An External Review of The Human Fertilisation and Embryology

An External Review of The Human Fertilisation and Embryology Authority’s
‘Internal Governance Review’ Document produced by Mr Peter Thompson.
External Reviewer: Mr Peter R Brinsden FRCOG
1 September 2011
Introduction.
1. Between June 2005 and January 2007 the Human Fertilisation and Embryology
Authority (HFEA) was involved in a series of events between itself and two licensed
Clinics owned and run by one Person Responsible (PR). An application was made by
the PR to renew the licence of one of his Clinics and, after several meetings of the
Licence Committee (LC), including meetings with the PR, a decision to withdraw the
licence was made. A decision was also made by the HFEA to seek a Police Warrant to
search the Clinics for documents in January 2007. Concurrently the BBC’s Panorama
programme were researching the activities of these Clinics, repeatedly seeking
information from the HFEA and finally screening the programme on 15 January 2007,
which maintained that the Clinics had been conducting fertility treatments without a
licence.
2. The HFEA’s reputation as a fair and unbiased regulator of assisted reproduction
treatments and Clinics in the United Kingdom was damaged by its management of
the licensing process for the two Clinics, its application for and execution of the
Warrant and for its dealings with the BBC in the preparation of a programme on the
two Clinics.
3. Following the departure of the then Chief Executive of the HFEA in October 2007,
the new Chief Executive (initially Acting), Mr Alan Doran CBE, initiated a major
review of the function and activities of the HFEA and made series of major changes
in the governance of the Authority, under the broad heading of “Programme 2010”.
The principal aim was to learn lessons from the HFEA’s poor performance in dealing
with these issues in the recent past, to put in place procedures and protocols to deal
with similar episodes in the future and to ensure that the HFEA was fully compliant
with the principles of ‘good governance’. The process of ‘Programme 2010’ began in
January 2008 and ended in October 2009.
4. The Chief Executive, Mr Doran, is now keen to establish whether or not the new
processes now in place are effective and in line with good governance, whether the
HFEA have learned from the unfortunate experiences of 2005 – 2007, and thus
preventing the possibility of any future such occurrences – in other words, whether
the HFEA’s new system of governance is “fit-for-purpose”.
5. The Chief Executive has therefore tasked Mr Peter Thompson, Director of Strategy
and Information at the HFEA since 2008, to write a Report on the changes effected
1
External Review by Peter R Brinsden
by “Programme 2010” and whether, in his opinion, the present system is “fit-forpurpose”. Mr Thompson was appointed to the HFEA well after the incidents
described above and he was thought therefore to be sufficiently divorced from these
events as to be able to give an unbiased and uninfluenced, but personal view.
6. Mr Doran’s terms of reference for Mr Thompson were:
"... to review the adequacy of the Authority's revised governance
arrangements in relation to the threshold between administrative
enforcement of our powers and the sphere of criminal law and to report back
to the Authority with any recommendations".
Mr Doran also stated that the document prepared by Mr Thompson (titled: “Internal
Governance Review”) should be subjected to an external review by an independent
assessor. Mr Doran asked the Author of this document, Mr Peter Brinsden (PB), to
undertake this task. He stated in his letter to PB of 23 March 2010:
“Your role would be to bring an outside perspective as someone who knows
what it is like to be regulated by the HFEA. We are not asking you to take on
authorial responsibility for the Review or its conclusions. Rather, we would
like you to give us an honest, informed reflection on the Review’s
recommendations. Do they seem grounded in an understanding of what
happened? Are they relevant to the HFEA today? Do they avoid internal bias?
Would they make sense to the sector?”
With this role in mind, I have attempted to give my personal, unbiased opinion on
the review document of Mr Thompson. I have not commented or given any opinions
upon the events occurring between 2005 and 2007 – it is not part of my remit. I will
deal with each Chapter in turn, draw some conclusions at the end of each Chapter,
and summarise my thoughts at the end.
