Editorial Cancer information under threat

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and epidemiological research, cancer registration data are increasingly .... recent report on cancer research. ... 3Northern and Yorkshire Cancer Registry and.
Annals of Oncology 12: 145-147. 2001.

Editorial Cancer information under threat: The case for legislation Editorial Comment. Once more cancer registration is under threat, this time in the UK although, given past experience, this will soon spread to other European countries. Cancer registration is an essential component of Cancer Control activity providing data regarding cancer incidence and survival in defined populations and giving the possibility to assist treatment provision and also to monitor the evolution of geographical and temporal cancer trends. The threat to their survival as effective tools is real and should not be taken lightly. David Brewster and his colleagues were invited to prepare this piece for the Annals of Oncology to lay out the arguments in support of population-based, cancer registration. As the debate widens, we hope that every Medical Oncologist in Europe, as well as all others involved in Cancer Control, will be able to support the continuation of high-level cancer registration schemes in population groups throughout Europe. Peter Boyle & David J Kerr, Editors, Annals of Oncology

healthcare services, and where those data are processed by a health professional subject under national law or rules established by national competent bodies to the obligation of professional secrecy or by another person also subject to an equivalent obligation of secrecy'. The 1998 Act has, however, led to widespread uncertainty in the clinical, public health and research communities [9]; it is currently unclear whether informed consent is necessary to fulfil the requirement for fair and lawful processing of personal data. Recent debate in the House of Lords suggests that the principal issue is not, in fact, one of data protection, but relates to 'understanding of the common law duty of confidence rather than any concerns about the 1998 Act' [10]. To appreciate the practical consequences of a move towards informed consent, it is important to understand how cancer registries operate currently, and why they have evolved in this way. In order to achieve data of high enough quality to address major concerns about cancer, the collection of identifiable information by cancer registries is unavoidable. Without it, quality assurance would be impossible; duplicate registrations would lead to inflated estimates of incidence; inability to link cancer records to follow-up information, such as the date of death would make survival analysis impossible; and inability to do small area analyses using postcode of residence would disable the investigation of cancer clusters. Registries do not generally receive notifications from individual clinicians. Reliance on such a mechanism would be likely to lead to inadequate ascertainment, as is the case now for some statutorily notifiable infectious diseases [11, 12]. Instead, registries use multiple sources of ascertainment, including computerised hospital discharge records, pathology records and death records. Most registries process several records from such sources to create a single validated cancer registration. Ascertainment is believed to be reasonably complete for most types

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The UK cancer registration system has been recognised by the current Chief Medical Officer for England as 'the best example of a disease register that attempts to provide comprehensive, routinely available data for the whole of Britain on an important group of diseases' [1]. By any standards, and often in the face of limited resources, the output from cancer registries is impressive [2]. As well as their traditional role in public health surveillance and epidemiological research, cancer registration data are increasingly being used in the evaluation of cancer screening and treatment services, and even to support direct patient care in the field of clinical genetics. Perhaps the most notable achievement in relation to oncology has been to contribute most of the evidence underpinning the trend towards multidisciplinary care and specialisation [3]. The central contribution of cancer registries to cancer control has recently been acknowledged in the government's NHS Cancer Plan for England [4]. Ironically, however, and despite high standards of data security and confidentiality within UK cancer registries [5], cancer information systems in the UK are currently under serious threat from conflicting interpretations of legislation intended, quite properly, to protect the privacy of individuals. Hitherto, cancer registries and other health information systems have operated on the basis of 'implied consent', which assumes that "the decision to seek or accept health care implies an acceptance by the patient that personal health information may be disclosed to ensure the proper performance of Health Service functions in relation to that care" [6]. The Data Protection Act (1998) [7] represents the UK's implementation of the European Directive on the protection of individuals in relation to the processing of personal data [8]. Article 8(3) of the Directive is quite clear that explicit consent is not required for the processing of personal data 'for the purposes of preventive medicine, medical diagnosis, the provision of care or treatment or the management of

146 dations was awaited, cancer registration was thrown into disarray by the circulation of new General Medical Council guidance on confidentiality. The guidance states explicitly that "the automatic transfer of personal information to a registry, whether by electronic or other means, before informing the patient that information will be passed on, is unacceptable save in the most exceptional circumstances" [21]. As hospitals throughout the UK began to suspend the flow of data to cancer registries, the GMC council agreed to publish a supplementary statement which provides for a transitional period up to October 2001, during which this issue must be resolved [22]. On a more optimistic note, the government has indicated, both in the NHS Cancer Plan for England [4], and in its response to the Committee on Science and Technology [23], that it "is determined to secure the future of cancer registration and will take the necessary action to ensure this". To those working in the field, it is difficult to see how this can be achieved without legislation [24]. Legislation would certainly dispel any ambiguity about the legitimacy of cancer registries in relation to the collection, processing, and use of cancer patient data for public health monitoring, clinical audit and research. Legislation will clearly need to spell out the necessary safeguards on data acquisition and constraints on the uses of data in order to reassure the public. However, cancer registries would continue to rely on ascertainment of cases from multiple sources, and it is important that restrictions applied to other health care databases do not make this impossible. Examples of suitable legislation are already available from several countries, including the USA [25]. The British public now faces a stark choice. On the one hand, total personal autonomy, informed consent before any data may be shared, and the loss of unbiased information about the burden of cancer in the community and the outcome of cancer treatments and cancer screening programmes; on the other hand, legislation to guarantee the availability of unbiased, population-based health information and the obvious benefits that flow from this to current and future cancer patients, and to the wider public. The views expressed are those of the authors and do not necessarily represent the views of their employing organisations.

