How do We Improve Health without Betraying Confidentiality within

EFGCP Annual Conference 2015
How do We Improve Health without
Betraying Confidentiality within Current
and Upcoming EU Regulations?
What is the cost of maintaining patient confidentiality in health research?
27 & 28 January 2015
Crowne Plaza Le
Palace, Brussels,
Belgium
Organised by the
In Partnership with
European Forum for Good Clinical Practice
[email protected] - www.efgcp.eu
EFGCP Annual Conference 2015 on
How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?
27 & 28 January 2015 – Crowne Plaza Le Palace, Brussels, Belgium (Preliminary Programme 14-12-12)
Conference Rationale
For twenty one years the European Forum for Good Clinical Practice has acted as a forum to bring patients, researchers,
sponsors, competent authorities and ethics committees together and debate current topics. It is one of the most important
fora for multi stakeholder debate. In the 2015 Annual Conference we will debate the tensions between confidentiality and
data access in health research. It will provide an opportunity to hear up to date information from experts involved, listen to
differing viewpoints, particularly those of patients and patient groups whose voice must be central in this debate. It will also
present opportunity to consider current solutions.
The importance of personal data in health care research is acknowledged within the new EU Clinical Trial Regulations but
some have claimed this could be seriously damaged by proposed Data Protection Regulations
“We, the undersigned European research organisations, believe it is vital that regulation strikes an appropriate balance to
protect the interests of individuals while enabling research that benefits all society. The European Union is at risk of getting
this dangerously wrong, and the Council of Ministers and European Commission must take steps to ensure that this does
not happen. “
http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/WTP055585.
pdf
It is also evident that misunderstandings exist even within member states. Our conference will seek to strike a balance in
answering the key questions “How can we protect privacy without undermining work toward better health? Where is the fair
balance?”
The tangible outcomes will be an EFGCP report and recommendations that will be provided to those involved in the
legislative process. Given how important it is to store and reuse research data, one plenary session will debate the
following statement on the secondary use of data.
Recent major progress in our understanding and measurement of different aspects of health and disease holds the
promise for better treatments. Much of this is built on the use of personal data (health records, payer or research
databases) and continuing access will be essential to further health care improvements.
To allow this progress and consequent benefit, patients should, wherever possible, be able to provide “broad
consent”* for future use of their tissue or data in research.
*“Broad consent” means that the details of new research in the future are not precisely specified at the time of consent. It
is consent that does not define the exact nature of future work but may indicate the areas of interest and the limitations
of use
“Broad consent” would allow future research to take place without exact definition of the research project at the time of
consent, provided that the research has been reviewed and approved by a Research Ethics Committee and that
appropriate governance arrangements and privacy safeguards are in place.
Programme Committee
Hugh Davies
Insa Bruns
Anna Chioti
Lode Dewulf
Nicky Dodsworth
Robert Frost
Yves Geysels
Sarah Hills
Laurence Hugonot
Health Research Authority (HRA), EFGCP, United Kingdom
Central Office of the KKS-Network, Germany
CRP Santé, Luxembourg
UCB, Belgium
Premier Research, EFGCP, United Kingdom
GlaxoSmithKline, United Kingdom
Quintiles, EFGCP, Belgium
EURADIA, United Kingdom
Broca Hospital, France
Page 2 of 8
EFGCP Annual Conference 2015 on
How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?
27 & 28 January 2015 – Crowne Plaza Le Palace, Brussels, Belgium (Preliminary Programme 14-12-12)
Heinrich Klech
Ingrid Klingmann
Olga Kubar
Rick Lilley
Marianne Maman
Anastassia Negrouk
Achenyo Ochuma
Heather Sampson
Mark Taylor
Beth Thompson
PharmaTrain, EFGCP, Austria
Pharmaplex, EFGCP, Belgium
Institut Pasteur, EFGCP, Russia
Vertex Pharmaceuticals Incorporated, United States
Novartis Pharma, Switzerland
European Organisation for Research & Treatment of Cancer (EORTC), Belgium
Association of the British Pharmaceutical Industry (ABPI)
University of Toronto, Office of Research Toronto East General Hospital, Canada
Confidentiality Advisory Group, University of Sheffield, United Kingdom
Wellcome Trust, United Kingdom
Faculty
Timo Ahland
Nicola Bedlington
Insa Bruns
Kim Champion
Hugh Davies
Nicky Dodsworth
Yves Geysels
Emma Greenwood
Steve Hitchins
Heinrich Klech
Ingrid Klingmann
Flaminia Macchia
Ronnie Moore
Wim Nauwelaerts
Anastassia Negrouk
Gérard Nguyen
Heather Sampson
Sebastian Semler
Daniel Strech
Paul Strickland
Mark Taylor
Beth Thompson
Jill Turner
Florian von Raison
Frank Wells
Beat Widler
Eva Winkler
Boehringer-Ingelheim, EFPIA Data Protection Working Group, Germany
European Patients’ Forum, Belgium
Central Office of the KKS-Network, Germany
University College London (UCL), EFGCP, United Kingdom
Health Research Authority (HRA), EFGCP, United Kingdom
Premier Research, EFGCP, United Kingdom
Quintiles, EFGCP, Belgium
Cancer Research UK, United Kingdom
EURADIA & Juvenile Diabetes Research Foundation UK (JDRF UK), United Kingdom
PharmaTrain, EFGCP, Austria
Pharmaplex, EFGCP, Belgium
EURORDIS, Belgium
Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE),
Ireland
Hunton and Wiliams, Belgium
European Organisation for Research & Treatment of Cancer (EORTC), Belgium
Rett Syndrome Europe, France
University of Toronto, Office of Research Toronto East General Hospital, Canada
TMF – Technology, Methods, and Infrastructure for Networked Medical Research,
Germany
Hannover Medical School (MHH), Germany
Strickland Quality Assurance, EFGCP, United Kingdom
University of Sheffield, Confidentiality Advisory Group, United Kingdom
Wellcome Trust, United Kingdom
Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE),
Ireland
Novartis Pharma, EFGCP, Switzerland
Lead Advisor on Integrity Fraud and Misconduct, UK Health Research Authority, United
Kingdom
Widler & Schieman, ACRES, Switzerland
Medical University of Heidelberg, Germany
Page 3 of 8
EFGCP Annual Conference 2015 on
How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?
