The EFPIA Perspective on the GDPR. Brendan Barnes, EFPIA 2 nd Nordic Real World Data Conference , Helsinki
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1 The EFPIA Perspective on the GDPR Brendan Barnes, EFPIA 2 nd Nordic Real World Data Conference , Helsinki 1
2 Key Benefits of Health Data Improved decision-making Patient self-management CPD More Personalised care Empowerment to engage in decision-making New types of analysis Stronger evidence base For funding Health service planning, demand management, commissioning, Pharmacovigilance, HTA, reimburseme R&D efficiencies, improved response To patient need, rational reimbursement, New industries - analytics
3 Presentation Summary GDPR Legal context of GDPR Scope of GDPR Key provisions relating to research The national dimension The Digital Single Market Finding the way forward Closing questions 3
4 Legal Context ECHR article 8 (excerpt) Everyone has the right to protection of personal data concerning him or her Such data must be processed fairly for specified purposes and on the basis of the consent of the person concerned..everyone has the right of access to data which has been collected concerning him or her, and the right to have it rectified Art 16(2) of the TFEU allows the EU to introduce legislation addressing the free movement of personal data 4
5 What kind of data are we talking about? Personal Data both directly-identifiable and in coded form Clinical Trial data Data extracted from biobank samples Pharmacovigilance data Medical records Prescription data Consumer data Patient-reported data E-health data M-health data Organisational data (employees, etc) Customer / HCP data 5
6 Health Data (under the Regulation) Definition: data concerning health means any information which relates to the physical or mental health of an individual, or to the provision of health services to the individual; Principles (article 5) Legal basis for processing (Article 6) The processing of personal data, and the processing of genetic data or data concerning health. shall be prohibited. (article 9) Safeguards (Article 89) 6
7 Definitions of re-use of data Primary Use Secondary Use Compatible Use Non-compatible use (Further Use) Processing to support the purpose for which data was gathered A subsequent use of data after the primary use A secondary use for which no new legal basis is required A secondary use that is noncompatible, for which a new legal basis is required, unless a derogation applies (eg: for scientific research) 7
8 Primary Use Scientific Research purposes Art 6.1a,c,e or f + Art 9.2 a or j + art
9 Primary Use Scientific Research purposes Art 6.1a,c,e or f + Art 9.2 a or j + art 89.1 Compatible Use Secondary Use Art
10 Primary Use Secondary Use Scientific Research purposes Art 6.1a,c,e or f + Art 9.2 a or j + art 89.1 Compatible Use Further Use Art 5.1 b + Art 89.1 Art
11 Primary Use Secondary Use Scientific Research purposes Art 6.1a,c,e or f + Art 9.2 a or j + art 89.1 Compatible Use Further Use Art 5.1 b + Art 89.1 Other Purposes Art 6.1a-f + Art 9.2 a-i Art
12 Primary Use Secondary Use Scientific Research purposes Art 6.1a,c,e or f + Art 9.2 a or j + art 89.1 Compatible Use Further Use Art 5.1 b + Art 89.1 Further Use Other Purposes Art 6.1a-f + Art 9.2 a-i Art. 6.4 Art 6.1 a,c or e+ Art 9.2 a,g, h, i 12
13 Primary Use Secondary Use Scientific Research purposes Art 6.1a,c,e or f + Art 9.2 a,i or j + art 89.1 Compatible Use Further Use Art 5.1 b + Art 89.1 Further Use Other Purposes Art 6.1a-f + Art 9.2 a-i Art. 6.4 Art 6.1 a,c or e+ Art 9.2 a,g,h,i 13
14 EFPIA supports harmonisation of requirements for research Harmonised data requirements will enhance cross-border research and enhance the development of pan-european research networks Larger data sets facilitated by harmonised data privacy requirements will enable research into rare diseases and personalised medicines Re-using and sharing healthcare data reduces unnecessary and redundant research Enhances healthcare including use of medicines Individuals are usually supportive of data-sharing with appropriate safeguards
15 The National Dimension Recitals 33,34,53,159,161 Articles1,4,5,6,9,13,14,15,16,17,18,19,20,21,22,32,34,89 Recitals and articles where the national perspective may shape the GDPR impact on research 15
16 The Regulation allows Member States to adjust the rules to local preferences Room for national rules Definitions to be clarified Additional conditions For processing genetic data, e.g., development of particular safeguards Health data Recital suggests broad interpretation, but legislative definition is less clear Further limitations Derogations to subject s rights For processing health data, e.g., processing limited to certain types of entities or purposes Data subject s right to be forgotten, right of access, etc., e.g. for scientific research Scientific research Recital suggests broad interpretation, including privately sponsored research, but no definition in actual legislation Consent requirements Exact scope of consent and possibility of opt-outs, e.g. for clinical trials Public interest Left to Member States to define The GDPR failed to harmonise rules across the EU and may not improve on existing disharmony
17 Raising a number of questions for key use cases of health data Use case Data needed Open questions Biomarker identification Requires large-scale processing of genetic data Which safeguards will be deemed acceptable for genetic data? Which additional limitations/ conditions could Member States impose? Identification of trial participants Can be performed based on electronic medical records Will preparation of a trial be considered scientific research? Will Member States views on this differ? Continuous patient monitoring Outcomes-based reimbursement Requires continuous mining of medical records and claims data for adverse events Calculation of the reimbursement amount can be based on a registry What additional limitations or conditions could Member States impose? Is there an appropriate legal basis for outcomes-based reimbursement? Will new rules have to be created and what conditions will they impose?
