Draft Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 Draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 Draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019

Lord Coaker Excerpts

Wednesday 19th December 2018 General Committees

[Vernon Coaker (Gedling) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Stringer. I agree with the comments made by everyone. We are all disappointed that we are where we are and that we have to come forward with these measures, although it is only right, given where we are, that we make contingency plans. In line with my hon. Friend the Member for Garston and Halewood, I believe it would be helpful for the Committee to have a bit more detail.

As the Minister said, only a small number of organisations are involved, but if someone needs an organ, cornea or cell, that is a critical matter. Without the support of masses of civil servants, it is difficult to understand the situation. Will the Minister confirm that there is no change in anything here—it is just a simple transposition of law? Will she also confirm that the Secretary of State has gained no additional powers? A huge number of regulatory powers are given to the Secretary of State.

There is sensitivity around these issues and the Acts referred to; we know about the debates on embryology, reproduction and research. Has anything changed in that area? References to a subsection of a subsection of a subsection sometimes mean that there is a change somewhere. The Minister’s confirmation would be helpful. My hon. Friend mentioned the transition arrangements of six months. What happens at the end of that if nothing has changed?

I had to look for the technical note. That was not referred to, yet it includes important information that relates to the SI. For example, it says:

“Further information on the agreement process will be published in November.”

I cannot find that further information. Has it been published? What are the written agreements? Who is supposed to be making them? Again, I am not opposed to what the Minister is saying, but if it says on her own website that further information will be published, where is it? My hon. Friend has obviously been looking for it, too.

The website also says:

“We’ll be publishing more information and instructions on putting written agreements in place in November 2018.”

Presumably, individual companies are supposed to be producing these written agreements, not the Government. So what has happened with those companies? Do they know? What discussions have taken place with them?

I have been reading in the media today that business is expressing a lot of concern—whatever the rights and wrongs of where we are—about what they are, or are not, supposed to be doing. Given the importance of this matter, who is producing these written agreements?

The website goes on to say:

“The aim is to give organisations, businesses and individuals as much certainty as possible, as soon as possible, and to ensure that any new requirements are not unduly burdensome.”

To be honest, Minister, the Committee could have done with seeing what the information is—given that it was supposed to have been published last month, and given its importance. Some clarity on that would be really helpful.

The technical note also says that

“This notice is meant for guidance only”,

but then goes on to say:

“You should consider whether you need separate professional advice before making specific preparations.”

I do not know what that means. Why would anyone need separate professional advice if everything was carrying on exactly the same as before? The situation has just moved on and people should just carry on. I would be grateful if the Minister clarified what the separate professional advice is. As my hon. Friend has just asked, who is paying for that?

I come to my last point. Yesterday, the Department published a note on funding for different health organisations, entitled:

“EU Third Health Programme funding if there’s no Brexit deal”.

Are all the organisations affected by this SI going to receive funding under that health programme funding arrangement, so that they can address some of the issues that will arise if there is no deal, which we all hope will not be the case?

Clearly, this is an important SI. As my hon. Friend has said, these SIs are all hugely important, because down the road we will suddenly find that something has changed or that there should have been a written agreement—even though it is on the website, nobody has asked what those written agreements actually are or what they are supposed to contain. Again, I would be grateful if the Minister clarified some of that.

--- Later in debate ---

[Jackie Doyle-Price]

It is a pleasure to follow the right hon. Member for Don Valley. I do not think I disagreed with a word she said. I recognise that, for some Members, it is a matter of regret that we are leaving the European Union. None the less, we are committed to delivering the instruction given by the British people in the referendum. I think I speak for most people in the room when I say we would prefer to do that on the basis of an agreed deal with our European allies, but we need to be ready for the eventuality that we are not able to secure such a deal. That is why we introduced these SIs. I am grateful to Committee members for their pertinent questions. They are evidence—if only the public could see it—of how seriously we are taking the challenges of a no-deal Brexit, which of course we all wish to avoid as best we can.

A number of Members expressed concerns about whether affected establishments had been properly communicated with and were ready for the changes in these regulations, and about costs. We issued a technical notice to all affected parties in August to give them due notice to be able to prepare for the regulations. As was referred to, there is a six-month implementation period, but we expect that preparation to have been undertaken now. Given that it effectively will be business as usual, we expect that preparation to be relatively straightforward. Some of the things we have put in, such as the six-month transition period, are really just a sort of legal process to set deadlines, but we expect all those affected to be compliant almost immediately.

On the issue referred to in the technical notice of whether establishments might need to seek separate advice, we expect establishments just to engage with the regulators. Again, this will be business as usual, but the regulators stand ready to give all those affected as much advice as they need to be able to comply.

The hon. Member for Gedling is quite right that the updated information was not published in November, but it has now been published. It was published on 7 December, so it was slightly delayed—that is not unusual when it comes to things associated with Brexit—but it can be found online, and I will draw his attention to it.

[Vernon Coaker]

Google couldn’t find it.

[Jackie Doyle-Price]

Google has its limitations, it has to be said.

On whether costs need to be reimbursed, it is worth noting that we expect the costs incurred by establishments to be extremely low. The main impact of the draft regulations relates to agreements that establishments have to put in place with whomever they trade with, but most establishments already hold import licences and are well used to making and applying such agreements. We expect them simply to roll over their existing written agreements. Again, however, NHSBT and the Human Tissue Authority will work with and support establishments to put those agreements in place. There will be no impact on organ transplant centres, and in the case of non-reproductive cells we think all the establishments concerned will already have such agreements in place. On that basis, we do not expect any establishment to incur significant costs, so there will be no need for any reimbursement.

The right hon. Member for Don Valley and the hon. Member for Washington and Sunderland West mentioned organ donation. Clearly, the 30 organs that come in and out of the country every year are a matter of life and death. It is of considerable concern to me that we have sufficient provision in place to ensure that that can continue. Much of that movement is between the Republic of Ireland and the north, and at this stage we do not anticipate significant problems there, but there is good reason to worry about Dover-Calais.

We have all heard the concerns about whether things will be able to get into the UK through that entry point. We are working with the Department for Transport to ensure that things such as medical supplies, including organs, can get through if there is traffic congestion. We are making such provisions—contingency plans will be in place. I hope we do not get to the point of having no deal, but we are determined to ensure as best we can that, if we do, it will be business as usual and that, for example, couriers are escorted so they can navigate traffic more quickly. It is very much on our agenda to ensure that we can enable that to happen.

Question put and agreed to.

draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

Resolved,

That the Committee has considered the draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019.—(Jackie Doyle-Price.)

draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019

Resolved,

That the Committee has considered the draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019.—(Jackie Doyle-Price.)