Clause 59 - Control of patient information
Health and Social Care Bill
9:30 am

Dr Liam Fox (Woodspring, Conservative)

I beg to move amendment No. 323, in page 51, line 10, at beginning insert—

`( ) The Secretary of State shall—

(a) consult such persons and bodies as reasonably appear to him to be interested in or concerned with the protection, distribution or dissemination of patient data in such manner as he shall reasonably consider appropriate; and

(b) publish a report on the consultations which he undertakes under (a) above and his conclusions as to any regulations under this section which are required as a result of them'.

Mr John Maxton (Glasgow Cathcart, Labour)

With this it will be convenient to discuss the following amendments: No. 286, in page 51, line 10, at beginning insert --

`To the extent that it is necessary in the interests of patients,'.

No. 228, in page 51, line 10, leave out `may' and insert `shall'.

Government amendment No. 334.

No. 319, in page 51, line 13, at end insert—

`( ) Regulations under subsection (1) may not make provision which interferes with, or otherwise causes detriment to, preventative medicine, medical diagnosis, medical research, the provision of care and treatment, the management of health and social care services, the monitoring and review of health and social care services or the obtaining or dissemination of information about the care and treatment available for individuals.'.

No. 229, in page 51, line 14, leave out `may' and insert `shall'.

No. 327, in page 51, line 14, after `provision', insert `in the public interest'.

Government amendment No. 335.

No. 230, in page 51, line 16, leave out from `processing' to end of line 19 and insert

`is carried out with the knowledge and consent of the data subject'.

No. 231, in page 51, leave out lines 20 to 25.

Government amendment No. 336.

Dr Liam Fox (Woodspring, Conservative)

Amendment No. 323 would ensure that any regulations made under the clause stemmed from a thorough process that involved all relevant bodies rather than from discussions between the Secretary of State and those who represent the interests of patients—as called for in Liberal Democrat amendment No. 286—or the whim of a Secretary of State, as could be construed from the present drafting.

The Bill restricts the availability of anonymised data, as the Secretary of State can prohibit or restrict the collection and use of data according to criteria determined by him. That is enforced by a £5,000 fine. The Bill can also require that patient identifiable data may be used without patient consent, if the Secretary of State deems it appropriate. The Government claim that they need those powers to prevent patient information from being used against the interests of patients, but they have not defined how such information could be used against the interests of patients, nor how those powers would affect the legitimate use of patient information—for instance, in drug trials.

The Secretary of State's powers to divulge data at his discretion do not appear in the national plan. They have been added without consultation as a way of restoring the attempted prohibition of the collection of anonymised data from retail pharmacists, which was rejected by the Court of Appeal in December 1999. The Government claim that the Bill closes a legal loophole, but the court did not find such a loophole. The judge said of the Department of Health's case that

``the law of confidence cannot be distorted''

for the Department's purpose. The Government may argue that clarity is required with regard to restrictions on the use of health data, but clause 59 does not provide that clarity.

Against what standards will the Government measure the public interest? The usual definitions are ``act of war'' or ``major infectious epidemic''. Are the Government aiming to expand that to include preventive medicine and medical research? The question remains whether the clause is designed to protect the NHS and Ministers or patients?

By restricting the control of data to prescribed commercial purposes, the Government overlook the fact that much of the research that charities and patient groups rely on for analysis originates from commercial bodies. Curtailing the availability of data to commercial bodies would curtail its availability to those monitoring groups that are not commercial.

Further clarification is needed. What consideration will be given to guidance issued by professional bodies when the Secretary of State uses his powers under the clause? How will he consult professional bodies and patient representative groups before using his powers? In what circumstances might it be necessary for confidential patient information to be shared without the knowledge or consent of the patient concerned?

In a letter to The Times, the president of the General Medical Council, Sir Donald Irvine, the chairman of the British Medical Association, Dr. Ian Bogle, the chairman of the Council of Heads of Medical Schools and Deans of UK Faculties of Medicine, Robert Boyd, the chairman of the Academy of Medical Royal Colleges, Denis Pereira Gray, and the chairman of the Joint Consultants Committee, James Johnson, stated:

``We agree with Alan Milburn . . . that we cannot accept the benefits of medicine, science or research regardless of the wishes of patients or their relatives.

However, Clause 59 of the Health and Social Care Bill threatens patient confidentiality by giving the Secretary of State for Health wide and ill-defined powers to determine what information should be disclosed in the public interest or for the improvement of patient care, without patients' consent.

We believe that any decision to override the citizen's right to privacy should be exceptional and must only be made—other than in an extreme medical emergency—after rigorous parliamentary scrutiny rather than by the order of a Secretary of State.

The Bill does not appear to provide for this.''

The letter that Committee members will have received from the Association of the British Pharmaceutical Industry raises the question of the appropriateness of the proposal. It states:

``In these days of deregulation and light-touch enforcement it seems inappropriate to deliver to the Government unfettered powers to suppress statistical information and prevent the use of anonymised data about patient treatment in the NHS, which should not be treated as the property of the NHS, and yet to give the Government very wide powers to obtain information confidential to patients.''

Indeed, the Government's approach contains a great contradiction. The Secretary of State said in a speech to patient groups in January 2000:

``The days have gone when the NHS could act as a secret society. It cannot operate behind closed doors. It cannot operate in the dark. It has to take patients into its confidence.''

Yet clause 59 will allow him to disclose identifiable information to third parties without patients' consent and despite their objections. The Government's approach is incoherent.

Other groups that have made representations--I imagine to both the Government and the Opposition--include the Royal College of Nursing, which is

``worried that the relationship of trust between themselves''—

that is, doctors—

``and their patients may be eroded by the Secretary of State's power to override their assurances of confidentiality.''

Behind the Government's action is the Source Informatics case, in which the Department of Health was found to have misinterpreted the law on the use of anonymised patient data. The Court of Appeal established that information about the treatment of patients was usable if anonymised, that pharmacists and doctors could supply it without breaching any obligation of confidence owed to patients, and that disclosure and use of information in that way was not unlawful. The Department had argued that pharmaceutical companies would use anonymised data to assist marketing efforts, which could affect the prescribing habits of GPs and therefore add to the NHS medicines bill. The Court of Appeal found that the Department of Health was wrong to seek to distort the law of confidence to achieve objectives relating to the medicines bill. It appears that clause 59 is an attempt to rectify matters, but the Government have undertaken no public analysis or discussion of the issues involved, and have not suggested what changes in the law they consider necessary or desirable. They have given no reasons for adding the clause to the Bill.

It could be argued that denying information to prescribers and manufacturers could increase the medicines bill by fostering inappropriate prescribing and delaying the introduction of new and more cost-effective drugs. Surely it is in the public interest that patients should be prescribed the appropriate medicine, and that the power to do that should not be arbitrarily curtailed by restrictions on the availability of accurate information. The court described the Government's arguments as not merely unconvincing but wholly unreal, and I am sure that that view will be echoed in Committee this morning.

The withdrawal of access to anonymised data will deprive pharmaceutical companies of access to such data. Research conducted by such companies is a key source of independent up-to-date information on drug usage. The clause will have a significant and damaging impact on monitoring the safety of medicines, and will hinder the ability of pharmaceutical companies engaged in medicines research. It will affect the fulfilment of regulatory obligations, including those that deal with adverse event monitoring and product withdrawals. Market shares of pharmaceutical companies will not be available. The success of this country's respected research and development sector will be compromised, and foreign pharmaceutical companies may gain an advantage.

One firm told us that commercial access to non-personal data provided considerable benefits to all concerned. The loss of that access will result in less efficient health care and less funding for medical research without any concomitant benefits to the Government, health care providers or patients.

The clause will also impede the collection of information by the likes of the national drugs safety research institute and the general practice research database. Such information is used to assess health care differences and inequalities, monitor drug safety and manage health care resources. The clause undermines all that good work. If the Government deny that that will happen, they must explain why they have introduced the clause and for what purpose they intend to use it. Even if the Government do not intend to use the powers in full, they must explain why they have given future Governments such massive scope to do so.

We believe that all those important changes in the law require the greatest scrutiny and the greatest consultation in advance. They are unacceptable increases in the power of Government, and could bring the medical profession into conflict with the law or the General Medical Council. They place unacceptable burdens on doctors and restrict information from many of those who would best use it in patients' interests, and in commercial interests.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

This group of amendments is about consultation. It is a great pity that the Government did not consult before they put the Bill before the House, as the clause has enormously wide-ranging implications. I will approach the matter more from the point of view of an individual patient rather than from that of research, which I will turn to later.

