Proposed EU data protection regulation is a threat to medical research

The need to share data is being unanimously recognised as an urgent necessity in medical research, to better understand the natural history of diseases, to speed up the development of new treatments and to monitor the efficacy and effectiveness of existing treatments.
This is particularly true in the study of rare diseases (RD), where the number of patients that are known to a single centre, can be so small that it may impede any kind of inference.

Indeed, RD patients can draw great benefit from RD registries since where they exist, and are developed with high standards, there is evidence that quality of care and life expectancy improves dramatically (e.g., the European Cystic Fibrosis Society Patient Registry (1) or the TREAT-NMD Neuromuscular Network (2).

This is why there has been a flourishing of registration activities for RD patients, often promoted by patients associations (3). EU Member States have agreed on increased cooperation to support data sharing on RD and a number of European infrastructures have been or are being established to support the exchange of patient health data (e.g. the EPIRARE project (4) and RD-CONNECT (5).

Many authors have already expressed their concern about the deleterious effects that the new regulation may have on medical research (6,7,8,9). In rare diseases, missing the opportunity of exploiting and sharing the small amount of data that are collected, will dramatically delay the improvement of health care of RD patients. De facto, it would result in discrimination of RD patients regarding their right to quality health care and will pose a serious ethical problem to the EU and national Institutions.

Health data are precious to many other aims and debate has already started on how to use the Big Data, the exponentially increasing wealth of data residing in web servers, which might connect health data, including Electronic Health Records, with other data posted individually on internet, resulting from mobile phones, devices or any other source of structured and unstructured information (10). Such research may possibly result in health improvement. However, its health aims, data controllers and beneficiaries are not clear yet even to its promoters and actors. This scenario suggests that individual specific informed consent may not protect effectively individuals’ privacy.

An online petition (11), closing by the end of next July, has been launched by the executive manager of EPIRARE, an EU-funded project aimed to prepare a European platform for RD Registries to be implemented within the services of the European Commission. The petition is proposing that more safeguards be set at the stage of data processing and dissemination thus avoiding the request of new forms of specific consent in retrospective research or just for similar research aims. This in fact will impact more on public and health research, which relies often on limited budgets and staff. The petition also proposes the use of pseudonymization in order to preserve the integrity of the data base, avoid duplicate records, and allow accountable merging of data and tracing of patient if needed.

We hope that the European Parliament agrees on the view that, although effective data protection safeguards should be established and strictly complied with, the solution should not affect responsible processing of data for health purposes. We think that the scientific community dedicated to the improvement of health and the progress of health knowledge, and the persons affected with diseases which are not yet curable, deserve that a balanced and effective solution is found in the European Parliament.

(1) Cystic Fibrosis Foundation Patient Registry http://www.ecfs.eu/
(2) TREAT-NMD Neuromuscular Network http://www.treat-nmd.eu/
(3) Orphanet. Disease Registries in Europe. Orphanet Report Series, Rare Diseases collection, January 2013. Available at: http://www.orpha.net/orphacom/cahiers/docs/GB/Registries.pdf
(4) www.epirare.eu
(5) http://rd-connect.eu/
(6) Mascalzoni D, Knopper BM, Ayme´S, Macilotti M, Dawkins H, Woods S, Hansson MG, Rare diseases and now rare data?, Nat Rev Gen 2013, doi:10.1038/nrg3494
(7) Editorial. Privacy in the digital age. Nature 497, 16 May 2013 doi:10.1038/497287a
(8) Wellcome Trust. Impact of the draft European Data Protection Regulation and proposed amendments from the rapporteur of the LIBE committee on scientific research. Available at:
http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtvm054713.pdf
(9) Ploem MC, Essink-Bot ML, Stronks K, Proposed EU data protection regulation is a threat to medical research. A suggested amendment would make most epidemiological and health research impossible. BMJ 2013;346:f3534
(10) Geissbuhler, A, Safran C, Buchan I, Bellazzi R, Labkoff S, Eilenberg K, Leese A, Richardson C, Mantas J, Murray P, De Moor G, Trustworthy reuse of health data: A transnational perspective. Int J Med Informatics, 82 (2013) 1–9
(11) http://www.change.org/en-GB/petitions/don-t-stop-research-on-rare-diseas...