Article originally published in Scrip Regulatory Affairs, June 2012
With off-label drug use in the EU moving into the regulatory spotlight, it is becoming clear just how limited member states are in their power to stimulate – or indeed allow – the practice.
Off-label use of medicines always used to be somewhat in the shadows in terms of pharmaceutical legislation and there were almost no discussions at EU level on the conditions under which it should be permitted. At national level, there have been treatment guidelines, general professional recommendations and reimbursement decisions or recommendations, but these only provide partial and often ad hoc regimes. More recently, however, various EU developments have brought the topic to the fore and provide some elements of more common EU principles.
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