House of Commons - Health - Written Evidence

Select Committee on Health Written Evidence

Evidence submitted by the Wellcome Trust (EPR 42)

1. The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending around £500 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and well being.

EXECUTIVE SUMMARY

2. The Wellcome Trust considers that the use of electronic patient records offers huge benefits in improving patient care and safety and that a secure system of access for biomedical researchers should be seen as an integral part of patient record use that contributes to these patient improvements.

3. One of the unique selling points for biomedical research in the UK is access to a National Health Service (NHS) with more than 50 million users. The National Programme for IT (NPfIT) being delivered by Connecting for Health (CfH) should:

— bring patient data into an electronic format, enhance patient safety and take patient care into the 21st century;

— provide an individual electronic care record for all England's 50+ million users, securely accessible to patients and their carers;

— enable researchers to access patient health information that is comprehensive, standardised, accurate, up to date and can rapidly be analysed on a large scale; and

— help to ensure that the UK maintains and builds on its global lead in biomedical research, attracting inward investment from the bio-pharmaceutical research sector.

4. Developing an appropriate infrastructure to enable secure access for biomedical researchers to NHS data is something the Wellcome Trust supports and we are committed to working, in partnership with others, to develop a programme of e-health research activity using electronic patient data, including that available through the NHS Care Records System. The forthcoming Research Simulation Report of the UK Clinical Research Collaboration (UKCRC) R&D Advisory Group to CfH is highly relevant here and we would recommend that report to this Committee when it is published in March. Richard Jeavons, Director of IT Service Implementation, CfH and Sally Davies, Director General for Research and Development, Department of Health were the sponsors of this report.

5. Establishing public confidence and support for the use of electronic patient records in patient care, for patient safety and for research, is a key priority and needs to be given further attention. From work recently commissioned by the Wellcome Trust we found that public awareness of the use of electronic patient records is low and there is a limited amount of research to understand public opinion in this area. Further research needs to be done to inform policy decisions.

RESPONSE TO SPECIFIC QUESTIONS

What patient information will be held on the new local and national electronic record systems, including whether patients may prevent their personal data being placed on systems

6. The UK Clinical Research Collaboration (UKCRC), of which the Wellcome Trust is a member, has recently commissioned a series of research simulation exercises to scope out what the research requirements for patient data available from the NPfIT are that would enable a wide range of public health research to be undertaken. The Report of Research Simulations, due to be published in March, will set out a number of recommendations pertinent to this inquiry including what research can be done, and the health benefits that can be realised, with anonymised data. It will also give examples of where the use of identifiable data will be beneficial for public health. The recommendations will:

— Inform future development of the NHS Care Records Service (NHS CRS).

— Highlight technical, regulatory and governance issues.

— Inform plans for any further simulations and full pilots to test the capacity of the infrastructure, using real patient data with appropriate safeguards when this becomes feasible.

7. The Wellcome Trust would recommend this report to the Committee and considers that a presentation of its findings from Professor Ian Diamond (Chief Executive of the Economic and Social Research Council (ESRC) and the Chair of the UKCRC R&D Advisory Group to Connecting for Health) would be highly relevant to the scope of this inquiry.

8. The Care Record Development Board (CRDB) Working Group on the Secondary Uses of Patient Information is also preparing a report that will make a number of recommendations on consent and governance issues. The Wellcome Trust would welcome further work to improve the guidance for researchers in this area.

Who will have access to locally and nationally held information and under what circumstances

9. Biomedical researchers should be seen as core, not secondary, users of patient records. Active research use of patient data improves the quality of the patient record and subsequent patient safety and care. An electronic record and the use of unique identifiers enable large-scale studies to be undertaken integrating data from different sources to answer questions important for public health.

