Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 Draft Medical Devices (Amendment Etc.) (EU Exit) Regulations 2020

Alex Norris Excerpts

Thursday 26th November 2020 General Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to discuss these instruments under your chairship, Mr Rosindell. As the Minister says, we have had a rolling tour of them in recent weeks, but happily we seem to have a rotating supporting cast, other than the Whips, so I can just about get away with repeating some of the same arguments.

I will start, as always, by saying that we are getting very close to the final opportunity for the deal with the EU that the Government promised to finalise. I know that business desperately wants no deal to be taken off the table, and will be looking at the proceedings with interest. Perhaps the Minister will update us on the progress. I suspect that he will say it is “ongoing”, as he generally does.

As has been set out, the draft regulations amend the post-Brexit regulatory framework for medicines and medical devices respectively to implement the Northern Ireland protocol and ensure that the UK meets its related obligations under that agreement. That is, of course, a necessary step towards maintaining the UK’s obligations—necessary, critically, to ensure that people are kept safe when using medicines and medical devices.

We will not divide the Committee, but I have a few areas where I would like greater clarity. At the heart of this is patient safety, which is important to all of us; however, I think we have detected a waning in the Government’s commitment in this area in recent months. It has now been four months since Baroness Cumberlege published the independent medicines and medical devices safety review. Campaigners for that review were ignored and derided, some for many decades, but with the publication of that report they were vindicated.

We are four months on. Frankly, the Government have sat on it. Campaigners got an apology on the first day, but have been unable to get a word out of the Government since. We cannot get anything by the written question route either. It is exceptionally disappointing. I know that the Government have a lot on, but the failure even to pick up the phone to talk to those who suffered and give them an update adds insult to injury. I speak to people affected each week, and they are heartbroken by the Government’s response.

Will the Minister make a commitment that he will prod and urge his relevant colleague to consult campaigners as a matter of urgency? I honestly would not let the day finish without doing that. The hurt is really significant. Will he also commit the Government to using the remaining stages of the Medicines and Medical Devices Bill to implement the relevant recommendations? It is a perfect vehicle for us to act quickly, and we really ought to do so.

The first set of draft regulations, regarding human medicines, amend the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, as the Minister said, as well as the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019. The 2019 regulations themselves amended the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Medicines (Products for Human Use) (Fees) Regulations 2016. They set out what the basis for the regulation of medicines and clinical trials will be in Great Britain from 1 January, and the draft regulations ensure that the 2019 regulations will remain effective at the end of the implementation period, which is, as I say, very important.

As well as making some technical amendments, the instruments will reverse some of the changes made by the 2019 regulations to limit them to Great Britain, while EU law will remain in effect in Northern Ireland, and implement policy changes to Great Britain’s regulatory regime only. As we would expect, EU marketing authorisations will now authorise sale or supply in Northern Ireland only, and UK marketing authorisations will no longer automatically apply for the whole of the UK. That often gets lost, but it is a very significant change.

I understand that the MHRA will have provision to pay regard to decisions taken by EU member states when making licensing decisions, but could the Minister explain what impact he thinks it will have on the MHRA in terms of the burden of its work when authorising products entering Great Britain? Will there be extra checks? Will there be extra pre-assessments?

Similarly I understand that, due to industry feedback, products used in clinical trials, investigational medicinal products, will no longer need to be certified by a qualified person—a QP—at both ends, which presumably would have increased the administrative burden twofold. Instead, the whole of the relevant UK manufacturer’s authorisation for import licence will simply have to ensure that any IMP has been QP certified by someone based in an approved country. There is a year before that comes into place, but could the Minister guarantee that it will not have a significant impact on the safety of the investigational products and of those using them in the trials? If so, how does he know that, and on what basis has he formed that decision?

Changes are made to a number of areas, but time is limited and I need to move on to the other draft regulations. I will conclude on this element with a slightly more general question. For absolute on-the-record clarity, can the Minister say that he is confident that the changes will not make users of medicines less safe, or leave UK businesses in a situation where they cannot compete? Those are the two points very much in play. I do not think that anybody, either in this room or in the country more generally, thinks that either of those possibilities would be a good thing, so clarity on the record about the judgment that he has made on that would be very helpful.

The draft medical devices regulations also amend the 2019 regulations to ensure that the regulatory landscape is fit for purpose at the end of the implementation period and, importantly, to keep us safe. Schedule 1 amends the principal regulations to ensure that devices placed on the Northern Ireland market meet EU legislation under the protocol. It also makes provision for persons placing devices on the market in Northern Ireland to register devices and for manufacturers of devices to appoint a UK responsible person where there is no other presence.

We talked much about the UK responsible person when considering the Medicines and Medical Devices Bill, because we know that there have been sharp practices previously. I am keen for the Minister to provide clarity and to commit to ensuring that people are not using responsible persons in name only. We know of examples of a single person, who seems to have very little connection to the businesses, being the responsible person for all manner of products, when their employment is in no way related to them. I am keen to hear any reflections on that.

The Minister discussed the UK conformity assessed marking. This is, of course, a significant moment. The assessments will be carried out by UK approved bodies, which will be converted from UK notified bodies by this instrument. What impact will that change have on the bodies and their capacity to make conformity assessments?

We support the continuation of the CE marking. That was a wise decision by the Government. I am interested to hear how the period of two and a half years was arrived at. I would like to hear an on-the-record commitment from the Government that there will be no risk to the supply of medical devices as a result of the conformity assessment.

Finally, the explanatory memorandum states:

“The MHRA will seek to minimise the legislation’s impact by providing guidance”.

Will the Minister say when that will happen and what other steps are being taken to support the MHRA in this process? The MHRA, which has always been important, is now a crucial body.

When it comes to the safety of medicines and medical devices, we are now on a high tightrope. We used to have the common eyes of the notified bodies of our EU partners looking at our products; now we will look at them alone. That is the decision that has been taken, but it means that if there is one mistake, there is no backstop. It would therefore be much appreciated if the Minister gave a sense of the capacity of the MHRA and its readiness to take on what is an absolutely crucial function.