Medicines and Medical Devices Bill

Baroness Watkins of Tavistock Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Baroness Watkins of Tavistock (CB)]

My Lords, I feel that I have drawn the short straw, speaking at this point.

Like other noble Lords, I broadly welcome and support this relatively short, important and necessary Bill. To promote patient safety, the meaning of

“the attractiveness of the … United Kingdom”

environment for medical research in future, particularly in relation to clinical trials, requires clarification. We see the global race to produce safe vaccines for Covid-19 that must, despite their urgency to protect populations, be tested for safety as well as efficacy. The UK currently adheres to the EU protocols that apply to ensure the safety of such products before licences are given for mass use. Can the Minister explain if there are any plans to relax our adherence to current EU legislation on clinical trials?

The Bill refers to regulations relating to medical devices and the fact that Ministers will be given delegated powers in relation to their approval. Do the Government intend to adopt the EU regulation on medical devices 2017/745, which is not due to come into force until after the end of the transition period? Will the Government ensure that, as well as approving new devices in future, any maintenance of devices necessary to keep them safe in operating terms will also be included in the provision of granting such licences? We know that patients have occasionally been put at risk due to inadequate and/or irregular maintenance of devices—for example, with smart infusion pumps used to deliver medication. What onus will the Government put on purchasers of approved devices not only for safe maintenance but for adequate training for people to use the new devices to protect patients? This does not seem to be mentioned at all in the legislation as drafted.

I too fully support the excellent report and recommendations produced by the noble Baroness, Lady Cumberlege, and the way it uses plain English to describe the horror that some patients and their families have suffered. I am reminded of trying to find out, when I was training as a nurse, what “iatrogenic complications” meant. I think it is stark that the noble Baroness uses modern language that we can all understand. That is so important.

Will the Bill be used to incorporate some of the principles of the Health Service Safety Investigations Bill, which reached a Second Reading in this House, or is it the intention that that Bill will not be timetabled for completion and therefore the medical devices Bill will need to take up many of those issues at the same time?

Without doubt, I fully support the concept of a patient safety commissioner being appointed.