Select Committee on Science and Technology Written Evidence


APPENDIX 13

Memorandum from the Lawyers' Christian Fellowship

INTRODUCTION

  This submission is made on the basis of Paragraphs 1 and 4 of the Science and Technology Committee's Call for Evidence in relation to Human Reproductive Technologies and the Law dated 30 March, 2004.

  All statutory references are to the Human Fertilisation and Embryology Act 1990 (the "1990 Act").

  Unless otherwise indicated, all emphasis is added.

EXECUTIVE SUMMARY

  The Human Fertilisation and Embryology Authority ("Authority" or "HFEA") is a public body established by statute to serve the public. However, the HFEA misunderstands its functions, purports to perform functions that are not within the 1990 Act, and indicates that it would like to extend its jurisdiction even further.

  The HFEA may have misunderstood its functions because the wording of the 1990 Act is ambiguous.

  Further, the HFEA's functions under the 1990 Act give rise to conflicts of interest. In particular, the HFEA's function in relation to research compromises its ability to discharge its other functions properly.

  Due to the controversial nature and importance of the HFEA's work, these matters should be addressed as a matter of urgency:

    —  The wording of the 1990 Act should be clarified so that there can be no doubts as to the functions to be performed. These matters should be settled definitively by Parliament and not left to the courts.

    —  These statutory functions should be separated out and performed by separate independent bodies.

    —  There should be independent scrutiny of each new body by way of internal systems supported by independent scrutiny:

      —  Internally, what is required is closer scrutiny at the lowest level possible, and as frequently as possible. Each new body should have a compliance committee comprised of legally qualified members who shall have the responsibility of ensuring that every act has lawful authority.

      —  Externally, each new body should be made accountable to a Parliamentary Select Committee advised by a body whose members have significant expertise in bioethics, law and medicine and are appointed by Parliament.

  This will help to ensure that the public, especially patients and donors, are properly served and protected.

SUBMISSION

The Authority misunderstands its functions and exceeds its jurisdiction

  1.  The Authority is a public body established by statute.[41]

  2.  Section 8 sets out the general functions of the Authority:

    "The Authority shall—

    (a)  keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters,

    (b)  publicise the services provided to the public by the Authority or provided in pursuance of licences,

    (c)  provide, to such extent as it considers appropriate, advice and information for persons to whom licences apply or who are receiving treatment services or providing gametes or embryos for use for the purposes of activities governed by this Act, or may wish to do so, and

    (d)  perform such other functions as may be specified in regulations. [42]"

  3.  Section 25 requires the Authority to maintain a code of practice giving guidance, among others, about the proper conduct of activities carried on in pursuance of a licence under the 1990 Act.

  4.  Section 31 provides that the Authority must keep a register of certain information obtained in relation to activities performed under the 1990 Act.

  5.  Section 11 gives the Authority power to grant licences for treatment, storage and research.

  6.  Schedule 1, Paragraph 2 provides the Authority with a general power to perform its statutory functions:

    "The Authority shall have power to do anything which is calculated to facilitate the discharge of its functions, or is incidental or conducive to their discharge, except the power to borrow money."

  7.  However, wide though this general power may be, it does not permit the Authority to create new functions for itself or to extend the functions given to it by Parliament. So the Authority may do anything (except borrow money) to perform any of its functions under sections 8, 25 and 31, but it can do no act outside of those functions in the absence of a specific power. If it does, the Authority would automatically be exceeding its powers.

The Authority misunderstands its statutory functions

  8.  In its Twelfth Annual Report and Accounts 2002-03[43] (the "Annual Report"), Suzi Leather, the Chair of the Authority, said this:

    " . . . We must continue to be a watchdog for patients, a guardian of Parliament's intentions, a supporter of good clinical practice, a protector of disciplined and lawful research and above all a protector of the interests of all those whose births we have celebrated in this special year."[44]

  9.  It is not the Authority's role to be a guardian of Parliament's intentions. That is the constitutional role of our courts of law and, in certain circumstances, Parliament itself. The Authority's role, as a public body created by statute, is simply to perform Parliament's intentions as set out in the 1990 Act.

  10.  Similarly, it is not the Authority's role to be a substitute or supplementary parent, social services department or child protection agency. Had Parliament intended such, it would have made it clear in the 1990 Act.

The Authority has admitted that it is unsure about its statutory functions

  11.  "The HFEA is constantly expanding its communication programmes, making every effort to engage, and seek the opinion of the general public, individuals and professionals about its role in regulating fertility treatment."[45]

  12.  "The Authority believes that it has a duty to provide easy access to up to date and accurate information and give greater clarity and openness in HFEA policy setting and operations."[46]

  13.  The Authority should know what its statutory role is. The 1990 Act sets this out. If the Authority is unsure, it should obtain legal advice.

