10 Dec 2020
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The Spring of 2014 saw the European Parliament vote on an EU propo sal for a General Data Protection Regulation (DPR), which is currently being negotiated among the institutions. Once the text has been agreed it will et the rules for handling personal data in the 28 Member States.
All EAPM stakeholders and the larger medical and scientific community feel that this text, if finalised in its current form, will severely harm research, may become a barrier to achieving optimal transparency in medical and specifically clinical research and could make clinical trial data sharing practically impossible.
EAPM believes it is vital that our doctors have access to the best information and diagnostic techniques available. Today's emerging technologies, such as analytics tools for "Big Data", can help healthcare professionals improve diagnoses and reshape the way medicine is practiced.
The EU regulation should aim to better coordinate and facilitate the international research by clarifying laws applicable in each case and, similarly, to the coordination applicable to international clinical trials. Such a provision will reinforce and harmonise measures already in place while fostering research and innovation.
EAPM strongly urges MEPs to ensure that the Regulation is appropriately amended to permit the primary and secondary use of data for health research purposes bearing in mind the safeguards already in place.
For more information on the activities of this initiative, please contact Denis Horgan, Executive Director