The Government need to take action on the possible problems that the provisions could cause to the workings of disease registers, especially cancer registers. When something of common usage has not been objected to by patients or their relatives, and has contributed enormously to our understanding of disease processes, we accept that it should not be hampered by subsequent legislation on data protection. The Government were right to seek a mechanism to cope with what was seen as a problem by some cancer research charities and other relevant parties.

The Government have done a great deal more than simply solve that problem, however. Under the Bill, the Secretary of State will have unprecedented powers over clinical information, anonymised or not. There is always conflict between the interests of patients collectively and the interests of patients as individuals. However, unless there are overwhelming reasons, it is the patient as an individual whose rights should be protected the greatest. The Secretary of State stated, in relation to the inquiry into the Royal Liverpool Children's NHS Trust:

``The national health service can no longer assume that the benefits of science, medicine or research are somehow self-evident, regardless of the wishes of patients or their families.

The relationship between patients and the service today has to be based on informed consent''.—[Official Report, 30 January 2001; Vol. 362, c. 178.]

If that holds for doctors—and it should—it should also hold for the Secretary of State. The Bill contains no requirement to consult individuals whose information is being traded or shunted about by the Secretary of State, and that is an enormous cause for concern.

We received a significant late submission from the chairman of the Patients Association, the director of Positively Women, the director of the National Aids Trust, the director of Pan London HIV/AIDS Providers Consortiums, the chairman of the UK Coalition of People Living with HIV and AIDS and the Network of Self-Help HIV and AIDS Groups. They are significant bodies and have not bought the Minister's reassuring words.

The Minister is a reasonable man, and I like to believe his reassurances, but Ministers come and go. I am not implying that his colleagues are unreasonable men or women, but that we might find such an interpretation less acceptable in respect of future changes.

The Government have gone in completely the wrong direction. Either the Bill should specify the terms under which information can be passed—and restrict that to circumstances in which there is a clear need to do so, such as cancer registers—or the Government should issue guidelines that are not enforceable by statute. We now have the worst of both worlds. The Government want to introduce through regulation rules that override the traditional and proper right of patients to control information that pertains to them.

That is my difficulty with the clause. I doubt whether the clause as it stands can be amended sensibly, although we will do our best. Given the well-argued objections to the clause, the Government should have done more than table a few amendments that merely add a few soothing words and do not change the essential framework, which gives absolute power.

Dr Liam Fox (Woodspring, Conservative)

The hon. Gentleman's point is amplified by a letter signed by the president of the Royal College of Physicians, the chairman of the Royal College of General Practitioners, the director of the WHO Uppsala monitoring centre, the chairman of the Patients Association and the chairman of Depression Alliance, who make the same point. The letter states,

``We urge the Government, in the spirit of open government to withdraw this clause until adequate consultation has taken place.''

Can the hon. Gentleman recall any other clause attracting such widespread opposition from so many of the most important groups involved in patient care?

Dr Peter Brand (Isle of Wight, Liberal Democrat)

The hon. Gentleman is absolutely right. I do not often read the letter column in The Times, but—

Dr Liam Fox (Woodspring, Conservative)

It was in The Guardian.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

The letter the hon. Gentleman quoted was in The Guardian, but there was a similar one in The Times yesterday. It is not a matter of some off-the-wall pressure group being paranoid about what the Government might or might not be doing, or an opportunistic Opposition trying to knife the Government in quasi-indignation. We are dealing with a provision that overturns the right of patients to own their information, which has been enshrined in medical practice since Hippocrates.

I always take with a slight pinch of salt the great indignation caused by the commercial activities of certain research establishments. After all, those organisations have to make a living, and it would be difficult for them commercially if the Secretary of State had the power to restrict information being sent out. However, I cannot understand why anonymised data should worry the Secretary of State, or why it has been included in this part of the Bill. There are two quite different issues at stake. One is the need for a system that allows cancer registries to continue to function, the other is the Secretary of State's apparent attempt to slip something through that overturns an inconvenient court judgment. That is not worthy of the right hon. Gentleman. I like to talk about matters of principle and that is definitely a matter of convenience.

I would also warn the Secretary of State, and I am sure that he knows, that most research nowadays, whether it is university research, multi-centre research or research in general practice, must get some of its funding, and often all of it, from commercial organisations. The whole structure of research now depends on industry putting in money and it is important that anonymised information is available to enable that research to take place. It is important that research ethical committees should have a say over how such information is controlled.

The Secretary of State may tell us that he would like to use local ethical committees for the control of anonymised information. I would not have much of a problem with that. However, he may tell us that the Department, centrally, wants the power to impose blanket bans on the use of anonymised information. I cannot see why that should be to the advantage of the Department of Health, unless it wants to set up an arm trading in information. It would be to the detriment of research. It would discourage general practitioners from using a research-based approach.

The first time that GPs get involved in any auditing or research is often when they do some post-marketing surveillance for drug companies. That surveillance is useful, provided that it is set up properly and has been evaluated, and is not just a way of getting GPs to prescribe a drug that is three times as expensive as another one that does the same thing. That used to happen, before GPs had to go to ethical committees for that sort of post-marketing surveillance. In carrying out such surveillance, GPs are often encouraged to look at things in a systematic way for the first time, and that has enormous consequences for auditing and clinical governance.

I do not understand the motivation, unless it is a purely commercial one on behalf of the Department of Health, for introducing total control over anonymised information. My concern is that the clause and the amendments do not place a requirement on the Secretary of State or any of his agents, such as clinicians, managers or administrators, to consult with the patient, who is the owner of the information. I hope that the Secretary of State will think about those issues after we have discussed the clause and its amendments in detail, and I hope that he will return on Report with something much more fit for the purpose and much more restricted in its scope.

Mr. Paul Burstow (Sutton and Cheam) rose—

Hon. Members:

Oh no, not another Front-Bench speech from the Liberal Democrats.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

Hon. Members' comments about the Liberal Democrats making two speeches on this group of amendments puzzle me, because the clause warrants a great deal of scrutiny, and there are many questions to ask. I regret the implication that we should not spend time on the matter.

Mr Philip Hammond (Runnymede and Weybridge, Conservative)

I speak on behalf of all members of the Committee, who were merely expressing surprise that the Liberal Democrats find it necessary to have two Front-Bench speeches on an endless sequence of clauses, when other parties manage with one Front-Bench speech for each group of amendments.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

I am interested in the hon. Gentleman's comments. I am sorry if he feels that the clause does not warrant two Front-Bench speeches. I am happy to make my speech from the Back Benches if that will help him. He ought to allow us to explore the clause in some detail, so I take it that he will make no further interventions. I am puzzled as to why he does not want us to explore the clause, as it warrants close examination. My hon. Friend the Member for Isle of Wight (Dr. Brand) made some specific points, and I want to speak to some of our amendments.

The Committee needs to consider further representations that have been made today. They add more weight to the case that the clause should not stand part of the Bill. I want the Minister to suggest that a certain process will take place after today's consideration of the clause, as representatives of many of the organisations listed by my hon. Friend and the hon. Member for Woodspring (Dr. Fox) have come to hear our deliberations today. They are alarmed about the powers that it will give the Secretary of State.

I ask hon. Members to consider the words in the Bill, rather than the words that any of us utter. They give sweeping powers to Ministers. The more I read representations and reflect on the clause and the explanatory notes, the more I think that I have not seen a clause drafted in such a way in my three years in the House. It appears to have no safeguards, limits or principles to govern its operation. That is why we have tabled some amendments on issues of public interest and patients' interests. The explanatory notes state that the clause should operate with regard to patients' interests. Will the Minister explain how he and the Department intend to translate that into practice? He must specifically tell us what principles will guide him in judging what is in the patient's interests when exercising powers under the clause.

Dr Liam Fox (Woodspring, Conservative)

It would not be acceptable for us simply to hear about the guidelines that Ministers will follow when they use the powers. It is unacceptable to have the powers in the Bill, because it gives the Secretary of State the freedom to use them on a whim at any time.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

The hon. Gentleman is right, and I suspect that none of us will be satisfied by what the Minister says. I hope that we will be, but I cannot see how, as there are no Government amendments to address our concerns. We must therefore hope to have some of our amendments accepted, or at least for the Government to table amendments at a later stage to rewrite the clause substantially. As it is currently drafted, the clause is far too wide. I want to solicit information from the Minister about the process of amending the Bill.

