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

I beg to move amendment No. 39, in clause 12, page 8, leave out line 31 and insert—

‘(1) Section 12 of the 1990 Act (general conditions of licences under that Act) is amended as follows.

(2) In’.

Roger Gale (North Thanet, Conservative)

With this it will be convenient to discuss Government amendments Nos. 40 to 43, 106, 108 and 115 to 117.

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

I was looking for clause 11, Mr. Gale—it has been rather a long afternoon already.

During the passage of the Bill through another place, a debate took place on the use of embryonic stem cells derived under research licences in therapeutic applications. The Government subsequently wrote to all peers involved in that debate setting out how, in the Government’s view, embryonic stem cells derived under an HFEA research licence could be used in therapeutic applications. The amendments are consequential to the  Government’s taking that view in another place. They will ensure that research centres deriving embryonic stem cells that are intended for therapeutic use are required to abide by the quality and safety standards set out in the European tissues and cells directive, in relation to stem cells and the embryos from which they are derived.

The directive lays down standards of quality and safety for human tissues and cells intended for human application, including gametes and embryos. The relevant requirements already apply to embryos used in reproductive treatment under the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. Stem cells derived from embryos are also regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. It is important that those standards are applied also to the embryos used to derive stem cells in human applications in order to ensure the necessary levels of quality and safety of tissues to be used in treatment.

I commend the amendments to the Committee.

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

I am grateful to the Minister for introducing this batch of amendments. I have one or two queries. I understand the logic of what she said, but there is no mention anywhere else in the Bill of therapeutic applications for humans. Indeed, on the Floor of the House I and the hon. Member for Oxford, West and Abingdon tabled separate amendments and new clauses to allow licence for therapies to take place, but they were rejected by the Minister.

It would be helpful if the Minister were to explain the wording used in the letter that she kindly sent Committee members. How does the phrase

“intended for non-reproductive therapeutic application for humans”

fit in with her view that she will not allow licences for therapies in the Bill? That letter then refers to

“Directives on safety and quality of cells and tissues for human applications”

and “the relevant requirements”. What are the relevant requirements to which the Minister refers? The letter refers euphemistically to “these safeguards”. Will the Minister explain what they are?

After the debates in the other place, I initially thought that the application of the EU directive did not apply to non-medical fertility services. However, the Minister has confirmed today that it does apply to them. Will she clarify that matter? Does it also cover the provision of gametes for such purposes for both non-medical fertility services and non-reproductive therapeutic applications?

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

I seek your advice, Mr. Gale. I think that the last two important questions raised by the hon. Member for Boston and Skegness, were clause stand part-type questions, because the deletion of the exception for non-medical fertility services is already in clause 12. We are debating, initially, additional amendments to that. Will you let me know shortly whether you wish me to deal with my questions around non-medical fertility services?

The hon. Member for Boston and Skegness has raised an important issue. I am aware that we cannot really reopen the question of licences for therapy at this stage, but, as he said, the issue involves stem cells intended for non-reproductive therapeutic applications to humans. My question for the Minister is simple. Would that cover non-research applications to humans, or would that always cover research applications for the lifetime of the Bill? If it includes non-research applications, then further questions are raised about whether the Government are right to be confident that any applications of stem cells derived from embryos created under a licence could be created under a licence for research, because there will always be research involved in the process? We cannot reopen that discussion here, and I am not proposing to, but it would be helpful for the Minister to clarify her view. Would those non-reproductive therapeutic applications to humans apply to non-research applications? Does her definition of research apply to clinical trials? That is one understanding—research carried out under a research ethics committee approval, with a clear protocol. Or is research to be read more widely—some would say much more widely?

I will make two more points. It is important, looking at the 1990 Act as amended, that the safeguards apply here. The safeguards referred to include the transfer of money and information and maintaining proper records. The clause is important, therefore, because those are the general conditions of licences.

My second question I cannot remember. I might seek to intervene on the Minister, if it occurs to me.

Roger Gale (North Thanet, Conservative)

Order. I indicated earlier that, in principle, I was perfectly happy to have a stand part debate at the start rather than at the end. For that reason, given that it is often easier to take matters in context, I am perfectly happy to allow the debate now. If the hon. Gentleman wishes to add to his remarks, please feel free to do so.

