Human Fertilisation and Embryology (Amendment) Regulations 2018

Baroness Chisholm of Owlpen Excerpts

Tuesday 27th February 2018 Grand Committee

Moved by

[Baroness Chisholm of Owlpen]

That the Grand Committee do consider the Human Fertilisation and Embryology (Amendment) Regulations 2018 and the Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018.

[Baroness Chisholm of Owlpen (Con)]

My Lords, today we are debating two regulations which are part of a wider set of European Union directives that set quality and safety standards for human tissues and cells that are used in patient treatment.

It is vital that UK patients should have every opportunity to access the kind of life-changing therapies covered by these regulations, such as stem cells used to treat blood cancers, corneas to restore sight, heart valves to treat heart conditions or skin grafts to treat burns. As noble Lords are probably aware, these tissues and cells may be donated in the UK or anywhere in the world and of course we need to know that they are safe to use.

I will touch on the history of the European tissues and cells directives. As the world leader in tissue banking, the UK welcomed the proposals to introduce a European tissue and cells directive. The Government supported the directive because it meant the voluntary accreditation scheme for tissue banks in operation at that time was placed on a statutory basis. The first directive included provision to make four Commission directives setting out the detail of the procedures needed to meet the prescribed standards. The coding and import directives are the final two of these Commission directives which we are discussing today.

--- Later in debate ---

[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.

[Baroness Chisholm of Owlpen]

I thank all noble Lords for taking part in this debate. It is a great pleasure to have the noble Baroness, Lady Thornton, here, because she is a great expert on these regulations. The reason why we in this country are so expert on these particular issues is probably that the noble Baroness helped to take the regulations through in the first place.

The noble Baroness asked whether we monitor. The department meets the HFEA and the HTA, and implementation will be on the agenda for discussion on a regular basis. On her other question, I might have to write to her if that is all right.

The noble Baroness, Lady Jolly, asked several questions, including one on the consultation. As I mentioned in my speech, the Department of Health and Social Care set up a stakeholder advisory group that included representation of professional bodies, tissue banks and service providers to give guidance on transposition and the potential impact on licensing establishments. I am also aware that the regulators, the Human Tissue Authority and the Human Fertilisation and Embryology Authority, have done a lot of work on the development of these regulations and preparing licensed establishments for implementation, and I am grateful to them for that.

--- Later in debate ---

[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.

[Lord Hunt of Kings Heath (Lab)]

The logic is that if the EU then changes regulations in this area, the UK will also change the regulations here, because of the point made by the noble Lord, Lord Deben. Or are we, having established that currently we will remain with European regulation, going to go out in Dr Fox’s brave new world and develop our own provisions?

[Baroness Chisholm of Owlpen]

No. We have to do these regulations anyway, that is the point. They should have been implemented on 29 April 2017 and, as I said, the delay was due in part to the complexity of the directives themselves—other member states have also experienced delays—and the initial timetable to make the regulations before the Summer Recess was paused because the general election was called in March 2017 and we then had a recess period. That is why we are doing the regulations now.

I think I have answered all noble Lords’ questions, so I commend the regulations.

Motions agreed.