Deregulation Bill

Baroness Warnock Excerpts

Wednesday 11th February 2015 Lords Chamber

The House should not forget that infertile people are deeply vulnerable. They are very distressed. They are often seemingly deranged—although of course they are not: they are sensible people like the rest of us. Noble Lords who have infertile relatives who have had these treatments will know well what it means to those individuals. This is a very serious issue. That combination of avarice and desperation is a serious worry. So when it comes to any kind of impetus to understand and to try to look at the commercial value of this activity—even though it is undoubtedly capable of producing an income to London and other parts of the country—we should be very aware that, as with the whole of healthcare, which my noble friend has covered in his amendment, we need to give it very serious consideration.

[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.

Deregulation Bill

Baroness Warnock Excerpts

Thursday 5th February 2015 Lords Chamber

[Lord Storey (LD)]

My Lords, I, too, support the amendment. With the UK now the second largest exporter of television programmes, the commercial PSBs’ investment in content is part of the engine of the UK TV content market, driving the independent production sector and playing a critical role in supporting the rich talent pool, both on- and off-screen, across the UK, including the north-west, where I live.

UK programmes are not only hugely popular with UK viewers but have global appeal. These programmes demonstrate that the commercial PSBs are not only producing high-quality entertainment for viewers in the UK, free at the point of use, but producing a highly valued product that can be exported around the world and contribute to the growth of the creative industries, including in the regions, such as mine of the north-west. To be able to continue making these programmes, the commercial PSBs need to make a return on successful content investment, which my noble friends have clearly demonstrated that Section 73 is undermining.

Many noble Lords have referenced the Ofcom figures that show that between 2004 and 2012 there was a significant real-terms decline in PSB investment in original new programmes of around £800 million, and that between 2007 and 2012 there was a 29% real-terms decline in PSB spend on original new drama programmes. We should be very concerned about these numbers. The drama figure in particular links directly to the impact of personal video recorders and ad-skipping.

As has been pointed out, the UK broadcast market is evolving very rapidly as technology changes and convergence continues, altering the economics of the industry fundamentally. Therefore, retaining legislation such as Section 73, which was designed for the challenges of an analogue era, makes little sense in today’s highly competitive global media market.

Section 73 does not support the growth of the UK’s international television sector. It is putting our commercial PSBs’ ability to compete in a global market at risk. Contrast this with the UK’s main competitor internationally, the USA, which has a system that provides a “retransmission consent scheme”, which means that free-to-air broadcasters in North America are paid for delivering content to competing platforms. These payments, which amounted to $3.3 billion in 2013—nearly 15% of total broadcast television revenue—have been crucial to the continued viability of television broadcasters, contributing significantly to the new “golden age of television” in the US. They also accounted for less than 3% of cable operators’ revenues and have had little or no impact on pay-TV prices.

These fees have helped to sustain programmes that could not otherwise be made, such as regional news. They have also helped free-to-air broadcasters secure rights to sporting events that would otherwise be shown on pay-TV channels and have helped, or are helping, with technological changes such as the move to HD television.

No two television markets are exactly the same, but it is instructive that our key rival in international TV markets is taking such a different approach to maximising investment in original TV content. It cannot be right that we hold on to a system that increasingly does the opposite, particularly given that it has long since achieved its policy objective.

Like many of my noble friends, I have been waiting to see what the Government propose to examine with their intended consultation and, like them, I have been waiting some time to see when the proposed review will be published. I am also eager to know whether the recommendations that result from this consultation have any chance of being implemented. How will the Government ensure that this does not become just another issue kicked into the long grass as part of a consultation doomed never to see the light of day again, with commercial PSBs’ investment being put at risk all the while?

Section 73 has been discussed in detail as the Bill has progressed through Parliament, and I welcome this sensible amendment that would ensure that the Secretary of State has the power to repeal the whole of Section 73 without primary legislation. It seems a sensible solution that would not pre-empt the findings of the review yet would still mean that action could be taken at the earliest possible opportunity.

[Baroness Warnock (CB)]

My Lords, there could hardly be a more learned, well informed set of people than those of your Lordships who have spoken up till now. My connection with commercial television ended in 1980. The amendment before us sets right what was put wrong then. It was put wrong largely out of prejudice against the commercial sector and a failure to believe in the public service broadcasting demands that were even then made on commercial television, which were often regarded with suspicion. It seems to me well beyond the time when this amendment should be accepted. The thought that we have to wait still longer for a review, the contents of which we do not know, is quite absurd. I urge the Government to accept the amendment here and now.

[Lord Stevenson of Balmacara (Lab)]

My Lords, once again, we have had a very good discussion about this topic. Although much stress was placed on the unanimity of view last time, I seem to recall myself being somewhat isolated and not in favour of what was proposed. I plead on this that I was simply arguing for good governance and not for a radical change in approach, because I share many of the views that have been expressed today. I simply think that the complexity of the matter is undervalued. The technological changes and all the other things that people are asserting without much evidence need to be tested by proper evidence-gathering and a proper report.

Like other noble Lords, I think that the way forward is to do something with Section 73 of the Copyright, Designs and Patents Act. There is some obvious logic in having the primary legislation already banked in order that it can be implemented when the time comes, but the right process would be to carry out the review to be absolutely certain that the complexities which are present are properly analysed, that the regulatory structure—in so far as it can be—is made future-proof, and that we come forward with a proposal in a coherent and proper way. I hope that the Minister will be able to shed light on the complicated manoeuvrings that are going on behind the scenes but have yet to see the light of day.