Research & Innovation International Rare Disease Consortium: Data Sharing Policy 3 rd International Traumatic Brain Injury Research Meeting Catherine BERENS Head of Sector Neuroscience Medical research and the challenge of ageing Unit DG Research & Innovation European Commission

Research & Innovation Goals of IRDiRC 200 new therapies for rare diseases by 2020 Means to diagnose most rare diseases by Images courtesy of FreeDigitalPhotos.net

Research & Innovation Basic principles of IRDiRC Co-operation at international level to stimulate, better coordinate & maximise output of rare disease research efforts around the world Teams up public and private organisations investing in rare diseases research Research funders with relevant programmes >$10 million US over a 5-year period can join & work together Each organisation funds research its own way Funded projects adhere to a common framework 3

Research & Innovation − 1 representative per funding body or group of funders − Representatives of umbrella organisations of patient advocacy groups − Chairs of the Scientific Committees Around 15 top-level experts with balanced representation of scientists, patients, industry, etc. Representatives of funded projects Executive Committee InterdisciplinaryTherapeuticsDiagnostics Scientific Committees Working Groups Ethics & governance Biobanks Registries & natural history Bio- informatics and data sharing Biomarkers Small molecules Repurposin g Bio- technology Regulatory OntologiesSequencing Model systems Genome/ phenome

Research & Innovation Policies Collaborative research: sharing resources, data and results among IRDiRC research projects; avoiding duplication; making publicly available Involve patients (or representatives) in all relevant research aspects International, national, regional and local legislation/regulation to be adhered to (data protection; ethics approvals) Generalized principles

Research & Innovation Guidelines Consider impact of research on patients as key: best ethical practices to ensure interest of individuals Disseminate and make available information about IRDiRC and IRDiRC projects Education, training and awareness of stakeholders to be encouraged by IRDiRC Generalized principles

Research & Innovation Policies Research projects should adhere to standards endorsed by IRDiRC Data producers acknowledge their responsibilities to (i) release data rapidly and (ii) publish initial analyses in a timely manner. IRDiRC members will encourage and facilitate rapid data release. Data sharing & standards Guidelines Data generated from research projects, incl. source data, to be deposited in appropriate open or controlled-access public databases

Research & Innovation Clinical Trials Regulation Responds to criticism of previous EU Clinical Trials Directive: Single submission portal for multinational trials Joint assessment by Member states' competent authorities Tacit-approval deadlines Reduced administrative burden (low-risk trials) Adopted on 16 April 2014 Applicable as from 6 months after the EU portal and database are functional (not earlier than May 2016) EU legislation revision (I)

Research & Innovation Personal Data Protection legislative framework Proposal of the European Commission: 25 January 2012: update and modernise the principles enshrined in the 1995 Data Protection Directive (digital age) build on the high level of data protection in place in Europe Positive vote of European Parliament: 12 March 2014 Awaiting position of Council Moving from a Directive to a Regulation: one continent = one law, with effective sanctions Level-playing field: operate on EU market = stick to EU law Right to be forgotten Simplification: "one-stop-shop" EU legislation revision (II)

Research & Innovation How does this link to InTBIR? IRDiRC policies and guidelines are broad Could be adapted to be fit for purpose Important aspects of Collaborative research Involvement of patients/representatives Respect legislation Conclusions

Research & Innovation Thank you!