There has been no consultation or dialogue since a relevant court case. From my discussions with a variety of the organisations, and from reading the representations that have been made, it is clear that the clause was conceived within the Department and published just before Christmas and has not been the subject of any serious dialogue on how the power will be drawn up. That is surprising considering the nature of organisations that ought to have been consulted.

The Government say that they want to involve all stakeholders in the delivery of the NHS plan. They consulted extensively on many aspects of the NHS plan, but there was no consultation on clause 59. I refer specifically to the court case, which seems to be the starting point for our consideration of the clause. The interesting thing about the court case—apart from what their Lordships said in the judgment—is who was joined in the action and what they said. It is worth bearing in mind that it was not just a court judgment on the commercial activities of a commercial organisation gathering anonymous information. The General Medical Council and the Medical Research Council also decided that they needed to be involved in that case—[Interruption.] There are alarms going off in the building, and alarms should also be sounded in the Committee—[Interruption.]

On a point of order, Mr. Maxton, I seek your guidance as to whether we need to do anything as a result of the alarms.

Mr John Maxton (Glasgow Cathcart, Labour)

I believe that the procedure is that we wait for voice instructions.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

I also look forward to the Minister's voice instructions in due course. Perhaps the clause is all about instruction and direction.

In a press release that was issued by the Department to give reassurance on the issue the Minister said:

``The Data Protection Commissioner, who champions privacy rights, accepts that our safeguards will protect the interests of the public.''

Can the Minister tell us about that consultation exercise? What did the Data Protection Commissioner have to say about the clause? Will the Minister publish the consultation exercise and the resulting correspondence?

Dr Peter Brand (Isle of Wight, Liberal Democrat)

I should be grateful if my hon. Friend will elucidate whether the Data Protection Registrar restricts her control to electronically held data or whether she can also give assurances over information held in the more traditional pen and paper form?

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

That is an important point. Perhaps the Minister will say more about it in his response.

In the court case, it was clear that the concern driving the Government involed the control of the drugs budget and the cost of prescribing. The hon. Member for Woodspring has already quoted parts of the judgment, which effectively tells the Department that if it continues to view such schemes as operating against the public interest, the Government must take further powers in an already heavily regulated area to control or limit their effect.

The law of confidence cannot be distorted for this purpose.

In other words, the court told the Department that the area was already well regulated and that it should consider the matter further. If the Government believe the regulation is inadequate, they should have undertaken consultation and dialogue about how the regulations should be changed prior to the publication of the clause.

I want to pick up on the point about commercial information and whether it is a basis for deciding whether information should be controlled. Can the Minister talk the Committee through the reasoning that led the Department in the first instance to pursue the court action and then to decide—after two years' reflection—that the Bill was the right vehicle for introducing further controls. Our amendments attempt to provide further clarity, but we accept that adding them to the clause will not go to the heart of the issue. The point that comes across in the representations from various bodies is that the court took the view—on representations from the Medical Research Council, the General Medical Council and the company that was party to the action—that if information was anomymised at source, it could in no way cause harm to an individual through its release. Will the Government explain, therefore, why they are of the opinion that harm might be done, necessitating such draconian and sweeping powers to enable them to regulate and prescribe? Indeed, not only does the clause provide that general power; it even allows the Secretary of State to rewrite the definitions of what is to be covered.

I hope that the Minister's reply to the debate will be more than reassuring words and while the hon. Gentleman's amendment about consultation is welcome, the clause as drafted contains a requirement for consultation. It is not so much a matter of consulting on the details of implementing the regulation-making powers in the provision; it is the principle of whether the Secretary of State should take such powers in the first place.

I conclude by referring to the comment of my hon. Friend the Member for Isle of Wight. The current Ministers may not be there in perpetuity and we should surely be drafting legislation that makes its purpose clear from the outset rather than leaving it open to future Ministers to reinterpret it without coming back to this place with a more detailed piece of primary legislation to achieve their ends.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

We have had a useful opening debate. With your permission, Mr. Maxton, I should like to set out the Government's position on several issues in the clause because a number of the amendments range across various aspects of the clause. I welcome the hon. Member for Woodspring to one of his passing appearances in the Committee. He has shown an all too infrequent interest in the proceedings, but we are pleased to see him here this morning.

It is interesting also that both Conservative and Liberal Democrat Members have advanced the argument that while people have nothing to fear from a Labour Government, we should be worried about what Ministers of other persuasions might do with the legislation. I assume that they are thinking of what they would be obliged to do if they were given the powers. It is a purely hypothetical circumstance, but we are all in favour of the precautionary principle, however remote the risk might be.

It is right that there should be a detailed debate about the provisions in the clause. We are inevitably dealing with fundamental issues of privacy and patient confidentiality and it is important to go through all the matters involved. I believe that much of the speculation and concern that has been expressed this morning and over the last couple of weeks is misplaced. I hope that the amendments that we tabled ahead of the debate today have assuaged some of those concerns and that my remarks will provide further reassurance.

The clause has two main parts and three main purposes. Subsections (1) and (2) provide powers to regulate the disclosure and processing of patient information or information derived from such information. Our amendments limit those powers to commercial purposes. The Government believe that this is a new and much needed protection against the use of patient information for purposes that run contrary to the interests of the patient and the NHS. I will say a little more about that in a moment.

Subsections (3) to (9) provide for the Secretary of State to make regulations to require the flow of patient information in prescribed circumstances. That will enable us to achieve two aims. First, patients will receive more information about their own clinical care, in accordance with the commitment in the NHS plan. Secondly, it will be possible to safeguard the continued operation of essential services that currently rely on patient-identifiable information.

The clause does not outlaw independent reports on NHS services and it is not an attempt to restrict medical research. A fundamental point is that it does not signal any change to the Government's view about the importance of patient consent. That is a key point in today's debate. Informed consent is crucial to the Government's view of how a modern NHS should work. We cannot move to a patient-centred service if patients are not informed, consenting participants in the services they receive.

As we all know, the NHS does not always operate in the way that I have described. Much of what is done in the NHS relies on implied consent. That is sometimes appropriate, for example when information is shared within a hospital to ensure that a patient receives appropriate care, but at other times the definition of implied consent is pushed too far. We are determined to deal with that, but it is no small task. Not only the relevant legislation, but the culture of the NHS will have to change radically as we move away from past habits into practice based on real consent.

The professions have recognised the need to change the current approach to consent. The General Medical Council issued guidance last year making clear its view that informed consent is the only secure legal and ethical basis for disclosing patients' confidential information. They too recognise how great a change in culture and systems will be necessary to bring this about, and they will not attempt to enforce their guidance until October.The Data Protection Commissioner has also drawn attention to the need to improve the way in which the NHS seeks consent for the use of patient information and we have made a commitment to her that we will do so. We are tackling the relevant areas of concern and a comprehensive implementation strategy dealing with all aspects of consent for the use of patient information in the NHS will be ready by October.

My right hon. Friend the Secretary of State has made it clear that the provision has implications for more than the use of information. His remarks have been mentioned in Committee this morning. The NHS can no longer assume that the benefits of science, medicine or research are somehow self-evident regardless of the wishes of patients. The relationship between patients and the service today has to be based on informed consent. That will require changes in practice and policy.

Dr Liam Fox (Woodspring, Conservative)

Can the Minister answer two questions? If the Government's view of the matter is so comprehensive, why was that not included in the national plan; and why were none of the groups mentioned by the Minister consulted about clause 59 before the Bill was published?

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

Several Government amendments reflect our discussions with interested groups. The clause was drafted partly in response to concerns raised within the medical profession, not least by the General Medical Council, which issued relevant professional guidance.

Dr. Fox rose—

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

I have been fairly generous and flexible about interventions during the Committee's sittings. I have noticed from Hansard that on occasion, because of the resulting swings in the debate, I have not said all that I had intended to put on record. While that may not always be a matter of great concern, as some of the issues that we have debated have been widely discussed outside the Committee, I am anxious that the record should include all the points that I consider important for the House to know about clause 59.

I shall give way again, but I hope that hon. Members will understand if I try to avoid bobbing up and down to take repeated interventions. I want to read my prepared text, because the matter that we are considering is of great public concern, and many allegations have been made in the media. It is important for issues to be put on the record and not inadvertently omitted because the debate swings from topic to topic.

