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Human Fertilisation and Embryology (Quality and Safety) Regulations 2007

My Lords, these regulations have been billed as being ““of medium controversy”” but the extent and nature of that controversy seems fairly modest. As the Minister explained, we are dealing here with the implementation of a European directive. The UK has a legal obligation to implement that directive and failure to do so would render us liable to infraction proceedings. To that extent, we must view these regulations as being necessary—on the assumption, of course, that they faithfully reflect the content of the directive without unwelcome gold-plating. In a purely domestic context, much of the benefit of the regulations is already enshrined in UK law. However, their wider benefits are clear. Over the years ahead, as new treatments are developed, especially in the area of stem cells, we are likely to see greater traffic in human tissues taking place between different countries. There is therefore every advantage in having common procedures governing the safety and quality of tissues across the EU. As an aside, I should be particularly interested to know from the Minister whether the implementation of the directive among member states will do anything, albeit indirectly, to help women and couples who look outside the UK to receive IVF and other fertility treatments. I was quite struck by the following sentence in the regulatory impact assessment. It said: "““The introduction of quality management systems is likely to encourage the creation of a ‘safety culture’, which will help establishments to prevent, analyse, and learn from errors, in keeping with the recommendations of the Department of Health report, An organisation with a memory””." To what extent is it the Government’s perception that a safety culture does not currently exist in relevant establishments? How serious a concern is this in relation to fertility clinics in the UK and in tissue banks? If it is a concern, why have the Government not acted more swiftly to deal with it? The document referred to, An Organisation with a Memory, was published as far back as 2001. The regulations also create a single regulatory framework for reproductive and non-reproductive tissue banking, which paves the way for the merger of the HFEA and the Human Tissue Authority. That merger will, we understand, be the subject of primary legislation in due course, and this is not the moment to anticipate our debates on that issue. However, in giving the regulations our approval, as I am sure we shall do, it should not be assumed that all of us in this Chamber view the creation of RATE, the proposed new regulator, as being necessarily well conceived. My noble friend Lord Jenkin of Roding, who is not in his place, has on a number of occasions voiced his disquiet over the rationale underpinning this merger and I have a great deal of sympathy with what he has said on that subject. So we will be ratifying these regulations very much on a ““without prejudice”” basis. In the immediate term, the issue that concerns me most is the regulatory impact of these instruments and their cost to business. We have available a very helpful regulatory impact assessment, which there is no need to go into in detail; but the compliance cost table shows that the implementation of the directive islikely to cost in aggregate between £16.22 million and £17.98 million upfront, with annual recurring costs of between £3.92 million and £11.18 million. Set against predicted annual benefits of £9 million, those costs look fairly hefty, and one wonders whether every effort has been made by the department to minimise them. I wonder also whether the Minister shares my concern that the monetary values assigned to the potential costs and benefits of the directive are unsatisfactorily vague. We are told that the consultation on the regulations has been extensive, and I am sure it has been, but it seems extraordinary that the annual recurring costs of implementing quality management systems should be incapable of more accurate estimates. The range of figures that we have are between£2.74 million and £9.59 million, which indicates to me that no one really has a clue what the costs will be. We are also told that most fertility clinics face few additional costs as a result of the regulations. But on the face of it this seems surprising in view of the inevitable increase in paperwork arising from some of the new controls. Can the Minister comment on this point, and can he can say to what extent establishments will be subject to new administrative burdens and whether these have been costed in? Bearing in mind that 80 per cent of fertility clinics are classified as being small firms, additional administrative burdens will be proportionately more serious for most of them than might be first thought. I hope the Government will aim to achieve the lightest touch in regulation, consistent with the aims of the directive.