Human Fertilisation and Embryology (Amendment) Regulations 2018

Baroness Thornton Excerpts

Tuesday 27th February 2018 Grand Committee

These regulations fulfil a UK obligation as a current member of the EU. Importantly, they bring into UK law provisions to enhance our existing robust controls that ensure donated human tissue and cells used in the treatment of others meet the highest quality and safety standards. These tissues and cells are increasingly travelling between countries. We want a safety system that protects patients and supports wide access to treatments. These regulations do just that.

[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.