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'(d) "identifiable patient information" in relation to subsection (1) means patient information in a form which allows the patient to be identified'.

No. 35, in page 58, line 38, at end insert--

'(e) regulations under subsection (1) may not prohibit or restrict the processing of patient information which is not identifiable patient information.'.

No. 15, in page 58, leave out from beginning of line 39 to end of line 26 on page 59 and insert--

'(3) The Secretary of State may by regulations make such provision for the collection, holding, processing, transmission and publication of patient information as he considers necessary for the purpose of maintaining disease registers.'.

No. 30, in page 60, line 3, at end insert--

'(8A) The Secretary of State shall establish an Expert Advisory Committee to advise him in connection with any regulations he proposes to make under this section, and shall consult the Expert Advisory Committee prior to making any regulations under this section.
(8B) The Secretary of State shall appoint a chairman of the Expert Advisory Committee established under subsection (8A) above who shall be empowered to appoint such persons as appear to him to represent relevant expert bodies to the committee.'.

Dr. Fox: The debate continues a discussion that we held in Committee. The question that we asked remains to be answered: do the Government aim to protect patients or the NHS and Ministers? Clause 59 in the original Bill is now clause 62, which allegedly clarifies matters but merely makes them murkier.

The Government claimed that new powers were needed to protect patients from abuse of the information that was held about them. They have not defined how such information could be used against patients or explained how the powers would affect its legitimate use, for example during drug trials. We tried to obtain clarification of the Government's arguments and assertions in Committee, but to no avail.

The Secretary of State's powers to divulge data at his discretion do not appear in the Government's national plan for the NHS. They have been included without consultation--surprise, surprise--as a method of restoring the attempted prohibition on the collection of anonymised data from retail pharmacists that the Court of Appeal rejected in December 1999. We debated that case at length in Committee. The Government claim that the Bill closes a legal loophole, without defining it. The court ruled that there was no loophole and the judge stated that

for the Department's purpose.

14 Feb 2001 : Column 363

In the Committee's 12th sitting on 8 February, the Minister stated:

However, the Minister failed to respond to the point that the clause grants the Secretary of State powers that future Secretaries of State could implement in a manner that is far more hard line than the Government's intentions as outlined by the Minister. His constant defence was, "We may have the powers, but we will not use them." That is unacceptable.

The Minister found it difficult to accept that the Bill's contents are what matters. Once a power is established, it can be used. We want greater clarification of the powers and when they can be used. New clause 1 seeks to achieve that.

British pharmaceutical companies could be at a severe disadvantage because of restrictions on research. Many expressed that concern to members of the Committee and other hon. Members. Access to anonymised data is essential to their work in developing new drugs and monitoring the safety and effectiveness of existing drugs. The restrictions would especially affect their fulfilment of regulatory obligations, including those that deal with adverse event monitoring and product withdrawals. In Committee, I quoted the words of one firm; they bear repeating tonight. NDC Health Information Services stated:

If the Government continue to deny the effect of their decisions, it is incumbent on Ministers to explain why, not content with abolishing community health councils, they have introduced a clause that gives future Governments massive scope to prevent independent scrutiny of the NHS. It is part of a consistent approach by Ministers to running health care.

6.15 pm

Ministers must also explain contradictions. In a speech to patients groups in January, the Secretary of State said:

Yet clause 62 allows him to disclose identifiable information to third parties without patients' consent and despite their objections. The Minister can introduce as many regulations as he likes, but the decision ultimately lies with the Secretary of State. He has the right to produce identifiable data, even when that is not in the patient's interest, if he believes that it is in the public interest or the wider health interest. That is unacceptable. Explaining the provision's operation in practice is not the same as defining it in the Bill. New clause 1 attempts to make the provision more explicit.

14 Feb 2001 : Column 364

A letter to The Times on 1 February was signed by Sir Donald Irvine, president of the General Medical Council; Dr. Ian Bogle, chairman of the British Medical Council; Robert Boyd, chairman of the Council of Heads of United Kingdom Medical Schools; Denis Pereira Gray, the chairman of the Academy of Medical Royal Colleges; and James Johnson, chairman of the Joint Consultants Committee. They are top people, who are well respected and represent almost the whole spectrum of those who practice in medicine. The letter stated:

No one would have a problem with that. It continues:

We raised those issues in Committee. None of the Minister's assurances has persuaded us or, I believe, the groups that wrote to The Times that the provision makes for a better system. The fear of its use at the whim of a future Secretary of State provokes anxiety.

Perhaps our most important debate in Committee and tonight is on disease registries. We considered the Bill's impact on cancer registries in particular. Despite our reservations about the Secretary of State's power to require the publication of unanonymised data, we acknowledge the need for action to protect specific registries, including cancer registries.

No hon. Member should take disclosure of information without consent lightly. If the Secretary of State can do that

or "in the public interest", he must justify granting such sweeping and unprecedented powers to override the cornerstone of patient confidentiality between health professional and patient.

We are concerned--as were hon. Members on both sides of the Committee--that disease registries, including those relating to cardiac disease and cancer, should be able to continue their valued work. The Government's acceptance that decisions regarding the application of the subsection should be subject to affirmative resolution in both Houses of Parliament was a concession, but it does nothing to alter the basic facts.

The clause establishes sweeping powers far beyond what is required to ensure the continued viability of disease registries. That point was also raised in the amendments tabled for the British Medical Association by the Liberal Democrats in Committee. By dealing with specific applications of the subsection on a case-by-case basis, the Government find themselves in the position of permitting everything pending future exclusions. Why not provide clarity by stating what is permitted, as we have done in new clause 1?

The Minister's comments in Committee appeared to be an attempt to establish procedure on the hoof. The proposals for the scrutiny of applications are at best

14 Feb 2001 : Column 365

opaque and at worst obscure. That is particularly disappointing because there had been broad cross-party agreement on the necessity of maintaining disease registries. If the Government wish to develop and consult on proposals for wider measures, they should do so, rather than seek to rush through ill-thought-through ideas without any semblance of consultation. As I said, that is an unsatisfactory way to legislate.

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