LEGISLATION .sx Rights , Restraints and Pragmatism :sx The Human Fertilisation and Embryology Act 1990 .sx Jonathan Montgomery .sx The Human Fertilisation and Embryology Act 1990 represents a milestone in biomedical regulation .sx Not only does it finally bring to fruition the long running government discussions about the proper limits of reproductive science , it also provides the first attempt in English law to provide a comprehensive framework for making medical science democratically accountable .sx Its interest therefore arises both from the solutions it adopts for particular issues and from the model of regulation on which it builds .sx If the licensing authority which lies at the heart of its provisions proves successful , it is likely to be replicated in the oversight of many controversial areas of medical progress .sx The 1990 Act is also significant as a model for establishing a workable compromise between incompatible ethical positions .sx The issues underlying the provisions of the Act are not ones on which a consensus exists within our society .sx This resulted in an unusual Parliamentary history .sx The Bill was introduced into the House of Lords as a Government Bill but was mostly unwhipped and it contained alternative versions of the crucial clause dealing with the permissibility or otherwise of research on human embryos .sx The original text of section 11 provided both an absolute prohibition of embryo research and a provision permitting the licensing of such research together with the proviso that both clauses could not be in force at the same time .sx Thus , while the Government was clear when it introduced the Bill that legislative provision had to be made , there was less clarity as to the content of that provision .sx The uncertainty extends back beyond the drafting of the Bill itself .sx The Committee of Inquiry into Human Fertilisation and Embryology ( the Warnock Committee ) received representations from the public , deliberated the issues and reported in 1984 .sx Yet this was felt to be insufficient consultation and a second document to elicit comment was published in 1986 .sx Only after this second consultation did the Government feel able to publish its own proposals in a White Paper .sx The primary reason for this reticence was the reluctance to deal with matters of conscience as Government proposals rather than by way of private members' bill .sx This in turn springs from the problems of identifying a consensus on such matters .sx In the event , the 1990 Act can be seen as providing an institutional framework in which compromises can be worked out rather than enshrining solutions to the disagreements .sx It is appropriate , therefore , to consider briefly why a consensus has proved so difficult to achieve .sx Behind the provisions of the Act lie at least two issues of principle on which there is wide disagreement and little scope for compromise .sx The first issue concerns the status of the human embryo .sx On the one side stand those who hold that human embryos have the same moral status as mature adults from the time of their conception onwards and that any steps leading to their destruction must be analysed as a breach of fundamental human rights .sx From this standpoint , research must be outlawed unless it can be carried out without interfering with the embryo's development .sx Abortion can only be permissible where it is carried out to protect this same value of human life , that is to save the life of the mother .sx On the other stand those who believe that whatever status should be accorded to the human embryo , it is less than that of mature adults and may therefore sometimes be outweighed by the interests of adults who stand to benefit from research or termination .sx The position of principle taken by the first group prevents compromise because any concession will necessarily be its abandonment .sx Concessions can be offered only as a tactical ploy to secure a regime as close as possible to the ideal .sx Accepting a less absolutist position on the rights of the human embryo does not , however , resolve the issues .sx It is necessary to determine the strength of the claims which are said to outweigh those of the embryo .sx Those who believe that abortion is permissible because the interests of the woman outweigh those of the fetus may still believe that the need for research cannot justify killing an embryo .sx To carry the debate further , it is necessary to consider the strength of the claims to be weighed against those of the embryo/fetus .sx Few would deny that pure research is valuable , but whether it outweighs that of the embryo must depend in large part on the importance of its application and here there is considerable disagreement .sx Research is largely , although by no means exclusively , expected first to improve our understanding of infertility and how to overcome it , and second to help reduce the incidence of genetic disorders .sx The latter issue is difficult enough , raising the acceptability of eugenic approaches to human reproduction .sx On the former there is even less agreement .sx The status of infertility raises the second of the major background issues to the 1990 Act on which consensus is absent .sx Much rhetoric has emerged under the slogan of 'the right to reproduce' but the concept remains an obscure one .sx It might refer to a range of claims .sx It can refer to no more than the negative right no to be robbed of the capacity to procreate without just cause .sx At the other extreme it might be said to entail a duty on the state to provide services to help overcome infertility .sx Between these two versions of the right is a claim that the state should facilitate assisted reproduction by removing any rules of law which prevent individuals taking steps to overcome their inability to have children .sx The Human Fertilisation and Embryology Act 1990 says nothing about claims of the first two types , but goes some way towards meeting the third type of claim in the new status provisions , which permit some of those who use assisted reproductive techniques to be defined in law as parents ( see below ) without recourse to a court .sx The strength of claims based on a right to reproduce depends on the way in which infertility is classified .sx If being