Chapter 1.
7. Content:
In Chapter 1, the details of the Terms of Reference set by Mr Doran are given, as
summarised in Paragraph 6. above, but also what he terms “the spirit of the review”:
“The spirit of the review will be to look into recent developments so that the
Authority can be satisfied that it has learnt the lessons that are there to be
learned, not to seek to attach blame to individuals.”
Mr Thompson (PT) states in his Introduction:
“...the views expressed are my own.”
2
External Review by Peter R Brinsden
“They concern the adequacy of the Authority’s governance arrangements
now, not the adequacy of those arrangements in the past. The Authority
wishes to assure itself that the new governance arrangements it has
introduced over the past two years will be effective and this review is part
of that process.”
“My terms of reference make it clear that it the Authority needs to satisfy
itself that the key lessons have been learned; this is not an exercise in
seeking to attach blame for past events. The Authority is, in short, trying
to do what a well-run public body should do – i.e. ensure that it learns
from its past experience.”
“Those terms of reference also mean that the review will not,
categorically, re-examine or comment on previous Licence Committee
findings, legal cases or the complicated background...”
“In view of the historical issues, I have focused my review on the adequacy
of the current governance arrangements at the HFEA in respect of three
broad issues: licensing, the relationship with the criminal law, and the
relationship with the media.”
The review is “internal” in two senses. First, it is conducted by someone
who is employed by the HFEA, though not at the time of the events in
question, rather than by an external figure. Second and more importantly,
the focus is internal in the sense that it is concerned with the HFEA’s
governance framework.
8. Comment:
a. The terms of reference for the preparation of this document by PT are clearly
set out by Mr Doran, with the specific focus on ‘lessons learned’ and whether
or not the major changes made at the HFEA in terms of governance under the
‘Programme 2010’ initiative, and currently in place, are effective in
preventing any similar episodes to those which occurred between 2005 and
2007, and that the new system of tighter governance is ‘fit-for-purpose’. It is
entirely appropriate that such a review should have been commissioned,
indeed, it is ‘best practice’ that such a review should take place, as it is, in
effect, an audit of the effectiveness of the new system.
b. It is also appropriate that the spirit of the Review should embrace the ‘no
blame’ principle for past actions.
c. Some might question whether or not a Public Enquiry, rather than an Internal
Review, should have been commissioned. I am certain that PT is correct in his
reasoning (Paragraphs 9 and 10) as to why an Internal Review is appropriate.
3
External Review by Peter R Brinsden
d. As far as the thoroughness of his research goes, I am staggered by the lengths
PT went to in his background research in the preparation of this Document –
a (title) review of 15,000 written documents and key word and date search of
3.4 million electronic documents – very impressive!
Chapter 2.
9. Content:
a. This chapter looks at the key issues of governance raised by the licensing and
enforcement activities undertaken by the HFEA in 2005-2007 in relation to
the two licensed assisted reproduction Clinics owned and run by the PR, Mr
Taranissi.
b. PT confines his review to: “Was there a framework which could assist the
Licence Committee when making decisions? Was the decision to seek a
warrant taken by the right individuals, did they follow any relevant protocols
or guidance and did they adequately record the decision? Was there guidance
or protocols to assist the HFEA executive staff in their engagement with the
Panorama team?”
c. The major content of this Chapter (Paragraphs 3 – 93) describes succinctly
the circumstances that provoked the three main problems encountered by
the HFEA and their conduct in managing the issues. PT also describes the
deficiencies in the HFEA’s management of these three main issues: The
licensing processes; the application to the Police for a Warrant and its
execution, and the dealings with the BBC’s Panorama programme. PT
concludes that the problem in all three of these is the lack of any guidelines
or protocols and the HFEA’s lack of experience in dealing with such problems,
which had not been encountered before. The major issues are well
summarized under the heading Observations (Paragraph 94).
