Clause 60
Human Fertilisation and Embryology Bill [Lords]
Public Bill Committees, 12 June 2008, 1:30 pm

John Pugh (Shadow Minister, Treasury; Southport, Liberal Democrat)
I beg to move amendment No. 152, in clause 60, page 50, line 1, leave out from (2) to end of line 2 and insert
after or human embryos, insert but includes human admixed embryos..
I move the amendment on behalf of the right hon. Member for Coatbridge, Chryston and Bellshill (Mr. Clarke). It would incorporate human admixed embryos into the definition of genetically modified organisms in the Environmental Protection Act 1990 as organisms that need to be regulated in case of any foreseeable danger to the environment or dissemination of dangerous developments. Clause 60 specifically excludes human admixed embryos from the Act. Part 6 of the Act, which deals with genetically modified organisms, states that it exists
for the purpose of preventing or minimising any damage to the environment which may arise from the escape or release from human control of genetically modified organisms.
Section 106(2) says:
In this Part the term organism means any acellular, unicellular or multicellular entity...other than humans or human embryos.
As I understand it, clause 60 adds to that or human admixed embryos. The amendment would change the wording to read:
In this Part the term organism means any acellular, unicellular or multicellular entity...other than humans or human embryos but includes human admixed embryos.
The rationale came as much as anything else from that august body the Select Committee on Science and Technology. When it recognised the possibility that new diseases could arise from mixing human and animal material and recommended cytoplasmic hybrid embryos, it said:
In the event that research using cytoplasmic hybrid embryos is authorised, we urge the Government to ensure that appropriate risk management procedures are established and implemented.
The Government responded:
The Government agrees with the Committee that researchers will have to apply appropriate risk management procedures for research that involves the mixing of human and animal materials. We will keep the current procedures under review.
What we are looking for in this probing amendment is recognition from the Government that they have considered all possible safety concerns and whether the Environmental Protection Act 1990 is the appropriate vehicle for addressing them.
The Science and Technology Committee received submissions from the Scottish Council on Human Bioethics, which told us that by undertaking such work, scientists risk creating new diseases and that it is
well known that many animals may harbour in their organs, cells and genome, microbiological and other entities which may cross the species barrier and develop in the host.
Given their concerns and those expressed by the Select Committee, the amendment is a probing one designed to find out whether the Government have taken those concerns on board, particularly as we all recognise, having read the legislation, that human admixed embryos is a fairly wide category.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West & Abingdon, Liberal Democrat)
As a member of the Science and Technology Committee that compiled the report, I can say that the quotes are correct. However, I would interpret the report slightly differently from my hon. Friend. We cite, as Select Committees do, evidence that we receive. The only evidence that we received on this pointI remember reading itwas from the Scottish Council on Human Bioethics, which is a mixed body. The council is not exclusively religious, but it is not recognised as a body that has the status of a peer review scientific or academic organisation. We noted what it said, but we did not share its conclusion. Its conclusion was that much stronger restrictions were needed. We merely pointed out a statement of the obvious, and the position was shared by the Academy of Medical Sciences. The academys report says that there needs to be risk-management procedures appropriate to the status of the scientific knowledge about the risks. There are already those procedures in labs and we welcomed the Governments response on that. Again, we stated the obvious, that there needs to be risk management. I share my hon. Friends view that this should be a probing amendment because whatever the risk management procedures are, treating this as a genetically modified crop does not seem to be the appropriate practical measure and runs the risk of allowing other people to argue that the issue is being trivialised, which is not the intention.
As far as I am aware, environmental release of human admixed embryos is not envisaged in any laboratory. While I am delighted that the Science and Technology Committee report has been citedand cited accuratelythe conclusions that my hon. Friend draws are not necessarily the ones that we would need to draw.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)
Despite the disparity of interpretation of the Select Committee quotes by the two hon. Gentlemen, can the Minister clarify whether this amendment, if it were to be included in the Bill, would undermine the special status of the embryo, which is the cornerstone of this particular piece of legislation?

Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)
Let me answer that question. Yes, it would undermine the legislation, and I shall explain why. It conflates two different issues. Genetically modified human embryos are presently excluded from regulation on genetic modification of organisms in the Environmental Protection Act 1990. The 1990 Act regulates the use of genetically modified organisms for the purpose of preventing or minimising any damage to the environment, which may arise from the escape or release from human control of genetically modified organisms.
The hon. Gentleman asked whether an embryo or human admixed embryo could cause damage to the environment if it was released. The answer is an unequivocal no. A pre-14-day embryo would be incapable of entering into the ecosystem as it would be insufficiently developed to survive. However, safeguards are provided. Clause 60 ensures that genetically modified human admixed embryos are excluded but that they are properly regulated in protocols and research laboratories with regard to their disposal. The clause prevents dual regulation that is not necessary and ensures that the HFEA requires centres to have a documented procedure for disposal of embryos, which is appropriate and takes into account the special status of human embryos. Therefore, it is a different set of requirements. I hope that I have clarified why we do not need the cross reference. I trust that the hon. Member for Southport is satisfied by my explanation and will withdraw the probing amendment.
