Deregulation Bill

Lord Alton of Liverpool Excerpts

Wednesday 11th February 2015 Lords Chamber

[Baroness Warnock (CB)]

I rise simply to underline everything that the noble Lord, Lord Winston, has just said. It seems to me a disgraceful possibility that individual private clinics might be allowed to exploit these vulnerable people. The words that the noble Lord quoted show that this could happen automatically. It is not just that people may be allowed: the suggestion is that they will be allowed, unless some very special consideration applies. I therefore beg the Minister to reconsider this part of the Bill.

[Lord Alton of Liverpool (CB)]

My Lords, the Minister may not be surprised to find that I am keen to intervene on this amendment, moved by the noble Lord, Lord Hunt of Kings Heath, but he may have been surprised by the noble Lord’s ability to put together an interesting coalition of voices which would not necessarily always agree on some of the substantive issues raised in the context of human fertilisation and embryology. On this occasion I strongly agree with what my noble friend Lady Warnock and the noble Lord, Lord Winston, have said, and I hope the House paid attention to the specific example that the noble Lord gave of someone having to spend £11,000 in a London clinic. I find that extraordinary and we are all grateful to the noble Lord for telling us about it.

I strongly agree with what the noble Lord, Lord Hunt of Kings Heath, said about some of the organisations mentioned in the amendment: the Care Quality Commission, the Human Tissue Authority, the Professional Standards Authority and the Human Fertilisation and Embryology Authority. What have they got to do with economic growth duties? They have much more important duties than that and I find it amazing that we are dealing with this issue at all in the context of the Deregulation Bill.

If we examine the press releases of the Human Fertilisation and Embryology Authority, or look at its website, we will see, in terms, the phrase that the noble Lord, Lord Hunt, used. The HFEA says:

“We are not an economic regulator”.

That is also emphasised in a previous Written Answer by the noble Earl, Lord Howe, in which he stated:

“The HFEA is not an economic regulator and, accordingly, does not publish information on costs at a clinic level”.—[Official Report, 22/1/13; col. WA 195.]

And nor should it. So, surely this serves only to emphasise that the HFEA is not competent to undertake any economic growth duty.

Indeed, at last year’s Progress Educational Trust’s annual conference, the noble Lord, Lord Winston, described how most NHS trusts charge above cost, and that they are driven by profit motives. Dr John Parsons, the former director of King’s College Hospital’s assisted conception unit, also argued at the same conference that simple greed had made profits, rather than compassion for patients, the top priority of many fertility clinics today. That point was underlined by the noble Lord, Lord Winston. Dr Parsons further argued that this encouraged the use of dubious technologies which are motivated simply by market forces rather than treatments motivated by compassion that are targeted to suit the needs of the individual patients about whom we have heard today. Are the Government proposing that the HFEA should emulate those whom it is failing to regulate?

If the HFEA, which is not an economic regulator, should now have the additional duty to make a profit, how might its judgments be further impaired by such pecuniary interests? How might this exacerbate what the report of the Progress Educational Trust’s last annual conference described as—I repeat what was quoted by the noble Lord, Lord Winston—

“the rampant commercialisation of IVF in the UK”?

If the profit motives of some avaricious clinics go unchecked by the regulator, and the regulator itself becomes increasingly motivated by profit, will this not make an already bad situation even worse?

It is far from clear that the HFEA has proven itself to be a particularly effective regulator as it is. The noble Lord and I do not agree on this point. I do not believe that it is sufficiently robust. To begin with, recent Written Answers to Parliamentary Questions reveal that it does not even maintain proper records on the number of human embryos used in research or allowed to perish. Instead, the HFEA seems more concerned about providing repeated references to a pinhead, the relevance of which to the number of human embryos destroyed is far from clear, except perhaps as a reflection on the competence of whoever is responsible for answering these Questions.

