Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I beg to move amendment No. 155, in clause 27, page 31, line 13, leave out ‘revocation or’.

This is a probing amendment to elicit from the Minister an explanation of why the authority has the power to charge for a revocation of a licence, and what happens in circumstances where the licensee who has had his or her licence revoked refuses to pay, or their business is wound up and no longer exists. Is it right that the licence is revoked at the discretion of the authority and that therefore the licensee is charged—the authority can both revoke the licence and make a charge—particularly since the Bill does not state that the charge may only cover costs and not generate revenue for the authority?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

The hon. Gentleman raised points earlier about the responsible person if a licence were revoked or a request to revoke a licence were made by the clinic. He made specific reference to the provisions for patients who might already be having treatment, and to ensuring that the storage of embryos, material and information is done in the proper way. I made it clear to him that those matters were requirements of the licence. The payment of the fee is to ensure that those arrangements can be made, and it may be that it is transferred to another clinic for treatment, for instance, or for maintenance.

The circumstances for a clinic that was closing down and submitted that it wished to have its licence revoked would be rather different to cases where the HFEA was revoking a licence for its own reasons, but none the less, administrative expenses would occur both for the HFEA and for patients going to other areas. It is not about income generation for the HFEA. As was said in our earlier discussion about fees charged by the HFEA, it may charge a fee, but it does not have to do so. Specific provision is not made in the Bill for such charges, but it is envisaged that they would be covered, because there would be consequential expenses. I assure the hon. Gentleman that it is not about income generation for the authority. I hope that that covers his questions.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I am grateful for the Minister’s clarification that total revocation of the licence and charges related to that are not temporarily—essentially—income generating. Has any thought been given to a charge that might have been made to a licence holder who has had the licence revoked and who refuses to pay? Would that bar, for example, somebody from getting a licence in the future?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

That would clearly reflect on the responsible person, and whether they were responsible enough to have a future licence, bearing in mind how they discharged their responsibilities for a licence that they no longer have. Either they revoked it themselves by wishing to withdraw from the licence, or the HFEA revoked it because of breach of licence. It comes back to that debate about responsible people.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I am grateful for that intervention, and I certainly do not wish to push amendment No. 155 to a vote. On that basis, I beg to ask leave to withdraw the amendment.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I beg to move amendment No. 156, in clause 27, page 31, line 26, at end insert

‘set out in regulations laid in draft before and approved by a resolution of each House of Parliament.’.

Jimmy Hood (Lanark & Hamilton East, Labour)

With this it will be convenient to discuss amendment No. 157, in clause 27, page 31, line 38, leave out ‘may’ and insert ‘must’.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

The amendments relate again to the fees that the HFEA can charge. I will detail what they would do, and then I want to talk a little more, if I may, Mr. Hood, and ask the Minister to provide information about the charging structure and the HFEA’s fees.

The Bill as drafted allows for the fees to be fixed by the authority with the approval of the Secretary of State and the Treasury. Amendment No. 156 would ensure that the fee is fixed in Parliament through regulations, which would go some way to ensuring that the fee is fair and proportionate and would not necessarily be passed on disproportionately to the patients by the clinics. The Minister will be aware of the enormous concern about that within both main political parties.

On amendment No. 157, the Bill as drafted says that any fee charged for the provision of information about genetic offspring, siblings or a potential partner, may have regard to the costs incurred, which clearly also implies that it may not have regard to the costs incurred. The amendment would change that “may” to “must”, which would therefore mean that fee charging must not be a revenue-raising exercise. I was grateful for the Minister’s confirmation that the fees charged for the revocation of a licence would not be a revenue-raising exercise and that the charges must be in direct proportion to the costs incurred in providing that information. The amendment would ensure that the fee charged is proportionate to the costs incurred in obtaining and providing that information.

With your permission, Mr. Hood, I would like to broaden the debate in terms of the charging structure of the HFEA, which relates to the amendments. I should like to elicit from the Minister some of the—

Jimmy Hood (Lanark & Hamilton East, Labour)

Order. I must ask the hon. Gentleman not to go there. He may want to raise those points in our debate on clause stand part, but not in relation to the amendments.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I am grateful for that advice, Mr. Hood, and I look forward to catching your eye then.

