Human Fertilisation and Embryology (Amendment) Regulations 2018

Baroness Jolly Excerpts

Tuesday 27th February 2018 Grand Committee

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for explaining these regulations with clarity. I have to confess that I have form with regard to the Human Fertilisation and Embryology Authority and its regulations which goes back to when I first arrived in your Lordships’ House 20 years ago. I have been involved in the development of these regulations at each stage as a Back-Bencher or a Health Minister or in opposition. The meticulous attention that this House has given to these matters at each stage is one of the reasons why we are a world leader in the use of embryos and human tissue to advance medical and fertility science, and we should be proud of that.

Like my honourable friend Sharon Hodgson in the Commons, we on these Benches will be supporting the updating and tightening of the regulations that these statutory instruments contain. It is important that these objectives support our aim of making sure that human tissue is stored and used safely, ethically and with proper consent, and is moved properly. I am pleased that the chief executive of the Human Tissue Authority, Allan Marriott-Smith said:

“We are committed to working with our stakeholders to ensure a smooth transition and proportionate approach to implementation”.


I have two questions for the Minister. First, how will that implementation be monitored by the Government? I am not actually expecting her to answer my second question today but I would like the Government to address it. Her remarks and those of her honourable friend the Minister in the Commons show, in almost their first sentence, that these regulations are being laid as a result of a European directive, so she will not be surprised that my question relates to that. In the Commons, the Minister’ said:

“the regulations fulfil a UK obligation as a current member of the European Union. More importantly, they bring into UK law provisions to enhance our already robust controls”,—[Official Report, Commons, Third Delegated Legislation Committee, 31/1/18; col. 4.],

and so on. The Minister must therefore have anticipated that my question is: what will happen to these regulations and to this function after Brexit? Are those discussions in hand? What is their timescale? If the Minister does not have those answers to hand, I am very happy for her to write to me about them.

[Baroness Jolly (LD)]

My Lords, I thank the Minister for her introduction. I do not intend to detain the Committee long. These two regulations are, I suspect, the first of many health regulations that transpose EU law into UK law. I shall outline my understanding. As the Minister has just outlined, there are two key directives: the coding directive and the import directive, the first to ensure traceability and the second to ensure imported tissues and cells meet quality and safety standards. As I see it, the aim of these SIs is to transpose these provisions in the coding and import directives. For many patients, it is critical that this is right. What was particularly interesting in the briefings were the impact assessments that accompanied them. The transition tables enable clarity about how elements of EU legislation are put into UK law and allow us to match one for one to ensure that nothing has been altered or omitted. As far as my inexperienced eye could tell, that has been achieved. Another interesting point is the cost to the sector of the work to achieve this.

I have a few questions for the Minister, of which I have given her prior notice. Will she tell the Committee what consultations were done and with whom? What practical changes will the sector see and how long is the sector allowing for such changes to take place, if any? What cost implications are there for both organisations? Much work has been done. Was it budgeted for in their income when they were funded or has the cost had to be found from existing budgets?

As I said earlier, these are our first regulations, and I wonder whether the Minister could tell us how many more to expect and the likely total cost of this exercise to the NHS. Does she anticipate that we will be able to process these changes before leaving the EU? Does she have any indication of whether this exercise is prioritised, or do the regulations come as they are available? I spoke to both the HFEA and the HCA and they are both content with these regulations, so we are also happy to endorse them.

[Lord Deben (Con)]

My Lords, I congratulate my noble friend on the elegant way in which she dealt with a very difficult issue. The only reason why I am speaking is that on every occasion we should draw the attention of the House to the fact that merely taking EU legislation into British law does not actually meet the case, because that is of no use unless there is equivalence. We cannot in future operate as if we could operate on our own, because the whole purpose of this legislation is that we can pass these things without difficulty across the whole of the EU.

I do not expect my noble friend to answer what I have to say. As I said, I thought her presentation of this difficult situation was as elegant as it is humanly possible to be. But we cannot escape the fact that this is another example where leaving the EU does not solve problems but causes really serious ones. When she said that we are looking for equivalence, I have to say that there is nothing else that we could look for because nothing else would meet the needs. Anything else would cease to enable us to use these very important elements across the whole of the EU; we would have our own system.

I have just spoken to the Society of Motor Manufacturers and Traders, and again I had to say that the idea that Britain is going to have her own rules about the carbon exhausts of vans is just barmy because we are not big enough to do that. Here, similarly, what we are seeing in reality in this SI is the serious damage that is being done by this whole enterprise. Although it may bore Ministers and some of my colleagues on this side of the House to be reminded of it, I do not think any of these should be passed without reminding people of the huge cost, the vast inconvenience and maybe even the lives that will be endangered by behaving as stupidly as we are by believing that we can operate without a connection with our neighbours. Indeed, we do not believe that; that is why the answer is that we will look for equivalence. If you look for equivalence, of course, what you are really doing is saying that the rules will be made by someone else and we will merely accept them.

--- Later in debate ---

The noble Baroness mentioned timing and benefit. These regulations will come into force this April and are not being introduced as a result of the decision to leave the EU.

[Baroness Jolly]

I did not mean to mislead the Minister, I just anticipated that many more regs would need a similar sort of exercise to that we have done today—in the NHS health sphere and in general. The question was really about workload: how many more do we expect to come down the track, when do we expect them to come and are we anticipating that they will be finished by Brexit date? Is there any indication that they are being done on a slightly ad hoc basis or are some being prioritised over others? I am sorry if the Minister is unable to answer that now, but if she wants to write to me, that will be fine.

[Baroness Chisholm of Owlpen]

I cannot give a timing on that now so I will have to write. These regulations needed to be dealt with anyway and they are slightly late, partly due to a general election, so we have to put them in place now. It actually has nothing to do with Brexit. We have to put them in place now, otherwise we would have heavy fines. In a way, that slightly answers the question from my noble friend Lord Deben about why we are doing it. We are making sure that our standards are as high as those of other EU countries, so this is actually transposing existing regulations and making us consistent with the EU; we are not adding anything new.