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

On the issue of non-medical fertility services, I think that what the Government are doing in the clause is removing the exception for such services from the provisions. The tissue directive and indeed the European Communities Act 1972 section 2 process did not permit the Government to apply the licence conditions that we see in the clause to non-medical fertility services.

What are non-medical fertility services? They are defined in section 2 of the Act as

“any services that are provided in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services.”

It would be useful for the Committee to know what are not the “medical”, which I guess is using drugs, “surgical or obstetric”, which speak for themselves, “services” that will be covered by the general licence conditions, which are extensive. How have we survived for so long under the 1990 Act with non-medical fertility services—my reading of the measure might not be correct—apparently not subject to the licence conditions? To put it another way, will the Minister assure us that this is not a discretionary regulation and, even if it is, that it is not over-regulation of services that would not necessarily require regulation by the HFEA? There is a general trend that as soon as an  authority is regulating things, it wants to continue regulating them and identify new things to regulate. It is sometimes the job of Parliament to retreat from that trend. [Interruption.] The ironic laughter of the hon. Member for Norwich, North reminds me that a number of Select Committee reports, particularly the report that came out under his chairmanship in 2005, argued that it was time that the HFEA did not regulate basic fertility treatment because it is now pretty standard. It is useful to collect information, but is it right that licensable matters are subject to all such regulations, while, for example, surgery to remove the blocking of fallopian tubes to treat infertility continue to be completely unregulated by the HFEA? Such treatment is currently subject to all the other regulation that currently binds doctors. That is a wider issue, but I have been provoked by the inclusion of non-medical fertility services in the scope of the licence conditions in the clause.

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

Can I reassure the hon. Member for Oxford, West and Abingdon that he should not be provoked by the use of the term

“non-medical fertility services”?

He asked me what they might be: essentially, the measure is about internet sperm delivery services—he may have mentioned those. They have to be described as “non-medical” in case any attempt is made to deliver services other than via the internet, which currently happens, apparently.—[Interruption.] Perhaps I should have used a different phrase.

Moving on, I should explain why the amendments are necessary, which will answer the point made by the hon. Member for Boston and Skegness. The quality and safety standards that are set out in the EU directive are aimed at preventing the transmission of disease from donor to recipient of tissues or cells. Two separate points were made and I do not want to lose the distinction. The EU directive requires that provision is based on the safety and quality of services, and that consent is obtained. That is the set of issues to which the amendments relate.

The second set of issues relate to therapeutic services. The Government believe that the measure applies to research only. Our view is that, under a research licence, an embryo can be used to derive stem cells for human application as long as it can be shown to be part of a project of research. The amendments would introduce a requirement to comply with the directive that is aimed specifically at the limited area of quality and safety, as I described. Two separate issues were conflated by my use of the word “therapeutic” in my earlier remarks. However, the issues are not connected. The amendments relate specifically to the directive arrangements.

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

I know what the Minister says, but it shows that the provision of stem cells for therapeutic application cannot be said to be irrelevant to the HFEA or to the Bill. It could be argued that it is a matter for the Human Tissue Act 2004 or the Medicines and Healthcare products Regulatory Agency; that once the cells are used, the embryo is long gone, so it is not a matter for the Bill or HFEA licences. I am keen not to provoke the Minister because we are nearing the end of the sitting, but does she recognise that, even as far as this relatively minor provision goes, when stem cells derived from embryos—not embryos—are put into humans, the licence conditions for the storage, use and creation of the embryo are relevant to the end use, at least in principle? That goes to the question, to which we might return, whether there needs to be greater specificity in other aspects of the licence arrangements for such end uses.

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

Was that an intervention, Mr. Gale?

Roger Gale (North Thanet, Conservative)

Yes, but it was a very long intervention.

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

Yes, and I listened very carefully to it. The Government have not said that the provision of stem cells for therapeutic application is irrelevant to the HFEA. The issue, which we discussed on the Floor of the House, is whether therapy licences are necessary. It is a separate issue. I can see the tenuous link that the hon. Gentleman is trying to make, which is why I was careful to anchor my comments by saying that we are talking about research for therapeutic services, not the therapies themselves. We had a debate on that on the Floor of the House, as I said. I have concluded my remarks on that and I hope that they were helpful to the Committee.