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While the European Union edges timidly towards updating its rules on clinical trials (of which more news in my next View from Brussels column in ACT), a further legislative complication is arising on data protection.
In late February one of the key committees in the European Parliament gave its backing to a proposal to update the EU's 1995 data protection rules. No one doubts that these rules need to brought into line with the transformation that the last couple of decades have brought to data collection, handling and storage. But the focus on data privacy could lead to new barriers emerging for clinical trials if the new rules fail to take account of the special needs of medicines development.
Already, the medical and scientific communities are mobilizing to seek the right balance between the protection of personal data and the need for some elements of patient data to circulate in the interests of science.
Europe's doctors – represented by the Standing Committee of European Doctors – were quickly into the fray. They showed broad support for the proposed new rules, but did raise some concerns over details on consent. While backing the principle of strengthening the subject’s consent as regards secondary use of health data, such as clinical audits and research, they urged that in "collecting and sharing of patient information in support of healthcare within a defined healthcare team," implied consent should be as acceptable as written consent. They also favoured some exceptions for health data in respect of subjects' “right to be forgotten,” because "healthcare data should be stored, with the appropriate security standards, in order to support future patient’s safety and also allow proving the medical treatments and decisions made by any European physician, with the highest degree of legal certainty and accountability."
Some organizations have been pushing even harder for the right balance, particularly for clinical trials. The European Alliance for Personalized Medicine this week warned that, "much research will simply be brought to a halt if specific informed consent is required each and every time data already acquired are to be consulted."
Similarly, it said, "excessive regulatory restrictions on the registries and biobanks that contain such data will make it impossible to carry out the comparisons that have to be made to answer research questions."
There is also anxiety that confusion between genetic data and health data may be influencing the debates, posing further risks to research efforts from superfluous legislation. The ability to transfer data across borders in international collaborative research is also under threat if the debate goes the wrong way, says the alliance.
The vote in the parliament’s committee on industry and research was immediately greeted by the European Commission – which is the progenitor of the text under discussion – as, "the latest step towards a swift adoption of the proposed legislation."
Other parliament committees, on employment and on civil liberties, will debate the matter further, and take a vote at the end of April. The full parliament is likely to reach a final opinion before the summer break.
Viviane Reding, the European commissioner responsible for the subject, says the proposed reform is, "good for business in Europe" because it will provide one uniform data protection law across the 27 EU member countries. In her view, it will, "help to boost economic growth, innovation and job creation in Europe" – but will also "ensure effective protection of people’s personal data." The Commission's principal aims with its proposal are "to strengthen online privacy rights and boost Europe's digital economy" – so it is an uphill struggle for the clinical trials community to win support from legislators with a very different view of the priorities in data protection.