The HFEA’s enforcement of its multiple births policy has already proven to be utterly toothless. That is exemplified by a press statement on the HFEA website from 13 November 2013, in which it was conceded that IVF clinics would no longer be subject to a condition on their licence that they keep their multiple births rate below the HFEA target. As the press statement further revealed, this was in response to a legal challenge launched by two UK clinics,

“resulting in considerable cost to the HFEA”.

How much easier it will be for the HFEA to cave into those it is supposed to be regulating if it has to prioritise an economic growth duty.

Strikingly, an ensuing Written Answer from the noble Earl, Lord Howe, on 9 December 2013 stated the following in relation to the incidence of multiple births and the HFEA’s publication of clinic success rates:

“It is not clear whether additional powers of economic regulation would alter the HFEA’s influence on such practice”.—[Official Report, 9/12/13; col. WA 79.]

If the profit motives of some clinics already remain unchecked in a continuing environment of IVF postcode lotteries, how will this not be made even worse by having the HFEA join the fray in prioritising profit over protecting patient interests?

Although the HFEA chief executive, Peter Thompson, may be trying to make some modest efforts to combat,

“the rampant commercialisation of IVF in the UK”,

this seems limited only to “tentative steps” for increased transparency on the part of clinics and an expectation that others will bring about a change in culture. This does not exactly sound like an effective regulator, does it? If it is up to clinics to bring about a change in culture, what is the HFEA there for? The impotence of the HFEA is already serious enough as it is. As Dr Geeta Nargund, who I met recently, pointed out in a Huffington Post article that I would encourage noble Lords to read,

“no-one appears to be monitoring the drugs given to women during IVF treatment. Extremely high doses of stimulation drugs and intravenous immune therapy injections are administered to women by some clinics with no scientific evidence to support those practices. The HFEA do not collect information about drugs and dosages given to women, but we need this information to study any adverse effects of the drugs on women and their children in the future”.

How is the HFEA protecting the interests of patients if neither it nor anyone else is monitoring this? Dr Nargund’s concerns are only reinforced by the Written Answer I received from the noble Earl, Lord Howe, just yesterday, in which it was admitted that the,

“administration of medicinal products to patients undergoing fertility treatment ... is not regulated by the Human Fertilisation and Embryology Authority ... The HFEA has advised that it does not collect information on the identity of medicinal products used in treatment”.

But it gets worse. The same Written Answer received yesterday goes on to describe nevertheless how the,

“HFEA is aware of some clinics that have administered reagents to permitted gametes or permitted embryos that are then introduced into patients when the reagents concerned have not been CE marked. … Although the HFEA does not hold information on the effects of particular dosages on the welfare of the developing child and the health of the mother, the HFEA expects clinics to do such monitoring as part of their licensing conditions”.

It should be noted that we are not just talking about unlicensed medicines but about off-the-shelf laboratory reagents, most of which I gather would typically be labelled as unsuitable for clinical application. It should also be noted that no mention is made here of the sanctions imposed by the HFEA on clinics for putting goodness knows what into patients without knowing the effects,

“on the welfare of the developing child and the health of the mother”.

It therefore seems that as long as the clinic is responsible for whatever happens, the HFEA is satisfied.

In closing, I would like to reinforce what the noble Lord, Lord Hunt, said in relation to proposed interventions for mitochondrial diseases. Regarding the question of profit, it is noteworthy that a “competing interests” statement on a recent paper by Shoukhrat Mitalipov—belatedly added as a corrigendum—includes the admission that he has a patent application entitled:

“Method for mitochondrial DNA replacement in oocytes”.

My understanding is that researchers at Newcastle have no similar patent applications for pronuclear transfer, which is probably unsurprising because their proposed use of this technique is not original, having already been attempted in humans in China with woeful results. However, how would the economic growth clauses in the Bill affect the HFEA’s consideration of such licence applications? Would the HFEA be compelled to favour proposals for spindle-chromosomal complex transfer over proposals for pronuclear transfer on the basis of patent applications and potential profits to be gained? Or can the Minister please spell out clearly how the projected use of pronuclear transfer in admittedly limited numbers of clients could be seen as a contributing factor to economic growth, such that the HFEA would be seen as satisfying the economic growth clauses in the Bill?