10. Comment:
a. The lack of consistency in the Licence Committee membership and the lack of
‘middle range’ sanctions on Clinics is well summarized, and recommendations
are made later for their solution. The escalation of the situation between the
time of the original refusal of renewal of the licence by the Licence
Committee in December 2005, through to the issuing of a Warrant and
search of the premises in January 2007, is remarkable in the way it occurred
and why, and the extraordinary time that the whole process took.
b. In Paragraphs 19 onwards, PT, quite rightly, concentrates on the issue of
Governance, where the existing deficiencies were in the governance process
and his personal observations on these. I have made 45 marginal comments
4
External Review by Peter R Brinsden
c.
d.
e.
f.
on PT’s observations and opinions in his Document, all of which I have not
detailed here. However, PT and Mr Doran may find them of interest. I will
only comment below on my main thoughts.
Paragraphs 23 – 29: Concerning membership of the Licence Committees (LC).
It is quite remarkable that there was any consistency of thought or decision
making with such changes in the composition of the LCs at the time –
especially when they were trying to address one very specific issue/clinic. As
PT states (Paragraph 29): “In any long licensing process consistency of
decision making is particularly necessary, both for the regulator and the
person or body being regulated.” The other issue raised about the LC is the
attendance of sometimes several Executive Staff at LC meetings, and the
issue of ‘imbalance’ and ‘even handedness’, or, as PT says – “the equality of
arms” principle. I believe this is a key issue. The question to my mind is: were
they allowed to contribute to the discussion at all and to give their own
opinions at the time? It would seem logical that they might be asked
questions about the inspections or paperwork, and for their opinions, which
would or might have considerably influenced the (frequently changing)
members of the LC. However, since the Executive are likely to have had more
knowledge of the facts, as well as of the Code/Law than the Members, it
would seem reasonable for them to give information at the meetings, but not
their opinions. However, attendance of Executive members might also have
brought some consistency to the meetings, as they would, more or less, have
been the same attendees.
Paragraph 29. The HFEA appeared to bend over backwards to communicate
with the PR and to be reasonable. This has always been my impression as an
ex-PR. Nobody wants to think of the HFEA as being unapproachable and
unwilling to listen, and the Executive appear to have been trying almost too
hard to be seen to be reasonable and willing to try to settle the differences. I
am certain also that, as Mr Taranissi was backed further and further into a
“corner”, he might have become increasingly difficult to deal with –
especially once his lawyers had also became involved.
PT states in Paragraph 39: “I found no evidence of any guidance to Authority
members or Executive staff as to how to manage the tension between
informal contact and the formal aspects of the licensing process.” In theory
none should be necessary if the standard protocol for the hearings by the LC
and the appeal process had been followed, without all the “goings on”, as it
were, “behind the scenes” of both the Exec and Members of the LC - all
meant in good faith - in an attempt to resolve this issue, but which caused
the whole process to become a disaster in the end for the Authority.
Guidance on the issuing of a Warrant was absent, and has now been dealt
with under the new governance system.
5
External Review by Peter R Brinsden
g. The issue of the HFEA’s dealings with the Panorama journalists is also very
difficult. Again, the HFEA appear to have bent over backwards to be helpful in
the provision of information, but this appears at times to have verged on
collusion. This would be completely inappropriate, but they could not simply
be ignored, especially a high profile programme like Panorama! Difficult!
h. Under Observations (Paragraph 94) PT lists 16 areas with which he has found
problems in the management of the three main issues: the LC process, the
Warrant and subsequent search and the dealings with Panorama. All these
points appear to me to be well founded and supported by the research
carried out by PT on the extensive documentation available to him, and are
covered in more detail in Chapters 3 and 4. I agree with them, and, as will be
seen in subsequent Chapters, I agree with his recommended courses of
action.
Chapter 3.
