Human Fertilisation and Embryology Bill [Lords]
Division No. 2]
Question accordingly negatived.
Question proposed, That the clause stand part of the Bill.
Mark Simmonds: 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
Dawn Primarolo: 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 Bills 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.
Question put and agreed to.
Clause 27 ordered to stand part of the Bill.
Inspection, entry, search and seizure
Question proposed, That the clause stand part of the Bill.
Mark Simmonds: Will the Minister help the Committee by saying how many times the powers of entry, search and seizure under warrant have been used between 1990 and the present time, and how many times they have resulted in prosecutions, if any? I think that the powers were granted under section 38 of the 1990 Act.
My understanding is that the clause allows for members of the authority to be in possession of embryos, gametes or human admixed embryos in the course of their employment. I just wondered what that means. Does it mean that members of the authority are allowed to seize embryos, gametes or human admixed embryos from licensed premises as part of their employment or that they can hold them separately in a different function? Will the Minister also confirm that this is only the case if the cells have been seized?
It would also be helpful if the Minister explained, in the context of the clause, the procedure for informing donors and owners of these embryos and gametes that they have been seized, and if she described the methods and places for their storage to prevent degeneration and loss. As well as seizing property, gametes and embryos from licensed premises, can the authority take control of a facility where it believes somebody has broken the clauses of the licence?
Dr. Harris: I want to raise the unfortunate recent case of Dr. Taranissis clinic and the HFEA. My understanding of the clause and new schedule 3B is that this is a significant move. It must be done carefully and not carelessly. In the Taranissi case, the appropriate steps were not taken when a sudden inspection entry involving search and seizure took place. It was unfortunate that it happened with television cameras from Panorama present down the street.
I am sure the Minister would agree that the clause covers a serious business and that inspections should not be carried out for the implied benefit of the media. The HFEA, which gets a lot of unfair criticism, should not be using its powers to have a public relations exercise to show Panorama, the BBC or any other broadcaster or media that it is being tough. The powers that it has speak for themselves. Implemented responsibly, they can do the job. I hope that the Committee agrees that there should be no repetition of that media circus in these matters. The HFEA was in court and had to settle a significant sum of money at the public expense for using the powers inappropriately.
Dawn Primarolo: Two sets of questions have been raised. The hon. Gentleman raised the Taranissi case and whether the current powers are being used correctly. The hon. Member for Boston and Skegness asked for clarification.
It is clearly not appropriate for me to comment on the case to which the hon. Member for Oxford, West and Abingdon referred. He speculatesI put it delicatelyas have others, as to whether the powers of the HFEA, which I think he accepts are appropriate in the circumstances, were used appropriately in that case. That continues to be debated. The hon. Gentleman does not raise questions about the inappropriateness of the 1990 Act, as amended by this Bill, but he does raise issues that the HFEA needs to reflect on. The HFEA is following these proceedings carefully, and I am sure that it will note the points raised.
The requirement to inspect licensed premises at least every two years was set out in regulations under a European Union directive. Previously, the 1990 Act had provided for inspection every year, although that requirement could be waived by a licence committee, if the authority considered an inspection in that year to be unnecessary. All this clause does is bring those requirements for inspection, entry, search and seizure in line with the changes that the Bill makes regarding electronic records. It means that there is a regulating power to ensure that the legislation is future-proof. That power will enable the Secretary of State to specify what information should be contained in the appropriate statement given to a person on the premises during the execution of a warrant. The requirements and what actually happens are not being varied from the principle.
The hon. Member for Boston and Skegness asked for details of specific seizures or caseshow many times and where. I cannot remember what time period he asked about. I am afraid that I will have to write to the Committee with those statistics, as I do not have them to hand. He then asked what the possession of gametes means. It means that in the course of duty, HFEA staff could seize embryos but would not be exempt from needing a licence in other circumstances. As I tried to explain, we are bringing the new provisions in line with the existing framework.
The hon. Member for Oxford, West and Abingdon raised questions on a particular case, and while it is entirely inappropriate for me to comment on it, I will perhaps see, having consulted the HFEA, whether I can put in writing to the Committee something helpful with regard to the interpretation of its powers.
Question put and agreed to.
Clause 28 ordered to stand part of the Bill.
Schedule inserted in the 1990 Act as Schedule 3B
Question proposed, That the schedule be the Fifth schedule to the Bill.
Mark Simmonds: I have a couple of questions about the schedule, which provides detail on inspection, entry, search and seizure. First, are the premises searched and the dates on which they are searched publicised? Is it public information? Is compensation paid if search and seizure has taken place but there was no prosecution or variation in licence? That is one reason why I asked a little earliera question that the Minister could not today answerhow many seizures have taken place since the 1990 Act came into force.
Secondly, how much notice, if any, needs to be given for entry under the schedule, or is it merely random, with those doing the inspection turning up as and when they see fit? Indeed, it may be sensible for someone to be there to demonstrate that there is nothing wrong or untoward with the licence.
