Contribution
My Lords, as with the previous instrument, this side welcomes the instrument being laid. Once again, the lack of people queuing up to speak in this debate demonstrates that it is relatively uncontroversial; we now outnumber the audience, as it were.
We obviously support this instrument. The Minister was absolutely right to refer to the report by the noble Baroness, Lady Cumberlege, and to the pain and misery that the valproate scandal—and other scandals—caused so many women. On that, I know that the Minister will not be able to answer me now but I wonder whether he can write to me on the recent report by the Patient Safety Commissioner. She suggested an initial sum to be paid to the victims of that scandal, as well as looking at future remedies. Are the Government any closer to considering the Patient Safety Commissioner’s recommendations? These women have suffered enough. They have been out of pocket and have suffered physically, financially and emotionally. I would welcome an answer on that at some stage, probably in writing.
It is obviously right that we increase the scope for post-market surveillance. As a quick aside, noble Lords may know that I was a Member of the European Parliament for a few years. British companies used to lobby me on their concern that manufacturers could go to certain jurisdictions to get a CE mark then sell that product across the EU; they sometimes wondered whether the surveillance or testing of that product was sufficiently strong compared to in the UK. This gives us a huge opportunity now to be more aware of CE marks. The Health and Safety Executive for Northern Ireland says that
“the CE mark is not a quality mark, nor a guarantee that the product meets all of the requirements of relevant EU product safety law”.
It places an onus on suppliers to make sure that they comply, but not every product is tested.
That is why it is important, particularly given the scandal to which the noble Baroness, Lady Cumberlege, referred in her report, that we now take the opportunity to ensure that these products are as safe as they claim to be—not only those manufactured in the UK and GB but, particularly, those coming from abroad. I want some sort of assurance that the Minister thinks this will be an effective way to make sure that we avoid that problem.
Secondly, having left the EU a few years ago, we have to be aware that there was clearly some friction. Hopefully, we will move to a better relationship between the UK and the EU. We want to avoid unnecessary conflict, but has the Minister thought about what happens when, in the post-market surveillance, the UK regulator deems that a product from an EU country which might have a CE mark is not safe? How do we ensure that that does not cause conflict with the EU regulators for that product, and is it going be a constructive relationship?
Are the EU standards organisations fully acquainted with what we will be doing here in the UK, and open to the fact that we might find that some products are not high quality and will therefore remove them from the UK market? Will that cause conflict with the EU, given that those products have a CE marking? It will be one way of trying to reduce some of that post-Brexit friction. We might be doing it for the best reasons, but they may feel it is undermining the CE mark.
Lastly, can the Minister commit to ensuring that Northern Irish regulations remain closely aligned to Great Britain’s, so as to avoid confusion and delay? We know that the Windsor Framework produced a solution for Northern Ireland after the Brexit negotiations, but there are concerns for people in Northern Ireland about alignment with GB, understanding that there is also an alignment with the EU. Can the Minister make some commitment or give an assurance that Northern Ireland will remain as closely aligned to GB as it possibly can?
With that, these regulations are not particularly controversial. We welcome the fact that there is post-market surveillance. We wish we could have done it as strongly before, given that there have been concerns about certain medical devices. It is really important that we learn the lessons from those scandals, particularly the pelvic mesh and other scandals that have caused so much misery and suffering. We must make sure that we do not see that sort of suffering again.