Dr Liam Fox (Woodspring, Conservative)

I want to press the Minister. The debate has been about consultation. We asked two questions, and we have a right to be answered; but the Minister, with his usual mastery of language, managed to avoid them. We want to know why it was not in the national plan, and why there was no consultation before the legislation was published. It is not good enough for the Government to say that they will consult on some of their amendments. There should have been consultation before the Bill was published, which is why many of the groups involved feel aggrieved.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

GMC guidance on timing was initially published in July, just before the NHS plan was finalised. The guidance to which we are attempting to respond will not be enforced until October 2001; it was issued in November 2000, well after the publication of the national plan.

We have sought to respond to the concerns expressed by the medical profession. Whether or not they were specifically dealt with in the NHS plan, the Government still need to address those issues in Committee. They cannot be put on one side for months or years, as though there was no external timetable. We have endeavoured to address the concerns of the professions, but we shall have to see as the discussion proceeds whether we have done so entirely. We are working with the professions to deal with their worries about the drafting of clause 59; and where appropriate we have tabled amendments.

Dr Doug Naysmith (Bristol North West, Labour/Co-operative)

I apologise for interrupting the Minister. Will he confirm that, immediately after the GMC's decision last July, the flow of information essential for cancer registries dried up and did not start again until that decision was put off for a further year? It is essential that information continues to be made available to cancer registries. It is suggested in some quarters that the provisions of clause 59 would make us the only country to impose such restrictions.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

My hon. Friend is right. He has highlighted some of the conflicts that the Government have to deal with.

Mr John Maxton (Glasgow Cathcart, Labour)

Order. That point is specifically covered in another group of amendments.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

We are attempting to square a number of circles; every position that is taken seems reasonable, but they do not all fit neatly together.

Making the changes needed in the NHS will be a huge task. We will need to identify where information is used, when it is appropriate to rely on implied consent and what we need to do to be more confident that we have the informed consent of patients. In many circumstances, traditional practice will have to change, either to gain consent or to use anonymised information rather than confidential information about patients, because it has always been done that way. That will take time, and it will cause some disruption to NHS services, but the principle is right and we must take action to address it. However, we cannot afford a disruption to the flow of information, because the cost to individual patients and the public would be too high. We seek to address those matters in the Bill by allowing patient information to be passed on lawfully without consent in prescribed circumstances. However, those circumstances will be reviewed each year and, as soon as we can, we will take away that support.

We do not take that step lightly, but we believe that it is essential. The need for some such powers is widely recognised, including by the BMA and GMC. Others have positively lobbied us to take those powers. We recognise the concerns that have been expressed about the scope of the powers provided under the Bill. Indeed, the Govt amendments seek to address some of the concerns that have been expressed by the GMC, the BMA and others. We have built rigorous safeguards into the Bill, and I am sure we will discuss these in depth later.

I shall set out the safeguards that will be in place if the clause is accepted. First, the use of non-anonymised patient information must be approved by Parliament, and we have made that subject to the affirmative resolution procedure--hon. Members will recognise that Governments do not usually do that when making regulations. The regulations must be positively supported by both Houses of Parliament. The Data Protection Act 1998 continues to apply in full, and compliance with human rights requirements is also necessary. Nothing in the Bill overrides those provisions that are already law.

The use of information must be for a medical purpose. The power does not support wider Government use of patient information. It must be used to improve patient care, or its use must otherwise be in the public interest. It cannot be used to determine the care or treatment given to a particular individual. There is no power to interfere in normal clinician-patient relationships. Specific obligations of confidentiality will be placed on the recipients of the information. There cannot be a reasonably practical alternative way of achieving the medical purpose. The use of the power must be reviewed annually, and if a cost-effective alternative has been determined, it must be adopted. That is a powerful series of tests.

There have been a number of suggestions, in the Committee and outside, that we are taking powers without safeguards. The hon. Member for Sutton and Cheam (Mr. Burstow) spoke of the whim of the Secretary of State. I do not believe that the clause allows the Secretary of State to act on a whim. Later, we will be able to debate in detail the process that would follow the enacting of clause 59. In particular, we shall discuss the consultation process for determining what mechanisms are used to apply the tests, and those who would be involved. Let me be clear that that process will include patient organisations and professional organisations. They must be built into the process of exercising the powers in the Bill.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

On that point specifically, will the Minister give an undertaking to table an amendment at a later stage to include in the Bill a requirement for the organisations to which he has referred to be consulted?

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

It might be helpful to examine the conclusions of the Data Protection Commissioner, who has considered the Bill. In her comments on this part of the Bill, the commissioner states:

``The Commissioner welcomes the process of consultation envisaged by the Bill and believes that this will provide patients as well as interested parties such as herself to have input into any proposals.''

Our view of the clause, shared by the Data Protection Commissioner, is that as it stands, we will need to consider patients' interests in drafting these regulations. It is worth saying at this point that the commissioner, who was consulted at an early stage, states:

``While the Commissioner is naturally concerned about any processing of personal data without consent, as these proposals will clearly allow, on balance she believes that in this particular case the issue of safeguards has been addressed.''

We can return to that in more detail in later amendments. The Data Protection Commissioner has examined the drafting of the Bill and on balance believes that the issue of safeguards has been addressed. I hope that that brings some balance to our discussions this morning.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

I appreciate the Minister giving way, and it is helpful that he is placing so much information on the record. However, in the interests of balance, will he explain why it was that, although he consulted the Data Protection Registrar, he did not consult professional interest groups such as the GMC and the BMA? Those groups have legitimate interests and concerns and should have been consulted.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

I do not have chapter and verse at hand, but the Data Protection Commissioner was consulted and involved in discussions in the early stages of the preparation of the Bill. I believe there to have been discussions with the General Medical Council and other interest groups about their concerns and their worries about abuse of patient confidentiality. The Government sought to take into account those concerns in the drafting of the legislation. I do not want to mislead people. That does not mean that every single line of every piece of legislation was a team effort, but in drawing up the legislation and instructing parliamentary counsel the Government have sought to reflect what we understood to be the concerns of those professional organisations.

On the amendments, subsections (1) and (2) give the Secretary of State a power to make regulations prohibiting or restricting the processing of patient information. That does not, as has been suggested, ban all disclosure or processing of information with the Secretary of State's consent. On the contrary: it allows for information to be disclosed and processed unless regulations have been made to the contrary. In simple terms, subject to other legislation such as the Data Protection Act, everything is permitted unless regulations have been made preventing it. Because of subsection (9), which applies to all regulations and not only those pertaining to the second part of the Bill, no regulations can be made until there has been consultation with bodies representing the interests of those affected.

As hon. Members have correctly surmised, the need for the clause became apparent as the result of a judicial review brought against the Department by a company called Source Informatics. Source was subsequently taken over by a company called IMS. In 1997, both Source and IMS, which at that time were competitors, began collecting information from GPs and pharmacies about doctors' prescribing habits in order to build up databases. The intention was —and I am using words that Source used in its evidence, so there is no dispute about this—that the database would primarily be used by pharmaceutical companies to allow them to target more precisely promotions and communications regarding their products.

The Department was concerned on two counts: first, that targeted marketing would increase the pressure on GPs to prescribe higher cost medicines unnecessarily; and, secondly, that passing on information about the medicines prescribed to a patient, even though the patient was not identified, was a breach of confidence. We sent a document to GPs and pharmacies warning of the legal risks and strongly discouraging disclosures on policy grounds. Source Informatics sought judicial review of that document. To cut a long story short, although the Department's case was initially upheld, the Court of Appeal decided that there was no breach of confidence or of the Data Protection Act.

Therefore, at present, anonymised information about a patient's health can be used for such commercial purposes and to put pressure on doctors to prescribe unnecessarily expensive medicines. Source Informatics envisaged that use of its database would result in improved efficiency for pharmaceutical companies. That is capable of interpretation. How much more efficient can a rep trying to sell medicines to a GP be if he knows that he or she already uses some of the company's products but in other therapeutic areas chooses cheaper, but equally effective, products? The type of targeting and the possible consequences are clear.

Of course, not all higher cost prescribing is bad prescribing. Of course, some doctors persist in using old-fashioned remedies when modern ones are far better. Of course, some doctors should perhaps be prescribing more of certain types of medicines. However, we are almost uniquely fortunate in this country in having comprehensive data about dispensed medicines. That information can be, and is, used by advisers employed by health authorities, primary care groups and trusts, and, increasingly, by GPs themselves to improve the quality of prescribing. Their advice is objective, impartial and in the combined interests of patients and the NHS. That cannot be the case for individual pharmaceutical companies or others with a commercial interest.

