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Lord Walton of Detchant: May I say that I totally agree with the views expressed by the noble Earl, Lord Howe. I totally agree with him when he says that the medical profession in its entirety and the entire pharmaceutical industry are deeply and bitterly opposed to Clause 67.

In commenting upon the issues relating to anonymised data prescribing I must declare an interest as I am a neuro-science adviser to a pharmaceutical company. Nevertheless, I must make the point that I have not been briefed by that company but have received a great deal of information from many other pharmaceutical companies and from the Association of the British Pharmaceutical Industry.

If this clause, unamended, were to go through it would restrict the use of anonymised data from the NHS in clinical trials. It would inhibit epidemiological research or pharmocovigilance based on UK data; it would inhibit the collection of data required for submission to regulatory authorities in relation to both EU and UK law; and it would introduce new restrictions on data generated from pharmacy transactions or anonymised data where these are aggregated at a level greater than individual physician prescribing. The industry has long used such aggregated data above the individual prescriber level without harm to the interests of the NHS. Also, as the noble Earl said, the Monopolies and Mergers Commission has come to the conclusion, quite contrary to the view of the department, that the use of such data and the implementation of the consequences of such data would in fact reduce costs for prescribing in the NHS and would render this very much more efficient.

I greatly appreciate the courtesy of the Minister in arranging for some of us to meet him to discuss these clauses. I am grateful for that, and I fully appreciate how, in Amendment No. 295, he has attempted to address some of the greater concerns that have been expressed. However, as the noble Earl said, this simply does not go far enough. My particular departments are engaged in a wide range of activities, which of course include investigating marketing needs, but also the development of new medicines.

The term "marketing" is so broad in meaning that all the commercial databases covering NHS activities remain under threat. These databases are very expensive to develop and maintain. The removal of commercial funding would close them down so that they would no longer be available for non-commercial uses. I believe that this particular part of Clause 67 is unamendable, as the noble Earl said.

Turning to the issues of patient confidentiality, I agree entirely with those who have said that confidentiality between doctor and patient is the cornerstone of medical practice. Yet Parliament,

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under the medical Act, has charged the General Medical Council with the responsibility of giving advice to the medical profession on issues of confidentiality. There are of course exceptions, which the GMC has for many years accepted, relating to the breaching of confidentiality. Thus, under the Police and Criminal Evidence Act it is perfectly appropriate for a doctor to breach confidentiality in order to assist the police in the investigation of a grave or very serious crime.

It is also perfectly appropriate when a patient with epilepsy proposes to continue driving, against medical advice, for a doctor to report that individual to the licensing authority. There are therefore exceptions. At the present time, the General Medical Council, in relation to databases which are used for disease registries--in the field of cancer, for instance--have said that doctors are not required to obtain signed consent before data are passed to such registries. However, the GMC proposes from December 2001 to make it mandatory upon all doctors who wish to pass such information to disease registries to seek written informed consent. It is in this situation that there is a serious conflict of opinion within the medical profession. Those involved in cancer research and many other fields of medicine are much opposed to those potential requirements of the GMC. I believe, for that reason, that to implement Clause 67 as it stands at present would inhibit further discussions between individuals involved in cancer research and other disease registers, on the one hand, and the GMC on the other. I believe that in the fullness of time this difference of opinion could be resolved, but to give these unfettered powers to the Secretary of State would, effectively, give him the power to override the advice of the General Medical Council to the detriment of patient confidentiality.

I have agonised over what might be done in relation to this clause. After studying it carefully, I can see no alternative but to ask the Minister and the Government to think again and to withdraw this clause for further detailed consultation with the industry and the profession.

12.15 a.m.

Baroness Northover: I speak to Amendments Nos. 298A, 302C, 304A, 305, 315A and 316A which stand in my name and to the other amendments in this group.

Clause 67 has generated enormous controversy. There are three strands. First, there is the problem of the wide powers taken here by the Secretary of State. They are powers so wide that the Delegated Powers and Deregulation Committee has pronounced upon this. The second and third areas of contention are the use to which anonymised data can be put and the issue of confidential patient information.

There are several features of the controversies that need not have been as they are. The Secretary of State did not have to seek such wide powers. The complex issues addressed here did not have to be sprung upon people with little or no consultation. The departments

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did not have to put together anonymised and confidential data in the one clause; however, this is where we are.