27 & 28 January 2015 – Crowne Plaza Le Palace, Brussels, Belgium (Preliminary Programme 14-12-12)
Conference Language
The language of the Conference will be English.
Registration & Information
E-mail [email protected] or visit www.efgcp.eu
Conference Venue
Crowne Plaza Le Palace
Rue Gineste 3
1210 Brussels, Belgium
Tel: + 32 (0)2 203 62 00 – Fax: +32 (0)2 203 55 55
Website: http://www.ihg.com/crowneplaza/hotels/gb/en/brussels/brube/hoteldetail
Support the conference with corporate or institutional sponsoring
EFGCP has decided to open sponsoring opportunities - both corporate with companies and institutional with universities,
NGOs and associations - to support this key discussion. Contribute to the success of this event while interacting directly
with all major stakeholders involved in clinical research, sharing your opinions with peers and renowned experts, and being
among the first to learn about the latest development on the topic! Ask for detailed information to [email protected].
Page 4 of 8
EFGCP Annual Conference 2015 on
How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?
27 & 28 January 2015 – Crowne Plaza Le Palace, Brussels, Belgium (Preliminary Programme 14-12-12)
Programme
Tuesday 27th January 2015
08:15
Registration and Welcome Coffee
09:00
Welcome
Ingrid Klingmann, Pharmaplex, EFGCP, Belgium
PLENARY SESSION 1
DATA: THE CLINICAL TRIAL REGULATION
AND THE PROPOSED DATA PROTECTION REGULATION
Chairpersons: Steve Hitchins, EURADIA & Juvenile Diabetes Research Foundation UK (JDRF UK), United Kingdom &
Sebastian Semler, TMF – Technology, Methods, and Infrastructure for Networked Medical Research,
Germany
09:05
Why access to personal data is important, definitions, current controversies and difficulties
Hugh Davies, Health Research Authority (HRA), EFGCP, United Kingdom
09:15
Data and the Clinical Trial Regulation
Insa Bruns, Central Office of the KKS-Network, Germany
09:35
Research and the proposed EU Regulation on Data Protection
Beth Thompson, Wellcome Trust, United Kingdom
09:55
How does the law approach identifiability and anonymisation?
Mark Taylor, University of Sheffield, Confidentiality Advisory Group, United Kingdom
10:15
Questions & Discussion
10:40
Coffee Break
PLENARY SESSION 2
PATIENT VIEWS AND EUROPEAN CONSIDERATIONS
Chairpersons: Jan Geissler, European Patients' Academy on Therapeutic Innovation (EUPATI), Germany & Yves
Geysels, Quintiles, EFGCP, Belgium
11:10
Patients’ perspectives on use of their data
Nicola Bedlington, European Patients’ Forum, Belgium
11:30
Empirical studies on patient views on genetic data usage
Eva Winkler, Medical University of Heidelberg, Germany
11:50
Current Data Protection arrangements for research: an EFGCP survey across the EU and beyond
Kim Champion, University College London (UCL), EFGCP, United Kingdom
12:10
Questions & Discussion
13:15
Lunch
Page 5 of 8
EFGCP Annual Conference 2015 on
How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?