If my understanding is correct, provisions in earlier parts of the Bill allow third parties to be contracted by the HFEA to enter and inspect premises under the schedule. Will permission need to be granted by the authority for those arms length bodies to undertake that work in individual cases, or will it be a block contract, with the bodies inspecting on behalf of the HFEA acting on their own discretion?
The Minister answered my question about two years, but I want clarification of a further matter in relation to paragraph 7(1)(a) to proposed schedule 3B about seizure in the course of inspection. I am puzzled as to why the HFEA or a body acting on its behalf would want seize anything when granting a licence or varying a licence at the request of a person who already has one. I understand why seizure might be applicable in revocation or suspension cases, particularly if it is to be used for evidence for the proceedings detailed in paragraph 7(2) to proposed schedule 3B.
Dawn Primarolo: We covered the question of qualified inspectors not directly employed by the HFEA in a previous debate, and what they would inspectthe laboratories and equipment, rather than some of the other issues. It would be necessary for that person to be a qualified inspector.
As for periods of inspection and notice of inspection, I do not have information to hand on that; it operates at present, and as far as I know we have not had any problems. However, if the evidence justifies it, we need to allow for spot inspections. I shall need to include that in the letter that I have written to the hon. Gentleman; it will be a subset. He asked whether details of seizures will be made publicperhaps on the HFEA websiteand if there is no such obligation, why not. There may be some caveats, so I shall certainly write to him on that.
The last point raised by the hon. Gentleman was about compensation when a search has taken place. No provision has been made for compensation. The whole point is that those making inspections and seizures under the 1990 Act should act reasonably. That means within a certain time, and it also requires a reason for the inspection. All that would have to be demonstrated, and I will put that into the letter too.
This regime has worked well. The hon. Gentleman will need to be satisfied when I give him the details of how many revocations there have been and how many inspections have resulted in revocation, but I say to him that the whole point of the regime is that it does not need to be used often and in the period since 1990apart from the required inspectionsthose spot inspections or seizures have not been used often. I hope that I will be able to reassure him and other members of the Committee on that in writing.
Mark Simmonds: I am grateful to the Minister for that answer. Perhaps she could add to that list of paragraphs in the letter that she is going to write a brief explanation of the last point that I made regarding paragraph 7(1)(a). In other words, why is it necessary to have as grounds for the seizure the purposes of the authoritys functions relating to the granting or variation of a licence, which would include the variation of a licence at the behest of a licensee? I cannot think of any situation where anything would be seized in those circumstances.
Question put and agreed to.
Schedule 5 agreed to.
Offences under the 1990 Act
(10B) It is a defence for a person (the defendant) charged with an offence of doing anything which, under section 3(1) or (1A), 4(1)(a) or 4A(2), cannot be done other than in pursuance of a licence, to prove that at the material time the defendant believed on reasonable grounds that what they did was not something to which the Act applied..
This amendment, which deals with a potential new defence under the clause, is a probing one that tries to clarify what will happen in the new situation. The problem is caused by the new definition of an embryo, which clearly has been decided already during the procedure and has been debated in this Committee. It is now accepted that that issue will not be re-opened, and that an embryo is as defined at the beginning of the Bill, in clause 1. It must be recognised that that is a new definition that, from enactment, will capture issues that are not currently captured, and which are therefore not subject to regulation and do not require licences. As a consequence, the criminal law will be brought into new areas.
That creates a new problem: due to the nature of science, it is not entirely clear when something might be defined as an embryo under the Bill. We touched on that problem when we debated the clause in question, and following an exchange that I had with the Minister, it was covered in a letter that was sent to you, Mr. Hood, your co-Chairman and members of the Committee. That letter makes it clear that there is, as far as researchers are concerned, a particular problem.
I shall set out briefly the problem that might require defence. I draw attention to the fact that it was first raised in the House of Lords, following representations made in a briefing to all relevant peers by the Academy of Medical Sciences, the Medical Research Council, the Law Society, the Wellcome Trust and the Association of Medical Research Charities. That briefing set out the problem in relation to the amendment, which I have re-tabled to try to take the debate on. The briefing states:
Embryos are broadly defined under the Bill to include an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo. Gametes are also broadly defined to include germ line cells at any stage of maturity. Our understanding
that is, the scientists or sciences understanding
of the processes by which eggs develop into embryos and cells develop into germ line cells is incomplete. It is therefore possible that a researcher could store or carry out research on cells that are not currently known to be or destined to become germ line cells, or could carry out research on eggs that are (unknown to current science) capable of resulting in an embryo.
The argumentthe thrust of the amendmentis that it should be a defence for a researcher if they can prove that they reasonably believed that what they stored or were creating was not a gamete, embryo or interspecies embryo as defined in the Bill. Of course, the researcher would have to cease their activity, seek a licence or destroy the material as soon as it became reasonably clear that that was necessary.