18 In Summary The better use of healthcare data will improve patient outcomes, make our healthcare systems more sustainable, drive innovation in research and help Europe to remain a centre for investment in medical research. The ability to capture and share personal health data among researchers will advance the understanding of diseases. Allowing re-use of data will avoid duplication of studies, guarantee the verification of clinical trials results and enable individuals who wish to, to share their data to benefit others with the same or other medical conditions. Robust and harmonised rules in Europe on the processing and use of patient data will reduce delays and duplication allowing new medicines to be developed and brought to market quickly for the benefit of patients. This will lead to better outcomes for individual patients, improve population health in general, contribute to the sustainability of health systems and preserve the EU s place as a global centre of research The industry and its partners are pioneering new uses of data. We recognize the need for this work to proceed in tandem with enhanced technical safeguards and forms of accountability to those whose data we use. We call on the member states to commit to the development of an aligned approach to these issues and to avoid undermining such efforts through an uncoordinated implementation of the research provisions of the General Data Protection Regulation. 18
19 19
20 type status relevance GDPR Legislation In effect 5/18 Research provisions VBOC International data transfers E-privacy Legislation Adopted 1/17 Transmission of information IMI Do-it Stakeholder solution Minimum consent standards EMA disclosure policy Policy Technical standards standards development Stakeholder solutions Various initiatives Anonymisation, consent, pseudonymisation Building a European digital economy Digital transformation of healthcare in the context of the digital single market type status relevance consultation Concludes Q normally followed by legislative proposals Free movement Ownership Access Liability Data portability Communication Consultation until oct 12 Reference networks/communicable disease surveillance/ E- prescriptions Digital Health Society Presidency Initiative Key event is conference on Oct Coalition of the willing M-health code Code of conduct Under review Code for apps developers E-Health network 20
21 Health Data Member state health data initiatives Type Status relevance Normally to advance public health Council of Europe Political/policy guidance On-going Research ethics and data protection OECD health data governance Political/policy guidance Policy framework adopted 1/17 Comprehensive framework for governance * ** *** 21
22 PATIENT- GENERATED DATA CLINICAL RESEARCH BIOBANKS SECURE SPACE FOR RE-USE OF DATA CONSUMER DATA Multiple initiatives Flexible approach appropriate to research consortia Needs-driven data sharing HEALTHCARE DATA Privacy controls Ethical oversight Accountability
23 Challenges with re-use of patient level data Data gaps Missing data elements (e.g. outcomes) Studies require details that may not be routinely collected Coding often only at first level (e.g. ICD-9) therefore missing granularity 80% of info stored as unstructured data Semantics Many standards many versions Complex care many HCP s involved many hand-overs Need to pool data cross sites and cross different countries Pharma focused on CDISC Data quality Longitudinal coherence Coding for administrative reasons (up down coding) Coding often months after patient encounter Data provenance who entered the data? Privacy Clearly a top priority Different interpretations by country, by region complex TRUST
24 Harmonisation EU-MS dialogue (Expert Committee) Support best practice in implementation Guidance from the Article 29 Committee Harmonised practices within European networks Political aspect lead the debate
25 GDPR & Codes GDPR emphasises self-regulation Codes are one option certification, standards, BCR s Codes Article 40 Encouragement to draw up codes Scope of codes Approval and legal effect Monitoring of approved codes Competences and accreditation of supervisory body 25
26 BBMRI code of conduct: GDPR implementation is complex GDPR is not alone in the EU s plans for digital Code approach is a good basis for collective engagement and external accountability endorsed by the Commission 26
27 How do we align approaches to reuse of data? If there are choices/trade-offs to be made to ensure public acceptability of uses of data, which considerations are most important? Who should be responsible for shaping data governance arrangements? Can we have European harmonization and National approaches at the same time? What is the most important factor driving the expansion of the re-use of data? How do you engage citizens? 27
28 Thank You 28
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