Robert Key (Salisbury, Conservative)

It is a pleasure to serve under your chairmanship, Mr. Hood. I support amendment No. 156, and if this Bill is sublime, then I should like to introduce the Committee to the ridiculous. First, I want to consider the principle behind the charging regime.

Several years ago, on behalf of a constituent, I challenged the HFEA on the fees that it was charging for in vitro fertilisation treatment, and I was told that the Treasury insists on the fees being charged. Indeed, clause 27 inserts proposed new section 35B(2), which, as my hon. Friend said, gives the Treasury the final word on these fees.

The Treasury does not object to NHS dentists charging for certain procedures and contraptions, and it seems that it does not object to NHS eye tests that result in contact lenses being purchased by patients. On the other hand, the NHS does not allow people to buy drugs that have not been approved for NHS use by the National Institute for Health and Clinical Excellence. It says—entirely out of spite, it seems—that the whole course of treatment might be jeopardised if additional drugs are purchased. The Department of Health therefore seems to be in a complete muddle about charging structures.

On my second point, proposed new section 35B(5) says:

“the Authority may have regard to the costs incurred”.

It is often said that this is all about legal fees, which might be huge. However, if legal fees are incurred in the health service—for example because an orthopaedic procedure goes wrong and results in litigation—the hospital or department concerned does not have to pay the legal costs involved in meeting that challenge. How, therefore, can it be justified to reflect legal costs in the fees charged to clients and patients under the HFEA regime?

Proposed new section 35B(6) says that the HFEA

“may fix different fees for different circumstances.”

Will the Minister clarify that? Does that mean that the authority can charge different fees for the same HFEA functions under different circumstances? If so, who will make the decision? What will the criteria be? Will the Minister give us examples of what is meant by new section 35B(6)?

How are our constituents affected by this regime? The cost of each IVF cycle to our constituents is about £3,500 for fresh gametes and £1,000 for frozen gametes.

Jimmy Hood (Lanark & Hamilton East, Labour)

Order. I think that the hon. Gentleman is going a wee bit away from the amendment. Again, the issue could be raised in the clause stand part debate, not on this group of amendments.

Robert Key (Salisbury, Conservative)

I obviously have to accept your ruling, Mr. Hood, but I am talking very specifically to amendment No. 156. May I please proceed?

Jimmy Hood (Lanark & Hamilton East, Labour)

Order. I tell the hon. Gentleman that clause 6 is not being amended, but he is speaking to it as if it is.

Robert Key (Salisbury, Conservative)

Mr. Hood, I am talking about amendment No. 156 to clause 27, which was moved by my hon. Friend the Member for Boston and Skegness.

Jimmy Hood (Lanark & Hamilton East, Labour)

Order. My guidance to the hon. Gentleman is to look to the clause stand part debate and to speak specifically to the amendment. That is in line with my earlier advice to the hon. Member for Boston and Skegness.

Robert Key (Salisbury, Conservative)

Of course, I accept your ruling, Mr. Hood. If I may, I will speak to clause 27, page 31, line 26—to amendment No. 156.

On the fees that are charged for cycles, NHS trusts will not pay for frozen cycles, and I wonder who made that ruling. An application for a separate licence must be made for each and every cycle, and that must be granted by the HFEA. The authority charges £104.50 per licence. That means that the Salisbury fertility clinic, which treats about 200 patients a year with fresh or frozen cycles, pays about £200,000 a year in fees. There are more than 100 IVF clinics in the UK, so our constituents pay about £2 million a year.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

It might help my hon. Friend if I give him the exact figures. In the 2006-07 financial year, HFEA income was £6.7 million, of which grant aid—I assume that it came from the Department of Health—was £1.95 million. That means that the authority got £4.8 million in fee income from our constituents.

Robert Key (Salisbury, Conservative)

That is absolutely right. The IVF cycles paid for by our constituents represent a significant proportion of that income.

The proportion of private and NHS patients being charged is about half and half. In half the cases, therefore, the HFEA fee is paid by the patients, while in the other half, it is paid by the primary care trusts. However, the primary care trusts are simply transferring money from one part of the NHS to the other, with all the concomitant bureaucracy involved in the procedure. That, in itself, must cost a substantial amount.