The Authority exceeds its jurisdiction: specific examples

Policy making

  14.  "The HFEA Corporate Plan was published in June 2003 to outline the HFEA's strategic aims and objectives for the five years 2004-09. The plan focuses on the HFEA's core functions: regulation, policy development and communication with patients and the public."[47]

  15.  There is no statutory basis for saying that developing policy is a "core function" of the Authority. Its core functions are set out in section 8 of the Act. The word "policy" does not appear there or anywhere else in the 1990 Act.

Research

  16.  "The Authority encourages research while ensuring that it is carried out responsibly and for good reason."[48]

  17.  "Whilst not a research organisation, continued public confidence and the need to provide patients with information upon which they can make fully informed choices requires the HFEA to take a lead in encouraging awareness and debate about research and treatment involving human embryos; that it consults widely; and that it communicates the outcomes of its consultations effectively."[49]

    This is not specified in the 1990 Act. To "keep under review" is not the same as "to encourage".

    "To encourage" means "1. to inspire (someone) with the courage or confidence (to do something). 2. to stimulate (something or someone) by approval or help."[50]

    However, "to review" means "1. to look at or examine again: to review a situation . . . 3. to inspect . . . ". "To examine" means "to inspect or scrutinise carefully or in detail; investigate . . . ". "To inspect" means "1. to examine closely, esp. for faults or errors. 2. to scrutinise officially (a document . . .)".

    So "to keep under review" means "to keep under careful scrutiny, especially for faults or errors". So, if anything, the function of the Authority is to act as a check on research rather than to encourage research in this area.

Providing information and advice

  18.  Another goal under the Authority's Corporate Plan is "[d]eveloping an information base which meets the needs of offspring and stakeholders, and the wider regulation and public health functions".[51].

  There is no statutory basis for saying that it is one of the Authority's functions to meet the needs of wider regulation and public health functions. Its regulatory function, by definition, is limited to its own regulatory function, which is limited to human fertilisation and embryology as set out by the 1990 Act. It cannot, of its own accord, step outside or extend its regulatory role and engage in "wider regulation".[52] Similar comments apply to "public health functions".

  19.  "The Authority's other statutory tasks are to . . . [p]ublicise the HFEA's role and provide relevant advice and information to patients, donors and clinics . . . "[53]

  There is no statutory basis for this statement. Section 8(b) provides that the Authority is to "publicise the services provided to the public by the Authority or provided in pursuance of licences", but it does not say that the Authority is to publicise its own role. Publicising its own role, rather than the services it provides, is doubly damaging because, as has already been demonstrated, it has exceeded its statutory role. It is telling the public that it has a wide statutory role whereas in fact, its role is very limited. Consequently, patients, donors and clinics would be misled into thinking that Parliament had given the Authority more power and authority than it in fact had.

Relations with the media

  20.  "The HFEA is currently developing a communications strategy . . . This strategy recognises the need for the HFEA to remain an accountable and open public body and to work with other organisations to ensure that patient, service provider, public and media interests are maintained and promoted in the UK and in other countries where assisted conception is not—as yet—regulated to the standards set in the UK."[54]

    Promoting media interests is not justified by the 1990 Act. Such activities do not fall within the function of publicising "the services provided to the public by the Authority or provided in pursuance of licences" under s8(b) or providing information and advice under s8(c).

The Authority indicates that it would like to extend its jurisdiction even further

  21.  "Underlying all these activities is the HFEA's determination to safeguard the interests of patients, children, service providers, scientists and the wider public."[55]

  22.  It is not the Authority's statutory role to act as a safeguard to the groups mentioned in this statement. Although it has not expressly declared that it will act as such, this statement shows its determination to do so.

23.  "Underlying all these activities is the HFEA's desire to safeguard the interests of patients, children, the general public, doctors, service providers, the scientific community, and also future generations."[56]

  24.  This statement amplifies the previous one. More groups are added. For example, "future generations" is new wording. Again, this shows that the Authority would like to have an increasingly expansive role.25.  It is convenient to set out the comments of the Chair of the Authority once again:

" . . . We must continue to be a watchdog for patients, a guardian of Parliament's intentions, a supporter of good clinical practice, a protector of disciplined and lawful research and above all a protector of the interests of all those whose births we have celebrated in this special year."[57]

  26.  Rather than be content to be a regulatory body established and governed by statute, the HFEA would like to be, inter alia, a body with much greater constitutional significance.

