Clause 1

Part of Human Fertilisation and Embryology Bill [Lords] – in a Public Bill Committee at 10:45 am on 3 June 2008.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health) 10:45, 3 June 2008

The drafting and the consultation about updating the legislation worked from the 1990 Act. During the passage through Parliament of the Bill that became that Act, the point at which the regulation of a human embryo should begin was discussed extensively. As a result, the Act provides that it should begin at the initiation of the process of fertilisation, rather than at the point at which the embryo reaches two cells.

To answer the point raised by the hon. Member for Boston and Skegness about the definition of fertilisation, the 1990 Act did not seek to define fertilisation. It was felt that that was a common term used in biology and that the HFEA should make a decision about the term and what it meant within legislation. As he pointed out in his opening remarks on the probing amendments, that Act has stood us in good stead and works. That is a specific answer. We sought to ensure that we were maintaining the position by keeping the wording that an embryo includes

“an egg that is in the process of fertilisation”.

The Science and Technology Committee stated in its 2005 report “Human Reproductive Technologies and the Law” that the definition of an embryo should be changed to begin only at the two-cell stage. That was based on concerns that research might be restricted into the treatment of mitochondrial diseases. Those concerns have been met in the Bill, first through the definition of “embryo”, as it now includes any human embryo created by any process, not just fertilisation, and, secondly, by removing the prohibition on the genetic modification of an embryo for research. Mitochondrial disease research has already been licensed by the HFEA and the changes in the Bill bring  further clarification on that matter. That answers the point with regard to legal cases.

We seek to put the position beyond doubt by ensuring that it is reflected in legislation, rather than dealt with by reference to a court judgment. I appreciate that these are probing amendments, but they would reverse the position outlined in the 1990 Act, so that, for the purposes of the legislation, an embryo would not come into existence until the two-cell stage—the point at which the nucleus of an embryo fully forms for the first time. They would, in effect, remove single-cell embryos from regulation, meaning that the creation, keeping, storage and use of single-cell embryos would fall outside the law.

Research on single-cell embryos could then be undertaken without a licence, provided the cell did not divide, and it has clearly been the view of Parliament that we cannot allow the creation, keeping, storage and use of single-cell embryos to fall outside the law. These embryos should be regulated in the same way as embryos at the two-cell stage or later. The Government’s position is therefore that the existing principle, which remains unchanged since it was formed in 1990, should be upheld.

The definitions of “egg” and “sperm” in clause 1 are of equal importance to the Bill and to the HFEA, because terms such as “gamete”, “sperm” and “egg” are vital in setting out the authority’s regulatory remit. While we are often clear about what these terms mean from a biological point of view, definitions can be interpreted differently in the context of legislation. These definitions are designed to set out an effective remit for the authority, clearly indicating what biological material it regulates. How are we to make sure that biological definitions can be interpreted through a regulatory framework? That has always been the challenge. It was the challenge faced by the Committee that considered the 1990 Bill, and, as the hon. Gentleman rightly said, the resulting Act has stood us in good stead.

The definitions of the terms “gamete”, “sperm” and “egg” were drafted to include cells of the germ line at any stage of maturity, and it should be noted that the wording of this provision follows the precedent of section 3A of the 1990 Act, which was inserted by the Criminal Justice and Public Order Act 1994 and ensured that female germ line cells taken from an embryo or foetus could not be used in treatment.

The Bill is drafted to include germ line cells to ensure that the storage and use of ovarian tissue containing immature egg cells to create embryos is regulated by the HFEA and that, following maturation in the laboratory, any egg produced can be used in treatment. It also sets out a prohibition on placing anything other than a permitted egg, sperm or embryo into a woman, and so it is important that the definition of “gamete” includes immature cells of the female germ line. This ensures that the use of in vitro maturation within the context of assisted conception treatment is regulated and permitted. I am sure the hon. Gentleman understands that this is particularly important for women who are undergoing chemotherapy or radiotherapy and will lose their future fertility. Freezing mature eggs is difficult and often unsuccessful, whereas freezing ovarian tissue containing immature eggs is much more reliable.

The legislation that deals with these difficult and complex areas needs to be as clear as possible to ensure that the legality of complex reproductive medicine is equally clear. The clause as it stands ensures clarity around the regulation and use of single human embryos and immature eggs and sperm, making it clear that single-cell embryos fall within the authority’s remit and that immature gametes may be matured in the laboratory and used in treatment.

If the amendments were made, clarity would be lost and single-cell embryos would fall outside regulation. The law would, at best, become uncertain and, at worst, prohibit the use of immature eggs and sperm in reproductive therapies. In trying to address what were the difficult challenges in 1990, the Government have listened very closely to the evidence presented and to debates about the Bill in another place. We have proposed the wording as it stands. I assure the hon. Gentleman that the Government seek to continue to regulate and enforce according to the principles of the 1990 Act, which I know that he and many of his hon. Friends support. I hope that he accepts that his probing amendment has secured comments on the record for clarity and that he will withdraw it at as suitable time.