The United Kingdom boasts the worlds largest national cancer registry system. Over the last 40 years, it claims to have collected, checked, cross-linked, stored, and analyzed identifiable data on millions of patients without ever once breaching patient confidentiality. But a legal question mark now hangs over the system and, according to one view, it is in breach of data protection law.
The situation has set the stage for a debate among cancer registries, politicians, patient groups, medical ethicists, and the government as to whether registration should be mandatory or based on informed consent. Five working groups are investigating different options.
The U.K. Association of Cancer Registries (UKACR) is campaigning for a statutory system similar to the ones operating in the Nordic countriesNorway, Sweden, Denmark, Iceland and Finland. But medical ethicists argue that statutory or mandatory registration runs contrary to the principles of confidentiality and to the new open health care culture with its emphasis on individual patient choice and "ownership" of personal medical information.
"It has always been possible to use patient information, either with the patients consent or by anonymizing it," said Richard Nicholson, B.M., B.Ch., editor of the London-based Bulletin of Medical Ethics. "But over the last 40 years many researchers and keepers of disease registries have failed to go down either route, and have instead used identifiable patient information without consent."
The UKACR, however, claims that it is impossible to run an effective population-based registry by relying on informed consent. In Holland, its privacy court recently agreed that it was impractical for cancer registries to work on the basis of informed consent. In Germany, a requirement for informed consent in Hamburg and Saarland resulted in what has been described as an unacceptable loss of completeness. A new German encryption system now produces anonymized databut only for limited use.
"You need identifiable data for research on risk factors and outcome of treatment to check back on any possible errors in linkages," said Hans Storm, M.D., president of the International Association of Cancer Registries and director of the Department of Cancer Prevention at the Danish Cancer Society. "In the Nordic countries we all have a unique identification number so we can be absolutely certain our linkages are correct."
The Danish indentification system was introduced about 30 years before the start of the long-running debate about confidentiality and data protection. "I suspect it would have been far harder to start it today, but weve always been completely open and honest about what we do," Storm said. "The biggest problem you can have with any data collection system is if you are perceived to do it in secret."
Secrecy or a "lack of transparency" is one of the United Kingdoms problems, according to a discussion paper recently released by the Department of Health in Northern Ireland. It is "clear," the report states, that the U.K. does not "fully comply with the fair and lawful processing requirement of the Data Protection Act 1998 and the Common Law."
The paper adds: "Instead it relies, by default, on the implied consent of service users for the processing of much, if not all, personal information." However, because "of the lack of transparency, service users are largely unaware of how their personal information is used, beyond the provision of direct care and treatment."
The publication of the discussion paper this summer highlighted a radical change in the U.K. health care system. For 40 years cancer registries quietly went about their work unfettered (without, they insist, being "secretive" about it). But the concept of "implied consent" became incompatible with the new order. Recognizing this in September 2000, the General Medical Council issued new guidelines to all doctors prohibiting transmission of data to cancer registries without patients informed consent.
"The response was predictable," said Nicholson, who is a former pediatrician. "There were howls of anguish from people who were being asked to work within the law. The usual crude utilitarian arguments beloved of doctors were trotted out: The cancer registry was worth its weight in gold. How could we ever beat cancer if there were gaps in the records because some patients might refuse consent to use of their personal data?"
The UKACR, which represents 13 registries, launched a robust counter-attack, highlighting the valuable information that U.K. registries had produced over the years. The registries, it said, had shown that U.K. cancer survival rates in poor areas were much lower than those in rich areas; that survival rates for most cancers were lower than those in the rest of Europe; and that there was wide variation in cancer treatment across the United Kingdom.
The GMC then performed a giant U-turn in support of the UKACR, revising its guidelines in the wake of government promises to protect patient confidentiality. In an interim measure, which is still in effect, the government added Section 60 to the Health and Social Care Act of 2001. It stipulates that patient-identifiable information can be used without patients consent to support medical purposes that are in the interest of patients and the wider public, where consent is not an alternative, and where anonymized information will not suffice.
Tom Davies, M.D., director of the Cancer Intelligence Unit at the University of Cambridge, part of the East Anglican Cancer Registry, in England, has strong reservations about Section 60. "Although it makes consent unnecessary, it doesnt make it statutoryas it is in the Nordic countries. Moreover, although physicians can now transfer data to a cancer registry without the patients consent, its not clear what registries are allowed to do with the data. For example, can they pass information to researchers without the patients consent?"
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The very process of obtaining informed consent can be difficult, said Hannes Botha, M.B., Ch.B., director of the Trent Cancer Registry and vice chair of the UKACR. "When during the consultation do you ask the patient for consent?," Botha said. "Before they know they have cancer or only when the diagnosis has been confirmed, at which time there are, from the patients viewpoint, many more important things to think about."
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And data gathering would be difficult if informed consent were required, said Janet Stephenson, B.Sc., registration manager of the West Midlands Cancer Intelligence Unit. "A lot of our data comes from [pathology laboratories], and they would err on the side of caution if they did not know whether or not a patient had given consent."
It could be several years before Section 60 is removed from the statute book in favor of a permanent solution. "The public must be shown the benefits of cancer registration," Storm said. "This brings an important dimension to the ethics debate."
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