I am sorry to have wearied the House with some of this but the point I am making is that these are complex and clear ethical, as well as medical and scientific, issues. This is not about things being driven by the state of the economy or deregulation, and it is a great error on the part of the Government to have included this in the Bill. I hope that between now and Third Reading the noble Earl will listen to what the noble Lord, Lord Hunt of Kings Heath, has said and give this much greater and more detailed consideration.

[Baroness Masham of Ilton (CB)]

My Lords, we should be protecting desperate patients from being ripped off by clinics whose main interest is to make money. I hope that the Minister will look at this again.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, I am very grateful to all noble Lords who have spoken. However, I am disappointed with the Minister’s response because I thought that at the least he would have been prepared to give this matter further consideration between now and Third Reading. With my noble friend Lord Winston here to talk about the Human Fertilisation and Embryology Authority and the noble Lord, Lord Alton, also present, I knew that we would have an interesting debate.

The point is that, however effective or not the HFEA is at the moment, the one thing that unites us all is that we do not want to see its regulatory function weakened. My noble friend Lord Winston spoke about London becoming the centre of a healthcare market, and the Minister welcomed that. When I took through the 2001 regulations that extended the purposes of research in the original 1990 Act, which was based very much on the extraordinary work of the noble Baroness, Lady Warnock, we clearly had in mind that there was research potential for the UK. That was one of the factors behind taking through those original regulations. The argument that we put forward then was that the UK would be able to attract research investment because, despite some of the doubts that noble Lords have expressed today, we were considered to have a first-rate regulatory function. I put it to the noble Lord that he is putting that reputation at risk by allowing ambiguity in the nature of the regulatory process.

My noble friend talked about the dangers of commercialisation in this field and he is surely right. It is interesting that the chief executive of the HFEA has recently been quoted as recognising the responsibility to take action against rampant commercialisation of IVF in the UK. That statement is very welcome. My noble friend has argued that at the moment it does not have the powers to do anything about it, but the noble Lord comes here with a proposal to weaken its already inadequate powers. That is quite remarkable.

The Government are very keen for the mitochondrial donation regulations to be approved on 24 February. I support them, but has the noble Lord considered the risk to that decision from the impact of this Bill? This will be a big issue when we debate those regulations. When the noble Earl, Lord Howe, comes to make proposals for the regulations, he will say that your Lordships can have confidence in passing the legislation because of the robustness of the HFEA. However, I, who support those regulations, will have to get up and say that actually the noble Earl is incorrect because of what the noble Lord here is proposing to do.

[Lord Alton of Liverpool]

I entirely agree with what the noble Lord is saying, but does it not also undermine the noble Earl, Lord Howe, who has consistently said that the HFEA is not an economic regulator, to now put him in that invidious position?

[Lord Hunt of Kings Heath]

That is absolutely right. The noble Lord then went on to say that we should be fine because the provisions in the Bill say that all the regulator has to do is to “have regard to” the desirability of promoting economic growth. However, the moment you include those words, the regulator becomes liable if it can be shown that he does not have regard to that, even though the noble Lord recognises that in many cases he ought not to have regard to it.

It is quite inadequate to say that we are consulting on this. This is absolutely wrong. We need to know by Third Reading whether the Government are going to keep in the HFEA and the PSA. I think that the noble Lord ought to allow further discussions to take place between now and Third Reading, and he ought to discuss this with his colleague—particularly the impact on the new regulations on mitochondrial donations that will be coming forward. As for his assurance that any of these bodies will be included by an affirmative resolution, how many times has an SI been defeated in Parliament? It is fewer than 10 times, so it is a meaningless safeguard in effect. I invite the Minister to say that he will at least give this further consideration before Third Reading before I make my decision.