33. The Government Reply published in September 2000
responded positively to the Committee's concerns. The Government
undertook to "set out plans to strengthen cancer registries
early next year ".
It concluded "the Government is determined to secure the
future of cancer registration and will take the necessary action
to ensure this".
The Government undertook to provide a legislative solution through
the Health and Social Care Bill. On 11 January 2001, when the
Committee's Report was debated in the House, the Parliamentary
Under-Secretary of State for Health acknowledged the importance
of these concerns. In May 2001, the Health and Social Care Act
came into force. Section 60 of that Act enables regulations to
be made to enable the passing on of confidential patient information
without explicit consent. Section 60 states:
"The Secretary of State may by regulations
make such provision for and in connection with requiring or regulating
the processing of prescribed patient information for medical purposes
as he considers necessary or expedient -
(a) in the interests of improving patient care, or
(b) in the public interest".
It also provides for annual review of any such regulations.
34. Section 61 of the Health and Social Care Act
provides that the Secretary of State should set up a Patient Information
Advisory Group (PIAG) "as soon as reasonably practicable".
He must consult this body before making any regulations under
Section 60. The fourteen
members of PIAG did not meet until December 2001
(a month after the GMC moratorium was due to expire). Sir John
Pattison told us "the delay is due to the fact of going through
a proper procedure of constituting the membership of a committee,
inviting a number of bodies to make suggestions about who should
be considered for membership and inviting applications for membership,
and then going through a Nolan procedure, making recommendations
to Ministers, getting their agreement, and then holding up the
announcement until we had actually heard from everybody who was
going to be on the committee that they would actually serve as
Department of Health expects the draft Regulations to be laid
before Parliament in February 2002. The Minister told us that
the Regulations under the Health and Social Care Act were intended
"to ensure that we would put cancer registries on a secure
footing because, clearly, the information that they gather is
essential in terms of our monitoring progress that we make on
cancer but also having just that database of information is very
The Department of Health expected the Regulations to be laid
before Parliament in February 2002. We note that this was
not achieved. We await the forthcoming Regulations with impatience.
35. The GMC moratorium was due to expire in November
2001: we understand it has been extended until the passing of
the Regulations. Interim advice sent by the GMC to those
seeking information in the meantime states "we fully support
the work of cancer registries and of other research, epidemiology
and surveillance, which is vital in protecting and enhancing the
public health. We have accepted assurances from the UK Health
Departments that systems for protecting patient confidentiality
will be implemented as soon as practicable. In light of those
assurances, we have agreed that the practical difficulties which
doctors face in seeking consent to disclosures ahead of the implementation
of new systems will be taken into account if complaints about
disclosures are made to the GMC".
T his does little to reassure those working in the field that
it remains permissible to supply data to cancer registries and
it fails to mention that the moratorium has been extended. The
GMC intends to publish its revised guidance to coincide with the
implementation of the first Regulations. The GMC's Guidance
on Confidentiality was very ill-advised and has been highly damaging
to information gathering for medical research and cancer registration.
36. The UKACR told us in detail of their dissatisfaction
at the situation: "progress since the Act was passed has
been frustratingly slow, with a lack of clear guidance from the
Information Policy Unit at the Department of Health. We have on
a number of occasions been given conflicting advice on how to
Paul Nurse told us "what I am aware of is that there is quite
a lot of confusion out there and it is not quite clear what the
present situation in fact is".
Clinicians also expressed concern about the effect of both the
GMC guidance and the legislative delay on research. The Society
of Academic and Research Surgery said "it is incomprehensible
to us how the situation with respect to the GMC and Health and
Social Care Act has been allowed to occur. [It] has rendered even
simple retrospective audit impossible, let alone substantive cancer
research based on retrospective data. This has led to the UK becoming
a far less attractive location for any form of cancer research
than it has been in the past".
Professor Gordon McVie, of the Cancer Research Campaign, described
the situation as "verging on chaos", and added "this
is one of the single biggest threats to the whole business of
evaluation of whether either cancer research works or cancer care
works. It is as simple as that, it could be devastating".
37. Professor Mike Richards dismissed worries that
healthcare trusts were not able to give enough information to
cancer registries. He assured us that 'I do not think that we
will lose the information, even if [trusts are not contributing
to registries], because it is still being held by the trusts'.
He thought that once the Regulations had been passed, any information
held back could then be passed on to the registries. The Department
does not seem to appreciate the depth of concern about problems
caused by the delay and confusions for cancer registration and
cancer research, nor the urgency required in seeking solutions
to these problems. The delay by the Department of Health in
setting up the Patients' Information Advisory Group and in bringing
forward draft legislation to address the situation of cancer registration,
is deeply regrettable. Unless legislation is put in place swiftly,
medical research will be irretrievably damaged.