Question
To ask Her Majesty's Government what measures the Department of Health intends to take to address the comments of the Merits of Statutory Instruments Committee in its 21st Report (HL Paper 118) about the quality control system for drafting statutory instruments in the department; and how they propose to address the committee's observation that the drafting errors might have been identified at an earlier stage if the department had put the proposal out for public consultation.
Answer
The draft Human Fertilisation and Embryology (Special Exemption) Regulations 2009 will replace the Human Fertilisation and Embryology (Special Exemption) Regulations 1991. The regulations have been updated to take account of the changes made by the Human Fertilisation and Embryology Act 2008 (the 2008 Act), specifically to the definition of embryo and the introduction of human admixed embryos. The regulations themselves do not introduce any new offences or new policy. The regulations are simply being remade in consequence of amendments made by the 2008 Act. The Human Fertilisation and Embryology Act 1990 Act prohibits storage of gametes and creating, keeping or using embryos without a licence. This key principle has been retained by changes made by the 2008 Act. There are two exceptions to this that were set out in the 1991 regulations. The same two exceptions have been retained in the updated regulations. The regulations do not remove the requirement for a licence to create or use and embryo. The first exception relates to the keeping of gametes or embryos in connection with an investigation or proceedings relating to an offence under the 1990 Act. This power to provide for such an exception is set out on the face of the 1990 Act. It refers only to gametes and embryos, not human admixed embryos, so there is no scope for the regulations to provide for this. If such circumstances arose, the human admixed embryos could be kept as evidence at a centre that had a storage licence. It does not alter the principle that no person may create, keep or use a human admixed embryo without a licence or mean that the HFEA would not investigate thoroughly any suspected offence under the 1990 Act. Earlier this year the department consulted on four sets of regulations in connection with the implementation of the Human Fertilisation and Embryology Act 2008. However, the department did not consider it necessary to specifically consult on the Human Fertilisation and Embryology (Special Exemption) Regulations 2009 as they do not represent a change in government policy. The changes made to these regulations were consequential to changes in the Human Fertilisation and Embryology Act 2008. There was extensive consultation, scrutiny and debate on the changes in the Bill leading to the 2008 Act, which these regulations reflect, during the passage of the Bill itself. However, we do regret that it was necessary to re-lay the draft special exemption regulations. We note the Merits Committee's acknowledgement that the department acted quickly to correct the draft regulations and we will look at any lessons learnt from the laying of these regulations.