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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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.