There is another unfairness for our constituents in the charging structure. If, in an IVF cycle, there were some spare gametes for a patient, some of them would routinely be frozen in case they were needed in the event of failure. If the fresh cycle fails, believe it or not a new licence costing another £104.50 has to be applied for and granted—for the same gametes. The patient is therefore paying twice yet the clinic incurs no extra cost, apart from the cost of the storage of spare gametes. How can the whole bureaucracy and fee structure be justified for what is now a routine procedure?

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

Is my hon. Friend aware that financial implications arise from the Bill? He has suggested that the expectations of increased expenditure by the HFEA will be met not by additional resources from the Department of Health, but only by additional fees being charged.

Robert Key (Salisbury, Conservative)

I detect the dead hand of the Treasury intruding once again into the personal lives of our constituents. I entirely support my hon. Friend’s amendment. On behalf of our constituents, it should be Parliament, not the Treasury, that decides whether the charging regime is justified.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I wish to explain what actually happens and why, rather than there being a dastardly plot set up by the Treasury.

Hon. Members:

It is quite possible!

Jimmy Hood (Lanark & Hamilton East, Labour)

Order.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

It is a little strange that Conservative Members wanted the regulation that was accepted when the 1990 legislation went through under their Government, whereby there should be a fee structure to recoup the costs of the regulation, yet they now consider that that principle should be broken in respect of what the fees are charged for and how they are arrived at.

Amendment No. 156 would provide for the fees to be set out in regulations to be approved by both Houses. The HFEA undertakes consultation on its fee scheme and levels involving the public and stakeholders. That is similar to provisions under the 1990 Act. The Bill provides that the HFEA can set its fees in accordance with the scheme approved by the Secretary of State and the Treasury, and I see no reason to change that. At present, the HFEA makes a recommendation, having discussed with stakeholders what they believe the fee levels should be. A review is undertaken every two years, and it is not the case that fees always increase.

This is not about the Treasury saying what will be charged, but the HFEA asking for endorsement. That ties in with the fact that the HFEA is a quasi-independent body. We made the important decision recommended by the Warnock report so that matters relating to the function of the authority, including how it carries out  its functions in respect of fees, are properly the business of the authority to determine and justify. That was where the authority was in 1990. That was recommended in the discussions on the independence of the HFEA in discharging its regulatory functions as determined by Parliament, and the fees are about recouping its costs.

Robert Key (Salisbury, Conservative)

Will the Minister give way?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I am happy to give way. I will answer in detail the points that the hon. Gentleman has already made. I accept that he has changed his mind since 1990, but the Government have not.

Robert Key (Salisbury, Conservative)

Eighteen years ago, when the Minister and I were fresh young things on the Standing Committee that considered the 1990 Bill, the HFEA was a new institution and nobody knew how much it would cost to run. The procedures for IVF were novel and nobody knew how they would be taken up or what that would cost the NHS. Caution, therefore, was entirely sensible. The point that I have already made, which the Minister has failed to acknowledge, is that these are now routine procedures and routine parts of NHS performance, and that we need to change our minds. Parliament needs to change its mind. We no longer insist on people walking in front of cars with red flags, and we should not insist on this charging regime.

Jimmy Hood (Lanark & Hamilton East, Labour)

Order. That was a rather long intervention.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I understand the hon. Gentleman’s point. We continue to regulate the system. Some argue that there should be no regulation on IVF because it is so mainstream. They say that we should not have the regulation that is provided in the Bill and that the matter should be removed entirely from the auspices of the HFEA. However, that is not the view endorsed by Parliament, nor is it the view of the Government. The HFEA’s independence would be eroded and undermined by the amendment, yet it has to have independence. The other question is where we would draw the line on the HFEA’s independence. Would we allow it to determine its own procedures for using its regulation powers, regulating according to the wishes of Parliament, and the costs for that? It may also be considered that removing from the authority the responsibility for setting such procedures will work against better regulation. We need to ensure that the authority has an incentive to reduce the regulatory burden and improve its procedures, that it regulates according to the wishes of Parliament and that it does so in dialogue with its stakeholders, and takes into consideration what they think. The first implication of amendment No. 156 is that it should not be the function of the HFEA to set its own fees. That is something with which the Government and I do not agree. It is appropriate that the HFEA seeks to recoup the cost of regulating clinics.