11. Content:
a. This chapter considers the issue at the centre of PT’s terms of reference: the
adequacy of the HFEA’s revised governance arrangements. It attempts to
“assess their merits as measured against the standards of modern regulatory
practice. … the crucial test is not merely whether the Authority’s governance
arrangements are better than they were in the past, but whether they are fit
for purpose now.” (Paragraph 1).
b. ‘Programme 2010’ set itself a number of objectives:
• to continuously improve the effectiveness of regulation;
• to ensure compliance with, and implementation of, the new
legislative requirements;
• to improve the quality and consistency of decision-making; and
• to ensure the Authority is able to offer the best guidance on scientific,
clinical, legal and ethical treatment.
c. The main changes that the implementation of ‘Programme 2010’ effected are
listed and reviewed in Paragraph 8 and its sub-paragraphs; briefly, they are:
i. A restructured compliance structure
ii. A revision of the Code of Practice
iii. A new ‘Risk Based Assessment Tool’
iv. A restructured Executive and Authority
v. A new system to present Clinic data
vi. A new HFEA Website
vii. A new approach to engagement with stakeholders
6
External Review by Peter R Brinsden
d. Much of this change was driven by the implementation of the new Human
Fertilisation and Embryology Act 2008, which amended the original 1990 Act,
and much of it driven by the initiative of the new Chief Executive.
e. Paragraphs 10 – 62 of Chapter 3 document the “very significant alterations to
the licensing framework in the last two years, some of it statutory, but most
of it in the form of guidance and protocols”. These cover, in particular, the
formation of an Executive Licensing Panel (ELP), Licence Committee (LC) and
Research Licence Committee (RLC), and a completely separate and
independent Appeals Committee; how they are constituted and that they are
all protocol and guideline driven. The Licence Committee, Research Licence
Committee and ELP now make their deliberations solely on the papers put
before them; no other members of the HFEA Executive are present, save for
the Committee secretary. The process for representation hearings and
appeals are different in that both allow for oral hearing as well as written
representation.
f. Paragraphs 63 to 88 cover enforcement of regulations. The limited range of
sanctions that may be required in an “escalating conflict situation” are
highlighted as being inadequate in the ‘middle range’ of possible sanctions.
The relationship with Police and the system for issuing of Warrants are also
covered in this section.
g. Finally, the present system for dealing with the media and the effect of the
Freedom of Information Act and how to deal with both are covered in
Paragraphs 88 to 97.
12. Comment:
a. This Chapter is really the “core” of this paper by PT and is very detailed in its
coverage of the changes that have been made to improve the governance
systems of the HFEA, with his comments on their effectiveness. He concludes
this Chapter with a list of the areas which he considers require improvement.
I will deal with some of the most important issues as he has set them out.
b. With regard to the licensing regimen, PT concludes: “that the current
licensing regime has a clear separation of functions between the inspection
and licensing functions of the Authority, including representations and
appeals, and the administrative support required to make those processes
work.” I agree. This is now a much more robust system than before and
would seem to me to capture the essence of good governance, fairness and
the independence of the “final arbiter”.
c. Paragraph 38: “I therefore conclude that the current licensing regime provides
equality of arms between both parties.” I agree.
d. Paragraph 46: “I conclude that the method by which members of the three
HFEA licensing bodies are appointed and the guidance on conflicts of interest,
7
External Review by Peter R Brinsden
e.
f.
g.
h.
i.
j.
k.
provides a secure framework in which members can make decisions in an
impartial way and be seen to do so”. I agree. However, if the ELP refuses a
licence or renewal of a licence, I can imagine that a “refused PR” might
complain that the ELP was made up only of Executive members, rather than
independent. Is there any other Public Authority which grants licences that
has a similar structure for its licensing committees? If there are other
precedents, the ELP might not be open to such potential criticism.