I have concentrated on prescribing information, because that is, as I said, the context in which the need for the power arose. However, similar considerations could apply in other areas where NHS expenditure is involved: for example, medical equipment. That is what this part of the clause is about. It is not about banning people from asking awkward or, indeed, perfectly sensible questions about the operation of the NHS, and it is certainly not about stopping independent assessment of the performance of the NHS. It is about preventing damage, especially financial damage, to the NHS through the use of information about patients.

We have listened to those who considered that the power as originally drafted was too widely drawn. Government amendment No. 334 restricts the regulation-making power so that regulations can only be made prohibiting or restricting the processing of patient information for commercial purposes. Government amendments Nos. 335 and 336 are consequential amendments. In particular, Government amendment No. 335 removes subsection (2)(a), which makes particular provision for restricting the use of anonymised patient information, so that it can be protected in similar ways to those by which identifiable information is protected under the Data Protection Act 1998. We have decided that we should regulate to restrict the processing of information for commercial purposes only, and regulations should be framed with that in mind. Government amendment No. 336 flows from the deletion of subsection (2)(a).

We considered various ways in which to amend the clause to reflect our intentions more precisely, and this seems to us to be the best fit. We are seeking powers to prevent the undesirable processing of information, and there will be a strong financial motivation to find a way round these restrictions. We had to strike a balance between allaying the fears of those concerned about the breadth of the powers as originally drafted, and reducing the risk of challenge to the use of the powers when it would be in the interests of the NHS to do so. We needed a form of words that was as clear as possible and that would allow little room for dispute about meaning. ``Commercial purposes'' is a phrase that appears in other legislation, such as the Town and Country Planning Act 1990 and various Finance Acts.

I accept that the power remains quite broad, but I have explained why too narrow a power would run the risk of not achieving its intended effect. We have no intention of preventing all commercial use of patient information. The amendment allows us to set out in regulations the commercial purposes that are affected. For example, we may want to prohibit the processing of certain patient information for the purpose of marketing goods and services to the NHS. It is difficult to envisage circumstances in which we would want to prohibit a company, such as a pharmacy, from using data from dispensed prescriptions for managing stock.

Amendment No. 319 would restrict or—if Government amendment No. 334 is accepted—further restrict the Secretary of State's powers under subsection (1) to make regulations prohibiting or restricting the processing of patient information. I have some sympathy with the sentiments underlying the amendment. I hope that that is apparent from what I have already said. The Government have no intention of introducing regulations that would run counter to the various worthy matters referred to in the amendments. Indeed, our intentions are, broadly speaking, quite the contrary. We want to be able, if necessary, to prevent patient information from being used in ways that would adversely affect the operation of the NHS in areas such as diagnosis, care and treatment.

I do not think that it would be right to include such detailed provisions in the Bill. I have some concerns about creating a lawyer's paradise. I fear that the amendment tabled by the right hon. Member for North-West Hampshire (Sir George Young) would do just that. When considering what amendments to table in response to the concerns that have been expressed about this part of the clause, I thought very carefully about the possibility of restricting the regulation-making powers to information that would be detrimental to the interests of the NHS or patients. I concluded that that would allow too much scope for legal argument.

I am happy to assure hon. Members that our intentions are wholly in line with the spirit of the right hon. Gentleman's amendment, but I cannot advise the Committee to accept it.

Amendment Nos. 286 and 228, taken together, would require, rather than permit, regulations to be made under subsection (1) prohibiting or restricting the processing of patient information, but would restrict this requirement to circumstances in which it was determined to be in the interests of patients. I am sympathetic to the proposition that regulations prohibiting or restricting the processing of information should be in the interests of patients, but I also think that the interests, including the financial interests, of the health service more generally need to be taken into account. It would not be right to require regulations to be made. We should regulate in this area only if and when it is necessary. We would prefer to proceed by discussion and agreement whenever possible.

The remaining Liberal Democrat amendments would, when taken together, entirely change the character of subsection (2). As it stands, and will stand if Government amendments are accepted, this subsection makes specific provision for regulations such as may be necessary to achieve the purposes that I outlined earlier: that is, to prevent damage, in particular financial damage, to the NHS through the use of information about patients. These amendments would change the purpose of the subsection completely. They would require regulations to be made ``in the public interest'', prohibiting the processing of such patient information as the regulations may prescribe from being processed without the patient's knowledge and consent. The provisions relating to terms of employment and other arrangements made by health service bodies and the provisions relating to offences and enforcement would relate to that—or at least, I suspect that is the intention, although they could still be used for other purposes. These amendments take us into areas relating to consent that we shall be debating at length a little later.

Amendment No. 231 would remove subsection (2)(b), which relates to the imposition of conditions on the disclosure or processing of information. The Consumers Association is concerned that the subsection will allow the processing of information from which a patient could be identified—albeit subject to conditions. That is a further inroad into the protection of confidential patient information. It also thinks that the subsection is unnecessary in order to achieve our policy aims.

The subsection is necessary. We need to make it clear that there is a middle way between releasing information and not releasing it. For example, we may wish to release information for research purposes subject to the condition that it should not be used for certain commercial purposes. The focus of subsections (1) and (2) is not on the disclosure of information, but on the prohibition and restriction of disclosure or other processing of information. Our intentions are the opposite of what the Consumers Association fears. We do not intend to use the subsection to free up information from which patients could be identified. Indeed, a condition could be imposed to anonymise and to aggregate information to ensure that individuals could not be identified. Nothing in the clause allows us to override the Data Protection Act 1998.

Amendment No. 323—unlike the other amendments mentioned so far—is not concerned solely with the provisions of subsections (1) and (2). It would introduce a general requirement to undertake consultations and to publish a report on the consultations and the conclusions as to what regulations may be required—whether under subsections (1) or (3) of the clause. The amendment is unworkable and unnecessary. It is unworkable because it assumes that at any one time it is possible to make a judgment on what regulations are required. That is clearly not possible: circumstances change and the need to regulate or not changes with them.

The amendment is unnecessary because the clause already provides for consultation with bodies that represent the interests of those affected by any proposed regulations. Regulations can—and under some parts of the clause must be—debated by Parliament. Therefore, it will be necessary for the Secretary of State or Ministers to justify regulations either under the affirmative procedure or under the negative resolution procedure if they are prayed against.

Dr Liam Fox (Woodspring, Conservative)

It is clear that the consultation on these measures that the Government believe has taken place is similar to the consultation on the abolition of community health councils. Members of the Committee would not recognise it as meaningful consultation. The Government, having been defeated in the courts, are now taking legal powers that go well beyond those required for the purpose. No proper consultation was held. The final nail in the coffin of the Government's argument was when the Minister said he had some sympathy for the sentiment expressed in the amendments. When Ministers say that it is code for the fact that they know they are on a sticky wicket. However, sentiment is not enough when it comes to the law, so we shall press the amendment to a Division.

Question put, That the amendment be made:—

The Committee divided: Ayes 7, Noes 9.

Dr Liam Fox (Woodspring, Conservative)

I beg to move amendment No. 326, in page 51, line 39, leave out from `expedient' to end of line 41 and insert

`for the purpose of maintaining Cancer Registries.'

Mr John Maxton (Glasgow Cathcart, Labour)

With this it will be convenient to take the following amendments: No. 331, in page 51, leave out lines 40 to 43 and insert

`for the purpose of disease registries in accordance with subsection (3A).'.

No. 333, in page 51, line 43, at end insert—

`(3A) For the purposes of this section the Secretary of State may make regulations specifying the purposes of disease registries including—

(a) the collection of demographic information about each case of a disease specified in the regulations;

(b) the collection of administrative information, including date of diagnosis and source of information;

(c) the collection of information (however recorded) which relates to the physical or mental health or condition of an individual, to the diagnosis of his condition or to his care or treatment; and

(d) other information (however recorded) which is to any extent derived, directly or indirectly, from such information.

(3B) Where regulations under subsection (3A) make provision for the establishment of a disease registry, the Secretary of State shall in regulations make provision for—

(a) the protection of the confidentiality of all prescribed case data reported to the disease registry, including a prohibition on disclosure to any person of information reported to the disease registry that identifies, or could lead to the identification of, an individual patient, except for disclosure to other disease registries;

(b) a means by which confidential patient data may in accordance with Schedules 2 and 3 of the Data Protection Act 1998 be disclosed to prescribed persons for the purposes of disease prevention, control and research;

(c) a means to assure complete reporting of the prescribed disease cases to the disease registry by health service bodies with respect to the prescribed disease.'.