Other costs that the HFEA might incur, such as legal fees, are met by the Department as part of the HFEA’s grant. Members of this Committee and of the House expect the Government to be concerned to ensure that the HFEA is fulfilling its functions in an efficient and  cost-effective way. That would always be part of the discussions about the rest of the running, not the regulation of the licences.

I hear what the hon. Member for Salisbury says about the level of fees, but I think that that is a separate issue. It is entirely appropriate that the HFEA intends to review its fee structure as part of the major project to consider how it operates and how it is undertaking its role. It must take into consideration the implications of the Bill, when it is approved by Parliament, and reflect on the points made by the hon. Member for Salisbury—whether it is timely to revisit when fees are applied, at what level and for what purpose.

I remind the Committee that the fees are paid by clinics and research centres towards the HFEA’s operating costs, including the continuing work to improve and strengthen regulation. The fees cover, for example, the cost of licensing and inspecting clinics to ensure that they are complying with the HFEA code. The authority reviews its fees annually and makes a recommendation to the Secretary of State, who agrees them. They are approved by the Treasury as well. As I said, they are not increased every year.

The current fees were referred to by the hon. Member for Salisbury, so I do not need to touch on them. The fees paid for costs depend on the type of treatment carried out or the complexity of the research, but, as I said, the HFEA is reviewing its fee structure. It is important that there is transparency on the level of the fees, why they are set at those levels, the costs that they are intended to cover, and that everyone understands that clearly. I do not accept that amendment No. 156 would improve how fees are set or take us any further forward. In fact, it would be in danger of questioning the independence of the HFEA.

Amendment No. 157 relates to the authority’s ability to charge a fee to people making an application for information from the register or for providing the information. Clause 27 is intended to enable the HFEA only to cover the costs of doing so and, as I have said repeatedly when the question of HFEA fees has been raised in Committee, it is not about income generation. The effect of amendment No. 157 would be that the authority “must”, rather than “may”, have regard to the costs incurred by it when dealing with an application or the provision of information about genetic parentage. On a straightforward technical point, the use of “may” is common in legal drafting and is appropriate in cases in which there is no obligation. That is clearly the point that we are trying to get across. The HFEA does not necessarily have to charge a fee for requests for such information as are proposed, and therefore “may” is entirely appropriate in such circumstances.

While I understand the points made by the hon. Members for Boston and Skegness and for Salisbury, and the force with they are making them, I hope that they agree that a more sensible way to proceed would be to allow the HFEA to continue to be accountable, to review its fees, to be in discussion with its stakeholders and then to make recommendations to the Secretary of State and the Treasury for approval, once those increases, decreases or no increase are decided. If the authority does that annually, it is entirely appropriate for that to  continue. If the hon. Member for Boston and Skegness feels that he needs to press his amendment to a Division on that principle, I will ask my hon. Friends to resist it.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West & Abingdon, Liberal Democrat)

Since there may well be a vote on the amendment, I ought to say one or two paragraphs on it. The Minister is absolutely right that if we believe that IVF has to be regulated, there must be fees to pay for it—that is if we agree that the regulator should be funded at least partly by the people whom it regulates, which is a common model.

I have long argued a point that I think the Select Committee report of 2005 made: now that we are 15 years on from the halcyon days of the fresh youth described by the hon. Member for Salisbury—perhaps others might argue that he and the Minister are still both fresh young things—IVF is just as routine, after the initial concerns about safety, as some unlicensed treatments involving drugs and surgery. Although there is an ongoing requirement of registration for the purposes of donor information and so on, I hope that it will be accepted that there is an argument for deregulation. That does not mean that there does not need to be quality assurance by the Healthcare Commission, involvement by the General Medical Council, or even close scrutiny of claimed success rates, because IVF is relevant to a particularly desperate population. However, should that mean licensing every routine IVF cycle? No, although I would still argue that some of the newer approaches should be licensed and that there should be no diminution of the regulation of research.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