10. For example a study in Denmark cross referenced data on the Danish Civil Registration System, which assigns a unique identification number to every live-born infant and new resident in Denmark, with MMR-vaccination status obtained from the Danish National Board of Health and combined that with children's autism status obtained from the Danish Psychiatric Central Register. This study, on more than 500,000 cases, provides strong evidence against the hypothesis that MMR vaccination causes autism.[68]

11. In a study in Scotland researchers used linkage of national pregnancy and perinatal death registries to undertake a retrospective cohort study of more than 130,000 women having a second birth in Scotland whose first infant was liveborn. This study, unable to be undertaken by any other method, indicates that complicated first births of liveborn infants are associated with an increased risk of unexplained stillbirth in the next pregnancy.[69]

12. The UKCRC R&D Advisory Group to CfH Research Simulation Report will cover these areas in some detail.

Whether patient confidentiality can be adequately protected

13. The UKCRC report and the CRDB Working group on the Secondary Uses of Patient Information report both make recommendations in this area and in deciding the appropriate governance structure to allow access for researchers to patient information a balance will need to be struck between preserving individual confidentiality and establishing practical mechanisms to enable public benefit research to be undertaken.

14. The Wellcome Trust has recently commissioned a research team from the University of Surrey to undertake a study on "Understanding Public Perspectives on the Governance of Biomedical Research: a qualitative study in a deliberative context". This report is currently undergoing peer review and will be completed and published after this.

15. From this work, and in a recent survey of public attitudes on the use of identifiable medical data from the National Cancer Registry published in the British Medical Journal,[70] it is clear that there is strong public support for medical research, particularly for research into cancer. There appears to be little evidence to support the policy position that the public will prioritise privacy over the use of their patient records for health research.

16. Therefore, it would appear that more engagement with the public is required to understand public attitudes to the use of their records for research; otherwise there is a danger that an overly restrictive governance framework is put in place that prevents the full range of beneficial health research to be undertaken.

How data held on the new systems can and should be used for purposes other than the delivery of care eg clinical research

17. Recent reports from the Council for Science and Technology[71] and Academy of Medical Sciences[72] have highlighted the potential of the CfH programmes for accelerating our knowledge and understanding of health and disease and improving the potential for conducting public health research on a national scale.

18. If the development of the CfH programmes engages researchers appropriately then it will provide research opportunities in the following areas:

Public Health

— Improved understanding of patient epidemiology and disease burden/unmet needs (especially when linked with disease registers, hospital episode statistics, Local Service Providers etc).

— Exploring the underlying causes of ill-health and health damaging behaviour from links with non-health data (eg housing, economy, environment).

— improved analysis of the effectiveness of different interventions/treatments (eg new vaccination schedules, screening programmes, devices etc).

— All of the above by specific groups (by age, geography, ethnicity).

Health Services Research

— Improved analysis of effective service delivery systems through linkages with other information such as clinical audit data.

Clinical Trials and Pharmaceutical Development

— Improved feasibility study and identification of the target size of a disease population.

— Recruitment of suitable patient groups made easier.

— Potential to directly link NHS records into a clinical trail database.

— Improved pharmacovigillance/adverse event reporting (identification of side effects, drug interactions and rare events).

— Post-approval monitoring.

Personalised Medicine

— When combined with information from cohort studies, use of platform technologies and other developments, the patient data available through the Secondary User Service could improve our understanding of the heterogeneity of diseases and population, accelerating the move towards pharmacogenetics/personalised medicine.

19. Following the UKCRC research simulation exercise one of the emerging recommendations is to build on the existing databases and clinical registries that currently provide a valuable resource to biomedical research in the UK using electronic patient records. For example, the General Practice Research Database (GPRD) and Q-Research as well as a number of ongoing population and cohort studies. The information on the Secondary User Service will add to this data but is not able to provide a complete solution. Therefore, there is a need and a real opportunity in the UK to develop a federation of databases that can link and integrate patient information, in a secure format to provide a more comprehensive and effective research service for public health.

20. The Wellcome Trust is committed to working with others in developing a roadmap to set out the physical and governance infrastructure for research using electronic patient records under an "e-health" programme banner. In developing such a roadmap all appropriate stakeholders in both academic and industry research will need to be engaged as well as taking into account the need to ensure patient confidentiality and maintain public support for biomedical research.

21. We would support the development and fund the research that would use such a service and would look to Government to provide a similar commitment within the next Comprehensive Spending Review to provide the resources to put in place the infrastructure to deliver such a research service including data on the Secondary User Service.

Current progress on the development of the NHS Care Records Service and the National Data Spine and why delivery of the new systems is up to two years behind schedule

22. No comments to make.

Mark Walport

Director, The Wellcome Trust

16 March 2007