PUBLIC LAW ANALYSIS OF THE AUTHORITY'S MISUNDERSTANDING OF ITS STATUTORY FUNCTIONS

The rule of law

  27.  Parliament must be taken to have conferred power on a public body subject to it being exercised on the correct legal basis. The contrary proposition would be that Parliament intended the public body to act unlawfully, which is not acceptable as a matter of constitutional principle.

  28.  This principle, that public administration must be conducted according to law, means that for every act performed in the course of public administration there must be legal authority. It is for the public body to prove that it has lawful authority for what it does; it is not for third parties to prove the absence of such lawful authority.

  29.  Acts of a public body that are outside its functions or powers are ultra vires, unlawful and invalid. Put simply, the public body would be breaking the law.

Public bodies must know their functions

  30.  The courts have held that a public body "must understand correctly the law that regulates [its] decision-making power and must give effect to it" [58]. If a public body misunderstands its duty, and that misunderstanding leads the public body to misdirect itself in relation to a decision or act, then that misdirection by itself renders the public body's decision or act unlawful. [59]

Public bodies cannot extend their own jurisdiction

  31.  No public body has power conclusively to determine the limits of its own jurisdiction. The House of Lords has unanimously held that the "question of jurisdiction . . . is a hard-edged question. There is no room for legitimate disagreement. Either the [public body] had jurisdiction or it had not. The fact that it is quite hard to discover the meaning of [the relevant statutory provision] makes no difference . . . a correct application of it to the facts of the case will always yield the same answer. If the [public body] has reached a different answer it is wrong, and the court can and must intervene" [60].

Zeal does not excuse unlawfulness

  32.  The exercise of a power for an improper purpose is invalid. Most instances of improper purpose have arisen out of a mistaken interpretation by a public body of its power, sometimes contributed to by an excess of zeal in the public interest[61]

THE WORDING OF THE 1990 ACT IS AMBIGUOUS

  33.  This is evidenced by the persistent and sometimes admitted misunderstanding by the Authority of its functions. The Authority's incorrect claims about its role could only be explained by saying (1) the wording is clear and the Authority knew what the 1990 Act meant but chose to ignore it; (2) although the wording of the 1990 Act was clear, the distinguished members of the Authority collectively misunderstood it; or (3) the Authority reasonably misunderstood its functions because the wording of the 1990 Act is ambiguous.

  34.  It is assumed that scenario (3) is the correct interpretation of affairs. Given the importance and controversial nature of the Authority's work, it is imperative that its functions are set out in statute as clearly as possible. These matters should be settled definitively by Parliament and not left to the courts.

CONFLICTS OF INTEREST

  35.  Certain of the Authority's functions under the 1990 Act give rise to conflicts of interest (whether real, apparent or potential). In particular, the Authority's function in relation to research compromises its ability to discharge its other functions properly.

Regulation vs providing information and advice

  36.  On a matter such as sex selection, it would be the Authority that would determine the nature and scope of a consultation (appearing to have the ability to influence the consultation in a particular direction) and then go on to recommend to the Government whether or not sex selection should be allowed. If the Government accepts the Authority's recommendations, the Authority would then be responsible for regulating sex selection. The Authority appears to be able to create work for itself. This would seem dubious in the private sector. This should not be acceptable as a matter of public administration.

Research vs membership

  37.  Under the 1990 Act, it is possible for a member of the Authority to apply for a licence to conduct research that could eventually result in great financial returns. Although that particular individual is prevented, in general, from voting in the decision whether or not to grant that licence[62], it may appear to the public that the decision is a foregone conclusion. Even worse, the Authority has the power to regulate its own proceedings[63], and the provision which prevents the member from voting in the decision whether or not to grant her the licence expressly subjects itself to this power[64]. So the Authority can allow the member to vote on granting herself a licence. This permits a clear and unacceptable conflict of interest.

Research vs keeping under review information on embryos etc

  38.  The Authority is responsible for granting licences authorising activities for the purposes of research. It is also responsible for keeping under review information about embryos and activities governed by the 1990 Act. This may explain (without excusing) why it mistakenly believes that encouraging research is one of its functions. The consequence of incorrectly assuming this function potentially gives rise to the perceived need to grant more licences for research or have the effect that licences would be granted without rigorous scrutiny of the merits of the research. That this possibility exists would be sufficient to undermine public confidence in the Authority.

Research vs storage of gametes and embryos

  39.  Within the Authority's regulatory functions, there is a danger of a conflict of interests. On the one hand, the Authority is responsible for regulating the storage of gametes and embryos and treatment services. But on the other hand, it is charged with regulating activities for the purposes of research. Conflict may arise, for example, where there is a shortage of gametes and embryos required for the purposes of research. This conflict of interest undermines the confidence of the public, especially patients and donors.