The hon. Gentleman is making a respectable case for having no regulation. I do not happen to agree with him, but surely the hon. Members for Boston and Skegness and for Salisbury need to address the point that the principle of regulation is that its costs are recouped from those who are regulated. That has been an absolute principle of all the relevant legislation since 1990. Not liking the fees is one thing, but a case has not been made for why we should deviate from the principle of regulation.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West & Abingdon, Liberal Democrat)

I made that point at the beginning. If we believe that IVF should be regulated, we must have a way of paying for it. I am making the point that it should be deregulated. However, given that there is regulation, and that the Select Committee did not win the argument on that point, the Government’s structure is a reasonable approach. That is the only reason why I do not plan to support the amendment. A better approach would be to deregulate. Although there will, of course, be sensitive issues and a need for special provisions when we discuss the next Bill, I hope that this medical treatment, which is now routine and, as far as we know, safe—no less safe than many other medical treatments—will be deregulated.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I am delighted that the amendments have stimulated such a detailed and comprehensive discussion. As my hon. Friend the Member for Salisbury said, there is concern about the issue and the possibility of fees being charged that will impinge on all our constituents.

The point of amendment No. 156 is not to remove the independence of the HFEA but to ensure that there is sufficient scrutiny by those who represent constituents, on whom the level of fees will have an impact. The Minister is not correct to say—I may have misheard her—that all HFEA income is recouped through recharging. It is not. There is a grant aid system, which pays some of the cost. There is no doubt that the Bill has the potential to increase the HFEA’s level of activity and its size. My understanding is that there is no proposal to increase the grant aid from the Department of Health, so the additional income will come from the charging of additional fees.

Of course, I acknowledge that while the Minister is in situ, she will consult the Secretary of State and the Treasury and will not allow the fees to be a revenue-generating exercise, but that may not always be the case. If I were a Minister rather than a shadow Minister, I would ensure that they only covered the costs rather than raised revenue. We must ensure that that happens as part of the Bill, because the 1990 Act, which we are amending, has been in place for 18 years, and we hope that this Bill will be as well. I do not think that the HFEA would have a rigorous and detailed charging regime imposed on it by Parliament, but is right that the HFEA should come to Parliament to justify its fees and the impact that they would have.

If I withdrew the amendment, it would be with some reluctance, so I am not going to do so.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

Just for clarification, do I need to withdraw amendment No. 157 formally?

Jimmy Hood (Lanark & Hamilton East, Labour)

It is deemed as having been withdrawn.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I do not wish to detain the Committee by getting the Minister to tell us verbally what the answers are, but it would help if she could furnish the Committee with the relevant information. Clearly, as we have said, there is concern about the HFEA charging regime and how it might grow. I imagine that people in the HFEA have done projections for the next three years about how they imagine the fee income will grow, how they imagine their expenditure and cost base will  expand, and what those additional costs and expenditures will be spent on. Will the Minister put that information in the public domain, because financial implications clearly arise from the changes proposed in the Bill—particularly if birth registration is changed. As the HFEA grows in its remit, the expectation is that increasing expenditure will be met by fee income. It would be helpful if the Minister could write a letter to members of the Committee or place something in the House of Commons Library on that matter. Doing so would ensure that both the Committee and the wider public have detailed financial information about the proposals on the financing of the HFEA.

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)

I am not quite sure how I can help the hon. Gentleman any further than I already have. The agreements in terms of finances for the HFEA are subject to public scrutiny through the information that it provides. I have said that the HFEA will consult on the level of fees. In addition, the Department would expect the enactment of the Bill to result in the HFEA reflecting on its future requirements and submitting a business case to us on the additional grant aid it might need to deal with the Bill’s implications. A letter would say no more than that until the Government are in a position to say more publicly, because all these matters are about to be consulted on. The fees and the future liabilities will need to be considered in the context of the Bill, which is not yet an Act.

I hear what the hon. Gentleman is saying and I will keep him informed of developments once the Bill is enacted. Until then, I am not able to say a great deal more because the HFEA will have to reflect on the matter.