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Crucial Directives Must be Revised to Protect Patients' Interests and Improve Access to Treatment
Date:9/1/2011

BRUSSELS, September 1, 2011 /PRNewswire/ --

The current revision of two European Directives that are crucial to successful research into blood-related diseases must ensure the safety of patients and enhance their access to vitally-important treatment.

This was a key message of a two-day conference, "Haematology and the next European decade", hosted by the European Parliament and attended by doctors, researchers, parliamentarians, patients' organisations and Commission officials.

The revision of the Clinical Trials Directive, which provides the regulatory framework for the testing of new drugs on humans, has reached its final stages before a draft law is proposed by the European Commission within the next few months, but some politically-sensitive issues still remain.

There is a clear consensus among all stakeholders that the existing processes are overly bureaucratic, costly and time-consuming. "If we want to keep modern scientific research in Europe, we need to modernise our Directive", said Philippe Juvin MEP, the European Parliament's rapporteur on the revision.

However, haematological researchers and patients' organisations insist that seeking to reduce costs and simplify the rules in order to encourage more clinical testing in Europe must not compromise patient safety.

Also, the changes must aim to reverse the economic pressure on independent academic research - "squeezing academic research into a commercial strait-jacket" - and so facilitate a rich source of new treatments for blood-related diseases, especially rare forms of cancer.

As part of its aim to highlight the positive impact of haematology research across a range of medical conditions, the conference - organised jointly by the European Cancer Patient Coalition and the European Hematology Association, the haematologists' organisation - also discussed today the ongoing revision of the 2005 Directive relating to professional qualifications.

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SOURCE European Hematology Association
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