There is an analogous defence in the Human Tissue Act 2004, which the Minister in the other place mentioned in the debate on the amendment. She said:
The noble Lord, Lord Patel, said that the Human Tissue Act had a similar defence and asked why it was not appropriate for the Human Fertilisation and Embryology Bill also to have a similar defence. Although this is a defence under the Human Tissue Act, the activities that require a licence under the Human Fertilisation and Embryology Act 1990 relate to the handling of human embryos and gametes, and the sensitivity of these activities means that it is imperative that scientists are aware of whether their activities require a licence under the Act.[Official Report, House of Lords, 28 January 2008; Vol. 698, c. 469.]
That is true, but I do not believe that it answers my point. We are not talking about a defence based on ignorance of the law, and it is unfortunate that that did not come across clearly in the Lords debate. Unquestionably, researchers in the field know what the law is and that an embryo that is createdthat outcome is likely or at least possiblepredictably and reasonably comes under the Act. This is about the uncertainty of the law, not the science.
Clearly, such a defence was felt necessary for inclusion in the 2004 Act, which also dealt with sensitive matters. It therefore seems reasonable to include a similar, if narrower, defence in the Bill if we accept that there is a problem.
I should set out the circumstances in which such a defence could be required. Again, I am grateful to the Newcastle scientists for meeting me last night to provide me with more specific information. They said that several centres in the UKthe problem is not rareare carrying out in vitro research on human eggs with the approval of a research ethics committee but not under an HFE licence, which is unnecessary because regulations under the HFEA exempt such research unless the eggs are fertilised or stimulated specifically to develop into an embryo. Lord Patel pointed that out in the Lords debate, and Mary Herbert, who is an expert in meiosis at the North East England Stem Cell Institute, has confirmed that although it is rare, the division of an egg cannot be ruled out because it may occur spontaneously and unexpectedly. There is no intention to create an embryo, but it is possible that any cultured egg may divide parthenogenetically; very occasionallythis is the pointthe cell may continue to divide to a two-cell stage with a full set of chromosomes.
It is the view of those scientists and the Government that such an entity would be covered by the definition in clause 1. Therefore, an offence would in theory have been committed if such a thing occurs in an unlicensed laboratory. Will all research on eggs in vitro require a licence to avoid the problem? Are we unravelling the whole point of the regulations made under the 1990 Act shortly after it was passed that allowed gamete research to continue without a licence, as it does?
It is important to give one example of the work specifically concerning the investigation of the meiosis process, because it is ongoing. Meiosis is the division of chromosomes in the egg immediately before fertilisation, so that the number of chromosomes is reduced by half. Errors occurring during meiosis result in miscarriage and cause congenital abnormalities such as Downs syndrome. The studies involve measuring proteins and other molecular signals within an egg as it undergoes meiosis. Research on how to store the eggs of young women to preserve their fertility before chemotherapy is another example.
In our exchange, which I shall not repeat, the Minister said that either embryos should be licensed or that the eggs that this might happen to should be destroyed, but her letter was clear. It is important that we recognise what it said. The Governments letter to the Committee said that
eggs can spontaneously activate and begin to divide without having been fertilised...It is highly unlikely that a human parthenote could implant and/or develop into a baby. However they do divide for several days in vitro allowing some research to be carried out on them.
That would be research under a licence, because it would involve a parthenogenetic embryo. However:
As well as occurring spontaneously, it is possible to stimulate parthenogenesis by exposing eggs to a specific chemical or by stimulating them with an electric shock.
Again, that would require a licence under the Bill, which is fair enough, because one anticipates that that sort of thing will continue. The letter said that such embryos would be covered by the definition, and went on to say:
As far as we understand, there are very few research projects involving human eggs which do not involve fertilisation of the eggs. The majority of research on eggs would involve creating an embryo, and therefore would require a license from the HFEA. However, we accept that where there was non-licensed research on eggs being carried out, there is a possibility that an egg may spontaneously begin to divide.
The Human Fertilisation and Embryology Act 1990 states that you cannot bring about the creation of an embryo in vitro without a license from the HFEA. Therefore, if a researcher were concerned that this might not be the case, they would need to obtain a license. The Bill does not change this position.
I do not seek to argue with the letter; I am just setting it out to save time. The Bill changes the position. There was some doubt before, but now it is clear that spontaneous parthenogenesis, because it involves the creation of an embryo, albeit not deliberately, would require a licence. Is it the Departments advice and the HFEAs likely advice that anyone culturing eggs in vitro, even if there is no intention of stimulating them or creating embryos, will require a licence?
If that is the case, certainty is needed about it, or researchers may believe that even if it is not their intention, the research ethics committee does not feel that it is a possibility and they do not publish anything about parthenogenetic embryos, they may still be liable for a criminal offence. Although they may be able to not have a problem, as it were, now that the matter has been raised in the House of Lords and here, it is important to be absolutely clear for those researchers and to realise that there will be more research licencesand, pursuant to previous debates, more income for the HFEAand an increase in regulation. I look forward to the Ministers response.
|©Parliamentary copyright 2008||Prepared 11 June 2008|