INTRODUCTION

  1.  The Department welcomes the opportunity to contribute to the Select Committee's consideration of an NHS-wide database of patient-specific genetic and clinical information, for use by doctors, clinical researchers and epidemiologists.

  2.  It has been suggested that such a database has the potential to act as a tool in the development of new or improved methods of achieving better prediction, diagnosis and treatment of disease and in establishing more cost-efficient ways of operating health services. It also raises significant issues about informed consent for use of data and tissues and confidentiality as well as feasibility and cost. All these issues would need to be explored fully with a wide public consultation before any decisions could be made on whether the establishment of an NHS data base was justified. These issues are dealt with in more detail from paragraph 9 onwards.

  3.  This memorandum also refers briefly to relevant research initiatives currently being led by the Medical Research Council (MRC).

BACKGROUND

  4.  The Human Genome Project (due for completion early in the new century) involves the determination of the genetic code of the entire human genome and, combined with appropriate studies, will eventually allow a much better understanding of disease mechanisms. There is therefore significant potential for developments in genetics and genetic technologies to provide new routes to the understanding of complex disorders and the nature of disease. The resources available to support developments in the new science of genomics will be critical.

  5.  The creation of a system of electronic health records currently under development within the NHS, with standard terminology and rapid, anonymised access will in itself create very important opportunities for research, evaluation, and public health monitoring.

  6.  Over time, health records will come to include more and more genetic information and diagnostic and predictive tests will become more widely available, and cheaper, in routine care. This information will add to the value of health records for research and evaluation to some degree, but will also increase the importance of a trusted system for protecting confidentiality.

THE CURRENT IT SITUATION IN THE NHS

  7.  Information for Health noted that use of patient-based information is at present difficult at both a clinical, operational and health authority level due to the lack of tools presently available to aggregate such data consistent and comparable ways. A range of actions that are to be taken in the NHS were set out with the aim of ensuring that relevant, complete, comparable data is available to support a range of functions, including assessment of performance of the NHS.

  8.  The NHS Information Authority has a programme of work to extend the development of electronic clinical records across the NHS over the next six years. These records are intended to have core standard elements, thus having the potential to provide the required source data for a national clinical database. Equally, work on classifications and groupings is continuing as part of the Information Authority's work programme, which has the potential to contribute to ways of analysing these clinical records for various purposes. In April 1999, the NHS Executive entered into an agreement with the College of American Pathologists (CAP) to create a new world standard for computerising medical terminology. This is necessary for the effective introduction of electronic health records as outlined in the strategy document Information for Health.

ETHICAL AND LEGAL CONSIDERATIONS

  9.  In England, personal health information is protected by the common law duty of confidence and, where held on computer in an identifiable form, by the Data Protection Act 1984. The Data Protection Act 1998 comes into force in March 2000 and will cover both computerised information and information held manually in certain types of files. This will include most if not all clinical records. The Data Protection Act 1998, like its predecessor, does not apply to anonymised information. Generally, it requires that:

—  the common law of confidentiality be complied with;

—  the data subject must not be misled or deceived into giving the data;

—  the data subject must be given basic information about who will process the data and for what purpose; and

—  in the case of health data, one of the conditions in Schedule 2 and one of the conditions in Schedule 3 of the Data Protection Act must be complied with (see Annex).

  10.  Under the 1998 Act, data legitimately processed for research or statistical purposes are exempt from certain provisions of the Act as long as the processing neither causes substantial harm or distress to the data subject nor supports measures or decisions in relation to individuals. Such data can be kept indefinitely and are exempt from the subject access rights if the results of the work are not made available in a form from which data subjects can be identified. Use of such data for research, although obtained for other purposes, is not unlawful. However, this does not absolve the data controller from the obligation to give the data subject general information about the intended uses.

  11.  In addition to compliance with the specific requirements of the data protection legislation, any disclosure of personal health information must also comply with the common law duty of confidence. Any disclosure made with the consent of the individual concerned will meet these requirements. In English law, confidential information can be disclosed without the consent of the individual where the public interest in the disclosure exceeds the duty of confidence to the individual. This is a test that must be carried out on a case-by-case basis. In other words, one research project may be sufficiently in the public interest to meet the test but this does not mean all research projects that could be carried out on the same data would meet this test. Even if there is an overriding public interest, where consent could be obtained to the release of confidential information, it should be sought. This applies to both identifying and non-identifying information.

  12.  A recent ruling (R v Department of Health ex parte Source Informatics Ltd; Times Law Reports 14 June 1999) confirmed that anonymised data derived from confidential patient information continues to be subject to a duty of confidence. This ruling is subject to an appeal due to be heard in late 1999.

  13.  Questions to be considered in relation to any large scale database of clinical and genetic information would include:

—  is the use of personal health information in large scale database justified by the potential research and treatment benefits?

—  should data be anonymised?

—  should explicit consent from an individual be required before entering information on a database, even if the data are anonymised?

—  what safeguards or legal controls should be required to protect confidentiality, consent and use.

  14.  The use of DNA samples also raises broader ethical questions because of their ability to reveal information about an individual and members of an individual's wider family that they may or may not wish to know. Issues about communication of research results and ensuring that the right "not to know" is respected would need further consideration. Broader issues such as the implications of gene patenting, commercial ownership of personal health information and questions about intellectual property would also need to be investigated further.

FEASIBILITY

  15.  The feasibility of establishing such a large and integrated resource of medical data has yet to be established. The current rapid development of genomic science means that it is difficult to predict how such a database might be used in the future. This would influence the data definitions and criteria for data entry to ensure amongst other things compatibility of data entered from different sources. The adequacy of existing clinical records to provide such data would need to be investigated.

  16.  Appropriate security arrangements would be needed to ensure that unauthorised access was prevented. Protective measures would be likely to include access controls to authenticate users, cryptographic techniques to scramble information and safeguard storage and audit logs to record accesses to the information. The exact methods to be adopted would have to be carefully considered both for their effectiveness and for their potential impact on NHS working practices.

  17.  Resource consequences would depend on the model chosen but are potentially enormous. Techical and security issues combined with the need for long-term maintenance suggest that any national database would be an expensive undertaking.

  18.  Illustratively, the costs of the Icelandic database of clincial information, which does not yet exist, have been estimated by the Icelandic Ministry of Health and Social Security at 10.5-19.3 billion ISK

129-244 million for a population of 270,000.

RESEARCH ISSUES

  19.  A number of small and medium-scale databases have been or are being established to study patients with a particular condition or for epidemiological studies. Such collections are funded by various charities, the MRC and by industry. The MRC is currently developing plans for a large prospective cohort to study interactions between genetic and environmental risk factor for disease. The studies will involve consenting patients selected according to specific criteria and will be subject to aprpoval by Research Ethics Committees.

CONCLUSION

  20.  In theory, a universal NHS health information and DNA database could be created. In the short-term there are questions about feasibility and affordability. There are also central ethical and legal questions which need to be addressed. Issues around confidentiality, security, control of data, consent to use of health information both prospective and retrospective would all need to be considered. Such issues justify widespread public debate and consultation before decisions are made. It is likely that the new Human Genetic Commission will wish to consider these important issues as a priority when the body convenes for its first meeting early next year.

November 1999