Paragraph 48: “First, since 1 October 2009 the HFEA has had a single Licence
Committee, drawn from a membership of seven members. This stands in
marked contrast to the previous regime described in chapter 2, where there
were three separate teams of members that met on a rotational basis. I am of
the view that this must make it easier to achieve a consistency of decisionmaking. A similar conclusion must apply equally to the single Research
Licence Committee and the ELP, both of which function with a tight core of
members.” I absolutely agree.
Paragraph 49: “Second ... the Licence Committee, Research Licence
Committee and ELP now have a set of detailed procedural rules relating to the
conduct of the meeting. ... Those rules provide a comprehensive framework to
ensure consistency in the way in which licensing takes place at the HFEA.”
This absolutely must be a good thing and part of good governance. One is
surprised that it was not in place before.
Paragraph 50: The use of ‘Decision Trees’. These are an established good
governance tool.
Paragraph 51: “The Indicative Sanctions Guidance is not a rigid tariff but it
does provide a consistent reference point for licensing decisions.” This is just
what is needed.
Paragraph 53: “HFEA Standing Orders now require that members of the
Licence Committee, Research Licence Committee and ELP shall attend regular
legal training on human rights and regulatory law. … this can only increase
the likelihood of consistent, well reasoned, licensing decisions being made.”
Absolutely, and with the authority of knowledge gained from attendance at
the legal courses.
Paragraph 54: “I conclude that the new rules on membership and the conduct
of meetings, use of Decision Trees and guidance on indicative sanctions and
the length of time that licences should be granted, and the compulsory legal
training for members, provide a robust framework so that licensing decisions
should be consistent.” I agree that the aggregate of all these measures should
lead to much more consistent decision making and should, in my view,
reduce to a minimum the chances of a repeat of the earlier problems.
“A problem for the Authority is the absence of civil powers, like enforcement
notices or fines, which might encourage compliance, without recourse to
8
External Review by Peter R Brinsden
more severe sanctions like proposals to revoke or suspend a licence.” I can
understand this, but how much of a problem is this really? In my ignorance of
the facts, I would have thought that the requirement of the Authority to
impose, say, fines, would be very limited if they had that power. Perhaps
there are many more “middle grade” infringements by Clinics than I was
aware of, even after being an External Inspector for about 15 years, but, I can
see that the HFEA should be able to impose less severe sanctions, such as
fines, before having to consider revocation or suspension of a licence.
l. “Section 4 of the new Compliance and Enforcement Policy sets out the
escalation and management of centres which are causing concern. This
makes it clear that the Authority will seek to achieve compliance through an
escalating scale of informal measures to formal enforcement action. In my
view this should greatly assist centres in understanding what the Authority is
looking for and how it will respond to non-compliances. I conclude that the
published Compliance and Enforcement Policy meets the essential
requirements of modern regulatory practice by providing a clear statement of
how the Authority will inspect, manage and enforce licensed centres. I agree.”
Sounds excellent. Both the Authority and Clinics will then be aware exactly of
how the ‘process’ can be escalated. Is this Policy in the Public Domain, so that
PRs can also be aware of how the logical escalation can occur in the event of
problems of compliance?
m. Paragraph 84: “I conclude that the Compliance and Enforcement Policy sets
out a clear process whereby the decision to seek a warrant can be agreed
among senior Executive staff and senior members of the Authority, which
ought to ensure that that decision is taken in a considered and controlled
manner. However, I also conclude that the absence of any criteria by which
the decision to seek a warrant can be measured against is a weakness of the
current governance arrangements.” I agree, but see above in (l.)
n. Paragraph 86: “I conclude that there are now adequate procedural rules
relating to the execution of a warrant under the amended HFE Act.” I agree.
o. Paragraph 91: “I conclude that there are now proper records management
systems in relation to media handling. There is very little likelihood of a media
story of any significance not being overseen by the Chair and Chief Executive.”