27 & 28 January 2015 – Crowne Plaza Le Palace, Brussels, Belgium (Preliminary Programme 14-12-12)
BREAK-OUT SESSIONS - WORKSHOPS 1-2-3
14:15
Workshop 1:
Data access issues for Clinical Trials of Investigational Medicinal Products
and subsequent research
Chair: Wim Nauwelaerts, Hunton and Wiliams, Belgium
Rapporteur: Nicky Dodsworth, Premier Research, EFGCP, United Kingdom
Workshop 2:
Confidentiality and the proposed Data Protection Regulations in pandemic
research: challenges and issues
(Organized by the PREPARE FP7 funded consortium http://www.prepare-europe.eu/)
Chair: Ronnie Moore, Platform for European Preparedness Against (Re-)emerging
Epidemics (PREPARE), Ireland
Rapporteur: Jill Turner, Platform for European Preparedness Against (Re-)emerging
Epidemics (PREPARE), Ireland
Workshop 3:
Data access, tissue banks and databases
Chair: Sebastian Semler, TMF – Technology, Methods, and Infrastructure for Networked
Medical Research, Germany
Rapporteur: Florian von Raison, Novartis Pharma, EFGCP, Switzerland
15:45
Coffee Break
16:15
Feedback from Workshops 1-2-3
Chair: Heather Sampson, University of Toronto, Office of Research Toronto East General Hospital,
Canada
PLENARY SESSION 3
THE JOSEPH HOET LECTURE ON ETHICS IN CLINICAL RESEARCH
Chairperson: Ingrid Klingmann, Pharmaplex, EFGCP, Belgium
16:45
Clinical Research in the EU
Speaker invited
17:15
EFGCP Annual General Meeting (for EFGCP Members)
18:30
EFGCP Annual Conference Social Event
Page 6 of 8
EFGCP Annual Conference 2015 on
How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?
27 & 28 January 2015 – Crowne Plaza Le Palace, Brussels, Belgium (Preliminary Programme 14-12-12)
Wednesday, 28th January 2015
08:30
Welcome Coffee
PLENARY SESSION 4
FAIR USE OF DATA IN RESEARCH: ACHIEVING A FAIR BALANCE
Chairperson & moderator: Heather Sampson, University of Toronto, Office of Research Toronto East General Hospital,
Canada
09:00
‘On the governance of “sufficient” confidentiality in research to ensure public trust.’
Daniel Strech, Hannover Medical School (MHH), Germany
09:30
Oxford Debate on Data Protection in Research with questionnaires and contributions from the
audience
For the motion: Emma Greenwood, Cancer Research UK, United Kingdom
Against the motion: (invited)
This house believes that:
To allow healthcare progress and consequent benefit, patients should, wherever possible, be able
to provide “broad consent”* for future use of their tissue or data in research.
Recent major progress in our understanding and measurement of different aspects of health and disease
holds the promise for better treatments. Much of this is built on the use of personal data (health records,
payer or research databases) and continuing access will be essential to further health care improvements.
*“Broad consent” means that the details of new research in the future are not precisely specified at the time
of consent. It is consent that does not define the exact nature of future work but may indicate the areas of
interest and the limitations of use
“Broad consent” would allow future research to take place without exact definition of the research project at
the time of consent, provided that the research has been reviewed and approved by a Research Ethics
Committee and that appropriate governance arrangements and privacy safeguards are in place
10:20
Summary
10:30
Coffee Break
BREAK-OUT SESSIONS - WORKSHOPS 4-5-6
11:00
12:30
Workshop 4:
How broad can consent be?
Chair: Heinrich Klech, PharmaTrain, EFGCP, Austria
Rapporteur: Beth Thompson, Wellcome Trust, United Kingdom
Workshop 5:
Who should be allowed unconsented access to our data?
Chair: Mark Taylor, University of Sheffield, Confidentiality Advisory Group, United Kingdom
Rapporteur: Paul Strickland, Strickland Quality Assurance, EFGCP, United Kingdom
Workshop 6:
Rare diseases and issues of identification
Chair: Flaminia Macchia, EURORDIS, Belgium
Rapporteur: Gérard Nguyen, Rett Syndrome Europe, France
Lunch
Page 7 of 8
EFGCP Annual Conference 2015 on
How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?
27 & 28 January 2015 – Crowne Plaza Le Palace, Brussels, Belgium (Preliminary Programme 14-12-12)
13:30
Feedback from Workshops 4-5-6
Chair: Frank Wells, Lead Advisor on Integrity Fraud and Misconduct, UK Health Research Authority,
United Kingdom
PLENARY SESSION 5
SOLUTIONS: ACHIEVING A FAIR BALANCE
Chairpersons: Anastassia Negrouk, European Organisation for Research and Treatment of Cancer (EORTC), Belgium
& Co-chairperson invited
14:00
The EMA position on data protection and confidentiality
Speaker invited
14:20
Health Data Cooperatives: How the Empowerment of Citizen can overcome the access to Health
Data Conundrum
Beat Widler, Widler & Schieman, ACRES, Switzerland
14:40
A view from Pharma
Timo Ahland, Boehringer-Ingelheim, EFPIA Data Protection Working Group, Germany
15:00
Questions & Discussion
15:30
Summary & Conclusions from the Conference
15:40
End of the Conference
Page 8 of 8

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