infertile is to be ill , then overcoming it can more easily be said to be a state responsibility .sx The National Health Service Act 1977 creates a duty to provide services for the diagnosis and treatment of illness ( section 3 ) and defines " illness " as " any injury or disability requiring medical or dental treatment or nursing " ( section 128) .sx Yet ( like kidney dialysis ) infertility treatment does not cure the underlying problem , but rather overcomes some of its effects .sx The question is :sx how important is it to overcome them ?sx In the view of some it is a low priority and cannot outweigh the interests of embryos :sx " Infertility is a grief , not a disease .sx Those who suffer it are not in pain and are not ill .sx " Assessed subjectively , however , infertility may be experienced as an extreme deprivation , particularly in the face of a culture which regards a childless woman as incomplete .sx These background issues are ones on which society is deeply divided .sx In passing the 1990 Act , Parliament could have sought to resolve them , but it will be argued here that the bulk of the provisions of the Act do not provide answers to the questions , but set up a forum in which they can be debated .sx Some parts of the Act prohibit certain types of research activity outright , the amendments to the Abortion Act 1967 alter the protection offered for the human fetus and the status provisions do promote assisted reproduction in some circumstances .sx These provisions can be seen as resolving debates , but at the heart of the Act is the new statutory licensing authority .sx Here the provisions do promote activities , but are facilitative rather than prescriptive .sx The balance between the competing views of the underlying issues of principle is left to be determined within the regulatory structure of the authority , it has not been established by Parliament itself .sx A Web of Regulation .sx The nature of the forum in which the debates about infertility treatment and embryo research are to be carried out is structured by a complex web of discretion , restraints , control and accountability .sx The Human Fertilisation and Embryology Authority is to be given powers to oversee the activities of individual health practitioners , and will not be limited to applying standards established by Parliament or government .sx It will be able , indeed required , to develop its own standards of what is acceptable and proper .sx The authority will thus have considerable autonomy .sx It will not be left entirely to its own devices , however , and a series of checks will exist to supervise the exercise of its power .sx At a statutory level the 1990 Act establishes the ground rules on which practitioners and the Authority will be required to operate .sx Section 3 sets out a wide-ranging prohibition on creating , keeping or using human embryos .sx Section 4 prohibits the storage and use of human gametes .sx Exemption from these offences is provided for those who have been licensed .sx Thus , an extensive dispensing power is conferred upon by the Authority .sx It is not unlimited .sx Licences may not authorise keeping an embryo beyond the appearance of the primitive streak , placing a human embryo in an animal or replacing the nucleus of an embryo ( intended to prevent cloning) .sx In addition to these provisions specifying what may not be authorised , the Act also sets down the type of activities which can be licensed ( see Sched 2) .sx These are , however , broadly phrased , and include in relation to treatment " using gametes " and " placing an embryo in a woman .sx " Licences for research must be " necessary or desirable " for specified purposes , but these include " promoting advances in the treatment of infertility " as well as increasing knowledge about the causes of miscarriages and congenital disease .sx These are narrower than the text of the Bill as originally printed , which would have allowed research to be licensed " for the purpose of increasing knowledge about the creation and development of embryos and enabling such knowledge to be applied .sx " However , the purposes for which the Authority can grant licences remain defined only at an abstract level .sx Having conferred this considerable flexibility upon the licensing authority , the Government has also reserved a number of powers to reduce it .sx The boundaries of the power to license may be contracted and expanded by regulations .sx By requiring annual reports to the Secretary of State , detailing both past activities and those projected for the following twelve months , the Act seeks to ensure that the Authority's practice can be monitored ( s 7) .sx The reports are to be laid before Parliament by the Minister .sx Nevertheless , pending the exercise of the power to make regulations , considerable trust is placed in the members of the Authority .sx The Act permits the Authority to exercise a high degree of control over practitioners .sx In addition to the power to grant or withhold licences , the Authority will be able to issue mandatory directions ( ss 23 and 24) .sx Failure to comply with these directions will sometimes constitute an offence ( s 41(2) ) , but will always empower the Authority to revoke a licence ( s18(1)(c)) .sx Secondly , a code of practice is to be drawn up to provide guidance as to the proper conduct of licensees .sx This is less coercive than the power to give directions in that disobedience will not in itself constitute an offence , but it may be taken into account by the Authority when considering revocation ( s 25) .sx In practice , this will make it difficult for practitioners to resist the power of the Authority to make policy on controversial matters .sx The difficulties of the Voluntary Licensing Authority in the face of practitioners who are sufficiently confident of the rightness of their activities to disregard peer pressure should not be repeated .sx This will represent a considerable inroad into such people's clinical autonomy .sx Opportunities to challenge decisions are limited .sx Appeal against refusal of a licence by the Authority's licence committee lies to the Authority and will take the form of a full rehearing ( s 20) .sx However , appeal outside the Authority will be available only on a point of law ( s 21) .sx