Select Committee on Science and Technology Fourth Report



1.1 This Report is about the opportunities and challenges arising from the use of human genetic databases. These are set to become valuable tools in developing a full understanding of the effects of genes and their variations. Armed with such knowledge, we should see a revolution in health care - not only in treatment but also, and perhaps more significantly, in disease prevention.

1.2 This chapter describes the Report in brief outline and, for ease of reference, concludes by drawing together our recommendations.

Structure of the Report

1.3 As described in Chapter 2, our Inquiry focused on the actual and potential uses of human genetic databases - that is, what can be done now and could be done in the future. We worked in close consultation with the Human Genetics Commission (HGC) as it planned to report to the Government on the future regulatory arrangements for the storage, protection and use of personal genetic information. The recommendations and other findings of our Report are addressed principally to the Government. We hope that these will assist them and the HGC in considering the need for regulation in this area of human genetic databases.

1.4 Genetics is a rapidly developing field of knowledge which has many novel and specialised concepts. Chapter 3, amplified by Appendix 7, provides a grounding in the subject sufficient, we hope, to support an understanding of the discussion in the subsequent chapters. In the light of the evidence we received about present practice in the use of human genetic databases, as we have defined them, we then consider the need for either regulation or guidance in this area.

1.5 In Chapter 4, we describe the research and consequent health care benefits already flowing from studies involving genetic databases, and those that should continue to flow in the future. A key point is the long time scale over which the expected benefits will be delivered. If those benefits are to be realised, however, appropriate preparations - supported by necessary investment - need to be made now.

1.6 The study of genetics and the development of the databases that are the subject of this Report will generate vast amounts of data. As explored in Chapter 5, storing and processing those data will make enormous demands on computing, pushing at the limits of hardware, software and the availability of suitably qualified staff - and, unless adequate preparations are made now, certainly exceeding those limits.

1.7 The unique information resource of the NHS should play a key role in developing the understanding of links between genetics, environmental factors and health. In Chapter 6, we discuss the distinctive issues raised by the need fully to mobilise this resource.

1.8 Progress in this hugely important field depends crucially on the availability of sufficient data. Chapter 7 considers the implications and complications of privacy and consent in using personal data for research, especially where the research programmes are not yet fully defined.

1.9 If we are to enjoy all the benefits of this research, the outcomes will need to be developed into commercially viable treatments. In Chapter 8, we discuss the ownership of genetic data, and the intellectual property rights and patenting implications for the commercial development of resulting discoveries.


1.10 Our various conclusions are set out chapter by chapter as they arise. For ease of reference, our recommendations are collected together below, in each case with a note of the source paragraph. Chapter 9 gives an overview of our conclusions as the context for these.


1.11 We recommend that the HGC and Government should conclude that the primary means of regulating human genetic databases should continue to be the Data Protection Act 1998 and that, except as recommended in paragraph 7.58[2], no additional protection is required for personal genetic data. (Paragraph 3.17)


1.12 We recommend that the Government should provide sufficient earmarked resources to the MRC and the Department of Health to ensure that the support and infrastructure required for this important initiative are in place. (Paragraph 4.33)

1.13 Recognising that the UK Population Biomedical Collection project will stand or fall on its ability to manage the data, we recommend that the MRC and The Wellcome Trust should give high priority to ensuring that all aspects of the data handling and computing requirements for this important project have been fully addressed, and make appropriate plans to meet its needs. (Paragraph 5.25)

1.14 We recommend that the Government should, in the light of our recommendation for a Medical Data Panel[3], consult the MRC and The Wellcome Trust about the committee which the latter have proposed for the UK Biomedical Population Collection. (Paragraph 7.61)


1.15 We recommend that the Government (and the various education funding councils), the Medical and other relevant Research Councils, The Wellcome Trust and other research charities, and the pharmaceutical companies should give high priority to funding training and supporting research in the areas of bioinformatics, statistical genetics and the computing science underlying database management. (Paragraph 5.27)


1.16 GP databases need to be made compatible with one another and held in a way that allows the computer retrieval of the wealth of clinical information they contain. Accordingly, we recommend that the Government should ensure that the necessary financial and other resources are made available for this purpose. The aim must be to have such systems operational nationally within five years. Achieving this will require an NHS-wide standard protocol for data capture and retrieval, and that will need to be in place much sooner. (Paragraph 5.28)

1.17 We recommend that the Government should review the strategy for instituting electronic patient records throughout the NHS, to include clinical information contained in GP, hospital and other health records. Delivering a fully functioning national system by 2005 will require firmness of purpose to drive forward the development of robust and standardised systems. This must be supported by appropriate funding, including proper investment in the NHS skills base. (Paragraph 6.23)