I agree. It is absolutely right that the system should be this tight.
p. PT concludes this Chapter with the statement: “the conclusions I draw about
the Authority’s revised governance arrangements in respect of licensing and
enforcement are largely positive”. I agree that all of the measures taken by
the HFEA to improve its governance systems, as summarized and commented
upon in PT’s Review, are appropriate and “fit for purpose”. PT does further
9
External Review by Peter R Brinsden
summarise his thoughts in his Conclusions to this Chapter, and I have
repeated them verbatim below for clarity and ease of reference:
•
•
•
•
•
•
•
•
•
•
that the current licensing regime has a clear separation of
functions between the inspection and licensing functions of the
Authority, including representations and appeals, and the
administrative support required to make those processes work;
that the current licensing regime ensures equality of arms between
both parties;
that the method by which members of the three HFEA licensing
bodies are appointed and the guidance on conflicts of interest,
provides a secure framework in which members can make
decisions in an impartial way and be seen to do so;
that the new rules on membership and the conduct of meetings,
use of Decision Trees and guidance on indicative sanctions and the
length of time that licences should be granted, and the compulsory
legal training for members, provide a robust framework to ensure
that licensing decisions can be consistent;
that the current licensing regime meets modern regulatory
standards of transparency in the information it provides centres
about the licensing process, the conduct of that process, the
criteria against which compliance will be assessed, and the
reasons for the individual licensing decision made;
that the representations hearing and Appeals Committee provide a
robust right of appeal and meet the key requirements of a modern
regulatory regime;
that the published Compliance and Enforcement Policy meets the
essential requirements of modern regulatory practice by providing
a clear statement of how the Authority will inspect, manage and
enforce licensed centres;
that the Compliance and Enforcement Policy sets out a clear
process whereby the decision to seek a warrant can be agreed
among senior Executive staff and senior members of the Authority,
which ought to ensure that that decision is taken in a considered
and controlled manner;
that there are now adequate procedural rules relating to the
execution of a warrant under the amended HFE Act;
that there are now proper records management systems in
relation to media handling.
10
External Review by Peter R Brinsden
I repeat that, after carefully analysing the Review of PT, I am in general
agreement that the measures taken by the HFEA since 2007 to improve their
governance system have had, and will continue to have, a marked impact on
the quality of the regulatory system which they are mandated to apply.
q. PT finally in this Chapter, does point out what he perceives to be deficiencies
that remain in the regulatory system – as he finally concludes: “However,
there are some aspects of those revised arrangements which do not fully
meet the standards of modern regulatory best practice; these are:
•
•
•
•
•
that the legislative scheme governing assisted conception can be a
rather blunt instrument for achieving compliance in all but the
most serious cases, and that the available powers under the RES
Act, because they relate to criminal offences only, would not
increase the range of useful civil sanctions to the Authority;
that the absence of any criteria by which the decision to seek a
warrant can be measured against is a weakness of the current
governance arrangements;
that the failure to set out the respective roles of the HFEA and the
Police in relation to the exercise the criminal sanctions [sic] in the
amended Act is a gap in the current governance arrangements;
that the standard operating procedure on the handling of media
relations is in need of revision;
that the guidance on information access is clear and broadly fit for
purpose, but that it would benefit from a discussion of the overlap
between information requests and media enquiries.
Chapter 4.
14. Content:
In Chapter 4, PT concludes and makes his recommendations for further change in the
hope and expectation that these changes will further improve the robustness of the
Authority’s revised governance arrangements. These recommendations have already
been summarised in (12.q) of my comments on Chapter 3 above, but I will set out again
in more detail the sections in PT’s final conclusions:
a. “Conclusion: That the legislative scheme governing assisted conception can be
a rather blunt instrument for achieving compliance in all but the most serious
cases, and that the available powers under the RES Act, because they relate
to criminal offences only, would not increase the range of useful civil
sanctions to the Authority.” I agree that it would be desirable for the
Authority to have some ‘middle grade’ sanctions that could be imposed,
11
External Review by Peter R Brinsden
b.
c.
d.
e.
however, I agree that, because it would require legislative change, it will not
occur. I agree therefore also with his recommendation as follows:
“Recommendation 1: That the Authority consider further bespoke legal
training focussing on the limitations of the powers to revoke, vary or suspend
a licence in relation to non-compliance with the amended Act.”
