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“Processing of sensitive data for historical, statistical and scientific research purposes is not as urgent or compelling as public health or social protection," says a report on data protection currently under discussion in the European Parliament. This report is no anodyne academic exercise. It is the latest stage in the day-to-day data drama being played out in Brussels at present. It forms part of the European Union's deliberations on how to update its twenty-year-old rules on data privacy. It has been drawn up by a German Green group MEP, Jan Albrecht, who has been put in charge of the parliament's input to the new rules. I am aware that this blog has already covered the subject recently, but this is a rapidly moving picture.
Even the European Patient's Forum, which is profoundly protective of patients' rights to protect their personal data, believes this goes too far in terms of protection. The Forum has consistently insisted that patients must be considered as data subjects and as owners of their health and genetic data, and is seeking guarantees in the new legislation that will enable patients to benefit from their rights effectively. It congratulates itself that the Albrecht report has taken some of these concerns on board. Albrecht explicitly refers to the right to informed consent in healthcare, which the Forum welcomes, "as in healthcare and research the processing of personal health and medical data is inextricably linked with the patient’s right to informed consent," it says. The report's strengthened requirements for transparency and information to data subjects are also welcomed, as are its insistence on the right to data portability, to make it possible for data subjects to have access to their data in a common format, or to have them transferred.
But the report's tough approach to research data is excessive, says the Forum, because it fails to recognize the value of the use of patients’ data for research purposes. "Health research is invaluable for the patient community," it said in late March, calling on the parliament to ensure that special exemptions are provided that would allow processing of such data.
And if the patients' organizations are hesitant over the intended rigour, their reservations are as nothing to those being expressed by researchers. An outraged Françoise Meunier, head of the European Organization for Research into Treatments for Cancer, claimed that over-regulation was threatening to stifle research. She was disconcerted by reports that draft amendments from the European Parliament were aiming to tighten up data use in clinical trials too, with recommendations that patient data should be destroyed five years after a trial is concluded. This, she said, would make it impossible to conduct long-term follow-up or retrospective studies.
The picture continues to move. More than 3,500 were tabled to draft legislation, and compromises must be found between opposing camps before the report is voted on in committee at the end of May. "I am optimistic that we will succeed in a common European Parliament position covering almost all fields," said Albrecht. Researchers are watching closely to see if his optimistic appraisal applies to their interests, too.