1. Primary and secondary use of EHR: Enhancing clinical research Pharmaceutical Industry Perspectives Dr. Karin Heidenreich Senior Public Affairs Manager/Novartis Brussels, 11th October 2007

2. 2 Agenda  Opportunities for the pharmaceutical industry  Potential risks  Questions to be solved  Possible solutions  Conclusion

3. 3 Background EHR  are primarily being created to improve healthcare for individual patients  are sensitive data, therefore their use need informed consent and measures to protect privacy and identity  provide comprehensive health information on a large number of people  offer a potential for the generation of important knowledge for the benefit of patients and society

4. 4 Opportunities for the pharmaceutical industry - in Epidemiology  Potential to use a broad spectrum of “real life” health information for  Epidemiological studies  Identification of medical need and rare diseases  Orphan drug designations  Market size estimations  Disease prioritization  Establishment of disease registries  Useful for strategic planning in the health sector

5. 5 Opportunities for the pharmaceutical industry - for Pharmacovigilance Critical for improving the Pharmacovigilance reporting system (similar to FDA-industry consortium in USA)  Allow for systematic detection of medical events, thereby avoiding huge under-reporting  Early detection of new safety signals linked with drug intake  Analyses of interactions between different simultaneously administered medication  Understanding of risk factors that lead to major averse reactions  Development of a safety reporting system via EHR  Via a project within the Innovative Medicines Initiative in the workstream “predictive drug safety“  Improvement of safety assessment and better labeling

6. 6 Opportunities for the pharmaceutical industry - in Clinical Trials Settings Data from EHR could  help to check protocol feasibility, with the potential consequence to change inclusion/exclusion criteria  Avoidance of amendments  help to identify investigators and clinical trial centers  Better planning of patient recruitment rates and drug supply  be used as source data from which relevant data are transferred to CRFs  Reduce data errors, resources, time, paper…  More efficient clinical trials for a faster development of medicinal products

7. 7 Opportunities for the pharmaceutical industry - others  Analyses of medication utilization patterns and the potential impact of utilization on outcomes  EHR data could be used as historical controls  For clinical trials as well as for health economic assessments  Validation of models  …

8. 8 Potential risks  Related to legal, privacy as well as regulatory issues  EHR are data collected for individual health care and not as tool for researchers (or other interested parties)  Access of non-authorised parties to EHR via hacking  Data quality  Regulatory acceptability

9. 9 Potential risks - legal/privacy point of view  EHR are data collected for created for individual health care and not as tool for researchers (or other interested parties)  Access to these sensitive data may lead to anxiety that patients are considered a “transparent patient” (even if data are “anonymised”, e.g. in case of rare diseases patients may easily be traced back)  Uncertainty where these data end up and what is done with them  Access of non-authorised parties to EHR via hacking

10. 10 Potential risks - regulatory point of view  Data quality may be low  Incorrect - since the capture of these data are not controlled and verified according to GCP  Incomplete – since they were collected for other purposes  Big amount of data with high variability  Regulatory acceptability questionable due to mixed quality of data  Results from such analyses can only be supportive in registration procedures

11. 11 Prerequisites - Industry standpoints & principles Secondary use of EHR should be guided by following principles:  Proper management of pseudonymised, anonymised, and aggregated information  Management of patient consent  Governance arrangements of security & confidentiality of data  Supporting cultural and good practice issues  Transparency and openness

12. 12 Questions to be solved  What data shall be in EHR? What about inclusion of genomic data?  Should industry have direct access to EHR? If so, to all available information?  Or access to EHR data via a 3rd party? Who is the 3rd party? Can it be a commercial entity?  How to manage informed consent with patients?  Shall patients have reading and editing rights for EHR?  Who owns the data in EHR and the derived analyses?

13. 13 Proposals for possible solutions - relating to privacy issues  Give researchers/industry access to EHR data via non- commercial 3 rd parties.  3 rd party  May be responsible to secure data privacy (via “anonymisation”)  May be responsible to obtain informed consent (via contact with doctors if necessary)  Could play the role of a broker, i.e. run searches & investigations on specific requests and get paid for that  Establish system for secure access to data  Via electronic signatures, passwords, data encryption etc.

14. 14 Proposals for possible solutions - relating to data quality  Promote uniform standards for collecting data for EHR across Europe and quality assurance  Systems need to be validated to ensure high quality  Link different systems in Europe  To prevent illegal data hacking: virtual health records, which build themselves up (“on the fly”) in the system as soon as they are requested

15. 15 Summary  Huge potential for medical research and safety surveillance via use of EHR data  Learn more about epidemiology of diseases  Save time and resources for faster development of medicines  Improvement of current pharmacovigilance system  There are lots of questions, but also many possible solutions  Industry is fully aware of the sensitivity of the use of patients’ health data and its responsibility in this field

16. 16 Conclusion  Primary and secondary use of EHR matters all  We need a thorough public debate with all stakeholders  We need to find constructive proposals for the safe use of EHR  Industry should agree on a codex on how to deal with these sensitive data

17. For attention and your questions. For input to this presentation from the EFPIA EHR Task Force and my colleagues with Novartis. THANK YOU