“Conclusion: That the absence of any criteria by which the decision to seek a
warrant can be measured against is a weakness of the current governance
arrangements.” I agree that PT’s recommendations as in his Paragraph 8 are
justified.
“Conclusion: That the failure to set out the respective roles of the HFEA and
the Police in relation to the exercise the criminal sanctions in the amended Act
is a gap in the current governance arrangements.” I agree and believe this is
desirable in the unlikely or rare event that it might be needed. An MOU
should be possible, but with whom, I am uncertain. I do not believe that the
ACPO are likely to be the appropriate authority.
“Conclusion: That the standard operating procedure on the handling of media
relations is in need of revision.” I agree. This will not be difficult to achieve.
“Conclusion: That the guidance on information access is clear and broadly fit
for purpose, but that it would benefit from a discussion of the overlap
between information requests and media enquiries.” Again, agreed and not
difficult.
15. Comment:
I agree that these issues are real and should be addressed as part of the continuing and
perpetual process that is “good governance”.
Summary and Conclusions.
16. The specific instructions to Mr Peter Thompson (PT) by the Chief Executive of the
HFEA in preparing his Internal Governance Review (IGR) were to determine whether
or not the major changes made at the HFEA as a result of “Programme 2010” were
appropriate and ‘fit-for-purpose’ in today’s regulatory environment. Also, whether
these changes are sufficiently ‘watertight’ as to prevent in the future the recurrence
of a situation similar to the series of events which occurred between the HFEA and
two Clinics run and owned by one Person Responsible (PR) in the period 2005 –
2007.
17. Chapter 2 of PT’s document looks at the key issues of governance raised by the
licensing and enforcement activities undertaken by the HFEA in 2005-2007 in
12
External Review by Peter R Brinsden
relation to the two licensed assisted reproduction Clinics owned and run by the PR,
Mr Taranissi. I believe that this is a brief, but fair and balanced summary of what
occurred. The task of summarizing what happened over more than two years, and
covering many hundreds of documents must have been an onerous one. There is no
place for or need in the IGR to go in to more detail or, in particular, to lay blame for
what happened on any one person or persons.
18. In Chapter 3, PT reviews the many changes in the governance processes introduced
at the HFEA following ‘Programme 2010’ and attempts to “assess their merits as
measured against the standards of modern regulatory practice. … the crucial test is
not merely whether the Authority’s governance arrangements are better than they
were in the past, but whether they are fit for purpose now.” (My Paragraph 11a.). PT
has critically assessed the changes individually and, in general, finds them to be
better or much better than the policies and procedures which existed during the
period 2005 – 2007. I agree that the changes made provide a much more ‘robust’
system of good governance by which the HFEA’s regulatory system can be, indeed, is
being, administered.
19. In Chapter 4, PT presents particular issues for which improvements still need to be
made – all of them are reasonable and justified, although points 14.a and 14.c (in
this document above) may be difficult or impossible. The other areas for
improvement will be easily achieved.
20. My final conclusion is that this Internal Governance Review is a fair and balanced
document, in which the events which occurred between 2005 and 2007 are
succinctly summarised, the changes made at the HFEA following “Programme 2010”
critically reviewed and favourably agreed, and a few suggestions made for further
improvement in the governance process. I am in general agreement with the review
findings and PT’s suggestions for further, relatively minor, changes. I believe that the
changes that have been made since “Programme 2010” are major improvements,
and have caused the HFEA to become a much more effective and efficient regulatory
organization. My hope is that, having achieved this, the HFEA will not now be
subsumed under another organization!
Peter R Brinsden MB BS FRCOG
1 September 2011
13
External Review by Peter R Brinsden