals. An obvious but important example is community pharmacists. We all agree that they play a key role in medical safety, for instance through medicine use reviews, new medicines services and keeping a look out for customers buying strong over-the-counter medications, or who appear to be suffering adverse side effects.

In conclusion, the debate has been excellent. I congratulate the noble Lord, Lord Carrington, on an outstanding maiden speech, and I thank the noble Lord, Lord O’Shaughnessy, for introducing the debate. I look forward to the Minister’s response.