Dr Liam Fox (Woodspring, Conservative)

The amendment would remove the open definitions in subsection (3)(a) and (b), and add to the Bill the specific intended purpose of ensuring that the good work of cancer registries can continue.

The disclosure of information without consent cannot be taken lightly. The clause enables the Secretary of State to make regulations requiring or regulating the process of prescribed patient information for medical purposes as he considers necessary or expedient

``in the interests of improving patient care, or...in the public interest''.

In effect, that gives the Secretary of State unprecedented powers to override confidentiality between doctors or pharmacists and patients. The amendment would make the perceived intentions of the Secretary of State explicit in the Bill. It would acknowledge the important function of maintaining cancer registries and doctor-patient relationships at the same time.

The Liberal Democrat amendments Nos. 331 and 333, which are supported by the British Medical Association, seek to achieve a similar goal for disease registries. As I understand it, their wording is based on the statute of the United States on the establishment of cancer registries.

The United Kingdom Association of Cancer Registries is in favour of clause 59. It claims that the national system for monitoring cancer would have collapsed by the end of the year without enabling legislation. We all understand its problems. However, if clause 59 is designed to assist the cancer registries, why does it have such a wide scope? Our amendment may be simplistic, but it seeks to ensure that the national system survives, and that the Bill clearly states the purposes of the provisions.

We recognise the benefits to the whole community of unbiased, high-quality information about the outcomes of cancer treatments and screening programmes. Cancer registries have performed important work in monitoring the higher cancer rates, for example, of children living near nuclear installations, the mesothelioma caused by asbestos and the wide variations in cancer treatment outcomes around the country. We all pay tribute to that work.

Cancer registries are the only source of information on how many people suffer from cancer and how long they live after diagnosis. If we are to move to targets based on the outcomes and success of the NHS, rather than input targets, the survival of the registries is essential. Their staff have collected, stored and analysed identifiable data on millions of cancer patients for more than 40 years, without once breaching the duty of confidentiality owed to those patients. If I am wrong about that, I am sure that the Minister will correct me. The cancer registries have been at the forefront of developing protocols to ensure that data are safely held.

In late 2000, General Medical Council guidelines were issued and caused a great deal of trouble for the cancer registries. As the hon. Member for Bristol, North-West said, there was a decline in notifications to the registries. That problem must be addressed. Although we are sympathetic to the Government's aims on the issue, we believe that the powers that they are taking to deal with the situation are unnecessarily wide.

I visited the Roy Castle centre for lung research in Liverpool last week. It is a good example of why we must get the provision right. It has identified people at risk of lung cancer who would benefit from prevention and early detection programmes. The study requires not only epidemiology and molecular genetics knowledge, but large population-based studies. As the lung cancer cases being studied may present at any of six NHS trusts, they may involve many consultants. Ethical approval was granted by three local research ethics committees in 1997. At that time, and with the clinicians' agreement, it was acceptable to access a minimum of patient information without prior consent. That would allow possible subjects to be approached without causing widespread distress.

We must ensure that we find the right balance. There is a clear public interest in protecting doctor-patient relationships and the information therein. I would like the Minister to address the amendment specifically, as it would make the intended purpose clear in the Bill. We believe that the powers granted in the clause are of undue scope. Both sides of the Committee agree that a problem exists and needs to be dealt with, but the powers' effect would be far wider than that. The question to be decided is what is appropriate and proportionate and I hope that the Minister will address that.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

Amendments Nos. 331 and 333—and my hon. Friend the Member for Isle of Wight and I are grateful to the BMA for its work on them—are intended to deal with a serious issue, and to enable the Committee to explore why the clause should be so widely drawn. A reason that has been advanced for its general approach is the facilitation of the production of cancer registries. The explanatory notes refer to the GMC guidance, which, it is implied, casts doubt on the potential for sharing relevant information for that purpose.

We were anxious, in preparing the amendments, to establish clearly a set of procedures that would deal not just with cancer registries, but with any disease registries that already exist or might be needed in future. We wanted the Bill to include procedures enabling the conditions or diseases in question to be prescribed, and the compilation process to be specified in regulations, subject to consultation.

As the hon. Member for Woodspring said, the origins of the clause can be found in United States law. We are not approaching the problem from thin air, but attempting to construct workable law. Our proposal is demonstrably practicable because it is in use in America. I hope that the Minister will accept a route that clarifies the Bill and establishes a clear mechanism for achieving what Committee members on both sides would want—the acceptance that it is appropriate, in the context of disease registries, for information to be made available, with safeguards. I look forward to hearing why a general power to allow that is preferable to the specific powers that the amendments would permit.

Dr Doug Naysmith (Bristol North West, Labour/Co-operative)

I should say, Mr. Maxton, that this is the debate to which you were referring when you ruled me out of order earlier. I did not challenge your ruling. I was trying to point out the justification for clause 59, which the hon. Member for Woodspring was arguing had not been sufficiently discussed.

I am in an interesting position, because I agree with most of what has been said by Opposition Members in moving their amendments. It is crucial that disease registries should be maintained. As someone who spent most of his life—when I had a real job before I came here—doing medical research, much of it related to cancer, I know the importance of maintaining the registries. That does not apply only to cancer registries, although they are the worry of the moment. I shall want my right hon. Friend the Minister to provide assurances about this when he replies. Perhaps I shall even vote for a Conservative or Liberal Democrat amendment, which would really be news.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

This debate has been slightly more temperate than the earlier one—[Interruption.] I shall give way to the hon. Member for Isle of Wight if he wants to lower the tone.

The starting point of our discussions should be the consensus that exists in Committee about the fact that there are some undertakings for which informed consent cannot practically be obtained at present, but which are so important that they should be allowed to continue. Cancer registries are clearly among those. What we are really debating in relation to this group of amendments is whether the Government have taken the right approach to defining the scope of the provision, or whether it should be defined very narrowly in the way that is proposed in the Conservative amendment with a list of specified registries? I know that in practice the hon. Member for Woodspring does not mean to refer only to cancer registries, but whether we should take Conservative approach of having a specified list of activities, the slightly broader approach of the Liberal Democrats which would define a set of activities while not actually listing them, or the Government's approach.

It is important for me to explain why, after a great deal of thought and consideration, we have taken the approach that we have to drafting clause 59. In so doing, it will be useful to set out the process that we intend to follow after the enactment of the clause so that hon. and right hon. Members can see how the whole system is designed to work.

It is clear from the amendments and the debate that there are circumstances where it is justified to override the basic requirement that confidential patient information should be disclosed only on the basis of informed consent. It may be because the public interest requires it or, as with notifiable diseases, because of existing requirements in law. I believe we all agree that the exceptions from this requirement should be limited. I want to make it clear that the Government are not seeking a replacement for informed consent as the basis for the release of confidential patient information.

The Government propose to set out a clear, transparent process whereby decisions can be reached on the merits of each case, following consultation with those likely to be affected by the regulations laid under these powers. Rigorous safeguards on the use of the powers are built into the process and the Bill. I will mention some of those safeguards again.

First, any regulations that would be subject to affirmative decision by both Houses of Parliament would need to pass two clear tests: first, that the regulations were in the interests of improving patient care or in the public interest; secondly, that it was not reasonably practical to meet the need for disclosure of patient confidential information in any other way.

I shall set out the process in as much detail as I can. We would initially set up an advisory group to design and document the process of implementing clause 59(3). Patient organisations, the GMC, the BMA, the Academy of Colleges, the Data Protection Commissioner, research and public health communities and others would all be represented. That would enable us to work out in detail, through consultation, the mechanism for enacting clause 59(3).

Clause 59 provides that the power may only be invoked for a medical purpose—either to improve the care and treatment of patients or in the public interest— where the purpose is not to determine the care and treatment given to specific individuals and where there is no reasonably practical alternative way of achieving the purpose. It will also be necessary to demonstrate that wherever the power is invoked to support a specific activity, the Data Protection Act 1998 and the Human Rights Act 1998 are complied with.