Addendum Since this manuscript was prepared, the Health and Social Care Bill has been published. The Bill provides (Clause 59) that the Secretary of State may require and regulate the processing of patient information for medical purposes, either to improve patient care or in the public interest. 'Medical purposes' is defined to include 'preventative medicine, medical diagnosis, medical research, the provision of care and treatment and the

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of cancer, and this is backed up by published evidence [13-15]. An overriding strength of cancer registration data is that they are population-based, that is, they include all patients with cancer, and are not subject to the selection bias of hospital-based data [16]. This is key to their utility in public health. Registries have made considerable efforts to define, consult on, and implement protocols designed to preserve patient confidentiality at all stages of the registration process, from data collection to use and dissemination. Almost all analyses are performed on anonymised data, and great care is taken to avoid publishing any data that might conceivably identify individuals. To our knowledge, there has been no serious breach of confidentiality since cancer registration in the UK began, more than 40 years ago. Unfortunately, arguments favouring total autonomy of the individual are often framed in absolute terms [17] and take little account of the rights of society to benefit from the knowledge which can be derived from unbiased, population-based data [18]. It is interesting to contrast the approach to control of infectious disease with the approach to control of cancer (and other chronic diseases). The latent period between exposure and disease is generally much shorter for infectious diseases, which makes the risk seem more immediate, but the control of infection often hinges upon the detection of environmental hazards, as it does for cancer. It seems illogical that we should be prepared to forego our absolute right to autonomy for the control of infectious diseases, but not for the control of cancer which causes a much greater burden of serious morbidity and mortality in the UK. A requirement to introduce informed consent would be costly and difficult to administer, since all electronic and paper patient records would need to be flagged with preferences about disclosure. More importantly, it would also lead to unquantifiable selection bias, making the data much less useful. This is not simply a theoretical risk: efforts to introduce informed consent in parts of Germany led to the effective collapse of cancer registration [19]. It seems that the main problem was not that patients refused to give consent, but that doctors often failed to ask (either because they forgot, perhaps because they were not directly involved in notifying cases, or because they judged that patients were too ill, or too distressed, having just been informed of their diagnosis). The Commons Select Committee on Science and Technology recognised the gravity of these concerns in its recent report on cancer research. It recommended that "as a matter of urgency, the advisory group on patient confidentiality should address the concerns posed by the 1998 Data Protection Act regarding the registration of cancer (paragraph 109)" [20]. It also recommended that "the government should introduce legislation to make the registration of cancer a legal requirement, both to ensure the completeness of cancer registry data and to ensure access to those data for legitimate research purposes (paragraph 112)" [20]. While the government's response to these recommen-

147 management of health and social care services'. This Bill, if passed, may eventually provide a legislative umbrella under which the UK can finally safeguard both public health surveillance and research into cancer and other diseases and the confidentiality of individual patient data (http://www.publications.parliament.uk/pa/ cm200001/cmbills/009/01009--l.htm#59). 1

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D. H. Brewster, M. P. Coleman, D. Forman & M. Roche4 'Scottish Cancer Intelligence Unit Information & Statistics Division (NHS in Scotland) and University of Edinburgh, UK 2 London School of Hygiene and Tropical Medicine, UK 3 Northern and Yorkshire Cancer Registry and Information Service and University of Leeds, UK 4 Oxford Cancer Intelligence Unit, UK

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1 (281): 31-50 (available at: http.//europa.eu.int/eur-le.\/cn/lif/ dat/1995/en395L0046.html). Strobl J, Cave E. Walley T. Data protection legislation: Interpretation and barriers to research. BMJ 2000; 321: 890-2. Lords Hansard. 22 November 2000 (available at: http:// www.publications.parliament.uk). Sheldon CD, King K, Cock H et al. Notification of tuberculosis: How many cases are never reported? Thorax 1993; 47: 1015-8. Davies LA. Assessing the value of different sources of information on meningococcal disease. Commun Mcd 1989: II: 239-46. Brewster D, Crichton J, Harvey JC et al. Benefits and limitations of pathology databases to cancer registries. J Clin Pathol 1996: 49: 947-9. Brewster D. Crichton J. Harvey JC, Dawson G. Completeness of case ascertainment in a Scottish Regional Cancer Registry for the year 1992. Public Health 1997; 111: 339-43. Bullard J, Coleman MP. Robinson D et al. Completeness of cancer registration: A new method for routine use. Br J Cancer 2000:82. 1111-6. Bell CMJ. Lawrence G. Pheby DFH et al. The role of cancer registries. Clin Oncol 1995: 7: 143-4. Goodare H. Studies that do not have informed consent from participants should not be published. BMJ 1998; 316: 1004-5. Brewster DH. Bain MRS. Chalmers JWTet al. Explicit consent is not needed for studies using medical records. BMJ 1998; 317. 948 (Letter). Becker N. Cancer epidemiology and privacy laws: Recent trends in Germany. Eur J Cancer 1993: 29A: 661-3. House of Commons. Sixth Report of the Science and Technology Select Committee. Cancer Research - A Fresh Look. London: The Stationery Office 2000 (available at: http://www.parliament. the-stationery-ofiice.co. uk /pa /cm 199900/cniselect /cmsclech / 332 / 33202.htm). General Medical Council. Confidentiality: Protecting and Providing Information. London: GMC Publications 2000. GMC Statement on Confidentiality and Cancer Registries (available at: http7/www.gmc-uk.org/n_hance/news/cancer_registrics. htm). Department of Health. Government Response to the Sixth Report of the House of Commons Science and Technology Committee: Session 1999/2000. Cancer Research - a Fresh Look. London: The Stationery Office Limited 2000. UKACR Statement on Confidentiality (available at: http.// www.thames_cancer_reg. org.uk/ukacr/ukacr.htm). US Cancer Registries Amendment Act. Public Law 102-515 (106 Stat3372), 24 October 1992.