1.18 We fully endorse the intention in Saving Lives: our Healthier Nation to extend and strengthen disease registers, and recommend that the Government should give this high priority. (Paragraph 6.24)

1.19 To facilitate proper communication and data linkage throughout the NHS, we recommend that the Government should urgently develop and implement a unified information system specifying and requiring adherence to completely compatible common standards. This will need to be backed with sufficient resources. Without such standards and the necessary resources, projects relying on large-scale use of NHS data will not succeed. (Paragraph 6.25)

1.20 Accordingly, we recommend that the Government should urgently make use of the NHS number mandatory as a common identifier. It should appear on all health records in the health service, including death certification. The NHS number must be assigned at birth (or on arrival in the United Kingdom for those born elsewhere). Furthermore, we recommend that the Government should give appropriate publicity to this change in practice, ensuring that patients not only know their NHS numbers but also understand why it is important to use them in their interactions with the health service. (Paragraph 6.26)


1.21 As a matter of urgency, we recommend that the GMC should make it clear that, as their representative told us in evidence[4], doctors are not required to obtain signed consent before data are passed to disease registries. Instead, patients need simply to know that data about them may be used in this way. Such clarification may require a rewording of the GMC guidelines to put their position beyond doubt. (Paragraph 7.55)


1.22 We recommend that the HGC and the Government should promulgate guidance for all those who collect or hold genetic data about identifiable individuals, reminding them of their obligations under the Data Protection Act 1998 and stressing the need to record, alongside the data or in an appropriately accessible form, whether or not the individuals concerned had been informed of the use to which their data might be put and whether they had expressed any reservations. (Paragraph 7.56)

1.23 We recommend that the procedure to be followed by all those involved in seeking consent for participation in research involving the collection and retention of biological samples that could be used for genetic analysis should include the following elements:

(a)  pointing out that

(i)  the medical treatment that all receive is based on studies carried out on very many earlier patients and that the request is for them to provide similar help for future generations;

(ii)  because medical science is changing very rapidly, some of the valuable uses to which the data could sooner or later be put are not foreseeable;

(b)  seeking the individuals' agreement

(i)  to participate in the study;

(ii)  to entrust oversight of secondary use of their data to the arrangements in place under the proposed Medical Data Panel;

(c)  asking whether participants would wish to be informed of any element in their genetic make-up that might be a cause for concern based on current knowledge - or to be alerted in the future in the light of new discoveries;

(d)  explaining the arrangements for withdrawing the consent; and

(e)  thanking participants for their help. (Paragraph 7.65)


1.24 We recommend that the Government establish a Medical Data Panel to provide a single, clear process for approving projects involving the secondary use of NHS and medical research data (including data derived from retained biological specimens). Its functions would be three-fold:

(a)  to consider for approval projects involving national or supra-regional secondary use of health and related data;

(b)  to set policy for approval of projects involving secondary use of such data at regional and local levels; and

(c)  to advise the Government and the Data Protection Commissioner on the interpretation of the Data Protection Act in its application to medical data - and, if necessary in the light of medical advances, changing public attitudes or other changing circumstances, to advise on possible amendments to the legislative framework.

This independent body should have wide representation, including both lay and professional members. (Paragraph 7.58)

1.25 We recommend that endorsement by this body, or by others within its policies, of a proposed use of data should constitute a sufficient protection under the terms of the Data Protection Act. The process should also afford additional protection for people's data (and any genetic implications for their relatives) after their death. (Paragraph 7.59)

1.26 We recommend that the Government amend the remit of the Research Ethics Committees to require them, as far as projects involving secondary use of health and related data at regional or sub-regional level are concerned, to operate within the policies set by the new Medical Data Panel. (Paragraph 7.60)


1.27 We recommend that the Government should establish an independent body, including lay membership, to oversee the workings of the National DNA Database, to put beyond doubt that individuals' data are being properly used and protected. (Paragraph 7.66)


1.28 We recommend that the Government should press, both within Europe and more widely, for patent rights over genes to continue to be granted only where a significant gene function has been established, and to ensure that the patent should cover only that function and direct extensions of it. Possible but not yet envisaged and speculative uses of a gene should not be patentable. (Paragraph 8.30)

1.29 For the future, we recommend that the Government should monitor closely patenting practices in the field of genetics and take steps as necessary to ensure that the proper balance is maintained between protecting inventors' interests, facilitating commercial development of ideas and allowing research to flourish. (Paragraph 8.31)

2   As repeated in paragraph 1.24. Back

3   See paragraph 1.24. Back

4   See paragraph 7.31. Back

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