Those requirements will necessarily form the backbone of any process of determining whether the power should be invoked, but they need to be fleshed out and added to, as the hon. Member for Sutton and Cheam said this morning. We want the advisory group to which I have referred to assist us in that process, but I am sure that it would need to look at a number of factors such as assessing the value and quality of the activity involved, the standards required, the fact that reasoned arguments by patient consent should not be sought, and the assessment of other practical or potential alternative ways of conducting the activity without access to confidential information, including an assessment of barriers and costs.

We want to establish a position where applications to utilise clause 59(3) should use an agreed template to make sure that all aspects of the testing process are effectively addressed. We envisage that applications would need to be submitted to a central point, which is likely to be the information policy unit of the NHS Executive.

Having set up the process, the next stage would be for applications to be considered by an expert committee, which would be relatively permanent. We are working out the detail of how it would operate. Clearly, it would require the participation of the groups to which I referred earlier, to ensure that the Secretary of State received expert advice before making regulations under the provisions of clause 59(3). In addition to dealing with what is explicit in the legislation and identifying the requirements that the Secretary of State must fulfil, the process must be backed up by advice to the Secretary of State.

Mr Paul Burstow (Sutton and Cheam, Liberal Democrat)

New and helpful information is emerging, but will the Minister say more about the process? An expert group will undertake the evaluation and submit its opinions to the Secretary of State before he exercises the powers in the clause. Will there be a requirement for the Secretary of State to set out his reasons for setting aside the opinions of the expert group? Will there be any further transparency in the process, at the point at which it reaches the Secretary of State? If so, will that be in the Bill?

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

Effectively, it is in the Bill, because any regulations will be subject to affirmative procedures of both Houses of Parliament. The regulations will not need to be prayed against. They will have to be tabled by the Secretary of State and debated in Committee, and potentially on the Floor of the House and in another place, and the regulations will have to be voted on before they can be put in place.

The procedure is a powerful safeguard. It is relatively rare, and takes up precious parliamentary time. It means that there will be public scrutiny, and Ministers will have to justify the approach taken by the regulations, both in the House and in the other place. I am sure that as part of that process, the Secretary of State would want to make it clear how he had arrived at his conclusions. It is not just a matter of the Secretary of State publishing a piece of paper that explains his actions. He, or one of his Ministers, will have to come to the House to justify the position. That is a powerful safeguard. It means that the Secretary of State will have to be cautious about rejecting advice.

There will be consultation on the regulations, as was said earlier. Our intention is that regulations will not be permanent. The clause places an obligation on the Secretary of State to review annually whether the case for them can still be made. The NHS's position is not static. We are constantly extending our investment in information technology, such as electronic patient records. All such devices make if far easier to anonymise patient information than it has been in the past. Even if the Secretary of State were justified in using the powers under clause 59(3) today, he might not be justified in doing so in one or two years' time. In future it might be possible to deal with the problem either on the basis of informed consent, or on that of anonymised data. We have sought to build a series of protections and hurdles into the Bill.

Mr Philip Hammond (Runnymede and Weybridge, Conservative)

In his last remark the Minister clarified the point that I wanted him to clarify. I thought that he said that regulations made under clause 59 would be subject to the affirmative procedure, but in fact only those made under subsection (3) will be subject to that procedure.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

The hon. Gentleman is right. We had to get the balance right. It is right that the most serious test should apply to the most sensitive issue, which is that of the use of patient information without informed consent. It was clear to us that such a test should apply to this part of the Bill. The same issue does not arise in the case of anonymised patient information, where although the considerations are serious enough to warrant the use of the powers, it is essentially a matter of protecting the financial interests of the NHS.

I hope that I have explained that the regulations are not intended to provide an easy way around the need to seek informed consent. They are safeguards to protect essential data flows as the NHS makes the transition to a service that operates on informed consent to the use of information. That is why subsection (6) requires the Secretary of State to review the regulations annually to determine whether they are still appropriate. If the regulations fail the tests set out in the review they will be revoked. We intend to make the outcome of the reviews public on an annual basis. Therefore, the regulations will have had to be approved by both Houses of Parliament under the affirmative procedure and the Secretary of State must review them after a year. He will have to make public whether he has decided that they should still apply or that they are no longer necessary and should therefore be revoked. As I mentioned earlier, the Data Protection Commissioner has, on balance, approved this approach to protecting patient interests.

The amendment proposed by the hon. Member for Woodspring narrows the use of the power so that it can be used only to require patient information to be disclosed to cancer registries and to regulate how they might subsequently use the information. I accept that in the public debate around the clause the example of cancer registries has probably been the most widely quoted and discussed. The fact that cancer registries are important should not free them from the obligation to satisfy the tests set out in the Bill. In other words there is no reason to say that because it is a cancer registry we should not explore over time whether it can use anonymised information. Under the amendment, cancer registries would not be subject to that test, and that would not be right. All registries should have to undergo the test. The amendment is restricted to cancer registries, but other disease registries should also be included.

The amendment tabled by the hon. Member for Sutton and Cheam suggests a slightly wider approach limiting the power to all disease registries. First, not all disease registries need to use patient-identifiable information. They too should be subjected to the testing process. If they do not need to use patient-identifiable information, they should not be permitted to do so. A greater difficulty is that the amendment would rule out the use of regulations to guarantee information flows to anything other than disease registries. That could rule out some vital projects. The Medical Research Council, in its sensible confidentiality guidance, cites research into possible links between parental mental illness and unexpected child deaths as an example of an area where consent may be unattainable. The Oxford register of attempted suicides is another example of a subject where consent may be difficult. It has proved to be a key piece of work in demonstrating the link between the open supply of paracetamol and successful overdoses. That led directly to restrictions on the amount of the drug that can be purchased at any time.

I do not know whether those two examples would pass the test that we have set out in the clause. They would have to go through the proper process, but they demonstrate the difficulty of putting the sort of restrictions that the hon. Member for Sutton and Cheam seeks into the Bill. We wanted to put something specific into the Bill that would meet the present needs of the NHS without inadvertently excluding something that would turn out to be a great patient benefit. That is why we have cast the legislation more broadly than the amendment and have built in a series of quite tough safeguards concerning the use of the legislation in practice.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

Will the Minister go through the process that he envisages in the two examples because we are now into the hard facts? This is no longer a decision based on the hard facts. It is no longer a decision for the ethical committee, but for the Secretary of State via affirmative action by both Houses of Parliament. The two examples that the Minister has cited do not justify passing on confidential information against the patient's wishes, particularly in view of the subject of research.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

Let us assume that we have moved forward a few months and, by working with the organisations that I mentioned earlier, a detailed template of issues to be taken into account by any application for a registry has been worked out. Anyone wanting to run or maintain such a registry would have to apply, and failure to do so would render them outwith the provisions of the clause.

In the first instance, an application should be made to an expert advisory committee, which would consider the application against the criteria in the template and advise the Secretary of State on whether regulations should be made. The advice will be made public, so people will know what the Secretary of State was told. If, following the guidance of the expert advisory committee, the Secretary of State is persuaded that regulations should be made, draft regulations will be published, setting out how the register will operate and including any necessary safeguards. Public consultation on the draft regulations would then follow before the Secretary of State tabled regulations that would be subject to the affirmative procedure of the House. That is how I envisage the process.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

That was extremely helpful, but I remain unsure whether the regulations will allow group actions to establish registers, or whether every individual research project requiring a register will be subject to the procedure.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

In practical terms, the Secretary of State must be able to include a broad group of activities or circumstances within a set of regulations. It is difficult to assess precisely how many registers will exist for how many activities at any particular time, but the agreement of both Houses of Parliament will be required, which is a sensible procedure. The scheme will be broader than requiring regulations for each individual activity.

The expert advisory committee will advise the Secretary of State on the wider range of issues and requirements—not expressly built into the Bill—that must be taken into account. It will be a probing body and, to respond to the recent point raised by the hon. Member for Isle of Wight, it will be able seriously to challenge whether the use of patient information is justifiable in a particular case. An alternative way of carrying out the exercise, using anonymised information, may be possible. The body will be able to challenge institutional laziness—doing things in a particular way, simply because it has always been done that way in the past—in the NHS.

I hope that the Committee is reassured about the Bill's safeguards on the use of this power, and that I have argued effectively in favour of assessing matters on a case-by-case basis and in favour of real consultation with the NHS, patients and their representatives.

Dr Liam Fox (Woodspring, Conservative)

The essence of this group of amendments is simple. There is a consensus in Committee that disease registers must be maintained. At issue is whether the powers in the Bill will allow that to happen. Our view is that the powers are much too wide for the reasonable and desirable purposes that the Minister expressed.