RECOMMENDATIONS

  40.  In the light of the above, the 1990 Act should be amended in a number of ways.

Clarification of the wording of the 1990 Act

  41.  The wording of the 1990 Act should be clarified so that there can be no doubts as to the functions to be performed. This is not to say that the wording of the 1990 Act should be extended to cover the functions that the Authority currently purports to perform. On the contrary, due to the controversial and sensitive nature of human fertilisation and embryology and the inclination of the Authority to exceed those functions that are already set out in statute, any function to be performed by a public body in this area should be as conclusively, as restrictively and as clearly delineated as possible after full and proper debate in Parliament. For the same reasons, section 8(d) (which allows new functions to be specified by regulations) should be deleted.

Separation of functions and performance by independent bodies

  42.  The statutory functions of the Authority should be separated out and performed by separate independent bodies (each a "New Body"). Each New Body should only perform one of the functions set out in the 1990 Act so as to avoid any conflict of interest. It would not be sufficient that these functions be performed by different committees within one body since they would not appear to be independent.

  43.  Each New Body should be named accordingly so that its members and employees are constantly reminded what its function is.

  44.  In particular, it is vital that responsibility for regulating research on human fertilisation and embryology be given to a body with responsibility for no other functions (the "Research New Body"). This will obviate the conflicts of interest described earlier.

Accountability and compliance

  45.  Analogous to the recommendations of the First Report of the Committee on Standards in Public Life, there should be independent scrutiny of each New Body by way of internal systems supported by independent scrutiny.

  46.  Internally, there should be the closest scrutiny at the lowest level possible, and as frequently as possible. For each New Body there should be established a compliance committee comprised of legally qualified members who shall have the responsibility of ensuring that every act has lawful authority.

  47.  Externally, each New Body should be subject to the intense scrutiny of a Parliamentary Select Committee. This is because MPs are more directly accountable to the public for safeguarding the public interest. However, this Parliamentary Select Committee should be supported and advised by a body of people who have considerable relevant expertise (in areas such as bioethics, law and medicine) and who are appointed by Parliament (as opposed to the Government) so as to secure public confidence.

CONCLUSION

  48.  It is worth being reminded that public bodies exist to serve the public. The public are entitled to expect public bodies and their officers to act competently and with lawful authority, seeking to serve the public interest to the best of their abilities.

  49.  It is hoped that the reform of the 1990 Act will reflect this.

May 2004






41   Section 5. Back

42   Halsbury's Statutes Annotations confirm that there have been no regulations made for the purposes of section 8(d) up to 1 February 2001; confirmed up to 8 April 2003, by the 2003 Cumulative Supplement. A search on the HMSO website on 26 May 2004, revealed that no regulations have been made for the purposes of section 8(d) since 1st February 2001. Electronic searches on Westlaw, Lexis and JustCite do not reveal any regulations made under section 8(d) up to 26 May 2004. Back

43   This can be obtained from http://www.hfea.gov.uk/HFEAPublications/AnnualReport. Back

44   Annual Report, p 2. Back

45   Annual Report, p 18. Back

46   Business Plan 2003-04 (the "Business Plan"), paragraph 2.6. The Business Plan can be obtained from http://www.hfea.gov.uk/HFEAPublications/BusinessPlan. Back

47   Annual Report, p 6. Back

48   HFEA Leaflet "Embryo Research", Introduction, page2. This may be obtained from http://www.hfea.gov.uk/HFEAPublications/HFEAleaflets. Back

49   Business Plan, paragraph 2.5. Back

50   All definitions in this part of the submission are from the Collins Concise English Dictionary, Third Edition Back

51   Annual Report, p 6. Back

52   See paragraph 31 of this submission. Back

53   Business Plan, paragraph 1.3. Back

54   Annual Report, p19. Back

55   Annual Report, p 6. Back

56   http://www.hfea.gov.uk/AboutHFEA. Back

57   Annual Report, p2. Back

58   Council of Civil Service Unions v Minister for the Civil Service [1985] AC 374, per Lord Diplock at 410. Back

59   "The Home Secretary misunderstood his duty. This misdirection by itself renders his decision unlawful." (R v Home Secretary, ex p Venables [1998] AC 407, 518-519, per Lord Steyn). Back

60   R v Monopolies and Mergers Commission, ex p South Yorkshire Transport [1994] ECC 231, per Lord Mustill at 241. Back

61   See Constitutional and Administrative Law, 13th Edition, Bradley and Ewing, p701. Back

62   Schedule 1, Paragraph 10(3). Back

63   Schedule 1, Paragraph 9(1). Back

64   "Except in such circumstances (if any) as may be determined by the Authority under paragraph 9(1) above . . ." (Schedule 1, Paragraph 10(3)). Back


 
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