The regulatory architecture:
getting the balance right
49. As well as requiring an appropriate ethical
framework, the draft Bill should set an appropriate, consistent
and workable regulatory architecture which achieves the right
balance of responsibilities between Parliament, the regulator,
clinicians and individuals. The Minister told us she was also
seeking that balance. (Q 519) This means finding the right
balance between flexibility and legal certainty. Hugh Whittall
said that it was "for Parliament to decide what the starting
point is where the line is drawn between the detail in statute
and the flexibility at the outer end". (Q 17)[39]
50. Much of the debate in evidence centred on
the degree of flexibility required. Some witnesses considered
that the provisions in the draft Bill were overly prescriptive
or prohibitive and favoured a more flexible approach. Hugh Whittall
told us, in the context of whether Parliament should legislate
for future developments, that "Parliament should [set] the
scope of the regulatory framework and [set] down the general principles
and standards by which the regulatory authority should work".
(Ev05(b)) The Royal College of Pathologists were concerned about
what they saw as "a strategy of legislating negatively"
which "gives the impression that practitioners in this field
are not to be trusted and that professional guidance is inadequate".
(Ev06(2), para 2)
51. Most witnesses supporting greater flexibility
did so in the hope of future-proofing the legislation. Dr Mark
Hamilton, Chair of the British Fertility Society, told us that
"the critical thing for those developing the legislation
is it has to retain flexibility for what is unknown for the future
in terms of developments and also unknown in terms of public and
societal attitudes". (Q 409) Fergus Walsh, Medical Correspondent
for the BBC, told us of concerns expressed by many scientists
that "if Parliament tries to second guess things now and
specifically outlaws things now then they will be caught out five
years down the line and really it should be left to whatever body
regulates this area to have the power to issue licences".
(Q 302) Professor Colin Blakemore expressed concern
that a draft Bill that is "fundamentally prohibitionist and
then allows certain things under licence will not be capable of
responding flexibly to developments in science". (Q 15)
Professor Brownsword supported "the way that the draft
Bill has tried to build in some more flexibility through the regulation
making powers that would anticipate changes that might come downstream".
(Q 16)
52. Others supporting the principle of flexibility
did so in order to allow more freedom of action for regulators
or clinicians. Professor Neva Haites, Chair of the HFEA Scientific
and Clinical Advances Group and Professor in Medical Genetics,
University of Aberdeen, told us that Parliament should provide
"a broad, strong framework in which the regulator can then
regulate." (Q 622) David Gollancz, a donor-conceived
person, felt that the draft Bill "confers too little flexibility
on the regulators themselves to respond to technological changes".
(Ev44) The British Fertility Society suggested that revised legislation
"must allow for sufficient flexibility to permit clinicians
and researchers to operate within a supportive regulated framework
which does not inhibit innovation". (Ev23, section A)
53. Others, however, argued that the draft Bill
was too flexible. The most serious concern for Comment on Reproductive
Ethics (CORE) was the "very deliberate flexibility and permissiveness"
built into the provisions allowing the Secretary of State to make
regulations. (Ev79, para 1.5) Dr Donald Bruce of the Church
of Scotland thought that the question of whether Parliament or
the regulator should decide a particular issue depended on the
nature of the issue and its gravity. (Evening Forum Report, Appendix
5). The Scottish Council on Human Bioethics felt that "legal
provisions should state only what is specifically acceptable,
thereby prohibiting all other procedures". (Ev25, para 2)
54. Many who supported this approach advocated
a greater degree of parliamentary control. Andrea Minichiello-Williams,
Public Policy Director of the Lawyers' Christian Fellowship, thought
that Parliament, not the regulator, should have the final say
on the regulation of any new, scientific developments. (Evening
Forum Report, Appendix 5) The Free Church of Scotland said that
"Parliament should retain as much control as possible".
(Ev24, para 2) The Scottish Council on Human Bioethics said that
legislation should "provide Parliament with greater powers
to debate and amend the law" (Ev25, para 2).[40]
55. We recognise that there is a balance to be
struck between legal certainty and flexibility. In the draft Bill,
the Government has favoured legal certainty. In doing so it has,
in our view, been over-prescriptive in many areas in an attempt
to provide for every eventuality. We favour a more flexible approach
within clearly defined parameters. Legislation of this sort is
difficult to future-proof. In taking this permissive view, we
recognise that this approach will be open to broader interpretation
and, perhaps, more frequent challenges in the courts.
56. We recommend that the draft Bill should
be amended to provide a clear framework based on the principle
of devolved regulation. Legislation should devolve regulatory
authority and decision making to the regulators, who in turn should
be given the power in legislation to define areas of 'exemption'
within their regulatory remit. This would provide a framework
of 'permitted regulation' and give greater freedom and authority
to the regulator and clinicians except where there is a good reason
to do otherwise. The draft Bill should also provide a statutory
power for the Secretary of State to make regulations subject to
affirmative resolution and only on the application of the regulator,
to make provisions where necessary for the remit or authority
of the regulator. We also note the criteria used by the Medical
Research Council to judge applications for research grants and
we recommend that that these could be built on to provide legislative
parameters for research set out in the draft Bill. If this recommendation
is accepted, it follows that the appointment of members of the
regulatory body would require a balance of ethical, scientific,
legal and medical expertise; and the Chair should be a proven
leader of the highest calibre and appropriately remunerated.
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