What the hon. Member for Sutton and Cheam described as the helpful new information being made available to the Committee might equally be described to anyone outside as an example of ``making it up as you go along''. Perhaps that information should have been made widely available before the clause was debated or, indeed, before any legislation was proposed. Details of exactly how the process will work should have been made available not only to the Committee, but to the House and interested groups outside, so that they understood how any replacement of the current arrangements would be put in place. We have not had enough detail or enough time to consider the matter.

The Bill is being rushed through while we are being given bits of detail. It is still not clear to the Committee exactly what the Minister meant in several interventions. Although we all believe that registries need to be maintained, the whole process in which we are involved is an unsatisfactory way to legislate. The explanatory notes on the clause say that further guidance will be issued. That is simply not acceptable to most of us.

The Minister said that the Government wanted to open themselves up to scrutiny on secondary legislation. He has many talents, but I did not realise that comedy was one of them. The idea that the Government want to open themselves up to scrutiny, particularly on secondary legislation, is laughable to anyone who has been in the House of Commons for the past four years.

I understand the Minister's arguments about specific amendments, but I am not satisfied with his general argument. We have made our point and will seek to amend the clause later in the Bill's passage through Parliament to take into account the arguments made in Committee, notwithstanding our intention to vote against clause stand part. Under those circumstances, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Dr Liam Fox (Woodspring, Conservative)

I beg to move amendment No. 325, in page 51, line 44, leave out subsection (4).

Mr John Maxton (Glasgow Cathcart, Labour)

With this we may discuss the following amendments: No. 332, in page 51, line 44, leave out from `Regulations' to `under' in line 36 on page 52.

Government amendment No. 337.

No. 233, in page 52, leave out lines 1 to 6.

No. 234, in page 52, leave out lines 7 to 11.

No. 235, in page 52, line 18, leave out from `regulations' to end of line 19.

No. 328, in page 52, line 18, leave out `the cost of and'.

Dr Liam Fox (Woodspring, Conservative)

Amendment No. 325 would delete clause 59(4). If, as the explanatory notes suggest, subsection (4) is intended to implement the NHS plan commitment that

``letters between clinicians about an individual patient's care will be copied to the patient as of right''

that should be explicit in the Bill. Its wording is confusing on that and many other issues that we have considered this morning.

We also need detail about the practical arrangements. For example, how will correspondence be communicated to a patient? The normal mail service may not be appropriate if the recipient wishes to keep his visits to the doctor secret from those who share his postal address. The phrase

``to whom the information relates''

in lines 47-8 is too vague. The BMA gives an example: if the information contains genetic information of relevance to other family members, they could be understood to be included in the definition.

The wider and perhaps most important issue is the potential clash of confidentiality. A doctor may be asked to disclose information about his patient, but believe that doing so is against the patient's interest. According to other measures in the clause, however, the Secretary of State may think that disclosing the information is in the public interest. The doctor faces being in conflict on one hand with the GMC and his own ethical guidelines, and on the other with the law. The medical profession will be placed in a difficult position. Although we do not have much time, this is one of the most important issues that we have considered during the Bill's passage. I want to give the Minister enough time to respond in detail to the serious reservations that many interested groups have expressed about that potential clash.

Like the hon. Member for Bristol, North-West, I had a real job before entering the House. Leaving aside my current role, I think that doctors will look for guidance on this important ethical issue. Will a doctor's first duty always be not to disclose information that could be harmful to his patient or must he act in accordance with the law and the powers set down by the Secretary of State, which he might believe were being used in a way that was detrimental to his patient? That is a very serious issue, and I look to the Minister for clarification.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

I share the concern of the hon. Member for Woodspring about subsection (4). Although I support the Government's approach to sharing information with patients, the drafting of subsection (4) could have some untoward effects. Patients should have the right not to receive information that they do not want. The subsection does not give that option, but requires that certain information must be shared. There is also a practical problem in that where a referral communication arises—to an orthopaedic department, a psychiatric department or a family therapy department—in connection with family problems, information about alleged activities by other family members has to be given for that referral to be meaningful. Does the subsection require that family members should also have a copy of the communication? If so, it would make the work of refuges for battered women, for example, virtually impossible because such information would be freely shared with people with whom it would be undesirable to share it. The same would apply to cases of child abuse, which quite commonly occurs in families, as we all know. Should people be obliged to pass on suspicions about a perpetrator who is a family member directly to a family member—as well as dealing with the child—before the case has become the subject of police inquiries? Although we support the concept of openness with patients, there are technical difficulties with the drafting of the subsection.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

The hon. Member for Woodspring said that we had little time. We have until 5 o'clock this afternoon—there is no reason for the hon. Gentleman not to come back after lunch, but perhaps he is under pressure to be somewhere else.

The group of amendments seeks to make changes to subsections (4), (5), (6) and (7). Alterations to the subsections will not remove the Secretary of State's basic power to make regulations requiring or regulating the disclosure or processing of confidential patient information. The subsections do not provide the basic power, but make clear how we propose to use that power and the safeguards we intend to put in place.

Amendments tabled by the hon. Member for Runnymede and Weybridge (Mr. Hammond) and the hon. Member for Sutton and Cheam seek to remove subsection (4). That would have three important consequences. It would make the extent of the powers in subsection (3) less clear and in particular would remove the provision outlining how we might require doctors to pass on information to their patients. We believe that that is a key issue and that patients should have more information about their care. The provision will allow us to deliver the NHS plan commitment to ensure that clinicians' letters are copied to the patient. It will also allow the question of whether processing confidential patient information, through regulations laid under subsection (3), is lawful and will prevent the establishment of offences in relation to regulations under subsection (3).

Amendment No. 332 goes further and would remove all the safeguards we have built in to the clause, including the provision ensuring that use of the power cannot directly impact on an individual's care and treatment and that the power to require processing of confidential information should be used only where there is no reasonably practicable alternative. It also stipulates that the use of the power should be annually reviewed. We have striven to build in effective safeguards for patients and were reassured by the comments of the Data Protection Commissioner.

Amendments Nos. 235 and 328 would have the effect of making it debatable whether cost can ever be used as a justification for not adopting a reasonably practical alternative to the use of confidential information. Although one might argue that the term ``reasonably practical'' may encompass cost, the amendments would make it a matter of argument. Where costs have to be met out of funds that might otherwise be used for patient care, of course the cost of alternatives must be a consideration.

Finally, Government amendment No. 337 clarifies to whom information relating to a particular individual may be copied. It is needed because the original wording might be construed to mean that the information ``confidential to one patient'' might legitimately be copied to others to whom it also relates in some way. Although other people may have a legitimate need to be informed about something that has an impact on their own health, they should not be informed through receiving a copy of someone else's confidential details. The amendment makes it clear that the information should be released only to the individual to whom it primarily relates, or to a designated person, such a parent, it if is not appropriate to send information directly to the individual. The amendment addresses a specific concern raised with us by the BMA, which we are happy to take on board.

The hon. Member for the Isle of Wight made some sensible observations on the need to consult carefully and widely with the profession about the use of the power to make sure that we get the regulations right. It is the right direction to move in to make sure that patients receive more information about their treatment than they have previously received. There are clearly complex issues about the flows of information and what is appropriate under certain circumstances, particularly in regard to third-party information. Those issues will need to be covered carefully in regulations. It is not desirable to include in the Bill or to consider in Committee today every conceivable issue that can be raised—the hon. Gentleman mentioned a couple of examples. I acknowledge that there are important issues that we will need to work through carefully with the profession to make sure that we get the regulations right. It is necessary as part of the proper extension of patients' rights to their own medical information to ensure that certain basic rights are set out in the Bill. The hon. Member for Isle of Wight asked if that meant that patients would have to receive information that they did not want. Clearly, one would not want to be in that position and that is why the regulations will have to be very carefully framed.

Dr Liam Fox (Woodspring, Conservative)

We feel that this is another part of the Bill that is far too widely drawn. When the Minister says that the Government need to consult widely about the use of that power, that only reinforces our impression that it has not been properly thought through, and is yet another part of the ``make it up as you go along'' legislation. The clause potentially leaves doctors in an impossible position, and some patients in an entirely unacceptable position, so we intend to divide the Committee.

Question put, That the amendment be made:—

The Committee divided: Ayes 7, Noes 10.