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New EC directive threatens life-saving trials

Letter: Evaluation of treatments is threatened by EC directive, BMJ Volume 325, p 222


Europeans should wake up to the threat of a new European Directive, which will make many potentially life-saving studies performed in emergency medicine impossible, warn researchers in this week's BMJ.

The Directive could stop trials of treatments for patients rendered suddenly mentally incapacitated by, for example, cardiac arrest, head injury, or stroke because many of these patients are in no position to give the consent that the directive demands for entry into a clinical trial, write the authors.

Sadly, in Scotland such trials may already be impossible, they add. The Adults with Incapacity (Scotland) Act, 2000 requires consent from the adult's proxy or next of kin; this is despite numerous attempts over four years by medical researchers to explain the consequences of this restriction to the lawyers drafting the bill.

Europeans should wake up to the threat to the evaluation of treatments for millions of future patients, say the authors. The lawyers and politicians must sort out just whose interest they are protecting when framing European legislation, they conclude.


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