The use and abuse of personal information is an increasingly sensitive issue in the era of identity cards, data theft and customer profiling.
As Information Commissioner Richard Thomas notes in his foreword to new guidelines published by the Association of the British Pharmaceutical Industry, people “have always considered information about their health to be particularly private”. The health professional’s duty of confidentiality reflects this – as indeed does resistance to the collection and use of electronic patient records under the NHS Connecting for Health programme.
At the same time, though, people want effective medicines. And in order to develop these medicines, Thomas says, “researchers need access to information about people. So, we have a potential tension: the desire for privacy on the one hand, the need for access to information on the other”.
The ABPI’s guidelines on the secondary use of data for medical research purposes are an attempt to resolve this paradox and strike a balance that benefits the pharmaceutical industry, individual patients and the wider public health.
As the association points out, medical data – including information from clinical trials – gathered in the course of developing a medicine may also be a valuable resource in efforts to invent and develop future medicines. Moreover, new and previously unexplored uses for a medicine may come to light following a fresh look at the data.
Safeguarding legal and ethical needs
Nonetheless, patients “rightly want their privacy respected and pharmaceutical companies are keenly aware of the need to protect personal data”, the ABPI maintains. The new guidelines draw together best practice in the field with the aim of setting “an effective standard which safeguards the legal and ethical needs of the community”.
As the ABPI notes, medical data that may be of use to pharmaceutical companies can arise in a number of contexts, including clinical trials with patients or healthy volunteers, prescribing information, post-marketing studies, clinical trials looking at new uses for existing medicines, off-label prescribing and adverse event reporting.
The guidelines both detail the legal framework governing the secondary use of research data – principally the Data Protection Act, which incorporated the European Union’s data protection Directive, 95/46/EC, into UK law – and address a range of practical considerations around secondary use, including data sources, consent, anonymisation and protection.
As the guidelines point out, the collection and use of individuals’ medical information in the context of clinical trials is subject to Good Clinical Practice, which requires informed consent, ethics committee approval and other measures such as removing information that can directly identify individuals and coding the data to protect patients’ privacy and confidentiality.
Researchers considering secondary use of these data should review the extent of anonymisation/codification already applied to the data and perform a risk assessment as to how easily the subject might be identified, the guidelines suggest. Researchers should also look at the nature and scope of any information provided to the data subjects and the consents supplied to them when the data were gathered for their primary purpose (e.g., to check whether there are any statements on potential future use of the data).
In general, acceptable secondary use of data without seeking re-consent from the patient/trial subject would include additional analysis within the scope of the original consent for further development of a drug, while ensuring this would cause no harm or distress to the individual concerned.
Testing hypotheses or carrying out studies outside the scope of the original consent would normally require re-consent or anonymisation of the data, the guidelines state. One exception might be if it is not practicable to locate a patient/subject to obtain re-consent without “unreasonable effort” and the likelihood of detriment to the patient is negligible. In these cases, use of previously collected data for research purposes may be justified based on the research exemption in Section 33 of the Data Protection Act.
The ABPI Guidelines for the Secondary Use of Data for Medical Research Purposes are available to download from the association’s website at www.abpi.org.uk.