I take the matter of anonymised data first. Like other noble Lords, I have received many submissions from those who will be affected by this section of the clause. I have met many delegations and I appreciate their desire to inform as fully as possible. Pharmacists have the right to sell anonymised data to companies who then sell it to the pharmaceutical industry and others who use it as a tool in their marketing strategy or in research. It is very clear that the NHS is unable to supply accurate, up-to-date information to those who need this for research purposes. It is clear that preventing such researchers from using this material in anonymous form, so that the patient could never be identified, would be a very retrograde step.

The Government sought to prevent the sale of anonymised data to the industry but lost the Source Informatics case on appeal, largely, it seems to me, because they were arguing that the patient's confidentiality was at risk, which it clearly was not. However, one of the judges stated that if the Department of Health,


    "continued to view such schemes as operating against the public interest, then they must take further powers in this already heavily regulated area to control or limit their effect".

They seem to be doing so. The report of the Monopolies and Mergers Commission in 1999 argued that the merger of two companies who dealt in this information produced a damaging monopolistic effect and this could drive up costs for the drug companies and, they deduced, the NHS. In that report, I note that whereas the Government spends £5 million a year on providing prescribers with information about medicines through such measures as the Drugs and Therapeutic Bulletin and, more recently, the Prodigy Scheme which gives prescribing support to GPs, the industry in 1997 spent around £270 million in promoting its products, mainly to prescribers. They had 6,000 sales representatives or about one for every five to six GPs.

Therefore, I have some sympathy with the Government in seeking to avoid the pharmaceutical industry being able to target such resources on GPs, using their knowledge of their prescribing habits. There is something of a David and Goliath situation here. However, my concern is that by blocking the pharmaceutical industry from its so-called "micro-marketing" the pharmacists will not collect the information to the detriment of the research community.

The clause has been narrowed down in a way that I welcome. As I see it, it will still allow the collection of data on a regional level, at a level that the industry could use to lobby the Government and the public about the poor up-take of useful medicines. However, I remain concerned at the clause's potential scope and impact. It is difficult to justify how it might be in the public interest to restrain pharmacists from communicating anonymous information to the companies that collect such information. My preference would be for the Prodigy scheme to be, as

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they say, "rolled out", so that doctors take that as their main source of information. Thus our Amendment No. 298A emphasises that any action--such as contemplated here--must be "in the public interest".

I turn now to the other can of worms in this clause; namely, confidential patient information. Here we have to balance the rights of the individual and the needs of society. The immediate problem over this also seems to have emerged from the Source Informatics case, after which the GMC advised doctors that they were in danger of breaking the law if they passed information about named patients, even to such organisations as the cancer registries. They were advised that if they did so without the informed consent of the patients they must be prepared to defend their actions in a court of law. Not surprisingly, that had an immediate effect. Although the GMC then offered a moratorium in its expectations of doctors in this respect, there has been a significant decrease in the amount of information going to the disease registries.

I have with me evidence from Dr Wendy Atkin from St Mark's Hospital, who is running trials for bowel screening programmes for the Department of Health. She had hoped soon to be able to introduce screening into the wider population to catch this disease when it is completely curable, given the fact that at present it kills 20,000 people a year at present. Dr Atkin has told me that the information is simply no longer complete enough for her to judge the effectiveness of the trials.

Yet, within law, it seems that the problem can be resolved. For example, the European Convention on Human Rights guarantees a patient's right to the protection of confidential information and personal privacy, but that is not an absolute right. As my noble friend Lord Lester of Herne Hill put it in advice to the GMC,


    "the public interest test for lawfully interfering with a patient's right to protection of confidential information and of personal privacy ... is whether there is a pressing social need and whether the interference is proportionate to the purpose".

It is clear that the disease registries, the Public Health Laboratory Service, and so on, can all fairly claim to be acting in the public interest. So, again, I have sympathy with the Government in putting forward proposals that will once again enable the free flow of information in the public interest, while at the same time protecting patient confidentiality where possible.

But, once again, too much power is in the hands of the Secretary of State. Let us suppose that we had a Secretary of State for whom it was not a high priority in the interests of society to allow such data to be collected, or who wished to hide, say, the collection of information that was embarrassing to the Government. Patient groups have expressed serious reservations about what they see as a power that might be abused.

We have therefore put down an amendment from the BMA which was tabled in Committee in another place and which has since been improved in the light of the discussions there. It seeks to define more precisely what we should seek to do. This amendment is loosely based on the existing United States federal statute which establishes cancer registries.

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The purpose of Amendments Nos. 302C and 304A is to make explicit in the Bill the intention of the Secretary of State here; that is, to make provision for disease registries and medical research and to provide a basis for the regulation of the use of patient information for these purposes.


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